QUALITY 
ASSURANCE 
GUIDELINES 
for 
Hernodialysis 
Devices 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Public Health Service 
Food and Drug Administration 
Center for Devices and Radiological Health  CDRH PUBLICATIONS - MEDICAL DEVICES 
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(flyer). 
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FDA 86-4209  An Introduction to Transcutaneous Electrical Nerve Stimulation:  TENS (PB 87- 
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FDA 86-4211  Hemodialysis Equipment and Practices in Massachusetts  (PB 86-242427/AS, 
$11.95). 
FDA 86-42 12  Protocol for the Study of Hemodialysis in Ohio (PB 86-245370/AS, $22.95). 
FDA 86-4213  State Participation in Dialysis System Investigation (PB 87-108825/AS, $24.95). 
FDA 87-4002  Impact Resistant Lenses:  Questions and Answers - June 1972 (FDA 81-4002) 
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FDA 87-4215  Orthopaedic Device Labeling -- Guideposts for Concerned Physicians (January 1987) 
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(Continued on inside back cover)  HHS Publication FDA 91-4161 
Quality  Assurance Guidelines for 
Hernodialysis Devices 
Douglas L. Vlchek, BA, CHT 
Sally Burrows-Hudson, MSN, RN, CNN 
Dialysis Management Incorporated 
Conifer, CO 
Nancy Pressly, Project Officer 
Office of Training and Assistance 
This work was carried out under FDA contract number 223-89-6021 
February 1991 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Public Health Service 
Food and Drug Administrat~on 
Center for Dewces and Rdd~olog~cHale alth 
Rockv~llM~,a ryland 20857  Foreword 
In October  1982,  the  Food  and  Drug Administration  established  the  Center  for 
Devices and Radiological Health (CDRH) by merging the Bureau of Medical Devices and 
the Bureau of Radiological Health. 
The Center develops and implements national programs to protect the public health 
in the fields of medical devices and radiological health.  These programs are intended to 
assure  the  safety,  effectiveness,  and  proper  labeling  of  medical  devices,  to  control 
unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation, 
and to ensure the safe, efficacious use of such radiation. 
The  Center  publishes  the  results  of  its work  in scientific  journals  and  in its  own 
technical reports.  These reports provide a mechanism for disseminating results of CDRH 
and contractor projects.  They are sold by the Government Printing Office and/or the 
National Technical Information Service. 
We welcome your comments and requests for further information. 
Acting Director 
Center for Devices 
and Radiological Health  Preface 
The Center for Devices and Radiological Health's  (CDRH) mission under the 1976 
Medical Device Amendments and the 1990 Safe Medical Devices Act  is to develop and 
implement national programs to protect the public from unsafe or ineffective medical 
devices.  One  important  aspect  of  the  Center's  activities  is  the  development  of 
educational  programs  for  health  professionals  and  consumers  in the  proper  use  of 
medical devices. 
Hemodialysis  is  a  critical  care  medical  technique  which  sustains  the  lives  of 
thousands of patients who suffer from acute or chronic kidney failure.  However, due to 
the inherent complexity and risk of thc  technique,  a few patients experience adverse 
events  which  are  avoidable.  Most  adverse  events  are  caused  by  user.error or  a 
combination of user  error and medical device  malfunction.  A  comprehensive device 
quality assurance program would help avoid many of these adverse events. 
This  publication,  "Quality  Assurance  Guidelines  for  Hemodialysis  Devices,"  is  an 
integral part of the Center's  educational program in hemodialysis.  It discusses quality 
assurance for water treatment equipment,  equipment used to evaluate the acceptability 
of the dialysate concentrate, dialysate delivery equipment with its associated monitors and 
alarms,  extracorporeal  blood components,  dialyzers,  dialyzer  reprocessing and  testing 
equipment, and all other equipment associated with the dialysis procedure. 
We hope that this manual will help dialysis facility personnel become more familiar 
with quality  assurance  procedures  for  dialysis  equipment.  The  manual will  assist  the 
facility in developing and implementing a facility-specific quality assurance program or in 
refining an existing quality assurance program.  Each chapter describes quality assurance 
methods and also provides examples of forms which can be adapted for each facility's 
specific needs. 
In addition to this manual,  the Center has published another  manual entitled "A 
Manual on Water Treatment for Hemodialysis" and has produced educational videotapes 
on various aspects of user safety in hemodialysis.  The videotapes have been produced as 
a cooperative effort among manufacturers,  professional associations, and the Center and 
were sent free of charge to each dialysis facility in the United States. 
For further information, please contact Ms. Nancy A.  Pressly (HFZ-240), Center for 
Devices and Radiological Health, 5600 Fishers Lane, Rockville, M- aryland 20857. 
- 
Joseph S. Arcarese 
Office of Training and 
Assistance 
iii  Acknowledgements 
Interim drafts of this manual were reviewed by the following individuals.  The authors are indebted 
to them for their careful and constructive reviews and many useful suggestions.  The reviewers are: 
Barbara Bednar, RN, CNN  Robert Fortner, MD 
Renal Treatment Centers  Bainbridge Island, WA 
Berwyn, PA 
Frank A Gotch, MD 
Lee Bland, MS  Ralph K. Davies Medical Center 
Centers for Disease Control  San Francisco, CA 
Atlanta, GA 
Consuelo F. Hill, BS, RN, CHN 
George Buffaloe, PhD  ESRD Network of New England 
CGH Medical, Inc.  New Haven, CT 
Lakewood, CO 
Martin V. Hudson, CHT 
Vera Buffaloe  V.A. Medical Center 
CGH Medical, Inc.  Palo Alto, CA 
Lakewood, CO 
Douglas Luehmann 
Larry M. Day, BA  Regional Kidney Disease Program 
Dialysis Management Inc.  Minneapolis, MN 
Golden, CO 
Donna Mapes, MSN, RN 
Martin Favero, PhD  Transpacific ESRD Network 
Centers for Disease Control  Sausalito, CA 
Atlanta, GA 
Mark Neumann 
Leroy J. Fishbach  Nephrology News and Issues 
MinntechIRenal Systems  King of Prussia, PA 
Minneapolis, MN 
Karen Stalla, RN 
Fresenius, Inc. 
Concord, CA  Acknowledgements (Cont.) 
During the initial research phase of this project a number of dialysis facilities, manufacturers, and 
other organizations were contacted and contributed information used in this manual.  The authors 
are indebted to them for their willingness to assist in this project and share their information. These 
contributors are: 
Abbott Laboratories  Health Care Financing Administration 
American Nephrology Nurses Association  Robert Wood Johnson University Hospital 
Amgen, Inc.  Joint Commission on Accreditation of 
Arnuchina  Healthcare Organizations 
Associates of Cape Cod  Mayo Clinic 
Association for the Advancement of  Medro Systems, Incorporated 
Medical Instrumentation  Mesa Medical Inc. 
Automata, Inc.  Mistebar Computer Consultants 
B. Braun Medical Equipment, Inc.  National Association of Nephrology 
Baxter Healthcare, Renal Division  Technologists 
Bicarbolyte Corporation  National Kidney Foundation 
Board of Nephrology Examiners-  National Medical Care, Medical 
Nursing and Technology  Products Division 
CD Medical, Inc.  National Medical Care, Dialysis 
Church and Dwight Co.  Services Division 
Clarkson Kidney Center  Northwest Kidney Center 
Centers for Disease Control  Occupational Safety and Health 
Cleveland Clinic Foundation  Administration 
CGH Medical, Inc  Organon Teknika Corporation 
(Cobe-Gambro-Hospal)  Oshner Clinic 
CompuMod Software  Polymetrics, Incorporated 
Continental Water Systems Corporation  Porter Memorial Hospital 
Culligan International Co.  Quantitative Medical Systems 
Dial Medical, Inc.  Quinton Instrument Company 
El Camino Hospital  Renal Physicians Association 
Emergency Care Research Institute  Renal Systems, Division of 
Enka, AG  Minntech Corp. 
Environmental Water Technology  Renal Treatment Centers 
ESRD Networks (all 18)  Separation Technology, Inc. 
Filmtec Corporation  Seratronics, Inc. 
Fresenius USA, Inc.  Serim Research Corp. 
Fresno Community Hospital  Shiley, Incorporated 
W.L. Gore & Associates, Inc.  Sporicidin International 
HemoTec, Incorporated  Surgikos, Incorporated 
Charlotte Hungerford Hospital  Terumo Corporation, USA 
Impra, Incorporated  University of Pennsylvania 
Individual State Departments of Health  Outpatient Dialysis Unit 
(all 50 states)  V.A Medical Center, Palo Alto 
Institute of Medicine  Vas-Cath Incorporated 
International Standards Organization  Whittaker Bioproducts 
Zyzatech Water Systems, Inc. 
Finally, the authors wish to acknowledge the assistance in manuscript preparation by Pamela Jajko 
(El Camino Hospital Library & Information Center), Peggy Layton (Dialysis Management Inc.), Joan 
W ~(DOialys is Management Inc.), Jason Vlchek (Douglas L. Vlchek & Associates), Patricia Vlchek 
(Douglas L. Vlchek & Associates), Colin Beaty, and Darlene Lamun (Executive Secretarial Service). 
v  Abstract 
Vlchek,  D.L.,  S.  Burrows-Hudson,  and  N.A.  Pressly.  Quality  Assurance Guidelines for 
Hemodialysis Devices.  HHS Publication FDA 91-4161 (February 1991)(233 pp). 
This manual is designed,to help dialysis facility personnel become more 
aware of quality assurance practices for hemodialysis devices.  Device areas 
covered include water treatment equipment, equipment used to evaluate the 
acceptability of the dialysate concentrate, dialysate delivery equipment with its 
associated monitors and alarms, extracorporeal blood components,  dialyzers, 
dialyzer  reprocessing  and  testing  equipment,  and  all  other  equipment 
associated with the dialysis procedure. 
This  manual can also  be used as  a  basic  guide for  designing a new 
quality assurance program.  The manual includes examples of forms which can 
be adapted for each facility's specific needs. 
The opinions and statements contained in this report are those of 
the authors and  may  not reflect the views  of the  Department of 
Health and  Human  Services  (HHS).  The  mention  of  commercial 
I 
products,  their  sources,  or their  use  in connection  with  material 
reported herein is not to be construed as either an actual or implied 
endorsement of such products by the Department.  Contents 
Page 
................................................. 
Introduction 
....................................... 
Chapter 1: Background 
...................... 
Chapter 2: The Basics of Quality Assurance 
................................... 
Chapter 3: Water Treatment 
............................ 
Chapter 4:  Dialysis Delivery System 
.................. 
Chapter 5:  Dialysate and Dialysate Concentrate 
..................................... 
Chapter 6:  Hemodialyzers 
..................... 
Chapter 7:  Ancillary Devices and Equipment 
.................................... 
Chapter 8: Anticoagulation 
............................. 
Chapter 9:  Vascular Access Devices 
............................... 
Chapter 10: Hemodialyzer Reuse 
.................................. 
Chapter 11: Infection Control 
........................ 
Chapter 12: Handling of Toxic Chemicals 
........................... 
Chapter 13: Medical Device Reporting 
................. 
Appendix A:  Summary of Incidents and Problems 
................................... 
Appendix B:  Trend Analysis 
................................. 
Appendix C:  Glossary of Terms 
................... 
Appendix D:  List of Tables. Figures. and Forms 
............................ 
Appendix E:  Annotated Bibliography  Introduction 
Quality Assurance in renal care covers a wide range  A source of basic background information of the 
of areas and applications.  Some of these include:  current risks and hazards associated with the 
monitoring appropriateness of therapy;  analysis  use of certain devices in hemodialysis today. Sug- 
of resource utilization and pursuing resulting nec-  gestions are made as to how to minimize those 
essary adjustments; assessing patient satisfaction;  risks, as well as how to implement quality assurance 
measuring morbidity and mortality with the sub-  measures used to monitor and control the success 
sequent implementation of attempted solutions; staff  of those actions. 
credentialing, and monitoring of technical and clini- 
A source of easy-to-use forms, monitoring instru- 
cal processes with suitable modifications when stan- 
ments, and other useful tools that can be im- 
dards are not met. 
mediately utilized in the facility-based quality 
assurance program. 
Since the title of  this manual is Quality Assur- 
ance Guidelines fir Hemadialysis Devices, the reader 
This manual is not meant to be: 
must be aware that only the technical aspects 
of hemodialysis are discussed herein.  As authors,  A complete "cookbookn quality assurance pro- 
we suggest two reasons for this focus.  gram for the dialysis facility.  It does contain 
many components of the comprehensive, facil- 
First, promoting the safe and effective use of medi- 
ity-based quality assurance program.  A num- 
cal devices is a mission of the Center for Devices 
ber of monitoring instruments, forms, and other 
and Radiological Health, Food and Drug Admini- 
tools presented in this manual can immediately 
stration-the  contracting agency for this manual. 
be utilized.  However, a truly meaninghl QA 
prqgram for dialysis facilities must include areas 
Second--and probably more importantiassuring 
that are beyond the scope of this document, in- 
the technical safety in hemodialysis continues to 
cluding patient care, medical, dietary, social serv- 
be one of the most critical facets of renal care.  A 
ices, patient satisfaction and others. 
number of  incidents that result in patient injury 
continue to occur every year-incidents  that could  A training manual for the technical aspects of 
be prevented with proper user training, conscien- 
dialysis.  Again, this publication does contain 
tious attention to the manufacturers' instructions 
materials that will help train personnel; but much 
for use and common industry practice, and a well- 
more in-depth knowledge of each of these tech- 
planned quality assurance program carried out at 
nical areas is essential for most dialysis staff 
the facility level. 
members.  An annotated bibliography appears 
at the end of the manual to assist the facility 
As authors we wish to convey to the readerluser  in finding other resources needed to complete 
of this manual our intent regarding what this pub  that training. 
lication "isn and what it "is notn meant to be: 
Standards of technical practice for hemodialy- 
This manual is meant to be:  sis.  This manual refers to various "standards" 
and "guidelines" that are already in existence. 
A first step in assisting the facility to develop 
Some are voluntary standards, others are regu- 
and implement a facility-specific quality assur- 
lations.  This manual should not be construed 
ance approach (or to refine one, if already in 
as a new set of standards to be followed by the 
place). 
Quality Assurance Guidelines for Hernodialysis Devices  facility.  The facility's  own policies and proce-  plied materials and reviewed drafts of individual 
dures are the basic standards by which its QA  sections; dialysis facilities that provided infonna- 
program should be built and functions judged  tion on their quality assurance programs; physi- 
and monitored.  In accordance with Quality Im-  cians, nurses, administrators, and technicians who 
provement principles, those &cility standards (Poli-  provided personal experiences; the regulatory agen- 
cies and Procedures) should continuously be scru-  cies, networks, and other governmental entities that 
tinized and improved upon.  provided input; and the professional organizations 
and voluntary standards associations. 
The authors would like to express their gratitude 
to all those who have assisted in the preparation  It is our hope that this manual will provide a means 
of this manual who are, literally, too numerous to  to assist all dialysis facilities in improving the quality 
name individually:  the manufacturers who sup  of renal care. 
Quality Assurance Guidelines for Hernodialysis Devices  Chapter 1 
BACKGROUND 
CONTENTS 
Page 
................................................... 
GENERAL  1-1 
OVERVIEW OF RECENT ACTIVITIES AND 
..................... 
PARTICIPANTS IN QUALITY ASSURANCE  1-2 
......................................... 
Manufacturers  1-2 
Association for the Advancement of Medical Instrumentation ...  1-3 
Joint Commission on Accreditation of Healthcare 
........................................ 
Organizations  1-3 
........................... 
Food and Drug Administration  1-3 
............................... 
Centers for Disease Control  1-4 
.................... 
Health Care Financing Administration  1-4 
.............. 
Occupational Safety and Health Administration  1-4 
....................... 
End Stage Renal Disease Networks  1-5 
....................... 
End Stage Renal Disease Facilities  1-5 
................. 
OVERVIEW OF PROBLEMS AND INCIDENTS  1-5 
Quality Assurance Guidelines for Hemodialysis Devices  Chapter 1  Background 
GENERAL  In 1984, the FDA awarded four contracts to study 
the practice of hemodialysis. The contractors were 
The ultimate purpose of this publication-Quality  the Health Departments of Ohio, California, Mas- 
Assurance Guidelines for Hedialysis Devices-is  sachusetts, and District of Columbia.  Results from 
to provide generic quality assurance and quality  these studies and data from the FDA's Device Ex- 
control procedures for each type of equipment used  perience Network (DEN) system suggest that the 
in an End Stage Renal Disease facility.  quality of dialysis treatment could be improved by 
increasing the utilization of quality assurance in 
The US. Food and Drug Administration (FDA) has  several areas: 
a history of encouraging the development of qual- 
ity assurance (QA) programs in facilities that use  the treatment of water and in the design, opera- 
medical devices. Wherever medical devices are used,  tion, and maintenance of water systems; 
QA profla&  should be established to ensure that 
the handling and dilution of concentrates; 
the devices are properly used and maintained. 
Incorporating effective QA programs into hemodi- 
the reuse of disposable components 
alysis facilities helps assure safe and effective ther- 
apy.  the operation and maintenance of dialysis deliv- 
ery systems; 
Quality assurance may be defined as those ac- 
tions that provide adequate confidence that a  the practice of Universal Precautions to control 
facility will administer consistently high-quality  the spread of human immunodeficiency virus 
policies, procedures, and practices.  (HIV) and hepatitis B virus (HBV); 
Quality control, as it relates to medical de-  other areas including patient care, patient edu- 
vices, comprises monitoring, testing, and main-  cation (including home dialysis patients), per- 
tenance.  sonnel training, and adequate record keeping. 
Quality administration comprises management  The Center for Devices and Radiological Health 
actions taken to guarantee that quality control  (CDRH&a  component of the FDA-has  had an 
procedures are performed properly, their results  educational program geared toward the safe and 
analyzed, and appropriate corrective measures  effective use of medical devices in hemodialysis fa- 
taken.  cilities. CDRH believes that the overall safety and 
effectiveness of  the hemodialysis process will be 
Hemodialysis, a therapeutic process in which sev- 
improved if facilities voluntarily establish and im- 
eral medical devices are used, has been an area of 
plement QA programs. 
focus for the FDA for many years.  In 1978, the 
FDA began a study of the problems associated with  The CDRH contracted to have this publication- 
dialysis devices, resulting in a report that discussed  Quality Assurance Guidelines for Hernodialysis De- 
the problems associated with all aspects of the sys-  vices-developed and written as guidelines for es- 
tem. The FDA's interest continued with active par-  tablishing quality assurance programs in hemodi- 
ticipation in the Association for the Advancement  alysis facilities. These guidelines can be helpful in 
ofMedica1 Instrumentation (AAMI), Renal Disease 
optimizing patient care and controlling the spread 
and Detoxification Committee, resulting in volun-  of infectious diseases in dialysis facilities.  This 
tary American National Standards for hemodialy-  publication  covers the information required to en- 
sis devices. 
sure that appropriate equipment is specified, pur- 
Assurance Guidelines  Hernodialysis Devices  chased, operated, calibrated, and maintained prop  2. The equipment is used in conjunction with other 
erly, and that administrative controls are effedively  equipment from another manufacturer; 
exearted,the&ycmsminga&and~h~ 
3.  Qualifications, credentialling, or training of per- 
process. 
sonnel differ from facility to facility; 
In a typical hemodialysis facility, the various pieces 
4. The original accompanying procedures may be 
of equipment can be grouped according to use, namely: 
inadequate (unclear, not detailed enough, too 
detailed, etc.). 
L Water treatment equipment; 
2 Equipment to monitor operation of the water 
treatment system; 
OWRVIEW OF RECENT 
ACTIVITIES AND  PARTICIPANTS 
3. Equipment to evaluate the acceptability of the 
IN QUALITY ASSURANCE 
dialysate concentrate; 
4. Dialysate delivery equipment with its associated  Over the years, there have been a number of Qual- 
monitors and alarms;  ity Assurance and Quality Control activities un- 
dertaken.  Among the entities involved are: the 
5. Extracorporeal blood components (including blood 
manufacturers,  the Association for the Advance- 
access, blood tubing, blood pumps (if appropri- 
ment of Medical Instrumentation (AAMI), the Joint 
ate), infusion pumps, and airRoam detectors); 
Commission  on  Accreditation  of  Healthcare 
Organizations (JCAHO), the Food and Drug Ad- 
ministration (FDA),  the Centers for Disease Con- 
7. Dialyzer reprocessing and testing equipment;  trol (CDC), the Health Care Financing Administra- 
tion (HCFA), the Occupational Safety and Health 
8. Any other equipment associated with the dialy- 
Administration (OSHA), the ESRD Networks, and 
sis procedure. 
the facilities themselves.  Briefly, the contribution 
Each piece of equipment requires written quality  of each: 
control procedures that include maintenance and 
calibration procedures.  The procedures should in- 
clude: 
Manufacturers 
1. Selecting appropriate parameters to monitor; 
The manufacturers are responsible for complying 
2. Selecting and specifying measurement techniques  with Good Manufacturing Practice (GMP) regula- 
(electronic, or manual);  tions enforced by the FDA  These regulations in- 
clude: written procedures, validation of procedures, 
3. Determining appropriate intervals at which to  monitoring of performance, documentation of re- 
monitor (continuous or periodic). 
sults, review of records, and action implementa- 
tion.  The GMP regulation is intended to assure 
These procedures need to be accomplished periodi-  that the manufacturer produces devices that are 
cally to ensure that equipment operates in accor- 
safe and effective and otherwise compliant with 
dance with the manufacturers' specifications. Some  the federal Food, Drug and Cosmetic Act.  The 
of the necessary written procedures, particularly  GMP regulation is described in the Code of Federal 
for maintenance and calibration, may accompany  Regulations, Title 21, Part 820, Good Manufactur- 
the equipment when it is received from the manu- 
ing Practice for Medical Devices.  The GMP is in- 
facturer. However, these may need to be modified  tended to ensure that devices are fit for their in- 
and additional procedures may have to be devel- 
tended use. The device GMP is primarily concerned 
oped for a particular hemodialysis facility. Specific 
with the quality of conformance of a device; that is, 
facility procedures may be needed because:  the extent to which a device conforms with its de- 
sign specifications. 
1. The circumstance of use of the equipment are 
unusual (application or type of patient); 
Quality Assurance Guidelines for Hernodialysis Devices  Association for the Advancement of  Food and Drug Administration 
Medical Instrumentation ( A m )   (FDA) 
AAMI, a volunteer organization, also assisted sig-  The FDA has also been extremely active in assist- 
nificantly in improving the quality assurance and  ing, investigating, and ensuring the safety of medi- 
quality control of dialysis facilities.  Since 1980,  cal devices through several programs. 
AAMI has introduced and published. 
The Investigation of Risks and Hazards As- 
The American National Standards for Hemodi-  sociated with Medical Devices. This report 
alysis Systems, which includes standards for con-  is a result of a study performed under contract 
centrate for hemodialysis, hemodialysis systems  by the Fkgional Kidney Disease Program in Min- 
equipment, water treatment equipment, dialy-  neapolis, Minnesota.  Published in 1980, this 
sate supply systems, and monitors of the blood  study reviewed water purification, concentrate 
circuit.  used for dialysate preparation, dialysate deliv- 
ery systems, access to recirculation, blood tub- 
The AAMI Recommended Practice for Reuse of 
ing and accessories, blood pumps, infusion pumps 
Hemodialyzers (incorporated by reference into 
for anticoagulation, airifoam detectors, dialyz- 
the Code of Federal Regulations in 1987). 
en, and the reuse of dialyzers. 
Standards for First Use Hemodialyzers. 
Hemodialysis System Investigation Reports:. 
As noted earlier, in late 1984, the FDA issued 
Standards for Hemodialyzer Blood Tubing. 
contracts which resulted in Hemodialysis Sys- 
AAMI continues to update and rehe these stan-  tem Investigation Reports from California, the 
dards on an ongoing basis.  AAMI also provides a  District of Columbia, Massachusetts, and Ohio. 
variety of educational resource materials, training  These contractors reported  that serious prob- 
sessions, technology analysis and review sessions,  lems existed in various areas of current hemodi- 
and workshops several times yearly.  For the past  alysis practice: water treatment systems; dialy- 
several years, AAMI has, at least once per year,  sate delivery systems and dialysate concentrate; 
provided courses on hemodialyzer reuse and on water  dialyzers; extracorporeal blood circuits; reuse of 
quality for hemodialysis.  disposables; orientation training programs of staff; 
qualification and experience of patient care sW, 
manufacturers' literature; and home dialysis 
patients.  The recommendations were compre- 
Joint Commission on Accreditation 
hensive for each area studied. 
of Healthcare Organizations 
(JCAHO)  Educational Projects.  Over the past several 
years, the Center for Devices and Radiological 
JCAH0-a non-governmental organization primar-  Health Office of Training and Assistance has, 
ily involved with accreditation of hospitals--has  also  with the assistance of the manufacturers and 
had impact on dialysis facilities in that all dialysis  several other professional groups, produced edu- 
facilities who are a department of hospitals have  cational materials and video tapes including Human 
been inspected according to JCAHO "Special Care  Factors in  Hemodiulysis, Water Treatment in 
Unitsn criteria. Additionally, JCAHO has begun to  Hemodialysis, Infection Control for Hemodialy- 
require implementation of, and to insped for, in-  sis, and Repmssing of Hemodialyzers.  Facili- 
corporation of the "10-Step Process" for quality as-  ties have enthusiastically received these materi- 
surance programs in dialysis facilities, as well as in  als, and the importance of the issues handled 
other  specialty areas within hospitals.  Chapter  therein certainly have been underscored.  The 
Two, The Basics of Quality Assurance, provides  Office of Training and Assistance also published 
the reader with details of this process.  A Manual on Water Treatment for Hemodialysis 
early in 1990. 
Guidelines for Hemodialysis Devices  Other FDA Activities: The FDA also gathers  Health Care Financing 
information through other programs such as the  Administration (HCFA) 
Problem Reporting Program (PRP) and the Medi- 
cal Device Reporting Program (MDR). The FDA  By definition, the Health Care Financing Admini- 
is also able to provide important feedback through  stration (HCFA) administers the Medicare funds 
the Device Experience Network regarding all of  for reimbursement of End Stage Renal Disease treatc 
the device related problems mentioned above.  ment.  An important aspect of that function is as- 
suring quality and appropriateness of care associ- 
ated with that treatment. 
Centers for Disease Control (CDC) 
In the final rulemaking for the End Stage Renal 
Disease (ESRD) program, the June 3, 1976, Fed- 
Since the early 1970's, the CDC has conducted sur- 
eral Register described the further conditions of 
veillance of hepatitis in hernodialysis centers. Through 
coverage of suppliers of ESRD services: 
a cooperative effort with HCFA, the CDC has been 
able to determine and report the frequency with 
These Health  Care Financing Administration 
which hepatitis and other infectious diseases occur  (HCFA)  regulations (Part 405 of Chapter N of 
over time,  factors associated with the occurrence  Title 42 Subpart U) established the initial stan- 
of these diseases, and the effect various infection 
dards by which facilities would be allowed to pro- 
control measures have had in preventing transmis- 
vide services to ESRD patients: network member- 
sion of disease in hemodialysis. 
ship; compliance with federal, state, and local laws 
and regulations; governing body and management; 
As a result of these surveillance efforts, the CDC 
patient care planning (long term and short term); 
established initial recommendations for control 
patient rights and responsibilities; medical records; 
measures for hepatitis-B (HBV) in dialysis centers. 
physical environment; director and staff qualifica- 
Issued in November, 1977, the measures focused 
tions; and minimal service requirements. 
on: serologic testing, record keeping, staff and pa- 
tient education, control and prevention, housekeep 
These conditions of  coverage, as interpreted by 
ing and sterilization, and disinfection.  These rec- 
HCFA,  are used by  the state and federal survey- 
ommendations have been continuously updated and 
ors to evaluate dialysis facilities. These federal stan- 
revised to reflect current technological practice and 
dards have been the only guide for all subsequent 
new problems. 
quality assurance activities undertaken. 
The CDC's approach has been to educate and moni- 
tor, reporting their findings, each year to the neph- 
rology community.  Networks and other organiza-  Occupational Safety and Health 
tions adopted the CDC recommendations as stan-  Administration (OSHA) 
dards encouraging facility compliance. As a result, 
these precautions, when employed, have demon-  During the past three years OSHA regulations have 
strated a significant reduction in the incidence of  also had a direct impact on dialysis facilities: 
HBV infection. 
In December of 1987 OSHA published a Final Rule 
The CDC has Mher developed their infection control  on Occupational Exposure to Formaldehyde which 
recommendations to include HIV (human immu-  includes exposure limits, required monitoring, regu- 
nodeficiency virus). Utilizing lessons learned from  lated areas, emergency procedures, medical sur- 
the dialysis field, the CDC issued the current Uni-  veillance, special record keeping requirements, com- 
versal Precautions for all areas of health care. Be-  munications with and training of employees, and 
cause use of serologic testing for HIV is not univer-  other actions. 
sally employed, the CDC has focused on the educa- 
tion of all health care workers in the application of  Additionally, OSHA has published a Notice of Pro- 
Universal Precautions.  posed Rule Making regarding Occupational Expo- 
Quality Assurance Guidelines for Hernodialysis Devices  sure to HIV and HBV. The final rule is to be pub-  cific QA programs.  This effort continues to be a 
lished in the very near future.  priority for Networks. 
OSHA's Hazard Communication Standardalsor ecphs 
employers to provide information to their employees 
End Stage Renal Disease (ESRD) 
about hazardous chemicals used in the work place. 
Facilities 
As the reader will note from the above, dialysis fa- 
End Stage Renal Disease (ESRD)  cilities have had to not only learn and grow with 
Networks  the technological advancements in the field, but 
also comprehend and apply the various standards, 
In June, 1976, the final ESRD regulations included  guidelines, and recommendations put forth. 
a mandate to the Secretary of Health, Education 
Facilities tend to be eager for information, forms, 
and Welfare (HEW) to regulate health care being 
models andlor programs that will help them with 
provided to persons with ESRD. In order to moni- 
all aspects of quality assurance. It is the intention 
tor and regulate the care provided to these pa- 
of this manual, Quality Assurance Guidelines for 
tients, the ESRD Networks were established with 
Hernodialysis Devices, to fill some of that need. 
the mandate that each Network was to organize its 
own medical review program.  Some changes have 
occurred since that time, but the Network func- 
tions established by HCFA are primarily to: 
Develop Network goals for placing patients in  OVERVIEW OF PROBLEMS 
settings for selfcare and transplantation;  AND INCIDENTS 
Encourage the use of medically appropriate treati  The past few years have seen an increase in the 
ment settings most compatible with patient re-  concern that quality of care be maintained as the 
habilitation;  basic cornerstone of dialysis delivery. 
Develop criteria and standards relating to the 
Events that have seriously jeopardized patient safety 
quality and appropriateness of patient care; 
in several different dialysis facilities have occurred 
Evaluate the procedures used by facilities in asses-  during the past three to four years.  These inci- 
sing patients for placement in appropriate treat-  dents have focused attention on the absolute ne- 
ment modalities;  cessity of completely competent, well-trained, medi- 
cal, nursing, and technical staffs, and on well-de- 
Make recommendations to member facilities as  signed use of today's technology and diligent qual- 
needed to achieve Network goals;  ity assurance programs. Occasionally, incidents have 
occurred during this time that have received na- 
Conduct on-site reviews of facilities as neces- 
tional media (newspapers, magazines, national tele- 
sary; 
vision) exposure: 
Collect, validate, and analyze data. 
I. 
In late September 1987,44 patients in one facil- 
Each Network has functioned independently of the  ity were treated for hemolysis due to chloramine 
.  others allowing considerable autonomy and crea-  contamination of dialysate.  It was later found 
tivity to best meet the HCFA requirements as well  that facility staff lacked adequate information 
as community need.  A significant amount of focus  regarding water treatment and water treatment 
for the Networks has been those technical aspects  system planning. Furthermore, inadequate staff 
attracting national attention; i.e., water treatment,  monitoring, and an overall lack of ongoing per- 
infection control, dialyzer reuse, et cetera.  formance appraisal contributed to this incident. 
In 1984, the HCFA specified that each Network  A few months later, a serious incident occurred 
would encourage the development of facility spe-  where injectable lidocaine was confksed with 
Assurance Guidelines  Hernodialysis Devices  mannitol. In this incident, one patient died and  and serious. Further, during this same period of 
another was seriously injured.  Proper storage  time, the controversy regarding the reuse of 
and labeling techniques, as well as protocols for  hemodialyzers continued, and this has been re- 
administration of medication, among other is-  viewed often in the media. 
sues, were implicated 
Appendix A provides the reader the opportunity 
In early 1989, patient injury occurred when a  to review the hundreds of other incidents that 
germicide and preservative (sodium azide) was  have occurred in recent years related to device 
not completely removed tiom a component of a  malfunction.  More oRen than not, these were 
water beatrnent system (ultrafilter). In this case,  related to improper use, improper user training, 
again, improper design and use, as well as in-  improper preventative maintenance, and other 
adequate training and monitoring were involved.  issues normally monitored and corrected by a 
quality assurance program. 
In mid-1989,36+ patients were treated for meta- 
bolic acidosis in a dialysis facility when acid di- 
The combination of all of these factors has drawn 
alysate concentrate was used with dialysis de- 
significant national attention from the public, leg- 
livery systems in the acetate mode.  The ma- 
islature, regulatory agencies, and even dialysis 
chines were all functioning according to specifi- 
facilities, and health care professionals. The im- 
cations, but the pre-dialysis safety checks speci- 
portance of strong and effective quality assurance 
fied by the manufacturer were not performed, 
programs in an effort to enhance safety and re- 
and other gaps in quality assurance and quality 
duce the risk of these sorts of incidents is on 
control contributed to this incident. 
everyone's mind. 
During these periods, the Centers for Disease Con- 
Please note that most of the following chaptirs in 
trol and other federal agencies investigated scores 
this manual, Quality Assurance Guidelines for 
of other similar incidents which did not appear in 
Hemodialysis Devices, contain a section on ad- 
the media: bacterial contamination of water treat- 
verse incidents--both pre-1980, as well as inci- 
ment systems, pyrogen reactions, HIV and HBV 
dents found in the FDA's Medical Device Report- 
exposure, problems with improper use of dialysate 
ing files.  These are offered to the readers as 
concentrate, other contaminations of water treat- 
background for consideration  as to whether or 
ment systems and water storage.  The list is long 
not such incidents could occur in their facility. 
Quality Assurance Guidelines for Hemodialysis Devices  Chapter 2 
THE BASICS OF 
CONTENTS 
Page 
................................................ 
DEFINITION  2-1 
QUALITY ASSURANCE METHODS  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-1 
The JCAHO 10-Step Process for Monitoring and Evaluation . . . .  2-1 
Comprehensive Quality Assurance Program: 
The Smith-Marker "Unit-Based Quality Assurance Model" . . . . .  2-4 
Quality Control  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-5 
Continuous Improvement Concepts: 
Derning's Principles  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-6 
............................................... 
REFERENCES  2-7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
TABLES, FIGURES, AND FORMS  2-8 
Assurance Guidelines for Hernodialysis Devices  Chapter 2  The Basics of 
Quality 
Assurance 
DEFINITION  gates the responsibility of conducting the QA ac- 
tivities to a committee. 
Quality assurance is a cyclical process by which 
problems and opportunities for improvement are  2. Form a oommittee. Committee members should 
include the dialysis unit's medical director, head 
identified and analyzed, solutions are developed and 
nurse, chief technician, dietitian, and social worker. 
implemented, and reassessment occurs. If the cycle 
If the unit is very large and has multiple shifts, 
is not completed, that is, if only the assessment 
the charge nurses responsible for each shift must 
component takes place, quality assurance (QA) will 
be included. When a QA coordinator is employed 
not occur (see Figure 1). 
or a staff nurse is assigned the position on a 
part-time basis,  that person should be involved 
and attend each QA committee meeting. 
QUALITY ASSURANCE METHODS 
Committee members must be those individuals 
Many hemodialysis facilities have successfidly de-  that have the authority to make decisions and 
veloped and implemented quality assurance pro-  implement the necessary actions to assure cor- 
grams.  Some use quality assurance methods that  rection of a problem. A chairperson for the com- 
they have developed themselves, modifying various  mittee must be elected or appointed.  The posi- 
models and plans; some use the Joint Commission  tion is usually assigned to the head nurse or 
on Accreditation of Healthcare Organizations' ten-  someone who can carry out the various coordi- 
step process for monitoring and evaluation; while a  nating activities involved. 
few use specific models developed by other people, 
3. Develop a plan.  A plan  must describe the 
including Carolyn Smith-Marker's, "Unit-Based Qual- 
facility's QA program purpose and goals. The 
ity Assurance Model." 
plan should include the scope of the QA pro- 
gram, how to achieve the purpose and goals that 
In this manual, the quality assurance cycle previ- 
are outlined, and the mechanisms to be used. 
ously described, the Joint Commission on Accredi- 
tation of Healthcare Organizations' (JCAHO) ten 
The plan also delineates the organization, re- 
step process for monitoring and evaluation, the Smith- 
sponsibility and authority of the QA program: 
Marker model for quality assurance, and Deming's 
who is to be involved in the QA program, com- 
continuous improvement concepts are offered to facili- 
mittee membership, the reporting mechanism, 
tate a comprehensive examination of quality for 
and the ultimate authority responsible for the 
the hemodialysis facility.  It is recommended that 
QA program for the facility (see Figure 2). 
the references listed at the end of this chapter be 
used to provide more comprehensive assistance with  4. Organize and meet. The committee must or- 
QA programming.  ganize itself and educate members who are not 
familiar with the QA process.  The appropriate 
resources need to be provided, such as articles, 
books, and educational programs. 
JCAHO 10-Step Process for 
Monitoring and Evaluation  Once organized and prepared, the committee must 
meet.  To assure a continuous monitoring proc- 
A  Getting Started  ess and commitment to improving quality, the 
committee should meet on a monthly basis. 
1. Assign responsibility, The governing body of 
the facility is the ultimate authority responsible  5. Minutes.  Minutes of all QA committee meet- 
for the QA program.  The governing body dele-  ings must be written and handled in a confiden- 
Quality Assumnce Guidelines for Hernodialysis Devices  tial manner and should be maintained in a file  1. The aspect occum frequently or affects a 
that is not within public access. It is highly rec-  large number of patients.  In a facility this 
ommended that each QA committee review their  particular factor is very important There are a 
specific state statute pertaining to the confiden-  number of things done that affect large numbers 
tiality of the QA committee minutes.  of patients. Examples include: the hemodialysis 
procedure itself; water treatment; reuse; and 
B. Define Scope of Care 
venipuncture. 
In the first step, critical indicators of care are de-  2. .Patients a ma t risk of serious consequences 
veloped dehing the scope of care provided by the  or am deprived of substantial benefit if the 
facility.  Table 1p rovides an example list describ-  care is not provided comtly, in a timely 
ing the scope of care in a hemodialysis unit  This  fashion or as properly indicated.  In other 
list was developed by using the brainstorming tech-  words, if the hemodialysis treatment is not pro- 
nique to answer a number of questions:  vided adequately or properly the patients may 
suffer the serious consequences of uremia or be 
1. lSpes of patients served. What are the char-  put at risk for other injury. 
acteristics of the patient population, such as age, 
residence, ethnicity, length of time on dialysis,  3. The aspect of care has tended in the past 
or other unique characteristics?  to produce problems for staff and patients. 
In the hemodialysis unit this may include infec- 
2 Conditions and diagnoses treated. Are spe-  tion control, water treatment, venipuncture, et 
cific types of renal diseases treated?  Are the  cetera. HBV and HIV pose numerous problems 
patients' conditions medically complex? Are the  for both staff and patients.  Venipuncture is an- 
patients all paraplegic? Diabetics? Hepatitis  other aspect of care that has produced problems 
positive?  Do the patients have multiple health-  for both patients and s t . .  
care problems? 
High volume, high risk and problem prone areas 
3. Services provided.  What treatments or ac-  that have been identified must be considered the 
tivities are performed in the dialysis unit? All of  most important aspects of care and require ongo- 
the activities that go into the hemodialysis pm-  ing monitoring and evaluation. 
ess should be listed:  patient orientation, vascu- 
lar access care, venipuncture, heparinization,  D.  Identzfy Indicators 
equipment maintenance, reuse, water treatment, 
infection control, environmental control, environ-  Indicators are chosen directly from those aspects of 
mental safety, et cetera.  care that have been identified as being most im- 
portant.  Using these indicators,  important as- 
4 The types of practitioners providing care. 
pects can then be monitored and evaluated on an 
Who are the people involved in the care of the 
ongoing basis. 
end stage renal disease patient in the dialysis 
unit?  Among the indicators that are finally chosen, the 
most current standards and regulations, as out- 
5. Sites where the care is provided. Is this an 
lined in Table 2, must be included. Rather than 
outpatient facility?  An in-hospital facility?  Or 
monitoring each specific entity of a regulation or 
an outpatient clinic associated with the hospi- 
standard, only those that are most important and 
tal?  Is it a freestanding facility? Or is it home 
have direct impact upon a patient should be se- 
dialysis? 
lected. The monitoring process should be both broad 
6. Times when  is provided. Are there dif-  and selective to provide an overview of the entire 
ferent shifts available for patients?  scope of facility operations. 
C.  Identify Important Aspects of Care  An indicator may also come from the unit's policy 
and procedure manual. Policies and procedures that 
The next step is to identify the important aspects  are current with regulations and standards and 
of care.  These are the things that we do that are  are up-to-date with all the equipment and supplies 
most important. Consider these three aspects:  used in the unit, can serve as an immediate re- 
source for developing indicators. 
Quality Assurance Guidelines for Hernodialysis Devices  2-2  To be comprehensive in this process, the QA com-  conducted in an accurate and speedy manner. The 
mittee should monitor a mix of structure, process,  collection process includes the identification of the 
and outcome indicators.  indicator to be monitored, an assignment of the 
staff  person to do that monitoring, and the appro- 
staructure is that which holds the organization  priate space and time provided. The staff person 
together; i.e., policies, building structure, equip-  should not try to care for a patient at the same 
ment.  time heishe is reviewing activities of their cowork- 
ers or trying to conduct a chart audit. 
process is that which is performed or provided 
by the facility; i.e.,  the performance of proce- 
Once the monitoring activity has been completed 
dures; and, 
and the data collected, it must be displayed in such 
outcome,t he end result of what has been done.  a way as to ensure that the QA committee can read 
it and accurately interpret the findings. Display- 
All staff, if not directly involved in the identifica-  ing the data is another difficult task to complete; 
tion of indicators, must be informed and have an  the Problem Tracking Form shown in Figure 3 can 
opportunity for input. Monitoring instruments will  accurately track problems over time and display 
be most successll if all staff participate in the  the results of the QA monitoring activities. 
development of and are aware of indicator expec- 
tations.  Examples of monitoring instruments de-  G. Evaluate the Results 
signed according to these guidelines and the addi- 
tional information presented below are included in  Problems identified by the monitoring activities (ie., 
many of the chapters in this manual, Quality As-  failure to achieve expected compliance threshold) 
sumnce Guidelines for Hedialysis Devices.  must be analyzed. In some cases, there may not be 
a clearly defined problem  It is important, how- 
E.  Establish Thresholds for  ever, to assure that areas for improvement are acted 
Compliance  upon. There may be problems that are readily solved. 
These actions should be implemented quickly. Some 
As indicators are identified and monitoring instru-  problems may be extremely complex and long term 
ments are developed, the committee must estab-  in resolution.  Decision making must focus on those 
lish thresholds by which the compliance level is  pieces of the problem that will have a direct im- 
expected. A threshold is simply that percentage of  pact upon patient safety. A threat to patient safety 
compliance with the indicators that you expect to  must be tackled swiftly.  When time permits, the 
find when monitoring the activities of your facility.  oommittee must carefully review the remaining pieces 
It is recommended that a threshold for action be-  of the problem. 
gin at 85%. While highly desirable, a 10Wo thresh- 
As problems are identified through monitoring, it 
old is not recommended at first.  Compliance of 
is important that the QA committee document or 
100% is not necessarily achievable in the begin- 
"track"  the identified problems.  One method is 
ning stages of monitoring. Begin at 85% and work 
the use of a Problem Tracking Form (Figure 3). By 
towards continuous improvement. 
noting the problems on a tracking form, the com- 
F. Collect and Analyze the Data  mittee will be able to track a specific problem, the 
activities required, and the person responsible for 
After the indicators have been identified, thresh-  assuring that the solution is implemented.  Each 
olds established and the monitoring instrument  time the QA committee reviews the status of a 
has been developed, the sources of information that  problem, a notation of the review date should be 
will be needed should be identified.  Table 3 de-  made on the form. The detailed committee discus- 
srribes where a variety of information might be  sion relating to the problem can be noted in the 
found.  It is important to keep in mind that the  minutes.  Until the problem is resolved, the com- 
SOUmes must match the required data and that  mittee should make similar notations on the form 
there are multiple sources already available in the  at each meeting.  When the problem is finally re- 
dialysis unit.  solved, the problem can be removed from the form. 
Note, however, that the past forms should be re- 
The collection process is also very important. Data  tained in the minutes of the QA committee meet- 
~llectiono r the gathering of information must be 
ings. 
lity Assurance Gui&lines fir Hernodialysis Devices  H.  Develop Solutions to Problems and 
Take Action 
The process described for monitoring and evalu- 
Analysis of the problems or areas for improvement  ation includes the assignment of responsibility, dehing 
will generate solutions. It is important to consider  scope of care, identifying important aspects of care, 
the best solution.  What is its value?  Is it cost  identifyng key indicators, establishing thresholds 
effective?  Is it feasible to implement?  Are re-  for evaluation, collecting and organizing data, evalu- 
sources readily available to implement this solu-  ating care, taking action, assessing and document- 
tion?  And, will the solution be accepted by staff  ing improvement, and communicating relevant in- 
and patients alike? StafF and patient involvement  formation. 
must be considered in the development of solu- 
tions. 
Comprehensive Quality Assurance 
A plan of action must be developed by identifying 
Program: The Smith-Marker" Unit- 
the steps involved in implementing the solution. A 
Based Quality Assurance Model" 
target date for implementation and reevaluation 
must also be determined.  The person responsible 
A comprehensive QA program involves all aspects 
for implementing that solution must be aware of 
of  unit activity and integrates each under one 
the expectations, responsibility, and authority re- 
"umbrellan. A comprehensive QA program includes 
quired to carry out the plan.  The plan must then 
nine activities: development of standards, staff ere- 
be implemented. If the solution is not implemented 
dentialing, performance appraisal, risk management, 
and if all activity stops at this point, the problem 
utilization review, concurrent monitoring, continu- 
will not be resolved and the assurance of quality 
ous and focused monitoring, active problem identi- 
will not occur. 
fication, and continuing education. 
I.  Reassess 
A  Development of Standards 
Reassessment and documentation of improvement 
is required to "bring the QA loop to a closen (see  This includes the use of the professional standards 
of practice for medicine, nephrology nursing, social 
Figure 1). This occurs &r  the solution has been 
workers, renal dietitians, and technicians. Federal 
given enough time to make a change or to correct a 
and state regulations also form the standards for 
problem The reassessment monitoring instrument 
many of the technical activities and structural as- 
should not be significantly different from the one 
used to identi@ the original problem. Through fol-  pects in the dialysis unit. 
low-up monitoring activity, the QA committee will 
B.  Staff Credentialing 
be able to determine if the problem has been solved. 
The monitoring process should be continued over a 
Staff credentialing, by either a professional license 
period of time to assure sustained resolution. 
or certification, is an important means of screening 
personnel. It provides an assurance that the indi- 
J.  Communicate 
vidual is capable of providing a recognized level of 
skill and expertise.  This means that for all staff, 
The results of all QA activities need to be commu- 
nicated to all dialysis staff.  It is not enough that  where licensure or certification are appropriate, the 
dialysis unit administration must assure that the 
the head nurse, the medical director and the chief 
documentation is current and maintained accord- 
technician and possibly the administrator decide 
what to do about certain problems that they have  ing to state laws. 
identified.  Further, when problems are resolved 
Other types of certification renewal or credentialling 
andlor improvement opportunities are acted upon 
are also important to validate and maintain on file. 
and resolved, the staff must be made aware of the 
For example, all direct patient care stafF should be 
outcome and they must be congratulated on a job 
certified for cardiopulmonary resuscitation, continu- 
well done. 
~ u a l iAbs surance Guidelines for Henodialysis Devices  ing education requirements, preventive back care  G.  Retrospective monitoring 
orientation, hazardous materials communication, 
and  other programs required by facility policy.  Monitoring retrospectively focuses  on that which 
has already occurred. Information found in the medi- 
C.  Performance appraisal  cal record is most commonly used for retrospective 
monitoring.  Infection control, special problem fo- 
Performance appraisal must flow from the role de-  cused studies, kinetic modeling, outcome monitor- 
scription and the QA program.  Standards of prac-  ing,  mortality review, infections,  vascular access 
tice, the role description and the performance ap-  problems, and technical audits can all be performed 
praisal process must tie together and create one  retrospectively.  There are a number of retrospec- 
unified method of evaluating professional employee  tive monitoring instruments included throughout 
behavior.  this manual. 
D.  Risk management  H. Active problem identification 
Risk management is focused on financial liability  Active problem identification flows from the results 
awareness. Risk management activities include  of monitoring activities: staff credentialing, perform- 
disaster planning, infection surveillance and con-  ance appraisal, risk management, utilization re- 
trol, the use of universal precautions, facility struc-  view, concurrent monitoring, and retrospective moni- 
tural aspeds such as handrails on the walls and  toring, with the addition of comments and prob 
non-skid floors in the unit.  The informed consent  lems presented by patients, s t . ,a nd management 
process is also a risk management activity, along  personnel. 
with patient relations, incident reporting, adverse 
occurrence reporting, safety and hazardous materi-  I.  Continuing education 
als education, and a grievance process for the facil- 
ity.  Continuing education should focus on the problems 
that are identified.  Continuing education should 
An up-to-date policy and procedure manual is also  come from and focus on those problems or opportu- 
an important component of risk management.  A  nities for improvement that have been identified 
well written manual  ensures that the policies and  through the ongoing monitoring and evaluation 
procedures expected to be used in the delivery of  process. 
services follow all current standards, guidelines, 
and regulations. 
E.  Utilization review  Quality Control 
Control is the process of regulating an adivity to 
When examining utilization factors related to the 
dialysis facility, the QA committee may focus on  verify its conformance to a standard.  Quality con- 
trol (QC) is the process for those activities that 
repeat dialyses, unscheduled acutes, emergency room 
measure a product's performance.  Quality control 
visits, blood utilization, and medication administra- 
tion.  is an important component of quality assurance. 
F.  Concurrent monitoring  In the hemodialysis unit, the purpose of QC is to 
assure that the equipment/devices used are safe 
Concurrent monitoring is the process of observing  and effective. This goal is met by the application of 
what is happening at the time of its occurence. Ex-  a cyclic process; that is, by establishing standards, 
amples of this include:  observing staff or patients  measuring performance, and correcting deviations. 
perform procedures; querying patient satisfaction 
A major aspect of quality control is reliability. Rt+ 
or a patient's  sense of  quality of  life; reviewing 
liability is the ability of the product to perform its 
treatment and care outcomes, especially functional 
*tuS.  There are a number of concurrent monitor-  intended function over a period of time.  A product 
ing instruments included throughout this manual.  that "worksn as it is designed, without mechanical  failure or errors, for a long period of time is a reli-  C.  Correcting Deviations 
able one. 
Each measurement taken must be evaluated against 
There are four aspects of reliability:  an existing standard.  These standards may be 
found in the manufacturer's literaturdrecornmen- 
1. The device will not fail during a particular time; 
dations for use or other sources as described in 
i.e., during dialysis. 
Table 2.  When a deviation from the standard OC- 
curs, the problem must be analyzed and corrected. 
2. The device is able to perform those applications 
for which it has been designed and as it is ex- 
Throughout this manual a number of quality con- 
pected to perform, i.e., accurately prepare, moni- 
trol instruments, procedures and measures will be 
tor and deliver dialysate. 
described.  It is important that quality control be 
3. The device's We expectancy" is known, and the  incorporated into the facility's quality assurance 
device lasts as long as expected.  PW-. 
4. The device will function in an appropriate envi- 
ronment. 
Continuous Improvement Concepts: 
Maintenance of all equipment has an important  Deming's Principles 
role in assuring reliability.  When maintenance is 
performed according to the manufacturer's guide  "Quality must be built into a product or service, it 
lines or facility policies and procedures it may save  cannot be inspected in." (Deming, 1982). The the 
the dialysis unit substantial dollars in costly repair  ory of continuous improvement is crucial for suc- 
or replacement work.  Preventative maintenance  cessful dialysis unit operations.  The following is 
also assures a safe and adequate dialytic therapy.  offered for consideration in the development of a 
facility QA program. 
Periodic monitoring and evaluation are required 
for prevention programs. They are essential to de-  Key points for improving quality: 
termine whether or not the equipment is operating 
Top to bottom organizational consistency of pur- 
satisfactorily. These periodic monitoring activities 
pose towards improvement of senrice. 
simply review the operation of the device in much 
the same manner as monitoring the medical record 
Find problems.  It is our job to work continually 
or personnel performance.  They should be sched- 
on the system--towards continual improvement. 
uled and performed by the technical personnel who 
know how to operate the equipment.  The results  Eliminatk inspections and substitute meaning- 
of the monitoring activity are, of course, written  ful measures of quality. 
and circulated within the dialysis program. 
Take immediate action to remove barriers to gualih 
A.  Establishing Standards  service. 
Throughout this manual, standards that are perti-  Institute long-range planning, cease focus on short- 
nent to the components or devices discussed in each  term profits. 
chapter have been identified. In relatively few cases 
do dialysis personnel need to develop new stan-  Eliminate barriers between staff groups; substi- 
dards.  The vast number and scope of standards  tute team work. 
and regulations that already exist must be used 
Introduce modem training methods. 
(See Table 2). 
Make use of practical statistical techniques and 
B.  Measuring Performance 
tools (control charts, flow diagrams, run charts, 
etc.) to facilitate learning and action. 
Equipmentldevice performance measurements are 
performed pre-dialysis (pH, conductivity, dialysate 
Recognize achievement. 
flow rate, temperature), during dialysis (blood flow 
rate, heparin infusion rate, volumetric controlled 
The careful integration and implementation of vari- 
fluid removal rate), and during maintenance and 
ous models and methods of quality assurance will 
repair procedures (ohms, volts, amps, flow rates). 
promote and enhance the high quality of care. 
~ u a l iAts~su rance Guihlines for Hernodialysis Devices  REFERENCES 
1. Joint Commission Guide to Quality Assurance. Joint Commission on Accreditation of 
Healthcare Organizations (JCAHO), Chicago, IL (1990). 
2.  Quality Assurance for Nephrology Nursing.  American Nephrology Nurses Association, 
Pitman, NJ (1989). 
3. WALTON, M., The Deming Management Method.  Putnam Publishing, New York, NY (1986). 
4.  SMITH-MARKER, C.  Monitoring Professional Nursing Practice.  Aspen Publications, 1:3, 
Rockville, MD (1987). 
5.  MICHNICH, M.E., HARRIS, L.J. WILLIS, R.A. and WILLIAMS, J.E. Ambulatory Care 
Evaluation: A Primer for Quality Review. UCLA School of Public Health, Los Angeles, CA 
(1976). 
Note:  A list of additional references on this topic can be found in Appendix E at the end of 
this manual.  These additional references are included to enable the reader to pur- 
sue further investigation for the purpose of training or research on this topic . 
Guidelines for Hemodialysis Devices  (i 
STANDARDS 
COLLECT DATA  L 
7 
f 
I 
[ 
REASSESS 
CHOOSE AND  ANALYZE PROBLEMS AND 
IMPLEMENT SOLUTION  GENERATE SOLUTIONS 
Quality Assurance Guidelines for Hemodialysis Devices  I. PROGRAM PURPOSE AND GOALS 
The overall goal of  dialysisAransplant program is to provide high quality 
services in an environment that is safe to both patients and providers and in a manner that will optimally 
benefit the patient's well-being. The purpose of the Quality Assurance Program is to objectively, sys- 
tematically, and comprehensively monitor and evaluate the quality and appropriateness of patient care, 
to reveal opportunities to improve patient care, and to resolve identified problems. 
II. ORGANIZATION AND AUTHORITY 
The Governing Body of  is responsible for assuring that a planned and sys- 
tematic process for monitoring and evaluating the quality and appropriateness of patient care services 
is in place, implemented, and is effective. A Quality Assurance (QA) Committee, consisting of at least 
the key members of the multidisciplinary team:  medical director, head nurse, social worker, dietitian, 
chief technician, and a representative from any other service provided, is established to assure 
completion of activities consistant with the purpose and functions of the QA Program. 
Ill. OBJECTIVES 
The QA program shall be: 
A.  Comprehensive in scope, reflective of the diversity of providers and services. 
B.  Designed to objectively and systematically monitor and evaluate the quality and appropriateness 
of patient care, pursue opportunities to improve patient care, and resolve identified problems. 
C.  Responsible for defining effectivem  echanisms for reviewing and evaluating patient care, as well 
as for an appropriate system for responding to such findings that emphasizes correction of identi- 
fied problems. 
0. Designed and expected to demonstrate verifiable improvement in patient care and clinical per- 
formance. 
E. Defined in a written plan that shall be re-evaluatedo n an annual basis. 
IV.  PROGRAM COMPONENTS 
A.  Data Gathering: the QA program shall facilitate the identification on a regular, ongoing basis of 
known or suspected problems in patient care through the establishment of a comprehensive and 
Coordinated system of information exchange and record maintenance regarding quality of care 
issues. Sources of problem identificationc an be based on either continuous monitors or on case- 
specific referrals. 
Assurance, Guidelines for Hernodialysis Devices  SAMPLE  QUALITY  ASSURANCPEL AN 
6. Problem Analysis: the QA program shall facilitate the collection, analysis, and presentation of 
appropriate data. Patient care issues brought to the attention of the QA program shall be screened 
and actedupon according to: 
1.  degree of adverse impact on patients; 
2.  feasibilty objective analysis; and 
3.  potential for riskhenefit 
C.  Reporting: the QA programs hall assure the reporting of data results to respectivep rovidergroups. 
D. Problem Resolution: the QA program shall facilitate and assure an appropriate plan for action 
including solution identification and implementation, problem tracking, and reassessment. 
V.  REPORTING AND CONFIDENTIALIN 
Minutes of QA committee meetings shall be recorded. Indicator monitoring results, actions taken, and 
follow-up monitoring will be fully documented. The documentation of all QA activities will be updated 
on an ongoing basis and will reflect current status of each identified problem.  On a routine basis, a 
summary of all QA activities will be reported to the Governing Body and integrated (as appropriate) into 
the organization-wide program. All information, analyses, records, and proceedings of the QA commit- 
tee shall be protected as confidential records. 
VI.  PROGRAM EVALUATION 
The QA committee will evaluate the QA program at least annually to assure that it meets the quality 
assurance needs and goals of the facility. Pre-establishedw  ritten objectives shall be used and a wriiten 
report shall be submitted to the Governing Body. 
Reviewed and Approved by: 
Date 
Director of 
Governing Body Representative  Date 
Reprinted with permission from ANNA'S Ouality Assurance for Nephrology Nursing, Copyright 1989. American Nephrology 
Nurses' Association, Pitman. NJ. 
Quality Assurance Guidelines for Hernodialysis Devices  2-10  DATES 
DATE  PROBLEM  ACTION PLAN  REVIEWED  1, Chronic Adult Hemodialysis Outpatients with ESRD 
Elderly  Diabetics  Patients with Ethnic/Cultural Diversity 
Non-ambulatory  Patients of Various Ages  Patients with Various Disabilities 
Drug Abusers  Nursing Home Patients  Patients of Low Economic Status 
2. Treatment and Care 
Hemodialysis  Home Training  High Flux Hemodialysis 
Conventional Hemodialysis  Rehabilitation  EPO Therapy 
IV Med Administration  Transfusions  Dietary Counseling 
PsychISocial Support  Family Support  Continuous Therapies 
Transportation  IDPN Therapy  Self Care 
Financial Counseling  Laboratory Tests  Quality Assurance 
Patient Education  Disaster Planning  Comfort Measures 
Staff Inservice  Staff Support  Medication Review 
Primary Nursing  Reuse  Patient Scheduling 
Equipment Maintenance  Universal Precautions  Isolation 
Safety Management  Water Treatment  Educate Students 
Handling Patient Grievances  Entertainment and Socialization  Research 
Purchasing  Coordinate Care with Nursing  Travel Arrangements for Vacations 
and Medicine 
Then, subcategories, under #2 above, such as Hemodialysis, can be divided into 
"Important Aspects of Care":  For example: 
Hemodialysis 
Venipuncture  Kinetic Modeling  Nutritional Counseling 
Water Treatment  Anticoagulation  Ultrafiltration 
Reuse  Equipment Maintenance  Patient Monitoring During Treatment 
3. Providers 
Physicians  Nurses  LVIPN's 
Social Workers  Renal Nutritionists  Secretaries 
Aides  Chief Executive Officers  House Keeping Personnel 
Laboratory Personnel  Transport Personnel  Volunteers 
Business Personnel  Surgeons  Technicians (Reuse, Equipment, 
Patient Care) 
Used with Permission by Transpacific ESRD Network, Sausalho, CA 
Quality Assurance Guidelines for Hernodialysis Devices  2-12  42 CFR Part 405, Subpart U (Conditions for Coverage of End-Stage Renal Disease (ESRD) 
Services 
-  HCFAIAAMI Recommended Practice for Reuse of Hemodialyzers (plus Final Rule in 
October 2,1987 Federal Register) 
-  HCFA Final Rule: Medicare Program: Protocol for the Reuse of Dialysis Bloodlines 
(42 CFR Part 405, Federal Register May 2, 1990, Vol. 55, No. 85, p. 18331-18335) 
Standards of Clinical Practice for Nephrology Nursing (ANNA) 
American National Standard (ANSIIAAMI) for Hemodialysis Systems 
29 CFR OSHA Regulation including: formaldehyde, infections materials, and other chemicals 
Various ESRD Network Standards of Patient Care 
FDA Safety Alert: Chloramines, 1987 
Various State Standards, including: 
- 
Minimum Standards to Comply with Existing Federal and State of California Regu 
tions ("Chloramines Removal from Renal Dialysis Water Supplies") 
- 
California Standard for Water Piping Systems in Hemodialysis 
Various Local Statutes 
JCAHO Standards 
Facility Policies 
ManufacturerssI nstructions for Use 
Ass  Guidelines for Hemodialysis Devices  It is usually not necessary to create new data sources for quality assurance purposes.  Existing 
sources include: 
Medical Record 
Dialysis RecordILog Sheets 
Patient Care Plans 
Hospitalization Record 
Laboratory and other Diagnostic Records 
Incident Reports 
Adverse Occurrence Reports 
Equipment Maintenance Reports 
Water Quality Monitoring Reports 
Culture Reports: Water, Reused Dialyzers, Dialysate, Environmental 
Hepatitis Surveillance Reports 
Electrical Safety Testing Reports 
Reuse Master File 
Patient Satisfaction Surveys 
State and Federal Survey Reports 
Medical Device Alerts 
Manufacturers' Recalls 
Performance Appraisals 
Utilization Review Reports 
Quality Assurance Guidelines for Hernodialysis Devices  . 
Chapter 3 
WATER  TREATMENT 
CONTENTS 
Page 
...................... 
TECHNICAL DESCRIPTION OF DEVICE  3-1 
....................................... 
RISKS AND HAZARDS  3-1 
I  ..................................... 
EXISTINGGUIDELINES  3-2 
... 
QUALITY ASSURANCE FOR WATER TREATMENT SYSTEMS  3-3 
.................................. 
Policies and Procedures  3-3 
............................ 
Staff Training and Education  3-3 
.............................. 
Monitoring and Evaluation  3-4 
................................. 
Daily Monitoring  3-4 
.............................. 
Monthly Monitoring  3-4 
................................ 
Patient Monitoring  3-5 
.......................... 
Home Dialysis Monitoring  3-5 
................................. 
Other Monitoring  3-5 
....................................... 
Prevention  3-5 
............................. 
Purchasing Guidelines  3-5 
............................................... 
REFERENCES  3-6 
............................. 
TABLES. FIGURES. AND FORMS  3-7 
;. 
ArsU?'ane Guidelines for Hernodialysis Devices  Chapter 3  Water Treatment 
TECHNICAL DESCRIPTION OF  incidents or complications can be summarized by 
DEVICE  fkmsingonpl.c331emsthatomuredwitheachcomponent 
Prior to the 1970ts,c hronic hemodiaysis was performed  Filters Bacterial growth, resulting in pyrogen 
using tap water to prepare the dialysate. In these  reactions; hemolysis, due to elution of formalde- 
early days, medical instability of the chronic renal  hyde from media; particle breakthrough, causing 
failure patient in combination with the multiple  damage to downstream equipment. 
problems related to other components of the dialysis 
therapy tended to mask problems that may have  Carbon Absorption: Bacterial growth, causing 
been due to impurities in the tap water.  pyrogen reactions; chloramine breakthrough, due 
to inadequate sizing or exhaustion of the media 
As the practice of hemodialysis progressed and the  resulting in hemolysis; release of carbon fines, 
equipment and other apparatus involved in the therapy  damaging the reverse osmosis RO.) membrane; 
improved, it became apparent that various chemical  inappropriate bypassing of carbon filter. 
and microbiological contaminants present in tap 
water were indeed responsible for a number of the  Softeners:  Bacterial contamination, resulting 
deleterious effects seen in the chronic hemodialysis  in pymgen reactions; hypercalcemia and hypermag- 
population.  Table 1A presents a list of the most  nesernia, due to inadequate regenemtion, improper 
common contaminants found in tap water, and Table  connections, and poor salt quality; hypematremia, 
1B  presents the clinical effects related to these  due to mistiming of regeneration while patients 
contaminants.  were on dialysis. 
Today, virtually all chronic hemodialysis facilities  Ion Exchange: Bacterial contamination, causing 
in the United States employ some type of water  pyrcgen reactions; elution offloride, toxic residues, 
treatment system to purify water before using it to  and acidic effluent, due to continued use of ex- 
produce dialysate.  hausted deionization system; elution of chemical 
toxins and impurities, due to the use of industrial 
Water treatment systems are a combination of a  grade resins; sloughing ofhes, due to poor quality 
variety of components, each with varying roles and  of resins; patient exposure to toxic chemicals, 
effectiveness in removing contaminants commonly  due to inadequate rinsing of disinfectant; low 
present in drinking water. Table 2 briefly reviews  pH,  due to acidic effluent; nitrosaxnines from 
the most common water treatment system components  use without carbon filter. 
used for producing purified water for hemodialysis. 
Reverse Osmosis: Bacterial contamination, due 
In 1989 the FDA produced and released a videotape  to inadequate disinfecting or membrane break- 
entitled Water Treatment in Hemdialysis and in  through; premature failure of membrane, due to 
1990 a manual entitled A Manual on Water Treat-  inadequate or improper pretreatment. 
ment for Hemdialysis  Both have been distributed 
to all dialysis facilities in the United States.  Storage: Bacterial contamination, resulting in 
pyrogen reactions; zinc toxicity, due to leaching 
from storage tank. 
#=KSAND  HAZARDS 
Distribution: Bacterial contamination, causing 
pyrogen reactions; back-siphoning of germicide 
prior to 1980 contains reports ofpatient 
from one machine to another, due to improper 
ons attributed to malfunctions or misuse 
distribution design. 
water treatment systems in hemodialysis. These 
Assurance Guidelines for Hernodidvsis Deoices  Literature review from 1980 through 1989 and the  treated as necessary to maintain a continuous 
more recent MDR files indicate the following additional  water supply that is biologically and chemically 
incidenwproblem areas:  compatible with acceptable dialysis techniques. 
Records of test results and equipment maintenance 
Inadequate removal of aluminum in the water  are maintained at the facility." 
purification  process  for dialysis, resulting in 
aluminum-inducedf racturing osteodystrophy and  2. The second set of guidelines is contained in the 
dialysis dementia.  American National Standards for Hemodialysis 
Systems (AAMI: RD5-1981).  In this document 
Bacteremia and pyrogen reactions, resulting from 
the standards are related to the manufacturer 
improper placement of water heater "downstreamn  and to the user.  A summary of the standards 
of reverse osmosis. 
for the manufacturers is found in Table 3 and a 
summary of the standards for the user is contained 
Contamination of water used for the reuse of 
in Table 4.  Recommendations to enable users to 
dialyzers with non-tuberculous micobacterium, 
achieve the standards are summarized in Table 
due to inadequate design andlor disinfection of 
5. 
water treatment system and distribution piping. 
Ethylene glycol intoxication, due to accidental  3. The third standard, in the Code of Federal Regula- 
attachment of air conditioning system to dialysis  tions 42 CFR Part 405.2150, is related to reuse 
water treatment system.  of hemodialyzers and other dialysis supplies. 
This section adopts, by reference, the AAMI 
Nitrate induced anemia in a home dialysis patient,  Recommended Practice for Reuse of Hemodialy- 
due to inadequate water treatment (sohner only).  zers.  Table 6 summarizes this standard. 
Metabolic acidosis, due to improper water bwdment  4. The fourth guideline is the Safety Alert issued 
and low pH of purified water.  by the Food and Drug Administration (FDAS that 
issued recommendations regarding chloramines 
Pseudomonas stutzeri bacteremia and pyrogen 
and their removal (February 19, 1988).  This 
reactions, due to contamination of deionizers. 
document states that the use of granular activated 
Generation of dimethylnitmsamine (a carcinogen)  filters for removal of chloramines should include 
in mixed-bed deionizer, due to non-use of pre-  the following 
carbon filter. 
a Whenever a change is made in the exisiting 
Accidental over-fluoridation of municipal (tap)  water treatment system, ascertain the capacity 
water combined with inadequate monitoring of  of the carbon filter to cope with that change 
deionization, resulting in use of exhausted tanks  by consulting with a water treatment engineer, 
and subsequent toxic patient reactions (including  contractor, or consultant who is experienced 
death) from fluoride contamination.  in the operation of hernodialysis water treatment 
systems. This is to assure that the maximum 
Many ofthe incidents could have been avoided through  expected level of chloramines from the municipal 
routine testing, observations, a  more thorough 
water supply can be effectively removed with 
understanding of water treatment, proper system 
the carbon filter being used. 
design, and quality control procedures. Although 
only a few of these incidents resulted in patient  b. Use charcoal filters containing granular activated 
death, almost all had the potential to cause death.  carbon (GAC) and replace rather than regenerate 
the filters when exhausted. It is recommended 
(Womia law requires) that the water treatment 
system contain two carbon filters in series. 
m T I N GG  UIDELINES 
c.  Test the water for chloramines as it exits the 
There are four standards/guidelines pertaining to  first filter at least once per patient shift.  If 
water for dialysis purposes: 
the level of chloramines exceeds the 0.1 ppm 
standard, there should be an immediate test 
1. The Code of Federal Regulations 42 CFR Subpart 
for the chloramine level in the water used to 
U, Part 405.2140 (a) (5)s tates that Water used 
prepare dialysate. 
for dialysis purposes is analyzed periodically and 
Quality Assurance Guidelines for Hernodialysis Devices  3-2  d. Establish a systematic plan for replacing the  Staff Training and Continuing 
filters as they become exhausted.  With the  Education 
filters in series, the exhausted first filter can 
be replaced with the second, and a new carbon  Role descriptions should include all personnel 
placed in the second position.  responsibilities for water treatment: supplies and 
equipment, testing and monitoring, and other similar 
e.  Whenever a carbon filter is replaced, disinfect 
responsibilities.  Each responsibility should stem 
and thoroughly rinse the filter housing before 
from a specific policy or procedure. 
the new filter is installed. 
StafF training should be a well-defined and organized 
process.  Content should be clearly defined for the 
QUALITY ASSURANCE FOR  learner and be based on behavioral objectives. The 
WATER TREATMENT SYSTEMS  behavioral objectives can be used to accurately and 
objectively measure learning.  At the end of the 
Policies and Procedures  didactic session(s), the instructor should confirm 
by a written test andlor return demonstration that 
An essential facility quality assurance activity is  learning has occurred and that the learner is able 
the development, writing, implementation, and evalua-  to perform the procedure(s) independently without 
tion of policies and procedures for the water treatment  error.  Documentation of testing results should be 
system.  All standards previously described must  placed in personnel files. 
be incorporated into these policies and procedures. 
Specifically, the policies and procedures must address  Comprehension of the purpose and function of each 
the scope oftreatment, components and related equip  component of the water treatment system requires 
ment and monitors, and testing expectations.  a basic understanding of  normal physiological 
concepts, as well as responses associated with uremia 
Comprehensive policies and procedures must also  and the hemodialysis therapy. Content should include 
address the interrelationships of each component  principles of dialysis and water treatment, patient 
of the water treatment system, as well as the various  response to therapy and related complications, and 
related components, such as the dialyzer, delivery  monitoring and evaluation. The interrelationships 
system and patient.  The risks involved must be  of  each system component, the delivery system, 
clearly identified and considered, and appropriate  dialysate, dialyzer, etc. must be incorporated into 
safety measures and preventative systems developed.  the training process. 
Policies and procedures must also address safe and  Need for further education, such as inservices or 
effective operation of the water treatment system,  intensive educational sessions, can be determined 
including  from the routine quality assurance monitoring process 
(see Form 1, 'Water Treatment System Monitoring 
basic technical operation 
Form",  used for concurrent quality assurance 
use of the equipment 
monitoring) and the ongoing staff performance 
safety checks  appraisal process.  When problems are identified, 
preventative maintenance  staff should be made aware of the problems and be 
involved in their resolution.  This nearly always 
cleaning and disinfection 
includes problem-specific continuing education. 
scheduled monitoring 
troubleshooting and repair  The medical director of the dialysis facility must 
record keeping  verify that the individual has successfblly completed 
the initial education and training program.  The 
patient monitoring. 
medical director is also responsible for assuring that 
an annual performance evaluation has been performed. 
Asswrance Guidelines 
Hernodialysis Devices  Monitoring and Evaluation  firms that water being delivered from the softener 
is at acceptable limits at that time. Some experts 
A  Daily Monitoring  recommend, however, that post sohner hardness 
also be tested at the end of the treatment day in 
To continually confirm that water produced by the 
order to confirm proper softener sizing and 
system is suitable for hemodialysis purposes as well 
regeneration protocols. 
as to confirm the integrity and proper functioning 
of all system components, an aggressive monitoring  7. Chloramines testing:T esting for chlorarnines should 
process must be followed. Form 2, Water Treatment  be performed as the water exits the  granular- 
System hg," provides a useable format 61-th e mrding  activated carbon filter. Using the recommended 
of these data:  DPD (N. Ndiethyl-pphenylene diamine) method, 
(Please note that this form is provided as a model  results should always be less than O.lmg;/L.  If 
only; actuul content may need to be altered to fl the  chloramine levels exiting the first tank exceed 
O.lmg/liter, a test of the effluent of the second 
specific system of the individual facility.) 
tank should be immediately performed. Dialysis 
1. Temperature: Daily confirmation of temperature  should not proceed if the water used for production 
should be performed.  of dialysate contains more than 0.1 m& 
2.  Pressure Monitoring: Monitoring of pressure levels  8. Audit: The reader will note the final line at the 
and pressure drops across components assures  bottom of the Water Treatment Log" indicates 
proper operating conditions.  "Auditn On a daily basis, someone who is knowledge 
able about the tests, measurements, and limits 
3. Softener timer check: In installations where a 
for the water treatment monitoring, as well as 
timer is used to actuate automatic regeneration 
the acceptable limits set forth in the facility's 
of the water softener, a daily check of clock set 
policies and procedures for each one of those 
time should be performed. 
measurements, should review the results.  The 
4. Reverse osmosis feed flow and permeate flow:  person performing the tests should be aware of 
Substantial reduction in product flow rate is an  the acceptable limits and should have performed 
indication that there may be problems with a  proper notification and taken appropriate action 
pretreatment component or the reverse osmosis  if the testdmeasurements performed indicated 
membrane may be degrading due to scaling or  results outside of acceptable limits. 
other types of membrane failure associated with 
B.  Monthly monitoring 
inadequate pretreatment. 
1. Conductivity meters require recalibration monthly, 
5. Feed water total dissolved solids CTDS), product 
following the manufacturers recommendations. 
water TDS, percent rejection:  AAMI Standards 
state that (for new RO. systems) "percent rejection  2. Microbiological testing of system components and 
should be continuously monitored." This provides  the distribution system must be performed monthly 
an indication of the condition of the RO. membranes  in the following manner: 
as well as helping monitor against any catastrophic 
compromise in membrane integrity.  a Post cadmn filhtkm AAMI (American National 
Standards for Hem-  systems) recommends 
The performance shall be such that the salt passage  that "carbon tanks be monitored for excess 
rate (100% minus the rejection rate) does not  bacterial levels." Although there is no standard 
exceed two times the salt passage rate of the  for bacterial levels exiting a carbon tank, very 
equipment at the time of its initial qualification.  high levels may indicate a load so high that 
domtxeam components are unable to adequately 
Calculate the salt rejection by the following formula: 
remove them. 
b. Post reverse osmosis: If a reverse osmosis 
system is used as a primary method for attaining 
microbiologically acceptable water, bacterial 
6. Post water softener hardness: The AAMI American 
levels should be assessed immediately aRer 
National Standard for Hemodialysis Systems also 
the R.O. to ascertain that this goal is being 
recommends that post waters oftener hardness 
achieved. 
be checked daily before dialysis begins. This con- 
Quality Assurance Guidelines for Hemodialysis Devices  3-4  c Post storage tank: If a storage tank is used  be performed.  A tool for assisting the facility in 
in the water treatment system, bacterial levels  this activity is shown as Form 3. 
should be cultured directly from this tank in 
F.  Prevention 
order to ascertain proper tank design and 
disinfection protocols.  1. Audit recordkeeping procedures semiannually. 
d. Post deionize= If the deionizer is used without  2. Policies and procedures related to water treatment 
reverse osmosis, or placed post reverse osmosis  and water treatment equipment should be reviewed 
without any downstream bacterial or endotoxin  annually. 
protection (an ukdlter), midological  integrity 
of the effluent must be confirmed.  3. Facility standards related to the water treatment 
system should be reviewed annually. 
e.  Post ultrafilter: If an ultrafilter is used as a 
final bacteriaVendotoxin filter, integrity and  4. Maintenance and repair logs related to the water 
proper disinfection of the ultrafilter must also  treatment system should be reviewed annually. 
be confirmed. 
5. Any utility (water, drain, electricity) requirements 
f  End of "return loop": A sample should be  related to the water treatment system should be 
performed at the end of the "return loop," if  reviewed annually. 
used, as a final measurement of bacterial 
G.  Purchasing Guidelines 
colonization anywhere in the system. 
1. Establish quality specifications for all equipment 
3. Any incident related to the water treatment system 
used. 
should be handled immediately, and should be 
included in monthly quality assurance meetings.  2.  Estimate quantity requirements; allow for future 
growth and possible membrane degradation. 
C.  Patient Monitoring 
3. Cite applicable standards. 
The following monitoring activities relate to patient 
response as it pertains to water treatment:  4. Require system validation by the vendor to assure 
specifications are met. 
1. Routine blood chemistries may indicate improper 
inorganic chemical concentrations or organic chemi-  5. Require the vendor to test for andfor disclose 
cal contaminates.  adverse conditions/substancest hat may effed the 
membrane. 
2. Normal intra-dialytic monitoring of patients and 
patient symptomology during the dialysis session  6. Rap& a detailed manual for operation, maintenance, 
can also provide indications of chemical water  monitoring, disinfection, and safety. 
contamination.  Symptoms seen with improper 
water treatment are presented in Table lA  7. Evaluate need for service contract. 
As mmmended by the Food and Drug Administration 
D.  Home Dialysis Monitoring 
in the February 19, 1988 Safety Alert, a qualified 
All of the monitoring procedures described above  water engineer or consultant familiar with the special 
should be performed by the home dialysis patient,  needs of dialysis facilities should be consulted when 
home dialysis support personnel, and reviewed by  designing or installing a new water treatment system 
the medical director, as appropriate.  or changing an existing one.  Whenever changes 
are made, it is essential to re-evaluate the design 
E.  Other Monitoring 
of the water system as a whole in order to be certain 
'he following water treatment system monitoring  that it is adequate.  The engineer or consultant, 
should be performed on at least a quarterly basis:  along with the facility, should be familiar with per- 
tinent chemical and bacteriological standards such 
1. Safety supplies. All safety supplies related to  as the A Mst andard andor local, state, and federal 
personnel handling of chemical toxins or biological  requirements. 
contaminants should be inspected. 
Additionally, the design and specification guidelines 
2 Trend analysis.  A trend analysis comparing  contained in the FDA publication, A Manual on 
microbial monitoring and system 
I  fhction should  Water llZaQtment@  HernodiaEysis, should be reviewed. 
Hernodialysis Devices  REFERENCES 
1. Association for the Advancement of Medical Instrumentation. American National Standard for 
Hemodialysis Systems (AAMI: RD5-1981). Arlington, VA (1982). 
2.  KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation of Risks and 
Hazards Associated with Hemodialysis Systems (Technical Report, Contract #223-78-5046). 
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration/ 
Bureau of Medical Devices, Silver Spring, MD (1980). 
3.  EASTERLING, R.  Mechanical Aspects of Dialysis Including Dialysate Delivery Systems and 
WaterforD  ialysate. inclinical Dialysis. A.R. Nissenson, R.N. Fine and D.E. Gentile, eds. Apple- 
ton-Century-Crofts, Norwalk, CT (1984). 
4.  LUEHMANN, D.A., KESHAVIAH, P.R., WARD, R.A., KLEIN,E . and THOMAS, A.  A Manual 
on Water Treatment for Hemodialysis (FDA Contract #223-87-6027). U.S. Dept. of Health and 
Human Services, Public Health Service, Food and Drug AdministratiodCenters for Devices and 
Radiological Health, Rockville, MD (1989). 
5. Water Treatment in Hemodialysis (Videotape). Food and Drug Administration  (1989). 
6.  VASQUEZ, L. and McELROY, V.L.  Validution Protocols for Hemodialysis Water Systems. 
Continental Water System Corp., San Antonio, TX (1988). 
Note:  A list of additional references on this topic can be found in Appendix E at the end of this 
manual.  These additional references are included to enable the reader to pursue further 
investigationfor the purpose of training or research on this topic . 
Quality Assurance Guidelines for Hemodialysis Devices  TABLE1A   
WATERC  ONTAMINANTS AND  THE LOWEST  CONCENTRATIONS 
ASSOCIATED WITH  TOXICITY  IN THE HEMODIALYSIS SETTING 
Lowest Concentration 
Contaminants  Associated with Toxicity (mg/L) 
Aluminum  0.06 
Chloramines  0.25 
Fluoride  1. o 
Copper  0.49 
Zinc  0.2 
Nitrate  21 (as N) 
Sulfate  200 
Calcium/Magnesium  88 (Ca**) 
Sodium  300 
- 
Microbial 
Luehmn. et a1 (1989) 
SIGNS 
AND  SYMPTOMS  AND  POSSIBLE  WATER 
CONTAMINANT-RELATED  CAUSES 
Sign or  Possible Water Contaminant-Related 
Symptom  Cause 
Anemia  Aluminum, chloramines, copper, zinc 
Bone disease  Aluminum, fluoride 
Hemolysis  Chloramines, copper, nitrates 
Hypertension  Calcium, sodium 
Hypotension  Bacteria, endotoxin, nitrates 
Metabolic acidosis  Low pH, sulfates 
Muscle weakness  Calcium, magnesium 
Nausea and vomiting  Bacteria, calcium, copper, endotoxin, lov 
magnesium, nitrates, sulphates, zinc 
Neurological deterioration  Aluminum 
and encephalopathy 
I 
Luehmn. et at. (1989) 
Quality Assurdnce Guidelines for Hernodialysis Devices  OPERATORR EOUI REMENTS 
-- 
Blending  Valve  Mixes hot and cold water to a fixed  Water temperature downstream 
predetermined temperature to  of blending valve should be moni- 
achieve optimal performance from  tored at least daily to maintain 
the reverse osmosis device.  optimum R.O. output, and to protect 
R.O. membrane and patients from 
excess temperature. 
Bed  Filter  Sand, multi-media, or diatomaceous  Filter should be backwashed at 
earth filter used to remove suspen-  frequent intewals.  Pressure drop 
ded matter or colloidal material  across filter should be monitored at 
before downstream components.  least daily. 
Carbon  Absorption  Activated carbon in tanks used to  Test water for chloramines after the 
remove chlorine, chloramine, and  first tank before every patient dialy- 
some organics.  Two tanks, each  sis shift.  If chlorarnines are > 0.1 
containing granular activated  mg/L (AAMI Standard), immediately 
carbon in series, are recommended.  test water exiting the second tank. 
Each tank should have an empty  If these levels exceed AAMl limits, 
bed contact time of 3 to 5 minutes.  dialysis should not proceed. When 
Carbon tanks should be followed by  chloramine levels reach AAMl limit 
particle filters to remove carbon  after first tank, replace carbon tank. 
fines from tank effluent. Do not  Monitor bacterial levels. 
install bypass piping. 
Water  Softener  A tank containing insoluble spheres  Test upstream for baseline. Main- 
or beads, called "resin." The resin  tain volume of salt in brine tank. 
exchanges cations (positively  Test post-softener water for hard- 
charged sodium ions) to remove  ness at least once daily. Check 
calcium and magnesium from in-  timer from proper setting at least 
coming hard water.  Most facilities  once daily. 
use "permanent" softeners which 
incorporate a brine tank containing 
concentrated sodium chloride 
solution and a control system to 
regenerate the softener at preset 
intervals. 
Reverse  Osmosis  A membrane separation process for  Periodic and validated disinfection 
removing solvent from a solution;  and cleaning should be performed to 
this system pressurizes feedwater  protect the R.O. membrane from 
on one side of a membrane.  By  scale deposition, particulate and 
creating a pressure high enough to  colloidal fouling, and bacterial 
exceed osmotic pressure, reverse  growth. Feed and product water 
osmotic flow of water occurs across  pressures, flow rates, and ionic 
a semipermeable membrane, giving  content (conductivity) should be 
"product water" essentially free of  monitored according to the manu- 
dissolved solids, microorganisms,  facturer's recommendations, but 
and endoxin.  at least daily.  Post-R.O. bacterial 
levels should be measured at least 
Variation in pH and temperature can 
affect performance. 
Quality Assurance Guidelines for Hernodialysis Devices  rank containing insoluble spheres,  Deionizers should be equipped with 
3r resin, which remove all types of  continuous monitors (temperature 
anions and cations and replace  compensated) indicating water ionic 
them with hydrogen and hydroxide  quality of at least 1 megohmfcm, 
ions which combine to form water.  and a visual and audible alarm, 
Deionizers may be categorized as  should the effluent fall below that 
'mixed bed," containing both cation  level. 
and anion resin in a single vessel, 01 Due to the propensity for bacterial 
'dual bed." where each resin type is 
growth in deionizers, they should be 
in a separate vessel. 
followed by a downstream compo- 
Due to the possibility of formation of  nent which removes bacteria and 
carcinogenic nitrosamines when  endotoxin. 
chlorine contacts the resin, carbon 
filtration should be used upstream 
of deionizers. 
A water tank that stores product  Monitor bacterial levels of tank 
water; requiredfdesired in some  effluent.  Disinfect tank and dis- 
installations. A water level detector  tribution system at intervals which 
controls the R.O.d elivery to the  have been validated to maintain 
tank and a recirculation pump  acceptable levels of microbiological 
maintains adequate flow and  contaminants. Monitor proper 
pressure to the distribution loop.  performance of level sensors. 
The Centers for Disease Control ha:  Confirm proper tank design: airtight 
recommended against use of stor-  tank with 0.2177 hydrophobic air 
age tanks due to hazards related to  filter; constant flow with no stagnanl 
bacterial contamination. However,  areas; able to be adequately disin- 
a number of facilities have been  fected and rinsed (bowl-shaped 
able to successfully use storage  bottom with drain); tank material 
tanks that are properly designed  should not add chemical contami- 
and effectively disinfected at  nants. etc. 
validated intervals. 
A low pressure mercury vapor lamp  Monitor loss of radiant energy out- 
protected by a quartz sleeve which  put. Perform regular maintenance, 
emits a bactericidal wavelength ligh  including lamp replacement and 
to water flowing past it. It should be  cleaning. 
noted, however, that certain bacter, 
ial species are resistant to ultravio- 
let irradiation and that this method 
does not remove endotoxins.  Bio- 
film will decrease effectiveness. 
Assurance Guidelines  Hernodialysis Devices  COMPONENNT AYE   OPERATORRE OURI EM ENTS 
Ultrafllter  A membrane filter capable of work-  Pressure drop and flow rate across 
ing solely off of existing circuit  the filter should be monitored on at 
pressure (no special pressurizatibn  least a daily basis. Filter should be 
pump is required (as with R.O.))  cleaned and disinfected on a routine 
which will remove smaller partides  and validated intewal. Post-filter 
than depth filters.  Ultrafilter mem-  bacterial levels should be moni- 
branes can be configured as hollow  tored. 
fibers or spiral wound flat sheets, 
and they can be operated in either a 
'dead-end" or "cross-flow filtration" 
mode. 
Ultrafilters are capable of removing 
bacteria and endotoxin. 
 --
Dlstrlbutlon  Loop  The distribution loop includes all  At least monthly monitor bacterial 
piping from other water treatment  levels in distribution piping at point 
system components, distribution  where dialysis delivery systems 
pumps, pressure tanks, etc.  connect.  Disinfect distribution 
system at intervals which have 
Current acceptable industry design 
been validated to maintain accept- 
suggests: 
able levels of microbiological 
constant flow through all distri- 
contaminants. 
bution piping, most commonly 
achieved via "recirculating loop" 
pipe materials which do not 
degrade the chemical or micro- 
biological quality of the water 
a minimum flow velocity in piping 
of 1.5 ftlsec to discourage bac- 
terial colonization 
avoidance of any dead-ends in 
piping. 
Quality Assurance Guidelines for Hernodialysis Devices  TABLE3  
AAMI RJZQUIREMENFTOSR   MANUFACTURERS 
GENERAL 
Device labeling 
Product literature 
Initial validation 
Materials compatibility 
SUPPLIERA:U  TOMATRICE GENERATDIOENV ICES 
Shall prevent excess levels of contaminants from entering downstream during 
regeneration 
SUPPLIERC:A RBOFNIL TERS 
5p filter downstream 
Discard and replace exhausted GAC 
SUPPLIERD:E  JONIZATION 
Continuous resistivity monitor (>l megohm/cm) 
Temperature compensated monitor 
Visual and audible alarm 
GAC upstream (nitrosamines) 
SUPPLIERPI:P ING, STORAGTEA NKS 
Shall not contribute contaminants (i.e., copper, zinc, lead, bacterial, etc.) 
SUPPLIER:R  EVERSOES MOSIS 
Capable of AAMl spec. water 
Monitor sall passage (2x initial) (salt passage = 100 - rejection rate) 
Audible and visual alarms (at highest rejection coefficient where contaminants 
reach unsafe levels) 
SUPPLIERS:E DIMENFTIL  TERS 
Opaque housings 
Assurance Guidelines for Hernodialysis Devices  TABLE4  
AAMI STANDARFODRS  F  ACILITIES/USERS 
MICROBIOLOGICAML ONITORING 
Should be performed at least monthly 
Total viable microbial counts shall not exceed 200lml in water used to prepare 
dialysate, or 2000lml in proportioned dialysate exiting the dialyzer. 
CHEMICACL ONTAMINANMTOSN  ITORING 
Should be performed at least yearly if prepared by Dl or RO, more frequently if 
prepared with lesser level of treatment. 
AAMl maximum levels of chemical contaminants*: 
Contaminant  Suggested Maximum Level (mgIL) 
Calcium  2 (0.1 mEq/L) 
Magnesium  4 (0.3 mEq/L) 
Sodium**  70 (3 mEq/L) 
Potassium  8 (0.2 mEq/L) 
Fluoride  0.2 
Chlorine  0.5 
Chloramines  0.1 
Nitrate (N)  2 
Sulfate  100 
Copper, Barium, Zinc  0.1 each 
Aluminum  0.01 
Arsenic, Lead, Silver  0.005 each 
Cadmium  0.001 
Chromium  0.014 
Selenium  0.09 
Mercury  0.0002 
The physician has ultimate responsibility for determining the quality of water used for 
dialysis. 
** 
230 mg/L (10 mEq/L) where sodium concentration of the concentrate has been 
reduced to compensate for the excess sodium in the water, as long as conductivity 
of water is being continuously monitored. 
Quality Assurance Guidelines for Hernodialysis Devices  TABLE5  
AAMI RECOMMENDATIONFOSR   USERS 
CARBOFNIL TRATION 
Disposable carton 
Monitor for bacteria 
Monitor for exhaustion 
DEIONIZATION 
Don't use "industrial" or process resins 
One megohm resistivity minimum quality with temperature compensated monitor 
Be aware of preservatives and anti-freeze solutions 
Carbon filtration for protection against nitrosamines 
DISINFECTION 
Good procedures for all equipment and systems 
Monitor for bacteria 
MONITORINPGR OGRAM 
Periodic water analysis 
In-line continuous monitoring 
Test kits for daily monitoring 
A procedures manual 
PIPINGS, TORAGEETC, . 
Don7 use copper, galvanized iron, or iron materials 
Monitor for bacteria 
REVERSOES MOSIS 
Monitor pretreatment 
Monitor operation 
SEDIMENFTIL TERS 
Opaque filters 
Monitor pressure drop (AP) 
Change filters periodically and/or monitor for bacteria 
WATERSO  FENER 
Automatic regeneration with bypass during regeneration 
Pellet salt designed for softeners 
Check timer before dialysis 
Check hardness before dialysis  AAMI RECOMMEND~ECD' l ' I C EF OR  REUSE OF HEMODIAL~ER: 
WATERR  EQUIREMENTS 
Must meet requirements (pressure, flow rate, chemical quality, microbiological 
quality, etc.) of reprocessing equipment operating under peak conditions. 
WATERU SEDF OR RINSINGCLEANINDGIA LYZER 
The water should have a bacterial colony count of less than 200lml and/or bacterial 
lipopolysaccharidec oncentration of less than 1 nglml (5EUlml). as measured by the 
Limulus amebocyte lysate assay. 
The water should have a bacterial colony count of less than 2001ml and/or bacterial 
lipopolysaccharidec oncentration of less than 1 ng/ml(5EU/ml), as measured by the 
Limulus amebocyte lystate assay. 
Quality Assurance Guidelines for Hernodialysis Devices  PROCEDURE FOR 
WATER TREATMENT SYSTEM 
MONITORING FORM (FORM 1) 
The purpose of this audit is to monitor technical  Perform the Audit 
staff compliance with standard practices and pro- 
cedures related to the water treatment system.  1. On the actual audit sheet, write in the date, 
When staff are aware of the importance of the  auditor's name, patient shift (or time of day), 
policies  and well  trained in the procedures,  and standard. 
compliance should be very high. 
2. Read each indicator carefully. 
Before the Audit 
3. Observe staff for actual performance. Auditor 
should not interfere with staff activities, be 
1. Provide adequate and appropriate inservice to 
obtrusive, or preceptibly obvious. 
assure total staff awareness and education of 
all components associated with water treatment  4. Under each staff code letter, write Y for yes if 
for dialysis.  indicator is met, N for no ifindicator is not met, 
or N/A for not applicable, not observed. 
2. Assure staff awareness of all elements of the 
concurrent audit and how performance will be  To achieve a Y (yes, indicator was met), staff 
observed and evaluated.  should be observed with complete compliance 
for each encounter.  For example, for a Y to 
3. The QA committee specifies the standard (ex- 
appear in the "Post-Softener Hardness Donen 
pected percentage compliance) desired for the 
box, the staff member must perform the test 
audit; begin not lower than 85%. 
before any patient dialysis is done and perform 
4. Schedule the audit with appropriate personnel  the test exactly according to the instructions 
(head nurse, charge nurse, chief technician).  for use of the test manufacturer and record the 
results as per facility policy. 
5. Make copies of  the audit for each auditor1 
observer.  5. Complete all observations within  timeframe 
specified. Assure that each indicator has one 
6. Assign code letters for each staff member to be  response. 
observed; for example: 
After the Audit 
Employee  A:  Glenn Close 
B:  Tom Hanks  1. Under each employee code letter, add total 
C.  William Hurt  number of Ys and Ns; do not count NAs. 
etc. 
2. For each employee, calculate compliance per- 
7. Determine how many staff are to be observed. 
centage by dividing the total Ys by the total 
Iti s recommend that one auditor should observe 
observations; again, do not count NAs. 
no more than three to four staff at one time. 
3. Calculate total compliance percentage for the 
8. Define the length of time for observation. It is  audit by dividing total Ys (all employee Ys) by 
recommended that the audit be conducted dur-  the total observations; do not count NAs. 
ing peak activity times (daily start-up, shift 
changeovers, etc.). The time frame should be  4. For each indicator, calculate compliance per- 
long enough to observe each staff member com-  centage by using the same method as above; 
pletely perform the listed activity.  again, do not count NAs. 
9. Assign a staff member to perform the audit.  5. Report results to QA committee and clinical 
Auditor  should  not be  assigned to other  management team with additional comments 
responsibilities during the audit.  andlor recommendations. 
rlity Assurance Guidelines  Hernodialysis Devices  WATER TREATMENTS YSTEMM  ONITORINGF ORM 
-  -  - -  -  - - 
Date  Patient  Shift  Auditor 
DayIDate 
Staff Member  (initials) 
DAILY MONlTORlNGlSYSTEM CHECKS  Threshold 
I I I I I I I  
All gauge readings recorded 
pp-  --  -  - - 
Post-softener hardness done 
Pre-softener hardness done 
Chloramines tested:  Before 1s t patient shift 
Chloramines tested: Before 2nd patient shift 
Chloramines tested: Before 3rd patient shift 
Blended water temperature recorded 
Feed and Droduct TDS, % rejection recorded 
-- 
Feed and product flow rates recorded 
Daily audit of log form done 
MONTHLY  FUNCTIONS  Staff  Member  Threshold  %  Compliant 
Svstem disinfection loaaed 
1  I 
Bacterial samples donelresults recorded: Site 
- 
Bacterial sampl&  donelresults recorded: Site 
Bacterial sam~lesd onelresults recorded:  Site 
I 
Bacterial samples donelresults recorded: Site 
Q.A. Committee Remmnended Aubn:  Mon  Tue  Wed  Thu  Fr i  Sat 
DATE 
GAUGE READINGS 
Pressure gauge #1 (psi) (pre-mix bed) 
AP-mixed bed 
Pressure gauge #2 (psi) (pre-softener) 
AP-softener 
Pressure gauge #3 (psi) (precarb 1) 
AP-carbon tank #1 
Presure gauge #4 (psi) (pre-carb 2) 
AP-carbon tank #2 
Softener timer check 
I Temperature (OF)  I  I  I  I  I  I  I 
Pressure gauge #6 (psi) (pre-filter) 
Pressure guage #7 (psi) (post-filter) 
AP-R.O. pre-filter 
Feedwater TDS 
- Product water TDS 
Percent rejection 
Feed flow 
Permeate flow 
Feed pressure 
Permeate pressure 
WATER  TESTS 
Pre-softener hardness 
Post-softener hardness (p.m.) 
7 
Post-softener hardness (a.m.) 
LOGGED BY 
CHLORAMINES  TESTS  (~0.1m gL) 
Before 1st patient shift (initials) 
Before 2nd patient shift (initials) 
Before 3rd patient shift (initials) 
-AUDIT  (initials)  (  Jan  I  Feb  (  Mar  I  Apr  I May  I  Jun  I  Jul  1  Aug  1  Sep  (  Oct  1  Nov  (  Dec 
DATE  I  1  I  I  1  I 
-. . . - 1  I  I  I  I  I  I  I  I 
BACTERIAL SAMPLES 
Station #I 
Station #2 
Station #3 
Station #4 
Station #5 
Station #6 
Station #7 
Station #8 
Station #9 
I 
Station #0I  
SOFTENER 
-- 
CHLORAMINES 
City Water 
Post GAC 1s t shift 
Post GAC 2nd shift 
Post GAC 3rd shift 
Post GAC 4th shift 
REVERSE  OSMOSIS 
Feed flow rate 
Product flow rate 
Percent recover 
Feed TDS 
Product TDS 
Percent rejection 
Feed temperature 
k5 
 '-t
00   Chapter 4  Dialysis Delivery 
System 
TECHNICAL DESCEUPTION OF  Appropriate dilutionlproportioning of concentrate. 
DEVICE 
Heating dialysate to physiological range. 
The dialysis delivery system (delivery system) sup 
Continuous monitoring of conductivity (and in 
plies dialysate to the hemodialyzer, maintaining 
some machines pH) and interruption of dialy- 
proper concentration, temperature, pressures, and 
sate flow to the dialyzer if these parameters differ 
flow in the dialysate circuit. The delivery system 
from preset limits. 
also monitors various functions related to the di- 
alysate compartment and the blood compartment:  Peasing the dialyzer's dialysate compartment 
dialysate pressure, ultrafiltration rate, blood leaks  at a desired flow rate. 
into the dialysate, changes in the pressure of the 
Monitoring desired dialysate circuit pressures. 
blood circuit, air or air foam in the blood, and other 
parameters. 
Controlling andlor monitoring ultrafiltration rate. 
Single patient, single pass systems discharge di-  Pumping the blood from the patient through the 
alysate to drain after one passage through the dia-  dialyzer and back to the patient. 
lyzer and are used to deliver dialysate to one pa- 
tient at a time. Dialysate is produced from propor-  Monitoring pressure in the extracorporeal blood 
tioning dialysate concentrate and water. Normally,  circuit. 
single patient systems, also called "negative pres- 
Monitoring for blood in the effluent dialysate. 
sure systems," maintain a subatmospheric ("nega- 
tive") dialysate pressure in order to accomplish fluid  Monitoring for appearance of  air in the blood 
removal.  circuit. 
The central delivery system maintains a  single  Interrupting power to the blood pump in such 
"centralnd ialysate proportioner which prepares dialy-  situations as blood leaks, incorrectly heated di- 
sate for a number of bedside consoles or bedside  alysate, incorrect dialysate pressures, incorrect 
stations.  Both the single patient/single pass sys-  blood compartment pressures, air in the blood. 
tems and the multi-patient/single pass systems re- 
Table 1 provides a Iummary of dialysis delivery 
quire a continuous supply of purified water and a 
system components. 
continuous source of concentrate.  "Spent," or "ex- 
hausted" dialysate is discarded to the drain after it 
has made a single pass through the dialyzer. 
RISKS AND HAZARDS 
The sorbent or regenerative dialysis system involves 
reprocessing dial~satet hrough a cartridge to re- 
The literature prior to 1980 contains a large num- 
move toxins from the spent dialysate, as well as 
ber of reports of patient complications attributed to 
adjusting electrolytes to the desired level. The stan- 
problems with dialysis delivery systems. Included 
dard volume used in regenerative dialysis is ap- 
are those that contributed to serious patient injury 
proximately 6 liters. This process does not require 
or death: 
a continuous supply of water or concentrate and 
does not drain spent dialysate. 
Dialysate mixing errors 
'he basic functions of a dialysate delivery system 
Improper settinghesetting of alarm limits 
are summarized below:  Proportioning pump failure  Machine operated in bypass mode without at- 
taching concentrate, resulting in hemolysis. 
Conductivity monitor failue 
Hemolysis, due to empty concentrate jug con- 
Temperature alarm failure  current with no alarm or by-pass. 
Dialysate pressure alarm failure  Adverse reaction, due to improper pH, alarm 
improperly set or disabled. 
Blood circuit dysfunction 
Hypercalcemia, due to improperly proportioned 
Incidents reported in the literature or through the 
concentrate. 
Medical Device Reporting Program since 1980 are 
summarized in Appendix A  A total of 160 inci-  Improper concentrate used concumn@ with hap 
dents were reported.  Sixteen were related to cen-  propriately adjusted conductivity circuit, result- 
tral delivery systems and 144 were related to single  ing in hyponatrernia and hemolysis. 
patient delivery systems. 
Hypernatremia, due to high dialysate sodium 
Ofthe 160 incidents, 77 were related to user error.  (248mEqA) caused by facility personnel revers- 
Of the remaining, 70 included some component of  ing plumbing inside of machine. 
user error in addition to malfunction of the equip 
Hemolysis, due to the machine in bypass during 
ment itsew. Unfortunately, some of these problems 
dialysis and technically altered so water flowed 
resulted in patient death. 
through dialyzer. 
Incidents related to user error, or combination of 
Patient death due to hypernatremia after staff 
user error and machine malfunction included: 
member responded to conductivity alarm by re- 
calibrating c&ductivity circuit while patient was 
dialyzing. 
Blood Circuit 
Blood line clamp not completely occluding blood 
Todc  Chemicals 
line; air introduction into blood circuit, resulting 
in air embolism. 
Formaldehyde back-siphoned from one machine 
Patient injury or death from air embolism, due  to another (one machine set with high negative 
pressure while the next machine, not in opera- 
to an unarmed or bypassed air/foam detector. 
tion, yet in line on the water distribution system 
Uncontrolled blood pump operation, resulting in  still contained formaldehyde); resulted in patient 
vascular damage and/or excessive extracorporeal  toxic chemical exposure. 
circuit pressures. 
Toxic reactions due to patient exposure to ger- 
Patient bleeding, caused by excess heparin ad-  micide used for disinfectant in delivery system. 
ministration due to lack of heparin pump pre- 
ventative maintenance. 
Blciod pump stopped working during dialysis;  Bacterial Contamination 
condition had occurred previously with no ac- 
tion; caused clotting of extracorporeal circuit  Pyrogen reaction due to contaminated delivery 
systems. 
Dialysate Conductivity/Electrolytic 
Concentration  Ultrafiltration Control 
Machine -lfwlction  ~USinghyper~noicr h p   Improper ultrafiltration  rate due to machine 
tonic dialysate.  Hypematremia due to grossly  malfunction concurrent with lack of  personnel 
malagiusted conductivity. These events resulted  intervention, resulting in hypovolemic hypoten- 
in hemolysis, vomiting, seizure, and death.  sion. 
Quality Assurance Guidelines for Hernodialysis Devices  42  Dialysate Temperature  of the delivery system, as well as the various re- 
lated components, such as dialysate, the dialyzer, 
Flow through dialysate circuit despite temper-  blood lines, and transducer protectors.  The risks 
ature alarm or rinse setting resulting in hemo-  involved must be clearly identified, considered, and 
lysis.  appropriate safety measures and preventative sys- 
tems developed. 
Dialysate at 42OC instead of 37C with no alarm; 
caused hemolysis.  Policies and procedures must also address safe and 
effective operation of the delivery system: 
.b asic technical 
Equipment failure alone is not necessarily dangerous 
if a~~ro~liuasetre m  onitoring and interventions  set up and use of  equipmenant d related 
are utilized.  When inadequate monitoring andlor 
ponents 
inappropriate interventions are implemented, the 
malfunction may exacerbate into a lethal situation.  safety checks 
Of particular note, 147 of the incidents could  preventative maintenance 
have been averted had the user followed manu- 
. cleaning and disinfection 
facturer's instructions for use, preventative 
maintenance, repair, and/or troubleshooting.  tmubleshooting and repair 
record keeping 
EXISTING GUIDELINES  patient monitoring. 
The American National Standards for Hemodialysis 
Systems were developed by the Association for-the 
Staff Training and Continuing 
Advancement of Medical Instrumentation (AAMI) 
Education 
and approved by the American National Standards 
Institute in May 1982 (see Table 2). 
Role descriptions should include all personnel r e  
sponsibilities for operation and use of the delivery 
The most complete guideline for the operation of 
system including preventative maintenance, trouble- 
dialysis delivery systems, however, comes from the 
shooting and repairs, daily or per-treatment safety 
manufacturer's instructions for use. These instruc- 
and other system checks and recordkeeping.  Each 
tions should be incorporated into the facility's poli- 
responsibility should stem from a specific policy or 
cies and procedures. 
procedure. 
Staff training should be a well-defined and organ- 
QUALITY ASSURANCE FOR  ized program.  Content should be clearly defined 
DIALYSIS DELIVERY SYSTEMS  for the learner and based on behavioral objectives. 
The behavioral objectives can be used to accurately 
Policies and Procedures  and objectively measure learning.  At the end of 
the sessiods), the instructor must confirm by a 
An essential step in designing the facility's quality  written test andlor return demonstration that learn- 
a~surancep rogram is the development, implementa-  ing has occurred and that the learner is able to 
tion, and evaluation of policies and procedures for  perform the procedure(s) independently without error. 
dialysis delivery systems. All standards previously  Documentation of test results should be recorded 
described must be incorporated into these policies 
i  in the personnel file. 
s  and procedures.  Specifically, the policies and pro- 
d-s  must address the scope of care and thera-  Comprehension of the purpose and hction of the 
Wtic choices, equipment, disposables, and sup  dialysis delivery system requires a basic under- 
plies used in the dialysis facility.  standing of kidney disease, fluids and electrolytes, 
principles of dialysis, infection control, and compli- 
Comprehensive policies and procedures must also  cations of the hemodialysis treatment.  Content 
address the interrelationships of each component 
should include theory of operation, pre and post 
lity Assurance Guidelines for Hemodialysis Devices  operational procedures, parameters of safety, clean-  2. Temperature should also be within the manu- 
ing and disinfection, electrical safety, emergency  facturer's specifications. Temperature may be 
procedures, troubleshooting, and water treatment.  checked with an independent reference meter or 
with a reference thermometer. As with pH and 
Need for further education, such as inservices or  conductivity, the actual numerical readings should 
intensive educational sessions, can be determined  be recorded on the patient's daily dialysis record 
from the ongoing  quality monitoring process and  and initials of the person performing the test 
the continuous staff performance appraisal proc-  noted (see Form 1). 
ess. When problems are identified, staff should be 
made aware of  the problem and involved in its  3. Absence of residual germicide should be verified 
resolution.  This nearly always includes problem  on all delivery systems connected to a single water 
specific continuing education.  treatment qoop" before dialysis begins.  Such 
testing must be performed with an assay known 
The medical director of the dialysis facility must  to detect the minimum standard level. The test 
ascertain that the individual has successfully com-  results should be documented on the patient's 
pleted the initial education and training program.  daily dialysis record.  The actual result should 
The medical diredor is also responsible for assur-  be recorded and initials of the person perform- 
ing that an annual performance appraisal has been  ing the test noted (see Form 1). 
performed. 
4. A test of proper functioning of the airKoam de- 
tector should be performed before dialysis is ini- 
Monitoring and Evaluation  tiated.  This test should be a direct test of func- 
tion of the alarm, causing interruption of  the 
The following section provides a summary of rec-  blood pump and actuation of the blood line clamp, 
ommendations for monitoring that should be per-  either by introducing air into the venous level 
formed to enhance safety and reduce the level of  detector or by removing the tubing so that air is 
risk of patient injury due to incidents related to  sensed by the detector-as recommended by the 
malfunction andlor improper use of dialysis deliv-  device manufacturer.  Test results should be 
ery systems:  documented on the patient's  daily dialysis rec- 
ord.  The actual result should be recorded and 
A.  Daily Monitoring  initials of the person performing the test noted 
(see Form 1). 
1. Conductivity of the final dialysate being deliv- 
ered to the dialyzer should be checked  before  5. The blood detector must be checked for proper 
every treatment.  When used, the pH of bicar-  armed status according to the method recom- 
bonate dialysate should also be confirmed before  mended by the manufacturer. Test result should 
each treatment.  Conductivity must be within  be documented on the patient's daily dialysis rec- 
the manufacturer's stated specifics. If the pH is  ord.  The actual result should be recorded and 
below 6.5 or above 7.5, dialysis should not be  initials of the person performing the test noted 
started, even when conductivity is within ac-  (see Form 1). 
ceptable limits. 
6. If the delivery system employed is equipped with 
According to manufacturers' instructions, the  ultrafiltration control, the user should perform 
conductivity should be checked with an inde-  applicable tests of the ultrafiltration control sys- 
pendent reference meter which is known to be  tem as prescribed by the manufacturer.  Docu- 
properly calibrated. The pH can be checked with  mentation of that testing should be performed 
a similar meter or pH paper.  (see Form 1). 
These readings should be documented on the  7. All other alarms must be tested according to the 
patient's daily dialysis record.  The actual nu-  manufacturer's instructions for use before every 
merical readings should be recorded and initials  treatment including low and high conductivity 
of the person performing the test should be noted  alarm, low and high temperature alarm, dialy- 
(see Form 1 for sample recording format).  sate pressure alarm, water pressure alarm, etc. 
Quality ~ssuranceG uidelines for Hernodialysis Deuices  (Pm: 
Documentation of that testing should be per-  3. Preventative Maintenance  Monitor- 
formed (see Form 1).  ing documentation of all PM should be performed 
to assure that it is completed within the sched- 
If the particular delivery system is equipped with 
uled time frame and performed according to the 
a "self-alarm checkn mode, it is important that 
manufacturer's recommendations (see Form 3). 
the user understand that, most ohn, it is a 
check of the electronic circuitry, and not a con-  C. Patient Monitoring 
firmation of some of the vital hctions of spe- 
1. Routine intradialytic monitoring of patient's 
cific alarms. 
physiological parameters and symptoms during 
8. Observation of dialysate flow  should be made  the dialysis treatment can provide indications of 
while the machine is in a "dialyzingf  mode. A b   improper delivery system function.  A few pri- 
sence of dialysate flow should be confirmed when  mary types of symptoms seen are: 
the machine is in "bypassn mode actuated by 
Nausea, vomiting, and headache may be 
both manual setting of the machine to bypass or 
related to incorrect electrolyte composition of 
via any of the alarm functions that will cause 
the dialysate due to an incorrect dialysate or 
the machine to enter a bypass mode. 
improper proportioning of the delivery sys- 
B. Monthly Monitoring  tem. 
1. Micmbiological testing: In accordance with  Hypotension or hypertension may be re- 
the AAMI American National Standard for Heme  lated to improper ultrafiltration either through 
dialysis Systems and in keeping with accepted  failure of the ultrafiltration controller or im- 
industry standards,  water for production of di-  proper blood or dialysate circuit pressure. 
alysate and actual dialysate proportioned and 
Pyrogen reaction (shaking chills, increase 
exiting the dialyzer should be monitored for bac- 
in patient temperature of more than 1C dur- 
terial levels on no less than a monthly basis. 
ing treatment) or septicemia (identified through 
Microbiological monitoring is performed to es- 
blood cultures) may occur from patient expo- 
tablish ongoing validation of proper disinfection 
sure to endotoxin or bacteria due to improper 
protocols. 
disinfection of the dialysate circuit. 
Regular monitoring of a representative sample 
Hemolysis (cherry red blood in venous blood 
of delivery systems will sate once protocols 
tubing, chest pain, dyspnea, hypotension, in- 
are validated. 
creased serum potassium, decreased hemato- 
As indicated in the American National Stand-  crit) may occur due to improper dialysate com- 
ard for Hemodialysis Systems, the samphg should  position, machine malfunction resulting in wa- 
be done "at the termination of dialysis at the  ter only in the dialysate circuit, or very high 
point where dialysate exits the dialyze?.  Re-  dialysate temperature. 
sults for total microbial counts shall not exceed 
Acute blood loss (obvious source of blood 
2,000 colony forming units per ml. The facility 
spill, shock, vomiting, convulsions) may r e  
must assure that the American National Stan- 
sult from extreme pressures in the blood cir- 
dard for Hemodialysis Systems assay protocol is 
cuit causing line separation. 
followed. 
Air embolism (evidence of air in blood lines, 
2 Assessing trends: Pertinent information, i.e., 
chest pain, dyspnea, coughing, cyanosis, vis- 
bacterial levels, conductivity and pH readings, 
ual problems, confusion, coma, etc.) may re- 
etc., should be logged on a chart across a page so 
sult from air entering the blood circuit due to 
that readings can be examined and compared 
over an extended period of time. This tool makes  failure of the air detectiodine clamping sys- 
tem. 
it possible to compare current readings to those 
taken during the past several daydweeks/months. 
Altered mental status (confusion, convul- 
Any untoward trends thus become immediately 
sions, and coma) may occur due to improper 
obvious (see ~ o r m2 f or sample trend chart). 
dialysate concentration. 
ity Assurance Guidelines for Hemodialysis Devices  D.  Home Dialysis Monitoring  when preventative maintenance is required (see 
Form 3 for sample Master Preventative Mainte- 
All of the monitoring procedures described above 
nance Schedule). 
should be performed by the home dialysis patient, 
home dialysis support personnel, and reviewed by  A history file of all repairs and maintenance for 
the medical director, as appropriate.  each piece of equipment should be maintained 
in a separate file. This file describes all techni- 
E.  Other Monitoring 
cal operations performed on the equipment, in- 
L At the prescribed recommendations of the manu-  cluding date, parts used, actions taken, tests per- 
facturer, or at least quarterly, dialysate flow rate,  formed to assure proper functioning before and 
blood D-  U ~- Pflo w rate. and Drooer calibration of  &r  maintenandrepair, and person perform- 
ing maintenancdrepair. 
the heparin pump should be tested didY.A  ctual 
flow rate should be measured over a prescribed 
A log of all maintenancehepair work for each 
time using precise volume measurements.  piece of equipment should be kept at the front of 
the "history file."  This log includes a very brief 
An annual review of all policies and procedures 
description of the maintenancehepair (e.g., "500 
related to dialysis delivery systems should be 
hr maintenancen or "adjusted conductivity" or 
performed. 
"repaired inoperable blood pump," etc.), date, and 
All incidents or adverse occurrences related to  person performing action. Such a log provides a 
didysis delivery systems should be documented  trend analysis of any problems related to the de- 
and reported at the monthly quality assurance  livery system, as well as a quick confirmation of 
meetings.  maintenance being performed according to sched- 
ule. 
Quarterly monitoring of actual implementation 
of dialysis delivery system procedures should be  3. Repair & Troubleshooting:E ven when dialy- 
performed (see Form 4 for sample Pre-dialysis  sis delivery systems are properly designed, moni- 
Checks Monitors and Form 5 for sample Techni-  tored, and maintained, the entire system may 
cal Equipment Audit).  unexpectedly fail or a component of the system 
- 
mav fail. Althoueh these failures cannot be fore- 
F.  Prevention  seen and occur very infrequently, when they do 
occur, it is important that patients are not at 
1. Maintenance: Chapter 42 of the Code of Fed- 
risk. The most important aspect of system fail- 
eral Regulations, $405.2140(a)(2) requires that 
ure is to have an established and agreed upon 
"All electrical and other equipment used in the 
plan of action. This plan should be approved by 
facility is maintained free of defects that could 
be a potential hazard to patients or personnel.  the medical director and communicated to all 
facility staff. 
There is established a planned program of pre- 
ventative maintenance of equipment used in dialysis 
Repair and maintenance on a delivery system 
and related procedures in the facility." 
should  be performed by "qualified personnel." 
The definition of "qualified personneln may dif- 
Each manufacturer provides comprehensive di- 
fer from facility to facility, and that definition is 
rections pertaining to preventative maintenance 
the final responsibility of the medical director. 
requirements for the entire dialysis delivery sys- 
Consider the following recommendations: 
tem.  Maximum time intemals--either  in num- 
ber of hours of operation of the system or in 
a Facility personnel trained by another facility 
calendar days-between preventative maintenance 
personnel member who has been certified by 
procedures are also specified. The schedules and 
the manufacturer as competent to perform 
procedures established must be followed. 
such training, or 
2. Recordkeeping: A master schedule of all pre- 
b. Facility technical personnel who have success- 
ventative maintenance should be developed. Such  Mly completed (certified) the manufacturer's 
a master schedule will list every machine by  technical training program, or 
serid number or other identifier and identify 
c.  Manufacturer's technical service personnel. 
Quality Assurance Guidelines for Hernodialysis Devices  46  G. Purchasing Guidelines  1. Choose the two or three different manufacturers' 
systems best suited to the facility's current and 
The following is a list of pertinent questions to ask 
future needs and desires, and 
when purchasing a delivery system: 
2. Request one of the chosen systems from each 
What are the electrical, water flow, pressure,  manufacturer for an on-site trial of one to four 
and drain requirements?  weeks duration, and 
Has the system proved safe and reliable in other 
3. Obtain subjective opinion from the technical and 
facilities? Seek and ve*  references.  patient care staff, as well as from the patients, 
and 
Does the manufacturer provide complete clinical 
training in use of the device?  4.  Obtain objective information from the patient 
care and technical staff.  Using a form such as 
Does the manufacurer provide acceptable tech- 
the one included at the end of this chapter may 
nical maintenance and repair?  Does the man- 
be helpll (Form 6). 
ufacturer provide technical maintenance and r e  
pair training to facility personnel? 
This process will enhance the likelihood of select- 
Does the system comply with existing standards,  ing a delivery system which suits the needs of the 
medical, clinical, and technical staffs. It also helps 
i.e., AAMI? 
to assure a system that is safe and effective in the 
After finding the answers to these questions the  facility's hands. 
facility should: 
Q~litAys surance Guidelines for Hernodialysis Devices  REFERENCES 
1. Association for the Advancement of Medical Instrumentation. American National Standard for 
Hemodialysis Systems (AAMI RD5-1981). Arlington, VA (1982). 
2.  KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation of Risks and 
Hazards Associated with Hernodialysis Systems (Technical Report, Contract #223-78-5046). US. 
Dept. of Health and Human Services, Public Health Service, Food and Drug Administration/ 
Bureau of Medical Devices, Silver Spring, MD (1980). 
3.  SHALDON, S. and LARSSON, L-A Hemodialysis Monitors a dM onitoring, in Replacement of 
Renal Function by Dialysis.  William Drukker, Frank M. Parsons, and John F. Maher, eds. 
Martinus Nijhoff, The Hague, The Netherlands (1988). 
4.  GOTCH, F. and KEEN, M.  Dialyzers and Delivery Systems in Introduction to Dialysis.  MG. 
Cogan and M. Garovoy, eds. Churchill Livingston, New York (1985). 
5.  KEEN, M., LANCASTER, C. and BINKLEY, C. Concepts a dP rinciples ofHemodialysisinCore 
Curriculum for Nephrology Nursing.  L.E.  Lancaster, ed.  American Nephrology Nurses' 
Association, Pitman, NJ (1990). 
6.  Emergency Care Research Institute. Improper Dialysate in Health Devices Report (1984). 
Note:  A list of additional references on this topic can be found in Appendix E at the end of this 
manual.  These additional references are included to enable the reader to pursue further 
. 
investigation for the purpose of training or research on this topic 
Quality Assurance Guidelines for Henodialysis Devices  Dlalysate  Proportioner  Mix dialysate concentrate(s)  Use correct concentrates; 
and water to produce final  calibrate conductivity circuit; 
dialysate of predetermined  measure conductivity and pH of 
and precise electrolytic  final dialysate before 
composition.  treatment. 
Fixed Ratio  Cylinders of known volume pro- 
portion dialysate concentrate 
and treated water in exact, pre- 
determined amounts; cyclic 
filling and emptying of each 
cylinder controlled through a 
series of valves. 
A control sensor monitors 
conductivity of final dialysate 
and regulates flow of dialysate 
concentrate within specific 
conductivity limits.  Flow can 
be regulated using variable 
speed pumps, variable orifice 
devices or other mechanisms. 
Dialysate  Pump  Maintains appropriate dialysate  Visually confirm dialysate flow 
flow rate through dialyzer.  through dialysate tubing andlor 
dialyzer.  Confirm dialysate flow 
rate per manufacturer's 
recommendations. 
Blood Circuit  Pressure  Monitors 
"Pre-pump"  Monitors extracorporeal pres-  Before every treatment: test 
sure between patient's "arterial"  monitors/alarms to confirm 
access and the blood pump.  proper function; confirm that 
Alerts operator to collapse in  any limits are properly set, 
tubing that has the potential to  secure all connections to 
cause hemolysis, damage to  blood tubing, transducer 
vascular access, or partial  protectors, etc. 
collapse in tubing, resulting in 
inaccurate blood flow readings. 
Monitors extracorporeal pres- 
sure between blood pump and 
dialyzer. Alerts operator to 
tubing separations and tubing 
obstructions. Also useful in 
calculating transmembrane 
pressures (TMP). 
'Venous"  Monitors extracorporeal pres- 
sure betweer! dialyzer and 
patient's "venous" vascular 
access.  Alerts operator to 
tubing separations and tubing 
obstructions. Also useful in 
calculating TMP. 
QUityA  ssurance Guidelines for Hernodialysis Devices  Precisely controls amount of  Perform predialysis tests of the 
ultrafiltration from the patient's  irltrafiltration control system 
blood during the hemodialysis  Der manufacturer's instructions 
treatment.  lor use.  Immediately investi- 
gate proper functioning of this 
mmponent if a patient's actual 
weight loss varies from expec- 
ted weight loss by more than 
the percentage indicated in the 
manufacturer's specifications. 
A controlled and measured 
amount of dialysate is 
removed, generally via a 
volumetric pump, from a 
closed, fluid-filled, non- 
compliant dialysate circuit. 
Dialysate inflow and dialysate 
outflow are precisely measured 
using sensitive flow meters. 
By subtracting dialysate inflow 
rate from outflow rate, a micro- 
processor calculates ultra- 
filtration rate and adjusts the 
machines' TMP to achieve 
desired ultrafiltration rate. 
-- 
A 'Wow through" sensor, with  Before every treatment: set 
adjustable sensitivity that  sensitivity as per manufac- 
detects the presence of blood  turer's procedures, confirm 
in the effluent dialysate. When  proper audible and visual 
the amount of blood detected  alarms, as well as blood pump 
by the device exceeds the limit  and dialysate pump action in 
set during calibration, audible  alarm condition. 
and visual alarms occur, and 
the blood pump stops.  In some 
systems, bypass of dialysate 
flow to the dialyzer also occurs 
- - - - - -  - 
Monitors the extracorporeal  Before every treatment: 
circuit for potentially lethal  confirm proper audible and 
quantities of air-in  either the  visual alarms, as well as blood 
venous blood tubing or the  pump interlock and venous line 
venous bubble trap.  Employs  clamp in alarm condition; 
ultrasonic device which mea-  confirm that airnoam detector 
sures changes in acoustic  is armed and that tubing is in 
transmission or photo-optical  the clamp assembly. 
device which detects change in 
optical density between a light 
source and a photocell. Upon 
detection of a quantity of air, 
audible and visual alarms are 
activated, the blood pump is 
stopped, and the venous blood 
tubing is occluded. 
Devices  TABIS2  
SUMMAORF YAA  MI DEL~VESRYYS TERME QUIREMENTS 
(MANUFACTURER STANDARDS) 
Devlce Markings 
Trade name of device 
Manufacturer name and address 
Model Number; serial Number 
Requirement for 
Identification of 
Product Ltterature 
List of monitors and warnings regarding that they must be used. 
Procedures for minimizing bacterial growth. 
Warning to check dialysate concentration with independent method. 
Accuracy and sensitivity of monitors. 
Preset monitor limits. 
Statement regarding microbiological isolation of blood circuit pressure monitors. 
Time delay to initiation of blood leak alarm. 
Specicafoiitns  and test methods for deaerator. 
Normal pressure drop specifications. 
Method of TMP measurement. 
Warning to check dialysate concentration (batch systems). 
Identification of materials in contact with dialysate circuit. 
Specifcations regarding airdoam detector. 
Alarm adjustment procedures for maximimizing sensitivity of blood leak detector. 
Warning regarding malfunctions that could lead to hemolysis and how to react. 
Monitors and Alarms 
General (visible to patient; temperature in "C;p ressure in mmHg). 
Temperature: monitor on-line; maintain range of 36-40 "C;r edundant safeties; audible and visual alarms; 
alarm condition adivates bypass; automatic heat sterilization prohibits dialysis mode. 
Dialysate Pressure: pressure entering dialyzer monitored f 20%; hightlow limits; audible and alarms. 
- 
TMP monitors: accuracy f 20%; higMow limits; audible and visual alarms. 
Blood circuit pressure: venous pressure monitoring required; accurxy It 10% of indicated pressure; highnow 
limits; audible and alarms; blood pump deactivated in alarm condition; instructions for validation. 
Concentration: on-line monitor; audible and visual alarms and bypass if dialysate concentration f 5%; 
redundant safeties; temperature compensated; hghnow limits. 
Blood leak detector: required in all machines; meets AAMIdidated blood leak amount parameters; test 
functions; calibration ability; audible and visual alarms; alarm condition inactivates blood pump. 
AirFoam detector: required on all systems where ingress of air is possible; audible and visual alarms; alarm 
condition stops blood pump and occludes venous line; audible and visual warning when not armed; shall not 
cause chemical changes to blood. 
Safety Requirements 
General: safe configuration; monitors minimize false alarms and inadvertent resetting; monitors cannot be 
disabled when patient at risk; audible alarms at least 70 decibels and unable to mute for > 180 sec; design 
facilitates cleaning. 
Electrid Safety: meet "nonisolated" patient connection requirement of ANS, Safe Current Limits for Electro- 
medical Appartatus; electrical ground provided; corrosion resistant metals; electrical circuits separate from 
hydraulic circuits and isolated from fluid leaks; main eledrical failure indicated by audible alarm. 
- 
t- 
Quality Assurance Guidelines for Hernodialysis Devices  Date  Patient Name 
DIALYSPIS RESCRI~ 
Dilyzer  Time on  Dry weight 
QB  QD  Actual time off  Predialysis weight 
Heparin Rx:  Rx time off  Desired weight bss   --
Prime  Rx dialysis length  Postdiisis weight   -.
Infusion  Actual dialysis length  UF rate 
Time off 
Dilysate Rx 
Expected cbning time 
Actual cbning time 
MACHINCEH ECKS  REUSE 
Bkal leak alann  Patient ID  I 
A& barn detect (ched)  Use number 
Ak faam detect (armed)  Dialyzer strudurelaesthetic 
UF check  Germicide dwell 
M e np ress set  Germicide presence 
Machine number  Germicide absence 
Quality Assurance Guidelines for Hernodialysis Devices   - --  - --- 
\--..--r  -- - 
I  I Jan  I  Feb  I Mar  I Apr  I May  I  Jun  I  Jul  I  Aug  I  Sep  I Oct  I Nov  I  Dec 
CI m-r  I  I  I  I  I  I  I  8  1  I  I  I 
Machine #I  I 
Machine #2 
Machine #3 
I 
nrv  I  I  I  I  I  I  I  I  I  I  I 
TEMPERATURE 
Machine #I  I  I  1  I  1  1  I  I 
I  I  I 
Machine #5  II   II  
' lachine #6 
7M,a mu~ h:f4i7~   I  1 
111 ICI R I 
- Machine #8 
- Machine #9 
Machine #10 
OTHERP ROBLEM SSP ECI IF^\  DELIVERYS  YSTEMM ASTERP REVENTATIVE  MAINTENANCSEC  HEDULE  FORM3  
I  (  1  I  I  I  1  (  I  I  I  I  I 
Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec 
Machine #5  X I   X I   X I  
Machine #6  X I   X I   X1   
Machine #7  X I   X I   X1   
Machine #8  X1    X I   X1   
Machine #9  X I   X I   X I  
Machine #10  X I   X I   X1   
Machine #11  X I   XI  X1   
Machine #12  X I   X I   X I   PROCEDURE FOR CONCURRENT 
MONITORING FORM: 
PREDIALYSIS TECHNICAL 
CHECKS (FORM4 ) 
The purpose of this audit is to monitor technical  Perform the Audit 
staff compliance with standard practices and pro- 
cedures related to the water treatment system.  1. On the actual audit sheet, write in the date, 
When staff are aware of the importance of the  auditor's name, patient shift (or time of day), 
policies  and well  trained  in the procedures,  and standard. 
compliance should be very high. 
2. Read each indicator carefully. 
Before the Audit 
3. Observe staff for actual performance.  Auditor 
should not interfere with staff activities, be 
1. Provide adequate and appropriate inservice to 
obtrusive, or preceptibly obvious. 
assure total staff awareness and education of 
all components associated with water treat-  4. Under each staff code letter, write Y for yes if 
ment for dialysis.  indicator is met, N for no if indicator is not met, 
or NfA for not applicable, not observed. 
2. Assure staff awareness of all elements of the 
concurrent audit and how performance will be  To achieve a Y (yes, indicator was met), staff 
observed and evaluated.  should be observed with complete compliance 
for each encounter.  For example, for a Y to 
3. The QA committee specifies the standard (ex- 
appear in the "Post-Softener Hardness Done" 
pected percentage compliance) desired for the 
box, the staff member must perform the test 
audit; begin not lower than 85%. 
before any patient dialysis is done and perform 
the test exactly according to the instructions 
4. Schedule the audit with appropriate personnel 
for use of the test manufacturer and record the 
(head nurse, charge nurse, chief technician). 
results as per facility policy. 
5. Make copies of the audit for each auditorfob- 
server.  5. Complete all observations within timeframe 
specified.  Assure that each indicator has one 
6. Assign code letters for each staff member to be  response. 
observed; for example: 
After the Audit 
Employee  A:  Glenn Close 
B:  Tom Hanks  1. Under each employee code letter, add total 
C.  William Hurt  number of Ys and Ns; do not count NAs. 
etc. 
2. For each employee, calculate compliance per- 
7. Determine how many staff are to be observed.  centage by dividing the total Ys by the total 
It is recommend that one auditor should ob-  observations; again, do not count NAs. 
serve no more than three to four staff at one 
time;  3. Calculate total compliance percentage for the 
audit by dividing total Ys (all employee Ys) by 
8. Define the length of time for observation. It is  the total observations; do not count NAs. 
recommended that the audit be conducted dur- 
ing peak activity times (daily start-up, shift  4. For each indicator, calculate compliance per- 
changeovers, etc.). The time frame should be  centage by using the same method as above; 
long enough to observe each staff member com-  again, do not count NAs. 
pletely perform the listed activity. 
5. Report results to QA committee and clinical 
9. Assign a staff member to perform the audit.  management team with additional comments 
Auditor should not be assigned to other re-  andlor recommendations. 
sponsibilities during the audit. 
Quality Assurance Guidelines for Hernodialysis Devices  Quality Assuraiwe Guidelines for Hernodialysis Devices  Date  Machine type and no. 
Auditor  Serial number 
Meter reading 
Last maintenance: 
Date 
TYP 
Meter 
STAFF RESPONSIBLE: Chief Technician, Medical Director, Head Nurse 
OBJECTIVE:  To assure that equipment is fully functional and safe for treatment use 
A.  SURVEY OF EQUIPMENT TECHNICAL  RECORDS 
YES 
1.  Do equipment maintenance records include documentation of an electrical 
safety check performed in accordance with interval recommended by 
manufacturer? 
2.  Is the documentation of maintenance on each dialysis machine current and 
complete? 
3.  Is monthly bacteriologicalt esting of each dialysis machine performed and 
the results documented in a permanent record? 
4.  Is each dialysis machine disinfected in accordance with unit policy or as 
indicated by bacterial testing? 
5.  Are the following machine functions calibrated at least every three months? 
a.  Bbod pump 
b.  Heparin pump 
c.  Air bubble detectorlline clamp 
d.  Blood leak detector 
e.  Audiohisual alarms 
. 
f  Temperature 
g.  Conductivity 
h.  Negative pressureluttrafiltrationp ump 
i.  Arterial pressure monitor 
j.  Venous pressure monitor 
6.  Have the screen filters been cleanedlreplaced during maintenance procedures? 
7.  Have the internal transducer protectors been changed during maintenance 
procedures? 
Quality Assurance Guidelines for Hernodialysis Devices  B. EQUIPMENT  VISUAL INSPECTION 
YES  NO  N/A 
. 
1  Outside  of  machlne 
a.  Are all the switches, knobs, and the venous clamp functioning properly? 
b.  Do the drip chamber level adjust knobdever operate properly? 
c,  Is the blood pump roller assembly secured tightly to its shaft, and do 
both rollers turn freely? 
d.  Is the mechanical zero of the drip chamber meters operating properly? 
e.  Are the Hansen connectors free of leaks? 
f.  Are the o-rings of the concentrate connectors free of cracks and leaks? 
g.  Is the acid concentrate connector free of residue buildup? 
h.  Is the bicarbonate connector free of residue buildup? 
i.  Is the air bubble detector housing clean? 
j.  Is the venous clamp clean? 
k.  Is the machine free of blood, salt crystals, etc? 
I.  Does the heparin pump carriage move freely? 
m.  Are all the lamps functioning? 
2.  Inside of  machine 
a.  Free of water leaks (no puddle at bottom of unit, connections) 
b.  Hoses and tubing assembly clear cnd clean 
c.  Check valves free of leaks 
d.  Fuses 0.k. 
e.  Tie-wraps around all hydraulic tubing pressure points 
C.  GENERAL FUNCTlONSlMAlNTENANCE 
1.  Is measured dialysate flow (mllmin) at the drain within the following specifications: 
a.  Machine #1 (570 f 50)  - 
b.  Machine #2 (560 f 70)  - 
c.  Machine #3 @ 300  - 
d.  Machine #4 @ 500  - 
e.  Machine #5 @ 800  - 
2.  Is the test alarm battery serviceable: 
a.  Machine #l (9.0 f 0.5 V) 
b.  Machine #2 (9.0 f 0.5 V) 
c.  Machine #3 (1.6 f 0.25 V) 
d.  Machine #4 (9.0 f 0.5 V) 
3.  Is the no-water alarm functioning?  - 
4.  Is the no-power alarm functioning?  - 
5.  Is the bypass function working?  - 
Quality Assurance Guidelines for Hernodialysis Devices  DIALYSISE QUIPMENTA UDIT (cont.) 
D. ARE  THE  FOLLOWING  MACHINE  FUNCTIONS CALIBRATED 
ACCORDING  TO  THE  MANUFACTURER'S  SPECIFICATIONS? 
YES 
. 
1  Values  for  conductivity  and  temperature: 
a.  Temperature  (37.0 f 0.5 OC)  - 
b.  Na = 1 and Bicarb = 30  (2.65 f 0.1 mmho/cm)  - 
c.  Na = 1 and Bicarb = 35  (3.05 f 0.1 mmholcm)  - 
d.  Voltage at TP1  (1.25 V)  - 
- 
e.  Na = 1 and Bicarb = 35  (12 .50 f 0.1 mmholcm)  (acid and bicarb) 
f .  Na = 3 and Bicarb = 35  (13.50 f 0.2 mmholcm)  - 
+ 
g.  Na = 5 and Bicarb = 35  (14.50  0.2 mmholcm)  - 
- 
h.  Na = 3 and on acetate  (13.50 rt 0.2 mmholcm)  (bicarb off) 
2.  Was acid rinse procedure performed within the last 1000 hrs of operation?  - 
3.  Has the effluent pump been oiled within the last 1000 hrs of operation?  - 
4.  Are the effluent pump stators serviceable (at least -525 mmHg)?  - 
5.  Is the pressure venffsampling port working properly (positive pressure  - 
dialysate alarm, pressure not in excess of +475 mmHg before venting)? 
6.  Is the concentrate pump occlusion 0.k. (at least -550 mmHg)?  - 
7.  Was the stabilizer recharged during maintenance procedures?  - 
8.  Does the four-way bypass valvelfluidic capacitor indicate that there is no leak?  - 
9.  Does the hydraulic leak test indicate that there are no leaks?  - 
10. Visual inspection (inside): 
a.  Fluidic capacitor free of residue 
b.  Stabilizer and air bypass lines free of residue 
c.  Cooling fan free of dust and lint 
d.  Air vents (top and bottom at back of unit) lint-free 
e.  pH probe free of residue 
f.  All cells (conductivity control mixer, monitor conductivity and 
temperature, electrode conductivity cell) free of residue 
g.  Pump segments free of discoloration or flattening 
h.  All pump rotor arm pins correctly aligned  . 
i.  Neucleation chamber material clear 
j.  Pump header and manifold blocks free of cracks and leaks 
k.  Drip chamber level tubes free of cracks 
I.  Effluent pump cover vents free of lint 
m.  Blood leak detector is clean 
- 
TOTALS 
PROBLEMS IDENTIFIED: 
Used wirh permission by Artificial Kidney Center. Palo Alto VA Medical Center, PPab Alto, CA 
Quality Assurance Guidelines for Hernodialysis Devices  FORM 6 
DELIVERY SYSTEM EVALUATION CHECKLIST 
1. CONDUCTIVITY 
A)  What type proportioning system is used? 
0) Can proportions be altered? 
C) High and low limits? 
D) Can limits be tested? 
E) What type of readout (monitor) is used? 
F) What type of internal monitoring? 
G) Does it have a bypass mode? 
H) Will blood pump run in bypass? 
I)  Can conductivity be falsified? 
J) Will machine bypass if probe fails? 
2.  TEMPERATURE 
A)  High and low limits? 
0) Can limits be easily tested? 
C) How is temp adjusted? 
D) What type readout? Scale? 
E) What type of heating element is used? 
F) Redundant monitoring? 
G) Utilize bypass? 
H) Will pump run in bypass mode? 
3.  DIALYSATE FLOW 
A)  Can it be altered? 
0) Type readout? 
C) Is there a (no water) alarm? 
4.  ARTERIAWENOUS MONITORS 
A)  What type readout? 
B) What measurements used? Scale? 
C) Transducer inlet type? 
D) Type of gauge? 
E) Sequential alarms? 
F) Can limits be moved? Preset? 
G) Can limits be tested? 
H) Does indicator float with movement? 
I) How does the alarm system work? 
J) 
K)  DELIVERY SYSTEM EVALUATION CHECKLIST tcont.) 
5.  DEAERATlON 
A)  How is it accomplished? 
B) How effective is it? 
C) How is air relieved? 
6. BLOOD LEAK DETECTOR 
Comparative? 
Effects of air? Scum? 
Cleaning? 
Can limits be tested? 
Sensitivity? (adjustalble) 
Do limits need to be altered, adjusted each dialysis? 
How does alarm system work? 
7.  AIR DETECTOR 
A)  Sensitivity 
i. Adjustment? 
ii. Testing 
B) Will it accomadate drip chamber? 
C) What type system? 
D) How does alarm system work? 
E) Line clamp incorporation? 
F) 
8. BLOOD PUMP 
A) Type roller head used? (self occlufing?) 
B) How is occlusion set? 
C) What type of readout? 
D) What scale is used? 
E) Cleaning? 
F) Cover? 
G) Maximum blood flow rate? 
9. HEPARIN PUMP 
A)  Syringe size used? 
B) Delivery rate variationlscale? 
C) What type pump used? 
D) How does system work? 
E) 
F) 
Quality Assurance Guidelines for Hernodialysis Devices  DELIVERY SYSTEM EVALUATION CHECKLIST (cont.) 
10.  RESET SYSTEM 
A)  Automatic/correction 
B) Protective shield 
11. RINSE MODE 
A) Can Paitient dialyize in rinse mode? 
B) Can it be "fooled"? 
C) How does it work? Does bypass get rinsed? 
D) 
E) 
12.  EXTERIOR 
Simplicity 
Breakables 
Weight 
Portability 
Cleaning 
Electrical leakage? 
13. OPERATOR'S MANUAL 
A)  Schematics-complete? 
B) Understandability? 
C) Procedures? 
D) Function descriptions? 
E) Detail? 
F) Service? 
G) CautionsNVarnings clear? 
14. DlALYZER ADAPTABILITY 
(defined by facility's therapeutic intent 8 dialyzer type) 
A)  Ultrafiltration Control? 
i. Principle (Volumetric or Servo-Feed Back 
ii. Accuracy (measured with dialyzers to be used) 
iii. 
8) Dialysate flow adjustable? 
15. ISOLATED ULTRAFILTRATION 
A)  P.U.F. capabilities 
B) Altering with venous pressure 
C) Can ultrafiltration be measured? 
Quality Assurance Guidelines for Hernodialysis Devices  DELIWRY SYSTEM EVALUATION CHECKLIST (cont.) 
16. BICARBONATE DIALYSATE 
A) What type proportioning system is used? 
6) Can proportions be alteredlprogrammed? 
C) High and low limits? 
D) Can limits be tested? 
E) What type of readout (monitor) is used (pH)? 
F) What type of internal monitoring (pH)? 
G) Will machine bypass if pH probe fails? (if applicable) 
17. COMPANY RELIABILITY 
A)  Service 
6) Follow through 
C) Availability 
18. SPARE PARTS 
A)  Necessary inventory 
6) Cost 
C) Availability/delivery time 
19. MAINTENANCEIREPAIRS 
A)  How often what required for P.M.? 
6) Special tools required? 
C)  Machine reliability 
D) Training timeleasy for stafflhome patients? 
E) Does company provide training? Cost? 
, 
20.  OPTIONAL FEATURES 
A)  VariablelProgramable Sodium 
6) Self-Diagnostics 
C) Computer Interface (machine data, patient data, etc) 
0) Blood Pressure Monitoring (patient) 
E) Autodisinfect 
e\ 
~ u aitly  Assurance Guidelines for Henod ialysis Devices  Chapter 5 
DLALYSATE AND 
DIALYSATE 
CONCENTRATE 
CONTENTS 
Page 
...................... 
TECHNICAL DESCRIPTION OF DEVICE  5-1 
....................................... 
RISKS AND HAZARDS  5-1 
QUALITY ASSURANCE FOR DIALYSATE AND 
................................. 
DIALYSATE CONCENTRATE  5-2 
.................................. 
Policies and Procedures  5-2 
............................ 
Staff Training and Education  5-3 
.............................. 
Monitoring and Evaluation  5-3 
................................. 
Daily Monitoring  5-3 
.............................. 
Monthly Monitoring  5-4 
................................ 
Patient Monitoring  5-4 
.......................... 
Home Dialysis Monitoring  5-4 
................................. 
Other Monitoring  5-5 
....................................... 
Prevention  5-5 
.......................................... 
REFERENCES  5-6 
............................. 
TABLES. FIGURES. AND FORMS  5-7 
Quality Assurance Guidelines for Hernodialysis Devices  Chapter 5  Dialysate and 
Dialysate  Concentrate 
TECHNICAL DESCRIPTION OF  Briefly, the problems related to manufacturers in- 
DEVICE  cluded: 
Dialysate, or dialysis fluid, is a non-sterile aqueous  Mimbial growth in liquid bicarbonate concentrate. 
solution with an electrolyte composition near that 
Actual electrolyte content of the concentrate was 
of normal extracellular fluid. Its electrolyte compo- 
different than described on the label. 
sition is designed to correct the metabolic imbal- 
ance that occurs as a result of uremia.  Foreign matter in liquid bicarbonate concentrate. 
Electrolyte content of dialysate includes sodium,  High levels of aluminum contaminating acetate 
potassium, chloride, magnesium, calcium, glucose  concentrate. 
(optional), and either acetate or bicarbonate as a 
Incidents related to user error, or machine mal- 
buffer. Concentration of these electrolytes in dialy- 
bction include: 
sate fluid is shown in Table 1. Dialysate contains 
none of the solutes that are eliminated from the 
Improper sodium concentrations due to miscalibra- 
blood during dialysis (urea, creatinine, and other 
tion of or improper proportioning by the dialysis 
waste products of nitrogen metabolism). 
delivery systems. 
Dialysate concentrate is a preparation of salts which, 
Use of wrong concentrates or improper mixing of 
when diluted with water, yields dialysate for use in 
concentrates due to staff misreading labels. 
dialysis. Dialysate concentrates are manufactured 
commercially in liquid or powder form.  Bacterial problems related to improper disinfection 
of storage containers or use of water containing 
The chemicals present in the dialysate have ac-  excess bacteria. 
cess, via the dialyzer, to the bloodstream of pa- 
tients undergoing the dialysis. Therefore, the proper  Many ofthe incidents could have been avoided through 
concentration of all of these chemicals as well as  fairly simple tests, observations, or quality control 
the quality of the concentrate and the water used  procedures implemented in the dialysis facilities. 
to dilute the concentrate is critical.  Further, although only a few of these incidents re- 
sulted in patient death, almost all had the poten- 
tial to cause death. 
The literature prior to 1980 contained only one report 
EXISTING GUIDELINES 
of patient complications attributed to concentrate: 
a case of hypermagnesemia due to the use of com- 
Guidelines currently available regarding dialysate, 
mercially prepared concentrate with a magnesium 
or dialysate concentrate, are found in the Associa- 
concentration ten times greater than specifications. 
tion for the Advancement of Medical Instrumenta- 
tion (AAMI) document, the American National Stan- 
Incidents reported in the literature and through 
dards for Hemodialysis Systems (RD5-1981). These 
the Medical Device Reporting program since 1980 
standards can be separated into two areas:  (1) 
are summarized in Appendix A  Of note, 50% of 
those related primarily to manufacturers' labeling 
the 18 incidents reported involved problems related 
and literature and manufacturers' specificationsf or 
to the concentrate when delivered from the manu- 
concentrate, and (2) those dealing with microbio- 
facturer. The remaining 50% were related to user 
logical suitability of final, proportioned dialysate. 
error or machine malfirnctions. 
Quality Assurance Guidelines for Hernodialysis Devices  5- 1  Table 2 summarizes these standards.  QUALm ASSURANCE FOR 
DIALYSATE AND DIALYSATE 
In the absence of federal, local, or other voluntary  CONCENTRATE 
standards, well accepted "industry" standards, that 
is, accepted technique for handling of dialysate and  Policies and Procedures 
dialysate concentrate, are available.  In 1983 the 
Emergency Care Research Institute (ECRI) sum-  Policies and procedures concerning dialysate and 
marized these and recommended the following steps  dialysate concentrate as it relates to hemodialysis 
as the appeared in Health Devices (1983):  therapy must be developed, written, implemented 
and evaluated.  All standards previously described 
1. Check the actual pH and conductivity ofthe ddysah  must be incorporated into these policies and proce- 
with an external meter.  dures. 
2. Check the conductivity, pH, and temperature alarm 
Specifically, the policies and procedures should ad- 
system before each dialysis treatment. 
dress the different therapeutic prescriptions avail- 
able in the facility, i.e., high-flux dialysis, high effi- 
3. Assure that all personnel in the dialysis unit are 
ciency dialysis, and conventional dialysis.  Each of 
well informed of the types of concentrates available, 
these differing therapeutic modalities may require 
even if you presently use only one type. 
different types of dialysate; for example, sodium 
4. Whenever possible, develop and use a system of  modeling, bicarbonate dialysis, acetate dialysis, 
labeling, connector types,a nd matching containers  ultrafiltration, or individual patient prescription. 
that prevent or minimize cross-connections or 
use of mismatched concentrates.  Comprehensive policies and procedures must also 
address the interrelationships of each component 
5. Store and dispense dialysate concentrates as though  of the dialysate as well as the dialysis delivery 
they were drugs. Develop a policy for inventory  systems. The risks involved must be clearly identi- 
management  and storage system that will  fied, considered, and appropriate safety measures 
effectively control the mixing and dispensing of  and preventative systems developed. 
all concentrates. Storing concentrates according 
to type, composition, and proportioning ratios  Policies and procedures must also address safe and 
should reduce the risks ofmismatched concentrates.  effective dialysate handling: 
Prohibit access to storage areas and allow only 
authorized, specially trained personnel to mix  mixing of concentrate additives 
and dispense concentrates. 
mixing of acid and bicarbonate concentrate 
6. Verify and record actual dialysate composition 
labeling 
on the patient's records to assure that what is 
being delivered is appropriate for what has been  container and delivery system connector systems 
prescribed by the physician (see Form 1). 
sanitary procedures used in handling and mixing 
7.  Do not dispense concentratesf rom large containers  the concentrate, both in large tanks as well as 
into smaller ones without a "keyed" dispensing  individual containers 
system.  Such a system should include labeling 
of the smaller containers as well as color-coded  length of time for storing the concentrate after 
or key-coded (shape) connections between caps  mixing 
of containers and uptake tubing on machines. 
frequency of sanitization of the mixing containers 
8. Always dispose of concentrates remaining from  and the delivery containers; use of a validated 
the previous treatment.  Do not pour remaining  sanitization procedure 
concentrate into another container or use in the 
measured microbiological condition of the water 
next treatment.  Replace empty or partially full 
used to prepare the bicarbonate concentrate 
containers with full ones.  Whenever possible, 
standardize equipment so that only one bicarbonate  monitoring of patient reactions during dialysis 
concentrate system is used.  and trend analysis. 
Qua1ity'~ssurancGe uidelines for Hernodialysis Devices  Staff Training and Continuing  A.  Daily Monitoring 
Education 
Conductivity of the final dialysate being delivered 
to the dialyzer should be checked before every 
Role descriptions should include personnel respon- 
tmatment The pH and temperakne ofthe ddysate 
sibilities for handling and testing of concentrate, 
should also be confirmed before each treatment 
ordering, confirmation of proper labeling, testing 
Conductivity should be within the manufacturel's 
and monitoring, and other similar responsibilities. 
stated specifications.  If the pH is below 6.5 or 
Each ~sponsibilitysh ould stem from a specific policy 
above 7.5 dialysis should not be initiated, even if 
or procedure. 
the conductivity is within acceptable limits. 
Staff training should be a well-defined and organ- 
Conductivity should be checked with a independent 
ized process.  Content should be clearly defined for 
reference meter which is known to be properly 
the learner and based on behavioral objectives. The 
calibrated. The pH can be checked with a similar 
behavioral objectives can be used to accurately and 
meter, or with pH paper. 
objectively measure learning.  At the end of the 
sessiods), the instructor should confirm by a writ-  Because temperature can alter conductivity Ileading, 
ten test andlor return demonstration that learning  the temperature  should also be within  the 
has occurred and that the learner is able to per-  manufacturel's specifications. Temperature may 
form the procedure(s) independently without error.  be checked with a reference meter or with a 
Test results should be documented and placed in  reference thermometer. 
employee's personnel file. 
AU three of these readings should be documented 
Comprehension of the purpose and function of di-  on the patient's daily dialysis record. The actual 
alysate and dialysate concentrate requires a basic  numerical readings should be recorded, not simply 
understanding of normal physiological concepts, as  a "check markn or  "0.k."  Initials of the person 
well as responses associated with uremia and the  performing the test should also be included (see 
hemodialysis therapy.  Content should include di-  Form 1f or sample recording format). 
alysate fluid composition, hction, preparation, 
Before initiating treatment, confirmation that the 
conductivity and pH, and potential complications 
prescribed concentrate is being used and that all 
with improper mixes of dialysate. 
manufacturer's safety devices and features are 
being employed should be done.  This should 
Need for further education, such as inservices or 
include reading the label on all concentrate con- 
intensive educational sessions, can be determined 
tainers, correct use of  any color-coding andlor 
from the routine quality assurance monitoring pm- 
any keycoding, and use of the proper facility- 
ess and the ongoing staff performance appraisal 
designated concentrate containers.  This safety 
process.  When problems are identified, all staff 
check should be documented on the patients dialysis 
should be made aware of the problem and be in- 
treatment record. Dialysis may be initiated when 
volved in its solution. This nearly always includes 
all of  these checks correspond to established 
problem specific continuing education. 
parameters. 
The medical diredor of the dialysis facility must 
If concentrates are mixed from powder in a large 
ascertain that the individual has successhlly com- 
container and then distributed into smaller "jugs," 
pleted the initial education and training program. 
each jug should be labeled with the following 
The medical director is also responsible for assur- 
information (see Form 2 for sample labeling 
ing that an annual review has been performed. 
formats): 
Contents, i.e., A concentrate, B concentrate, 
Monitoring and Evaluation  acetate concentrate, etc., plus proportioning 
ratio. 
To prevent patient injury associated with the use 
of improper concentrates, concentrate mix-ups, mis-  Time the solution was mixed and initials of 
calibrated dialysis delivery systems, and improper  person(s) mixing the solution. 
function of the dialysate delivery systems propor- 
tioning or conductivity circuit, the following moni-  Time the solution was dispensed and identifica- 
toring activities are recommended:  tion of person(s) performing this procedure. 
Quality Assurance Guidelines for Hernodialysis Devices  5-3  Other special additives inserted into the  confirm that the sanitization and handling 
concentrate (i.e., potassium, a potassium "spike,"  procedures for these jugs are also valid. 
calcium, etc.).  This information should also 
A culture sampling of the dialysis delivery 
be recorded on the label by the person pexforming 
systems for dialysate as described in the AAMI 
the addition. (Many facilities require that at 
American National Standardsf or Hemodialysis 
least two individuals watch this procedure and 
Systems provides an overview of the efficacy 
initial the container.) 
of all systems for maintaining microbiological 
4. A monitoring andlor coding system should also  standards. 
be included  the daily ior&ring  of rinsing, 
sanitizing, or disinfecting procedures for the  3. To assess trends, pertinent infonnation, ia,b acterial 
bicarbonate mixing tank or "concentrate jugs";  levels, conductivity, pH readings, etc., should be 
logged on a chart across a page so that readings 
for example: 
can be examined and compared over an extended 
A daily log for sanitization and rinsing of the  period of time. This makes it possible to compare 
mixing tank should include time performed  current readings to those taken during the past 
and initials of person(s) performing the task.  several days/week&nonths. Any untoward trends 
thus become immediately obvious (see Form 3 
A daily log might also include proper recording 
for sample trend chart). 
of any procedures required on "concentrate 
jugs".  This can more easily be performed if  C.  Patient Monitoring 
each jug is identitied with a serial number 
The following patient monitoring aspects have re- 
(see below for more information on coding of 
lationships to dialysate and dialysate concentrate 
concentrate jugs). 
handling: 
The daily log should also include results of 
any test performed to verify adequate rinsing  1. Routine blood chemisbies may provide an indication 
(absence) of  the disinfectantfgermicide used  of improper use of concentrates. These are further 
so as to prevent any introduction of  toxic  explained below. 
substances into the patient. 
2. Routine intradialytic monitoring and patient 
symptoms during the dialysis treatment can also 
B.  Monthly Monitoring 
provide indications for improperly used concentrates 
L On at least a monthly basis, calibration of any  or~.Afewoftheprimarytypesofsym~ 
reference meters used to perform daily or other  seen with incorrect use of  concentrates are 
conductivity, pH, and other monitoring of dialysate  summarized below: 
should be performed using a reliable Standard 
Solution (see Chapter 7 for more information on  Hyponatremia induced by low sodium content 
use of Standard Solution). Manufacturers may  in the dialysak, may result in hemolysis, nausea 
recommend more frequent confirmation of proper  and vomiting, and death. 
calibration. Be sure to follow the recommenda-  inducedbyimproperfimctioning 
0 
tions of the device manufacturer. 
dialysis proportioning system or too much 
2.  On at least a monthly basis, validate the handling  sodium in the dialysate; may result in nausea 
and disinfection procedures to prevent micro-  and vomiting, seizures, and death. 
biological contamination. To do this, the following 
Acidosis or allraZosis resulting h mi mproperk 
is recommended: 
used, or mix-ups in concentrates; will become 
Obtain a sample of the bicarbonate concentrate  apparent by respiratory problems, nausea and 
from any mixing tank.  This should be done  vomiting, headaches, seizures, and death. 
on a "worse case" basis, i.e., draw the sample 
after the ' --st  period since the last disinfection1  Hyperkalemia induced by high potassium 
content in dialysate; may result in death. 
sanitization, and after the longest storage time 
for concentrate in that container. 
D.  Home Dialysis Monitoring 
A random  sample of  the concentrate fiom 
All of the monitoring procedures described above 
concentrate jugs should also be performed to 
should be performed by the home dialysis patient 
~ualitAjs surance Guidelines for Hernodialysis Devices  5-4  and home dialysis support personnel, and reviewed  should be perfbrmed (see Form 4 for sample dhlysd~ 
by the medical diredor as appropriate.  concentrate safety monitor). 
E.  Other Monitoring  F.  Prevention 
Other monitoring includes assuring proper use and  Follow exactly all of the manufacturer's instnrctions 
for use. 
outcome related to dialysate and dialysate concen- 
trate handling: 
Test conductivity and pH with a properly cabakd 
independent refmce meter before every treatment 
1. An incoming materials log should be maintained. 
Included in this log should be the identification 
If final proportioned dialysate is determined to 
of the product, delivery date, lot number, and  be not ofthe proper chemical concentration (im& 
person receiving the products. Dialysate should 
conductivity, incomct pH, particulate contamina- 
be received, inspected, and released for use only 
tion, etc.), do not initiate dialysis. 
by authorized personnel who are trained in the 
use and expected specifications of the product.  If a determination is made that the chemical 
Confirmation that the product is properly labeled  concenmi s improper after a patient is connected 
as ordered should be performed.  Any product  to a machine, verify that the delivery system is 
with labels that are not intact or that are incorrectly  in bypass mode. Troubleshoot the problem with 
labeled should not be accepted.  the dialysate hoses disconneded from the dialyzer. 
Confirm presence or absence of delivery system 
2. An annual review of all policies and procedures  malfunction.  If the equipment malfunction is 
related to dialysate and dialysate concentrate  confirmed, the patient should be immediately 
handling should be performed. 
disconnected. 
3. All incidents or adverse occurrences related to 
Maintain a well-validated system of sanitization1 
dialysate or dialysate concentrate handling should 
disinfection of all components of the concentrate 
be documented and reported at the monthly quality 
andlor dialysate handling system (water treatment 
assurance meetings. 
system, dialysis delivery system, mixing tank, 
individual jugs, etc.). 
4. Quarterly monitoring of actual implementation 
of dialysate and dialysate concentrate procedures 
Quality Assurance Guidelines for Hemodialysis Devices  1. Association for the Advancement of Medical Instrumentation. American National Standard for 
Hernodialysis Systems (AAMI RD51981). Arlington, VA (1982). 
2. KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation ofRisks and 
H m d s A  ssociuted with Hemodialysis Systems (Technical Report, Contract m23-78-5046). 
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration1 
Bureau of Medical Devices, Silver Spring, MD (1980). 
3.  Emergency Care Research Institute. Impmper Dialysrrte. Health Devices (October, 1983). 
4.  FAVERO, M.S. Dialysis Associuted Diseases and Their Control. Hospital Infections, J.V. Bennet 
and P.S. Brachman, eds.  Little, Brown, & Co., Boston, MA (1985). 
6.  VLCHEK, D La nd BURROWS-HUDSON. Quality Ass-  in Bicarbonate Dialysate Handling. 
Nephrology News & Issues, 4.9: 14-15( 1989). 
Note:  A list of additional references on this topic can be found in Appendix E at the end of this 
manual.  These additional references are included to enable the reader to pursue firther 
investigation for the purpose of training or research on this topic. 
Quality Assurance Guidelines for Hemodialysis Devices  Sodium 
Potassium 
Calcium 
Magnesium 
Chloride 
Bicarbonate or Acetate 
Glucose (mg%)  TABLE2  
Smmwz~ AAMI D'IALYSCAOTEN CENTRASTTEAN DARDS 
OF 
Manufacturer: Labeling and Documentation 
Name and address of manufacturer 
Date of manufacture 
Lot number (capable of tracing manufactuing history) 
Composition (including metric weight) 
Ratio of water for mixing for proportioning systems; volume for batch systems 
Composition of diluted solution (conductivity, concentration) 
Fill volume of container 
Trade name of product 
For aqueous concentrates: 
- 
Storage temperature range 
- 
lnstructions for mixing 
- 
lnstructions regarding precipitates 
- 
Warning regarding damaged containers 
- 
Warning regarding issues related to bacterial growth 
- 
System for readily distinguishing between different solutions 
For dry concentrates: 
- 
Storage temperature range 
- 
lnstructions to keep container tightly sealed until use 
Manufacturer: Requirements for Concentrate 
Physical state: either aqueous or dry 
* 
Solute concentration shall be f5% of stated concentration, except sodium & chlorine which must be  2% 
"AAMI Quality water" must be used in manufacture of concentrate 
Fill volume must be within 2% of labeled volume if for use with batch system 
Acidity or alkalinity 
- 
acetate concentrate: pH range 6.0 to 8.0 and require <1  mEq of acid or base to titrate 1 liter to pH of 7.4 
- 
bicarbonate concentrate: include directions for proper mixing and prevention of calcium or magnesium 
precipitation 
Chemical grade must meet current requirements of USP/National Formulary 
Final dialysate arsenic content must not exceed 0.05 mgA 
Particulates: aqueous concentrate must be filtered through 1.5 p or finer, non-fiber releasing filter not 
containing asbestos 
Additives: concentrate must contain no substances other than those listed on label; no indicators or pre- 
servatives shall be added 
Containers: 
- 
shall not interact chemically or physically with contents that would in any way alter strength, purity, or 
quality 
- 
shall have closures that prevent contamination or loss of contents 
- 
shall contain not less than 97% of labeled volume or weight 
Water and chemicals used must be non-pyrogenic 
User: Requirements for Dialysate 
Water used to prepare dialysate: 
- 
total microbial count 1200/ml 
- 
within AAMVANSl maximum chemical contaminant levels 
Dialysate: 
- total microbial count s 2000/ml 
Quality Assurance Guidelines for Hernodialysis Devices  5-8  XYZ DIALYSICSE  NTER 
Date  Patlent Name 
Dialyzer  Time on  Dry weight 
QB  QD  Actual time off  Predialysis weight 
Heparin Rx:  Fk time off  Desired weight loss 
Prime  Fk dialysis length  Postdialysis weight 
Infusion  Actual dialysis length  UF rate 
Time off  Expected clotting time 
Diaiysate Rx  Actual clotting time 
Conductivity  Blood leak alarm  Patient ID  I 
PH  Air foam detect (check)  Use number 
Temperature  Air foam detect (armed)  Dialyzer structure/aesthetic 
Special Rx  UF check  Germicide dwell 
Mixed by  AWen press set  Germicide presence 
Dispensed by  Machine number  Germicide absence 
Quality Assurance Guidelines for Hernodialysis Devices  FORM2  
DIALYSATE CONCENTRATE LABELS 
r 
Dialysate Concentrate Tank Label 
Date  Proportioning Ratio 
Time Mixed  Initials 
Additives  Initials 
Comments 
Dialysate Concentrate Jug Label 
Date  Proportioning Ratio 
Time Mixed  Initials 
Time Dispensed  Initials 
Additives  Initials 
Comments 
Quality Assurance Guidelines for Hernodialysis Devices  Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Se p  Oct  Nov  Dec 
DATE 
CULTURE  SITE 
Machine #1 
Machine #2 
Machine #3 
Machine #4 
Machine #5 
Machine #6 
Machine #7 
Machine #8 
Machine #9 
Machine #10 
MIXING TANK  PROCEDURE FOR CONCURRENT 
MONITORING FORM: 
DIALYSATE CONCENTRATE 
SAFETY MOMTOR (FORM 4) 
The purpose of this audit is to monitor technical  Perform the Audit 
staff compliance with standard practices and pro- 
cedures related to the water treatment system.  1. On the actual audit sheet, write in the date, 
When staff are aware of the importance of the  auditor's name, patient shift (or time of day), 
policies and well trained in the procedures, com-  and standard. 
pliance should be very high. 
2. Read each indicator carefully. 
Before the Audit 
3. Observe staff for actual performance.  Auditor 
should not interfere with staff activities, be 
1. Provide adequate and appropriate inservice to 
obtrusive, or preceptibly obvious. 
assure total staff awareness and education of 
all componentsassociated with water treatment  4. Under each staff code letter, write Y for yes if 
for dialysis.  indicator is met, N for no if indicator is not met, 
or N/A for not applicable, not observed. 
2. Assure staff awareness of all elements of the 
concurrent audit and how performance will be  To achieve a Y (yes, indicator was met), staff 
observed and evaluated.  should be observed with complete compliance 
for each encounter.  For example, for a Y to 
3. The QA committee specifies the standard (ex- 
appear in the "Post-Softener Hardness Done" 
pected percentage compliance) desired for the 
box, the staff member must perform the test 
audit; begin not lower than 85%. 
before any patient dialysis is done and perform 
4. Schedule the audit with appropriate personnel  the test exactly according to the instructions 
(head nurse, charge nurse, chief technician).  for use of the test manufacturer and record the 
results as per facility policy. 
5. Make copies of  the audit for each auditor1 
observer.  5. Complete all observations within timeframe 
specified. Assure that each indicator has one 
6. Assign code letters for each staff member to be  response. 
observed; for example: 
After the Audit 
Employee  A:  Glenn Close 
B:  Tom Hanks  1. Under each employee code letter, add total 
C.  William Hurt  number of Ys and Ns; do not count NAs. 
etc. 
2. For each employee, calculate compliance per- 
Determine how many staff are to be observed. 
centage by dividing the total Ys by the total 
It is recommend that one auditor should observe 
observations; again, do not count NAs. 
no more than three to four staff at one time. 
Calculate total compliance percentage for the 
Define the length of time for observation. It is  audit by dividing total Ys (all employee Ys) by 
recommended that the audit be conducted dur- 
the total observations; do not count NAs. 
ing peak activity times (daily start-up, shift 
changeovers, etc.).  The time frame should be  For each indicator, calculate compliance per- 
long enough to observe each staff member com-  centage by using the same method as above; 
pletely perform the listed activity.  again, do not count NAs. 
9. Assign a staff member to perform the audit.  Report results to QA committee and clinical 
Auditor shouldnotbe assigned to otherresponsi-  management team with additional comments 
bilities during the audit.  andlor recommendations. 
Quality Assurance Guidelines for Hernodialysis Devices  --  -- 
Date  Patient  Shift  Auditor 
Station  Number  1 2 3 4 5 6 7 8 9 1 0  
Staff Member  (initials) 
PER TREATMENT FUNCTIONS 
Prowr concentrate confirmed on patient record 
1  I 
Proper connectors used (color codedkey coded) 
1  1  1  I 
Conductivity checkedlrecorded before treatment 
pH checked and recorded before treatment 
Concentrate jug properly labeled 
DAILYIWEEKLYIMONTHLY FUNCTIONS  Staff  Member  YIN 
Most recent mixing tank sanitzation recorded on log 
Most recent concentrate jugs sanitization recorded on log 
Most recent concentrate iua bacterial culture within limits 
I  I 
Most recent mixing tank bacterial culture within limits 
Q.A. Cornittee Recommended Actbn:  Chapter 6 
HEMODIALYZERS 
: 
CONTENTS 
Page 
...................... 
TECHNICAL DESCRIPTION OF DEVICE  6-1 
....................................... 
RISKS AND HAZARDS  6-2 
...................... 
QUALITY ASSURANCE FOR DIALYZERS  6-2 
.................................. 
Policies and Procedures  6-2 
............................ 
Staff Training and Education  6-3 
.............................. 
Monitoring and Evaluation  6-3 
................................. 
Daily Monitoring  6-3 
.............................. 
Monthly Monitoring  6-4 
................................ 
Patient Monitoring  6-4 
.......................... 
Home Dialysis Monitoring  6-4 
................................. 
Other Monitoring  6-5 
....................................... 
Prevention  6-5 
............................. 
Purchasing Guidelines  6-5 
............................. 
TABLES. FIGURES. AND FORMS  6-7 
Qrurlity Assuran:ce Guidelines for Hedialysis Devices  Chapter 6  Hernodialyzers 
Note: Information specific to reuse of hemodialyz-  Ultmfiltmtion is the simultaneoust ransfer of a solvent, 
ers, as well as some other general discussion re-  with the small amount of solutes that it contains, 
garding dialyzers may also be found in Chapter 12,  across a membrane. 
Hemodialyzer Reuse. 
The rate of ultrafiltration depends on the effective 
surface area and the hydraulic permeability of the 
membrane, as well as transmembrane hydrostatic 
TECHNICAL DESCRIPTION OF  pressure. 
DEVICE 
In practical terms, solute removal (incorporating 
The hemodiulyzer (dialyzer) is a device that per-  both diffusion and ultrafiltration) from the blood to 
. 
mits electrolyte metabolic and fluid exchange be-  the dialysate is most often defined as clearance 
tween the blood and the dialysis fluid. A semi-per- 
meable membrane separates two compartments;  Dialysance describes dialyzer efficiency when sol- 
the patient's blood flows through one and the di-  ute concentration in the dialysate is not zero, or 
alysis fluid, or dialysate, flows through the other.  the volume of blood cleared of that solute per min- 
ute, if the dialysate concentration was zero (see 
The solute and fluid removal capabilities of a dia-  Table 3). 
lyzer are referred to asp erformance characteristics. 
Other characteristics such as materials of construc- 
tion, priming volume and compliance, residual blood  Dialyzer Membranes 
volume, fluid dynamic parameters, etc. are referred 
to as design characteristics.  There are three basic membrane types: 
Several of  these basic characteristics of the dia-  1.  The conventional cellulosic membrane (Cupro- 
phanq saponified cellulose ester, regenerated 
lyzer are described below: 
cellulose, cuprammonium rayon, etc.) 
Mass Transfer. Mass transfer is used to calcu- 
2.  Cellulose acetate, and 
late the amount of solute transfer across the semi- 
permeable membrane. Mass solute transfer is the 
3.  Noncellulosic and high flux (polysulfone, poly- 
quantity of a solute transferred from the blood into 
acrylonitrile, polymethylmethacrylate, polyamide, 
the dialysis fluid (or vice-versa) per unit of time. 
polycarbonate, etc.) 
Mass transfer across a semi-permeable membrane  kom a quality assurance perspective, membranes 
includes two basic mechanisms, difiswn and d-  must be evaluated prior to use based on their sol- 
trafiltration .  ute transport characteristics, biocompatibility, wa- 
ter removal, reuse, clotting, and membrane integ- 
Diftcusion is the passive transfer of solutes across a 
rity. 
membrane in the absence of net solvent transfer. 
The amount of solute crossing a membrane by dif-  Design Characteris tics 
fusion depends on three factors: (a) the mean con- 
centration ingredient of the solute on either side of  Dialyzer design characteristics may also influence 
the membrane, (b)  the effective dialysis surface  the facility's selection of a specific dialyzer for a 
area available for diffiion, and (c) the total dia-  given patient.  These characteristics include the 
lyzer permeability coefficient.  priming volume and the compliance of the blood 
Quality Assurance Guidelines for Hernodialysis Devices  compartment, blood  and dialysate compartment  Dialysate leak at dialysate port, resulting in 
hydraulic pressure drops, the residual blood vol-  inadequate dialyzer clearance. 
ume, the uniformity of flow distribution in blood 
Membrane leaks on dialyzm secon*  to damaged 
and dialysate compartments, as well as more sub- 
dialyzer housing, &r  a case of dialyzers was 
jective characteristics such as size, weight,  shape, 
dropped without being reported. 
etc. 
Large plate dialyzer membrane leak secondary 
See Table 1 for a summary description of types of 
to clotting, due to inappropriate anticoagulant 
hemodialyzers and their characteristics. 
administration and monitoring. 
Many of the incidents could have been avoided thrugh 
RISKS AND HAZARDS  fairly simple tests, observations, or quality control 
procedures as specified in the manufacturer's in- 
The literature prior to 1980 contains a large num-  structions for use.  Further, although only a few of 
ber of reports and patient complications attributed  these incidents resulted in patient death, almost 
to problems with dialyzers.  These include prob-  all had the potential to cause death. 
lems with the structural design ofthe dialyzer, patient 
allergic responses to the membrane material andl 
or the chemical used to make or sterilize the mem- 
EXISTING GUIDELINES 
brane, and human errors. 
Guidelines currently relavent to dialyzers are the 
Incidents reported in the literature and through 
International organization for Standardization (IS01 
the Medical Device Reporting system since 1980 
Document 8637, International Standard for Hemodia- 
are summarized in Appendix A 
lyzers, Hemofilters, and Hemoconcentrators, and 
the American National Standard for First Use 
A total 342 incidents were reported; apparent dia- 
Hemodialyzers (ANSUMMI: RD16-1984) devel- 
lyzer hypersensitivity reactions comprised 205 of 
these.  Of the remaining incidents, many included  oped by the Association for the Advancement of 
Medical Instrumentation (AAMI).  Both of these 
some component malfunction of the device, due to 
documents are, primarily voluntary standards for 
manufacturer quality control error. 
manufacturers of hemodialyzers. 
Incidents related to user error or a combination of 
Table 2 summarizes AAMI's  American National 
user error and device malfunction included: 
Standards for First Use Hernodialyzers. 
F'yrogen reaction and sepsis, indicating bacte- 
rial contamination of dialyzer due to poor set- 
up technique.  QUALITY ASSURANCE FOR 
DIALYZERS 
Dialyzer hypersensitivity reaction when dialyzer 
was not primed according to manufacturer's rec- 
Policies and Procedures 
ommendations. 
Extreme blood loss, due to broken blood port on  An essential step in designing a facility's quality 
dialyzer, blood line separation, cracked dialyzer  assurance program is the development, implemen- 
header, or fiber rupture with no blood detector  tation, and evaluation of policies and procedures 
alarm.  for hemodialyzers.  All standards previously de- 
scribed must be incorporated into these policies and 
Clotting of extracorporeal circuit, due to improper 
procedures.  Specifically, the policies and proce- 
anticoagulation monitoring. 
dures must address the scope of care and thera- 
peutic choices, equipment, disposables, and sup 
Air embolus, due to improper blood linddialyzer 
plies used in the dialysis facility. 
connection. 
Inadequate dialyzer clearance, associated with  Comprehensive policies and procedures must also 
poor priming technique and incomplete removal  address the interrelationship of each component of 
of air.  the hemodialyzer, as well as the various related 
Quality Assurance Guidelines for Hernodialysis Devices  6-2  components, such as the dialysate, delivery sys-  complications management and troubleshooting, 
tem, blood lines and transducer protectors.  The  patient monitoring, and documentation. 
risks involved must be clearly identified and con- 
sidered, and appropriate safety measures and pre-  Need for further education such as inservices or 
ventative systems developed.  intensive educational sessions can be determined 
from the ongoing quality monitoring process and 
Policies and procedures must also address the safe  the continuous staff performance appraisal proc- 
and effective handling and use of the hemodialyzer:  ess. When problems are identified, all staff should 
be made aware of the problem and be involved in 
1.  Storage conditions  its solution; this nearly always includes problem 
specific continuing education. 
2.  Inspection of dialyzer before use 
The medical director of the dialysis facility must 
3.  Priming of blood and dialysate path 
ascertain that an individual has successfblly com- 
4.  Intra-dialytic monitoring of blood circuit pres-  pleted the initial education and training program. 
sure  The medical director is also responsible for assur- 
ing that an annual performance appraisal process 
5.  Intra-dialytic monitoring of dialysate pressure  has been performed. 
6.  Intra-dialytic monitoring for dialyzer blood leak 
7.  Technique for termination of dialysis 
Monitoring and Evaluation 
8.  Anticoagulation 
The following section provides a summary of rec- 
9.  Management and troubleshooting of complica-  ommendations for monitoring that should be per- 
tions  formed to enhance safety and reduce the level of 
risk of patient injury. These recommendations will 
10. Patient monitoring" 
also ensure that the dialysis being received by the 
patient is as prescribed by the physician. 
Staff Training and Continuing  A.  Daily Monitoring 
Education 
1.  Physical inspection of the dialyzer for appropri- 
ate labeling, undamaged packaging, intact caps, 
Role descriptions should include all personnel re- 
and any other obvious defects should be per- 
sponsibilities for general handling and use of the 
formed. 
hemodialyzer, treatment safety and record keep 
ing.  2.  Confirm that the dialyzer prescribed by the physi- 
cian for the patient's treatment is being used. 
Staff training should be a well-defined, organized 
program with content clearly defined for the learner  3.  Confirm that the dialysate flow rate and blood 
based on behavioral objectives.  The behavioral  flow rate prescribed by the physician are actual 
objectives can be used to accurately and objectively  delivery rates.  Clarify that equipment settings 
monitor and measure learning.  At the end of the  conform with prescription.  Any reduction in 
session(s), the instructor must confirm by a written  blood or dialysate flow rate must be documented 
test andor return demonstration that learning has  with rationale (see Form 1). 
occurred and that the learner is able to perform 
4.  Confirm that actual dialysis duration is that 
the procedure(s) independently without error. 
prescribed by the physician. Any departure from 
the prescribed treatment time (in minutes) should 
Comprehension of the purpose and function of the 
be explained on the record. 
hemodialyzer requires a basic understanding of 
kidney disease, fluids and electrolytes, principles of 
5.  Test and document results of all components of 
dialysis, infection control, and complications of the 
the dialysis delivery system, including: 
hernodialysis treatment.  Content should include 
dialyzer principles and function, dialyzer related  the ultrafiltration control system 
procedures, aseptic technique, parameters of safety, 
the blood leak detector 
Quality Assurance.Guidelines for Hernodialysis Devices  arterialhenous pressure alarms; setting  blood cultures), from patient exposure to an 
limits  improperly sterilized dialyzer or a break in 
aseptic technique. 
Acute blood loss, which may be the result of 
6.  Blood flow through the dialyzer as well as di- 
extreme pressures in the blood circuit, caus- 
alysate distribution and flow through the dia- 
ing dialyzer membrane rupture, blood leak- 
lyzer should be observed at the beginning and 
ing through the actual dialyzer housing, or 
throughout the treatment. 
bloodline separation from the dialyzer. 
7.  Monitoring and recording of anticoagulation 
3.  Routine monitoring and evaluation of antico- 
therapy must be performed to assure that the 
agulation therapy needs to be conduded for both 
delivery rate is as prescribed. 
patient and dialyzer clotting times. Real andlor 
potential complications related to anticoagula- 
8.  Special events such as blood leaks, pyrogen re- 
tion need to be addressed and documented in 
actions, cracked dialyzers or other complications 
the patient record. 
should be recorded on the patient's record. 
The performance of the above tests and observa-  4.  When treatment delivery is not as prescribed, it 
is recommended that the patient's vascular ac- 
tions should be recorded on a daily patient dialysis 
cess be evaluated for recirculation. 
record.  The initials of the person performing the 
test and the specific machine number should ap 
5.  First Use Syndrome signs and symptoms in- 
pear on that record (see Form 1). 
clude chest pain, anxiety, shortness of breath, 
and back pain. 
B. Monthly Monitoring 
Any case of First Use Syndrome (FUS),o r Dia- 
An essential component of assuring adequacy of 
lyzer Hypersensitivity Reaction, should be ad- 
the dialysis treatment is to confirm that the dialyz- 
dressed immediately.  Signs and symptoms of 
ers and the way the dialyzers are being used are in 
these reactions include asthmatic reaction, res- 
compliance with facility expectations and national 
piratory arrest, pruritis, urticaria, erythema, pe- 
standards. A welldesigned urea kinetics program 
ripheral and facial edema, hypertension, hypo- 
will enable the facility to monitor adequacy of treat- 
tension, and cardiac arrythmia.  The reactions 
ment  The patient should have one or more of the 
range from very mild to very severe, including 
following measured on, at least, a quarterly basis: 
death. The following should be done in the case 
pdpost BUN reduction  of a suspected FUS reaction: 
KTN urea (delivered or actual) 
Immediately discontinue dialysis on the pa- 
tient without returning the contents of the 
prdpost creatinine reduction 
extracorporeal circuit. Provide medical treat- 
Individual characterization of the dialyzers may also  ment for any resulting symptoms. 
be performed. 
Many experts recommend that the same dia- 
lyzer type not be used on the patient, if pos- 
C. Patient Monitoring 
sible.  If the same dialyzer must be used, be 
1. Routine monitoring of BUN as described above.  sure to rinse diligently according to the manu- 
facturer's recommendations prior to use. 
2.  Routine intradialytic monitoring of the patient's 
physiological parameters and symptoms can provide  Note: A positive history of hypersensitivity re- 
indications of improper dialyzer function. A few  action is an indication for careful monitoring for 
of the symptoms seen are:  such signs and symptoms during dialysis. 
Hypotension or hypertension, related to gross  D.  Home Dialysis Monitoring 
dialyzer performance error, especially in the 
All of the monitoring procedures described above 
absence of an ultrafiltration controller. 
should be performed by the home dialysis patient, 
F'yrogen reaction (shaking, chills, increase in  home dialysis support personnel, and reviewed by 
patient temperature of more than 1C during  the medical director, as appropriate. 
treatment) or septicemia (identified through 
Quality Assurance Guidelines for Hernodialysis Devices  E.  Other Monitoring  entire dialysis delivery system. The established 
schedules and procedures must be followed. 
1. Using the prescribed recommendations of the 
manufacturer, dialysate flow rate, blood pump 
2.  Water and dialysate must be tested and evalu- 
flow rate and proper calibration of the heparin 
ated to assure at least minimum compliance 
pump should be tested directly.  Actual flow 
with AAMI standards. 
rates should be measured over a prescribed time 
using precise volume measurements. 
2.  An annual review of all policies and procedures  G.  Purchasing Guidelines 
related to hemodialyzers should be performed. 
The following is a list of pertinent questions to ask 
Assure that current standards andfor regula- 
when purchasing hemodialyzers. 
tions are incorporated as appropriate. 
Does the dialyzer meet the facility's definition 
3.  All incidents or adverse occurrences related to 
of adequacy? 
hemodialyzers should be documented and re- 
ported at the monthly quality assurance meet- 
What are the performance characteristics of the 
ings.  To assess trends that may compromise 
dialyzer? How do these performance character- 
patient safety, adverse occurrences associated 
istics fit in with the facility's and physician's 
with the dialyzer should be recorded on a "flow 
therapeutic intent? 
chart" so that the information can be exam- 
ined, analyzed, and compared over an extended  What are the specific equipment needs related 
period of time by the quality assurance com-  to the use of this dialyzer? 
mittee.  Any trends thus become immediately 
What are the graphic representations of "in-vim" 
obvious and appropriate action can be taken. 
expectations of performance according to the 
See Form 2 for a sample trend analysis format. 
therapeutic parameters that will be used in the 
4.  Quarterly monitoring of actual implementation  faility? 
of hemodialyzer procedures should be performed. 
Has the specific dialyzer been proven safe, reli- 
See Form 3 for sample "Dialyzer Usen monitor- 
able and effective in other facilities? 
ing instrument. 
These questions will enhance the likelihood of se- 
F.  Prevention 
lecting a hemodialyzer that best suits the need of 
1. Each manufacturer provides comprehensive di-  the patient.  It will also help to assure a treatment 
rections for the preventative maintenance of the  that is safe and effective. 
Quality Assurance Guidelines for Hernodialysis Devices  REFERENCES 
1. Association for the Advancement of Medical Instrumentation. American National Standard, 
First Use Hemodialyzers  (AAMI:  RD16-1984). Arlington, VA (1984). 
2.  KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation of Risks and 
Hazards Associated with Hemodialysis Systems (Technical Report, Contract #223-78-5046). 
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administra- 
tion/Bureau of Medical Devices, Silver Spring, MD (1980). 
3.  SARGENT, J.A. and GOTCH, F.A.  Principles and Biophysics of Dialysis in Replacement of 
Renal Function by Dialysis.  William Drukker, Frank M. Parsons and John F. Maher, eds. 
Martinus Nijhoff, The Hague, The Netherlands (1988). 
4.  HOENICH, N.A.,  FROST, T.H. and KERR, D.N.S. Diulyzers inReplacement of Renal Function 
by Dialysis. William Drukker, Frank M. Parsons and John F. Maher, eds. Martinus Nijhoff, The 
Hague, The Netherlands (1988). 
5.  SHINABERGER, J.H.,  MILLER, J.H.  and GARDNER, P.W.  Characteristics of Available 
Diulyzers  in Clinical Dialysis. A .R. Nissenson, R.N. Fine and D.E. Gentile, eds. Appleton- 
Century-Crofts, Norwalk, CT (1984). 
6.  DHEW. Evaluation of Hemodiulyzers and Dialysis Membranes (report of a study group of the 
Artificial Kidney-Chronic Uremia Program, E. Klein, Chairman.  DHEW  Pub. No. (NIH)77- 
1294). US. Department of Health, Education and Welfare, Washington, DC (1977). 
7.  VLCHEK, D.L. and BURROWS-HUDSON S. Quality Assurance Challenges in Short Dialysis. 
Nephrology News & Issues, 5,l: 12-14 (1990). 
8.  GOTCH, F. Kinetic Modeling in hemodialysis.  Clinical Dialysis. AR. Nissenson, R.N. Fine 
and D.E. Gentile, eds. Appleton and Lange, Norwalk, CT (1990). 
9.  KEEN, M., LANCASTER, C. and BINKLEY, L. Concept and Principles ofHemodialysis. incore 
Curriculum for Nephrology Nursing.  L.E.  Lancaster, ed.  American Nephrology Nurses' 
Association, Pitman, NJ (1990). 
Note:  A list of additional references on this topic can be found in Appendix E at the end of this 
manual.  These additional references are included to enable the reader to pursue further inves- 
tigation for the purpose of training or research on this topic. 
Quality Assurance Guidelines for Hemodialysis Devices  I 
I 
Membrane  Type  Transport  Ultraflltratlon  Blocompatlblllty 
Conventional Membrane 
(Cuprophan, Regener- 
ated Cellulose, SCE, 
etc.) 
Cellulose Acetate 
Non-Cellulosic and 
+ 
Key  =  Effective 
++ 
=  VeryEffective 
+++ 
=  Extremely Effective 
Quality Assurance Guidelines for Hernodialysis Devices  TABL2 ~ 
AAMI DIALYZERRE QUIREMEN(TMS ANUFACTURSETRA NDARDS) 
LABELING AND DOCUMENTATION  Names of materials in contact with blood or dialy- 
sate 
Device Markings 
Common chemicals and processes with known 
Manufacturer name and address 
1  adverse effects on dialyzer materials 
Product trade name and generic name 
Statement that the following is available upon 
Catalog number 
D  request: detaills of test methodologies, results 
Lot number  of clinical performance tests, number of particu- 
Sterilization date  lates in effluent, results of toxicological tests. 
Identification of blood and dialysate ports 
Unit Container  PERFORMANCE REQUIREMENTS 
Sterilization Date  Ultrafiltration Rate 
Statement regarding "sterile and nonpyrogenic"  *lo% of stated 
Special conditions of storage and handling 
Solute Clearance 
Statement: "Caution: Federal law restricts device to 
f1 0 % of stated 
sale by or on order of a physician" 
Pressure drop across the hemodialyzer measured 
A warning that the device must be rinsed before use 
Blood compartment volume and compliance 
Maximum TMP 
measured 
Statement: " Caution: See Directions for Use before 
Residual blood volume measured 
using this device" 
Other descriptive information, warnings, etc. 
MECHANICAUSTRUCTURALI NTEGRITY 
Warnings regarding flow maldistribution under 
REQUIREMENTS 
certain conditions 
General 
Warning if ultrafiltration rate is not linear with 
Able to withstand pressure 1.5 x recommended 
relation to TMP 
Membrane integrity tested 
Package lnsert/lnstructions  for Use 
Packaging integrity to minimize damage during 
Instructions for priming, operating parameters, 
shipping 
monitoring, termination, etc. 
Warranty for first use 
DEVICE CLEANLlNESSlREQUlREMENTS FOR 
Dialyzer description/specifications 
MATERIALS 
Indications for use 
Must be sterile and nonpyrogenic 
Adverse Reactions 
All materials in contact with blood must be biocom- 
Recommendations regarding anticoagulation 
patible 
Contraindications  Residual EtO must be within federal limits 
Warning regarding conditions for backfiltration 
Method of sterilization 
TUBING CONNECTORS 
Any particular features 
Blood port shall meet IS0 (International Standards 
Ranges for blood flow rate, dialysate flow rate, 
Organization) requirements for design 
TMP, temperature, etc. 
Dialysate port shall meet IS0 requirements for 
Characteristics (UF coefficient, clearances, pres- 
design 
sure drops, blood compartment volume, etc. 
Quality Assurance Guidelines for Hernodialysis Devices  CLEARANCE 
In practical terms, solute removal (incorporating both diffusion and ultrafiltration) 
from the blood to the dialysate is most often defined as clearance (K). 
K,  (C,  -  )C, Q , + Q,  C,
(for the blood side of the dialyzer) 
where: 
C , is solute concentration entering the dialyzer, 
 C, is solute concentration exiting the dialyzer, 
Q , is blood flow rate, and, 
Qf  is ultrafiltration rate 
And, similarly, 
(for the dialysate side of the dialyzer) 
Dialyzer efficiency when solute concentration in the dialysate is not zero (such as 
recirculating dialysate systems). Dialyzer dialysance (Dd describes the volume of blood 
cleared of that solute per minute if the dialysate concentration is zero. 
Quality Assurance Guidelines for Hernodialysis Devices  PATIENTD AILYD IALYSISR ECORD 
XYZ DIALYSISC ENTER 
Date  Patient Name 
Dialyzer  Time on  Dry weight 
QB  QD  Actual time off  Predialysis weight 
Heparin Rx:  Rx time off  Desired weight loss 
Prime  Rx dialysis length  Postdialysis weight 
Infusion  Actual dialysis length  UF rate 
Time off  Expected clotting time 
Dialysate Rx  Actual clotting time 
Conductivity  Blood leak alarm  Patient ID  1 
PH  Air foam detect (check)  Use number 
Temperature  Air foam detect (armed)  Dialyzer structure/aesthetic 
Special Rx  UF check  Germicide dwell 
Mixed  ArtNen press set  Germicide presence 
Dispensed  Machine number  Germicide absence 
Quality Assurance Guidelines for Hernodialysis Devices  Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec 
DATE 
-- 
Model #5 
Model #6 
BLOODL EAKS(H OUSING) 
Model #1 
Model #2 
Model #3 
Model #4 
Model #5 
Model #6 
UF RATE D VS EXPECTED 220% 
Model #1 
Model #2 
Model #3 
Model #4 
Model #5 
Model #6 
Other Dialyzer Pnoblems:  PROCEDUREFORCONCURRENT 
MONITORING FORM: 
DIALYZER USE MONITOR 
(FORM 3) 
Perform the Audit 
The purpose of this audit is to monitor technical 
staff compliance with standard practices and pro- 
cedures related to the water treatment system.  1. On the actual audit sheet, write in the date, 
When staff are aware of the importance of the  auditor's name, patient shift (or time of day), 
policies and well trained in the procedures, com-  and standard. 
pliance should be very high. 
2.  Read each indicator carefully. 
Before the Audit 
3.  Observe staff for actual performance. Auditor 
should not interfere with staff activities, be 
1. Provide adequate and appropriate inservice to 
obtrusive, or preceptibly obvious. 
assure total staff awareness and education of 
all components associated with water treat-  4.  Under each staff code letter, write Y for yes if 
ment for dialysis.  indicator is met, N for no ifindicator is not met, 
or N/A for not applicable, not observed. 
2.  Assure staff awareness of all elements of the 
concurrent audit and how performance will be  To achieve a Y (yes, indicator was met), staff 
observed and evaluated.  should be observed with complete compliance 
for each encounter.  For example, for a Y to 
3.  The QA committee specifies the standard (ex- 
appear in the "Post-Softener Hardness Done" 
pected percentage compliance) desired for the 
box, the staff member must perform the test 
audit; begin not lower than 85%. 
before any patient dialysis is done and per- 
form the test exactly according to the instruc- 
4.  Schedule the audit with appropriate person- 
tions for use of the test manufacturer and 
nel (head nurse, charge nurse, chief techni- 
record the results as per facility policy. 
cian). 
5.  Complete all observations within timeframe 
5. Make copies of  the audit for each auditor1 
specified. Assure that each indicator has one 
observer. 
response. 
6.  Assign code letters for each staff member to be 
After the Audit 
observed; for example: 
Employee  A:  Glenn Close  1. Under each employee code letter, add total 
B:  Tom Hanks  number of Ys and Ns; do not count NAs. 
C.  William Hurt 
2.  For each employee, calculate compliance per- 
etc. 
centage by dividing the total Ys by the total 
7.  Determine how many staff are to be observed.  observations; again, do not count NAs. 
It is  recommend that one auditor should 
observe no more than three to four staff at one  3.  Calculate total compliance percentage for the 
time.  audit by dividing total Ys (all employee Ys) by 
the total observations; do not count NAs. 
8.  Define the length of time for observation. It is 
recommended that the auditbe conducted dur-  4.  For each indicator, calculate compliance per- 
ing peak activity times (daily start-up, shift  centage by using the same method as above; 
changeovers, etc.).  The time frame should be  again, do not count NAs. 
long enough to observe each staffmemberc om- 
5.  Report results to QA committee and clinical 
pletely perform the listed activity. 
management team with additional comments 
9.  Assign a staff member to perform the audit.  andlor recommendations. 
Auditor should not be assigned to other re- 
sponsibilities during the audit. 
Quality Assurance Guidelines for Hemodialysis Devices  - 
Quality Assurance Guidelines for Hernodialysis Devices  Chapter 7 
ANCILLARY  DEVICES 
AND  EQUIPMENT 
CONTENTS 
Page 
................................. 
TECHNICAL DESCRIPTIONS  7-1 
........................................ 
RISKSANDHAZARDS  7-2 
..................................... 
EXISTINGGUIDELINES  7-2 
...................................... 
QUALITY ASSURANCE  7-3 
.................................. 
Policies and Procedures  7-3 
............................ 
StaffT raining and Education  7-3 
.............................. 
Monitoring and Evaluation  7-3 
.................................... 
Blood Tubing  7-4 
............................. 
Transducer Protectors  7-4 
........................... 
Single Needle Equipment  7-5 
.............................. 
Conductivity Meters  7-5 
.................................... 
Home Dialysis  7-5 
............................. 
TABLES. FIGURES. AND FORMS  7-6 
Quality Assurance Guidelines for Hernodialysis Devices  Ancillary Devices 
Chapter 7 
and Equipment 
Drip Chambers or Bubble Traps.  These com- 
ponents are used primarily for removing any air 
Blood Tubing'  that may have inadvertently entered the extracor- 
poreal circulation.  Most dialysis delivery systems 
Blood tubing is the conduit through which blood is  also monitor for air andfor foam in the blood at the 
taken from the patient, delivered to the dialyzer,  'Genous bubble trap."  This is accomplished by ul- 
and returned to the patient during dialysis ther-  trasonic or optical sensors which are placed at or 
apy.  Blood tubing sets include various combina-  near the bottom of the bubble trap to alert the user 
tions of special purpose components in addition to  if bubbles are present. 
the tubing itself  Common components of a blood 
tubing set may include:  Bubble traps also serve the purpose of "pressure 
buffers" in the extracorporeal blood circuit since 
Patient Connectors.  Both arterial and venous  there always is some air near the top of these com- 
end pieces of the blood tubing are used to conned  ponents. Wide pressure variations in the extracor- 
the tubing to the fistula needle, catheter, etc. These  poreal circuit due to variability in vascular access, 
connectors include both simple her connectors as  the blood pump, or single needle dialysis can be 
well as her locking connectors.  minimized as compression and expansion of the air 
at the tops of these bubble traps occurs. 
Dialyzer Co~ectors.T  he connection between 
the arterial and venous blood lines and the dia-  Blood Pump Segment.  The blood bump seg- 
lyzer itself may be a "soR connector" made of pli-  ment is a short piece of the arterial blood tubing 
able plastic or a "rigid her connector."  that is inserted into the roller section of the blood 
pump.  It is generally made of durable material 
Other Co~ectors.V arious other connectors may 
(most often polyvinyl chloride (WC) but in some 
be attached to the blood tubing including: heparin 
cases silicone) in order to withstand the constant 
line, pressure monitoring lines, solution admini- 
mechanical stress placed upon it. 
stration lines, and other ports.  As with the dia- 
lyzer connectors and the patient connectors, these  Clamps. Some blood lines are equipped with their 
"service line connectors" can either be straight hers  own dedicated clamping devices on the arterial and 
or "her lock connectors."  venous tubii, heparin administration lines, solu- 
tion administration lines, monitoring service lines, 
Injection Sites.  Also called "access ports," these 
and other areas. 
are comprised of a "sleeve" around the tubing itself 
(composed of latex or a similar material) or a small  Service Tubing.  A variety of "service lines" or 
similar port attached to another primary compo-  "accessory tubing" also appears on most blood tub- 
nent of the blood tubing, such as a bubble trapldrip  ing sets. These are used for such hctions as ad- 
chamber. A needle can be directly inserted for the  ministration of heparin or heparin infusion, solu- 
purpose of administering medications, fluids, ob- 
tion administration, pressure monitoring, and other 
taining a blood sample, or other purposes.  Most  functions. 
injection sites are (and should be) equipped with 
Some sort of hard plastic protection device to guard  BIood Tubing.  Finally, the tubing itself acts as 
against accidental needle sticks to the patient care  the primary conduit of the blood from the patient 
staff when inserting needles through the injection  to the dialyzer and back to the patient. 
site. 
- 
Q&irr  Assurance Guidelines for Hernodialysis Devices  Transducer Protectors  fluid and an alternating current of high frequency 
pulses through the fluid.  When changes in tem- 
The purpose of these devices is to isolate the inte-  perature are compensated, the only variable will 
rior of the blood tubing and protect the pressure  be the electrical resistance of the dialysis fluid which 
sensor within the dialysis delivery system.  Pres-  will cause an alteration in the current passing be- 
sure monitoring creates a direct and open channel  tween the electrodes which may be read on a me- 
between the sterile internal surfaces of the blood  ter. 
tubing and the non-sterile components of the dialy- 
sis delivery system.  An impermeable flexible dia-  Many of these independent reference conductivity 
phragm or a submicron filter must be placed at  meters also enable the user to measure other para- 
this interface.  meters with relation to the dialysate, including 
temperature, pressure, and pH. 
Single Needle Devices 
RISKS AND HAZARDS 
"Single needle systemsn accomplish hemodialysis 
with only one venipuncture, the flow through the  Literature prior to 1980 contains a number of re- 
needle alternating between flow from the patient  ports of patient complications attributed to prob 
to the dialyzer (arterial or fill phase) and flow from  lems with blood tubing, transducer protectors, single 
the dialyzer back to the patient (venous or return  needle devices, and conductivity meters. Problems 
phase).  While this can also be accomplished with  are usually related to  manufacturer.'^ error in prod- 
"dual lumen" catheters, the following discussion is  uct design or manufacturing quality control, inap- 
limited to single lumen, single needle systems.  propriately calibrated equipment, user error in ham 
dling the devices, or a combination of user error 
Single needle systems are comprised of:  and design/operation malfunction. 
a  single, intermittently operated blood pump  Incidents reported in the literature between 1980 
and a single clamp (venous) or  and 1989 are summarized in Appendix A  Many 
of these incidents could have been avoided by strict 
a single, continuously operating blood pump and 
adherence to the  manufacturer.'^ instructions for 
two clamps (arterial and venous) or 
use, preventative maintenance, repair protocols, as 
well as ongoing monitoring and evaluation activi- 
two intermittently operating blood pumps with 
ties. 
no clamps, with pump occlusion providing the 
necessary clamping action with the pump off. 
Conductivity Meter (Independent Refer- 
Blood lines.  There are three guidelines that ad- 
ence Test Meter). 
dress blood lines. 
Basically, the independent reference conductivity 
The first two, the Association for the Advancement 
meter operates under the same principle as the 
of Medical Instrumentation (AAMI) American Na- 
conductivity measurement system in the dialysis 
tional Standard for Hemodialyzer Blood Tubing 
delivery system. A variety of such meters are cur- 
(RD17-1984) and the International Organization 
rently available in the United States, however, not 
for Standardization (ISO) Standard for Blood Tub 
all of these meters are temperature compensated, 
ing and Dialyzer Connectors, both are directed to 
which may present measuring problems for the user. 
the manufacturers of blood tubing. 
The principle of checking mechanical dilution of 
A third standard is the HCFA Final Rule: Medi- 
concentrate is an indirect one which depends upon 
care Program: Protocol for the Reuse of Dialysis 
the specific conductivity of the total ionic content of 
Blood Lines (42 CFR Part 405, Federal Register, 
the dialysis fluid. Temperature changes influence 
May 2,1990, VoL 55, No. 85, p. 18331-18335). This 
measurement by about 1.7% per OC  in the range of 
rule requires that if a facility reuses blood lines, it 
38C.  Two electrodes are immersed in the dialysis 
must reuse only a blood line for which the FDA 
Quality Assurance Guidelines for Hernodialysis Devices  7-2  storage and inventory control, usehandling, dis- 
has accepted the manufacturer's protocol for reuse 
posal, complication management, and repair. 
of that particular blood line.  Additionally, the fa- 
cility must reuse blood lines only in accordance 
with that protocol. 
Staff Training and Continuing 
In the absence of any other standards of practice or 
Education 
use for dialysis facilities and personnel, we will dis- 
CUSS proper use and handling later in this chapter. 
Role descriptions should describe all personnel re- 
Manufacturers' instructions for use serve as the 
sponsibilities for handling and use of ancillary sup 
best standard. 
plies and equipment, ordering, confirmation of proper 
Transducer protedors.  Manufacturers' instruc-  labeling, testing and monitoring, and other similar 
tions for use will serve as the best standard.  The  responsibilities.  Each responsibility should stem 
Centers for Disease Control and Health Care F'i-  from a specific policy or procedure. 
nancing Administration stipulate that transducer 
Staff training should be a well defined and organ- 
protectors should not be reused. 
ized process.  Content should be clearly defined for 
Single needle control.  Single needle control  the learner and based on behavioral objectives. The 
devices are included in the AAMI American Na-  behavioral objectives can be used to accurately and 
tional Standard for Hemodialysis Systems as well  objectively measure learning.  At the end of the 
as in the IS0 Standard for Hemodialysis Systems.  sessiods), the instructor should confirm by a writ- 
Manufacturers' instructions for use may serve as  ten test andlor return demonstration that learning 
the best standard to follow.  has occurred and that the learner is able to per- 
form the procedure(s) independently without error. 
Independent reference meters. Two standards  Testing results should be documented and placed 
refer to conductivity reference standards including:  in the employee's personnel file. 
the National Institute of Standards and Technol- 
ogy (N.I.S.T.); and the Organization of Legal Me-  Comprehension of the purpose and function of each 
trology (a European bureau similar to the N.I.S.T.).  piece of equipment or supply requires a basic un- 
The standards relate to specific aqueous electro-  derstanding of normal physiological concepts, as 
lytic conductance.  well as responses associated with uremia and the 
hemodialysis therapy. Content should include prin- 
ciples of dialysis, patient response to therapy and 
related complications, aseptic technique and inven- 
QUALITY ASSURANCE 
tory control. The interrelationships of each device 
and the delivery system, dialysate, dialyzer, etc. 
Policies and Procedures 
must be incorporated into the training process. 
Policies and procedures concerning ancillary equip 
Need for Wher education, such as inservices or 
ment and supplies as they relate to the hemodialy- 
intensive educational sessions, can be determined 
sis therapy must be developed, written, implemented 
from the routine quality assurance monitoring proc- 
and evaluated. All standards previously described 
ess and the ongoing staff performance appraisal 
must be incorporated into these policies and proce- 
process.  When problems are identified, all staff 
dures. 
should be made aware of the problem and be in- 
volved in its solution. This nearly always includes 
Specifically,t he policies and procedures should address 
problem specific continuing education. 
purpose and function of each device, use, mainte- 
nance, safety factors, troubleshooting and repair, 
The medical director of the dialysis facility must 
and related documentation. The risks involved must 
authorize that the individual has successfidly com- 
be clearly identified and considered, and appropri- 
pleted the initial education and training program. 
ate safety measures and preventative systems de- 
The medical director is also responsible for assur- 
veloped. Specifically, the procedures must address 
ing that an annual performance evaluation has been 
performed.  Monitoring and Evaluation  A pyrogen reaction (shaking chills, increase in 
patient temperature of more than 1C during 
To assure patient safety through the proper use of  treatment) or septicemia (identified through blood 
ancillary equipment and supplies as well as test  cultures) may be the result of  an improperly 
instruments, the following monitoring activities are  sterilized blood line. 
recommended. 
Air embolism (evidence of air in blood lines and 
.entering patients, chest pain, dyspnea, cough- 
ing, cyanosis, visual problems, confusion, coma) 
Blood Tubing 
that may be the result of the disconnection of 
specific connectors in the blood line set or air 
A.  Daily Monitoring 
entering through a damaged component. 
On a per-treatment basis, patient care staff should 
C. Other Monitoring 
confirm that the blood lines are compatible with 
the delivery system and dialyzer, and that packag-  An incoming materials log should be maintained. 
ing and all caps on the blood tubing sets are intact,  Included in this log should be the identification of 
ensuring that the manufacturer's intent for a ster-  the product, delivery date, lot number, and person 
ile, non-pyrogenic extracorporeal circuit is main-  receiving the products. Confirmation that the prod- 
tained.  uct is labeled as ordered should be performed. Any 
product with labels not intact or incorrectly labeled 
A physical check of all blood line connectors (dia- 
should not be accepted. 
lyzer, accessory ports, heparin syringe, etc.) should 
be confirmed before attachment to the patient and  An  annual review of  all policies and procedures 
starting the blood pump. Arterial and venous pres-  related to blood tubing handling should be per- 
sure alarms should be appropriately set to detect  formed. 
excess pressures that could cause line separation. 
All incidents or adverse occurrences related to blood 
A visual inspection of the blood tubing and blood  tubing should be documented and reported at the 
tubing connectors for damage, leaks, and whole or  monthly quality assurance meetings. 
partial occlusions, etc., should be performed. 
D.  Prevention 
Assure that the aidfoam detector is in the proper 
Follow exactly all of the manufacturer's instruc- 
position and armed. 
tions for use. 
At the time of setup, all connectors and lines should 
be inspected by the staff member to ensure ab- 
sence of kinks, partial occlusions, or other physical 
Transducer Protectors 
damage. 
A  Daily Monitoring 
All connections should be double checked for se- 
cure fitting.  Visually confirm that the packaging and caps are 
intact before use. 
B.  Patient Monitoring 
Visually confirm that the transducer protector does 
The following should be part of regular intradia- 
not contain water or blood at the beginning of treat- 
lytic monitoring and may be related to malfunction 
ment and periodically throughout treatment. 
or improper use of blood lines: 
Assure that the transducer protectors are compat- 
Acute blood loss (obvious source of blood spill, 
ible with specific dialysis delivery systems. 
shock, vomiting, convulsions) that may be the 
result of extreme pressures in the blood circuit 
Double check that connections of the transducer 
or poor connections, resulting in disconnection 
protector to the dialysis delivery system and to pres- 
of connectors or other leaking from the blood 
sure monitoring tubing of the blood tubing set are 
lines. 
secure. 
Quality Assurance Guidelines for Henodialysis Devices  ing function, patient safety, and treatment effec- 
Before use, the staff member setting up the system 
tiveness. 
should confirm that the transducer pmtedor does 
not have occluded ports, cracks, or any other physi- 
Conductivity Meters (Independent 
cal damage- 
Reference Meters) 
B.  Other Monitoring 
A.  Daily Monitoring 
An incorning materials log should be maintained. 
Most conductivity meters include a "self-test" func- 
This log should include the idenacation of the 
tion of electronic circuitry and battery. If the user's 
delivery date, lot number, and person re- 
meter is equipped with this fimction, the "self-test" 
miving the product, confirmation that the product 
is labeled as ordered should be performed.  Any  should be performed before every use. 
products with labels that are not intact or that are 
Before using a meter to recalibrate a dialysis deliv- 
incorrectly labeled should not be accepted. 
ery system, the conductivity meter should be checked, 
An  annual review of dl policies and procedures  according to manufacturer's instructions, with a 
related to transducer protectors should be performed.  standard conductivity solution.  That conductivity 
should be entered on a regular conductivity meter 
All incidents or adverse occurrences related to trans-  log (see Form 1a t the end of this chapter). 
ducer protectors should be documented and reported 
at the monthly quality assurance meetings.  Manufacturers of some conductivity meters recom- 
mend that proper calibration of the meter be con- 
C.  Prevention  firmed with standard solution daily. 
Follow exactly all of the manufacturer's instruc- 
B.  Monthly Monitoring 
tions for use. 
On no less than a monthly basis, conductivity me- 
ter calibration should be confirmed using a Stan- 
dard Conductivity Solution following manufacture& 
Single Needle Equipment 
instructions. That conductivity reading should be 
entered onto a Conductivity Meter Log (Form 1). 
A  Daily Monitoring 
During setup, check that the blood clamp andlor  To ensure that all monitoring described above is 
blood pump occludes tubing and interrupts flow.  performed, systems checks should be included on a 
"Daily Patient Treatment Record" (see Form 2) or 
Confirmation that pressure alarms are set accord-  a "Daily Dialysis System Checklist" (see Form 3) 
ing to manufacturer's specifications.  which requires that the staff members setting up 
the dialysis delivery system check off all vital func- 
Calculate the stroke volume at the beginning of 
tions of the procedure on a specific form before ini- 
treatment and confirm that the stroke volume fits 
tiation of treatment. 
within the prescription and the manufacturer's rec- 
ommendations.  Review all logs and monitoring instruments relat- 
ing to these pieces of equipment at the monthly 
B.  Monthly Monitoring 
quality assurance meeting. Any data outside of ac- 
An  annual review of  all policies and procedures  ceptable limits must be addressed. Trend analysis 
related to single needle equipment should be per-  (see Form 4) of parameters related to the instru- 
formed.  ments' function should be a part of this review. 
All incidents or adverse occurrences related to single 
needle equipment should be documented and re- 
Home Dialysis Monitoring 
ported at the monthly quality assurance meetings. 
C.  Prevention  All of the monitoring procedures described above 
should be performed by the home dialysis patient, 
All  preventative maintenance required by the 
home dialysis support personnel, and reviewed by 
manufacturer must be performed to assure ongo- 
the medical director, as appropriate.  Today's  Meter  Date  Standard Solution  Meter 
Date  Serial Number  Last Checked  Conductivity  Conductivity 
-  -  -- 
Quality Assurance Guidelines for Hernodialysis Devices  PATIENTD AILYD  IALYSISR ECORD 
XYZ DIALYSISC ENTER 
Date  Patient Name 
Dialyzer  Time on  Dly weight 
QB  QD  Actual time off  Predialysis weight 
Heparin Rx:  Rx time off  Desired weight loss 
Prime  Rx dialysis length  Postdialysis weight 
Infusion  Actual dialysis length  UF rate 
Time off  Expected clotting time 
Dialysate Rx  Actual clotting time 
Conductivity  Blood leak alarm  Patient ID  I 
pH  Air foam detect (check)  Use number 
~emperature  Air foam detect (armed)  Dialyzer structurelaesthetic 
Special Rx  UF check  Germicide dwell 
Mixed  ArVVen press set  Germicide presence 
Dispensed  Machine number  Germicide absence 
- 
~ssurance~.u  idelinefso r ~ernalial~s~iesv ices  PreDialysis 
Correct concentrate (check label) 
I  I 
EAdequateantity of concentrate in jug 
Correct conductivity confirmed 
Correct pH confirmed (if applicable) 
Dialysate flow confirmed 
Bubble trap levels set 
Blood leak detector checked 
Bypass mode checked 
o- r checked 
=detector  armed 
Arterial and venous pressure limits set 
UF controller checked (if applicable) 
Weight recorded 
Ultrafiltration calculated and set 
Vital signs done and recorded 
I  I  I 
Dialysate temperature 
Post-Dialysis 
I 
Weight recorded 
E n sdon e and recorded 
I  I  I 
Unusual events charted 
I 
Machine cleaned and disinfected 
Patient Name  Date 
Machine type  Machine No. 
This checklist is meant as a reminder to the patient care giver to perform the 
vital functions necessary for safe and effective hemodialysis.  It does not 
replace any ordinary records or charting which should be done (i.e., daily 
dialysis reoords7Iow sheets, system logs, etc.). 
Quality Assurance Guidelines for Hernodialysis Devices  CONDUCTIVITMYE TER  TRENDA NALYSIS 
Jan  I  Feb  II   Mar  I  Apr  II  May  1  Jun  I  Jul  11   Aug  1  Sep  \  Oct  \  Nov  I  Dec  , 
DATE 
CONDUCTIVITY 
Meter  #1 
Standard solution conductivity 
Meter conductivity 
Standard solution pH 
Meter pH 
Actual temperature 
Meter temperature 
Recalibration required 
M...a-.t-a.r   P"2-   1 
1I   1  I  I  I  I  I  I  1  I 
Standard solution conductivity 
Meter conductivitv  I  I 
I  1  I 
Standard solution pH 
I 
Recalibration required 
Meter  #3 
Standard solution conductivity 
Meter conductivity 
Standard solution pH 
Meter pH  I  1  1  I  I  I  I  I 
Ad~~tanml nwraturn  I  1  I 
I  I 
Meter temperature 
Recalibration required  I  I  1  I 
INCIDENTS 
I  I  I  I  1  I  I  I  I  I  I  Chapter 8 
ANTICOAGULATION 
CONTENTS 
Page 
............................................... 
BACKGROUND  8-1 
....................................... 
RISKS AND HAZARDS  8-1 
............. 
QUALITY ASSURANCE FOR ANTICOAGULATION  8-2 
.................................. 
Policies and Procedures  8-2 
............................ 
Staff Training and Education  8-2 
.............................. 
Monitoring and Evaluation  8-3 
................................. 
Daily Monitoring  8-3 
.............................. 
Monthly Monitoring  8-3 
................................ 
Patient Monitoring  8-3 
.......................... 
Home Dialysis Monitoring  8-3 
................................. 
Other Monitoring  8-3 
....................................... 
Prevention  8-3 
TABLES. FIGURES. AND FORMS  ............................. 8-6 
Guidelines for Hemodialysis Devices  Anticoagulation 
Chapter 8 
Low Dose Heparinization: An alternative to 
BACKGROUND 
regional heparinization is minimal, controlled, 
tight or low dose heparinization. The objective is 
Hemodialysis treatment is dependent upon the 
to administer, either continuously or intermit- 
free flow of blood over the dialysis membrane and 
tently, just enough heparin systemically to slightly 
through the arterial and venous blood tubing. 
elevate the patient's  clotting time so that the 
Blood, however, has a normal tendency to clot 
when it comes in contact with a foreign surface  dialyzer does not clot. This requires close moni- 
such as the extracorporeal circuit of the artificial  toring by frequent clotting time measurements. 
kidney.  It is necessary to prevent this clotting 
Regional Citrate Anticoagulation: This 
during dialysis. The purpose of anticoagulation 
method of anticoagulation infuses sodium citrate 
duringhemodialysis is to prevent blood clottingin 
into the arterial bloodline to complex calcium and 
the extracorporeal circuit. 
prevent clotting in the extracorporeal circuit. 
There are a variety of anticoagulation techniques  Calcium is infused into the venous bloodline to 
that are employed for hemodialysis:  restore serum calcium to normal limits.  The 
dialysate used must be calcium-free. The patient 
Systemic: Systemic heparinization prolongs the  must be closely monitored for hypocalcemia and 
patient's clotting time, preventing thrombus for-  citrate toxicity. 
mation in the extracorporeal  circuit.  This is 
achieved by continuous or intermittent infusion of  Heparin-free: Using high blood flow rates and 
heparin throughout the dialysis treatment.  A  intermittent saline flushes of the dialyzer through- 
heparin loading dose, or bolus, is usually given  out dialysis, dialysis can be achieved using no 
prior to the initiation of dialysis. During dialysis,  heparin or other anticoagulant. 
heparin is injected into the arterial blood line 
using either an infusion pump to deliver a con-  There are also a variety of techniques for monitor- 
tinuous amount of heparin throughout the dialy-  ing anticoagulation. They are: 
sis, or periodic intermittent injections of heparin 
into the extracorporeal circuit.  Activated clotting time (ACT) 
Lee-White clotting time (LWCT) 
Regional Heparinization: This method of anti- 
coagulation is used when the patient is at risk for 
Whole blood activated partial thromboplastin 
hemorrhage or where systemic anticoagulation is 
time (WBFTT) 
contraindicated by the patient's condition.  Re- 
gional heparinization is the continuous infusion  Plasma partial thromboplastin time ~P'I"l') 
of heparin into the the arterial bloodline assuring 
anticoagulation of the extracorporeal circuit. At  To determine an effective anticoagulation regi- 
the same time, protamine sulfate solution is in-  men for the patient, three key patient parameters 
fused into the venous bloodline. This neutralizes  must be assessed: normal or baseline clotting 
the effecto fheparin before the blood is returnedto  time, response and sensitivity to heparin, and 
the patient.  l%sadvantages associated with re-  elimination rate of heparin. 
gional heparinization  include the difficulty of 
RISKS AND HAZARDS 
simultaneous  dosage determination  for both 
heparin and the protamine sulfate as well as the 
The most common complication reported in the 
potential  for post-therapy heparin-rebound, 
literature pertinent to anticoagulation therapy is 
resulting in hypercoagulability. 
hemorrhage. The incidence of post dialysis bleed- 
Quality hs~ rnweGu idelines for Hernodialysis Dovices  ing secondary to dialysis-related heparinization  Comprehensive policies and procedures must also 
has been reported to be as high as 21%.  address the interrelationships of anticoagulation, 
the patient, and the dialyzer.  The risks involved  *2 
The risk of hemorrhage is so significant that hep-  mustbe clearly identified and considered, and ap  "i 
arin infusion is contraindicated in patients with  propriate safety measures and preventative sys- 
pre-existing bleeding tendencies such as hemo-  tems developed. 
philia, jaundice,  post-operative oozing, threat- 
ened abortion, bacterial endocarditis, suspected  Policies and procedures must also address safe  . 
intracranial hemorrhage, inaccessible ulcerative  and effective operation of the equipment used to  ' 
lesions especially of the gastrointestinal tract,  deliver and monitor anticoagulation during dialy- 
heparin hypersensitivity, and shock.  sis: 
Several factors such as fever, drugs like digitalis  drug inventory, handling, and use 
and tetracycline, nicotine, and antihistamines 
complication management 
affect the activity of heparin.  One might even 
expect that the same patient may react differently 
basic technical operation 
atd ifferent times to the same dose ofheparin. The 
variables inherent in the drug also effect patient  set up and use of the equipment and related 
response including commercial source, molecular  components 
weight, and potency from lot to lot. The effective- 
safety checks 
ness of heparin can be altered when in contact 
with pH levels (dialysate) exceeding a normal 
routine patient monitoring 
range.  It has also been reported that heparin 
tolerance varies not only in different individuals,  preventative maintenance 
but in the same individual during surgical proce- 
cleaning and disinfection 
dures. 
troubleshooting and repair 
record keeping 
EXISTING GUIDELTNES 
patient education 
The best guidelines to follow must be those of the 
manufacturer's instructions for use.  This in- 
cludes instructions for use of the drugs as well as  Staff Training and Continuing 
the equipment related to drug administration and  Education 
anticoagulation monitoring.  Current literature, 
including anticoagulation research, must be re- 
Role descriptions should include all personnel re- 
viewed and facility policies and procedures up- 
sponsibilities for handling and use of anticoagu- 
dated accordingly. 
lants, infusion pumps, monitoring devices, daily 
or per-treatment safety and other system checks, 
recordkeeping pertinent to anticoagulation, and 
QUALITY ASSURANCE FOR  other similar responsibilities. 
ANTICOAGULATION 
Staff training should be a well-defined and organ- 
Policies and Procedures  ized program.  Content should be clearly defined 
for the learner and based on behavioral objectives. 
An essential step in designing the facility's qual-  The behavioral objectives can be used to accu- 
ity assurance program is the development, im-  rately and objectively measure learning. At the 
plementation, and evaluation of policies and pro-  end of the session(s), the instructor should con- 
cedures for hemodialysis anticoagulation.  All  firm by a written test and/or return demonstra- 
standards previously described must be incorpo-  tion that Ieaminghas occurred and that the learner 
rated into these policies and procedures. Specifi-  is able to perform the pmcedure(s) independently 
cally, the policies and procedures must address  without error. The results of the testing process 
the scope of care and therapeutic choices, equip-  shouldbe documented and placed in the ernplo~@*~ 
ment, disposables, and supplies.  personnel file. 
Quality Assurance Guidelines for Hernodialysis Devices  6.  Monitor the anticoagulation level until stabi- 
comprehension of the purpose and function of 
lized. After stabilization, monitor as per phy- 
anticoagulation requires a basic understanding of 
sician directive or whenever problems are 
normal  concepts, as well as responses 
suspected. 
aswciatd  with uremia and the hemodialysis 
therapy.  Content should include principles of  B.  Monthly Monitoring 
dialysis, patient response to therapy and related 
mmplicati~na~se,p tic technique, monitoring, care  1. Confirm proper calibration of the monitoring 
and patient education.  device using standard provided by the manu- 
facturer. 
Need for further education such as inservices or 
intensive educational sessions can be determined  2.  Confirm proper calibration of infusion pumps 
following the manufacturer's  recommenda- 
from the ongoing quality monitoring process and 
tions. 
the continuous staff performance appraisal proc- 
ess. When problems are identified, all staff should 
3.  Complete monitoring documentation ofall pre- 
be made aware of the problem and be involved in 
ventative maintenance to assure that it is 
its solution; this nearly always includes problem- 
performed  within  the scheduled  timeframe 
specific continuing education. 
and according to the manufacturer's recom- 
mendations. 
The medical director of the dialysis facility must 
authorize that the individual has successfully 
C. Patient Monitoring 
the initial education and training pro- 
gram. The medical director is also responsible for  The anticoagulation regimen should be based on 
assuring that an annual review has been per-  the clotting time results, patient's condition, pat- 
formed.  ency of the extracorporeal circuit, and response to 
previous anticoagulation. The patient should be 
assessed by reviewing hematocrit,  clotting stud- 
ies, and history of complications per facility pol- 
Monitoring and Evaluation 
icy.  Anticoagulant administered and results of 
monitoringshouldbe documented on the patient's 
The following section provides a summary of rec- 
daily dialysis record (see Form 1). 
ommendations for monitoring that should be per- 
formed to enhance safety and reduce the level of 
D.  Home Dialysis Monitoring 
risk of patient injury due to incidents related to 
malfunction andlor improper use of equipment  All of the monitoring procedures described above 
related to anticoagulation:  should be performed by the home dialysis patient, 
home dialysis support personnel, and reviewed by 
A.  Daily Monitoring  the medical director as appropriate. 
1. Confirm anticoagulation goals as prescribed. 
E. Other Monitoring 
2.  Confirm vial contents and strength. 
1. Trend monitoring and analysis of  various 
complications, including incidents or adverse 
3.  Confirm the use of aseptic technique in han- 
occurrences related to anticoagulation should 
dling the device. 
be conducted. 
4.  Inspect syringes and connectors for damage, 
leaks, and whole or partial occlusions. All con-  2.  Trend monitoring and analysis of monitoring 
nections should be double checked for secure  equipment can be documented using Form 2. 
fit. 
F.  Prevention 
5. Administer the drug within the time frame 
The patient should be advised as to the side effects 
specified by the manufacturer or as close to 
of heparin therapy and should be encouraged to 
syringe preparation as possible. The individ- 
report any unusual changes prior to the initiation 
ual preparing the drug for infusion must ad- 
of each dialysis.  The patient should also be in- 
minister the drug. 
formed of how to prevent hemorrhaging or bleed- 
Quality ~ssumnceG uidelines for Hernodialysis Devices  ing after dialysis and after the patient has lea the  monitoring procedures. The patient should un. 
dialysis unit. The patient should be informed of  derstand the signs and symptoms andlor con&. 
the rationale for anticoagulation therapy includ-  tions to report regarding complications of coagu. 
ing its purpose, route, dosage, side effects, and  lation therapy. 
Quality Assurance Guidelines for Hernodialysis Devices  REFERENCES 
1. KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation ofR  isks and 
Hazards Associated with Hernodialysis Systems (Technical Report, Contract m23-78-5046). 
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administra- 
tion/Bureau of Medical Devices, Silver Spring, MD (1980). 
2.  LINDSAY, RM. Practical Use ofAnticoagzthnts.i nbplacernent of Renal Function of Dialysis. 
William Drukker, FrankM. Parsons, and John F. Maher, ede. Martinus Hijhoff,The Hague, The 
Netherlands (1988). 
Note: Additional references on this topic can be found in Appendix E at the end of this manual. 
These additional references are included to enable the reader to pursue further investigation 
. 
for the purpose of training or research on this topic  PATIENTD AILY DIALYSISR  ECORD 
XYZ DIALYSISC ENTER 
Date  Patlent Name 
Dialyzer  Time on  Dry weight 
QB  QD  Actual time off  Predialysis weight 
 ,-
Heparin Rx:  Rx time off  Desired weight bss 
Prime  Rx dialysis length  Postdialysis weight 
 ,--
Infusion  Actual dialysis length  UF rate 
Tlme off  ~lcpecredc lotting the 
Dialysate Rx  Actual clotting time 
Conductivity  Blood leak alarm  Patient ID  I 
PH  Air foam detect (check)  Use number 
Temperature  Air foam detect (armed)  Dialyzer structurelaesthetic 
Special Rx  UF check  Germicide dwell 
Mixed  ArtNen press set  Germicide presence 
Dispensed  Machine number  Germicide absence 
Quulity Asswam Guidelines for Hemadialysis Devices  FORM2  
ACTIVATED CLOTTING TIME METER CALIBRATION LOG 
Meter  High  Meter  Low  Meter 
Date  Serial No.  Standard ACT  Low ACT  Standard ACT  Low ACT 
Quality ~ssuranceG uidelines for Hedialysis Devices  L 
Chapter 9 
VASCULAR ACCESS 
DEVICES 
CONTENTS 
Page 
..................... 
TECHNICAL DESCRIPTION OF DEVICES  9-1 
....................................... 
RISKS AND HAZARDS  9-1 
..................................... 
EXISTING GUIDELINES  9-2 
.... 
QUALITY ASSURANCE FOR VASCULAR ACCESS DEVICES  9-2 
.................................. 
Policies and Procedures  9-2 
............................ 
Staff Training and Education  9-2 
.............................. 
Monitoring and Evaluation  9-3 
................................. 
Daily Monitoring  9-3 
............................... 
Monthly Monitoring  9-3 
................................ 
Patient Monitoring  9-3 
........................... 
Home Dialysis Monitoring  9-3 
................................. 
Other Monitoring  9-3 
...................................... 
Prevention  9-4 
............................................... 
REFERENCES  9-5 
Guidelines for Hernodialysis Devices  Chapter 9  Vascular Access 
Vascular access, for purposes of hemodialysis, is  Internal Arteriovenous Graft.  This is the 
the patient's life-line.  It has been stated that  surgical implant of a biologic or artificial graft. 
each time there is a real or potential threat to  The ends of the graft are surgically attached to 
the patient's  access, the patient experiences a  an artery and a vein.  Large bore needles are in- 
sense of impending death. (Lundin, 1989).  For  serted into the graft to provide blood access. The 
patients with multiple vascular access problems,  graft can be used for long-term hemodialysis. 
this experience can be extraordinarily stressful,  There are various configurations of the surgical 
limiting the sense of well being, quality of life,  anastomoses. 
and certainly rehabilitation. 
Temporary Access. A catheter can be used on 
a short term or temporary basis for vascular ac- 
cess.  It is frequently used while a more perma- 
TECHNICAL DESCRIPTION OF 
nent access can be created or when the patient 
DEVICES  may be waiting for a different type of renal re- 
placement therapy such as transplantation. 
To perform long-term hemodialysis, reliable ac-  Long-term use of the temporary access is not 
cess to the blood  circulation is required. A fully  uncommon today.  The locations for placement 
functional  and patent access is imperative.  of  these catheters are usually the subclavian 
Access can be achieved in a number of  ways.  vein, the femoral vein, and occasionally the jugu- 
For each of the following accesses, there are vari-  lar vein. 
ous modifications, types and brands. 
External Arteriovenous Shunt. This consists 
of two rigid Teflon@ tips implanted in an artery  RISKS AND HAZARDS 
and a vein with Silastica  tubing attached to 
the Teflon tips in the vessels.  Each piece of the  The literature has reported several problems as- 
Silastic tubing is brought to the outside of the  sociated with vascular access types and devices. 
skin and connected together for continuous blood  It has been noted that the primary reason for 
flow. When used for hemodialysis, the two Si-  hospitalization  of  the hemodialysis patient is 
lastic tubings are separated and attached to the  related to the vascular access. 
two bloodlines leading to and from the dialyzer. 
The risks and hazards identified in the litera- 
Although not commonly used today, the shunt  ture can be classified into the following catego- 
can be used as a temporary access while the  ries: 
patient is awaiting maturation of  an internal 
fistula, or for acute or reversible renal failure.  MechaniCaYtechnique. These are the incidents 
which pertain to the cannulation or venipunc- 
Internal Arteriovenous Fistula.  The fistula  ture techniques used and the reports regarding 
is created with a surgical anastamosis between  performance of the various devices used for ac- 
an artery and a vein. This allows increased blood  cess, including flow and long term durability. 
flow through the vein, causing engorgement and 
enlargement. When the vein has had an oppor-  Infectious complications. There are numer- 
tunity to mature, large bore needles are inserted  ous incidents related to various microbiological 
into the vein to provide blood access for hemodi-  organisms that have resulted in serious infec- 
alysis.  The fistula is the ideal access for long-  tions and are related to surgical techniques, ven- 
term hemodialysis.  ipuncture or handling techniques. 
Qmlity Assurance Guidelines for Hernodialysis Devices  In the manufacturer's literature and the medi-  The policies and procedures should address the 
cal device reporting system, the incidents re-  purpose and function, use, safety factors, moni- 
lated to vascular access devices can be divided  toring, preventive measures, patient education, 
into three categories:  and related documentation.  The risks involved 
must be clearly identified and considered, and 
Mechanical. Reports pertaining to mechanical  appropriate safety measures and preventative 
risks or hazards are related to hubs, lines andl  systems developed.  Specifically, the procedures 
or connectors separating from each other before,  must address storage and inventory control, use/ 
during, and after treatment.  These unexpected  handling, complication management, anticoagu- 
disconnections create numerous problems with  lation therapy, and care post operatively, as well 
bleeding, excess vessel trauma, and even death.  as before, during and after the dialysis treat- 
Also reported are cracks in connectors or tub-  ment. 
ing, causing blood loss or air inhsion leading to 
air embolus. Other incidents are reported that 
pertain to kinking of tubing, faulty packaging, 
Staff Training and Continuing 
etc. 
Education 
Infection. There are numerous reports of vari- 
ous organisms that have caused patient morbid-  Role descriptions should describe all personnel 
ity or access failure. These organisms were ana-  responsibilities for handling and use of vascular 
lyzed and found to be due to improper technique  access devices.  Each responsibility should stem 
in either the handling or use of the device.  from a specific policy or procedure. 
Physiological complications.  Incidents in-  Staff training should be a well-defined and or- 
clude aneurysms, thrombus, hemothorax, pneu-  ganized process.  Content should be clearly de- 
mothorax, infection and sepsis, fibrin deposition,  fined for the learner and based on behavioral 
dermatitis from the device material, excessive  objectives. The behavioral objectives can be used 
bleeding around the access site (during and af-  to accurately and objectively measure learning. 
ter dialysis), and injury and loss of access due to  At the end of the session(s), the instructor should 
inappropriate administration of drugs.  confirm by  written test andlor return demon- 
stration that learning has occurred and that the 
learner is able to perform the procedure(s) inde- 
pendently without error. Test results should be 
EXISTING GUIDELINES 
documented and placed in employee's personnel 
file. 
The best guidelines to follow are the manufac- 
turer's instructions for use.  Current research 
There needs to be comprehension of the purpose 
related to each particular vascular access device 
and function of each vascular access device being 
in use within the facility must be reviewed and 
used within the facility and a basic understand- 
evaluated for use as a new or modified facility 
ing of normal physiological concepts, as well as 
standard. 
responses associated with uremia and the hemo- 
dialysis therapy.  Content should include princi- 
ples of dialysis, patient response to therapy and 
QUALITY ASSURANCE FOR  related complications, aseptic technique, and, for 
VASCULAR ACCESS DEVICES  each access device type, indications for use, ad- 
vantages and disadvantages, monitoring, care, 
Policies and Procedures  complications, anticoagulation, patient education 
and venipuncturehandling technique.  The in- 
Policies  and procedures  concerning vascular  terrelationships of each device and the delivery 
access devices and supplies as they relate to the  system, dialysate, dialyzer, etc. must be incor- 
hemodialysis therapy must be developed, writ-  porated into the training process. 
ten, implemented and evaluated.  All standards 
previously described must be incorporated into  Need for further education such as inservices or 
these policies and procedures.  intensive educational sessions can be determined 
Quality Assurance Guidelines for Hernodialysis Devices  9-2  from the routine quality assurance monitoring  Recirculation may be calculated by direct meas- 
process and the ongoing staff performance ap-  urement according to the following formula: 
praisal process.  When problems are identified,  P' 
all staff should be made aware of the problem  % recirculation = P- v A 100 
and be involved in its solution; this nearly al- 
ways includes problem specific continuing edu-  where, 
cation. 
P = peripheral concentration  (BUN) 
The medical director of the dialysis facility must  A = sample from  arterial blood line (BUN) 
authorize that the individual has successfully 
V = sample from venous bloodline (BUN) 
completed  the initial education and training 
program.  The medical director is also respon- 
sible for assuring that an annual performance  B.  Monthly Monitoring 
evaluation has been performed. 
1. Complications associated with venipuncture. 
2.  Hospitalizations associated with vascular ac- 
Monitoring and Evaluation  cess infections,  revisions, or other related 
complications. 
To assure patient safety and device effective- 
C.  Patient Monitoring 
ness, the following monitoring activities are rec- 
ommended:  Continuous assessment for signs and symptoms 
of vascular access complications: 
A.  Daily Monitoring 
1. Occlusion, mechanical failure 
1. Inspect the device and connectors for dam- 
age, leaks, and whole or partial occlusions,  2.  Thrombosis 
etc. All connections should be double checked 
3.  Infection 
for secure fitting. 
2.  Verifj. access patency and flow direction.  4.  Skin erosion 
3.  Confirm the use of aseptic technique in han-  5.  Dislodgement 
dling the access device. 
6.  Hemorrhage 
4.  Monitor anticoagulation therapy until stabi- 
7.  Aneurysm; psuedoaneurysm 
lized. 
8. Arterial insufficiency, steal syndrome 
5.  Monitor arterial and venous pressures. 
D.  Home Dialysis Monitoring 
6.  Monitor blood flow rate. 
All of the monitoring procedures described above 
7.  Assess for signs and symptoms of complica- 
should be performed by the home dialysis pa- 
tions. 
tient, home dialysis support personnel, and re- 
viewed by the medical director as appropriate. 
8.  It may become apparent that the prescribed 
treatment is not being delivered as evidenced 
E.  Other Monitoring 
by: 
1. Trend monitoring and analysis of  various 
.a. Increase in patient's blood chemistries such 
complications, including incidents or adverse 
as BUN, creatinine, potassium, etc. 
occurrences related to venipuncture. 
b. Percent reduction in urea significantly less 
2.  Trend monitoring and analysis of hospitali- 
than prescribed. 
zations due to vascular access devices. 
c.  Apparent change in flow andfor pressure. 
3.  Trend monitoring and analysis of the relia- 
In such a case the patient's  vascular access 
bility of a vascular access device. 
should be evaluated for recirculation. 
Qmlity Assurance Guidelines for Hernodialysis Devices  I?.  Prevention  2 Conduct and validate  patient and staff educa- 
tion. 
1.  Follow all of the manufacturer's instructions 
for use and all facility policies and pr0C.e-  3.  Develop p m ~ lfosr   administration 
dures.  using vasucular access devices. 
Quality Assurance Guitlelines for Hernodialysis Devices  REFERENCES 
1. KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation of Risks and 
Hazards  Associuted with Hemodialysis Systems (Technical Report, Contract #223-78-5046). 
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administra- 
tionfBureau of Medical Devices, Silver Spring, MD (1980). 
2.  BELL, P.RF. and VEITCH, P.S.  Vascular Access for Hemodialysis in Clinical Dialysis. AR. 
Nissenson, RN. Fine and D.E. Gentile, eds. Appleton-Century-Crofts, Norwalk, CT (1990). 
3. HARTIGAN, M.  Circulatory Access for  Hemodialysis in Core Curriculum for Nephrology 
Nursing.  L.E. Lamaster, ed. American Nephrology Nurses' Association, Pitman, NJ (1990). 
4.  LUNDIN, P.  Personal Communication.  1980. 
Note:  A list of additional references on this topic can be found in Appendix E at the end of this 
manual.  These additional references are included to enable the reader to pursue further 
investigation for the purpose of training or research on this topic. 
Assurance Guidelines  Hemodialysis Devices  Chapter 10 
HEMODIALYZER  REUSE 
CONTENTS 
Page 
.................... 
TECHNICAL DESCRIPTION OF PROCESS  10-1 
....................................... 
RISKSANDHAZARDS  10-1 
..................................... 
EXISTINGGUIDELINES  10-1 
......... 
QUALITY ASSURANCE FOR HEMODIALYZER REUSE  10-2 
Policies and Procedures  .................................  10-2 
............................ 
Staff Training and Education  10-2 
.............................. 
Monitoring and Evaluation  10-3 
................................. 
Daily Monitoring  10-3 
.............................. 
Monthly Monitoring  10-3 
................................ 
Patient Monitoring  10-4 
.......................... 
Home Dialysis Monitoring  10-4 
................................. 
Other Monitoring  10-4 
....................................... 
Prevention  10-4 
............................. 
Purchasing Guidelines  10-4 
............................................... 
REFERENCES  10-6 
............................. 
TABLES. FIGURES. AND FORMS  10-7 
Guidelines  Hernodialysis Devices 
.  Chapter 10  Hemodialyzer 
Reuse 
TECHNICAL DESCRIPTION OF  an established procedure or the use of an inappro- 
PROCESS  priate procedure.  The literature describes patient 
experiences with pyrogen reactions, boluses of toxic 
Hemodialyzer reuse is the practice of using the  chemicals, decreased adequacy of dialysis, blood loss, 
same dialyzer for multiple dialyses without replace-  and potential immunological problems. 
ment of membranes or other surfaces in contact 
with blood.  This is accomplished utilizing restora-  The 20 incidents that have been reported since 1980 
tion techniques including cleaning the blood sur-  are summarized in Appendix A 
faces, followed by disinfection or sterilization. 
Fifteen incidents were related to pyrogen reac- 
Dialyzer reprocessing can be performed manually  tions andlor bacteremia, due to inappropriate 
or through use of an automated, commedly avail-  water treatment.  The causes included use of 
able "reprocessing system."  Most automated re-  endotoxin-contaminated water and too low a 
processing systems automatically rinse the dialyzer  concentration of germicide used to disinfect the 
of residual blood and blood products, perform some  dialyzers. 
manner of "cleaning" process, test the dialyzer for 
Four incidents involved patient reactions to re- 
leaks and performance parameters, and fill the dia- 
sidual germicide. 
lyzer with an appropriate concentration of a germi- 
cide.  Some automated systems also provide data  One case was related to excessive ultrdltra- 
storage and labeling functions automatically.  tion rate. 
A variety of materials are commonly used in dia-  Many of the incidents could have been avoided through 
lyzer reprocessing including cleaning agents, ger-  simple tests, observations, and/or quality control 
micidal agents, and purified water used to dilute  procedures implemented in the dialysis facilities. 
both of the above. Commonly used cleaning agents 
include hydrogen peroxide, sodium hypochlorite, re- 
verse ultratiltration of water from the dialysate com- 
EXISTING GUIDELINES 
partment into the blood compartment and out through 
the blood ports, and pressurized water.  Germi- 
Unlike many other technical areas of hemodialysis, 
cides used for the high level disinfection required 
hemodialyzer reuse has comprehensive standards 
for dialyzer reuse include formaldehyde, peroxy- 
of practice.  The practice is regulated by HCFA ac- 
acetic acid (trade name Renalinq, glutaraldehyde 
cording to 42 Part 405.2150. The regulation, incor- 
(trade names Sporicidin@N, ephre*,  Cide*)  and 
porating the Association for the Advancement of 
others. 
Medical Instnunentation( AAMI)R ecommended Prac- 
In 1990 the FDA produced and released a vide  tice for Reuse of Hemodialyzers, contains standards 
otape entitled Reprocessing $HemOdialyzers which  and conditions for safe and effective hemodialyzer 
has been distributed to all U.S. dialysis facilities.  reuse and reprocessing, enforceable as conditions 
of Medicare coverage. 
Table 1r eviews the AAMI Recommended Practice 
RISKS AND HAZARDS  for Reuse of Hemodialyzers.  The Recommended 
Practice addresses facility requirements, reuse equip 
The literature prior to 1980 includes reports of patient  ment, cleaning and disinfection methods, labeling, 
complications attributed to problems with dialyzer  preparation for multiple use, controls, and patient 
Ruse.  The problems were due to user error with  aspects.  Several states, including California, Colorado, Geor-  H Dialyzer performance validation. 
gia, and Washington DC,a lso have regulations per- 
I.  Patient monitoring. 
tinent to the reuse of hemodialyzers. 
Staff Training and Continuing 
QUALITY ASSURANCE 
Education 
Role descriptions should include all personnel re- 
Policies and Procedures 
sponsibilities for the operation, preventative main- 
tenance, repairs of reprocessing equipment, daily 
Policies and procedures concerning the reuse of 
safety andlor system checks, appropriate recordkeep 
hemodialyzers must be developed, written, imple- 
ing, acceptance of incoming supplies and inventory 
mented, and evaluated. All standards and regula- 
control, performance and safety checks of reproc- 
tions previously described must be incorporated into 
essed dialyzers, and other similar responsibilities. 
these policies and procedures. Spedcally, the poli- 
Each responsibility should stem from a specific policy 
cies and procedures must address disposables, equip 
or procedure. 
ment, personnel, practice, and the patient 
Staff training should be a well-defined and organ- 
Comprehensive policies and procedures must also 
ized process.  Content should be clearly defined for 
address the interrelationships of reuse, the dialyzer, 
the learner and based on behavioral objectives. These 
and the delivery system. The risks involved must 
objectives can be used to accurately and objectively 
be clearly identified and considered, and appropri- 
measure learning. At the end of the session(s), the 
ate safety measures and preventative systems de- 
instructor should confirm by written test andlor 
veloped and incorporated. 
return demonstration that learning has occurred 
Specifically, policies and procedures must assure  and that the learner is able to perform the procedure(s) 
the safe and effective operation of a reuse program:  independently without error.  Test results should 
be documented and placed in employee's personnel 
Reprocessing Equipment:  file. 
Equipment operation  Comprehension of reuse principles and practices 
requires a basic understanding of normal physio- 
Basic technical operation 
logical concepts, as well as the basic principles of 
Setup and use of  the equipment and related  hemodialysis therapy.  Content should include the 
components  facility's specific reprocessing procedures, documen- 
tation requirements, aseptic technique, collection 
Safety checks  and handling of specimens, risks and hazards of 
multiple use, consequences of not performing tasks 
Preventive maintenance 
correctly, risks and hazards associated with toxic 
Cleaning and disinfection  substances used in the reprocessing procedure, 
emergency actions, and principles of infection con- 
Troubleshooting and repair  trol. 
Mixing and storage of cleaning agents and ger- 
Need for fiuther education such as inservices or in- 
micides. 
tensive educational sessions can be determined from 
the routine quality assurance monitoring process 
Testing for presence or absence of germicide; 
and the ongoing staff performance appraisal proc- 
effectiveness of germicide. 
ess (see Forms 1, 2, and 3).  When need for im- 
Labeling.  provement or problems are identified, all staff should 
be made aware of the problem and be involved in 
Recordkeeping. 
solution identification and implementation.  This 
nearly always includes problem specific continuing 
Storage of reprocessed dialyzers. 
education. 
Preparation of the reprocessed dialyzer for use. 
Quality Assurance Guidelines for Hernodialysis Devices  The medical director must approve the written  Verify by the time and date the dialyzer was 
curriculum for training.  The medical director of  filled with germicide, noted on the dialyzer la- 
the facility, or his or her designee, must verify  bel, that the "dwell time" for the germicide has 
that the individual has successfXly completed the  been at least the minimum recommended by 
initial education and the training program.  The  the manufacturer (see Form 5). 
medical director is also responsible for assuring 
Prior to initiating dialysis, staff, and the pa- 
that an annual performance appraisal has been 
tient when possible, should confirm that the 
performed. 
dialyzer about to be used is the patient's dia- 
lyzer. This can be accomplished by comparing 
patient name and medical record number (or 
Monitoring and Evaluation  other secondary identification) on the dialyzer 
label with the same information on the patient's 
This section provides a summary of recommenda-  chart (see Form 5). 
tions for monitoring and evaluation that should be 
performed to enhance the safety and reduce the  StafF should test that the level of residual ger- 
level of risk of patient injury due to incidents re-  micide (absence of germicide) aRer "rinse out" 
lated to the reuse of hemodialyzers, and to assure  and before clinical use of the dialyzer is at or 
the efficacy of dialyzers that have been reprocessed.  below acceptable levels (see Form 5). 
k Daily Monitoring  Any tests recommended by the manufacturer to 
confirm proper functioning of the reuse system 
Dialyzer performance must be validated during  must be performed (see Form 1). 
the reprocessing procedure by total cell volume 
0an dor membrane resistance as determined  B.  Monthly Monitoring 
by in vitro ultrafiltration rate. Alternatively, if 
1.  Confirm that all water used in the reprocessing 
the facility performs urea kinetic modeling the 
program (dialyzer rinsing and cleaning, dilu- 
"actual dialyzer clearance" data from the ki- 
tion of germicides and cleaning chemicals) meets 
netic modeling program may be correlated with 
AAMI microbiological requirements. Not more 
TCV.  Documentation of the information/test 
than 200 colony-forming units per ml of water 
results is required (see Form 4). 
andlor not more than 1n dml bacterial lipopoly- 
saccharide (endotoxin), as measured by Limu- 
2.  A test of membrane integrity (leak rate) for each 
lus amoebocyte lysate assay (LAL), should be 
dialyzer need be done only if the leak rate of 
present. 
the reprocessed dialyzers is greater than the 
leak rate of new dialyzers.  If the reprocessing 
It should be noted that the choice as to which 
equipment includes such a test, it should cer- 
test (bacterial counts or LAL) to perform is one 
tainly be a routine monitoring activity (see Form 
that should be carellly evaluated. For example, 
4). 
with certain water treatment system configura- 
tions, performing only bacterial counts may yield 
3.  The person performing the dialyzer reprocess- 
acceptable results, while utilizing concurrent LAL 
ing, the staff  member setting up a reprocessed 
testing would indicate a potential problem. The 
dialyzer and, when possible, the patient, should 
simpler bacterial count methodology may not 
verify that the dialyzer does not appear to be 
always identify a problem, and could place pa- 
physically damaged, the reuse label on the dia- 
lyzer is complete and legible, the headers ofthe  tients at risk. 
dialyzer do not contain any large quantities of 
2.  If formaldehyde is used in the dialyzer reproc- 
dotted blood or other materials, and that the 
essing program, formaldehyde vapors should be 
hollow fibers appear to be relatively free of any 
monitored at least monthly and whenever indi- 
blood product (see Forms 4 and 5). 
cated by discomfort of personnel or patients. 
4.  A statistically significant number of dialyzers 
Additionally, OSHA has set mandatory maximum 
should be checked for concentration of germi- 
formaldehyde levels: 
cide adequate for effective high level disinfec- 
tion before "rinse out" prior to clinical use (see  8-hour time weighted average CrWA) exposure 
Form 5). 
limit = 1p pm 
Qmlity Assurance Guidelines for Hernodialysis Devices  15 minute short-term exposure limit (STEL) =  Trend analysis, performed by the quality assur- 
ance committee, should include patient adverse 
2 PPm 
reactions such as fever, chills, improper ultrafil- 
Action level (AL) = 0.5 ppm in 8 hour TWA  tration, unexpected changes in BUN and matinine, 
incident reports, small molecule clearances, lev- 
See Chapter 12 for a hrther dicsucssion on OSHA 
els of toxic chemicals, other dialyzer failures 
Regulations. 
(leaks, structural damage, etc.), equipment main- 
C.  Patient Monitoring  tenance, and repair logs (see Form 6). 
1. Routine blood chemistries may provide an indi-  3.  ~e;formancea ppraisal of all personnel partici- 
cation of the effectiveness of the reuse proce-  pating in the reuse program should be performed. 
dure and subsequent dialyzer performance. 
4.  An annual review of facility policies and proce- 
2.  Routine intradialytic monitoring of the patient's  dures for applicability to current best practices 
physiological parameters and symptomotology  and current standards and regulations must be 
during the dialysis treatment can provide indi-  completed. 
cations of adverse events related to reuse.  A 
F.  Prevention 
few of the symptoms seen are: 
All equipment must be free of defects that may be 
a Hypotension or hypertension, related to im- 
a potential hazard to patients or personnel. An es- 
proper ultrafiltration  due to change in dia- 
tablished preventative maintenance program must 
lyzer performance characteristics. 
be implemented and evaluated. 
b.  Pymgen reaction (shaking chills, increase in 
Before equipment is placed back in use (following 
patient temperature of more than 1C during 
maintenance or repair), confirmation must assure 
treatment) or septicemia (identified through 
that all aspects of the device are functioning ac- 
blood cultures), from improper disinfection of 
cording to manufacturers' specifications and proce- 
the dialyzer or endotoxin in the dialyzer. 
dures. 
c.  Acute blood loss (obvious source of blood spill, 
shock, vomiting, convulsions),f rom membrane  Water quality for all aspects of the reuse process 
damage related to dialyzer reprocessing  must be tested and evaluated to assure compliance 
with AAML standard and federal regulation. 
d Pain around vascular access site, respiratory 
symptoms, and other indications of toxic or 
All components of the reprocessing equipment must 
allergic reaction, caused by incomplete removal 
be tested and safety parameters set prior to use. 
of the germicide from the dialyzer before use. 
G.  Purchasing Guidelines 
e.  Increase in the patient's  requirements for 
anticoagulation, related to excess clotting in 
Any dialyzer reprocessing system being considered 
reused dialyzers.  for use should comply with the federal regulations. 
D.  Home Dialysis Monitoring  which incorporate the AAMI Recommended Prac- 
tice for Reuse of Hemodialyzers. Any state or local 
When reuse is performed at home, all of the moni-  regulations which apply for the specific facility should 
toring procedures described above should be per- 
also be met. 
formed by the home dialysis patient, home dialysis 
support personnel, and reviewed by the medical  1.  Equipment 
director. 
Complete instructions for use must be avail- 
E.  Other Monitoring  able. 
1. All safety equipment and supplies (protective  Instructions for preventative maintenance and 
equipment and clothing, emergency equipment,  repair of the equipment are required. 
spill control supplies, etc.) should be inspected 
Training for facility personnel in equipment use 
to confirm usability and proper condition (see 
is essential. 
Form 4). 
~ualitAys surance Guidelines for Hernodialysis Devices  The system should be equipped with indicators  that are included in the Material Safety Data 
that show proper function.  Sheet (MSDS) for the particular chemical. 
Specifications for utilities must be met, includ-  b.  Germicides 
ing water pressure, flow rate, chemical quality, 
The facility should assure that the germicide, 
bacterial and pyrogenic quality, electrical and 
when used according to the manufacturer's 
drain requirements. 
instructions, is at least as effective in killing 
Design of the reprocessing system should as-  microbial contaminants as 4% formaldehyde 
sure ease of disinfection.  with a minimum contact time of  24 hours 
and a temperature of at least 20C. 
Upon installation and prior to clinical use, vali- 
The germicide used should be shown to be 
dation of dialyzer performance test methods and 
compatible with the dialyzer membrane, the 
tests of concentration of germicide must be per- 
dialyzer potting material, and the casing, as 
formed. 
well as all components of the manual or auto- 
The system should be designed to minimize any  mated dialper reprocessing system. 
exposure to potentially toxic substances, i-e., 
The manufacturer of the germicide should pro- 
closed exhaust system for venting toxic fumes, 
vide andlor the facility should develop poli- 
systems to minimize skin or eye contact with 
cies and procedures for minimizing risk re- 
toxic liquids, etc. 
lated to airborne toxicity, as well as direct 
2.  Chemicals  skin or eye contact. The Material Safety Data 
Sheet for the chemical should be obtained. 
Two types of chemicals are commonly purchased 
Instructions should be obtained for inspection 
for dialyzer reprocessing, cleaning agents and ger- 
of the chemical upon receipt to assure that it 
micides. 
is being delivered in a manner that will ren- 
a  Cleaning Agents  der it effective for its intended use. 
Storage and environmental requirements should 
The facility should validate that a specific clean- 
be specified. 
ing agent does not substantially alter the per- 
formance or safety characteristics of the dia-  Information regarding compatibility with other 
lyzer.  chemicals (other germicides, cleaning agents, 
etc.) should be obtained. 
All cleaning agents must be compatible with 
the membrane, the potting material, and the  Appropriate tests or test kits for determining 
casing of the dialyzer, as well as with all com-  the concentration of the germicide in solu- 
ponents of the automated dialyzer reprocess-  tion, as well as the relative presence of the 
ing system or manual reprocessing system.  germicide and absence of the germicide, should 
be developed or secured. 
The facility should obtain or establish, for all 
cleaning agents used, safe handling practices 
Guidelines  Hernodialysis Devices  REFERENCES 
1. Association for the Advancement of Medical Instrumentation. Recommended Practice:Reuse of 
Hemodialyzers. (AAMI ROH-1986). Arlington, VA (1986). 
2. KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation ofRisks and 
H d sAs sociated with Hemodialysis Systems.  (Technical Report, Contract t223-78-5046). 
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administra- 
tiodBureau of Medical Devices, Silver Spring, MD (1980). 
3.  Proceedings of the National Workshop on Reuse of Consumables in Hemodialysis. J.H. Sadler, 
ed.  Kidney Disease Coalition, Washington, DC (1984). 
4. Hemodialyzer Rew: Issues & Solutions (an AAMI Analysis and Review).  Association for 
Advancement of Medical Instrumentation, Arlington, VA (1985). 
5. Reprocessing of Hemodialyzers (Videotape). Food and Drug Administration. (1990). 
No&:  A list of additional references on this topic can be found in Appendix E at the end of this 
manual.  These additional references are included to enable the reader to pursue further 
investigation for the purpose of training or research on this topic. 
QUU&  Assurance Guidelines for Hernodialysis Devices  TABLE1  
AAMI RECOMMENDEPDR ACTICE: REUSE 
OF HEMODIALYZERS 
Records  Specific storage area requirements for new and 
Master record  reprocessed dialyzers 
Reprocessing record  Tests that do not require special facilities may be 
done in reprocessing or treatment area 
Equipment maintenance and material quality 
record  Personnel protection: gloves. protective clothing, 
eyeprotection, eyewash stations, spill control 
Personnel health monitoring records 
equipment, etc. 
Complaint investigation records 
Environmental safety: evaluate chemicals for safe 
Quality assurance and quality control records 
storage and handling; written procedures; comply 
with OSHA and other regulatory requirements. 
Personnel Qualifications and Training 
Qualifications (adequate education and back-  Reprocessing Supplies 
ground; repairs by qualified technicians) 
Speafications and testing: certification by supplier 
Written curriculum  or appropriate testing; proper documentation 
Documentation of successful completion of  Incoming supply control: log results of quality tests 
training course 
Inventory control: first in, first out; prdper log 
Patient Considerations 
Hemodiaiyzer Labeling 
Medical issues: written policies and procedures 
Use reprocessed dialyzer on same patient; 
relative to special patient medical conditions 
patient's name on label 
Legal review of any lnformed Consent; if used, 
Label prior to first use; update with each reproc- 
lnformed Consent belongs in medical record 
essing 
Open physicianlpatient relationship 
Label and markings should withstand reprocessing 
and dialysis procedures; should not obscure 
Equlpment  manufacturer's label or disallow inspection of 
Appropriate design, construction, and validations  interior of dialyzer 
Required information on label: patient's name, 
Water Systems  number of previous uses, date of last reprocessing 
Meet specifications of reuse equipment operating 
at peak load  Reprocessing 
Proper disinfection  Handle and transport dialyzers in a clean and 
Water quality testing  sanitary manner 
Rinsing and cleaning: written time limits; effective 
Reprocessing Systems  procedures; water quality requirements; cleaning 
agents must not adversely affect dialyzer 
Utility requirements specified and followed 
Both dialysate and blood sides should be free of 
Validation testing initially and periodically 
visible clotted blood except for a few clotted fibers 
Written preventative maintenance schedule and 
and small clots around periphery of header 
hl 
Repairs by qualified personnel; test equipment 
Performance Measurements 
function before reinstituting use 
In-vitro small molecule clearance should be actual 
rejection criterion 
Environmental Control and Safety Equipment 
Total cell volume is allright, but validation of corre- 
Validation of adequate function initially, periodi- 
lation with clearance (inital and periodic) is 
cally, and after any repair 
required 
Written preventative maintenance schedule and 
In-vitro uttrafiltration should not change f 20% 
log 
manufacturer's specifications (initial and periodic 
Safety equipment inspected and maintained ac- 
validation) 
cording to manufacturer recommendations 
Blood path integrity should be validated initially 
and when any changes are made in process 
Physical Plant and Environmental Safety 
Leak tests on all dialyzers not required if leak rate 
Considerations 
is equal to or less than that for new dialyzers 
Reprocessing area clean and sanitary; ventilatio 
maintains acceptable level of toxicity  TABLE1 ( cont.) 
AAMI RECOMMENDPERDA CTICREEU:S E OF HEMODIALYZERS 
Germicide  Rinsing should prevent rebound to inappropriate 
level (validate) 
Capable of high-level disinfection when tested 
against highly resistant water microorganisms  Set-up procedures: maximum waiting time to 
prevent bacterial problems; verification of germi- 
If formaldehyde is used: 4% for 24hrs at 20C or 
cide dwell time 
demonstrated equivalent 
Validated and documented test of residual germi- 
Do not mix reactive materials 
. cide 
Minimum water quality (microbiological) require-  ' 
Monitor patient and dialyzer for complications 
ments for dilutent 
during dialysis; record any problems 
Dialyzer should be filled with disinfectant until 
effluent is within 10% of original concentration 
Symptoms 
Use disinfected or new caps 
Measure temperature before and after dialysis; 
Testing of concentration of germicide 
evaluate reprocessing if patient shows fever, chills 
Exterior of dialyzer: clean and use low-level 
Evaluate reprocessing if other sypmtoms such as 
germicide 
pain in access arm or other unexplained symp- 
toms 
Inspection 
"Special Incident Report" if problems 
Dialyzer jacket free of visible blood or foreign 
Dialyzer failures (leaks, excessive deviations from 
material 
expected performance, etc.) should be docu- 
No leaks or cracks  mented, investigated, and placed in complaint file 
No more than a few clotted fibers 
Headers free of all but a few small peripheral clots  Quality Assurance and Quality Control 
Blood and dialysate ports capped with no leakage  QA personnel should: 
Label properly filled-out and legible  Review and audit master record at least annually 
Audit complaint invesitgation file and perform trend 
Disposition of Rejected Dialyzers  analysis at least quarterly 
Policies  Audit job descriptions, training materials, and 
documentation of training at least annually 
Proper contamination prevention (of blood-borne 
pathogens) procedures  Audit compliance with informed consent policy at 
least annually. 
Storage  Be involved in equipment and supplies specifica- 
tions and purchases 
If greater than one month, validation of safety and 
effectivess of dialyzer  Audit written policies and procedures at least 
annually, and whenever problems 
Preparation for Dialysis and Testing for  Audit written maintenance and repair policies at 
Potentially Toxic Residues  least annually 
Visual inspection of dialyzer and label for safety  Audit physical plant and environmental safety 
and efficacy  parameters at least quarterly 
Verification of patient identification (two people)  Audit parameters related to reprocessing supplies 
-  at least semiannually 
Testing for presence of germicide on at least 
random sample  Audit parameters related to hemodialyzer labeling 
at least quarterly 
Validation of proper germicide concentration 
(initially and periodically)  Audit compliance with actual reprocessing tech- 
nique at least monthly initially, and at least semi- 
Priming procedure and elution of germicide (docu- 
annually later; trend analysis should be performed 
mented procedure) 
at least quarterly. 
Testing for residual germicide: written procedure; 
Audit written procedures regarding QA and QC 
assure level is below maximum recommended 
and verify their implementation at least quarterly 
level 
Audit results of performance validation 
Quality Assurance Guidelines for Hernodialysis Devices  PROCEDUREFORCONCURRENT  changeovers, etc.). The time frame should be 
MONITORING FORMS:  long enough to observe each staffmember com- 
pletely perform the listed activity. 
REUSE LABELING AND 
RECORDKEEPING (FORM 1)  9.  Assign a staff member to perform the audit. 
Auditor should not be assigned to other re- 
REUSED DIALYZER PREPARA-  sponsibilities during the audit. 
TION FOR USE (FORM 2) 
Perform the Audit 
REUSE PHYSICAL PLANT AND 
1.  On the actual audit sheet, write in the date, 
ENVIRONMENTAL SAFETY 
auditor's name, patient shift (or time of day), 
MONITOR  (FORM 3) 
and standard. 
The purpose of this audit is to monitor technical  2.  Read each indicator carefully. 
staff compliance with standard practices and pro- 
cedures related to the water treatment system.  3.  Observe staff for actual performance. Auditor 
When staff are aware of the importance of the  should not interfere with staff activities, be 
policies and well trained in the procedures, com-  obtrusive, or preceptibly obvious. 
pliance should be very high. 
4.  Under each staff code letter, write Y for yes if 
indicator is met, Nfor no ifindicator is not met, 
Before the Audit 
or NIA for not applicable, not observed. 
1.  Provide adequate and appropriate inservice to 
To achieve a Y (yes, indicator was met), staff 
assure total staff awareness and education of 
should be observed with complete compliance 
all components associated with water treat- 
for each encounter.  For example, for a Y to 
ment for dialysis. 
appear in the "Post-Softener Hardness Done" 
box, the staff member must perform the test 
2.  Assure staff awareness of all elements of the 
concurrent audit and how performance will be  before any patient dialysis is done and per- 
observed and evaluated.  form the test exactly according to the instruc- 
tions for use of the test manufacturer and 
3.  The QA committee specifies the standard (ex-  record the results as per facility policy. 
pected percentage compliance) desired for the 
5.  Complete all observations within timeframe 
audit; begin not lower than 85%. 
specified. Assure that each indicator has one 
4.  Schedule the audit with appropriate person-  response. 
nel (head nurse, charge nurse, chief techni- 
After the Audit 
cian). 
5.  Make copies of  the audit for each auditor/  1. Under each employee code letter, add total 
observer.  number of Ys and Ns; do not count NAs. 
6.  Assign code letters for each staff member to be  2.  For each employee, calculate compliance per- 
observed; for example:  centage by dividing the total Ys by the total 
observations; again, do not count NAs. 
Employee  A:  Glenn Close 
B:  Tom Hanks  3.  Calculate total compliance percentage for the 
C.  William Hurt  audit by dividing total Ys (all employee Ys) by 
etc.  the total observations; do not count NAs. 
7.  Determine how many staff are to be observed. 
4.  For each indicator, calculate compliance per- 
It is  recommend  that one auditor  should 
centage by using the same method as above; 
observe no more than three to four staff at one 
again, do not count NAs. 
time. 
5.  Report results to QA committee and clinical 
8- Define the length of time for observation. It is 
management team with additional comments 
recommended that the audit be conducted dur- 
andfor recommendations. 
ing peak activity times (daily start-up, shift  REUSE LABELINGA ND  RECORDKEEPING  MONITOR  FORM 1 
Threshold  % Compliant 
Log record completed 
Dialyzers properly labeled 
Dialyzers properly stored 
Predialysis dialyzer check done and recorded 
Predialysis TBV check done and recorded 
I  I  I 
Q. A. Comnfttee Recommended Adbn:  hb wame Guidelines for Hernodialysis Devices  REUSE PHYSICALP LANTA ND  ENVIRONMENTASLA FETYM  ONITOR 
=F=l 
Threshold  % Compliant 
MSDS for toxic substances posted 
Spill control procedures posted 
Spill control materials available 
Exhaust fan operating during reprocessing 
Environmental testing meets OSHA standard 
- 
Q. A. Cornittee Recommended Action:   PATIENTD AILYD  IALYSISR ECORD 
XYZ DIALYSISC ENTER 
Date  Patient Name 
DIALYSIPSR ESCRIPTION 
Dialyzer  Time on  Dry weight 
QB  QD  Actual time off  Predialysis weight 
Heparin Rx:  Rx time off  Desired weight loss 
Prime  Rx dialysis length  Postdialysis weight 
Infusion  Actual dialysis length  UF rate 
Time off  Expected clotting time 
Dialysate Rx  Actual clotting time 
DIALYSATE  MACHINCEH  ECKS  REUSE 
Conductivity  Blood leak alarm  Patient ID  I 
PH  Air foam detect (check)  Use number 
Temperature  Air foam detect (armed)  Dialyzer structure/aesthetic 
Special Rx  UF check  Germicide dwell 
Mixed  ArtNen press set  Germicide presence 
Dispensed  Machine number  Germicide absence 
Quality Assurance Guidelines for Hernodialysis Devices   Chapter 11 
INFECTION CONTROL 
+ 
CONTENTS 
Page 
............................................. 
BACKGROUND  11-1 
QUALITY ASSURANCE  ......................................  11-4 
................................. 
Policies and Procedures  11-4 
StaffT raining and Education  ............................  11-4 
.............................. 
Monitoring and Evaluation  11-5 
............................................... 
REFERENCES  11-6 
............................. 
TABLES. FIGURES. AND FORMS  11-7 
Guidelines for  Devices  Chapter 11  Infection Control 
BACKGROUND  Hedialysis which has been distributed to all di- 
alysis facilities in the United States. 
Infection control is a mechanism by which the ad- 
herence, colonization, or invasion of an infectious 
organism is prevented. Infection control is used in 
EXISTING GUIDELINES 
dialysis units to prevent patients from acquiring 
infections specific  to the dialysis unit. The purpose 
Throughout the years the CDC has issued and up 
of infection control is to ensure the prevention of in- 
dated blood-borne infection control strategies and 
fections through appropriately applied policies and 
precautions (including universal precautions) for the 
procedures. Continuous surveillance and other moni- 
renal dialysis community as well as other health 
toring and evaluation activities assist in identi@- 
care agencies. The dialysis community has com- 
ing factors that may influence the occurrence of in- 
plied with the CDC recommendations over the years 
fections. 
as a voluntary standard.  Now the Occupational 
Although the risk to patients and staff in a hemodi-  Safety and Health Administration (OSHA) has regu- 
alysis unit for contact with viral and bacterial in-  lations that would enforce the use of universal pre- 
fections is quite high, the use and monitoring of  cautions as well as other infection control strak 
carefully developed procedures can significantly limit  gies for all of health care. 
the degree of risk involved. The Center for Disease 
Federal OSHA Regulation, Subpart Z of  29CFR 
Control (CDC) has reported that from 1980 to 1985 
Part 1910.1030, addresses control of blood-borne 
attention to infection control has systematically de- 
pathogens.  The regulation specifies facility infec- 
creased the incidence of Hepatitis B among dialysis 
tion control strategies as follows. 
patients and staff alike.  Infection control proce- 
dures in hemodialysis today require isolation of HBV 
1. Written Plan 
patients.  The CDC notes that isolation of HIV pa- 
tients is not necessary.  It is expected that each employer having employ- 
ees whose anticipated duties may result in occupa- 
Further, the CDC has noted that infections due to 
tional exposure to infectious agents shall establish 
contaminated water, dialysate, andlor dialyzers have 
a written infection control plan designed to mini- 
been significantly reduced as a result of appropri- 
mize or eliminate employee exposure.  The plan 
ately applied surveillance and control efforts. Infec- 
shall include a determination of that exposure, and 
tion control-oriented procedures for vascular access 
the schedule for and method of implementation for 
venipuncture and other direct invasions to the patients  each of the following requirements. The plan shall 
circulatory system have been shown to successfully 
be reviewed and updated as necessary to reflect 
Protect the patient from exposure to infection. 
significant changes in tasks or procedures.  The 
plan shall be made available for inspection by fed- 
Each manufacturer describes the infection control 
eral and state surveyors. 
strategies that are to be employed for their particu- 
lar medical device in the directions for use. Within 
a  Universal precautions shall be followed 
this manual, infection control is addressed for each 
Of these devices in the respective chapters.  This  b.  Certain control measures shall be examined and 
Particular chapter will focus on the control of blood-  maintained or replaced on a regular schedule to 
borne infections.  ensure effectiveness.  For example, employees 
shall wash their hands immediately or as soon 
In D~mbeorf   1989 the FDA produced and re-  as possible after the removal of gloves or other 
& a videotape entitled Infection Control for  personal protective equipment and after hand 
contact with blood.  c.  All personal protective equipment and cloth-  when visibly soiled, torn, or punctured.  They 
ing shall be removed immediately upon leav-  shall not be washed or disinfected for reuse. 
ing the work area and shall be disposed in an  Utility gloves may be disinfected for reuse if 
appropriately designated area or container for  the integrity of the glove is not compromised. 
storage, washing, decontamination or disposal. 
Masks, eye protection and face shields shall be 
d.  Used needles and other sharps shall not be  worn whenever splashes, sprays, droplets or 
sheared, bent, broken, recapped or re-sheathed  aerosol of blood or other potentially infectious 
by hand. These needles shall not be removed  materials may be generated and there is a po- 
from the disposable syringes and they shall be  tential for eye, ear, nose or mouth contamina- 
discarded in puncture-proof and color-coded  tion. Gowns, aprons, and other body clothing 
containers.  shall be worn when the employee has a poten- 
tial for occupational exposure.  The gowns, 
e.  Eating, drinking, smoking, applying cosmet- 
coats or aprons shallbe worn if there is a poten- 
ics or lip balm, and handling contact lenses are 
tial for soiling of clothes with blood or other 
prohibited in the work area. 
infectious materials. Fluid-resistant clothing 
shall be worn if there is a potential for splash- 
f.  Food and drink shall not be stored in refrigera- 
ing or spraying of blood or other potentially in- 
tors, freezers, or cabinets where blood or other 
fectious materials. 
potentially infectious materials are stored. 
3.  Housekeeping 
g.  All procedures involving blood or other poten- 
tially infectious materials shall be performed  a.  Employers shall ensure that the work site is 
in such a manner as to minimize splashing,  maintained in a clean and sanitary condition. 
spraying and aerosolization  of  these sub-  There will be a written schedule for cleaning 
stances.  and methods of disinfection based upon the lo- 
cation within the facility, type of surface to be 
2.  Personal Protective Equipment 
cleaned, type of soil present, and tasks and 
a.  When there is a potential for occupational ex-  procedures being performed. 
posure, the employer shall provide and ensure 
b.  All equipment and environmental and work- 
that employees use appropriate personal pro- 
ing surfaces shall be properly cleaned and dis- 
tective equipment such as but not limited to 
infected after contact with blood or other po- 
gloves, gowns, fluid-proof aprons, laboratory 
tentially infectious materials. Work surfaces 
coats, face shields or masks and eye protection. 
shall be decontaminated with an appropriate 
b.  The employer shall assure that the appropri-  disinfectant when surfaces are overtly con- 
ate personal protective equipment in the ap-  taminated after completion of procedures or 
propriate sizes is readily accessible att he work  immediately after any spill ofblood and at the 
site or issued to employees.  Hypo-allergenic  end of the work shift.  Equipment that may 
gloves shall be readily accessible to employees  become contaminated with blood or other po- 
who are allergic to gloves normally provided.  tentially infectious materials shall be checked 
routinely and prior to servicing or shipping 
c.  The employer shall provide for the cleaning, 
and shall be decontaminated as necessary. All 
laundering, or disposal of personal protective 
bins, pails, cans and similar receptacles in- 
equipment. 
tended for reuse that have a potential for be- 
coming contaminated with blood shall be in- 
d.  The employer shall repair or replace required 
spected, cleaned and disinfected on a regularly 
personal protective equipment as needed to 
scheduled basis.  If the contamination is evi- 
maintain its effectiveness. 
dent they should be cleaned and disinfected 
e.  Gloves shall be worn when the employee has  immediately.  Broken glassware shall not be 
the potential for hands to have direct skin con-  picked up by hands.  It shall be cleaned up 
tact with blood or other blood products, mu-  using mechanical means. Specimens of blood 
cous membranes, non-intact skin and when  or other potentially infectious materials shall 
handling items or surfaces soiled with blood.  be placed in a closable, leak-proof container, 
Gloves shall be replaced as soon as possible  labeled andlor color-coded accordingly. 
Quality.Assurance Guidelines for Hernodialysis Devices  11-2  4.  Infectious Waste Disposal  an explanation of the employer's infection con- 
tJ.01 pragram; 
All infectious waste destined for disposal shall be 
placed in closable, leak-proof containers or bags  an explanation of the appropriate methods for 
that are color-coded or labeled as required  If out-  recognizing tasks and other activities that may 
side contamination of the container or bag is likely  involve exposure to blood and other potentially 
to occur, then a second leak-proof container or bag  infectious materials; 
which is closeable and labeled or color coded shall 
be placed over the outside of the first and closed to  an explanation of the use and limitations of 
practices that will prevent or reduce exposure 
prevent leakage during handling, storage and trans 
to blood borne pathogens including appropriate 
port. 
engineering controls, work practices and per- 
All disposal of infectious waste shall be in accor-  sonal protective equipment; 
dance with applicable federal, state and local regu- 
information on the types, proper use, location, 
lations.  Immediately after use, sharps shall be 
removal, handling, decontamination andlor dis- 
disposed of in closeable puncture-resistant dispos- 
posal of personal protective equipment; 
able containers which are leak-proof on the sides 
and bottom and are labeled or color-coded accord-  an explanation of the basis for selection of per- 
ingly.  These containers shall be easily accessible  sonal protective equipment; 
to personnel and located in the immediate area of 
use.  They shall be replaced routinely, not allowed  information on the Hepatitis B vaccine includ- 
to overfill, nor be reused.  ing information on its efficacy, safety, hazards 
(potential side effects), and the benefits of being 
5. Laundry  vaccinated; 
Laundry that is contaminated with blood shall  information on the appropriate actions to take 
handled as little as possible with a minimum of  and persons to contact in an emergency; 
agitation.  Contaminated laundry shall be bagged 
at the location where it was used and shall not be  an explanation of the procedures to follow if an 
sorted or rinsed in patient care areas.  Contami-  exposure incident occurs including the method 
nated laundry shall be placed and transported in  of reporting the'incident and the medical fol- 
bags that are labeled and color coded.  The em-  low-up that will be made available; 
ployer shall ensure that laundry workers wear pro- 
information on the medical counseling that the 
tective gloves and other appropriate personal pro- 
employer is providing for exposed individuals 
tective equipment to prevent occupational exposure. 
and an explanation of the signs and labels andl 
6.  Training Program  or color coding required by the various stan- 
dards within thisregulation. 
The training program of the employee shall be pro- 
vided at the time of initial employment or within  , .A   copy of the facility's universal precautions pro- 
ninety days &r  being hired. At least annually  ,c edure. 
thereafter  the employer shall ensure that all em- 
Medical Records 
ployees with occupational exposure participate in 
the training program.  The material should be a p  
The employer shall establish and maintain an ac- 
Propriate in content and vocabulary to the educa- 
curate record for each employee.  The record shall 
tional level, literacy and language background of 
include the name and social security number of the 
the employees The training program shall contain 
employee, a copy of the employee's Hepatitis B vac- 
the following elements: 
cination records and medical records relative to the 
employee's ability to receive vaccine or the circum- 
a a copy of the OSHA regulations and an expla- 
stances of an exposure incident.  A copy of all re- 
nation of its contents; 
sults of physical examinations, medical testing and 
b. general explanation of the epidemiology and symp  followup procedures as they relate to the employee's 
toms of blood-borne diseases;  ability to receive vaccination or to postexposure 
evaluation following an exposure incident should 
an explanation of the modes of transmission of 
also be included in the medical record. 
blood-borne pathogens; 
Guidelines  Hernodialysis Devices  The employer's copy of the physician's written opin-  Housekeeping practices 
ion and a copy of the information provided to the 
Infectious waste disposal 
physician as required by the various standards in 
this regulation  are to be included in the medical  Laundry disposition 
record.  The employer shall assure that the em- 
ployee medical records are kept confidential and  Medical recordkeeping 
are not disclosed or reported to any person within 
Employee records 
or outside the work place except as required by 
law.  The employer shall maintain this record for 
at least the duration of the employment plus thirty 
years in accordance with Federal Regulation 29CFR  Staff Training and Continuing 
19 10.20.  Education 
8. Training records  Role descriptions should describe all personnel re- 
sponsibilities for infection control practices.  Each 
Training records shall include the following infor- 
responsibility should stem from a specific policy or 
mation: the dates of the training sessions, the con- 
pmedure. 
tents or a summary of the training session; the 
names of persons conducting the training, and the 
Staff training should be a well-defined and organ- 
names of all persons attending the training ses- 
ized process.  Content should be clearly defined for 
sions.  These records shall be maintained for five 
the learner and based on behavioral objectives. The 
Y .- objectives can be used to accurately and objectively 
measure learning, At the end of the sessioxds), the 
The employer shall assure that all records required 
instrudor should confirm by a written test ador 
to be maintained by this section shall be made 
return demonstration that learning has occurred 
available upon request. The employee training rec- 
and that the leamer is able to perform the pdure(s) 
ords required shall be provided upon request for 
independently without error.  Test results should 
examination and copying to employees, employee 
be documented and placed in personnel file. 
representatives, and any state or federal survey- 
ors. 
Comprehension of the purpose and function of in- 
fection control principles and procedures requires a 
basic understanding of normal physiological con- 
QUALITY ASSURANCE  cepts, as well as responses associated with uremia 
and the hemodialysis therapy.  Content should in- 
Policies and Procedures  clude the specific areas spelled out in the OSHA 
regulation previously described. 
Policies and procedures pertaining to infection con- 
trol must be developed, written, implemented, and  Need for further education such as inservices or in- 
evaluated.  All standards and regulations previ-  tensive educational sessions can be determined from 
ously described must be incorporated into the poli-  the routine quality assurance monitoring process 
cies and procedures.  and the ongoing staff performance appraisal proc- 
ess. When problems are identified, all s t -sh ould 
Comprehensive policies and procedures must ad-  be made aware of the problem and be involved in 
dress the interrelationships of the equipment, the  its solution; this nearly always includes problem 
people involved and the environment.  The risks  specific continuing education. 
must be clearly defined and considered, and pre- 
ventative systems developed and incorporated.  The medical director of the dialysis facility must 
verify that the individual has successhlly completed 
Policies and procedures must assure safe and effec-  the initial education and training program.  The 
tive practices:  medical director is also responsible for assuring that 
an annual review has been performed. 
Universal precautions 
Quality Assurance Guidelines for Hernodialysis Devices  Monitoring and Evaluation  All policies and procedures must be reviewed and 
updated annually to reflect changes in regulations 
On a periodic basis, quality assurance monitoring  andlor standards. 
of facility personnel's compliance with policies and 
procedures should be perfonned A concurrent moni-  Trend analysis, performed by the quality assurance 
bring instrument may be used for this purpose  committee, should include incident reports and sur- 
(see Form 1).  veillance monitoring results. 
Guidelines  Hernodialysis Devices  REFERENCES 
1. Centers for Disease Control. Recommendations for Prevention of HN Transmission in Health 
Care Settings.  MMWR, 36 (Supplement no. 251, pp. 144-185( 1987). 
2. Occupational Safety and Health Administration. Occupational Exposure to Blood Borne Pa- 
thogens H N a  nd HBV Notice of Proposed Rule Making, 29 CFR Part 1920, Federal Register, 
May 30, 1989. 
3. Infection Control for Hernodialysis (VideoTape).  Food and Drug Administration. (1989). 
4.  Centers for Disease Control.  Protection Against Viral Hepatitis.  MMWR, 39 (1990). 
5. ALTER, M.J. and FAVERO, M.S. National Surveillance of Dialysis-Associated Diseases in 
the United States, 1987.  Centers for Disease Control, Atlanta, GA (1988). 
Note:  A list of additional references on this topic can be found in Appendix E at the end of this 
manual. These additional references are included to enable the reader to pursue further 
investigation for the purpose of training or research on this topic. 
Quality Assurance Guidelines for Henodialysis Devices  PROCEDURE FOR CONCURRENT 
AUDIT: 
UNIVERSAL PRECAUTIONS 
MONITOR (FORM 1) 
The purpose of this audit is to monitor technical  Perform the Audit 
staff compliance with standard practices and pro- 
cedures related to the water treatment system.  1. On the actual audit sheet, write in the date, 
When staff are aware of the importance of the  auditor's name, patient shift (or time of day), 
policies and well trained in the procedures, com-  and standard. 
pliance should be very high. 
2.  Read each indicator carefully. 
Before the Audit 
3.  Observe staff for actual performance.  Auditor 
should not interfere with staff activities, be 
1.  Provide adequate and appropriate inservice to 
obtrusive, or preceptibly obvious. 
assure total staff awareness and education of 
all components associated with water treat-  4.  Under each staff code letter, write Y for yes if 
ment for dialysis.  indicator is met, N for no if indicator is not met, 
or NIA for not applicable, not observed. 
2.  Assure staff awareness of all elements of the 
concurrent audit and how performance will be  To achieve a Y (yes, indicator was met), staff 
observed and evaluated.  should be observed with complete compliance 
for each encounter.  For example, for a Y to 
3.  The QA committee specifies the standard (ex- 
appear in the "Post-Softener Hardness Donen 
pected percentage compliance) desired for the 
box, the staff member must perform the test 
audit; begin not lower than 85%. 
before any patient dialysis is done and per- 
4.  Schedule the audit with appropriate person-  form the test exactly according to the instruc- 
nel (head nurse, charge nurse, chief techni-  tions for use of the test manufacturer and 
cian).  record the results as per facility policy. 
5.  Make copies of  the audit for each auditor1  5.  Complete all observations within timeframe 
observer.  specified. Assure that each indicator has one 
response. 
6.  Assign code letters for each staff member to be 
After the Audit 
observed; for example: 
Employee  A:  Glenn Close  1. Under each employee code letter, add total 
B:  TomHanks  number of Ys and Ns; do not count NAs. 
C.  William Hurt 
2.  For each employee, calculate compliance per- 
etc. 
centage by dividing the total Ys by the total 
7.  Determine how many staff are to be observed.  observations; again, do not count NAs. 
It is  recommend that one auditor should 
observe no more than three to four staff at one  3.  Calculate total compliance percentage for the 
time.  audit by dividing total Ys (all employee Ys) by 
the total observations; do not count NAs. 
8.  Define the length of time for observation. It is 
recommended that the audit be conducted dur-  4.  For each indicator, calculate compliance per- 
ing peak activity times (daily start-up, shift  centage by using the same method as above; 
changeovers, etc.). The time frame should be  again, do not count NAs. 
long enough to observe each staffmember com- 
5.  Report results to QA committee and clinical 
pletely perform the listed activity. 
management team with additional comments 
9.  Assign a staff member to perform the audit.  andfor recommendations. 
Auditor should not be assigned to other re- 
sponsibilities during the audit. 
Ass' U?  Guidelines  Hernodialysis Devices 
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1 1 1 1 1 1 1 1 1 1   Chapter 12 
HANDLING  OF 
TOXIC  CHEMICALS 
CONTENTS 
Page 
.............................................. 
BACKGROUND  12-1 
E S T S   T .......... ............................  12-1 
Hazard Communication  .................................  12-1 
Occupational Exposure to Formaldehyde  ................... 12-3 
........................... 
MONITORING AND EVALUATION  12-5 
Daily Monitoring  ......................................  12-5 
Monthly Monitoring  ....................................  12-6 
Other Monitoring  ...................................... 12-6 
............................................... 
REFENCES  12-7 
............................. 
TABLES, FIGURES, AND FORMS  12-8 
Guidelines  Hernodialysis Devices  Chapter 12  Handling of 
Toxic Chemicals 
BACKGROUND  Formaldehyde 
Glutaraldehyde 
The average dialysis unit has a number of toxic 
Sodium Hypochlorite (Bleach) 
or hazardous chemicals present.  They are used 
Hydrogen Peroxide 
as cleaning and disinfecting agents, janitorial 
Povidone Iodine Solution 
supplies, and for other purposes.  A list of the 
common chemicals present in a dialysis facility  Chlorhexidine Gluconate 
include, but are not limited to:  Hexachlorophene 
Ethyl Alcohol 
Acids 
Ethyl Chloride 
BasesICaustics 
Benzalkonium Chloride 
Cleaning Agents 
Degreasing Agents 
Disinfectants  EXISTING STANDARDS 
Flammables 
Three Occupational Safety and Health Admini- 
Greases 
stration (OSHA) standards are especially rele- 
Paints 
vant to the dialysis community and must be in- 
Solvents  corporated into policies and procedures and clini- 
Surfactants  cal practice: 
Water Treatment Agents 
1. hazard communication 
Sterilants 
Bactericidal Agents  2.  occupational exposure to formaldehyde, and 
Janitorial Supplies 
3.  occupational exposure to blood borne patho- 
Although it is impossible to avoid all risk asso-  gens. 
ciated with use of these toxic chemicals, the fa- 
A separate chapter in this manual, Chapter 11, 
cility can significantly reduce that risk by fol- 
entitled Infection Control, discusses the occupa- 
lowing some practical quality assurance meas- 
tional exposure to blood-borne pathogens stan- 
ures. The first step is to be aware of the chemi- 
dard. 
cals found in the unit.  A chemical that meets 
the criteria of  a hazardous substance  may be: 
Corrosive to living tissues; carcinogenic; toxic 
when  administered  orally,  cutaneously,  or  Hazard Communication Standard 
through inhalation; irritant; sensitizer; toxic to 
target organs including the liver, kidney, cen-  This standard requires employers to provide in- 
tral nervous system, blood, lung, reproductive  formation to their employees about the hazard- 
system, or eyes.  Some of the chemicals that  ous chemicals used in the work place through 
meet this definition that are commonly found in  the development and the implementation  of a 
the dialysis facility include:  "hazard communication program." 
Acetic Acid 
Compliance  with  this rule can be  achieved 
-*  Peracetic Acid  through a four step process as described below. 
Chlorine Dioxide 
@ Amwance Guidelines for Hernodialysis Devices  Step 1 List the hazardous chemicals in the fa-  Additionally, a list of all toxic chemicals used in 
cility. In general, these chemicals will have a  the facility and all of the MSDS's should be in 
label warning of a potential hazard such as eye  one file.  This file must be available to all em- 
irritation.  ployees.  Finally, the facility is required to pro- 
vide a copy of a MSDS upon the request of any 
Step 2. Obtain the Material Safety Data Sheets  employee, designated representatives of employ- 
(MSDS) for all chemicals identified.  The MSDS,  ees, emergency personnel, and to OSHA 
prepared and supplied by the manufacturer of 
the chemical, contains information including:  Step 3.  All toxic chemical containers must be 
appropriately labeled.  The label must contain 
identification (trade name, chemical name,  the product name, as well as appropriate warn- 
chemical family, formula);  ings regarding use.  Upon  delivery  of  these 
chemicals, proper labeling should be confirmed 
hazardous ingredients (components, specific 
and employees should be instructed not to re- 
chemical identity, common name); 
move labels under any circumstances.  Empty 
physicaVchemica1 characteristics (boiling  containers from toxic chemicals should be im- 
point, vapor pressure, vapor density, solubil-  mediately  discarded and not reused for other 
ity in water, appearance and odor, specific  purposes. 
gravity, melting point, evaporation rate); 
Step 4. A written hazard communications pro- 
fire and explosion hazard data (flash point,  gram must be developed and implemented. Such 
extinguishing media; special fire fighting pro-  a program should be included in the initial train- 
cedures, flammable limits, unusual fire and  ing of  all  staff members, and during annual 
explosion hazards);  review.  The program  should include at least 
the following. 
reactivity data (stability, conditions to avoid, 
incompatibilities, materials to avoid);  Discussion of the contents of all regulations 
related to handling of hazardous chemicals. 
hazardous decomposition or bioproducts (haz- 
ardous polymerization); health hazard data  Discussion of the contents on Material Safety 
(routes of entry: inhalation, skin, ingestion);  Data Sheets of  all hazardous chemicals in 
the facility. 
health hazards (acute and chronic) carcino- 
genicity, signs and symptoms of hazardous  Description of any medical surveillance pro- 
exposure, medical conditions generally aggra-  grams related to hazardous chemicals avail- 
vated by hazardous exposure, and emergency  able in the facility. 
first aid procedures; 
Description of potential health hazards re- 
precautions for safe handling and use (steps  lated to exposure of  any hazardous chemi- 
to be taken in case the material is released  cals and description of signs and symptoms 
or spilled, waste disposal method, precautions  of that exposure. 
to be taken in handling and storing, other 
precautions);  Instruction to immediately report any adverse 
signs or symptoms that the employee sus- 
control measures (respiratory protection), ven-  pects are attributable to hazardous chemical 
tilation (total exhaust, special, etc.), protec-  exposure. 
tive gloves, eye protection, other protective 
clothing or equipment, and workhygienic  Description of all operations within the facil- 
practices.  ity or procedures where potential exposure 
to a hazardous chemical is present. 
The MSDS for specific chemicals should be 
posted in any area where that chemical is used.  Purpose for, proper use of, and limitations of 
This is done to assure the staff direct access to  all personal protective  clothing and equip- 
information about the risks involved with the  ment  related to hazardous chemical use. 
chemicals, proper handling procedures, and in- 
Instructions for handling of spills, emergen- 
formation required in case of an emergency. 
cies, and clean-up procedures. 
Quality Assurance Guidelines for Hernodialysis Devices  12-2  An explanation of the importance of any en-  California  North Carolina 
gineering andlor work practice controls for  Connecticut  Puerto Rico 
employee protection and necessary instmc- 
Hawaii  South Carolina 
tion in the use of these controls. 
Indiana  Tennessee 
A review of emergency procedures including  Iowa  Utah 
specific duties or assignments of  each em-  Kentucky  Vermont 
ployee in the event of a hazardous chemical 
Maryland  Virgin Islands 
emergency. 
Michigan  Virginia 
Whenever a new hazardous chemical is intro-  Minnesota  Washington 
duced, training must be understaken and com-  Nevada  Wyoming 
pleted. 
If your facility is located in a state with a OSHA- 
Upon completion of the training program, the  approved plan, you must comply with the Haz- 
employer should verify and document employee  ards Communications Requirements of  that 
comprehension.  This should be repeated on an  state. 
annual basis and be incorporated into the per- 
formance appraisal process.  It is recommended 
that documentation of successful completion of 
Occupational Exposure to 
the  program be included in the employee's per- 
sonnel file.  Formaldehyde 
The facility should also have written  policies  The OSHA standard for Occupational Exposure 
regarding hazard communication  for any out-  to Formaldehyde stipulates: 
side contractors.  Should any outside contractor 
bring hazardous materials into the dialysis fa-  A.  Exposure Limits 
cility, that contractor should provide the facility 
1. Permissible exposure limit: the employer 
with an MSDS along with written procedures as 
shall ensure that no employee is exposed to 
to how the material will be used,  monitored, 
an airborne concentration of formaldehyde 
and eliminated.  An example may be a water 
that exceeds one part formaldehyde per mil- 
treatment vendor bringing materials to disin- 
lion parts of air (1 ppm), as an.8 hour time- 
fect or clean  water treatment system compo-  weighted average (TWA). 
nents. 
2. Short term exposure limit: the employer shall 
The facility is required to complete and main-  ensure that no employee is exposed to an air 
tain OSHA Form 200 reporting all occupational  borne concentration of formaldehyde which 
injuries and illness.  The form must be recorded  exceeds two parts formaldehyde per million 
within six months of occurrence.  A copy of the  parts air as a 15 minute short term exposure 
total  number  of  occupational injuries and ill-  limit (STEL). 
nesses must be posted in each facility in a place 
where employee notices are posted on an an-  3.  Action level equals 0.5 parts per million (ppm) 
nual basis.  in a 8 hour time-weighted average (TWA). 
To obtain a copy of the OSHA hazard communi-  B . Required Monitoring 
cation standard, specify Federal Register 52 
1. Initial monitoring shall identify all employ- 
(163): 31852-31886, August 4, 1987.  ees who may be exposed at or above the ac- 
tion level or above the short term exposure 
Certain states and territories have "approvedn 
limit and accurately determine the exposure 
Programs that meet the requirements of  the 
of each employee so identified. 
federal regulation but also have additional laws 
a d r egulations.  These states and territories  2. Unless the employer chooses to measure the 
include: 
exposure of each employee potentially exposed 
to formaldehyde, the employer shall develop 
Alaska  New Mexico 
a representative sampling strategy and meas- 
Arizona  New York  ure sufficient exposures within each job clas- 
Guidelines for Hernodialysis Devices  sification of each work shift.  The purpose of  4.  Employees have the right to observe moni- 
this is  to correctly characterize and not un-  toring procedures. 
derestimate the exposure of  any employee 
within each exposure group.  F.  Regulated Areas 
These are areas where airborne formaldehyde 
3.  The initial monitoring process shall be re- 
exceeds 8 hour time weighted average or short 
peated  each time there  is a change  in pro- 
term exposure limit. 
duction, the equipment process, personnel, 
or control measures which may result in new 
In these areas: 
or additional exposure to formaldehyde. 
1. A notice regarding the danger and hazard 
C.  Periodic Monitoring 
must be posted. 
1. The employer shall periodically measure and 
2.  Access to these areas must be restricted to 
accurately determine exposure to formalde- 
authorized personnel who have been trained 
hyde for employees shown by initial monitor- 
ing to be exposed at or above the action level  as described earlier. 
or at or above the short term exposure limit. 
3.  Respiratory protection  must be provided 
(permanently) if engineering or workplace 
2.  If the last monitoring results reveal employ- 
practice cannot reduce employee exposure to 
ees exposure at or above the action level, the 
acceptable limits, or temporarily in the in- 
employer shall repeat monitoring of the em- 
terval until feasible engineering or workplace 
ployees at least every six months. 
practice changes are made to correct expo- 
3.  If the last monitoring results reveal employee  sure levels. 
exposure at or above the short term  expo- 
sure limit, the employer shall repeat moni-  4,  Protective clothing must be worn and work 
practices performed. 
toring of the employees at least once a year 
under worst conditions. 
5.  Employee training programs in hazards and 
D.  Termination of Monitoring  proper handling must be provided. 
The employer may discontinue periodic moni-  6.  Proper housekeeping (preventative mainte- 
toring for employees if results from two consecu-  nance, proper storage, spill contingency plans) 
tive samples, taken at least seven days apart,  must be implemented and practiced. 
demonstrate that the employee exposure is be- 
G.  Emergency Procedures 
low the action level and the short term exposure 
limits.  This must be a statistically significant  For all areas where there is a possibility of an 
sample.  emergency involving formaldehyde, the facility 
must assure that appropriate procedures  are 
E.  Other Monitoring Information  adopted to minimize injury.  Appropriate proce- 
dures must be implemented in the event of any 
1. Monitoring shall be accurate at the 95% con- 
such emergency. 
fidence level to within plus or minus 25% of 
airborne formaldehyde concentration at time- 
H.  Medical Surveillance 
weighted exposure and short term exposure 
limits and to within plus or minus 35% for  The facility must institute a medical surveillance 
action level.  program for all employees exposed to formalde- 
hyde at concentrations equal to, or exceeding, 
2.  Monitored employees must receive the results 
the action level. Also medical surveillance must 
of the monitoring within 15 days. 
be performed when concentrations exceed the 
3.  If employee exposure exceeds the 8 hour time  short term exposure limits, as well as for any 
weighted average or the short term exposure  employee developing signs or symptoms of for- 
limit, the employer shall develop and imple-  maldehyde overexposure. Such surveillance and 
ment a written plan to reduce employee ex-  any examinations must be performed by or un- 
posure to or below either (both) and give writ-  der the supervision of a physician and provided 
ten notice to employees.  without cost, loss of  pay, and at a reasonable 
time and place. 
Quality Assurance Guidelines for Hernodialysis Devices  12-4  The facility must also administer a medical dis-  Proper formaldehyde handling 
ease questionnaire to any employee prior to being 
Proper use of protective equipment 
assigned to a job where formaldehyde exposure 
is at or above the action level or above the short  Spill contingency plans 
term exposure limit including:  work history, 
Use of engineering environmental controls 
smoking history, any evidence of  eye, nose or 
throat irritation, chronic airway problems, hy-  Emergency procedures 
droactive airway disease, allergic skin conditions, 
Proper use of each type of eyewash station 
dermatitis, respiratory problems. This question- 
in facility. 
naire must be administered annually. It should 
also be given to employees experiencing signs  5.  All employees must be informed of the loca- 
and symptoms indicative of possible over expo-  tion of the written training materials. These 
sure to formaldehyde.  Assuming that the facil-  must be available to the employees at no cost. 
ity has already instituted all possible engineer- 
K.  Recordkeeping 
ing control measures, the physician must deter- 
mine on the basis of this questionnaire, his ex-  Recordkeeping must include: 
amination, and other information whether the 
employees are required to wear respirators to  1. Results of all scheduled and unscheduled air- 
reduce exposure to formaldehyde.  borne formaldehyde exposure measurements. 
I.  Medical Examinations  2.  Objective documentation if the employer has 
determined that no measurements are nec- 
Medical examinations are to be given to any em-  essary (no employee is exposed to formalde- 
ployee if the physician feels, based on informa-  hyde at or above the action level). 
tion in the medical disease questionnaire, the 
employee may be at risk from hazardous expo-  3.  An accurate record of each employee who is 
sure to formaldehyde.  This requirement for  subject to medical surveillance under this 
physical examination  also pertains to employ-  standard. 
ees exposed during an emergency situation. The 
4.  Records regarding fit testing of all respira- 
physician's opinion must be documented. 
tors. 
J.  Employee Training and Information 
5.  All records must be retained for 30 years af- 
1. Training must be provided to all employees  ter employment ends and all records must 
assigned to work places with a health haz-  be available for OSHA inspection (Federal 
ard.  Register, December 4, 1987, 29 CFR Parts 
1910 and  1926, Volume 52, Number  233, 
2.  Training must be provided at the time of ini-  Pages 46168 to 46312). 
tial assignment and whenever new hazards 
from formaldehyde are introduced into the 
work place. 
MONITORING AND EVALUATION 
3. Training must be provided at least annually 
for all employees at or above the action level  The following are recommendations for monitor- 
or the short term exposure limit.  ing that should be performed  to enhance the 
safety and reduce the level of risk to patients or 
4.  The training program shall be conducted in 
staff.  These recommendations are in addition 
a manner that all employees are able to un- 
to those previously described. 
derstand and must include: 
Contents of the regulation and of the MSDS 
Medical surveillance program purpose and  Daily Monitoring 
description 
A.  Test for the absence of clinically significant 
Potential health hazards (how to identify 
levels of germicide or cleaning agents (toxic 
and what to do)  chemicals) in clean/sanitized/disinfected di-  0t her Monitoring 
alysis delivery systems. 
A Emergency equipment should be inspected 
B.  Test for the absence of clinically significant  for proper functionhondition according to the 
levels of germicide or cleaning agents (toxic  manufacturer's instructions or facility policy. 
chemicals) in clean/sanitized/disinfectedw a- 
ter treatment systems.  B.  A trend analysis of incidents and/or regular 
monitoring pertaining to use of toxic chemi- 
C. Test for the absence of clinically significant  cals should be performed.  Performance ap- 
levels of germicide or cleaning agents (toxic  praisal of all personnel responsible for han- 
chemicals) in cleanlsanitizedldisinfeded re-  dling tmic chemicals should also be performed 
processed dialyzers before clinical use.  (see Form 1). 
C. All incoming supplies and records should be 
inspected periodically for completeness. 
Monthly Monitoring 
D. All policies and procedures related to han- 
' 
A. If formaldehyde is used as the disinfectant 
dling of toxic chemicals must be reviewed an- 
in reuse of hemodialyzers, the AAMI Recom- 
nually. 
mdnded Practice for Reuse of Hemodialyzers 
states that "formaldehyde vapors should be  E. Performance appraisal process for all person- 
monitored at least monthly, and whenever  nel responsible for handling toxic chemicals 
indicated by the discomfort of personnel."  and facility review should be completed an- 
nually (see Form 2). 
B.  Incident reports related to use of toxic chemi- 
cals should be reviewed and analyzed by the 
quality assurance committee. 
Quality Assurance Guidelines for Hernodialysis Devices  REFERENCES 
1. Occupational Safety and Health Administration (OSHA) Standard.  Hazard Communication 
Standard.  Federal Register, 52 (163): 31852-31886, August 4,1987. 
2.  Occupational Safety and Health Administration (OSHA) Standard. Occupational Exposure to 
Formaldehyde.  Federal Register, 52 (233): 46168-46312, December 4,1987. 
3. BEDNAR, B. Meeting OSHA Hazard Communication Standards. Nephrology News & Issues. 
4,6:  14-15, 1989. 
Note: A list of additional references on this topic can be found in Appendix E at the end of this 
manual.  These additional references are included to enable the reader to pursue further 
investigation on this topic for the purpose of training or research.  FORM1  
TOXIC CHEMICALSH ANDLING TRENDA  NALYSIS 
Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec 
DATE 
MONITORINGA:I RBORNEL EVELS 
Location #I 
Location #2 
Location #3 
Location #4 
Location #5 
Location #6 
Location #7 
Location #8 
SPILLS 
Location #1 
Location #2 
Location #3 
Location #4 
ACCIDENTAELY  EC ONTACTE,X . 
Location #1 
Location #2 
Location #3 
Location #4 
Other:  PROCEDUREFORCONCURRENT  9.  Assign a staff member to perform the audit. 
MONITORING FORM:  Auditor should not be assigned to other re- 
TOXIC CHEMICAL HANDLING  sponsibilities during the audit. 
(FORM 2) 
Perform the Audit 
1. On the actual audit sheet, write in the date, 
The purpose of this audit is to monitor technical 
auditor's name, patient shift (or time of day), 
staff compliance with standard practices and pro- 
and standard. 
cedures related to the water treatment system. 
When staff are aware of the importance of the  2.  Read each indicator carefully. 
policies and well trained in the procedures, com- 
pliance should be very high.  3.  Observe staff for actual performance. Auditor 
should not interfere with staff activities, be 
Before the Audit  obtrusive, or preceptibly obvious. 
4.  Under each staff code letter, write Y for yes if 
1. Provide adequate and appropriate inservice to 
assure total staff awareness and education of  indicator is met, N for no if indicator is not met, 
all components associated with water treat-  or NIA for not applicable, not observed. 
ment for dialysis. 
To achieve a Y (yes, indicator was met), staff 
2. Assure staff awareness of all elements of the  should be observed with complete compliance 
concurrent audit and how performance will be  for each encounter.  For example, for a Y to 
observed and evaluated.  appear in the "Post-Softener Hardness Done" 
box, the staff member must perform the test 
3.  The QA committee specifies the standard (ex-  before any patient dialysis is done and per- 
pected percentage compliance) desired for the  form the test exactly according to the instruc- 
audit; begin not lower than 85%.  tions for use of the test manufacturer and 
record the results as per facility policy. 
4.  Schedule the audit with appropriate person- 
nel (head nurse, charge nurse, chief techni-  5. Complete all observations within timeframe 
cian).  specified. Assure that each indicator has one 
response. 
5.  Make copies of  the audit for each auditor1 
observer.  After the Audit 
6.  Assign code letters for each staff member to be 
1. Under each employee code letter, add total 
observed; for example: 
number of Ys and Ns; do not count NAs. 
Employee  A:  Glenn Close 
2.  For each employee, calculate compliance per- 
B:  Tom Hanks 
centage by dividing the total Ys by the total 
C.  William Hurt 
observations; again, do not count NAs. 
etc. 
3.  Calculate total compliance percentage for the 
7.  Determine how many staff are to be observed. 
audit by dividing total Ys (all employee Ys) by 
It is  recommend that one auditor  should 
the total observations; do not count NAs. 
observe no more than three to four staff at one 
time. 
4.  For each indicator, calculate compliance per- 
centage by using the same method as above; 
8.  Define the length of time for observation. It is 
again, do not count NAs. 
recommended that the audit be conducted dur- 
ing peak activity times (daily start-up, shift 
5.  Report results to QA committee and clinical 
changeovers, etc.).  The time frame should be 
management team with additional comments 
long enough to observe each staffmember com- 
andlor recommendations. 
pletely perform the listed activity.  I 
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Chapter 13 
MEDICAL DEVICE 
REPORTING 
+ 
I 
CONTENTS 
Page 
BACKGROUND  .................................. ...........  13-1 
PROBLEM REPORTING MECHANISMS  . . . . . . . . . . . . . . . . . . . . . . .  13-1  
. . . 
Medical Device and Laboratory Problem Reporting Program  13-1 
Guidelines for Reporting  . . . . . . . . . . . . . . . . . . . . . . . . . . .  13-1 
Guidelines for Not Reporting . . . . . . . . . . . .............  13-2 
. . . . . . ............ 
Required Information for Reporting  13-2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . 
How the Program Works  13-3 
Medical Device Reporting Regulation . . . . . . . . . . . . . . . . . . . . . .  13-3 
Safe Medical Devices Act of 1990 . . . . . . . . . . . . . . . . . . . . . . . . . .  13-4 
A FACILITY'S RESPONSIBILITY FOR REPORTING  . . . . . . . . . . . .  13-4 
TABLES, FIGURES, AND FORMS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  13-6 
tY Assurance Guidelines for Hernodialysis Devices  Chapter 13  Medical Device 
Reporting 
In Appendix A the reader will find a complete analy-  2.  The "Medical Device Reporting" regulation, 
sis of all Medical Device Reporting (MDR) files per- 
3.  The Medical Device Amendments of  1976, as 
taining to hemodialysis devices for the period from 
amended by the Safe Medical Devices Act of 
January 1,1980 through December 31,1989. 
1990, and 
4.  Manufacturers' Complaint investigation files. 
BACKGROUND 
As has been noted elsewhere in this manual, a  Medical Device and Laboratory 
large number of these incidents are related to user  Problem Reporting Program 
error or to inappropriate or inadequate maintenance 
and repair of the devices.  Other incidents may 
The Problem Reporting Program, or PRP, is fi~ded 
have been less severe had the user acted in accor-  by the Food and Drug Administration, Center for 
dance with the manufacturer's instructions.  An- 
Devices and Radiological Health, and coordinated 
other large segment of these incidents involves some  by the United States Pharmacopeia (USP). One of 
degree of device or equipment malfunction.  the USPs objectives is to improve product quality 
and to inform industry and government about the 
The primary protection that providers and patients 
health hazards caused by medical devices.  The 
have to ensure that unsafe or ineffective devices do 
PRP provides healthcare practitioners and other 
not remain on the market is provided by the Food 
medical device users with an effective and expedi- 
and Drug Administration (FDAI.  The FDA per- 
ent way to report problems related to the safety 
forms routine inspections of manufacturers' facili- 
and efficacy of medical devices. 
ties and recordkeeping systems to ensure compli- 
ance with "Good Manufacturing Practices."  A  Guidelines for Reporting 
Another method by which safety is maintained is  The PRP encourages users to report incidents of: 
by the FDA's investigation of problems reported in 
the use of the devices.  Thus, the absolute impor-  Death, 
tance of all users reporting any problemdincidents 
Serious injury, or 
related to use of the devices is underscored. Essen- 
Malhctions that could result in hazards or 
tially, if dialysis personnel do not inform the FDA 
of problems related to devices, it may take longer  injuries. 
to become aware that a device may be unsafe or 
Problems with medical devices, in-vitro diagnostic 
ineffective. 
equipment, and radiological health products should 
also be reported: 
PROBtERl REPORTING  When there is user error. It is important to 
determine if the design of the device contrib- 
MKmANrsMs 
utes to user error or if incomplete labeling 
may have contributed to the event. 
mere are basically four mechanisms by which prob 
lems related to hemodialysis can be reported:  When a decision is made to no longer use a 
piece of equipment due to a malfunction which 
The "Medical Device and Laboratory Problem  has occurred or recurred  It is better to re- 
Reporting Program," 
port the event rather than just  discard the 
Quality Assurance Guidelines for Hernodialysis Devices  13-1  device, place it in storage, or return it to the  ers are experiencing the same problem, con- 
manufacturer.  tacting the facility's centralized reporting area, 
such as the Biomedical Engineering, Purchas- 
When repeated repairs do not solve the prob- 
ing,  or Risk Management departments, may 
lem. 
be helpful before deciding not to report an 
When a manufacturer's design or repair changes  isolated occurrence. 
to the product adversely affect the perform- 
C.  Required Information for Reporting 
ance, safety, or efficacy in the opinion of the 
practitioner.  Reporters are encouraged to supply as much infor- 
mation as possible when reporting.  A copy of the 
When the problem indicates poor quality con- 
Product Problem Reporting Program Form is in- 
trol by the manufacturer. 
cluded at the end of this chapter.  The report can 
When a problem of incompatibility between  be submitted in writing or by telephoning a toll- 
devices of different manufacturers results in a  free number: 1-800-638-6725( in Maryland call col- 
serious hazard or injury.  led 301-881-0256). 
When a malfunction results in medical treat- 
When reporting, it would be helpful to include the 
ment, hospitalization, repeat surgical proce- 
following. 
dures, or readmission. 
Identification numbers (lot number, model num- 
Even when a problem has occurred only once, if 
ber, serial number, etc.). These numbers can 
the practitioner believes that the possibility for re- 
help to identify if problems are recurring in 
currence may exist, the problem should be reported. 
one particular lot or involve one particular 
The USP informs both the manufacturer and the 
model and enable the FDA and the manufac- 
FDA  Analyses of other "isolated incidentsn that 
turer to rapidly solve the problems. 
may have occurred and a trend analysis are then 
performed.  It is possible that a single problem  Complete name of the device and the manu- 
reported from one facility may be seen to fit into a  facturer name that appears on the label. 
pattern of incidents reported by many facilities and 
Whether the same firm or another firm is 
therefore be more significant than might first a p  
identified as the distributor and/or manufac- 
pear. 
turer. 
B.  Guidelines for Not Reporting 
Whether it is a disposable device that has 
If the device involved does not have the potential to  been reused. 
cause or contribute to a death or serious injury, it 
If the directions for use were properly fol- 
probably should not be reported. These include: 
lowed; if not, could the directions have been 
improved. 
Changes to a product that are only cosmetic 
in nature and do not affect, or have the po-  Indicate whether a  sample of  the device(s) 
tential to affect, the performance, safety, or  has been retained.  If possible and practical, 
efficacy of the device.  This includes personal  it is important to retain a sample of the de- 
preference for a device.  vice, as well as other devices that may have 
been related to the particular problem. 
Normal wear and tear of a device or routine 
service complaints where no performance prob  Identify the location of the event (i.e., hospi- 
lems exist such as consumer senrice complaints,  tal, clinic, home, transport, etc.). 
nonresponsiveness of the firm, unavailable service 
Include the title or practice specialty of the 
manuals, or parts and replacements not read- 
practitioner (physician, nurse, technician, etc.) 
ily supplied. 
who was using the device when the problem 
Isolated occurrences where the problems oc-  occurred. 
cur only once, the chance of recurrence is, in 
Include a complete description of the problem 
the practitioner's opinion, either zero or highly 
including any actual or potential adverse ef- 
unlikely, and there is no potential for death 
fects upon  the patient or practitioner.  In- 
or injury. If interested in determining if oth- 
clude any results of physical examinations or 
Quality Assurance Guidelines for Hernodialysis Devices  13-2  laboratory tests performed in conjunction with  The PRP form (see Form 2) at the end of this chap 
the problem in assistance or treatment of diag-  ter summarizes actions for the problem reporting 
nosis or that can otherwise assist in under-  program.  It is recommended that this form be phe 
standing the problem  tocopied and posted in a prominent place in the di- 
alysis center, head nurse's office, medical director's 
D.  How the Program Works 
office, and chief technician's office. 
USP is an independent,  nongovernmental body 
composed of approximately 300 representativesf rom 
associations and colleges of pharmacy, nursing and 
Medical Device Reporting 
medicine.  Once the PRP is notified by submitting 
Regulation 
the problem on the reporting form or by calling the 
toll-free telephone number, copies of the report are 
Note:  The following information on the Medical 
forwarded to the FDA on the day that it is re- 
Device Reporting rule applies to manufac- 
ceived. The USP also sends a copy to the manufac- 
turers of medical devices only. It is included 
turer  so that it is aware of the problem and your 
in this manual solely for informational pur- 
concern. The USP will acknowledge receipt of the 
poses. 
report and provide additional reporting materials 
for future use. 
The Medical Device Reporting (MDR) final rule, 
Reports submitted to the USP are subject to the  dated December 13, 1984, requires manufacturers 
Privacy Act.  The USP will delete the reporter's  to report information to the FDA when one of their 
name on the manufacturer and/or FDA copy of the  devices may have caused or contributed to a death 
report if requested.  However, it should be noted  or serious injury or when a malfunction may con- 
that the manufacturer and the FDA may be lim-  tribute to death or serious injury. The MDR regu- 
ited in the amount of follow-up that can be done if  lation is intended to ensure that the FDA is in- 
the reporter's name is not available.  In addition,  formed promptly of all serious or potentially seri- 
FDA will delete the hospital, patient, and physi-  ous problems associated with marketed medical de- 
cian names (or any other data that can be used to  vices. 
identi& them) prior to public release of s report 
Under the Good Manufacturing Practices (GMP) 
under the Freedom of Information Act. 
regulations, a manufacturer is required to review, 
If a name is given, the reporter may be contacted  evaluate, investigate, and maintain a failure rec- 
by the FDA, the manufacturer, or both for addi-  ord of its devices. 
tional information or to inform the reporter about 
The MDR regulation requires the manufacturer to 
their evaluatibn of the report. Manufacturers have 
notify the FDA as follows: 
other responsibilities regarding the investigation, 
evaluation, and reporting of device-related prob- 
In case of a death, the manufacturer  must 
lems ("complaint investigations" according to Good 
submit the report to the FDA by telephone as 
Manufacturing Practices, Medical Device Report- 
soon as possible, but no later than five calen- 
ing regulations, etc.). 
dar days of receipt of the information and must 
file a written report within 15 days of receipt 
Although the primary purpose of the PRP system 
is to improve the products utilized in healthcare, it  of the information. 
is also a vital means of quickly bringing health 
In the case of serious injury or a malfunction 
hazards to the attention of officials in government 
that is likely to cause or contribute to a seri- 
and industry. In this way, appropriate action may 
ous injury or death if it recurs, a report should 
be taken, either in the fom of product improve- 
be made to the FDA as soon as the necessary 
ments or recalls. 
information for making the report is obtained, 
but no later than 15 working days after ini- 
mh Wtem is not designed to replace any re- 
tial receipt of the information. The manufac- 
Porting requirement8 that the institution may 
turer must report to the FDA each time it 
WYha w. Remember to also use any mr- 
becomes aware of a reportable event or mal- 
mat fmility reportirg procedures such as in- 
function. 
&nt  mports. 
%Y ~suranceG uidelines for Hernodialysis Devices  A FACILITY'S RESPONSIBILITY 
Safe Medical Devices Act of 1990 
FOR REPORTING 
On November 28,1990, President Bush signed into 
In the event of a death or serious injury related to 
law the "Safe Medical Devices Act of 1990," which 
the use of a medical device or in the event of a mal- 
amends the Federal Food, Drug, and Cosmetic Act. 
fhction of a medical device that is likely to cause 
Several of the provisions of this new legislation have 
or contribute to death or serious injury if it recurs 
an impact on the requirements of reporting medical 
the facility may report to the manufacturer as well 
device problems. The new law will impose reporting 
as the PRP.  Once the new law goes into effect (no 
requirements on users for the first time.  Certain 
later than November 28, 1991), facilities will be 
device user facilities, including hospitals, nursing 
required to report deaths to the FDA and serious 
homes, ambulatory surgicalf acilities, and outpatient 
injurylserious illness to the manufacturer or the 
treatment facilities that are not physician's offices, 
FDA if the manufacturer is not known.  These are 
will be required to report deaths related to medical 
important reporting mechanisms for the swveil- 
devices to the FDA They are also required to submit 
lance of products by both the manufacturer and 
reports of  serious illnesses or injuries related to 
the FDA  It is only through such reporting that 
devices to the manufacturer or to the FDA if the 
serious product defects or other problems can be 
manufacturer is not known. These provisions of the 
discovered, investigated, and resolved. 
law will go into effect upon publication of the ha1 
regulations or 12m  onths from the date of enactment 
Reportable events also include improper labeling, 
(November 28, 1991), whichever is earlier. 
defective components, performance that does not 
meet the specifications of the product, poor packag- 
Other provisions ofthis law include that distributors 
ing, incomplete or confusing instructions, and erro- 
of medical devices will be required to provide copies 
neous information. This information may be filed 
ofMDRreportsto the manufacturer ofthe device and 
as a complaint with the manufacturer as well as 
that manufacturers, importers, and distributors who 
with the PRP. 
make MDR reports will be required to certify the 
number of reports submitted to the FDA in a year. 
All facility staff members should be trained in the 
Also, manufacturers of permanently implantable or 
problem reporting process.  This should be a com- 
life-sustaininga ndlife-supportingdevicesu sed out- 
ponent of the initial training of new employees and 
side a device user facilitya nd that are reasonably 
reviewed annually. 
likely to have serious adverse health consequences 
will be required to establish tracking systems for 
these devices. 
Quality Assurance Guidelines for Hernodialysis Devices  FORM 1 
Fonn Approved: OMB No. 08104143 
DATE RECEIVED 
ACCESS NO 
I 
PRODUCT IDENTIFICATION:  Lot Number(s) and Expiration Date@) (If applicable) 
Name of Product and Type of Device 
(Indude sires or othec identifying  characteristics and attach labeling, If available) 
Serial Numbefls) 
Manufacturer's Name 
Manufacturer's City, State. Zip Code  Manufacturer's Product Number andlor Model Number 
Is this a disposable item?  YES  NO 
2.  REPORTER INFORMATION: 
Your Name  Today's Date 
Title and Department 
Facility's Name 
Street Address 
- 
City  State  Zip  Phone(  )  Ext: 
3.  PROBLEM INFORMATION:  0 
Date event occurred  This event has been reported to:  Manufacturer  FDA 
Pkue Indicate how you want your ldentlty publlcly disclosed:  Other 
No public disclosure  If requested, will the actual product in- 
volved in the event be available for eval- 
[7 
To the manufact~rerldistributor  uation by the manufacturer or FDA?  YES  NO 
Tothe manutacturer/distributor and to anyone who requests a 
of the report irgm the FDA 
Robkm noted orouopectd (Describet he event In as much detail as necessary. Attach additional pages if required. lnclude how and where 
the product was used.  Include other equipment or products that were involved.  Sketches may be helpful in describing problem areas.) 
REfURN TO  OR  CALL TOLL FREE ANYTIME 
Unlted States Pharmacopeia  800-638-6725. 
12601 Twinbrook Parkway  IN THE CONTINENTAL UNITED STATES 
Rockville, Maryland  20852  'In himyland. call collect (301) 881-0258 
Attention:  Dr. Joseph G. Valentino  be-  9:00 AM and 430 PM 
#ur FDA Zl9f (3/85) 
%'Assurance Guidelines for Hemodialysis Devices  FORM  2 
. 
1  WHAT TO REPORT? 
Anythlng you conslder to be a problem with a device: 
When a device problem causes serious hazard, injury, or death (even I user error was involved) 
Repeated device repairs are required and problem is not solved 
Incompatibility in two products could or did create a hazard and you were not warned of this 
possibility by the manufacturer 
Improper labeling 
Defective components 
Performance failures 
Poor packaging 
Incomplete or confusing instructions 
Erroneous information 
Again, anything you consider to be a problem with a device! 
2.  WHATT O HAVE READY WHEN YOU MAKE THE CALL OR FlLL OUT THE FORM: 
Your name and title 
Facility name, address, telephone number 
Product name 
Lot number, model number, serial number, product expiration date 
Manufacturer's name and address (also Distributor's if notes both) 
Problem noted: 
Was a disposable device reused? 
Were instructions for use followed (could they be improved?) 
Has a sample of the device been retained? 
Identify location of the event 
Identify titlelpractice specialty of person using device at time of problem occurence 
Include complete description of problem including any actual or potential adverse effects upon the 
patient or practitioner 
3.  MAKE THE CALL! (OR FlLL OUT THE FORM AND SEND IT) 
CALL  TOLL  FREE  ANYTIME 
800-638-6725 
(in Maryland call collect (301) 881-0256 between 9:ooAM  and 4:30PM) 
4.  PERFORM ANY  OTHER  REGULAR  REPORTING PROCEDURES REQUIRED BY 
FACILITY  POLICY. 
Quality Assurance Guidelines for Hemodialysis Devices  Appendix A 
Summary of Incidents/Problems   Appendix A (Cont.)  Summary of IncidentslProblems 
a i t yA  ssurawe Guidelines for Hernodialysis Devices  CATEGORY  DATE  DESCRIPTION  POTENTIAL HAZARWRISK  ACTION REWIRED 
bD el Sys-Sngl R  2/18/86  Air embolus; details unkmwn; suspecl air detector not armd  Air embolus; death  Fadliy podalysls checks; 
Del Sys-Sngl R  3/21/86  High sodium; pt sodum.187; damd a@~stebdy  fadlity  Hypematreria; mslvorn; selmes; death  Check con&MV befao diwis; proper mmmPpairXX: pocodus 
Del Sys-Sngl R  4/10/86  Exmss UF due to ? equipmnt mlfundon; posdMe user urw  Hypvderria; hypotendon  Fadlity tdlow maM1( ImtwcUons; Menu( action 7 
Del Sys-Sngl R  4/18/86  Addods due to low bkabpH; lmpoper mnmmate used  Addods; death  Fadlly hat conc as drug (pocd); pH and mnd chedt before dldysls 
Del Sys-Sngl R  4/22/86  Hemdysis due to enpty concentrate )ug; no darm  Hypnatrenia; nmkom; hemolyds  Proper pocedues; mnut adon 
Del Sys-Sngl R  488/86  Fyrogen reactions 2" to gross machine baaerial cantanindon  Pyrogen reactions; sepsis  Roper dldnfecllon pomdves, water Ueatmm badefial mnitodng 
Del Sys-Sngl R  4/28/86  Pyrogen readions 2O to gross water system baaerld contamination  Pyrogen reactions; sepsis  Roper didnfedon pomues, water reatmem bacterial mrindng 
pDel Sys-Sngl R  4/-29/86  Po tentid air embolus; detdls unknown; suspect user error  Air embolus; death  Fadliy pedalyds checks; 
Del Sys-Sngl R  56/88  Heater overheated due to din in water  Hemclyjs  Roper water treatment; proper machine dntenanm 
Del Sys-Sngl R  7/18/86  High dldpte sodun( 234); alarm and pmporcloning mdadjusted ly fadI4kj  Hypnuemia; m L m ;s ei~esd;e ath  Check mn&m blued iws; proper mmPpairmp romdues 
Del Sys-Sngl R  86/86  High didysate sodurn; details unkmwn  Hypernauemia; nars&om; seimes; death  Check mn&c+MV  before dialysis; proper m$lmPpairlO(: promdues 
Del Sys-Sngl R  8/13/86  Appar. pyogen rxn; Renallnpoorw ater ueatment; pw.b aMner (high flux)  Pyrogen reaction; sepsis  Proper water tmnt design 6 disinfect; prow miaoUol modlor 6 germidde dllulion 
Del Sys-Sngl R  9/19/86  Blood pnpm  Fped wklng dulng ddysis; also dd pedidysis (gmed)  lneffecdve dalysis; potemid of dotllng  Manut adon; poper machine dntenmWpedldyds checks 
Del Sys-Sngl R  -11/17/86  Ex cess UF due to 7 equipment mltundon  Hypvdenia; hyptension  Manut adon 
118/87  Ex-  UF due to 7 equip meHundon; user w dcdib r equirermm 
Del Sys-Sngl R  2/11/87  Punp operaled at rnax speed (700) despite sening; control mahtunclion  Excessive Mood now  Manuf adon; fadliy pedalysis checks 
Del Sys-Sngl R  2/12/87  Excess UF due to ewpment mdfundon  Hypvdenia; hypotendon  Maruf adon 
Dd Sys.Sngl R  2118187  R gained weight 7 2O to positrve didysate pess; no predidysls mach checks  Hypervolemia; hypertendon  Roper fadlky pocedures; mand don 
Del Sys-Sngl Pt  3/2/87  PupO perated at accelerated sped despite setting; control maltundon  ~xcessiveb lood now  Manut adon; fadlity pedalysis checks 
Del Sys-Sngl R  3m7  Stan used machine despite knowledge of mnductMty poblem; high sodium  Hypematremia; ws)vorn; seimes; death  Check mnd before dhlysis; paper rrtWrepdr/O(:  pocedures 
Del Sys-Sngl R  4/13/87  Punp operated at accelerated sped despte setting; control maltundon  Excessive Mood now  Manutamer action; fadlity pedidysls checks 
-Del Sys-Sngi PI  4R4/87  -Patient recsived smdl electrical  sh5d ue to wiring poblem  EleclrMon  Proper mMepalr pomdves; elec checks; QC procedues 
Del Sys-Sngi PI  4/29/07  Potentid ire mbolus: Ud pmpc ontinred to run 8 no damp despite 5r darm  Air embolus; death  Fadlity peddysis checks; mfr action 
Del Sys-Sngi R  4RO187  Potentid air embolus: Md pmpm  ntiwdt o run & no damp despite rir alarm  Air embolus; death  Fadllty peddyds checks; mfr action 
Del SpSngi R  5/1/87  Potentid ar embolus: Md pump mntiwdt o run a no dampdespite dr darm  Air embolus; death  Fadlity peddysis checks; mh action 
Dd Sys-Sngi Pt  511187  Potentid air embolus: Md pmpc ontinred to run a no damp despite dr dam  Air emb~lusd; eath  Fadlity peddyds checks; mh action 
Del Sys-Sngl R  6/12/87  Air embolus; mdfunclion of reset switch dsaued alrm  Air embolus; death  Fadlity peddyds checks; mfr action 
Del Sys-Sngi PI  6/23/07  Formldeyde exposure due to backsiphon from upstream mchim  Toxic rxn; death  And siphon valves; paper pocedures 
Del Sys-Sngl PI  6/25/87  Excess UF due to equip malf; user dd rot follow rntr's promdues  Hypvolenia; hypotension  Fadlity fdlow mfr I~s~N~o~s; 
Del SysSngi PI  6/25/07  Pot. air erbdus: Md pmp mnt to run 8 ro danp despite air alrrm; inprop repair  Fadlity peddysis checks; follow mih repairlmtnc pocd; OC 
pDel Sys-Sngi PI  61-30187  Air  embolus; ar detector stuck in reset position  Air embolus; death  Fadlity peddysis ch*  mfr action 
Dd Sys-Sngl PI  7/1/87  Pot. air emtdus: Md pump mnt to run 8 no danp despite air alrm; poor mnc  Air embolus; death  Fadlity peddyds checks; fdlow nih repairlmtnc pocd; (X: 
Del Sys-Sngl PI  7/16/87  Art & ven pressure darm but no Mood pump stop;  Problems assac with excess pessure  Fadllty peddysis checks; mfr action 
Del SyrSnd PI  7/17/87  Excessive UF cased dalo memb ~pturem; aif due to poor fadlity wipr tnc  bodlo ss; lptendon; sepsis  Proper mdntenanmhepalrp romdues; (X: pomdues 
Del Sya-Sngi R  7131187  Excess UF due to equipment mdtunclion  Hypvdenia; hypotendon  Manufachrer action 
Del Sys-Sngl R  8/11/87  Punp operated at accel speed despite sening; mmdm dtutunclion  Excessive Mood now  Manufamu action; fadlity pedidyJis checks  L 
uolwdsq pumpl uow leme~nreyy  uo!wrqpu eu~w:ulj  empl ~ueuodwos:( 6u!1w pue eqaus) sueuoduco ~nuuelepe reeqlem  LBIFUZL  u PUS-sAs led 
geqs sMeg-ed lsuwawd k!lpll ed04  uoau0lredkl !epe!~NedAH  gws.ed wosels.W umpd edw pp IWI!  ww   jn J, i 146!em peu!e6 7d  LWLLRL  u PUSSAS lea 
.A 
uope w !pp uoleq  p puco elsshep y~q:sp od ~!~dwul~uerd o~d  sphlweq :wo~yleu:e peJwOd&  pe-  sgApureq we!&  vlq ApwJod suq wale :,lq6~ :eresAlep wn!pos moi  LQIPUII   ~US-SAS lea 
uoww   lsy3~ws! sApg-ed k!lpj  lUW :WW@JI V  unp ou 'durep ou'uru 01 penuwos dund p(q :snlwe JIV  LBIPUL I  u Pu~-dpsa  
uowJ JUI :qww spApp-ed k!~wj   ~ e:spn! ~eJIV   u~wwsn~ mep:s n!oqwelp ppuelod  LBICULL  ~d P US-^^ lea 
uoww   :qws p@p-ed kllpej  weep Isnloqwe JW  umwyun s~mep:s n~oqweJ !V  L~I~LL IL u BUS- AS lea  Appendix A (Cant.)  Summary of Incidents l Problems  S 
Quality-Assurance Guidelines for Hemodialysis Devices  IDATE  I 
CATEGORY  ~DESCRIPTION  ~POTENTYHLA ZARDIRBK  ACTION REWIRED 
- 
Dl*-  7nOB1  Ipmpr sodum mnc (low); inproper dlludon of concantate by user  Hyponalrenia; ncuslvom: hemotpis  ManufacaJ.oh don;c hedc condixhity befue dialysis 
a*-  liMW  lpmpr sodummncenhllon (low)  Hypwrenia; n~)vomh;e mdyds  Fdlow tm~facblohpo cedues; chedc mnd before datysis 
Dl*-  8UB4  lnpmper potassium content low and high)  NausWvomhing; cardac poMems  Manutaatrw% don 
Dl*-  11BB4  pH of add mncontrate too high  Alkylods; mdac pmtlems  Manufacaroh don; chedc pH befwe dalyds 
ow- 
5IlM  lnprqmr sodumconc (high); 7 fadlky oqJp callb  Hypomaremla; na~sWms;e lme; death  Manufaduer's don; chedc mndue(vlhy  before diws 
8BB5  Inproper Potassium mntem; fadMy staff niroad label  Nausmoriflng;  wdac poblems  Manuf cducodo lWs;f adl teal mnc as drug (poce&res) 
Lw'W  817B6  Maatial gwth in tlquid mncenuate; recall  Pyrogen readions; sepsis  Manutamoh don; fadlity miwtioioglcd mnllorlng 
Dl*-  lOn4B6  Maoblal q MIn  liquid concentate; red  Pyrogen reaalons; sepsis  Manufachlroh don; fad(ty mlwblologid mnitodng 
?*-  lORgm6  Maatid q MIn  Hquid cOnMhte; recall  Pyrogm reactions; sepsis  Manufacaroh don; fedtty mlwtiologlcA mnltodng 
or*-  11/5/88  Maatial g MIn  Hqid mcemrate; red  Pyrogen reactions; sepds  Manufacarer's don; fadky mlmblological mniiorlng 
a*-  3/16/87  Used inproper mnc;p mqhrod medical imrvomlon  Hypernauenia; mh)vom; winre; death  Mh cdorcode labek;fadl teat mnc as h gb ocd); 4  before dial 
a*-  7RlB7  Sodum content on label was mng (off by 100%)  Hypemaremla; na~h)voms; eime; death  Manufachrreh don; chea condwwty Maed ims 
Dl*-  8rZO8.3  Maatidq  MIn  Wquld mcanaato; recall;  Pyrogen reactions;s epsis  Manufacarer's don;f adtty mlwtiologicd mnltorlng 
pijv-  Qn2/80  Inproper Potassium content; fadlity staff nisread label  Nausmomhing; cardac poblems  Manuf cola-code labels; fadlity troa concantate sc dNg bocedures) 
Didysate  5MM  23 pts dldzd with add lnstd of mtate conc on acetate mech; stall enu  Addods; death  FadMy mat mnc as dug (poce&res); chedc mndlpH before daysis   w - snj  weep :spe$qdsuy  w W @ J k l i W P J ~ k ~ S W6  jtl-~kl 
WNWU snj  weep :weWuv  u o ~ k l w b s r e d k i ~EO /FM  jwm4w 
sewmod krpup OIWW MOIPI :wnms n j  wmp :spe!Aqdsuy  P@WWJJ  rmd esw w :UOPWJk lweuad& iuemidv  wtue  JH-BZ~KI 
sen=  snd  weep :speWuv  UOP~~kJl wesredb wersddV  EBN~  jn-*zi(leiu 
senm snj  weep :spe!Aqdsuy  UOPWJ Weuedbw emidv  wgu~  JH-J=CKI 
sen-  snlr  weep :spewdsuy  UW~Jk l w ~ a dui- b   WL  ~H-BZCKI 
senm snj  wmp :spe&&uv  UOP~Jk lweued4.1 iue~edd\l  smug   senm snj  weep :speh&uy  WPWJ klnppleuedhi 1ue~W gwuii   jH-*zCa 
sen-  snj  weep :spe&&uy  WP~Jk~ nppeued&i ~ue-  WUL1   jH-~zhl 
sensww ~ n 3   weep :spe&&uy  UOluee~k !weuedhl ue~eddv  9 ~ ~ 0 1  dH-~Z&Kl 
m=w snj  weep !spe&&uy  z x UOPJ  klnplweuedl~lu e~eddv  ~WUOL  jH-leZ&Kl 
uoge m-wepuw :esn uopq mApg p3q3  E x MIw ewd ou-leoeeu le weel worn  98muo~ 
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I 
uope yur :&lpwau bwwe dold !mu oleq m@p ~431  spdes :uopuaodk( :sol worn  Appendix A (Cont.)  Summary of Incidents /Problems 
qua lit^ Assurance Guidelines for Hernodialysis Devices  1 
w '*q  w!ps 'eluop uladeq 'les uwpe uolnps 'SWII  won 'lezC!p JUWIJ~'I.6 ulqhne.  e m01  weuWS I I! wowear e!!w 10 esn eqU~I  
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'6u!q6m 'uopsdum ~eau'bpyon'e uds UM) bu!~!peu~!e d '.auo&k~~lse ylleunqlse. 'wee4 lo sswuoqs 'eesneu 'upd 1seq3 '6u~31'!b uueeqm 'neasp hw~dse:Glu !leel  IOU.  '6uneqs 'u!edyJeq :eppul pewde~w odwA~    Appendix B 
Trend Analysis 
Recommendations that trend analysis be performed  bacterial culture results showed > 30,000 colonies1 
on various aspects oftechnical data have been included  ml in Odober. 
in several sections throughout this manual. Trend 
analyses can be performed in a variety of different  The facility had not been charting bacterial levels, 
ways, using many formats. To assist the reader in  but simply filing the lab slips in a manner similar 
understanding how to perform and use trend analysis  to that described above.  To investigate and solve 
as a quality assurance tool the following case his-  the problem, the initial step taken was to array all 
tory is presented.  culture results obtained in 1989, for all six of the 
facility's machines on one spreadsheet. The results 
It is recommended that all hemodialysis facilities  are presented in Figure 1. 
perform certain ba&riological monitoring on a monthly 
basis.  These should include at least water bacte-  Using a line chart further enhances the visibility of 
rial levels and dialysate bacterial levels to confirm  trends.  In Figure 2 the constantly increasing level 
compliance with AAMI Standards.  of bacterial colonization in machine #2 is obvious. 
Most hemodialysis facilities draw cultures monthly;  A simple rule of thumb is that any value which 
and, when results are received back from the labo-  shows three consecutive increases or decreases in 
ratory, many stack the actual lab reports in a three-  such a line chart indicates a trend.  Thus, if the 
ring binder or drawer &r  checking that the re-  Mt. Evans Dialysis Facility had been using a line 
sults are within AAMI limits.  chart, they would have realized that an unaccept- 
able trend was occuring when they charted the 
Although such a practice gives the facility some  July results on machine #2.  July was the third 
assurance that the water and dialysate are micro-  consecutive month with a significant increase in 
biologically acceptable for dialysis, a few additional  colony count.  Since no changes had been made in 
actions will provide more helpful information. They  disinfection protocols, or any other policies or pro- 
may also prevent problems, long before they occur.  cedures that would affect bacterial growth, they 
could have anticipated that the month-to-month 
In addition to simply looking at the laboratory report  increase in colony count would continue. 
form and filing it, the facility should also record the 
results on a spreadsheet.  In the end, the problem was determined to be a 
buildup of biofilm in the inlet water line of  the 
Sample Case History 
machine.  This part of the system was not subject 
to the routine disinfection performed at the Mt. 
Trend Analysis of Delivery System Dialysate 
Evans facility. 
Bacterial Levels 
Thorough disinfection and cleaning, through the 
An anecdote about an actual occurence reported in 
water distribution loop eliminated the problem. No 
a hernodialysis facility indicates the value of such 
permanent patient injury occurred. 
a recordkeeping system. The name and location of 
the facility has been changed.  The purpose of the anecdote is to illustrate the use- 
fulness of trend analysis in anticipating problems, 
Mt. Evans Dialysis Facility in Conifer, Colorado 
and in solving them before serious consequences do 
contacted the authors in November 1989 complain- 
occur.  Tools and methods such as those described 
k 
that two of their patients were experiencing 
in this appendix section should be used in any of 
Wgen reactions.  Upon interview with facility 
the areas discussed in this manual where trend 
Personnel, it was found that one delivery system's 
analysis is recommended. 
QmlitA~s surance Guidelines for Hernodialysis Devices 
L  - 
Appendix B (Cont.)  Trend Analysis 
Figure 1 
Delivery System Dialysate Culture Results 
Jun  Jul  Aug  Sep  Oct  Nov 
MACHINE # 
Figure 2 
Machine #2 Dialysate Culture Results 
Jan  Feb  Mar  Apr  May  Jun  Jul  Aug  Sep  Oct  Nov  Dec 
Month (1989) 
Quality Assurance Guidelines for Hernodialysis Devices  B-2  Appendix C 
Glossary of Terms 
Automated hemodialyzer reprocessing sys-  Depth filter (or sand filter or multi-media 
tem:  A device that automatically  rinses the  filter or diatomaceous earth filter): A tank- 
dialyzer of residual blood and blood products,  type filter, usually including a backflushing sys- 
performs some manner of  "cleaning" process,  tem, which is used as a first stage treatment to 
tests the dialyzer for leaks and performance  remove suspended matter, colloidal material or 
parameters, and fills the dialyzer with an ap-  silt from the water before introduction to other 
propriate concentration of a germicide.  downstream water treatment components. 
Blending valve: A device, generally at the be-  Dialysance: Describes dialyzer efficiency when 
ginning of the "pre-treatment," that mixes warm  solute concentration in the dialysate is not zero 
and cold water to achieve an optimum tempera-  (such as recirculating dialysate  delivery sys- 
ture for operation of the reverse osmosis mem-  tems); the volume of blood cleared of that solute 
branes.  per minute if the dialysate concentration is zero. 
Carbon filter (or granular activated car-  Dialysate (or dialysis fluid ):  A non-sterile 
bon filter):  A cylindrical tank containing an  aqueous solution with  an electrolyte composi- 
activated carbon filter medium  with a central  tion near that of normal extra cellular fluid. 
drainage core.  This type of filter is used pri- 
marily to remove chlorine and chloramine, as  Dialysate concentrate: A preparation of salts 
well as some organics.  which, when diluted with water, yields dialy- 
sate for use in dialysis.  These concentrates are 
Central dialysate delivery system:  A sys-  manufactured commercially in liquid or powder 
tem that utilizes a single "centraln dialysate pro-  form. 
portioner which prepares dialysate for a num- 
ber of bedside consoles or bedside stations.  Dialysis delivery system: A device that de- 
livers dialysate to the hemodialyzer maintain- 
Clearance:  Describes the performance of the  ing proper concentration, temperature,  pres- 
dialyzer for solute removal; the amount of blood  sures, and flow in the dialysate circuit.  The 
completely cleared of  a solute by the dialyzer  dialysis delivery system (delivery system) also 
per minute expressed in ml/min.  monitors various functions related to the dialy- 
sate compartment and the blood compartment: 
Concurrent monitoring:  The process of ob-  dialysate pressure, ultrafiltration  rate, blood 
serving or measuring something at the time it  leaks into the dialysate, changes in the pressure 
is occuring.  of the blood circuit, air or air foam in the blood. 
Deionizer (or deionization tank or DI):  A  Dialyzer:  The device where the exchange be- 
tank of insoluble spheres or beads, called resin,  tween blood and the dialysis fluid takes place; a 
which exchanges all types of cations and anions  semi-permeable membrane separates two com- 
and replaces them with hydrogen and hydrox-  partments, one in which flows the patient's blood, 
ide ions which combine to form water.  Deioniz-  and the other the dialysis fluid, or dialysate. 
ers may be categorized as "mixed bedn, contain- 
ing both cation and anion resin in a single ves-  Diffusion (or conductive transfer): The pas- 
sel, or "dual bedn, where each resin type is in a  sive transport of solutes across a membrane in 
Separate vessel.  the absence of net solvent transfer. 
Quality Assurance Guidelines for Hernodialysis Devices  Appendix C (Cont.)  Glossary 
Endotoxin:  Bacterial lipopolysaccharide found  Reverse osmosis:  A membrane  separation 
in the bacterial cell wall.  It is a pyrogenically  process for removing solvent from a solution. In 
active material  an RO system feed water is pressurized on one 
side of a semi-permeable membrane.  The pres- 
Fixed-ratio proportioning system:  A deliv-  sure is high enough to exceed the osmotic pres- 
ery system in which cylinders of known volumes  sure and cause reverse osmotic flow of water. 
are used to proportion dialysate concentrate and 
treated water in exact amounts, and through a  Sediment filter:  A cylindrical cartridge filter 
series of valves control the cyclic filling and emp-  used to remove particulates. 
tying of each cylinder. 
Servo-controlled proportioning systems: A 
Important aspects of care: Those things that  delivery system that uses a  control sensor to 
are performed or provided in a health care set-  monitor the conductivity of  the dialysate and 
ting that are most important.  These aspects  regulate the flow of  the dialysate concentrate 
tend to be high volume, high risk or problem  within the specific conductivity limits.  Flow can 
prone.  be regulated using variable speed pumps, vari- 
able orifice values, or other mechanisms. 
Kinetic modeling:  A means of quantifying and 
individualizing dialysis treatment and nutri-  Servo-feedback ultrafiltration control sys- 
tional plan.  tem:  A delivery system where dialysate inflow 
(Q,)  and outflow (Q,)  are measured constantly, 
Langelier saturation index:  A calculation of  using sensitive flow meters.  By subtracting Q, 
the propensity of a reverse osmosis membrane  from Q,  the system measures ultrafiltration flow 
for scaling with calcium carbonate crystals per-  rate (Q,).  Once that value is known, the mi- 
formed by using total dissolved solids, total al-  croprocessor (in which a desired Q , has been 
kalinity, calcium  concentration, pH, and tem-  programmed by the user) automatically adjusts 
perature of the R.O. reject stream.  the machine's TMP so that desired Q,-,   equals 
measured Q ., * 
Limulus amoebocyte lysate assay:  A labo- 
ratory test for p~rogenicityw hich employs a ma-  Sieving coefficient:  A mathematical expres- 
tkal derived from the blood of the horseshoe  sion that describes the fraction of specific solute 
crab.  retained by a membrane during ultrafiltration 
(c&,w>. 
Mass solute transfer:  The quantity of a sol- 
ute transferred from the blood into the dialysis  Silt density index:  A measurement of  the 
fluid (or vice-versa) across the semipemeable  membrane-fouling and filter-plugging character- 
membrane of the dialyzer per unit of time.  isitics of tap water. 
Pyrogen:  A fever-producing substance.  Single patient, single pass dialysate deliv- 
ery sys&ms:  A system-where dialysate is de- 
Pyrogen reaction:  A patient reaction charac- 
livered  to  one patient  at a time;  also  called 
terized by shaking chills and fever. 
"negative pressure systems." 
Quality assurance: A cyclical Process by which 
Sorbent (or regenerative) dialysis system: 
problems and opportunities for improvement are 
A delivery system that involves the reprocess- 
identified and analyzed, solutions are developed 
ing of  dialysate through a cartridge to remove 
and implemented, and reassessment occurs. 
uremic toxins from the spent dialysate, as well 
as adjusting electrolytes to the desired level. 
Quality control:  The process by  which  a 
product's performance is measured. 
Threshold for compliance:  A percentage of 
compliance with the indicators that are expected 
Retrospective monitoring:  The process of 
to be found when monitoring the activities of 
measuring something that has already occurred. 
the facility. 
Quality Assurance Guidelines for Hernodialysis Devices  Appendix C (Cont.)  Glossary 
Toxic substance:  Any chemical that is corro-  is produced by means of a low pressure mercury 
sive to living tissues; carcinogenic; toxic when  vapor lamp that emits the majority of its light 
administered  orally, cutaneously, or through  at a bactericidal wave length.  Water passing 
inhalation; irritant; sensitizer; toxic to target or-  through an ultraviolet radiator typically flows 
gans.  over and around a quartz sleeve and does not 
contact the lamp itself. 
Ultrafilter:  A membrane filter that will re- 
move  smaller particles (10,000 to 50,000 MW  Volumetric ultrafiltration control system: 
cutoff) than depth filters.  A delivery system that employs a fluid-filled, 
closed, non-compliant dialysate circuit from 
Ultrafiltration:  The process by which plasma  which a controlled and measured amount of fluid 
water is removed from the blood due to a pres-  (dialysate) is removed, generally, via a volumet- 
sure gradient between the blood and dialysate  ric pump, from a closed circuit. 
compartments; expressed in mVmin, mVhr, or 
Uhr.  Water softener:  A tank of insoluble spheres or 
beads, called resin, which exchange cations in 
Ultraviolet radiation:  A means of disinfect-  removing calcium and magnesium from incom- 
ing hemodialysis  water that utilizes radiant  ing hard water. 
energy for the destruction of bacteria.  UV light  Appendix D 
List of Tables, Figures, and Forms 
Chapter 2:  The Basics of Quality Assurance 
Figure 1  The Quality Assurance Process 
Figure 2  Sample Quality Assurance Plan 
Figure 3  Quality Assurance Problem Tracking Form 
Table 1  Scope of Care 
Table 2  Regulations, Guidelines, and Standards 
Table 3  Data Sources 
Chapter 3: Water Treatment 
Table lA  Water Contaminants 
Table 1B  Signs and Symptoms and Possible Water Contaminant-Related Causes 
Table 2  Water Treatment System (summary of components) 
Table 3  AAMI Requirements for Manufacturers (summary) 
Table 4  AAMI Requirements for FacilitieslUsers (summary) 
Table 5  AAMI Recommendations for Users (summary) 
Table 6  AAMI Recommended Practice for Reuse of Hemodialyzers 
Water Requirements (summary) 
Form 1  Water Treatment System Log 
Form 2  Water Treatment System Monitoring Form (concurrent monitor) 
Form 3  Water Treatment System Trend Analysis 
Chapter 4: Dialysis Delivery System 
Table 1  Dialysis Delivery System (summary of components) 
Table 2  Summary of AAMI Delivery System Requirements 
(Manufacturer Standards) 
Form 1  Patient Daily Dialysis Record 
Form 2  Delivery System Trend Analysis 
Form 3  Delivery System Master Preventative Maintenance Schedule 
Form 4  Predialysis Technical Checks Monitor (concurrent monitor) 
Form 5  Dialysis Equipment Audit 
Form 6  Delivery System Evaluation Checklist 
Chapter 5:  Dialysate and Dialysate Concentrate 
Table 1  Typical Ranges of Dialysate Fluid 
Table 2  Summary of AAMI Dialysate Concentrate Standards 
Form 1  Patient Daily Dialysis Record 
Form 2  Dialysate Concentrate Tank Label and 
Dialysate Concentrate Jug Label 
Form 3  Dialysate Cultures Trend Analysis 
Form 4  Dialysate Concentrate Safety Monitor (concurrent monitor) 
Chapter 6: Hemodialyzers 
Table 1  Dialyzerhlembrane Characteristics 
Table 2  AAMI Dialyzer Requirements (Manufacturer Standards) (summary) 
Table 3  Some Useful Formulas in Working with Dialyzers 
Form 1  Patient Daily Dialysis Record 
Form 2  Dialyzer Problems Trend Analysis 
Form 3  Dialyzer Use Monitor (concurrent monitor) 
 wit^ 
&~wanceG  uidelines for Hernodialysis Devices  List of Tables, Figures, & Forms 
Appendix D (Cont.) 
Chapter 7: Ancillary Devices and Equipment 
Form 1  Conductivity Meter Calibration Check Log 
Form 2  Patient Daily Dialysis Record 
Form 3  Dialysis Systems Checklist 
Form 4  Conductivity Meter Trend Analysis 
Chapter 8: Anticoagulation 
Form 1  Patient Daily Dialysis Record 
Form 2  Automated Clotting Time Meter Calibration Log 
Chapter 10: Hemodialyzer Reuse 
Table 1  M IRe commended Practice: Reuse of Hemodialyzers (summaly) 
Form 1  Reuse Labeling and Recordkeeping Monitor (concurrent monitor) 
Form 2  Reused Dialyzer Preparation for Use Monitor (concurrent monitor) 
Form 3  Reuse Physical Plant and Environmental Safety Monitor 
(concurrent monitor) 
Form 4  Dialyzer Reprocessing Log 
Form 5  Patient Daily Dialysis Record 
Form 6  Reuse Problems Trend Analysis 
Chapter 11: Infection Control 
Form 1  Universal Precautions Monitor (concurrent monitor) 
Chapter 12: Handling of Toxic Chemicals 
Form 1  Toxic Chemicals Handling Trend Analysis 
Form 2  Toxic Chemicals Handling Monitor (concurrent monitor) 
Chapter 13: Medical Device Reporting 
Form 1  Problem Reporting Form 
Form 2  Problem Reporting Program Summary 
Quality Assurance Guidelines for Hernodialysis Devices  Appendix E 
Annotated Bibliography 
Contents 
The Basics of Quality Assurance 
Water Treatment 
Dialysis Delivery System 
Dialysate and Dialysate Concentrate 
Hemodialyzers 
Anticoagulation 
Vascular Access Devices 
Hemodialyzer Reuse 
NOTE TO TNE READER 
In performingt he research necessary to produce this  In order to allow the reader to hrther review the 
document, Q~alit~~ssum~nucied elinesfor~emodi-  literature availableb etween 1980 and 1989 on these 
alysis Devices, an extensive literature search was  topics, this section, Appendix E, contains an addi- 
performed. Although afew ofthe principle references  tional annotated bibliography related to the devices 
for the material provided are included at the end of  included in the above subject areas. 
each oftheindividual chapters, significanta dditional 
citations were reviewed prior to writing the manual.  This appendix is also included to allow the reader to 
pursue additional study of these areas and to assist 
the facility as a training tool. 
 wit^ 
AssuraIU:e Guidelines for Hernodialysis Devices  Appendix E (Cont.) 
Annotated Biblwgmphy 
Chapter 2 
The Basics of Quality Assurance 
Techncal~entsforrapidhigh-efEciencytherapies.  Guthke, R, Gunther, K, Stein, G. and Knorre, W.A 
Keshaviah, P., Luehmann,D  ., Ilstrup, K andcollins,  ComputPqpumsB  iomed, 19( %3),pp.1 89-95( 1985). 
A Artif Organs, 10( 3), pp. 189-94 (Jun 1986). The  Four parameters of a two-pool model are evaluated 
key technical elements necessary for such implem-  by an iterative method using the explicit solutions of 
entation include high blood flow rates, higher effi-  the linear differential equations. 
ciencydialS7zers/~ters,ultrafiltration~0n~l~s, 
and bicarbonate as the buffer source. In addition,  Insufficient documentation of the hemodialysis pre- 
hemodiafiltration requires schemes to ensure steril-  scription: delaying the definition of adequate dialy- 
ity and nonpyrogenicity of the infusion fluid and ap-  sis.  Lundin, AP., Tarras, M. and Friedman, E.A 
propriate balancing of the rates of ultrafiltrationa nd  Nephron, 37 (3), pp. 200-2 (1984). The authors ana- 
reifision.  lyzed 953 articles published in three established 
nephrology journals to select those pertaining to 
A digital computer model for optimal programming  treatment with hemodialysis. A total of 152 papers 
of hemodialytic treatment.  Lamberti, C., Sarti, E.,  were selected on the criteriat hat the reported results 
Santoro,A  ,S pongano,M.,Z  ucchelli,P. andRossi,M  .  might have been affected by variation in the dialysis 
Int J Artif Organs, 11 (4), pp. 23542 (Jul1988). A  prescription. Only a small proportion of the papers 
mathematical model of hydroelectrolyte exchanges  studied (11.8%) detailed the complete dialysis pre- 
and arterial pressure regulation in the human body  scription including type of dialyzer, blood flow rate, 
during dialysis has been set up. It is conceived as a  and duration and frequency of dialysis. A surprising 
tool for a new dialysis unit  which will be able to  29% of papers provided no details of the dialyzer 
"interpret" the signals supplied by suitable instru-  employed.  Other potentially important variables 
ments connected to the patient and modify the ma-  such as the type of blood tubing or method of water 
chine set-pointsi n real time in order to obtain clinical  treatment used were rarely mentioned.  Compara- 
results defined by the physician.  tive studies of the course and outcome of hemodialy- 
sis regimens require specification of exactly how 
An advanced, user-friendly microcomputer program  dialysis was performed. It is suggested that manu- 
for hemodialysis kinetics.  Buur, T. A&  Exp Med  scripts provide this information as a condition of 
Bwl, 223, pp. 23944 (1987).  suitability for publication. 
Relative importance of membrane Limulus ame-  Quality of treatment issues in maintenance dialysis. 
bocyte lysate-reactivem  aterial and ethylene oxide in  Stewart, J.H. Med  JAust, 2 (9), pp. 430-3 (Oct 30 
hypersensitivity reactions.  Pearson, F.C.  Contrib  1982). 
Nephrol, 59, pp. 134-44 (1987). 
The dialysis nurse's role in an interdisciplinary pro- 
Evaluation report: dialysis and ancillary equipment.  gram.  Hopper, S A  J Am Asxx Nephml Nurses 
JMed Eng Technol, 10(3),p p. 141-7( May Jun1 986).  Tech, 6 (I), pp. 204 (1979). 
Report of the continuingp rogramme of evaluation of 
medical equipment sponsored by the UK Health  Adjustment and +ty  ofpatient-nurse interaction 
Departments, the evaluation of dialysis and ancil-  among dialysis patients, Tucker, C.M., Mulkerne, 
lary equipment camed out within the University of  D.J., Panides, W.C. and Ziller, R.C.  Nephrd Nurse, 
Sheffield,u nder the direction 0fPmfessorM.M. Black.  3 (2), pp. 26-32 (Jan-Feb 1981). 
'Health Equipment Information' Number 148, pub- 
lished in December 1985, carries full reports. Two-  Implementation of  ANA's  quality assurance pro- 
pool model analysis of data in hemodialysisby means  gram for clients with end-stage renal disease. Bruce, 
of programmable pocket calculator TI 59.  G.L, Hinds, P., Hudak, J., Mucha, A, Taylor, M.C. 
and Thompson, C.R  ANS,  2 (2), pp. 79-95 (Jan 
1980). 
Quality Assurance Guidelines for Hernodialysis Devices  E-2  Appendix E (ContJ  Chapter 2 
Anndated Biblwgmphy  The Basics of Quality Assurance 
The change from hctional to primary nursing.  Mortality, morbidity, and life satisfaction in the very 
Dean, L.P.  Nurs Clin North Ant, 14 (2), pp. 357-64  old dialysis patient. Westlie, L., Umen, A, Nestrud, 
(Jun 1979).  S. and %ellstrand, C.M.  Trans Am SocA  rtifIntern 
Organs, 30, pp. 21-30 (19 84). Discussion ofmortality, 
Nursingmanagement of multiple dialysisunits: roles  morbidity and life satisfaction of 157 patients 70 
andresponsibilities. Momssey, Z.M. Nephrd Nurse,  years of age and above. The authors conclude that 
1( 11, pp. 43-5 (Jan-Feb 1979).  older patients are excellentd ialysis candidates and it 
is wrong not to consider them for dialysis. 
Satisfaction with health care of hemodialysis pa- 
tients. Ferrans, C.E., Powers, M. J. and Kasch, C.R  Assessing the quality of nursing care in a dialysis 
Department of Medical-Surgical Nursing, College of  unit. &J=,  KL., Feltman, B.A and Smeltzer, C.H. 
Nursing, University of Illinois, Chicago 60680. Res  ANNA J, 12 (11, pp. 11-5,53 (Feb 1985). 
Nurs Health, 10( 61, pp. 367-74 (Dec 1987). The pur- 
pose of this study was to assess the satisfaction with  Aprotest movement in a private clinic: an analysis of 
care of hemodialysis patients, and to explore the re  a patient strike. Waissman, R. Soc Sci Med, 20 (21, 
lationships between satisfaction with care, quality of  pp. 129-32 ( 1985). Behind this protest movement 
life, and background variables. No generalizations  among chronic patients on dialysis was a dispute 
can be made.  between the specialist who headed the service and 
the director of the clinic. This dispute eventually 
Minimum performance standards for double-lumen  involved the patients, who felt that the quality of care 
subclavian cannulas for hemodialysis. Bregman, H.,  was ats take. Their 'therapy strike', as exceptionala s 
Miller, K and Berry, L. ASAIO Trans, 32 (I), pp.  it is in the world of illness, brings to mind forms of 
500-2 (Jul-Sep 1986).  action used by the consumer movement or by labour 
unions. The reasons that this small group ofpatients 
Technology assessment.  How effective is medical 
interrupted treatment are analysed in terms of their 
care? Hazelton,A  E. Clin GeriatrM  ed, 2 (3), pp. 4.81- 
relations to medicine and their conceptions of illness. 
90 (Aug 1986). Technology assessment helps the 
physician by determining which technologies are  Monthly home patient checklist: a dialysis assess- 
most apt to benefit the patient, allowing the physi-  ment tool. Rhodes,V.S. JNephrol Nurs, 2 (1 ), pp. 28- 
cian to recommend a prudent course of action. Tech-  9 (Jan-Feb 1985). 
nology assessment should encourage skepticism of 
new technology, causing the clinician to be more  The computer in medicine. Its application to medical 
rigorous about accepting the latest invention.  By  practice, quality control, and cost containment. Pol- 
shunning the useless technologies, physicians can  lak, V.  JAMA, 253 (I), pp. 62-8 (Jan 4,1985). 
prevent rationing of the useful techniques and avoid 
being caught in the ethical dilemma of doing what is  The liaison psychiatrist and the outpatient hemodi- 
best for the patient but is detrimental to society.  alysis unit.  Part I: Reliability and validity of stafF 
assessments ofpatient compliance on a hemodialysis 
Quality hemodialysis: a "gold standard" treatment  unit. Manley, M.  Clin Exp Dial Apheresis, 7 (41, pp. 
for survival. Lundin, AP. Kidney Int, Suppl, 17, pp.  349-56 (1983). Staffratings for global impressions of 
S12-4 (Dec 1985).  patient compliance are collected in an outpatient 
hemodialysis unit, inter-rater reliability is calculat- 
Investigation of the Karnofsky Performance Status 
ed, and the rating averages are correlated with three 
as a measure of quality of life. Grieco, A and Long, 
biological markers. Ahigh degree of exact inter-rater 
C.J. Health Psychol, 3 (21, pp. 129-42 (1984). The 
agreement is found and correlation of ratings with 
Karnofsky Performance Status appears to be the  inter-dialysis weight gain, mean BUN, and mean K 
most widely used scale for objective assessment of 
are determined. 
medical patients' quality of life.  Evidence for its 
reliability and validity is reviewed and new data  Reliability and validity of a quality assurance instru- 
Presented. Tests of inter-rater reliability, concurrent  ment for a renal dialysis unit.  Molzahn-Yanitski, 
validity, and discriminant validity indicate that,  AE. Nephrol Nurse, 5 (6), pp. 8-12 (Nov-Dec 1983). 
with standardized observational procedures based 
0x1 a mental status exam, the Karnofsky scale is  A statistical review of variables predictive of adjust- 
Veptably reliable and valid as a global measure but  ment inhemodialysispatients. Olsen, C.A Nephrd 
tdoes not adequatelycapturethe conceptual domain  Nurse, 5 (6), pp. 16-27 (Nov-Dee 1983). Document 
O f ~ tofy lif e.  Type: Review (68 refs.). 
wit~~ssuranGeuei delines for Henodialysis Devices  Appendix E (Cont.)  Chapter 2 
hnnotated Bibliography  The Basics of Quality Assurance 
Effect of an algorithm and patient  information on  Fadors influencing survival of patients on chronic 
serum phosphoms levels. Deimling, A, Denny, M.,  hemodialysis: implications for nursing. Rogers, K, 
Harrison, M., Kerr, B., Mayfield, M., PelleShearer,  Tzamaloukas, AH. and Avasthi, P.S. J Nephrol 
M., Seaby, N. andTownsend S. AANNTJ, 11 (11, pp.  Nurse, 3 (3), pp. 1014 (May-Jun 1986). 
35-8,50 (Feb 1984). 
Sudden death in hemodialysis patients. Cohle, S.D. 
Assessment ofrehabilitationo utcomesa mongc hronic  and Graham, M.A JForensic Sci, 30 (I), pp.158-66 
dialysis patients. Kutner, N.G. and Cardenas, D.D.  (Jan 1985). Hemodialysis patients may die suddenly 
Am JNephml, 2 (31, pp. 128-32 (1982). The physical  and unexpectedly from a number of causes. These 
status of 137 chronic dialysis patients was assessed  deaths may be divided into those due directly to and 
by both objective and subjective measures; education  occuningduringhemodialysis,th ose occurringwhile 
and employment statuses were also determined.  the patient is not undergoing dialysis, and those that 
Below normal grip strength characterizedt he major-  may occur ata ny time. The first groupincludesbrain 
ity of patients; slowed nerve conduction and subjec-  herniation, air embolism, acute hemorrhage as a 
tive fatigue were also observed among a subset of pa-  result of machine malfunction or fistula rupture, 
tients.  However, patients demonstrated good to  electrocution, cardiac arrhythmia caused byhypoka- 
normal muscle strength and relatively normal pinch  lemia, complicationso f subclavianintra-venousc athe- 
strength, and activities of daily living presented no  ter insertion, thirddegree heart block as a result of 
problems for the large majority of patients. Employ-  triglyceride emulsion, and disseminated intravascu- 
ment probability was directly related to educational  larcoagulation(D1C)orhyperkaIemiacausedby~eated 
status.  Despite dialysis requirements and other  dialysate. The second group includes deaths due to 
employment disincentives, 42% of non-diabetic men  pericardial tamponade because of effusion and suici- 
aged 21-59 were employed.  dalcausesofdeath(exSangcLinati~n,electro~imbalance 
as a result of excessive intake of salt, fluid, or potas- 
Monitoring standards instead of problems. Hexum,  sium) as well as more conventional methods of sui- 
J.M. J Nurs Qua1 Assur,l(3), pp. 8-13 (May 1987).  cide.  The  last category includes people dying of 
arterio-sclerotic cardiovascular disease, hyperten- 
The computer in quality control of hemodialysis 
sive cardiovascular disease, and internal hemor- 
patient care. Pollak, V.E., Peterson, D.W. and Flynn 
rhage. Investigation of these deaths, including per- 
J. QRB, 12 (6), pp. 202-10 (Jun 1986). Describes a 
tinent historical, laboratory, and autopsy data and 
computerized, custom-designedmedical information 
investigation of dialysis equipment is discussed. 
system (MIS) that has been used for more than eight 
years in the care ofpatients with chronic renal failure  An unsuspected cause of acute hemolysis during 
treated by hemodialysisi n a medical center. Appli-  hemodialysis. Francos, G.C., Burke, J.F. Jr,B  esarab, 
cation of the MIS in the day-bday management of  A, Martinez, J., Kirkwood, R.G. and Hummel, L.A 
patients in one limited-cared ialysis clinic is detailed,  Trans Am Soc Artif Intern Organs,  29, pp. 140-5 
with particular attention to its capacity to contribute  (1983). 
to the quality of care of the individual patient. 
Computer modellingofhaemodialysis/ultrafiltration 
Morbidity and mortality oflong-term haemodialysis:  explaining the pathogenesis of the disequilibrium 
areview. Gabriel, R JRS oc Med, 77 (7), pp. 595-601  syndrome. Dawids, S.G. and Caspersen, AH. P m  
(Jul1984). Document Type: Review (90 refs.).  Eur Dial Transplant Assoc,  19, pp. 360-5 (1983). 
Based on the hypothesis that rapid correctionso fpH, 
Selected health care maintenance policies in chronic 
Na+ and osmolalityg ive rise to disequilibrium (DES) 
dialysis centers.  Dillingham, M.A and Anderson, 
during efficient haemodialysis (HD), a 14 compart- 
R.J. Am J Kidney Dis, 6 (4), pp. 23740 (Oct 1985). 
ment model has been designed for dynamic analysis 
f i ra  survey approach, the authors postulate that 
oftheinduced fluid shifts and the resultinghaemody- 
prospective studies to determine optimal methods of 
namic reactions. The model reactions correlated re- 
health care maintenancein the chronicdialysisc enter 
markably with clinical findings and indicate how far 
are indicated. 
a patient's haemodynamic compensation can pre- 
vent circulatory collapse and hypovolaemia, mainly 
Risks and hazards associated with dialyzers and 
through lowering the mean pressure in a major 
dialysate delivery systems.  Keshaviah, P.R.  and 
portion of the capillaries.  Steady weight dialysis 
Luehmann, D.A Cn't Rev Biomed Eng, 9 (3), pp. 201 - 
causes reduction of blood volume up to 65 percent 
44 (1983). Document Type: Review (83 refs.). 
before circulatory collapse occurs. 
Quality Assurance Guidelines for Hernodialysis Devices  E-4  Appendix E (Cont.)  Chupter 2 
Annotated Bibliography  The Basics of Quality Assurance 
Mortality risk factors in patients treated by chronic  Core Curriculum for Nephmkgy Nursing. L. Lan- 
hemodialysis. Report of the Diaphane collaborative  caster Cedl. American Nephrology Nurses Associa- 
study. Degoulet, P., Legrain, M., Reach, I., Aime, F.,  tion; Pitman, NJ (1990). Designed to provide afoun- 
Devries, C., Rojas, P. and Jacobs, C. Nephron, 31 (2),  dation from which the professional nurse can apply 
pp. 103-10( 198). A survival analysis was applied to  the nursing process to the care of renal patients, 
1,453 patients treated between 1972 and 1978 in 33  prepare for certification, and continue the study of 
French dialysis centers and prospectively followed  nephrology nursing practice. 
up in the computerized Diaphane Dialysis Registry; 
198 deaths (overall mortality (OM) were registered,  Evolution of a Quality Assurance Program. SeabyN  . 
of which 87 (43%) were secondary to cardiovascular  Nephrdogy News & Issues, 2 (8), p. 34 (1988). A brief 
complications( cardiov8SCUIarmortality=CVM)).R  isk  step-by-stepd escription on how to put together a QA 
factors for OM and CVM (p values less than 0.05)  program for a dialysis facility. 
were age, male sex, nephroangiosclerosis or diabetic 
Quality Assurance: You Can Do It Too!  Seaby, N., 
nephropathy as the primary renal disease, elevated 
Bower, M. and Burrows-Hudson, S. ANNA Journal, 
systolic and diastolic blood pressure and two weekly 
14(1), pp. 15-21 (1987). 
dialysis rather then three.  In contrast with the 
results observed for the general population, a high 
QualityA  ssurance for Dialysis. Burrows-Hudson,S  . 
body mass index and elevated cholesterol, triglyc- 
ESRD Network #3: Sausalito, CA (89 pp.) (1984). 
erides and uric acid were not found to be associated 
with significantly increased CVM or OM.  On the 
Quality assurance vs. cost containment: "damned if 
contrary, low body mass index (less than 20 kg/m2), 
you do, damned if you don'tw Schron, S.R AANNT 
low cholesterol (less than 4.5 mmoV1) and low mean  J, 9 (2), pp. 13-23 (Apr 1982). 
predialysis blood urea (less than 4.6 mmoV1) were 
associated with increased OM and CVM, and more  Control and prevention of infection on hemodialysis 
especially with high stroke mortality.  Results for  units. Clarke, B.H. Nurs Clin North Am, 15 (4), pp. 
urea but not for cholesterol remain significant &r  883-90 (Dec 1980). An approach is presented which 
adjustment for age, sex, weekly dialysis schedule and  illustrates that&ectivecontrolandpreventionmea~u~e~ 
body mass index. They suggest that, in addition to  evolve from an organized method of identifying the 
elevated blood pressure, apoor nutritional state and,  pertinent data, definingthe problems, creatingwork- 
or low protein intake may be important factors for  able and reasonable control measures, implement- 
explaining the high cardiovascular mortality, par-  ing the measures, and then evaluating their effec- 
ticularly for strokes, observed in dialyzed patients.  tiveness.  Since infection control and prevention 
measures affect them directly, nurses must assume 
The Joint Commission Guide to Quality Assurance. 
a predominant role in the development, application, 
JCAHO, Chicago, IL (1988). An indepth presenta- 
and evaluation of these measures. 
tion of the "1 0-Step Monitoring and Evaluation proc- 
ess" providing explanations of each step and ex-  Home monitoring of diabetes: a comparison of four 
amples on how to accomplish each phase.  fieldmethodsf or analysingglucosel evels. Baumgart, 
R, Cregan, D., France, M.W. and Dnuy, M.I. Ir Med 
Standards of Clinical Practice for Nephmlogy Nurs- 
J, 74 (ll), pp. 319-20 Wov 1981). 
ing. AmericanNephrologyNur~esAssociationP:i tman, 
NJ, (130 pp.) (19 88). Acomplete set of structure, pro-  Tracking Problems. Stoten, S. ANNA J,1 4,5, p. 328 
cess, and outcome standards for clinical nephrology 
(Oct 1987). Aproblem-trackingmodelw  as developed 
nursing practice.  to identify and resolve problems that existed in a 
dialysis facility and serve as a communications link 
Quality Assurance for Nephmlogy Nursing. Ameri- 
among unit coordinators, physicians, and staff. The 
C8n Nephrology Nurses Association; Pitman, NJ 
article presents a tool for recording topic, date, sus- 
(1989).  A guide for the application of the quality 
pected problem, investigation results, cause, action 
assurance process in nephrology nursing.  Follows 
needed, and date resolved. 
the JCAHO 10-Step process and presents clinical/ 
Practical examples for all areas of nephrology nurs- 
"lg.  Appendix E (Cont.) 
Annotated Bibliography 
Chapter 3 
Water Treatment 
Effect of water deionisers on 'fracturing osteodystro-  ommended, including heating units, air traps and 
phy'anddialysisencephalopathyinPlymouth. Leather,  valves. 
H.M., Lewin, I.G., Calder, E., Braybrooke, J. and Cox, 
RR Nephron, 29 (1-21, pp. 80-4 (1981). When water  Serum nickel concentrations in hemodialysis pa- 
deionisers were not used routinely, a bone disease  tients with environmental exposure. Hopfer, S.M., 
with multiple fractures, 'fracturing osteodystrophy,'  Fay, W.P. and Sunderman, F.W. Jr. Ann Clin Lab 
and dialysis encephalopathyo ccurred in a sign5cant  Sci, 19 (3), pp. 161-7 (MayJun 1989). Nickel was 
number of patients.  When water deionisers were  apalyzed by electrothermal atomic absorption spec- 
used commonly, fracturing osteodystrophy and di-  trophotometry in serum specimens from 22 healthy 
alysis encephalopathy  occurred extremely infie-  hospital workers and 30 patients with end-stage 
quently. Duration of dialysis without a water deion-  renal disease treated by extracorporeal hemodialy- 
iser appeared to be the most important factor in the  sis, who resided in Sudbury, Ontario, Canada, a city 
development of these two conditions.  The use of  with extensiven ickel mines and smelters. This study 
water deionisersu sually led to healing of fractures in  confirms the presence ofhypernickelemiainh emodi- 
patients with fracturing osteodystrophy and also led  alysis patients, but does not suggest thathemodidy- 
to improvement in 4 of the 11 patients with dialysis  sis patients have sigdicantly increased risk ofnickel 
encephalopathy. Neither condition has occurred in  toxicity in Sudbury, compared to Hartford, despite 
any patient using a water deioniser from the first  the high nickel concentrationsi n Sudbury tap water. 
dialysis. Water deionisers, therefore, appeared to be  The outcome is attributed to the efficient deioniza- 
effective in both the treatment and prevention of  tion of water used to prepare hemodialysis solutions 
fracturing osteodystrophy and dialysise ncephalopa-  in Sudbury. 
thy. 
Correctiono fmicrocytosis followinge limination of an 
Surgeon General's advisoryont reatment of water for  occult sourceofaluminumc ontamination ofdialysate. 
use in dialysis.  FDA Drug Bull, 11 (I), p. 3 (Mar  Abreo, K, Brown, S.T., Sella,M  . Am JKitEney Dis, 13 
1981).  (61, pp. 465-8 (Jun 1989). A higher prevalence of 
aluminum-associated microcytic anemia was noted 
FDA safety alert: sodium azide contamination of  in hemodialysis unit A (n=67) compared to unit B 
hemodialysis water supplies. ANNA J, 16 (41, p. 273  (n=39). This hdingc ould not be explained by differ- 
(Jun 1989).  ences in the aluminum content of reverse osmosis 
(RO) water or intake of antacids containing alumi- 
Bacterial contaminationo fdialysatein dialysis-asso-  num by patients in the two units. Because contami- 
ciated endotoxaemia Watzke, H.,Mayer, G., Schwan,  nation was missed in spite of water testing att he RO 
H.P., Stanek, G., Rotter, M., Hirschl, AM. and Gra,  site, these findings underscore the importance of 
H.  J Hosp Infect, 13 (21, pp. 109-15 (Feb 1989).  measuring water aluminum and TDS content at the 
Bacteriological investigations and endotoxin (ET)  dialysis stations. Frequent water testing at dialysis 
determinations were performed during a routine  stations, familiarity with the design of water treat- 
haemodialysis session for six patients. Inspection of  ment facilities, and recognition of aluminum over- 
the dialyzer machines revealed that air-traps and  load can lead to early detection and correction if 
heater-unit for the incoming (untreated) tap water  similar types of aluminum contamination should 
before mixing with the dialysate concentrate were 
occur. 
the only sites where high bacterial release was fea- 
sible, as this part of the machine escaped disinfection  Uptake of  trihalomethanes by  patients during 
due to the construction of these devices.  Regular  hemodialysis. Cailleux, A,S  ubra, J.F., Riberi, P. and 
disinfection of all parts of a dialyzer machine is rec-  Allain P. Clin Chim Acta, 181 (I), pp. 75-80 (Apr 28 
Quality Assurance Guidelines for Hemodialysis Devices  E-6  Appendix E (ContS  Chapter 3 
Annotated Biblwgmphy  Water Treatment 
1989). Trihalomethanes CTHM)p resent in tap water  FDA safety alert:  chloramine contamination  of 
were also found in dialysis fluid because they were  hemodialysis water supplies Detterl. Am J Kidney 
not eliminated by water treatment. THM, absorbed  Dis, 11 (51, p. 447 (May 1988). 
through the dialyser membranes, increased consid- 
erably in blood and in expired air of patients on  Ethylene glycol intoxication due to contamination of 
hemodialysis during the dialysis sessions. The u p   water systems. MNWR, 36 (36), pp. 611-4 (Sep 18, 
take of THM during each dialysis session was about  1987). 
1m  g. 
Aluminiium-relatedoste0malacia:responsetor everse 
Aluminium and fluoride in the water supply and  osmosis water treatment. Smith, G.D., Winney, RJ., 
their removal for haemodialysis.  Cameron, A.P.,  McLean, A. and Robson, J.S. Kidney Int,32 (11, pp. 
Drury, P.J., Harston, G.A, Ineson, P.R.  Sci Total  96-101 ( Ju11987). Those patients in whom  bone 
Environ, 76 (l),p p. 19-28 ( Sep 15,1988). Aluminium  mineralization status improved developed hyper- 
and fluoride in the water supply and their removal  parathyroidism aRer reverse osmosis water-treat- 
for haemodialysis were investigated in the Trent  ment, whewt he staticpatientsr emainedeuparathy- 
Region, U.K, and wide variations noted. A compari-  mid. The results suggest that resolution of alumin- 
son ofnew andolderwatertreatment systems showed  ium related osteomalacia may occur with reduction 
that there is a deterioration in performance with use.  in dialysis fluid aluminium, and that parathyroid 
However, some cases poor removal may be due to the  hormone plays a role in the healing of aluminium 
installation of unsuitable equipment or, more proba-  related osteomalacia The therapeutic implications 
bly, due to a change in the waters used to supply the  are twofold: attempts to remove all traces of hyper- 
different homes.  Thus, adequate maintenance of  parathymidism may be detrimental to the bone 
equipment and frequent sampling of both untreated  mineralization status; and stimulation of the para- 
and treated waters are required in order to maintain  thyroid glands by means of a mild reduction in 
the provision of waters suitable for the preparation of  dialysis fluid calcium may be ofvalue in the manage- 
dialysate.  ment of those cases with persistent osteomalaciaa nd 
low bone turnover. 
Aluminum and chronic renal failure: sources, ab- 
sorption, transport, and toxicity. Wills, M.R and Sa-  Bacterial colonization and endotoxin content ofanew 
vory, J. CRCCrit Rev Clin Lab Sci, 27 (I), pp. 59-107  renal dialysisw  ater system composed ofacrylonitile 
(1989). Document Type: Review. An increased br@n  butadiene styrene. du Moulin, G.C., Coleman, E.C. 
content of aluminum appears to be the major etiologi-  Jr. andHedley-Whyte,J . ApplEnviron Microbwl, 53 
cal factor in the development of a neurological syn-  (61,p p. 1322-6 (Jun 1987). The authors measured 
drome called either "dialysis encephalopathy" or  endotoxin and bacterial levels in tap water, in water 
"dialysis dementia," an increased bone content, caus-  purified by reverse osmosis, and in dialysate samples 
ing a specific form of osteomalacia. An excessof alu-  over a 4-month period in a new 10-bed renal dialysis 
minum also appears to be an etiological factor in a  unit. Even &r  disinfection ofthe system, there was 
microcytic, hypochromic anemia that occurs in some  no significant decrease in culturable bacteria from 
patients with chronic renal failure on long-term  the water even though endotoxin levels were lower. 
treatment with hemodialysis.  Species isolated from the renal dialysis system were 
predominately pseudomonads, whereas species iso- 
Prevalence of non-tuberculous mycobacteria in wa-  lated from the tap water were Bacillus and Fla- 
ter supplies of hemodialysis centers. Carson, L.k,  vobaderium species. 
Bland, L.A, Cusick, LB., Favero, M.S., Bolan, GA, 
Reingold, AL. and Good, C. AppZ Environ Microbial,  Water quality-a  neglected problem in hemodialy- 
54 (121,p p. 3122-5 (Dec 1988). This study was an-  sis. Bommer, J. and Ritz, E. Nephron, 46 (11, pp. 1- 
d~tedtdoe terminet he prevalence ofN'I'h4a nd other  6 (1987). Document Type: Review (25 refs.). 
bacteria in water samples collected over a 13-week 
Period from 115  randomly selected dialysis centers in  Aluminum in the dialysis fluid Rahman, H., Chan- 
the United States. The results of this study support  non, S.M., Parkinson, I.S., Skillen,A  W., Ward, M.K. 
-commendations  to use 4% HCHO or a chemical  and Kerr, D.N. ClinN  ephd, 24 Suppl 1, pp. S78-83 
germicidal equivalent for disinfecting dialyzers that  (1985). DomentT  ype: Review (44Refs.) The major 
to be reused.  source of aluminum in patients with chronic renal  Appertdir E (Cont.)  Chapter 3 
Annotated Bibliography  Water Treatment 
failure treated by hemodialysis is the hemodialysis  by a single centre: evidence for "safe" upper limit of 
fluid. The aluminum is derived from both the water  aluminium in water.  Platts, M.M.,  Owen, G. and 
and the chemical concentrate usedinthe preparation  Smith, S. Br Med J [Clin Resl, 288 (6422), pp. 969- 
of the hernodialysis fluid. Due to the complex phys-  72 (Mar 31,1984). The authors discuss the fact that 
ico-chemistry of aluminum in water and dialysis  when aluminium was removed from water by deion- 
fluid,b oth the total aluminum concentration and the  isation the incidence of fractures diminished during 
proportion of aluminum species able to cross the  the next year and no patient developed dialysis 
hemodialysis membrane may vary from water sup-  encephalopathy. Their findings show that 1.O  rnumoll 
ply to water supply and from day to day within a  L is a safe maximum concentration of aluminium in 
supply.  water for use in home haemodialysis. 
Hemodialyzer reuse: practices in the United States  Granular activated cahnu sage inchloramineremoval 
and implicationf or infectionc ontrol. Bland, L., Alter,  from dialysis water. Meyer, M.A andKlein, E. Artif 
M., Favero, M., Carson, L. and Cusick, L. Nontuber-  Organs, 7 (4), pp. 484-7 (Nov 1983). This is a report 
culous mycobaderia were isolated from the water in  on the bench-scale testing of five kinds of GAC from 
83% of 115h ernodialysis centers surveyed across the  three manufacturers. The experimentalr esults were 
United States and could constitute a potential infec-  used to estimate the capacity of a 9" diameter, 45" tall 
tion risk because of the organisms' greater germicide  column of the best carbon. These scale-up estima- 
resistance than most other naturally occurringwater  tionsindicatethatthis sorbentmays afely last through 
bacteria. Two percent formaldehyde is not an effec-  156 5-h. 
tive germicide for high level disinfection of hemodia- 
lyzers. Reprocessed hemodialyzers should be disin-  Heparin inactivation, acidosis and copper poisoning 
fected with 4% formaldehyde or an equivalent disin-  due to presumed acid contamination of water in a 
fectant.  hernodialysis unit.  Eastwood, J.B., Phillips, M.E., 
Minty, P., Gower, P.E. and Curtis, J.R. Clin Nephrol, 
Nitrate induced anaemia in home dialysis patients.  20 (4), pp. 197-201 (Oct 1983).  An accident in a 
Salvadori,M  ., Martinelli, F., Cornparini, L., Bandini,  hemodialysis unit involving 13p atients is reported. 
S. and Sodi A.  Proc Eur Dial Transplant Assoc Eur  Circumstantial evidence suggests that acid contami- 
Ren Assoc, 21, pp. 321-5 (1985). Many home dialysis  nation of the water supply to the unit resulted in in- 
patients in Florence and the surrounding area sud-  activation ofheparin with widespread extracorporeal 
denly showed an unusual anaemia. All used a so&-  clotting and secondary copper intoxication which 
ener for water treatment.  They  demonstrated  proved fatal in one patient. Serum copper concentra- 
methaemoglobinaernia, Heinz bodies and reduction  tions were raised in 6 of the11 patients and whole 
in plasma haptoglobin, indicating Hb oxidation. Tap  blood copper concentrations were raised in four pa- 
water analysis showed excessive nitrates. The sub-  tients. Results of serum ceruloplasmin, whole blood 
stitution of the softeners with deionisers solved this  lead and zinc analyses are reported, together with 
important and unusual clinical problem.  tissue analyses for copper in the fatal case.  The 
majority of the patients showed evidence of a meta- 
Aluminium-induced anaemia in haemodialysis pa-  bolic acidosis. 
tients. McGonigle, R.J . and Parsons, V. Nephron, 39 
(11, pp. 1-9 (1985). Evidence has accumulated that  Generation of dimethylnitrosarnine in water p d -  
aluminium is the most likely ion responsible for me-  cation systems. Detection in human blood samples 
mia, but other ions, trace metals in excess or defi-  during hemodialysis. Simenhoff, M.L., Dunn, S.R, 
ciency, and potentially toxic substances cannot be  Fiddler, W., Pensabene, J.W. and Smiley, J. JAMA, 
excluded yet.  250 (15), pp. 2020-4 (Oct 21,1983). Dimethylnitro- 
sarnine (DMNA), a carcinogen, was detected atl evels 
The use of ion exchange to remove aluminum from  up to 32 microgramsfl; in dialysate from 5 of 16 
water used in hemodialysis. Petrie, J.J .,F leming, R,  dialysis units surveyed. Blood drawn from patients 
McKinnon, P., Winney, R.J. and Cowie, J. Am J  ato ne oftheseunitsin which DMNAwasraised in the 
Kidney Dis, 4 (11, pp. 69-74 (Jul1984). A discussion  dialysate showed asignificanti ncreasei n the amount 
of a modified ion exchange resin for the removal of  of DMNA in the patient's blood when predialysis 
aluminum.  levels were compared with 15-minute intradialysis 
levels. The presence of a mixed-bed deionizer with- 
Water purification and the incidence of fractures in 
out an antecedent carbon filter appeared tobe neces- 
patients receiving home haemodialysis supervised 
sary for DMNA production. 
Quality Assurance Guidelines for Hernodialysis Devices  E-8  Appendh E (Cont.1  Chapter 3 
Annotated Bibliography  Water Treatment 
Heinz-body haemolysis in haemodialysed patients  available bicarbonate-containingd ialysates, pH and 
caused by chloramines in Sydney tap water. Cater-  pC02 were determined. Side effects resulted from 
son, RJ.,Savdie, E.,Raik,E., Coutts, D. andMahony,  low pH and high pC02. Use of two of the six dialy- 
J.F.  Med JAust, 2 (81, pp. 367-8 (Oct 16 1982). In  sates was associated with fatigue, muscle cramps 
August 1981, there was an outbreak of Heinz-body-  and somnolence. 
positive haemolytic anaemia among patients who 
were undergoing dialysis in Sydney Hospital. This  Bone disease in patients on maintenance haemodi- 
appeared to be due to excessive chloramines in, and  alysis using softened or deionized water.  Hudson, 
G.A,Milne,F.J.,Oliver,N.J.,Reis,P.,Murray,J.and 
inadequate carbon filtration of, the water used for 
haemodialysis. &r  improvement of the carbon fil-  Meyers, AM. SAfr MedJ, 56 (ll), pp. 439-43( Sep 8, 
tration system, there were no M e r c ases of an-  1979). The results showed that symptomatic osteo- 
aemia  malacidosteopenia occurs more frequently in the 
units using softened water, which has a higher alu- 
Water supply  aluminium concentration, dialysis  minium content, than in the deionized water unit. 
dementia, and effect of reverse-osmosisw  ater treat-  The patients dialysed on soRened water also have 
ment. Davison, AM., Walker, G.S., Oli, H. and Le-  significantly higher serum calcium and phosphorus 
wins, AM. Lancet, 2 (83021, pp. 785-7 (Oct 9,1982).  levels. It is suggested that in Johannesburg, water 
Dialysis dementia appeared in 18 of 258 patients  softeningalone is inadequate, and that the high alu- 
treated by haemodialysis.  All cases developed in  minium levels in our water may be responsible for ac- 
patients treated by home dialysis (15 0) and none in  celerated osteomalacidosteopenia. 
patients treated exclusivelyby hospitaldialysis(108). 
Analysesofthedomesticw  ater supplyf or each month  Acute nickel intoxication by dialysis. Webster, J.D., 
on dialysis showed that dementia occurred only in  Parker, T.F., Alfrey, AC., Smythe, W.R., Kubo, H., 
those whose water supplyh  adahigh aluminium con-  Neal, G. and Hull, AR. Ann Intern Med, 92 (51, pp. 
centration (greater than 80 microgramdL). Reverse  631-3( May 1980). Nickel intoxication was observed 
osmosis treatment satisfactorily removes alumin-  in a group of dialyzed patients when leaching of 
ium and many other substances from water.  Its  nickel-plated stainless steel water heater tank con- 
application had a beneficial effect on 7 of 9 patients  taminated the dialysate. Symptoms occurred during 
previously exposed to dialysate prepared from water  and after dialysis atp lasma nickel concentrations of 
with a high aluminium content and prevented the  approximately 3 m&.  Symptoms included nausea, 
appearance of dementia in 24 patients whose water  vomiting, weakness, headache, and palpitation. Re- 
was so treated from the start of haemodialysis.  mission of symptoms occurred spontaneously, gen- 
erally 3 to 13h ours after cessation of dialysis. The 
Ionic and nonionic fluoride in plasma (or serum).  evidence indicated that the nickel became bound in 
Singer, I,. and Ophaug, R. Crit Rev Clin Lab Sci, 18  the plasmaafter crossingthemembrane, resultingin 
m: 
(21, pp. 111-40(1982). Document  Review (113  a higher concentration in the plasma than in the 
refs.).  dialysate and preventing its removal by dialysis. 
Bone aluminum deposition in maintenance dialysis  Dialysis dementia: therole ofdialysate pHin altering 
patients treated with aluminium-free dialysate: role  the dialyzability of aluminum. Gacek, E.M., Babb, 
of aluminium hydroxide consumption.  Heaf, J.G.,  AL.,U  velli, D.A, Fry,D.L. andscribner, B.H. Trans 
Podenphant, J., Andersen, J.R. Nephron, 42 (31, pp.  Am Soc Artif Intern Organs, 25, pp. 409-15  (1979). 
210-6 (1986).  It is concluded that bone aluminium 
deposition occurs despite the use of aluminium-free  Bacterialc olonization andendotoxin content ofanew 
dialysate and is associated with total and present  renal dialysisw  ater system composedofacrylonitrile 
ahninium hydroxide consumption; heavy alumin-  butadiene styrene. duMoulin, G.C., Coleman, E.C. 
ium deposition is associated with severe and sympto-  Jr. and Hedley-Whyte J. Appl Environ Microbial, 53 
matic osteomalacia, but can also be observed in the  (6), pp. 1322-6 (Jun 1987). The authors measured 
Presence of predominant hyperparathymidism.  endotoxin and bacterial levels in tap water, in water 
purifiedby reverse osmosis, and in dialysate samples 
Side effectsi n bicarbonate dialysis due to low dialy-  over a 4-month period in a new 10-bed renal dialysis 
mte pH.  Wagner, L., Schindler, B., Marhoffer, W.,  unit. Even after disinfection of the system, there was 
vanE~lO, ., Strauch, M. P m E ur Dial Tmnsplant  no significant decrease in culturable bacteria from 
h s ~19,  pp. 346-50 (1983).  In six commercially  the water even though endotoxin levels were lower. 
-% ' fharance Guidelinesf or Hedialysis Devices  Appendix E (ContS 
Annotated Biblwgmphy 
Chapter 4 
Dialysis Delivery System 
Shear-inducedf ormation ofaggregatesd uringhemodi-  to determine the safety of prolonged reductions in 
alysis. Leonard, E.F.,VanVooren, C., Hauglustaine,  dialysate flow rate. Authors conclude that QD 300 
D. and Haumont, S. Contrib Nephml, 36, pp. 34-45  does not impair dialysis efficiency for most small 
(1983).  molecules and saves $1 -38p er patient per dialysis. 
The current status and future of the artificialk idney.  Mechanical Aspects of Dialysis Including Dialysate 
Funck-Brentano, J.L. Artif Organs, 9 (2), pp. 119-26  Delivery Systems and Water for Dialysate. Easter- 
(May 1985). Document Type: Review ( 32 refs.) Dis-  ling, R ~JJC  linical Dialysis.  AR.  Nissenson, RN. 
cussion of the technology, use and determination of  Fine and D.E.  Gentile [edsl.  Appleton-Century- 
adequacy and related cost.  Crofts, Norwalk, CT,p p. 53-96 (1984). Excellent in- 
depth overview of water treatment basics and compo- 
Comparative analysis of two volumetrical ultrafil-  nents operation as well as on operation of dialysis 
tration monitors for hemodialysis.  Berden, J.H.,  delivery systems. 
Wokke, J.M. and Koene RA. Int JArtif Organs, 9 (3), 
pp.163-6 (May 1986). Controlled ultrafiltration (UF)  Staying Tuned into the High-Tech World Part Two: 
duringhemodialysismay prevent dialysis associated  Dialysis Delivery Systems. Vlchek, D. Dial &Tnzns- 
hypotension. A prerequisite for controlled ultrafil-  plant, p. 453 (Aug 1989). A review of ultrafiltration 
tration is an accurate measurement of ultrafiltra-  control principles, risks and hazards associated with 
tion. Volumetric measurement is the best currently  dialysate, variable sodium, and other considerations 
available method for this purpose. In this study the  necessary for today's advanced dialytic techniques. 
authors compared in a clinical settingt wo volumetric 
ultrafiltration monitors.  Volumetric monitoring of  Inadequacy of Heat Alone for Dialysis Machine Dis- 
UF is accurate and reliable, but its accuracy is  infection.  Francos, G.C., Murphy, S.A, Jungkind, 
dependent on the type of dialyzer used.  D.L. and Bondi, J.M.  Dialy & Transplant, p. 438 
(Aug1987). Heavy bacterial overgrowth is described 
Technical aspects of high-flux hemodiafiltration for  of each dialysis machine in a facility that chemically 
adequate short (under 2 hours) treatment.  Miller,  disinfectedm  onthlya ndheat disinfectedd aily. Weekly 
J.H., von Albertini, B., Gardner, P.W. and Shina-  chemical disinfection and daily heat deinfection was 
berger, J.H. Trans Am Soc Artif Intern Organs, 30,  finally the protocol that was able to maintain accept- 
pp. 377-81 (19 84). The efficiencyo fhemodialysis can  able baderial levels. 
be more than doubledb y usingmuchhigher than nor- 
mal blood and dialysate flows, employing dialyzers  Hemolysis and consumption coagulopathy due to 
with greater surface area and permeability, bicar-  overheated dialysate.  Tielemans, C.L., Herbaut, 
bonate dialysate, and an apparatus capable of rigid  C.R, Geurts, J.O. and Dratwa, M. Nephron, 30 (21, 
volumetric control ofthe dialysate. Coupled with the  pp. 190-1 (1982). 
better treatment tolerance described elsewhere in 
Overview of renal assist systems. Smith, J.W. Ann 
this volume, this self-contained and automated tech- 
Biomed Eng, 8 (4-61, pp. 473-86 (1980). 
nique, providinghigh diffusive and convective trans- 
fer, permits drastic reductionsin treatment timeover 
Volumetic mimmputer-based ultrafiltration monitor 
conventional dialysis: to under 6 hrdwkin this study. 
for hemodialysis.  Wokke, J.M.P., Berden, J.H.M., 
Slegere,J .F.G. and Koene, R.AP. Int JArt Org, 8,1, 
Long-term hemodialysis at reduced dialysate flow 
rates.  Kirchner, KA, White, AR., Kiley, J.E. and  pp. 33-6 (1985). This article describes the UFM (ul- 
trafiltration monitor) which uses twomicro-ovalflow- 
Bower, J.D.  Am J Nephrol, 4 (I), pp. 7-12 (1984). 
meters that measure the flow rate of the diaysate 
Twenty stable hemodialysis patients were main- 
entering and leaving the dialyzer.  It showed an 
tained on adialysate flow rate of 300mVmin (QD 300) 
Quality Assurance Guidelines for Hemodiulysis Devices  E-10  Appendix E (Cont.)  Chapter 4 
Annotated Bibliography  Dialysis Delwery System 
accuracy of 90% using a conventional cuprophan  Disinfection of Hernodialysis Machines. Townsend, 
membrane dialyzer.  T.R, Wee, S.B. and Bartlett J. Dial & Transplant, 
14,5 (May 1985). The article notes that none ofthree 
On the Origin and Control of Rust-Colored Precipi- 
disinfectants tested (3.7% formaldehyde, 134d ilu- 
tates in Bicarbonate Dialysate Lines. Stephens, D.  tion Cidex HD, or 1:34 dilution of Sporicidin) was 
Dial & Transplant, 15,5, pp. 250-4 (May 1986). Due  effective in disinfecting a Psuedomonas aeruginosa 
to the particular chemistry of the solution involved,  contaminated dialysis machine when contact time 
bicarbonate dialysates are particularly pmnebpm  was 5,10, or 15 minutes.  However, after 24 or 72 
cipitation of iron in the delivery system.  These  hours, the formaldehyde and the Cidex were effec- 
precipitates are not only unsightly, but can result in  tive. 
machine malfunction if allowed to accumulate. The 
article discusses methods of avoiding and eliminat- 
ing such an accumulation. 
Guidelines  Devices  Appendix E (Cont.) 
Annotated Bibliography 
Chapter 5 
Dialysate and Dialysate Concentrate 
Bacterial contamination of dialysate in dialysis-as-  Almost no febrile episodes were observed when ster- 
sociatedendotoxaemia.W  atzke, H.,Mayer,G.,Schwam,  ile dialysate was used. 
H.P.,Stanek,G.,Rotter,M.,H irsch1,AM. andGra,H. 
JHosp Infect, 13( 21, pp. 109-15( Feb 1989). Bacterio-  The role of dialysate in the stimulation ofinterleukin- 
logical investigations and endotoxin (El') determi-  1p roduction duringclinical hemodialysis. Port, F.K, 
nations were performed during a routine haemodi-  VanDeKerkhove, KM., Kunkel, S.L. and Huger, 
alysis session for six patients.  Inspection of the  M. J. Am JKidney Dis, 10( 2), pp. 118-22( Aug 1987). 
dialyzer machines revealed that air-traps andheater-  Authors conclude that IL-1 is produced during clini- 
unit for the incoming (untreated) tap water before  cal HD and that endotoxin or its fragments play a 
mixing with the dialysate concentrate were the only  role in the stimulation of IL-1 production, probably 
sites where high bacterial release was feasible, as  through monocytes adhering to the dialysis mem- 
this part of the machine escaped disinfection due to  brane. In addition to this dialysate factor, IL-1 pro- 
the construction of these devices. Regular disinfec-  duction appears also to be stimulated by a blood- 
tion is recommended of all parts of a dialyzer ma-  membrane interaction. 
chine, including heating units, air traps and valves. 
Aluminum in the dialysis fluid. Rahman, H., Chan- 
Correction ofmicrocytosis followinge limination ofan  non, S.M., Parkinson, I.S., Skillen,A  W., Ward, M.K 
occult sourceo f aluminum contamination ofdialysate.  and Ken, D.N. Clin Nephml, 24 Suppl 1, pp. S78-83 
Abreo, K,B  rown, S.T. and SellaM. Am JKidney Dk,  (1985). Document Type: Review (44 refs.) The major 
13( 6), pp. 465-8 (Jun 1989). A higher prevalence of  source of aluminum in patients with chronic renal 
aluminum-associated microcytic anemia was noted  failure treated by hemodialysis is the hemodialysis 
in hemodialysis unit A (n=67) compared to unit B  fluid. The aluminum is derived from both the water 
(n=39). This finding could not be explained by dif-  and the chemical concentrate used in the preparation 
ferences in the aluminum content of reverse osmosis  of the hemodialysis fluid. Due to the complex phys- 
(RO) water or intake of antacids containing alumi-  ico-chemistry of aluminum in water and dialysis 
num by patients in the two units. Because contami-  fluid,b oth the total aluminum concentration and the 
nation was missed in spite of water testing at the RO  proportion of aluminum species able to cross the 
site, these findings underscore the importance of  hemodialysis membrane may vary from water sup- 
measuring water aluminum andTDS content at the  ply to water supply and from day to day within a 
dialysis stations. Frequent water testing at dialysis  supply. A "safe" level of aluminum in dialysis fluid, 
stations, familiarity with the design of water treat-  which will prevent aluminum transfer from dialysis 
ment facilities, and recognition of aluminum over-  fluid to blood, and promotes aluminum removal from 
load can lead to early detection and correction if sim-  blood, has yet to be determined. 
ilar types of aluminum contamination should occur. 
Effect of an optimum dialysis fluid calcium concen- 
Easy production of sterile, pyrogen-free dialysate.  tration on calcium mass transfer during mainte- 
Erley, C.M., vonHerrath, D., Hartenstein-Koch, K,  nance hemodialysis. Carney, S.L. and Gillies, AH. 
Kutschera, D., Amir-Moazami, B. and Schaefer, K  Clin Nephml, 24 (I), pp. 28-30 (Jul1985). The effect 
ASAIO Trans, 34 (31,  pp. 205-7 (JulSep 1988).  of an optimum dialysis fluid calcium concentration 
Hemodialysis (HD) hypotension is frequently en-  (1.625mmoM) on calcium mass transfer from dialysis 
countered during conventional acetate HD. The data  fluid to patient was assessed in patients on routine 
obtainedin this study show that the filtered dialysate  hemodialysis.  A significant correlation was noted 
was always pyrogen-free when tested with alimulus-  between the mass transfer of calcium and the dialysis 
amebocyte-lysate assay. In addition, in 80% of cases  fluid calcium concentration (e0.834, p less than 
no bacteria were detected aRer the sterilizing filter.  0.01) which was found to vary by at least 5%. This 
Quulity~AssuranceG uidelines for Hemodialysis Devices  E-12  Appendix E (Cont.)  Chapter 5 
Annotated Bibliography  Dialysate and Dialysate Concentrate 
variation was due to a manufacturing variation and  across plasma a mitochondria1m  embranes, and de- 
not due to inaccurate dilution of the dialysis fluid  crease most of the untoward reations now associated 
concentrate. These data suggests that such a manu-  with dialysis, while at the same time improving the 
facturingvariationmay exposemaintenanceh emodi-  sense of well being in patients. 
alysis patients to periods of excessive calcium loss or 
gain and thereby favor renal osteodystrophy or soft  Potential bacteriologic and endotoxin hazards asso- 
tissue calcification.  ciated with liquid bicarbonate concentrate.  Bland, 
LA, Ridgeway, M.R., Aguero, S.M., Carson, L.A 
Sodium modeling during hemodialysis: a new ap-  and Favero, M.S.  ASAIO Trans, 33 (3), pp.  542-5 
proach.  Petitclerc, T., Man, N.K and Funck-Bren-  (Jul-Sep1 987). Usingliquidbicarbonate concentrate 
tano, J.L. Artif Organs, 8 (4), pp. 418-22 (Nov 1984).  from two commercial sources and one facility source, 
Sodium volume modeling during hemodialysis en-  bacterial contaminationa nd excessive endotoxin levels 
counters severaldifficulties. First, the actual sodium  were found in all cases.  This contamination was 
distributionv olume ist he extracellular water, whereas  amplified in dialysis fluid to levels well in excess of 
the ultrafiltration flow reflects the variation of total  AAMI's Recommended dialysate standard. 
body water. Thus, a two-pool model must be consid- 
ered.  This will complicate the model by increasing  Microbiologic contamination of liquid bicarbonate 
the number of parameters and boundary conditions.  concentrate for hemodialysis.  Ebben, J.P., Hirsch, 
An alternative is to consider the total body water as  D.N., Luehmann, D. A, Collins, A J. and Keshaviah, 
the apparent distribution volume of loaded or re-  P.R. ASAlO Trans, 33 (3), pp. 269-73 (JulSep1 987). 
moved sodium, which leads to a single-pool model.  With the growing use of bicarbonate dialysate, cau- 
Second, convective sodium transfer induced by ul-  tion must be paid to microbiology of dialysate. The 
trafiltration is not negligible compared with difbive  following precautions are suggested: (1) avoid pro- 
sodium transfer. Therefore, sodium transfer model-  longed storage ofliquidbicarbonate concentrate( LBC), 
ing must simultaneously take into account the diffu-  (2) perform W sterilization ofRO water and LBC, (3) 
sive and the convective part, with the coupling part  thoroughly clean storage and mixing containers, (4) 
related to both processes. Third, the Donnan effect,  disinfect dialysis machines at least twice weekly, and 
due to nondiffusible anionic plasma proteins, modi-  (5) when performingbacterial cultures, use standard 
fies the sodium transfer through the membrane.  plating techniques with a medium supplemented 
with NaCl (e.g., commercially available trypic soy 
Pseudomonas stutzeri bacteremia associated with  agar). 
hemodialysis. Goetz, A,Y u,V .L., Hanchett, J.E. and 
Rihs, J.D. Arch Intern Med, 143( lo), pp. 1909-12( Oct  Pressure controlled single needle hemodialysis us- 
1983). Pseudomonas stutzeri bacteremia developed  inghigh fluxdialysers and volume regulated ultraf2- 
in six patients undergoing hemodialysis.  Fever,  tration: the problem of dialysate back flow. Zbinden, 
shaking chills, nausea, and vomiting were observed.  M. and Binswanger, U. Life Support Syst, (England) 
All patients recovered, although only two received  3, Suppl 1( 1985). 
specific antibiotic therapy. The infections occurred 
sporadically over a period of nine months.  Pseudo-  Dialysate concentrate: a potential source for lethal 
monas stutzeri was subsequently isolated from the  complications. Brueggemeyer, C.D. and Ramirez, G. 
dialysate. The ultimate source was the deionized  Nephron, 46 (4), pp. 397-8 (1987). Report of two inci- 
water. The emphasis on handwashing, strict compli-  dents where patients were dialyzedwith acid concen- 
ance with disinfection procedures, and elimination of  trate on an acetate machine.  Recommends that 
prolonged sitting times for the filled machine after  placement of dialysate concentrate be regarded as an 
disinfection resulted in no firrther cases of P stutzeri  important medical task with concomitant care and 
infection.  liablility for the responsible individuals that set up 
the machines. Any additional available safeguards 
The untoward effects of the anions of dialysis fluids.  should be used. 
Veech, RL. Kidney Int, 34 (5),p p. 587-97 (Nov1988). 
Areview containing124references.D  ialysis fluidsin  Rapid  high-efficiency  bicarbonate hemodialysis. 
current use contain unphysiological amounts of the  Keshaviah, P. and Collins, A ASAIO Trans, 32 (I), 
Bnions, acetate and D-lactate, both of which may  pp. 17-23( Jul-Sep 1986). A dialysis time of approxi- 
induce specific toxic syndromes. Use of bicarbonate  mately 2.5 hours was achieved by using blood flow 
in place of acetate may: improve control of cellular  rates of approx 400 mVmin and large surface area 
energy status, improve ion and water distribution  dialyzers in order to achieve BUN clearances of 
Qai@A ssurance Guidelines far Hernodialysis Devices  Appendix E (Cont.)  Chapter 5 
Annotated Bibliography  Dialysate and Dialysate Concentmte 
approx 280 mlhnin. Rapid bicarbonateh emodialysis  Hemolysis and consumption coagulopathy due to 
was associated with lower incidence ofhypotension,  overheated dialysate.  Tielemans, C.L.,  Herbaut, 
nausea, and vomitingt han rapid acetate or standard  C.R, Geurts, J.O. and Dratwa, M. Nephron, 30 (2), 
acetate therapies.  pp. 190-1 (1982). A patient on chronic hemodialysis 
was accidentally accidentally exposed to overheated 
Stableliquidbicartwnatehemodialysate(LBD).N iison,  dialysate (52C) for 100 minutes due to the audible 
AR, Ackerman, RA., Meyers, S A  and Birdsall,  and visual alarms not being activated due to human 
S.K Trans Am Soc ArtifIntern Organs, 30, pp. 630-  error (the system contained a freely adjustable alarm 
4 (1984). Normally bicarbonate concentratem  ust be  range of 0" to 60'  C which had not been set to the 
prepared shortly before dialysis to prevent destabili-  proper range of 35- 2 "C) and a malfunctioning of the 
zation before or during dialysis and also requires a  heater.  This resulted in acute hemolysis and con- 
dual pump proportioning system.  This paper de  sumption coagdapathy. 
scribes a trial ofaliquid bicarbonate concentratet hat 
is stable over a 2.5 year period, and has been shown  Reversal of aluminum-inducedhemodialysisanemia 
to be safe and easy to use.  by a low-aluminum dialysate.  O'Hare, J.A. and 
Murnaghan, D.J. N Eng2 JMed, 306 (ll), pp. 654-6 
Hypoxemia during hemodialysis: effect of different  (Mar 18,1982). 
membranes and dialysate compositions. DeBacker, 
WA, Verpooten, G.A, Borgonjon, D. J., VanWaeleg-  Acetate vs. bicarbonate dialysis. Lesch. EM.N eph- 
hem, J.P., Vermeire, P Aa nd DeBroe, M.E. Contrib  rol Nurse, 2 (5), pp. 14-7( SepOct 1980). Life threat- 
Nephrol, 37 pp. 134-41  (1984).  Comparing AN69  ening hypokalernia during hemodialysis. Wiegand, 
membrane, cuprophan membrane, acetate dialy-  C., Davin, T., Raij, L and &ellstrand, C. Duns Am 
sate, and bicarbonate dialysate, it is found that the  Soc Artif Intern Organs, 1979,25, pp. 416-8.  The 
degree of dialysis-related hypoxemia increases in  serum potassium concentration can be dependent on 
severity as follows: combination of AN69 and bicar-  acid-base status of the patient's serum. Even with a 
bonate shows little hypoxemia; AN69 and acetate, as  dialysate concentration of potassium 42% higher 
well as cuprophan and bicarbonate, show intermedi-  than that of the serum, the authors report ofdecrease 
ate results; and acetate and cuprophan the most  in serum potassium.  If a patient is in metabolic 
significant drop. Indications are that there are two  acidosis, they recommend a dialysate potassium of 
componentst o the dialysis hypoxemia: a membrane-  6.3 mE&. 
related component, and a dialysate buffer compo- 
nent.  Dialyskdementia: ther ole ofdialysatep Hin altering 
the dialyzability of aluminum. Gacek, E.M., Babb, 
Side effects in bicarbonate dialysis due to low dialy-  AL,U  velli, D.A., F'ry, D.L and Scribner,B  .H. Trans 
sate pH.  Wagner, L., Schindler, B., Marhoffer, W.,  Am Soc Artif Intern Organs, 25, pp. 409-15 (1979). 
vanEyl, 0. and Strauch, M.  Proc Eur Dial Trmns-  The pH can alter dialyzability of aluminum. If the pH 
plant Assoc, 19, pp. 346-50 (1983). In six commer-  is between 6.5 and 7.6 there is negligible dialyzabil- 
cially  available bicarbonate containing dialysates  ity; if lower or higher, the clearance is sigdicant 
pH and pC02 were determined. Side effects resulted 
from low pH and high $02.  Use of two of the six  Trace metal changes in dialysis fluid and blood of 
dialysates was associated with fatigue, muscle cramps  patients on hemodialysis. Salvadeo, A, Minoia, C., 
and somnolence.  The importance of bicarbonate  Segagni, S. and Villa, G. Int JArtif Organs, 2 (I), pp. 
dialysate with a higher pH (7.48) and low pC02 (c 60  17-21 ( Jan 1979). Discussion of trace metals in di- 
mmHg) in alleviating patient syrnptomology is con-  alysate which can dialyze across the membrane and 
h e d .   result in harmful effects or harmful accumulation in 
the patient. 
Pancreatic affection aRer acute hypotonic hemodi- 
alysis.  Paus, P.N.,  Larsen, E.W.,  Sodal, G.  and  Haemolytic anaemia caused by overheated dialy- 
Erichsen, A Acta Med Scad, 212 (1-21, pp. 83-4  sate. Lynn, KL., Boots, M. A, Mitchell, T.R Br Med 
(1982).  Four male outpatients, all on stable long-  J, 1 (6159), pp. 306-7 (Feb 3,1979).  Home patient 
term hemodialysis, were by accident simultaneously  admitted with hemolysis several times. Finally, the 
exposed to hypotonic dialysate. Three of them devel-  patient noted that the blood lines were "hot" during 
oped increased serum amylase values and one died  dialysis. Upon investigation it was found that the 
from the consequences of a fulminant pancreatitis,  dialysate temperature was 58OC due to a defective 
which had been verified by laparatomy.  heater and defective temperature gauge. 
Quality Assurance Guidelinesf or Hernodialysis Devices  E-14  Appendix E (Cont.)  Chapter 5 
Annotated Biblwgmphy  Dialysate and Dialysate Concentrate 
The mechanisms of  arterial  hypoxemia during  Acetate dialysate versus bicarbonate dialysate: a 
hemodialysis. Romaldini, H., Rodriguez-Roisin, R,  continuing controversy.  Diamond, S.M. and Hen- 
Lopez,F.A,Ziegler,T.W., Bencowitz,H.Z andWagner,  rich, W.L.A m JKidney Dis, 9(1),pp. 3-11 (Jan1987). 
P.D. Am Rev Respir Dis, 129( 5) pp. 780-4 (May 1984).  Document Type: Review (91 refs.). The use of bicar- 
The findings suggest that the hypoxemia observed  bonate dialysate ast hebdfer during routine dialysis 
duringhemodialysis is primarily due to a decrease in  is growing. This discussion reviews several of the 
alveolar ventilation and respiratory quotient associ-  comparative trials in which bicarbonate and acetate 
ated with removal of metabolic C02 in the dialyzer.  buffers have been tested.  Patients who seem most 
Secondary factors affecting arterial PO2 were the  likely to benefit from bicarbonate dialysate include 
slight improvement in ventilation-perfusion rela-  those with a reduced muscle mass in whom a high 
tionships, tending to increase it, and the decrease in  sodium dialysate has not prevented hypotension. 
cardiac output tending to decrease it. There was no 
evidence for diffusion impairment because the meas-  Benefits of bicarbonate dialysis.  Mastrangelo, F., 
ured VA/Q inequality accounted for the degree of  Rizzelli, S., Corliano, C., Montinaro, AM., DeBlasi, 
hypoxemia.  V., Alfons, L,A prile, M., Napoli, M. and Laforgia, R 
Kidney Znt, Suppl, 17, pp. S188-93 (Dec 1985). 
Calcium  carbonate  precipitation in bicarbonate 
hemodialysis. Klein, E., Ward, R A  and Harding,  A mechanism of hypoxemia during hemodialysis. 
G.B.  Artif Organs, 10 (31, pp. 248-50 (Jun 1986).  Consumption of C02 in metabolism of acetate. Oh, 
Sparging of the bicarbonate-containingc oncentrate  M.S., Uribarri, J., Del Monte, M.L,H eneghan, W.F., 
with carbon dioxide converts any carbonate to bicar-  Kee, C.S., Friedman, E.A and Carroll, H.J.  Am J 
bonate, thus avoidingthe formation ofprecipitateso n  Nephrd, 5 (5), pp. 366-71 (1985). The present study 
addition of calcium ions.  is an investigation of the role of acetate metabolism 
in dialysis-induced hypoxemia and of the relative 
Dialysis-induced hypoxemia and hypotension are  roles of acetate metabolism, bicarbonate loss, and 
not causally related Keshaviah,P., Carlson, L,C on-  C02 gas (g)l oss in causation of hypoxemia.  The 
tantini, E. and Shapiro, F. TransAm Soc ArtifIntenz  results indicate that acetate metabolism can lead to 
Organs, 30, pp. 159-62 (1984).  reduction in respiratory exchange ratio and hypoxe 
mia and suggestt hat the same mechanism is respon- 
Dialysis leukopenia, hypoxemia, and anaphylatoxin  sible for hypoxemia during hemodialysis using ace- 
formation: effect of membrane, bath, and citrate  tate dialysate. 
anticoagulation. Wiegrnann,T.B., MacDougall, M.L. 
and Diederich, D.A Am JKidney Dis, 11 (5) pp. 418-  Effects ofhigh sodium dialysate during maintenance 
24(May1988). The findings indicate that leukopenia  hemodialysis.  Cybulsky, AV., Matni, A.  and Hol- 
is directly and exclusively related to membrane com-  lomby, D.J. Nephron, 41 (I), pp. 57-61 (1985). The 
position while hypoxemia only relates in .part to  effects of high sodium 144 mmoVl (mEqA) dialysate 
membrane effects.  were studied in normotensive, hypertensive and 
anephric chronic hemodialysis patients.  High so- 
Sodium fluxes duringhemodialysis. Bosch, J.,P onti,  dium dialysate is beneficial for normotensive and 
R,Glabman, S. and Lauer, A Nephron, 45(2), pp. 86-  anephric patients in reducing dialysis-inducedh ypo- 
92 (1987). Three sets of experiments were performed  tension and was not associated with any deleterious 
to determine the effect of the dialysate sodium con-  effects on long-term blood pressure control.  In hy- 
centration on the sodium balance of patients under-  pertensive patients, the benefit is less clear, and 
going maintenance hemodialysis. First, we demon-  hypertension may increase. 
strated that the pretreatment plasma sodium con- 
centration was independent of the sodium concentra-  Comparison ofhigh and low sodium bicarbonate and 
tionofthe dialysate used. Second, the plasma sodium  acetate dialysis in stable chronic hemodialysis pa- 
s., 
ancentration availablef or diffusion duringthe treat-  tients. Bijaphala,  Bell, AJ.,Bennett,C.A, Evans, 
ment was calculatedhmthe plasma sodium concen-  S.M. and Dawborn, J.K Clin Nephml, 23(4),pp. 179- 
htion and the plasma proteins. Third, the sodium  83 (Apr 1985). Eight stable center dialysis patients 
fluesu sing a hypernatremic or hyponatremic dialy-  completed four, 10-week study periods in which 
satewerec alculatedf or1O Oml of plasmagoingthrough  either acetate or bicarbonate dialysis was used, each 
Ued ialyzer. At steady state, no significant difier-  with high or low sodium concentration. Duringhigh 
ences in net sodium fluxes were demonstrated be-  sodium dialysis, blood pressure wasbetter controlled, 
heen hyper- and hyponatremic dialysis.  weight loss more easily tolerated and dialysis was 
 wit^ 
~sswanceG uidelines for Hernodialysis Devices  E-15  I 
Appendix E (Cont.) 
Annotated Bibliography  Dialysate and Dialysate Concentmte 
mostsatisfactoryfrom the patient's point ofview with  predialysis blood pH higher with the bicarbonate 
regard to dialysis-associated symptoms.  Careful  than with the chloride-added dialysate. 
choice of dialysate sodium concentration appears to 
1 
be important in lessening dialysis side-effects. Sub-  Advantages ofbicarbonateh emodialysis. Hampl, H., 
stitution of bicarbonate for acetate in chronic stable  Klopp, H., Wolfgruber, M., Pustelnik, A, Schiller, R,  2 
9 
dialysisp atients has comparatively little benefit and  Hanefeld, F. and Kessel, M. Artif Organs, 6 (4), pp. 
the choice can legitimately be made on the basis of  410-6 (Nov 1982). During acetate dialysis the pa- 
cost and technical considerations.  tients showed a frequent onset of sudden hypoten- 
sion and arrhythmia with concomitant symptoms of 
Effect ofvariations in dialysate temperature on blood  the so-calledd isequilibrium syndrome, whereast hese 
pressure duringhemodialysis.S herman,R  A,F austino,  symptoms were nonexistent in the same patients 
E.F., Bernholc, AS. and Eisinger, RP. Am JKidney  during bicarbonate dialysis. 
Dis,  4 (I), pp. 668 (Jul1984). The effect on BP of 
alteration in dialysate temperature was studied in  The role of acetate in the etiology of symptomatic 
150 hemodialysis treatments in 17 patients using a  hypotension. Keshaviah, P.R. Artif Organs, 6 (41, pp. 
randomized, double-blind protocol. Each patient was  378-87 (Nov 1982). Studies comparingcardiovascu- 
treatedusingdialysateat 35.6"C, 36.7"C, and37BC.  lar stability during acetate and bicarbonate dialysis 
Dialysate cooler than that routinely employed has a  indicate that bicarbonate dialysis is beneficial only 
beneficial effect while warmer dialysate has a detri-  when the fall in serum osmolality during dialysis is 
mental one on intradialytic BP. The use of dialysate  significant. If the fall in serum osmolality is blunted 
at least 1C cooler than "isothermic" levels may be  either with a high-sodium dialysate or mannitol 
appropriate.  fisions, there is little difference between acetate 
and bicarbonate. From a practical viewpoint, high- 
Cold as cardiovascular stabilizing factor in hemodi-  sodium dialysis is technically less complex and ex- 
alysis: hemodynamic evaluation. Coli, U., Landini,  pensive than bicarbonate dialysis. 
S., Lucatello,S., Fracasso,A  ,M  orachiello, P.,Righetto, 
F., Scanferla, F., Onesti, G. and Bazzato, G. Trans  The untoward effects of the anions of dialysis fluids. 
Am Soc ArtifIntern Organs, 29, pp. 71-5( 1983). Vas-  Veech, RL. Kidney Int, 34 (51, pp. 587-97 (N0~1988). 
cular instability represents the most frequent intra-  A review containing 124 references. 
dialytic complication of uremic patients.  Catechol- 
amine impairment, changes in plasma sodium or  Hemodialysisw  ithlow-temperatured ialysate: along- 
term experience. Marcen, R., Quereda, C., Orofino, 
osmolality and, more recently, temperature Q of 
dialysate have been proposed to explain this phe-  L., Lamas, S., Ternel, J.L., Matesanz, R and Ortuno, 
J. Nephron, 49 (I),  pp. 29-32 (1988). This study 
nomenon.  Our hemodynamic study confirms the 
important role played by T on intradialytic vascular  shows that dialysis ata  lower dialysate temperature 
stability and may explain the better control observed  (35C) as compared to the normal (37C) offered a 
duringhemofiltration compared to standard W-HD.  reduction of some intradialytic symptoms including 
symptomatic hypotension. Lower temperature also 
Risks and hazards associated with dialyzers and  assisted in stabilization of predialysis systolic blood 
dialysate delivery systems.  Keshaviah, P.R. and  pressure (SBP) at a lower level and was associated 
Luehmann, D.A Crit Rev Biomed Erg,9  (3),p p. 201 -  with a higher ultrafiltration. 
44 (1983). Document Type: Review (83 refs.). 
Hypoxemia during hemodialysis: a critical review of 
Increment in dialysate sodium with sodium chloride  the fads. Cardoso, M., Vinay, P.,Vinet, B., Leveillee, 
or bicarbonate addition. Raja, R.M., Fernandes, M.,  M.,  Prud'homme, M., Tejedor, A, Courteau, M., 
Kramer, M.S., Rosenbaum,J .L. and Barber, K. Artif  Gougoux, A, St-Louis, G., Lapierre, L; et al. Am J 
Organs, 7 (21, pp. 154-8 (May 1983). Hemodialysis  Kidney Dis, 11 (4), pp. 281-97 (Apr 1988). The litera- 
was performed in 12p atients for 2 weeks each utiliz-  ture describing the fall in Pa02 during dialysis is in- 
ing acetate dialysate containing 134 mE@  sodium  tensively and critically reviewed. This phenomenon 
anddialysatecontaining143 mEq/Lsodium, achieved  is related to both the type of membrane used (cellu- 
by the addition of sodium chloride or sodium bicar-  losic v noncellulosic membrane), and to the composi- 
bonate to Che acetate dialysate. Intradialytic morbid-  tion of the dialysate (acetate us. bicarbonate), which 
ity was lower, dialysis hypoxemia less marked, and  results in hypoventilation and is the major cause of 
hypoxemia (92 refs.). 
Quality Assurance Guidelines for Hemodialysis Devices  Appendix E (Cont.)  Chapter 5 
Annotated Bibliography  Dialysate and Dialysate Concentrate 
Potential bacteriologic and endotoxin hazards asso-  deposition occurs despite the use of aluminium-free 
ciated with liquid bicarbonate concentrate. Bland,  dialysate and is associated with total and present 
L.A, Ridgeway, M.R., Aguero, S.M.,  Carson, L.A  aluminium hydroxide consumption; heavy alumin- 
and Favero, M.S. ASAIO Trans, 33 (31, pp. 542-5  ium deposition is associated with severe and sympb 
(Jul-Sep 1987).  matic osteomalacia, but can also be observed in the 
presence of predominant hyperparathymidism. 
Microbiologic contamination of liquid bicarbonate 
concentrate for hemodialysis.  Ebben, J.P., Hirsch,  Influence of blood temperature on vascular stability 
D.N., Luehmann, D.A, Collins, A J. and Keshaviah,  during  hemodialysis and isolated ultrafiltration. 
P.R. ASAIO Trans, 33 (31, pp. 269-73 (JulSep 1987).  Maggiore, Q., Pizzarelli, F., Zoccali, C., Sisca, S. and 
Nicolo, F.  Znt JArtif Organs, 8 (4), pp. 175-8 (Jul 
Hernodialysis associated hypotension and dialysate  1985). It is concluded that the temperature changes 
temperature.  Quereda, C., Marcen, R, Lamas, S., 
in blood flowing through the extracorporeal circuit 
Hernandez-Jodra, M., Oroho, L., Sabater J., Vil-  largely account for the differing vascular stability 
lafruela,J . and Ortuno, J. L$eSupportSyst, 3, Suppl  between isolated UF and simultaneous ultrafiltra- 
1, pp. 18-22( 1985). Incidence of intradialytic symp  tion-hemodialysis. 
tomatic hypotension was significantly reduced by 
lowering dialysate temperature from 37C to 35OC.  Amelioration of hemodialysis-associated hypoten- 
This improvement seems not to be mediated by tem-  sion by the use of cool dialysate.  Sherman, RA, 
perature-inducedc hanges in membrane biocompati-  Rubin, M.P., Cody, RP. and Eisinger, RP. Am J 
bility, since leukocytes,p latelets and complementa c-  Kidney Dis, 5 (2), pp. 124-7( Feb 1985). Cool dialysate 
tivation were similar in both situations.  reduced the frequency of symptomatic hypotension. 
In addition, the rate of fall of  mean BP during 
Dialysate concentrate: a potential source for lethal  treatment was substantially slowed with the reduc- 
complications. Brueggemeyer, C.D. and Ramirez, G.  tion in dialysate temperature. Cool dialy sate (34.4"C) 
Nephron, 46 (41, pp. 397-8 (1987).  substantially ameliorates hemodialysis-associated 
hypotension. 
Hypersensitivity reactions related to acetate dialy- 
zate and cellulose acetate membrane. Caravaca, F.,  Carbon dioxide removal in acetate hemodialysis: 
Pizarro, J.L., Arrobas, M., Cubero, J.J., Antona, J.M.  effectso n acid base balance. Bosch, J.P., Glabman, 
and Sanchez, E. Nephron, 45 (2), pp. 158-9 (1987).  S., Moutoussis, G., Belledonne, M., vonAlbertini, B. 
and Kahn, T. Kidney Int, 25 (5), pp. 830-7( May 1984). 
Rapid  high-efficiency  bicarbonate hemodialysis. 
Studies were performed in patients on maintenance 
Keshaviah, P. and Collins, A RSAIO Trans, 32 (I), 
acetate hemodialysis to assess the quantity and 
pp. 17-23( Jul-Sep 1986). 
processes involved in the removal of carbon dioxide 
((202) during the treatment.  The data presented 
The role of glucose in hemodialysis: the effects of 
suggest that multiple factors related to the removal 
glucose-free dialysate.  Ramirez, G., Bercaw, B.L, 
of C02 during acetate dialysis may be responsible in 
Butcher, D.E., Mathis, H.L,B rueggemeyer, C. and 
part for the low plasma bicarbonate observed in 
Newton, J.L. Am JKidney Dis, 7 (51, pp. 41 3-20 (May 
patients on chronic maintenance hemodialysis. 
1986). Glucose-free dialysate has been traditionally 
used in patients on chronic hemodialysis, reportedly 
A report of data acquired under varying conditions 
without any side effects. Although hypoglycemia is 
and a review ofthe literature. Sherlock, J., Ledwith, 
not produced, several other metabolic changes must 
J. and Letteri, J. Am J Nephrol, 4 (3), pp. 158-68 
occur to maintain the euglycemic state. This study 
(1984).  The major reason for hypoxemia during 
looks at patients on chronic hemodialysis usingboth 
acetate dialysis is a decrease in alveolar oxygen 
a glucose-free bath and a glucose bath.  Abnormal 
tension due to changes in metabolism and a decrease 
EEG changes were observed after dialysis without 
in pulmonary C02 excretion when C02 is lost from 
glucose that were not present or were minimal with 
the dialyzer. The increasing pH may contribute to 
a glucose bath. 
the metabolic change during acetate dialysis and the 
hypoventilation during bicarbonate dialysis. There 
Bone aluminum deposition in maintenance dialysis 
is little evidence to support an effect of pulmonary 
patients treated with aluminium-free dialysate: role 
capillary obstruction or changes in oxy-hemoglobin 
~faluminiumh ydroxide consumption.  Heaf, J.G., 
associationon the decrease in arterial oxygen tension 
Pdenphant, J., Andersen, J.R. Nephron, 42 (31, pp. 
observed 
210-6 (1986). It is concluded that bone aluminium  Appendix E (Cont.1  Chapter 5 
Annotated Bibliography  Dialysate and Dialysate Concentrate 
Long-term hemodialysis at reduced dialysate flow  Electroencephalogrami nvestigationso fthe disequili- 
rates.  Kirchner, KA., White, AR, Kiley, J.E. and  brium syndrome during bicarbonate and acetate 
Bower, J.D.  Am J Nephrol, 4 (I), pp. 7-12 (1984).  dialysis. Hampl, H., Klopp,H.W.,Michels,N., Mahiout, 
Twenty stable hemodialysis patients were main-  A, Schilling, H., WoIfgruber, M., Schiller, R, Hane- 
tained on a dialysate flow rate of 300 mVmin (QD 300)  feld, F. and Kessel, M.  Proc Eur DiaC Transplant 
to determine the safety of prolonged reductions in  Assoc, 19, pp. 351-9 (1983).  Continuous long-time 
dialysate flow rate. Authors conclude that QD 300  electroencephalographic (EEG) monitoring was per- 
does not impair dialysis efficiency for most small  fbrmedduringacetateandbicarbonate~P.e rsisting 
molecules and saves $1.38 per patient per dialysis.  normal basic activity of the EEG without neurologi- 
cal symptoms was found only during the course of 
Bacterial contamination of the blood compartment  bicarbonate dialysis. The decrease in PaC02 and the 
originating from the dialysate in haemodialysers.  deterioration in EEG activity in the patients during 
Kolmos, H.J. JHospI nfect, 5 (l), pp. 70-5( Mar 1984).  acetate dialysis was concomitant with severe neuro- 
Microorganisms originating from the dialysate com-  logical alterations, e.g., the typical symptoms of so- 
partment invaded the blood compartment ofahodial  called 'disequilibrium' causing a cessation of dialysis 
RP6' 2.5 percent of  the time.  Analysis of the data  in three patients. 
suggested that the probable access of bacteria to the 
blood compartment was by way of minor defects in  Danger of haemodialysis using acetate dialysate in 
the dialysis membrane. The patients experiencedn o  combinationw  ithalatge surface areadialyser. Viljoen, 
obvious symptoms or signs of sepsis which could be  M. and Gold, C.H. SAfr Med 4 56 (5), pp. 170-2( Aug 
ascribed to the presence of microorganisms in the  4,1979). Large surface area, high mass transfer di- 
blood compartment  alysers have recently come into widespread use, and 
it has been shown that they promote the loss of large 
A difference in complement and neutrophil activa-  amounts of bicarbonate when acetate is used in the 
tion.  Ivanovich, P., Chenoweth, D.E., Schmidt, R.,  dialysate. In the chronic dialysis patient in a steady 
Klinkmann, H., Boxer, LA, Jacob, H.S. and Ham-  state, these effects may be inconsequentialb ut, in an 
merschmidt, D.E.  Contrib Nephrol, 37 pp. 78-82  acutely ill patient, the combinationo fa dialy sate con- 
(1984).  taining acetate and a high-efficiency dialyser may be 
extremelyh azardous. Areturn to the use ofbicarbon- 
Side effects in bicarbonate dialysis due to low dialy- 
ate as the source of base would avoid such hazards 
sate pH. Wagner, L., Schindler, B., Marhoffer, W., 
and would promote the more physiological correction 
vanEyl, 0. and Strauch, M.  P mE  ur Dial Tmns- 
of the metabolic acidosis of renal failure. 
plant Assoc, 19, pp. 346-50 (1983). In six commer- 
cially availableb icarbonate containingdialysatesp H  Acute nickel intoxication by dialysis. Webster, J.D., 
and pC02 were determined.  Side effects resulted  Parker, T.F., Alfrey, AC., Smythe, W.R, Kubo, H., 
from low pH and high $02.  Use of two of the six  Neal, G. and Hull, AR Ann Intern Med, 92 (5), pp. 
dialysatesw  as associated with fatigue, muscle cramps  631- 3 (May 1980). Nickel intoxication was observed 
and somnolence.  in a group of dialyzed patients when leaching of 
nickel-plated stainless steel water heater tank con- 
Contrasting alterations in pulmonary gas exchange 
taminated the dialysate. Symptomso ccurred during 
during acetate and bicarbonate hemodialysis. Eiser, 
and after dialysis at plasma nickel concentrations of 
AR., Jayamanne, D., Kokseng, C., Che, H., Slifkin, 
approximately 3 m&.  Symptoms included nausea, 
RF. and Neff, M.S. Am J Nephl, 2 (3), pp. 123-7 
vomiting, weakness, headache, and palpitation. Re- 
(1982). Our studies revealed that oxygen consump 
mission of symptoms occurred spontaneously, gener- 
tion increased significantly during acetate dialysis, 
ally 3 to 13 hours after cessation of dialysis.  The 
while it decreased slightly during biwbonate dialy- 
evidence indicated that the nickel became bound in 
sis. Since C02p roduction decreased with bothbaths, 
the plasma after crossing the membrane, resultingin 
the respiratory exchange ratio derreasedduringacetate 
a higher concentration in the plasma than in the 
dialysisb  ut did not change duringbichnate dialy- 
dialysate and preventing its removal by dialysis. 
sis.  We conclude that hypoxemia during dialysis 
relates to decreases in minute ventilation and that a  Life threatening hypokalemia during hemodialysis. 
greater decrease during acetate dialysis is a conse-  Wiegand, C., Davin, T., Raij, L. and @ellstrand, C. 
quence of enhanced oxygen consumption and its  Trans Am Soc Artif Intern Organs, 25, pp. 416-8 
effect on respiratory exhange ratio. Bicarbonate dial-  (1979). 
ysis does not increase oxygen consumption. 
QdityA  ssurance Guidelinesf or Hernodialysis Devices  Appendix E (Cont.)  Chapter 5 
Annotated Bibliography  Dialysate and Dialysate Concentrate 
Trace metal changes in dialysis fluid and blood of  Robinson, P.J. and Davison, AM. Kidney Int, 21 (21, 
patients on hemodialysis. Salvadeo, A, Minoia, C.,  pp. 411-5 (Feb 1982). Bone fractures were signifi- 
Segagni, S. andvilla, G. Int JArtifOrgans, Jan 1979,  cantly more common in patients exposed to high 
2 (I), pp. 17-21.  dialysate aluminium concentrations. The histologic 
indices of osteomalacia were significantly related to 
A Clinical Test of a New Device for On-line Prepara-  the prevailing dialpate aluminium concentration,i n 
tion of Dialysis Fluid from Bicarbonate Powder: The  such a way that higher aluminium levels were asso- 
Gambro BiCart. Delin, K, Attman, P.O., Dahlberg,  ciated with more osbmalacia. These findings sug- 
M. and Aurell, M.  Dial & Transplant, p. 468 (Sep  gest that aluminium is a toxic agent associated with 
1988).  a mineralizing defect in the bone of renal failure 
patients. 
Issues in Dialysis: Reuse, Dialysate Toxicity, Short 
Dialysis.  Vlchek, D.  Dialy & Transplant, p.127  "Physiologid*and"pharmacologicalndialy~tseo dium 
(March 1988). Areview of an ASN conference on the  concentrations. Bocatelli, F., Pedrini, L., Ponti, R, 
three title topics. The benefits and limits of each of  Costanzo, R.,D iF'ilippo, S., Marai, P., Pozzi, C. and 
these highly topical factors in dialysis are discussed.  Bonacina, G.P. Int JArtif Organs, 5 (I), pp. 17-24 
(Jan 1982). Using "physiological" and "pharmacol- 
A double-blind controlled trial of acetate versus bi- 
ogically high" sodium dialysate, the removal of water 
carbonate dialysate. Uldall, P.R, Kennedy, I.,Craske, 
and sodium by convection improves the cardiovascu- 
H., Porrett, E., Aid, J., Woods, F. and Levine D. P m  
lar stability and the patient's well-being, without 
Clin Dial Transplant Forum, 10, pp. 220-3 (1980). A 
bringing about the feared long-term cardiovascular 
significantly lower incidence ofdialysis-related symp- 
side effects, if an appropriate dry body weight is 
toms has been shown during dialysis with bicarbon- 
achieved, because of better correction of the cellular 
ate rather than the previously used acetate. The level 
overhydration. 
of well-being in the intervals between dialysis was 
not appreciably affected by the dialysis mode.  It is  Severe hypokalemia induced by hemodialysis. Wie 
suggested that bicarbonate dialysis should be made  gand, C.F., Davin,T.D., Raij, L. and Kjellstrand, C.M. 
available to all patients receivingregular hemodialy-  Arch Intern Med 141( 2), pp. 167-7O(Feb1 981). Dur- 
sis for end-stage renal failure provided that this can  ing dialysis, it is assumed that the serum electrolyte 
be done reliably and safely.  levels asymptotically approach the concentration in 
the dialysate. In five patients, we observed an aver- 
Hemolysis and consumption coagdopathy due to 
age 20% fall in serum potassium level, although the 
overheated dialysate.  Tielemans, C.L.,  Herbaut, 
dialysate contained 42% more potassium than the 
C.R.,G eurts, J.O. and Dratwa, M. Nephron, 30 (21, 
predialysis serum.  The cause of the hypokalemia 
pp. 190-1 (1982). 
was a rapid shift of potassium from the extracellular 
to the intracellular space secondary to correction of 
Acute haemolysis due to concentrated dialysis fluid. 
acidosis. All patients entered dialysis with ahism 
Mulligan, I., Pafiey, P., Phillips, M.E., Brown, E.A 
suggesting prolonged potassium loss, marked acido- 
and Curtis, J.R. Br Med JCClin Resl, 284 (63231, PP. 
sis, and moderate hypokalemia; thus, the dialysate 
1151-2 (Apr 17,1982). Fatal acute haemolysis oc- 
potassium concentration should be higher than nor- 
curred in a 65-year-old man undergoing regular 
mal, and frequent determinations of the serum po- 
home haemodialysis for terminal renal failure. Cir- 
tassium level should be performed. Therapy result- 
cumstantial evidence indicating that the haemolysis 
ing in rapid correction of acidosis in uremic patients 
resultedhm exposuret o concentrated dialysis solu- 
undergoinghemodialysismay cause large transcom- 
tion was supportedb y in-vitros tudies. Frank haemo- 
partmental shifts of potassium. Potassium transfer 
lysis in blood samples occurred ata dilution ofgreater 
across the dialysis membrane may be inadequate to 
than or equal to 112o f dialysisf luid. Osmotic fragility 
compensate  for such shifts, and life-threatening 
tests of survivingred blood cells showed 47% haemo- 
hypokalemia may occur. 
lysis at a dilution of 1/2a nd greater than 90% haemo- 
lysis at a dilution of lh. Urgent design modifications 
A Short Study on the Sodium Controller. Murray, 
to the proportioning machine are being undertaken 
M.K. J. Nephml Nursing, pp. 106-8( SeptlOct, 1984). 
to Prevent such an accident recurring. 
The device is safe and effective and provides the fol- 
lowing benefits: fewer medications required to con- 
Dialysate aluminium concentration and renal bone 
trol hyovolemic hyotension, incidence of complica- 
disease.  Walker, G.S., Aaron, J.E., Peacock, M., 
Assurance Guidelines for Hernodialysis Devices  Appendix E (Cont.) 
Annotated Biblwgmphy 
tions reduced with higher sodium dialysate, no a p   Haem*&-induced~spiratorychanges.  Faww 
preciable Merent of blood pressure or weight gain  S., Hoenich, NA, Laker, M.F., Schorr, W. Jr.,Ward, 
on higher sodium, and weight losses increased with  M.K and Ken; D.N. NephdDial Zhnsplant, 2 (3), 
fewer attendant complications.  pp. 161- 8 (1987). Amelioration of hypoxaemia may 
be achieved by the use of bicarbonate, but its caw 
Sodium Balance. Fleming, S. Dial & Transplant, pp.  is multifadorial, with contributions from hmmti- 
55-65 (Jan 1988). The article discusses the cation,  lation secondary to dialyser C02 losses and pubo. 
sodium, as the principal osmotic component of the  nary dysfunction due to leucostasis. These obsem- 
extracellular fluid. It gives an overview of the inap-  tions suggest that the treatment ofpatients whohave 
propriate fluid movement between the intraocclular  compromised cardiovascular function is most opti- 
compartment and the extracellular compartment  mal with the use of biocompatible membranesw  hich 
that can cause blood pressure changes, hydrational  induce minimalleucopenia,u sedin conjunction with 
imbalances, edema, and other pathoIogic conditions.  dialysate that utilises bicarbonate as the base re 
placement. 
Measurement of the effective dialyzer Na diffusion 
gradient in vitro and in-vivo.  Gotch, FA, Evans, 
M.C.  and Keen, M.  Trans Am Sm Artif Intern 
Organs, 31, pp. 354-8 (1985). 
W i t yA ssurance Guidelines for Hedialysis Devices  Appendix E (ContS 
Annotated Bibliogrmphy 
Chapter 6 
Hemodialyzers 
A study on limulus amebocyte lysate (LAL) reactive  Dinarello, CA Kidng, Int, 33 (I), pp. 29-35 ( Jan 
material derivedfromdialyzers.Y  oshioka,T.,Ikegami,  1988). In order to study the integrity ofdialysismem- 
K, Ikemura, K, Shiono, S., Uenishi, M., Sugimoto,  branes to pyrogens, the dialysate side of a closed loop 
H. and Sugimoto, T. Jpn JSurg, 19 (I), pp. 3841 (  hemodialysis (HD)c ircuit was challenged with E, coli 
Jan 1989). The amebocytes ofhorseshoe crab (Limu-  microfiltrate containing500 ngfml endotoh. These 
lus)h emolymph contain a coagulation system highly  studies demonstrate that: (a) in the presence of 
sensitive to bacterial endotoxins.  Limulus ame-  plasma, 1Ll-inducing factors pass into the blood 
bocyte lysate (LAL) reactive material derived h m   compartment of a dialysis system challenged with 
cuproammonium membranes, however is not an en-  bacterial pyrogen; and (b)M NC production of IL-1 is 
dotoxin and acts as a pathway in the coagulation  enhanced in the presence of plasma. 
cascade found in Limulus amebocyte lysate.  This 
study confirmed these facts by using the coagulation  Foreign particles contaminating hemodialyzers and 
system of Limulus without factor G, which is a  methods of removing them by rinsing. Inagaki, R, 
substrate of the alternative pathway.  Hamazaki, T., Kuroda, H. and Yano, S.  Nephron, 
1987,46( 41, pp. 343-6. Foreign particles contaminat- 
Beta 2micmglobulinkineticsi n maintenanceh emodi-  ing hemodialyzers constitute a risk of rnicroem- 
alysis: a comparison of conventional and high-flux  bolism and allergic reactions in hemodialysis pa- 
dialyzersa nd the &eds ofdialyzerreuse, DiRaimondo,  tients. Authors investigated the size distribution of 
C.R, Pollak and V.E.  Division of Nephrology, Uni-  particles, and the efTects of strikingh eaders of dialyz- 
versity of Cincinnati Medical Center and Dialysis  ers and flow rates ofrinsing saline on the elimination 
Clinics, Inc. An J Kidney Dis, 13( 5), pp. 390-5 (May  offoreign particles from dialyzers. To rinse dialyzers 
1989). To define the kinetics ofbeta2M duringhemo-  effectively, at least 1,000 ml of saline are necessary, 
dialysis and the effects of dialyzer reprocessing, se-  and strikingt he headers of dialyzers throughout the 
rum beta 2M, plasma C3a, and neuhphil counts  rinsing procedure is important. 
were measured immediately predialysis; 15,90, and 
180m  inutes &r  beginning dialysis; and 15m  inutes  The possible role of Limulus-amebocyte-lysate-reac- 
postdialysis in ten chronic hemodialysis patients.  tive material in hemodialysis. First-use syndrome. 
Complement  activation and neutropenia during  Pearson, F.C. BkwdPu~f5i  (2-31, pp. 115-22( 1987). 
dialysis were significantly more marked with cu-  In this chapter,c urrent knowledge about LALRMis 
prammonium, but were not affected by reprocessing  presented and integrated with the major mecha- 
of either dialyzer.  In-vitro adsorption of 1241-beta  nisms generally recognized to induce hypersensitiv- 
2Mtopolysulfonef ibers was greater than to cupram-  ity-type reactions. These mechanisms include: clas- 
monium; adsorption was not influenced by dialyzer  sical induction of allergy by IgE and classical comple- 
reprocessing.  ment activation by IgG and IgM. 
Interleukin-1-its  multiple biological effectsa nd its  Ultrafiltration to reject human interleukin-l-induc- 
association with hemodialysis. Dinarello, C.A Blbod  ingsubstancesderivedfrombcterialc ultures. Dinarello, 
%f,6  (3), pp.  164-72 (1988).  Document Type:  CA,L  onnemann, G., Maxwell, R and Shaldon, S. J 
Review (29 refs.).  The conclusion was made that  CZin Microbid, 25 (7), pp. 1233-8 (Jul 1987). The 
PYrogens, solutes, complement components and the  results indicate that: the IG1-inducing material(s) 
ph~sicanl ature of the dialysis membrane itself con-  present in bacterial cultures of gram-negative organ- 
tribute to monocyte activation and cytokine release.  isms is rejected by a factor of 100 to 100,000b y mo- 
lecular size exclusion and by absorption; rejection is 
w o n o f endotaxin-like interleukin-1-inducing  sustainedf or at least 32 liters of fluid;t he rejection of 
during in-vitro dialysis.  Lonnemann, G.,  Limulus-reactive materialb y theultraflter is greater 
' ~ 1 ,M .,F loege, J., Koch, KM., Shaldon, S. and  for purified endotoxin than for native endotoxins de- 
?@& 
hsurance Guidelines for Hemaliulysis Deuices  E-21  I 
Appendix E (Cont.)  Chapter 6 
Annotated Bibliogmphy  Hedialyzers 
rived from live bacterial cultures; and nonendotoxin  addition,h emodidtration requires schemes to ensure 
IL1-inducingtoxins (molecular weight, 24,000)from  sterility and nonpyrogenicityo fthe infusion fluid and 
Staphylococcusa ureus are not rejected or absorbed.  appropriate balancing of the rates of ultrafiltration 
and reinfbsion. 
No evidence for endotoxin transfer across high flux 
polysulfone membranes. Bommer, J., Becker, KP.,  The current status and b r eof  the artificialk idney. 
Urbaschek, R., Ritz, E., and Urbaschek B.  Clin  Funck-Brentano,J .L. Artif Organs, 9 (2), pp. 119-26 
Nephrol, 27 (61, pp. 278-82(J un 198).T  oevaluate the  (May 1985). Document Type: Review (32 refs.). Dis-  j 
safety of high-flux polysulfone dialyzers, an in-vitro  cussion of the technology, use and determination of 
recirculation system was examined.  It was con-  adequacy and related cost. 
cluded that LPS and lipid A do not pass from either 
side through the filter system used when saline was  Role of dialyzer contaminants in the allergic epiphe- 
recirculated for more than 10 h on both sides of the  nomena ofhemodialysis. Ward, R.A, Feldhoff, P.W. 
membrane.  and Klein E. Artif Organs, 8 (3), pp. 338-49 (Aug 
1984).  Cuprophan hollow-fiber dialyzers contain 
Acute anaphylactoid reactions during hemodialysis .  contaminants includingl,2,3-propanetriolc,a rbohy- 
in France. Foret, M., Kuentz, F., Meftahi, H., Mil-  drates, Limulus amebocyte lysate-reactivem  aterial, 
ongo, R, Hachache, T., Elsener, M., Dechelette, Eand  and particulates. In a clinical study, the role of these 
Cordonnier, D. Artif Organs, 11 (2), pp. 168-72 (Apr  substances in the allergic-typer esponse seen in some 
1987). A retrospective survey of anaphylactoidr eac-  hemodialysisp atients was examined. Dialyzerprepa- 
tions during dialysis in France was conducted. The  ration had no effect on predialysis eosinophil counts 
presence of cellulose-derivedp articles in the rinsing  or IgE levels. All patients demonstrated transient 
fluid of such dialyzers and the possible increased in-  leukopenia and complement activation during dialy- 
cidence of reactions &r  the long (weekend) inter-  sis, the magnitudes of which were unaffected by the 
dialytic interval suggest that allergy to cellulose-  type of dialyzer preparation. At the levels found in 
derived  particles eluted from cellulosic dialyzers  the dialyzers studied, it was questioned whether 
may contribute to dialyzer hypersensitivity reac-  water-soluble extractables or particulates play any 
tions.  role in the allergic epiphenomena of hemodialysis. 
Effect of dialyzer reprocessing methods on comple-  Anaphylactoid reactionsdue tohaemodialysis,h aemo- 
ment activation and hemodialyzer-related symp-  filtration, or membrane plasma separation. Nicholls, 
toms. Dumler, F., Zasuwa, G. and Levin, N.W. Artif  AJ. andPlatts,M.M. BrMed J[Clin Resl,285 (63551, 
Organs, 11 (2), pp. 128-31 (Apr 1987). The effects of  pp. 1607-9 ( Dec 4,1982). A previously undescribed 
differentd ialyzer processing methods and ofreuse on  anaphylactoid reaction to haemodialysis, haemofil- 
complement activation and dialyzer-related symp  tration, or membrane plasma separation occurred in 
toms were studied in 96 maintenance hemodialysis  15 patients receiving regular dialysis.  The illness 
patients. The percentage of patients without symp  varied in severity from urticaria, sneezing, and wa- 
toms during dialysis was significantly greater with  tering ofthe eyes to severe bronchospasm and cardio- 
reused dialyzerst han with new dialyzers. The sever-  vascular collapse, and began within aminute ofblood 
ity oftotals ymptomsc orrelated signifimntly(p=0.0004)  being returned from the dialyser or filtration device 
with complement activation.  The results suggest  to the patient.  Reactions developed only when a 
that total symptoms during dialysis are correlated  dialyser sterilised with ethylene oxide was used for 
with the degree of complement activation. However,  the first time and never after sterilisation with for- 
trends in the data pertaining to chest pain suggest  malin. Several patients had more than one reaction 
that factors other than complement activation may  while three had a reaction each time a new dialyser 
be important in the pathogenesis of some dialyzer-  was used. Incorrect priming of the dialysers maybe 
related symptoms.  a partial explanation of these attacks, but the exact 
reason for their occurrence is unknown. 
Technical  requirements for rapid high-efficiency 
therapies. Keshaviah, P., Luehmann, D., Ilstrup, K  Beta 2-microglobulink inetics in maintenance hemodi- 
and Collins, A Artif Organs, 10( 31, pp. 189-94( Jun  alysis: a comparison of conventional and high-flux 
1986). The key technical elements necessary for such  dialyzers and the effects of dialyzer reuse.  DiRai- 
implementation includeh igh blood flow rates, higher  mondo, C.R. andPollak,V.E. Division ofNephrology, 
efficiency dialyzerddiafilters, ultrafiltration control  University of Cincinnati Medical Center and Dialy- 
systems, and bicarbonate as the buffer source.  In  sis Clinics, Inc. Am J Kidney Dis, 13 (5), pp. 390-5 
Quality Assurance Guidelines for Hernodialysis Devices  E-22  Appendix E (Cont.)  Chapter 6 
Annotated Bibliography  Hedidyzers 
(May 1989). To define the kinetics of beta 2M during  dotoxin, that pyrogenic material may stay in the 
hemodialysis and the effectso f dialyzerr eprocessing,  membrane even &r  rinseout of the disinfectant 
serum beta 2M, plasma C3a, and neutrophil counts  Methods for avoiding introduction of this endotoxin 
were measured immediately predialysis, 15,90, and  to the patient include discarding the recirculating 
180minutes afterbeginningdialysis, and 15m  inutes  solution to waste. Water used for dilution ofgermi- 
postdialysis in ten chronic hemodialysis patients.  cide should be endotoxin-free. 
Complementa ctivationa ndneutmpeniaduringdialysis 
were significantly more marked with cuprammo-  Neutrophil behavior during hemodialysis.  Role of 
nium, but were not affected by reprocessing of either  membrane contact. Neveceral, P., Markert, M. and 
dialyzer.  In-vitro adsorption of 1241-beta 2M to  Wauters, J.P. ASAIO Trans, 34 (3), pp. 5647 (Jul- 
polysulfone fibers was greater than to cuprammo-  Sep 1988). The in-vivo effect of membrane contact on 
nium; adsorption was not influenced by dialper  oxygen radical productionandchemotaxiso fdialyzed 
reprocessing.  neutrophils isolated simultaneously from the arte- 
rial and venous sites during dialysis with cupro- 
Biocompatibility of artificial organs: an overview.  phane, polycarbonate, polysulfone, and polyacriloni- 
Henderson, L.W.a nd Chenoweth, D. B l dP ruif, 5  trile membranes was studied.  Cells remaining in 
(2-3), pp. 100-11 (1987). Review (41 refs.).  circulation aRer 15 minutes of dialysis showed defec- 
tive responses only when collected at the venous site 
Cellulose acetate hemodialysis membranes are bet-  of the cuprophane dialyzer, in spite of a similar 
ter tolerated than Cuprophan. A difference in com-  leukopenia att he venous and arterial sites. With the 
plement and neutrophil activation.  Ivanovich, P.,  other membranes tested, no defects in neutrophil 
Chenoweth,D  .E.,Schmidt, R, Klinkmann, H., Boxer,  hctionsw  ere evidenced. These results suggest that 
LA,J acob, H.S. and Hammerschmidt, D.E. Contrib  down-regulation occurs within the dialyzer and that, 
Nephrd, 37, pp. 78-82 (1984). The newer cellulose  besides complement activation, the membrane plays 
acetate membranes show lower degree of comple-  an additional role. 
ment activation and a smaller drop in neutrophil 
count during the first 30 minutes of dialysis than do  First-use syndrome in patients treated with hollow- 
the cuprophan dialyzers.  It is suggested that pa-  fiber dialyzers. Villarroel, F. B l dP urif, 5 (2-3), pp. 
tients with intradialytic symptoms related to mem-  112-4 (1987). A two-year survey on first-use syn- 
brane biocompatibility will tolerate the procedure  drome (FUS) in  hemodialysis showed that there 
better on these newer membranes.  were an average of 181 FUS reactions per year. 
Nearly 39% of the patients who experienced a FUS 
Hypoxemia during hemodialysis: effects of different  reaction had experienced previous FUS reactions. A 
membranes and dialysate compositions. DeBacker,  strong correlation was found with respect to the age 
WA, Verpooten, G.A, Borgonjon, D.J., Vermeire,  and race of the patients.  The fact that a patient 
PA,L  ins, RR and DeBroe, M.E.K idney Int, (51, pp.  recently starteddialysis treatmentorhasbeentreated 
738-43 Way 23, 1983).  Comparing AN69 mem-  with dialysis for some time appears to have no 
brane, cuprophan membrane, acetate dialysate, and  bearing in the risk of experiencing a FUS reaction. 
bicarbonate dialysate, iti s found that the degree ofdi- 
alysis-relatedh ypoxemia increases in severity as fol-  Hypersensitivity to hemodialysis: the United King- 
lows: combination of AN69 and bicarbonate shows  dom experience. Nicholls, AJ. Artif Organs, 11 (21, 
little hypoxemia;A  N69 and acetate as well as cupro-  pp. 87-9 (Apr 1987). A survey of all U.K hemodialy- 
phan and bicarbonate showingi ntermediate results;  sis centers was conducted to investigate the preva- 
and acetate and cuprophan the most significant drop.  lence ofhypersensitivityi n the first use of disposable 
Indications are that there are two components to the  dialyzers. A total of 11 7 patients with 243 separate 
dialysish ypoxemia: a membrane-related component,  reactions were identified, suggestingt hat 1i n 20 to 1 
md a dialysate buffer component.  in 50patientsmay be susceptible toan anaphylactoid 
reaction to a new hemodialyzer at some time, while 
Bacterial endotoxin in new and reused hemodialyz- 
the risk of reaction occurring with any singleh emodi- 
em: a potential cause of endotoxemia. Petersen, N.J.,  alysis is approximately 1 in 1,000 to 1 in 5,000. No 
C-n,  L.A. and Favero, MS. Trans Am Soc Adf 
particular brand or type of hemodialyzer nor any 
Organs, 27, pp. 155-60( 1 981). New dialyzers  identifiable  technique of priming procedure was 
may contain an LAGreactive material, but it is not 
associated with reactions, but in those few patients 
mgenic.  However, if reuse dialyzers are reproc- 
who suffered repeated reactions, further problems 
essedand stored with a disinfectant that containsen- 
were avoidedby increasing the volume ofsaline in the 
~ssuranceG uidelines for Hemdialysis Deuiees  Appendix E (Cont.)  Chapter 6 
Annotated Bibliogmphy  Herrwdialyzers 
initial rinse of the hemodialyzer or by changing to  that their observations provide direct evidence that 
another brand of hemodialyzer.  anaphylatoxin formation during hemodialysis is a 
transient phenomenon and indicate that the biocom- 
Effect offirst and subsequent useofhemodialyzerso n  patibility of dialysis membranes, as reflectedby their 
patient well-being the rise and fall of a syndrome  complement activating potential, may be signifi- 
associated with new dialyzer use.  Charoenpanich,  cantly different 
R., Pollak,V.E., Kant, KS., Robson, M.D. and Cathey, 
M. Artif Organs, 11 (2), pp. 123-7 (Apr 1987). In a  Nursingmanagement of the new dialyzer syndrome. 
single large dialysis unit in which dialyzers are  Butsick, E.A, Clyde, C.A, Hudson, P.C., Manion, 
routinely subjected to multiple use, the incidence  BAa nd Smith, L.J. AANNT J, 10( 7), pp. 35-9 (Dec 
rates of intradialytic symptoms during first use and  1983). 
reuse were compared. The results of this investiga- 
tion suggest that subjecting dialyzers to an auto-  Long-term results of dialysis therapy with a highly 
mated reuse processing system before first use can  permeable membrane.  Chanard, J., Bnmois, J.P., 
markedly diminish the incidence of first-use syn-  Melin, J.P.,  Lavaud, S. and Toupance, 0.  Artif 
drome.  Organs, 6 (3),p p. 261-6 (Augl982). Afive-year study 
of short-term dialysis using highly permeable poly- 
Effect offirst and subsequent useofhemodialyzerso n  acrylonitrilem  embrane AN 69 was started in March 
patient well-being. Analysis ofthe incidence of syrnp  1973t o compare the &eds of AN 69 and Cuprophan 
toms and events and description of a syndrome asso-  membrane (CM). The dialysis sessions were signifi- 
ciated with new dialyzer use. Robson, M.D., Charo-  cantly better tolerated with AN 69 than with CM, 
enpanich, R., Kant, KS., Peterson, D.W., Flynn, J.,  however, the main advantage of using AN 69 is the 
Cathey, M. and Pollak, V.E. Am JNephrd, 6 (2), pp.  shortening of dialysis time. The duration of dialysis 
101-6 (1986).  To determine the effect of multiple  was 9.5 k0.2 hours per week with AN69 andl6.4kO.2 
dialyzer use on intradialytic symptoms, data from  hours per week with CM. Shortening of dialysis time 
26,592 successive dialyses on 147 patients were ana-  permits better social rehabilitation of the patients. 
lyzed. Over the 26-month period of study 4,933 new  The shorter dialysis was not associated with any rec- 
dialyzers were used.  All symptoms, considered to-  ognizable side effects that could be demonstrated by 
gether, occurred 1.3 times more frequently during  routine clinical and biological analysis. 
the initial than during the subsequent use of the 
dialyzer. No symptom occurred more frequently in  Hemodialysis-associatedc omplicationsd ue to steril- 
the second or subsequent use ofthe dialyzer. Concur-  izingagents ethyleneoxide andf ormaldehyde. Kessler, 
rent chest and back pain were 41 times more fre-  M., Cao-Huu, T., Mariot, A and Chanliau J. Contrib 
quent when the dialyzer was used for the first time.  Nephrd, 62, pp. 13-23 (1988). Document Type: Re- 
A syndrome associated with the first use of the  view (57 refs.). 
dialyzer is described. 
Allergy in long-term hemodialysis 11: Allergic and 
A survey on hypersensitivity reactions in hemodialy-  atopic patterns of a population of patients undergo- 
sis. Villarroel, F., Ciarkowski, AA Artif Organs, 9  ing long-term hemodialysis. Bousquet, J., Maurice, 
(3), pp. 231-8 (Aug1985). This survey was conducted  F., Rivory, J.P., Skassa-Brociek, W.,  Florence, P., 
from 1982 through 1984 by  a cooperative effort  Chouzenoux, R, Mion, C. and Michel, F.B. JAlEergy 
among the Health Industries Manufacturers Asso-  Clin Zmmunol, 81 (3), pp. 605-10 (Mar 1988). Pa- 
ciation, seven dialyzer manufacturers, and the Food  tients did not have serum-specific IgE against the 
and Drug Administration. This article presents an  released chemicals. Five of 17 patients who had a 
analysis of the 1982-83s urvey data and a summary  pruritus during dialysis had either positive RAST to 
of the 1984 data.  released chemicals or skin tests to the effluent. Five 
of 8 patients who suffered from anaphylaxis had 
Anaphylatoxin formation during hemodialysis: ef-  positive RAST to released chemicals, but only those 
fects of different dialyzer membranes. Chenoweth,  whohad apositive RASTpresenteda severer eaction. 
D.E., Cheung, AKa ndHenderson, LW. Kidney Int, 
24 (6), pp. 764-9 (Dec1983). MeasurabIe complement  Ethylene oxide in dialyzer rinsing fluid: effect of 
activation resulting in the formation of both C3a and  rinsing technique, dialyzer storage time, and potting 
C5a anaphylatoxins was observed in 12 patients  compound. Ansorge, W., Pelger, M., Dietrich,W  . and 
undergoingmaintenance dialysis treatment with cu-  Baurmeister, U. Artif Organs, 11 (2),p p. 118-22( Apr 
prophan hollow fiber dialyzers. The authors surmise  1987). Ethylene oxide (ETO) is recognized as one of 
Quality Assurance Guidelinesf or Hernodialysis Devioes  E-24  Appendix E (ContS  Chapter 6 
Annotated Bibliography  Hemodialyzers 
the main causes of dialyzer-associated hypersensi-  hypersensitivity syndrome presents as an acute ana- 
tivity reactions. The authors results suggest that the  phylactoid reaction, the symptoms of which may 
dose of ETO administered to the patient at the outset  range from mild to life-threatening in severity. The 
of dialysis can be minimized by rinsing the dialyzer  cause of this syndrome is unknown, but affected pa- 
with 2 L offluid at 37C and by avoiding administra-  tients appear to have a high incidence of positive 
tion of rinsing fluid that has been allowed to remain  radioallergosorbent tests to a conjugate of human 
in contact with the dialyzer for more than several  serum albumin and ethylene oxide, suggesting that 
minutes. Use of a long storage interval and use of  ethylene oxide, a substance used to dry sterilize arti- 
dialyzers containing reduced amounts of potting  ficial kidneys, may be an offending allergen. 
material will also reduce the ETO load. 
Severe reactions duringh emodialysis. Rault, R and 
Mediation of  hypersensitivity  reactions during  Silver, M.R.A m JKi&nqD  is, 5 (21, pp. 128-31 (Feb 
hemodialysis by IgE antibodies against ethylene  1985). Severe reactions during dialysis occurred in 
oxide. Lernke, H.D. Artif Organs, 11 (21, pp. 104-10  1.7%o f hemodialysisp atients. Respiratoryd istress, 
(Apr 1987).  We conclude that ETO causes most  agitation, pruritus, and alterations in BP were the 
severe hypersensitivity reactions by an IgE-medi-  dominant clinical findings, and one patient suffered 
ated mechanism. On the other hand, the pathogene  arespiratoryarrest. Current evidenceimplicatesthe 
sis of mild (type I) reactions is less clearly associated  dialyzer as the most likely culprit, and experience 
with ETO allergy. The results also suggestt hat other  suggests that none of the commonly used dialysis 
potentially allergenic substances in dialyzers (e.g.,  membranes are truly biocompatible. 
IPM, 2-chloroethanol)  rarely induce specific IgE 
antibodies in dialysis patients.  haphylatoxin  formation during  hemodialysis: 
comparison of new and re-used dialyzers.  Che- 
Extractable  ethylene oxide from cuprammonium  noweth, D.E., Cheung, AK, Ward, D.M. and Hen- 
cellulose plate dialyzers: importance of potting com-  derson, L.W. Kidney Znt, 24 (6), pp. 770-4 (Dec 1983). 
pound. Ing, T.S. and Daugirdas, J.T. ASMO k s ,   Hemodialysis of 11 endstage renal failure patients 
32 (l), pp. 108-10( Jul-Sep 1986). The results suggest  with new cuprophan hollow fiber dialyzersp roduced 
that ethylene oxide retention aRer sterilization is in-  signifjcant leukopenia as well as increased plasma 
creased in cuprammonium cellulose plate dialyzers  levels ofboth C3a and C5a antigens during the initial 
containingp otting compound. In contrast, cupram-  phases of the procedure. These observations suggest 
monium cellulose plate dialyzers without potting  that C3b deposition on the cellulosic membrane sur- 
compound were characterized by a rapid disappear-  face during first use markedly diminishes the com- 
ance of retained ethylene oxide after sterilization.  plement-activating potential of cuprophan dialyzers 
Whether these findings explain the low incidence of  when they are subsequently reused. 
SARD with cuprammonium cellulose plate dialyzers 
that do not contain potting material is a matter for  Risks and hazards associated with dialyzers and 
continued study and experimentation.  dialysate delivery systems.  Keshaviah, P.R. and 
Luehmann, D.A Crit Rev Biomed Eng, 9 (31, pp, 201- 
Association of ethylene-oxide-induced IgE antibod-  44 (1983). Document Type: Review (83 refs.). 
ies with symptomsin dialysisp atients. Rumpf, KW., 
Seubert, S., Seubert, A, Lowitz, H.D., Valentin, R,  Hypersensitivity reaction on first-time exposure to 
Rippe, H., Ippen, H. and Scheler, F. Lancet, 2 (8469-  cuprophan hollow fiber dialyzer. Key, J., Nahmias, 
701, pp. 1385-7( Dec 21-28 1985). High RAST values  M. and Acchiardo, S. Am JEdney Dis, 2 (6), pp. 664- 
were commonly associated with anaphylactoid reac-  6 (May 1983). The cause of the hypersensitivityr eac- 
ti~nsdurin~dial~sisandwithchronicastEhmthay lene  tion is unknown. It could be due to substances used 
oxide antibodies should be sought routinely in pa-  in the sterilization procedure, to the membrane itself, 
tients presenting with these symptoms and the ne-  or to substances that leach out of the potting com- 
cessity of ethylene oxide sterilisation of disposable  pound or membrane.  Hypersensitivity  reaction 
dialysis equipment should be re-evaluated.  during hemodialysis has been reported to be very 
severe or even fatal.  Personnel delivering direct 
Dialyzer hypersensitivity syndrome: possible role of  patient care should be aware of the symptoms and 
dkgy to ethylene oxide.  Report of four cases and  react quickly with proper treatment.  Patients sus- 
review of the literature. Caruana, R.J., Hamilton,  pected to have this reaction should be changed to a 
RW.a nd pearson, F.C. Am JNephrd, 5(4), pp. 271-  dialyzer without a cuprophan membrane. 
40985). Document Type: M e w( 12 refs.). Dialyzer 
 wit^ 
Assurance Guidetine for Hemodialysis Devices  Appendk E (ContS  Chapter 6 
Annotated Bibliogmphy  Hemodialyzers 
Severe reactions to Cuprophan capillary dialyzers.  even during a treatment and quickly returns to the 
Popli, S., Ing, T.S., Daugirdas, J.T., Kheirbek, A.O.,  pretreatment level after iti st erminated. (2) In short- 
Viol, G.W., Vilbar, R.M.  and Gandhi, V.C.  Artif  term evaluations, occurrence of P rebound during a 
Organs, 6 (3),p p. 312-5 (Aug 1982). Five severe reac--'  treatment does not correlate with factors such as 
tions occurred in four maintenance hemodialysis pa-  meal, Al gel, dialyzer type, dialyzer membrane and 
tients 1t o 5 minutes aRer initiating dialysis with Cu-  therapeutic mode, but with the pretreatment P con- 
prophan capillary dialyzers. All reactions were life-  centration. Onceitreachesathresholdlevelinherent 
threatening and one resulted in death. Inadequate  to each patient, plasma P seems to rebound. (3) Re 
rinsing of the dialyzers was probably the cause of the  treatment P concentration in each patient seemed to 
reactions.  The severe reactions were managed by  be controlled in a relatively narrow range. (4) While 
immediate discontinuation of dialysis and the insti-  apparent generationr ates (GI estimated with asingle 
tution of supportive treatment.  Antianaphylactic  compartmental kinetic model are stable during in- 
measures were also attempted, but their therapeutic  tra- and interdialytic phases as to BUN, CR and UA, 
effectiveness remains to be determined.  Gfor P seems to be significantly enhanced, especially 
during the latter period of the treatment and imme- 
Hemodialysis-associated neutropenia and hypoxe  diately &r  the termination of the treatment. 
mia: the effectofdialyzerrnembrane~~mterialHs.a kim, 
R.M. and Lowrie, E.G.  Nephron, 32 (I),  pp. 32-9  A clinical study on different cellulosic dialysis mem- 
(1982). The fall in white blood cells (WBC) and arter-  branes.  Falkenhagen, D., Bosch, T., Brown, G.S., 
ial oxygen pressure that occurs during hemodialysis  Schmidt, B., Holtz, M., Baurrneister, U., Gurland, H. 
was investigated as a bction of different dialysis  and Klinlanann, H. Nephrd Dial Transplant, 2 (6), 
membranes and different sterilization methods. No  pp. 537-45 (1987).  A comparison of dialysis mem- 
significant differences were seen in pH, PC02 or bi-  branes made of modified cellulose (Hemophan)w  ith 
carbonate. The results indicate differences in bio-  classical regenerated cellulose (Cuprophan).  The 
compatibility between Merent membranes. Clini-  efficacy of the modified cellulosic membrane with 
cal implications are discussed.  respect to urea and creatinine clearance was shown 
to be comparable to that of regenerated cellulose and 
Bacterial contamination of the blood compartment  celldoseacetate. However, modified celluloses howed 
originating from the dialysate in haemodialysers.  an increased clearance for inorganic phosphate, sig- 
Kolmos, H.J. JHosp Infect, 5 (11, pp. 70-5( Mar 1984).  nificantly different from that demonstrated by both 
Microorganisms originating from the dialysate com-  regenerated cellulose and cellulose acetate. Demon- 
partment invaded the bloodcompartmento fahodial  strated that in comparison to regenerated cellulose, 
RP6' 2.5 percent of the time. Analysis of  the data  modified cellulose resulted in significantly less com- 
suggested that the probable access ofbacteria to the  plement activation and WBC reduction, and appears 
blood compartment was by way of minor defects in  to be due to the substitution of hydroxyl groups of 
the dialysis membrane. The patients experienced no  regenerated cellulose. 
obvious symptoms or signs of sepsis which could be 
ascribed to the presence of microorganisms in the  Compartmental distribution of complement activa- 
blood compartment.  tion products in artificial kidneys.  Cheung, AK, 
Chenoweth, D.E., Otsuka, D. and Henderson, L.W. 
Hypoxemia during hemodialysis: effect of Merent  Kidney Znt, 30 (1) , pp. 74-80 (Jull986). Hemodialysis 
membranes and dialysate compositions. DeBacker,  membranes may differ with regard to their comple- 
W.A, Verpooten, G.A, Borgonjon, D.J.,VanWaeleg-  menbactivating potential as well as their ability to 
hem, J.P., Vermeire, P Aa nd DeBroe, M.E.C ontrib  remove circulating anaphyla-toxins fiom the blood 
Nephrol, 37, pp. 13441( 1984).  path. Clinical measurements of anaphylatoxh p* 
duction during hemodialysis reflect these dynamic 
Dynamic behavior of plasma phosphate in chronic 
events. 
dialysis patients.  Sugisaki, H., Onohara, M. and 
Kunitomo,T  . TransA  m Soc ArtifIntern Organs, 28,  Direct calculation of KIN. A simplified approach to 
pp. 302-7 (1982). (1) Change in the plasma P con-  monitoringo fhemodialysis. Barth, RH. Nephron, 50 
centration during intra- and interdialytic phases is  (31, pp. 1916( 19 88). A simplef ormulaf or calculation 
notably different fiom that for BUN, CR and UA  of KTN fiom pre, post- and mid-dialysis blood urea 
Reduction rate for P depends on its pretreatment  nitrogen is presented.  An evaluation by measure 
concentration. Plasma Pis apt to level off or rebound  ment of total dialysate urea revealed that urea ki- 
E-26 
Quality Assurance Guidelines for Hernodialysis Devks  Appendiv E (ContJ  Chapter 6 
Annotated Bibliography  Hedialyzers 
netic modeling consistently overestimated V and K,  Bacterial and endotoxin permeability of hemodialy- 
and that KTNderivedhm the simplef ormulamore  sis membranes.  Bernick, J.J., Port, F.K, Favero, 
precisely estimated true KTN.  M.S. and Brown, D.G.  Kidney Int, 16 (4), pp. 491-6 
(Oct 1979). Dialysis fluids containing at least la71 
A study on hemodialysis leukopenia using various  bacteria per milliliter and asm  uch as1 2,500ngofe n- 
dialyzers. Shin, J.,Matsuo, M., Shinko, S., Fujita,Y.,  dotoxin equivalents per milliliter were dialyzed and 
Inoue, S., Sakai, R and Nishioka, M. JDial, 4 (I), pp.  ultrafiltered with three types of disposable hemodia- 
51-62 (1980). Hemodialysis leukopenia was studied  lyzers. Neither bacteria nor endotoxin, as measured 
using various dialyzers and membranes.  The au-  by the Limulus lysate assay, was detected in the 
thors found that dialyzersw  ith cellulosicm  embranes  sterile compartment despite ultrafiltration.  Under 
caused marked leukopenia, buti n recently developed  these favorable conditions for endotoxin transfer, the 
non-cellulosic membranes, its occurrence was sig-  maximum transfer rate was calculated to be less 
nificantly less.  Additionally, the results showed a  than 3.5 ngofendotoxin equivalents per hour. At this 
newly developed cellulose acetate membrane to cor-  rate, it is unlikely that pyrexia during hemodialysis 
relate well with the non-cellulose membranes re  is due to the transfer of endotoxin across an intact 
gardingleukopenia, in spite of itb eing a derivative of  dialyzing membrane. Provided that the integrity of 
cellulose.  the dialyzing membrane is maintained, this investi- 
gation indicates that the risk of  endotoxemia or 
Absence ofbacteremia and endotoxemia despite con- 
bacteremia associated with the use of contaminated 
taminated dialyzate.  Bernick, J.J. and Port, F.K. 
dialysis fluids is negligible. 
Clin Nephrd, 14(1), pp. 13-7( Jul1980). Feversasso- 
ciated with hemodialysish ave been attributed to the  Chapter six: clinical evaluation. Evaluation ofhemo- 
transfer of relatively large endotoxin molecules andl  dialyzers and dialysis membranes. Report of a study 
or bacteria from contaminated dialyzate across the  group for the Artificial Kidney-Chronic Uremia Pro- 
dialyzingmembrane. In this study, due to amalfunc-  gramNIAMMDD-1977. Klein, E., Autian, J., Bower, 
tion, dialysisf luids containedb acteria and endotoxin  J.D., Buffaloe, G., Centella, L.J., Colton, C.K, Darby, 
at levels previously reported to be associated with  T.D.,  Farrell, P.C.,  Holland, F.F.,  Kennedy, R.S., 
pyrogenic reactions. Neither endotoxin nor bacteria  Lipps, B. Jr, Mason, R,N olph, KD., Villarroel, F. 
was detected; venous and arterial blood specimens  and Wathen, R.L Artif Organs, 3 (1) , pp. 47-61 (Feb 
were collected at the termination of hemodialysis.  1979). 
Temperature elevations did not occur.  In an ex- 
tended study, 20 dialyzers were collected aRer single  Mannitol and maintenance hemodialysis. Swamy, 
patient use and the dialyzate compartment was filled  AP. and Cestero, RV. Artif Organs, 3 (21, pp. 116-9 
with highly contaminated dialyzate, while the blood  (May 1979). The extensive use of mannitol during 
compartment was filled with sterile pyrogen-free  maintenance hemodialysis prompted a study  of 
saline.  Following 5 to 7 days incubation, bacteria  mannitol kinetics. Despite an apparently adequate 
were present in the blood compartments of4 of 20 dia-  clearance rate, mannitol administered during dialy- 
lyzers, probably due to contamination during dia-  sis is incompletely removed. Repeated use of manni- 
lyzer handling.  However, the much smaller en-  to1 during dialysis leads to mannitol accumulation. 
dotoxin molecule could not be detected in the absence  Clinical significance of the residual mannitol levels 
of bacterial contamination. These results indicate  needs further evaluation. 
that the intact cellophane membrane is an effective 
barrier to endotoxin and bacteria under clinical con-  Characteristics of Available Dialyzers. Shinaberger, 
ditions.  J.H., Miller, J.H. and Gardner, P.W. in Clinical Di- 
alysis. AR. Nissenson, R.N. Fine, and D.E. Gentile, 
Comparison of  solute permeability and rejection  [edsl. Appleton-Century-Crofts, Nowalk CT, pp. 53- 
characteristics of normal and flux cellulose haemodi-  98 (1984). Methods for characterization of dialyzers 
alysis membranes.  Klein, E.,  Holland, F.F.  and  and performance characteristics of many dialyzers 
Eberle, K. P mE ur Dial Transplant Assoc, 16, pp.  used. 
198-204 (1979). Permeability and rejection proper- 
ties of new, high flux cellulose membranes and fibres  Issues in Dialysis: Reuse, Dialysate Toxicity, Short 
have been compared with Cuprophan. The greater  Dialysis.  Vlchek, D.  Dial & Transplant, p. 127 
solute and water flux is explained in terms of larger  (March 1988). Areview of an ASN conference on the 
"pores," which permit greater transport of large  three title topics. The benefits and limits of each of 
molecules.  these highly topical factors in dialysis are discussed. 
Quality Assurance Guidelines for Hernodialysis Devices  E-27  Appendix E (Cont.)  Chapter 6 
Annotated Biblwgmphy  HemocEialyzers 
Staying Tuned into the High-Tech World (Part One).  200-10,000 back to the patients was compared with 
Vlchek, D. Dialy & Transplant, p. 305 (Jun 1989). A  the effect ofconventionalh emodialysis. The patients 
review of  treatment modalities used in the late  treated with this  system obtained a more stable 
1980's with descriptions of each, dialyzers and dialy-  hemoglobin concentration without blood transfu- 
sis membranes, includingfUnctiona1 characteristics.  sions. They also increased mean nerve conduction 
velocity and their plasma increased in quality as 
Volumetrically controlled ultrafiltration.  Current  culture medium on human mononuclear phagocytes 
experiences and future prospects.  Roy, T., Ahren-  grown in-vitro. 
holz, P., Falkenhagen, D. and Klinkmann, H. Int J 
Artif Organs, 5 (3), pp. 131-5( May 1982). Exact con-  Hemodialysish ypoxemia: evaluation of mechanisms 
trol of ultrafiltration (UF) is a prerequisite for high  utilizing sequential ultrafiltration-dialysis. Braut- 
flux dialysis and hemodiafiltration. Volumetric di-  bar, N.,  Shinaberger, J.H., Miller, J.H. and Nach- 
alysate balancing is the best current method for the  man, M.  Nephron, 26 (2), pp. 96-9 (1980).  The 
use of dialyzers with high water permeabilities. The  authors studied the role ofblood-dialyzer-membrane 
precision of UF control by volumetric dialysate bal-  interactions in hemodialysis-induced hypoxemia by 
ancing is in agreement with all medical require-  measuring Pa02 and white blood cell counts during 
ments. A positive influence of volumetric UF control  isolated ultrafiltration (UF) compared to hemodialy- 
on patients undergoing chronic hemodialysis can be  sis (HD, utilizing the same dialyzer and membrane). 
shown by the frequencies of dialysis side effects.  Patients in the UF period displayed no hypoxemia 
Volumetric UF control is only a first step towards an  and rather a slight increase in Pa02; on contrast, 
intelligent UF module to correlate water removal,  these patientsdisplayed significanthypoxemiaw  hen 
solute removal and sodium balance.  HD was imposed.  The authors suggest that the 
hypoxemia characteristic of  HD initiation is not 
Dialyzer ultrafiltration coefficients: comparison be-  solely dependent on blood-dialyzer-membranei nter- 
tween in-vitro and in-vivo values. Keshaviah, P.R.,  actions, but also requires blood-dialysate interac- 
Constantini, E.G., Luehmann, D.A, Shapiro, F.L.  tions. 
Artif Organs, 6 (I), pp. 23-6 (Feb 1982). This study 
describes a simple, convenientm  ethod for the in-vivo  Evaluation of dialysis adequacy. Gotch, F.A Contrib 
measurementoftheultrafiltrationcoelicientofhemodia-  Nephrol, 69, pp. 101-8; discussion 162-7 (1989). Re- 
lyzers. The method is based on a scheme of isolated  view (20 refs.). 
ultrafiltration, i.e., ultrafiltration without dialysate 
flow through the dialyzer. Results with this method  Preliminary  clinical results with sodium-volume 
indicate that it is more accurate than the conven-  modeling ofhemodialysist herapy. Gotch, F.A  ,L  am, 
tional bed scale technique. Measurements on three  M.A, Prowitt, M. and Keen, M.  P m  Clin Dial 
different  dialyzers demonstrate that the in-vivo  Transplant Forum, 10, pp. 12-7 (1980). 
ultrafiltration coefficienti sonly between l%and 10% 
Mathematic modeling of dialysis therapy. Sargent, 
lower than the correspondingi n-vitro value. This is 
J.A and Gotch, F.A Kidney Int, Suppl, Suppl10,p p. 
in contrast to the rule of thumb used by some manu- 
S2-10 (Sep 1980). 
facturers that in-vivo coefficients are 30%l ower than 
in-vitro values.  The deviation of the in-vivo value 
American National Standard: First Use Hemodia- 
from the in-vitro one seems to be higher with higher 
lyzers. (ANSVAAMIR D16-1984).  Association for 
dialyzer ultrafiltration coefficients. Based on these 
Advancement of Medical Instrumentation; Arling- 
results it is recommended that to estimate ultrafil- 
ton, VA (1984). This standard is intended to provide 
tration rates in the clinical setting, the in-vitro ul- 
minimum requirements to ensure safe and effective 
trafiltration coefficientbeu sed, transmembrane pres- 
performance ofhemodialyzer devices that are manu- 
sures being correctedfor the colloid osmotic pressure 
factured ready-to-use. 
of plasma proteins. 
Is a Clean Dialyzer a Good Dialyzer? A Hypersensi- 
Toxicity of middle molecules: clinical evaluation us- 
tivity Data Collection Proposal.  Chenoweth, D.E. 
ing a selectivef iltration artificial kidney. Jorstad, S., 
and Henderson, L.W.  Contemp Dial (Mar 1984). 
Smeby, L.C.  and Wideroe, T.E.  Artif Organs, 4, 
Discussion of possible causes of First Use Syndrome, 
Suppl, pp. 98-103( 1981). Patients were treated with 
or dialyzer hypersensitivity reactions.  Includes a 
a dialyzer able to remove molecules between 10,000- 
proposal for further study of the phenomenon. 
40,000 daltons. Returning substances with mol wt 
Quality Assurance Guidelines for Hemodiulysis Devices  Appendix E (Cont.)  Chapter 6 
Annotated Biblwgmphy  Hemodialyzers 
Recommendations to Dialysis Facilities Regarding  Calculation of combined diffusive and convective 
Dialyzer Hypersensitivity Reactions (letter). H&-  mass transfer. Sigdell, J.E. Int J h i fO  rgans, 5 (61, 
ner, M.E. Food and Drug Administration (Novl983).  pp. 361-72 (Nov 1982). In this study, the permeabili- 
Recomrnendationsrnade: stridlyfo11owmanufacturer's  ties of the boundary layers on both sides are treated 
rinsing procedures; all staff should be informed of  as included in the (equivalent)m  embrane. In an a p  
those rinsing procedures; any reaction be fully and  pendix, the stacking of membranes is studied, giving 
promptly reported.  a general law for the calculation of overall permea- 
bilities of a stack of individual membranes, regarded 
Dialysis of the future. Gotch, F.A Kidney Int, Suppl,  as one (equivalent) membrane (such as a physical 
24, pp. S100-4 (Mar 1988). The followingpredictions,  membrane with two boundary layers). Permeability 
scientifically based, are made for dialysis of the  data for boundary layers are quoted from earlier 
1990's: (1)t reatment time will approach two hours;  works. In other appendices, the variation of the local 
(2) a KW Ud.0 must be provided in two hours; (3)  ultrafiltration along the dialysis path is studied, as 
this will require a dialyzer &A U 750-1250,Q  B 200-  well as its effect on the effective permeability of the 
500, and QD 500-750 for individual patients; (4) bi-  membrane. 
carbonate dialysate will be required; (5) delivery 
systems with precise UF control will be required; (6)  Clinical Estimates of Treatment Adequacy.  Tes- 
sodium, urea, and possiblly potassium modeling will  chan, P.E. Artif Organs, 10 (3), pp. 201-4 (1986). 
probably required; (7) high hydraulic permeability 
membranes and high biocompatibility membranes  Principles and biophysics ofDialy sis. Sargent,J . and 
and pyrogen free dialysate may be required.  The  Gotch, F. Replacemento fRenal Functwn by Dialysis, 
article includes background on all of these issues.  [ed. Drukker], Marinus Nijhoff, pp. 53-93 (1983). 
A mechanistic analysis of the National Cooperative  National Cooperative Dialysis Study. Lowrie, E.G. 
Dialysis Study (NCDS).  Gotch, F.A and Sargent,  and Laird, N.M. [eds.]. Kidney Int, S-13 (1983). 
J.A Kidney Int, 28 (3), pp. 526-34 (Sep 1985). The 
Effect of the Hemodialysis Prescription on Patient 
purpose of the NCDS was to determine the probabil- 
Morbidity (Report from the National Cooperative 
ity of clinical failure (PF) as a function of the level of 
Dialysis Study). Lowrie, E.F., Laird, N.M., Parker, 
dialysis and protein catabolic rate (pcr, gflrg/day). 
T.F. and Sargent, J.A  NEJM, 305: 20, pp. 1176-81 
The level of dialysis prescribed in the NCDS was 
mechanistically defined as IWV (product of dialyzer  (1981). 
urea clearance and treatment time divided by body 
Release of pyrogens during clinical hemodialysis. 
urea volume), which exponentially determines de- 
Weingast, J.A, VanDeKerkhove, KM., Eiger, S.M., 
crease in BUN during dialysis and is also a mathe- 
Kluger, M.J. and Port, F.K  Trans Am Soc Artif 
matical analogue of pcr, BUN. 
Intern Organs, 31, pp. 359-62 (1985). 
Quality Assurance Guidelines for Hernodialysis Devices  Appendix E (Cont.) 
m a t e dB iblwgntphy 
Chapter 8 
Anticoagulation 
Outbreak of pyrogenic reactions at a dialysis center.  removal was significantly shorter in FUT than that 
Association with infusion of heparinized saline solu-  in heparin.  During HD, the prolongation of celite- 
tion. Kantor, R.J., Carson, LA, Graham, D.R, Pe-  activated coagulation time (CCT) of the intracor- 
tersen, N. J. and Favero, M.S. Am J Med, 74 (31, pp.  pored blood was significantly milder in FUT in 
449-56 (Mar 1983). An epidemiologic and laboratory  heparin than that of blood passing through the 
investigation documented that reactions occurred  dialyzer, increased in FUT compared with LH. F'UT 
only in patients who had anticoagulation with a  showed no prolongation of CCT after HD. 
dilute solution of heparin.  Analyses of heparinized 
saline solution used during the outbreak revealed a  Hemodialysis without  anticoagulation. One-year 
bacterial count of 7.4 X 10(5)/ml and a bacterial  prospective trial in hospitalized patients at risk for 
endotoxin level of 1,300 ng/ml.  Acinetobacter cal-  bleeding. Schwab, S.J., Onorato, J.J., Sharar, L.R 
coaceticus var. Iwoffi was isolated from the solution.  and Dennis, P A A  m JMed, 83 (3), pp. 405-10 (Sep 
Dilutedheparin solution was prepared att he dialysis  1987). This prospective study evaluated a protocol 
centerby addingcommenzially suppliedsodiumheparin  for hemodialysisw  ithout anticoagulationi  n a d e  
to 0.9 percent sodium chloride infusion fluid. Bacte-  group of hospitalized patients in unstable condition 
ria and endotoxin were not detected in vials of stock  with relative contraindications to anticoagulation. 
heparin and bags of unopened 0.9 percent sodium  Of 262 attempts ath emodialysis without anticoagu- 
chloride infusion fluid. The authors conclude that  lation in 49 patients, 239 hemodialysis treatments 
contamination ofthe solution occurred att he dialysis  (91 percent) were successfully completed. This study 
center. ARer changes in the preparation and use of  concludes that hemodialysis without anticoagula- 
heparin were instituted on December 4, 1978, no  tion can be reliable and effective in closely monitored 
pyrogenic reactions occurred in more than 400 subse-  situations. 
quent dialyses. 
Heparin free dialysis: comparative data and results 
Regional citrate anticoagulation:a report ofl Omonths  in high risk patients.  Caruana, RJ., Raja, RM., 
experience. Boyd, L.M., Felton, S.E., Highfill, B.K  Bush, J.V., Kramer, MS. and Goldstein, SJ. Kidney 
and Underhill, V.L. J Nephrol Nurs, 2 (4) pp. 162-4  I&,  31 (6), pp. 1351- 5 (Jun 1987). Heparin-freeh emo- 
(Jul-Aug 1985).  dialysis was compared to systemic heparinization, 
intermittent saline flushes and constant saline infu- 
Coagulation problems in artificial organs. Flamen-  sions in eight, stable chronic patients dialyzing on 
baum, W. ASAlO Trans (United States), 32 (2), pp.  hollow-fiber artificial kidneys (HFAK) atb lood flows 
656-61 (Oct-Dec 1986).  of 250 to 300 mllrnin.  Since the data showed that 
heparin-freehemodialysisw  ithout supplemental saline 
Comparativec linical trial ofregional anticoagulation  was feasible in this patient group of stable, chronic 
for hemodialysis. Akizawa, T., Kitaoka, T., Sato, M.,  patients, 29 judged to be at increased risk of hemor- 
Koshikawa, S., Hirasawa, Y., Kazama, M., Mimura,  rhage h mh eparinization were then prospectively 
N. and Ota, K ASAIO Trans (United States), 34 (3),  studied. Although higher hematocrit values were 
pp. 176-8 ( Jul-Sep 1988). The regional anticoagu-  associated with greater degrees of dialyser clotting, 
lating effects of mPT-175 (protease inhibitor), and  stepwise discriminatory analysis employing blood 
regional or low dose heparinization (RH or LH) were  flow, blood pressure, hematocrit and transfusion ad- 
examined comparatively by randomized controlled  ministration could not develop an accurate predictor 
protocol on 157 hemodialysis (HD) patients with  or combination of predictors of clotting. No patient 
hemorrhagic complications.  Increases in bleeding  experienced de novo or increased bleeding and prob- 
because of HD were milder in RPT as compared with  lems with inadequate dialysis were not observed. 
RH and LH, and the bleeding time after needle 
Quality Assurance Guidelinesf or Hernodialysis Devices  Appendix E (Cont.)  Chapter 8 
Annotated Bibliography  Anticoagulation 
Pharmacokinetic monitoring of heparin therapy for  unchanged sieving coefficient fador compared with 
regular hemodialysis. Khazine, F. and Simons, 0.  that of heparin alone, while the ultrafiltration vol- 
pp. 
Artif Organs, 9 (1)  59-61 ( Feb 1985). The paper  ume significantly (P less than 0.001) improved. The 
describes the use of a pharmacokinetic model for  results of this study confirm those of earlier studies 
heparin prescription during hemodialysis leads to a  and suggest that prostaglandin I2 together with low- 
precise monitoring of the coagulation time (CT)w ith  dose heparin improve the biocompatibility and effi- 
25% less heparin required.  Two different popula-  ciency of dialysis treatment. 
tions were distinguished: the first group maintained 
stable sensitivity and elimination constant, pennit-  Regional anticoagulation: hemodialysis with hyper- 
ting stable prescription and giving stable CT values  tonic trisodium citrate. vonBrecht, J.H., Flanigan, 
for up to 2 years.  The other group exhibited wide  M. J., Freeman, RM. and Lim, V.S. Am JKidney Dis, 
variations of these parameters, necessitating daily  8 (3), pp. 196-201( Sep 1986). Describes a simplified 
dose monitoring.  method for performing regional citrate anticoagula- 
tion during hemodialysis.  This method of citrate 
The effect of in-vitro use of heparin in blood transfu-  dialysis is safe and effective during continuous blood 
sions during dialysis on dialyzer clotting. Lowrey,  flow (doubleneedle) hemodialysis, and is no more 
S.J ., Femea, P.L.  AANNT J, 11 (2) pp. 26-9 ( Apr  difFicult to perform than conventional heparin dialy- 
1984).  sis. Singleneedle (reciprocatingb lood flow) hemodi- 
alysis was successllly performed by the additional 
Dialysis membranes and coagulation system. Noto-  use of a calcium-free dialysate and separate calcium 
hamiprodjo, M., Andrassy, K, Bommer, J. and Ritz,  chloride inhsion (10% calcium chloride), but risks 
E. Blood Purif, 4 (1-3), pp. 13041 (1986). Artificial  the production of unexpected hypercalcemia. 
membranes used for hemodialysis differ from en- 
dogenous membranes, i.e. endothelial cells, by their  Heparin-free hemodialysis with Cuprophan hollow 
variable thrombogenicity. The key step in activation  fiber dialyzers by a frequent saline flush, high blood 
of the coagulation system by dialysis membranes is  flow technique. Agresti, J., Conroy, J.D., Olshan, A, 
thrombocyteactivation whichisprecededbyf ormation  Conroy, J.F., Schwartz, A, Brodsky, I., Krevolin, L. 
of a protein layer of critical thickness. C~ciaqlu es-  and Chinitz, J. Trans Am Soc Artif Intern Organs, 
tions concerning the quality of this protein mem-  1985,31 pp. 590-4. 
brane asa  determinant ofthrombocyte activation are 
not well understood.  Clinicalu se of heparin fractions,f ragments, and hep 
arinoids. Messmore, H.L. Jr. Semin Thromb Hemost, 
Heparin and its biocompatibility.  Stiekema, J.C.  11 (2), pp.  208-12 (Apr 1985).  Document Type: 
Clin Nephml ,26, Suppl 1, pp. S3-8 (1986). Recently  Review (37 refs.). 
heparin fractions and a heparinoid of low molecular 
weight (LMW) have been developed because of their  Hemodialysiswithoutanticoagulation.S anders,P.W., 
potential to diminish the hazard ofhemorrhagew  hile  Taylor, H. and Curtis, J.J. Am JKidney Dis, 5 (l),pp. 
retaining their antithrombotic properties.  Prelimi-  32-5 (Jan 1985). In patients ath igh risk of bleeding, 
nary reports from pilot studies have confirmed the  however, use of heparin significantly increases their 
increased efficacy in preventing deep vein thrombo-  morbidity and, presumably, mortality.  Over one 
sis (DVT) of some of the new LMW heparin(oid)s;  year, the authors performed 156h emodialysis proce- 
however, improved safety with regard to bleeding  dures successfully without heparin in the transplant 
stillneedstobe shown. Theuse ofLMWheparinsand  dialysis unit.  No dialysis procedure produced or 
of a new I;MW heparinoid in acute and chronic  aggravated bleeding.  Conversely, a coagulopathy 
hemodialysis has also been shown to be effective.  was not induced or worsened by dialysis without 
heparin. A significantc omplication, defined as com- 
Pmbyhandheparinduringhae-:a,-  plete clotting of the artificial kidney with or without 
effects. Carmici, M. and Evangelisti, L. Life Support  clottingin the lines occurred in eight dialyses (5.13% 
Syst, 4 (31, pp. 205-9 (Jul-Sep 1986). Haemodialysis  of the total) and resulted in an average blood loss of 
neutropenia was improved by prostacyclin.  The  150 ml. Partial clotting of the dialyzer did not inter- 
membrane sieving coefficient fador and ultrafiltra-  rupt the procedure and occurred nine times (5.8% of 
tion volume were not improved by prostacyclin alone  the total). These results compare favorably with pre- 
(dialysis ID.  Prostacyclin, together with heparin  viously documented complications from low-dose and 
(dialysis III), showed, 60 minutes after the start, an  regional heparin. 
Quality Assurance Guidelines for Hernodialysis Devices  Appendix E (Cont.)  Chapter 8 
Annotated Bibliography  Anticoagulation 
Hemodialysisw  ithout anticoagulants: efficiency and  Hematol, 26 (3), pp. 255-62 (Nov 1987). The authors 
hemostatic aspects.  Casati, S., Moia, M., Graziani,  speculate that the majority of subjects exposed to 
G., Cantaluppi, A, Citterio, A, Mannucci, P.M., and  heparin develop an antibody or a proaggregator that 
Ponticelli, C. Clin Nephrol, 21 (2), pp. 102-5 (Feb  can aggregate or agglutinate platelets in the pres- 
1984). In 29 patients with high risk ofbleeding, 111  ence ofheparin andcause destructiono fplatelets,b ut 
hemodialyses have been performed without heparin  only in a small percentage of subjects receiving 
(WHD) or other anticoagulants. The same patients  heparin ist his reaction severe enough to causet hrom- 
were switched to low dose heparin dialysis (LDHD)  bocytopenia 
as soon ast he bleeding risk had ceased. The dialyzer 
had to be changed in 11 and the drip chamber in 20  Citrate regional anticoagulation in haemodialysis. 
WHDsbecause of partial clotting. This phenomenon  Hocken, AG. and Hurst, P.L. Nephron, 46 (11, pp. 7- 
did not occur during LDHD.  10( 1987). Using synchronous pre- and post-dialyser 
blood samples, measurement of the whole blood clot- 
Regional citrate anticoagulation in chronic hemodi-  ting times demonstrated the restriction ofanticoagu- 
alysis patients. Seaton, R.D., Duncan, KA, Pinnick,  lation to the extracorporeal circulation.  It is con- 
RV., Diederich, D.A and Wiegmann,T.B. TransAm  cluded that citrateanticoagulationis safe, acceptable 
Soc Artif Intern Organs, 29, pp. 414-8 (1983). The  and simple for use in haemodialysis for patients at 
pronounced leukopenia caused by cuprophane dia-  risk from systemic anticoagulation. 
lyzer membranes was significantlybluntedb y citrate 
regional anticoagulation. Cellulose acetate produced  Long-term comparisons of citrate and heparin as 
less leukopenia than the cuprophane, regardless of  anticoagulants for hemodialysis.  Wiegmann, T.B., 
anticoagulant. The p02 response to the initiation of  MacDougall, M.L. and Diederich, DA Am JKidney 
hemodialysis was not affectedb y dialyzer membrane  Dis, 9 (5), pp. 430-5 (May 1987). Citrate was com- 
or anticoagulant choice. The authors conclude that  pared to heparin as an anticoagulant during chronic 
citrate anticoagulationr educes dialyzer-inducedleu-  hemodialysis. Use ofcitrate ast he sole anticoagulant 
kopenia. Citrate anticoagulation does not, however,  for periods of two months was easily accomplished, 
change the hypoxemia present with acetate dialysis.  free of complications, and resulted in comparable 
The dissociation of leukopenia and hypoxemia with  clearance of solutes.  Major laboratory parameters 
citrate anticoagulation suggests that pulmonary  were similar with both anticoagulants. 
sequestration is not a major cause of hypoxemia 
Severe metabolic alkalosis  complicating regional 
during hemodialysis. 
citrate hemodialysis. Kelleher, S.P. and Schulman, 
Heparin binding and release properties of DEAE  G.  Am J Kidney Dis, 9 (3), pp. 235-6 (Mar 1987). 
cellulosemembranes. Schmitt,E.,Holtz,M,Klinkmann,  Regional citrate hemodialysis has been effectively 
H., Esther, G. and Courtney,J .M. Biomaterials,4(4),  used as an alternative to heparin anticoagulation 
pp. 309-13 (Oct 1983). Heparin release was studied  during dialysis ofpatients ati ncreased risk for bleed- 
by contacting heparinized membranes with saline,  ing.  This paper reports the occurrence of severe 
glycinebaer,p hosphate buffer and plasma Incuba-  metabolic alkalosis in two patients requiring high 
tion with plasma brought about the release of ~ WofO    infusion rates of citrate during hemodialysis while 
the attached heparin.  Crosslinking of the hepar-  being mechanically ventilated. Careful monitoring 
inized membrane with glutaraldehyde reduced the  of acid-base status is mandatory in this setting, and 
heparin release by one half. The release reaction is  reduction of citrate dose may be advisable. 
more critical in the case of increased heparin uptake 
Reducing the hemorrhagic complications of hemodi- 
and a more efficient immobilization of heparin a p  
alysis: a controlled comparison of low-dose heparin 
pears necessary. 
and citrate anticoagulation. I?lakigan, M.J., ~onBre- 
Regional citrate anticoagulation for hemodialysis in  cht, J., Freeman, RM. and Lim, V.S. Am J Kidney 
the patient at high risk for bleeding. Pinnick, R.V.,  Dis, 9 (2), pp. 147-53( Feb 1987). Dialysis-associated 
Wiegmann, T.B. and Diederich, DA N EngWMed,  bleeding was more frequent following low-dose con- 
308 (51, pp. 258-61 (Feb 3,1983).  trolled heparin anticoagulation than during hyper- 
tonic citrate therapy.  Dialysis effectiveness meas- 
Effect of heparin on platelet count and platelet aggre-  ured by postdialysis chemistries and weight loss was 
gation.  Shojania, AM. and Turnbull, G.  Am J  equivalent in the two groups. 
Quality AsAseurancGe uidelines for Hedialysis Devices  Appendix E (Cont.)  Chapter 8 
Annotated Bibliography  Anticoagulation 
Regional citrate anticoagulation:a reporto f lomonth's  tientsusing3 differenth eparin regimens: (1)i ntrave- 
experience. Boyd, L.M., Felton, S.E., Highfill, B.K  nousloading dose only; (2)primingofthe dialyzer and 
and Underhill, V.L.  J Nephrol Nurs, 2 (4), pp. 162-4  continuous infusion of heparin for two hours; and (3) 
(Jul-Aug 1985).  intravenous loading dose and continuous infusion of 
heparin based on anticoagulationk inetics. The anti- 
Studies of coagulation and platelet functionsinhepa-  coagulation kinetic regimen offered no advantage 
rin-freehemodialysis. Ivanovich,P.,Xu,C  .G.,Kwaan,  over the single loading dose regimen with regard to 
H.C.. and Hathiwala, S. Nephron, 33 (2), pp. 116-20  the formation and deposition of fibrin in the dialyz- 
(1983). Usingacellulose acetate dialyzer, both hemo-  ers. 
dialyzer and blood tubing were periodically flushed 
with physiologic saline, but no heparin was used. No  Measurement of fibrinopeptideA  in the evaluation of 
signscant clottingof the hemodialyzers was encoun-  heparin activity and fibrin formation duringhemodi- 
tered in uneventful dialyses. These findings support  alysis. Wilhelmsson, S., Asaba, H., Gunnarsson, B., 
clinicalexperiencethatthisanticoagulation-hmethod  Kudryk, B., Robinson, D. and Bergstrom, J.  Clin 
can be used safely and effectively to dialyze patients  Nephrol, 15 (5), pp. 252-8 (May 1981). In order to 
at risk for bleeding.  monitor heparin activity during hemodialysis, they 
evaluatedthree commonly used methods: whole blood 
Preventing hemorrhage in high-risk hemodialysis:  activated coagulation time (WBACT), whole blood 
regional versus low-dose heparin. Swartz, RD. and  thrombin time (WBTT), and heparin concentration 
Port, F.K  Kidney Int, 16 (4), pp. 513-8 (Oct 1979).  in plasma, determined with a  chromogenic sub- 
Hemodialysis in patients with increased risk for  strate.  They three different heparin regimens: a 
hemorrhage can be accomplished with either a re-  single intravenous loading dose only, priming of the 
gional or a low total dose of heparin. The incidence  dialyzer with heparin followed by a heparin infusion 
of hemorrhage correlated with the estimated degree  and a pharmaco-kinetic model.  Good correlations 
of bleeding risk both at expected and at occult bleed-  were found between WBACT, WBTT and heparin 
ing sites, and was the same or higher with regional  concentration.  Heparin activity during a dialysis 
heparin in all categories. Hemorrhage was not corre-  may be monitored with any of these three methods 
lated with preexisting coagulation abnormalities,  with equal reliability.  However, from a practical 
concurrent anticoagulant drugs, level of azotemia, or  point of view, WBACT appears most attractive be- 
ability to successllly limit systemic heparinization  cause of its simplicity. FPAgeneration, frequency of 
during dialysis. The incidence of partial clotting of  visible clots in the dialyzer and hemorrhagic mani- 
the dialyzer was 3% to 5% with both heparin proto-  festations were essentially the same for each of the 
cols. The authors conclude that regional hepariniza-  heparin dose regimens. The simple administration of 
tion has no clinical or practical advantage over low-  a single loading dose was as safe as the more compli- 
totaldose heparin in preventing bleeding associated  cated infusion technique. 
with hemodialysis. 
Hemodialysis using prostacyclin instead of heparin 
Low-doseheparin in routine hemodialysismonitored  as the sole antithrombotic agent.  Zusman, RM., 
by activated partial thromboplastin time. Shapiro,  Rubin, R.H., Cato, AE., Cocchetto, D.M., Crow, J.W. 
W.B.,  Faubert, P.F., Porush, J.G. and Chou, S.Y.  and Tolkoff-Rubin, N.  N Engl J Med, 304 (16), pp. 
Artif Organs, 3 (11, pp. 73-7 (Feb 1979). Use of the  934-9( Apr 16,1981). Anticoagulationduringhemodi- 
activated partial thromboplastin time (APTT), as  alysis is necessary to prevent clotting of the blood on 
measured by (Coag-A-Mate)s emi-automatic unit, in  contact with the dialysis membrane. Heparin is the 
lowering the dosage of heparin in stable chronic  usual anticoagulant used, but systemic anticoagula- 
hemodi~sispatientsw8sanal~eAdP. IT,asmeasured  tion may persist for hours, and hemorrhage is com- 
by the Coag-A-Mateu nit, provides a simple means of  mon. The authors successfully used an infusion of 
lowering heparin requirements in routine dialysis  prostacyclin, whichhas an in-vitroh alf-life ofthree to 
patients.  five minutes, as the sole anticoagulant on long-term 
hemodialysis.  Prostacyclin caused no clinically 
The effects of three different heparin regimes on 
important changes in the intrinsic clotting system, 
heparin concentrations in plasma and fibrin forma- 
and there were no hemorrhages or clotting of the coil. 
tionindialyzers. Gunnarsson, B., Asaba,H., Dawidson, 
The authors conclude that prostacyclin can safely 
S., Wilhelmsson, S. and Bergstrom, J. Clin Nephrol, 
replace heparin as the sole antithrombotic agent 
15( 3),pp. 135-42(Mar1 981). Anticoagulation effects 
duringhemodialysis and maybe more advantageous 
were studied during a 4-hour hemodialysisi n six pa- 
if anticoagulation is contraindicated. 
Quality Assurance Guidelines for Hernodialysis Devices  E-33  Appendix E (Cont.)  Chapter 8 
Annotated Bibliography  Anticoagulation 
RegionalCitrateAntic0agulation:AViableAl 
Boyd, L.M. and Felton, S.E. ANNA J, 13,5,p . 267 
(Oct 1986).  Regional citrate anticoagulation is a 
positive alternative to conventional methods of anti- 
coagulation during hemodialysis. For the patient at 
moderate to high risk of bleeding, as well as those 
patients with active bleeding at the time of dialysis, 
regional citrate anticoagulation can be a safe, effec- 
tive approach, when performed properly. One of the 
major disadvantages, excessive cost, can be reduced 
to an acceptable level. 
Quality Assurance Guidelines for Hernodialysis Devices  Appendix E (Cont.) 
Annotated Bibliography 
Chapter 9 
Vascular Access Devices 
Cannulation of arteriovenousf istulae. Stansfield, G.  Renal replacement therapy. 2-1. Access for haem- 
Nurs Times, 83 (41, pp. 38-9 (Jan 28-Feb 3 1987).  odialysis. Pavitt, L. Nurs Times, 78 (18), pp. 749-52 
Discussion of gaining and maintaining access to the  (May 5-1 1,1982). Very basic article on different va- 
A-V fistula for hemodialysis in order to obain maxi-  rieties of vascular access devices and long-term man- 
mum effects while creating the minimum of trauma  agement ofthem. Short discussion on complications. 
to the fistula. The paper notes that there is a lack of  Includes shunts, A-V fistula, subclavian. 
research on this subject, but that there is strong 
evidence that good needling technique contributest o  Non-invasive blood flow measurement in expanded 
fitula survival. Evidence suggests that constant site  polytetrafluomthyleneg  rabf or hemodialysisa ccess. 
insersion in an antegrade direction should be the  Rittgers, S.E., Garcia-Valdez, C., McCormick, J.T. 
method of choice. Needles and tubing sets shouldbe  and Posner, M.P. JVascSurg, 3 (4), pp. 63542 (Apr 
chosen carefully (sideh oles are important, and inter-  1986). Volume flow rates were measured in 31 ex- 
nal diameter and length areimportanti n minimizing  panded polytetrafluoroethylene gr&  (6 mm) of 26 
pressure drop).  patients undergoing hemodialysis. Flow was calcu- 
lated from the known access graft diameter and by 
The  fluid mechanics of  hemodialysis catheters.  measurement of the mean Doppler shift frequency 
Mahurkar, S.D. Trans Am Soc ArtifIntern Organs,  waveform. The study demonstrated a safe, repeat- 
31, pp. 124-30 (1985). Use oftwo individual catheters  able noninvasive measure of access grafk hemody- 
is the most efficient, but two procedures are required  namics, which maybe useful as a functional monitor 
for treatment. ComparingC  o-axiald uallumen cathe-  and a warning of impending failure. 
ters to two semi-circular dual lumen catheters, the 
latter is preferable due to ease of insertion, better  Dialysis performance of  single lumen subclavian 
efficiency, less trauma, and fewer complications.  hemodialysis: a comparative study with single lu- 
men fistula hemodialysis. Vanholder, 8,H oenich, 
Renal nursing. Vascular access techniques. Mack-  N. and Ringoir, S. Artiforgum, 6 (41, pp. 429-32 (Nov 
enzie, S.  Nurs Mirror, 160 (151, pp. 27-9 (Apr 10,  1982). Study ofhemodialysisp erformance and recir- 
1985). This article reviews the nursing techniques  culation ratios of subclavianc atheter hemodialysis is 
involved with subclavian catheters, femoral cathe  reported. Data are compared to the results obtained 
ters, and the Scribner shunt. Requirements for care  when a conventionalin~single-lumenhemodi- 
and complications of each are listed. Excellent tables  alysisneedleisusedundersimilarconditiom.H owever, 
listing the above in this article.  the differences were not significant, and overall ex- 
traction ratios, calculated for the entire dialysis pe- 
Evaluation tool for hemodialysis arterial-venous fis-  riod with both access methods in 43 patients, were 
tula needle.  Parker, J. Nephrol Nurse, 5 (3), p. 9  identical. Recirculation averaged l2.5%for the fistu- 
(MayJun 1983). This is a one-page format for eval-  lar approach and 20% for the subclavian approach. It 
uation of A-V fistula needles. It gives some reliable  is concluded that, as a whole, dialysis performance is 
and consistentg uidelinesfore valuation of the needle  somewhatl ower with the subclavianv ascular access 
most appropriate for the patient's needs.  method. 
Hemodialysis access site morbidity.  Aman, L.C.,  Percutaneous subclavian vein catheterization for 
Levin, N.W. and Smith, D.W. Pnx: Clin Dial %ns-  hemodialysis: a report of 57 insertions. Al-Mohaya, 
plant Forum, 10, pp. 277-84 (1980).  S., Sadat-Ali, M.,  Al-Muhanna, F.  and Ibrahim- 
Saeed, A Angiology, 40 (61, pp. 569-73 (Jun 1989). 
Developing a teaching unit on vascular access of a 
The authors report an analysis of 57 subclavian vein 
hemodialysis client.  Sell, D., Greenspan, B. and 
catheterizations for hemodialysis.  A total of  51 
Hess, M. AANNT J, 9 (3), pp. 10-25,66 (Jwi 1982). 
Quality Assurance Guidelines for Hernodialysis Devices  E-35  Appendix E (Cont.)  Chapter 9 
Annotated Bibliogmphy  Vascular Access Devices 
patients (34 men, 17 women) kept the Cobe single-  Nephml, 6 (5), pp. 339-45( 19 86). Personal experience 
and double-lumen catheters for 1,726 days.  Their  with subclavian vein cannulations for hemodialysis 
experience indicates that percutaneous subclavian  are given, and the pertinent literature on the subject 
vein catheterization is safe and provides quick access  is reviewed. Taking into account all the complica- 
for hemodialysis with no morbidity and mortality if  tions discussed, recommendations are made for the 
done correctly, patiently, and meticulously.  The  use of subclavian dialysis catheters. 
authors believe that this should be the first choice in 
patients with reversible renal failure and in patients  Subclavian vein thrombosis: a frequent complication 
with chronic renal failure, who are usually elderly  ofsubc]avianvein~annulationforhem~Vsa. nher- 
and medically compromised, until a permanent vas-  weghem, J.L.,  Yassine, T., Goldman, M., Vanden- 
cular access is ready for use.  bosch, G., Delcour, C., Struyven, J. and Kinnaert, P. 
Clin Nephrd, 26 (5),p p. 235-8 (Nov1986). Subclavian 
Clinical experience of arteriovenous fistulae for di-  vein cannulation was suggested as a temporary vas- 
alysis during an eighteen year period. Sisto, T. and  cular access for hemodialysis since one of its advan- 
Riekkinen, H. Ann Chir Gynaeool, 77 (3), pp. 108-10   tages was considered to be no damage to blood ves- 
(1988). 382 Brescia-Ciminot ype arteriovenousf istu-  sels. As they observed six patients with symptomatic 
lae were created for chronic haemodialysis. Success  subclavianveinthrombosisamongl48p atientshaving 
rate at the first attempt was 73.6% of281 cases. The  received subclavian vein cannulation for hemodialy- 
most common method of anastomosis was end to side  sis, theysystematicdyperformedsubclavianven~ 
vein to artery type.  Thrombosis was the most fre-  in 42 asymptomatic patients selected on the basis of 
quent complication, other miscellaneous complica-  a history of previous subclavian vein cannulation. 
tions were less common.  The authors conclude that the subclavian vein can- 
nulation leads to significant damages of the vessels, 
Complicationsf rom permanent hemodialysis vascu-  excluding a whole arm, for future vascular access in 
lar access.  Zibari, G.B., Rohr, MS., Landreneau,  some patients. 
M.D.,  Bridges, R.M.,  DeVault, GA, Petty, F.H., 
Costley, KJ., Brown, S.T. and McDonald, J.C. Sur-  High incidence of subclavian dialysis catheter-re- 
gery, 104 (41, pp. 681-6 (Oct 1988). Use of PTFE to  lated bacteremias. Pezzarossi, H.E., Ponce dehon, 
construct permanent hemodialysis vascular access  S., Calva, J.J., Lazo, de la Vega, S.A and Ruiz-Pala- 
has a signZcantly higher incidence of thrombosis,  cios, G.M. Infect Control, 7 (12), pp. 596-9 (Dec 1986). 
infection, pseudoaneurysm formation, and limb loss  This retrospectivec ohort study reviews the incidence 
(p less than 0.01 for all complications) and a signifi-  ofbacteremia in 48 patients undergoing hemodialy- 
cantly lower mean length of patency (p less than  sis using subclavian vein dialysis catheters (SDC) as 
0.0001) when compared with autogenous fistulas.  temporary vascular access. They found that the use 
Age, sex, hypertension, diabetes mellitus, and the  ofresterilizedc atheters was not arisk factor. Specific 
use of perioperative antibiotics were not found to be  guidelines for SDC insertion and care were estab- 
related significantly to access complications.  lished and followed, after which the infection fre- 
quency was reduced to 7.5% (1 episode per 45.5 
An evaluation of expanded polytetrafluoroethylene  patient-weeks ofcatheter use) in this high-risk popu- 
(PTFE) loop grafts in the thigh as vascular access for  lation. 
haemodialysisinpatients with access problems. Slater, 
N.D. and Raftery, AT. Ann R Coll SurgE  ngl, 70 (4),  Graft infection and baderemia with a tolerant G 
pp. 243-5 (Jul 1988).  A total of 21 patients with  form of Streptococcus sanguis in a patient receiving 
vascular access problems received 22 PTFE loop  hemodialysis. Chmel H. JClin Micmbwl, 24 (21, pp. 
graftsin the thigh asvascular accessforhaemodialysis.  294-5 (Aug1986). Reportofacase ofatolerant Gform 
Eighteen of 22 grafts supported haemodialysis dur-  Streptococcus sanguis infection involving an artifi- 
ing the patient's lifetime. Actuarial patient survival  cial vascular access site. The organism was isolated 
was 50% at two years with a cumulative graft pat-  from a pet dog of the patient. The organism was also 
ency in the survivors of 80.5%.  felt to be tolerant to penicillin. The patient was suc- 
cessfully treated by removal ofthe artificialg raft and 
Complications related to subclavian catheters for  intravenous erythromycin therapy. Microorganisms 
hemodialysis. Report and review. Vanherweghem,  acquired from nonhuman sources are potential pa- 
J.L., Cabolet, P., Dhaene, M., Goldman, M., Stolear,  thogens in the immunocompromised patient. 
J.C., Sabot, J.P., Waterlot, Y. and Marchal, M. Am J 
Quality Assurance Guidelines for Hernodialysis Devices  Appendh E (Cont.)  Chapter 9 
Annotated Bibliogmphy  Vm*  Access Devices 
Internal jugular vein cannulation using 2 silastic  Incidenceofsubclavian~catheter-~)ated~ons. 
catheters. Anew, simple and safe long-term vascular  Kozeny, G.A, Venezio, F.R, Bansal, V.K, Vertuno, 
access for extracorporeal treatment.  Canaud, B.,  L.L. and Hano, J.E.  Arch Intern Med, 144 (9), pp. 
Beraud, J.J., Joyeux, H. and Mion C. Nephron, 43 (2),  1787-9( Sep 1984). Report of more than 1,300 dialy- 
pp. 133-8 (1986).  Subclavian vein cannulation, al-  ses in 74 patients who have had subclavian dialysis 
though a major progress in temporary vascular ac-  catheters (SDCs) in place for a total of 3,065 days. 
cess, was associated with a significantm  orbidity and  Sixty-one of these patients (82%) have had their 
mortality. For the last two years, the authors devel-  SDCs in place for 7 to 21 days, including 37 (5Wo) for 
oped a new approach consisting in internal jugular  longer than 21 days. 
vein cannulation (IJVC) with two silicone rubber 
catheters with a long-term proved biocompatibility.  Complications of subclavian catheter hemodialysis: 
a 5-year prospective study in 257 consecutive pa- 
Infections associated with subclavian dialysis cathe-  tients.  Vanholder, R, Larneire, N., Verbanck, J., 
ters: the key role of nurse training. Vanherweghem,  vanRattinghe, R, Kunnen, M. and Ringoir, S. Int J 
J.L., Dhaene, M., Goldman, M., Stolear, J.C., Sabot,  Artif Organs, 5 (51, pp. 297-303 (Sep 1982).  The 
J.P., Waterlot, Y., Serruys, E. and Thayse, C. Neph-  complications related to  the use of  subclavian 
mn, 42 (2), pp. 116-9 (1986).  The incidence was  catheters for hemodialysis were prospectively stud- 
greater in hospitalizedpatients(15bacteremiasduring  ied in 257 consecutivea cute and chronic renal failure 
1,948 catheter days) than in ambulatory patients (2  patients.  Using 394 catheters, 3006 single needle 
bacteremias during 850 catheters-days) as well as  dialyseswereperformed Mosthazardouscomplications 
during a period corresponding to a greater number of  were sepsis (9), malposition (6), hemothorax (3), 
untrainednursesenrolledin the dialysist eam. During  bleeding(2), vena cava thrombosis (2), and pneurnot- 
this period, 6 sepsies occurred in 19 catheters (other  horax (2). 
periods: 7 sepsiedl16 catheters, p less than 0.01). Six 
of 28 nurses had less than three months of profes-  Single-needle venous dialysis: a comparison of three 
sional experience (other periods: 1o f 25, p less than  systems. Weinstein, AM., Frederick, P.M. and Sul- 
0.01).  These data underline the key role of nurse  livan, J.F. Uremia Invest 85,8 (2), pp. 69-77 (1984). 
training in the prevention of catheter-related infec-  A comparison of a pressurekime, a timdtime device, 
tions.  and a pressurdpressure device.  Recirculation was 
highestwiththe pressurdtime system,b ut was easily 
Staphylococcus aureus bacteremia in patients on  compensated for with higher blood flow of that sys- 
chronic hemodialysis.  Quarles, LD., Rutsky, E.A  tem.  Clearances actually measured were in good 
and Rostand, S.G. Am JKidney Dis, 6 (6),p p. 412-9  agreement with those predicted from theoreticalc on- 
(Dec 1985). Staphylococcus aureus bacteremia oc-  siderationso frecirculationa nd blood flowin acounter- 
curred 96 timesin 58of671 patients on chronichemo-  current dialysis system. 
dialysis during a nine-year period.  The authors 
suggest that chronic hemodialysis patients with S  High-flux hemodiafiltration: under six hourslweek 
aureus bacteremia have a relatively low mortality  treatment. vonAlbertini, B., Miller, J.H., Gardner, 
and a low risk of infective endocarditis.  Antibiotic  P.W. and Shinaberger, J.H.  Trmns Am  Soc Artif 
treatment should be given for atl east 28 daysin order  Intern Organs 1984,30 pp. 227-31. Better utilization 
to minimize the risk of relapse.  of existing high blood flow in mature vascular ac- 
cesses with the described new technique of simulta- 
Vascular access for hemodialysis. Patency rates and  neous high diffusion and convection results in a 
results of revision.  Palder, S.B., Kirkman, RL.,  marked increase of treatment efficiency.  Coupled 
Whittemore, AD., Hakirn, R.M., Lazarus, J.M. and  with the better tolerance to high solute and weight 
Tilney, N.L. Ann Surg, 202 (2), pp. 235-9 (Aug1985).  removal rates, this approach permits drastic reduc- 
Failures of Cimino fistulae usually occurred early in  tion of treatment time over conventional hemodialy- 
the postoperative period, secondary to attempts to  sis without sacrificing treatment adequacy. 
use inadequate veins. Thrombosis caused the major- 
ity of PTFE graft failures and was generally the  Blood recirculation duringhemodialysis with a coax- 
result of venous stenosis. Correction of such venous  ial counterflow single-needle blood access catheter. 
stenosis is mandatory to restore graft patency and  Ogden, D.A and Cohen, I.M.  Tr&ns Am Soc Artif 
can result in prolonged graR survival.  Intern Organs, 25, pp. 325-7 (1979). (1) The average 
Quality Assurance Guidelines for Hedialysis Devices  Appendix E (Cod  Chapter 9 
Annotated Bibliography  Vasculw Access Devices 
and the range of blood recirculation during hemodi-  Successlluseo fdouble-lumen, silicone rubber cathe- 
alysis employing a coaxial counterflow single needle  ters for permanent hemodialysis access.  Shuster- 
blood access catheter are markedly reduced com-  man, N.H., Kloss, K and Mullen, J.L. Kidney Int, 35 
pared to those observed in the same patients using a  (3), pp. 887-90 (Mar 1989), ISSN 0085-2538. 
standard 'Y" type needle and external flow direction 
control device.  (2) In a large group ofpatients, the  Topical anaesthesia for fistula cannulation in haem- 
average measured recirculation of blood of .8% at a  odialysis patients.  Watson, AR, Szymkiw, P. and 
blood flow rate of 200 drnin is sufficiently small as  Morgan, AG.  Nephrd Dial Transplant, 3 (6), pp. 
to have little or no effect on the efficiency of dialysis.  800-2 (1988).  A local anaesthetic cream (EMLA; 
(3) Recirculation increases with increasing extracor-  Astra) gave more pain relief and improved the ease of 
pored blood flow rate but remains sufficientlyl ow to  venepuncture compared to lignocainei njections. Pa- 
not significantly affect increased dialysis efficiency  tients expressed a strong preference for the EMLA 
obtained at higher blood flow rates. (4) The coaxial  cream,w hich has advantages that outweigh the cost 
counterflow single needle catheter permits single  and convenience factors. 
fistula puncture, eliminates the need for a flow direc- 
Subclavians tenosis: amajor complication ofsubclavian 
tion control device, and is associated with negligible 
dialysis catheters. Barrett, N., Spencer, S., McIvor, 
blood recirculation. 
J. and Brown, EA Nephd Dial Transplant, 3 (4), 
In-vivo measurement of blood recirculation during  pp. 4235 (19 88). Subclavian catheterisation is fre- 
'Y" type single needle dialysis. Ogden, D A  J Dial,  quently used for acute vascular access for haemodi- 
3 (2-3), pp. 265-76 (1979).  A method has been de-  alysis and is thought to rarely result in long-term 
scribed andvalidated for obtaining a sample ofblood,  clinical problems. Venography in 36 cases, however, 
without separate venapuncture, which has the same  revealed subclavian stenosis in 18( 50%), of whom 5 
urea and creatinine composition as systemic venous  developed clinical problems.  The incidence of sub- 
blood during hemodialysis. Using this technique, re-  clavian-vein stenosis was related to the duration of 
circulation in-vivo during "Y" type single needle  catheterisation 8 less than  0.05).  It may also be 
dialysis, measured in 20 bovine fistulas, ranged from  morecommoninblackp atients. Subclavianc atheteri- 
6.9% to 56.5% and averaged 19.4%. These results .  sation is therefore not necessarily an ideal form of 
suggest that fistula puncture methods and devices  acute vascular access. 
that eliminate recirculation in the ex-vivo blood 
circuit shouldbe used to maximize dialysise fficiency.  Recirculation: review, techniques for measurement, 
and ability to predict hemoaccess stenosisb efore and 
Topical thrombin and control of bleeding from the  after  angioplasty.  Nardi, L and Bosch, J. B M  
fistula puncture sites in dialyzed patients.  Vaziri,  PuriL 6 (21, pp. 85-9 (1988). The measurement of re- 
N.D. Nephmn, 24 (51, pp. 254-6 (1979). The length of  circulation duringtwo-needleh emodialysis provides 
bleedingfrom the puncture sites ofinternal arteriov-  valuable information about hemoaccess integrity 
enous channels was markedly reduced with the use  and indicates potential problems with possible com- 
of topical thrombin in 12p atients treated with hemo-  promiseofdialysis effectiveness (improperc learances). 
dialysis. This procedure can, therefore, save patient  Recirculation greater than 10% is an indication fbr 
and staff time, minimize recurrent blood loss with  further study. 
each dialysis, and prolong the life of vascular access 
Morbidity and mortality of central venous catheter 
by diminishing the length of potentially hazardous 
hemodialysis: a review of 10y ears' experience. Van- 
compression needed for proper hemostasis. 
holder, V., Hoenich, N. and Ringoir, S. Nephron, 47 
A review of  Hemodialysis Catheters and Access  (41, pp. 2749 (1987). The morbidity and mortality of 
Devices.  Hiclunan, RO. and Watkin, S.  Dial &  hemodialysis by internal central venous catheteriza- 
Transplant, p. 481 (Sep 1987). Abrief description of  tion in the subclavian and internal jugular positions 
the access devices, other than the A-V fistula, often  are reviewed. The most frequent complications were 
used in hemodialysis vascular access.  Article in-  inadequateflow(7.6%),inadvertentwithdrawal(5.6%), 
cludes a table that lists devices from 10 diferent  and bacteremia (5.1%  ). The overall complicationr ate 
manuPacturers by product, catheter, material, size  was 27.2%.  Kinking, bleeding, and bacteremia oc- 
maximum flows, priming volume, and other infor-  curred more frequently in patients with chronic renal 
mation. 
Quality Assurance Guidelines for Hemodialysis Devices  Appendix E (Cont.)  Chapter 9 
Annotated Bibliography  Vascular Access Devices 
failure, compared to patients with acute renal fail-  Cannulation of arteriovenous fistulae. Stansfield,G  . 
ure.  Baderemia occurred more frequently after  Nurs Times, 83 (4), pp. 38-9 (Jan 28-Feb 3 1987). 
prolonged periods of catheterization (greater than 10 
days).  The mortality of catheter dialysis could be  When avascular access site complicates care. Alt, D., 
estimated to be between 0 and 1. 25/l ,000 catheteri-  Balduf, R. and Thompson, E. RN,4 9 (lo), pp. 36-9 
zation~.  (Oct 1986).  High incidence of subclavian dialysis 
catheter-relatedb aderemias. Pezzarossi, H.E., Ponce 
Adequacy studies of fistula single-needle dialysis.  de Leon, S., Calva, J.J., Lazo, de la Vega, S.A and 
Vanholder, R, Hoenich, N. and Ringoir, S. Am J  Ruiz-Palacios, G.M.  Infect Control Dec 1986,7 (12) 
Kidney Dis, 10 (61, pp. 417-26 (Dec 1987). It is con-  pp. 596-9. This retrospective cohort study reviews 
cluded that urea kinetic data (KTN averaged 0.98)  the incidence of bacteremia in patients undergoing 
and other parameters of dialysis adequacy indicate  hemodialysis using subclavian vein dialysis cathe- 
that the efficiency ofthe single-needle technique is at  ters (SDC) as temporary vascular access. The pres- 
least as good as that obtained in the more currently  ence of possible risk factors for SDC-relatedb adere- 
used two-needle technique.  Fistula survival was  mia, includingdurationo fcatheterization andnumber 
higher, and hospitalization rate and mortality not  of hemodialysis procedures, were not statistically 
different from two-needle dialysis.  Subsequently,  differentw  hen patients with and without bacteremia 
the current reluctance towards single-needle dialysis  were compared, with the exception of a significantly 
as a routine procedure in chronic renal failure, a p   lower incidence of bacteremia among those patients 
pears to be unjustified.  receiving antibiotict herapy att he time ofcatheter in- 
sertion. The use of resterilized catheters was not a 
Thromboticcomplicationso findwellingcentral cathe-  risk factor. Specific guidelines for SDC insertion and 
ters used for chronic hemodialysis.  Caruana, R.J.,  care were established and followed, after which the 
Raja, RM., Zeit, R.M., Goldstein, S.J. and Kramer,  infection frequency was significantly reduced. 
MS. Am JKidney Dis, 9 (6), pp. 497-501 (Jun 1987). 
A new double-lumen silicone-rubber dialysis cathe-  Reassessment of fistula puncture site blood loss. 
ter, designed to be placed surgically in central veins,  Vaziri, N.D., Miyada, D.S., Saiki, J.K and Robinson, 
is now available. A review of the literature suggests  MA. JDial, 3 (4), pp. 361-6 (1979). Fistula puncture 
that pericatheter thrombus formation with or without  site blood loss during and after hemodialysis was 
occlusion of major veins has been a complication of  measured in 12 patients with end-stage renal dis- 
chronic centralvenouscatheterizationw  ith avariety  ease. The values obtained in this study are 5 to 10 
ofcatheters, inboth dialysis and nondialysis settings.  folds less than those found in the original reports. 
Recent advances in dialytic technology are probably 
Complications related to subclavian catheters for  responsible for the observed improvement.  The 
hemodialysis. Report and review. Vanherweghem,  results also suggest that Cimino A-V fistulas are 
J.L., Cabolet, P., Dhaene, M., Goldman, M., Stolear,  superior to the heterologous graft. 
J.C., Sabot, J.P., Waterlot, Y. and Marchal, M. Am J 
Nephd, 6 (5),p p. 33945 (1986). Complications in-  In flow  time and recirculation in  single-needle 
clude pneumothoraxes and hemothoraxes due to  hemodialysis. Blurnenthal, S.S., Ortiz, M.A, Mein- 
subclavian artery puncture; bacteremia related to  man, J.G. and Piering, W.F. Am J Kidney Dis, 8 (31, 
subclavian catheter infections; clinical evidences of  pp. 202-6 (Sep 1986). The recirculation of previously 
subclavian vein thrombosis; pericardial tamponade  dialyzed blood in the lumen of the single-needle 
due to right atrium perforation; and mediastinal  catheter reduces dialysis efficiency andis a drawback 
hematoma and right hemothorax due to superior  of  single-needle dialysis.  Maximizing the inflow 
vena cava perforation. Review of the literature indi-  volume is essential for minimizing recirculation in 
cates that  pneumothoraxes andlorhemothoraxes  single-needle hemodialysis. Clinically insignificant 
occurred in 1.7% of the catheter insertions and that  recirculation ensues when inflow time is maintained 
sepsis related to subclavian dialysis catheters oc-  between three to five seconds and time-time single- 
curred in 8.9% of the patients, as systematically  needle devices are used, even in patients dialyzed 
investigated subclavian vein thrombosis involved at  with single-lumen subclavian catheters. 
least 50% of the patients.  Taking into account all 
these complications,r ecommendations are made for 
the use of subclavian dialysis catheters. 
Quality Assurance Guidelines for Hemodialysis Devices  Appendix E (Cont.)  Chapter 9 
Annotated Bibliography  Vascular Access Devices 
A prospective study of the mechanisms of infection  the incidence was greater in hospitalized patients 
associated withhemodialysisc atheters. Cheesbrough,  than in ambulatory patients as well as during a 
J.S., Finch, RG., Burden, RP. J Infect Dis, 154 (4),  period correspondingtoa greakrnumberofuntrained 
pp. 579-89 (Oct 1986). Comparison of isolates with  nurses enrolled in the dialysis team.  These data 
skin cultures from the insertion site suggested that  underlinet hekeyr ole ofnurset rainingin thep revention 
the origin of the colonizing organisms was the skin  of catheter-related infections. 
(36% of total), intralumenal contamination (57%), or 
both routes (7%). Comparison of cultures taken dur-  Complications of vascular access in a dialysis popu- 
ing catheter insertion with those at removal rarely  lation.  Porter, JA, Sharp, W.V. and Walsh, E.J. 
suggested that organisms introduced at insertion  Curr Surg, 42 (4), pp. 298-300 (Jul-Aug 1985). 
caused subsequent colonization.  This study has 
High incidence of infectious complications with the 
demonstratedthatinfectiouscomplicationshmusing 
Hemasite vascular access device.  Barth, RH., 
subclavianhemodialysis catheters exceed reported 
Schwartz, S. and Lynn, RI.  Trans Am Soc Artif 
rates for all other modes of vascular access used for 
Intern Organs, 30, pp. 450-7 (1984). 
hemodialysis, as well as other indicationsf or central 
venous catheterization. 
Renal nursing. Vascular access techniques. Mack- 
enzie, S.  Nurs Mirror, 160 (15), pp. 27-9 (Apr 10, 
Subclavianhemodialys isc atheteri nfections. Dahlberg, 
1985). 
P.J., Yutuc, W.R and Newcomer, KL. Am JKidney 
Dis, 7 (5), pp. 421-7 (May 1986). Overall catheter 
A morphological study ofbacterial colonisation of in- 
colonization rate was 21- 6% and catheter-associated 
travenous cannulae. Cheesbrough, J.S., Elliott, T.S. 
bacteremia occurred in 9.4%.  Catheters removed 
and Finch, RG. J Med Microbiol, 19 (2), pp. 149- 
from febrile patients had much higher colonization 
57(Apr 1985).  Microbiological findings indicated 
(48.3%) and bacteremia (34.5%) rates. In a random- 
colonisation of the intravascular portion haemodi- 
ized study comparing infection rates in catheters 
alysis cannulae, largely with skin commensal organ- 
tunneled subcutaneously or not tunneled, there was 
isms. Surface defects on the cannulae were shown to 
no significant difference in the incidence ofinfection. 
be associated with microbial colonisation which oc- 
Catheters inserted over a guidewire to replace clotted 
curred either as isolated colonies or in association 
or malfknctioningc atheters were not associated with 
with a cellular fibrinous matrix. These observations 
higher infection rates. 
are illustrated and discussed. 
Prevention of thrombosis in arteriovenous fistulas. 
Fatal hemothorax caused by a subclavian hemodi- 
Uldall, R. Blood Purif, 3 (1-31, pp. 89-93 (1985). To 
alysis catheter.  Thoughts on prevention.  Tapson, 
prevent thrombosis in arteriovenous fistulas it is 
J.S., Uldall, P.R Arch Intern Med, 144 (8,p p. 1685- 
necessary to obtain the knowledgeable cooperation 
7 (Aug1984). A19-year-old woman died when a sub- 
not only of the whole health care team, but also ofthe 
clavian catheter that had provided vascular access 
patient.  The first step is preservation of forearm 
for plasmapheresis penetrated her right atrium, 
veins  by avoiding unnecessary venipunctures in 
pericardium, and parietal pleural, causing a hemot- 
patients with chronic renal failure. Avoidance of pre- 
horax. Precautions are recommended to minimize 
m a t u r e ~ c a n n u l a t i o n a n d c o f i e c t n ~  
the risk of this complication in patients in whom 
help to prevent vein wall damage. Alertness to the 
subclavian catheters are used as a vascular access 
presence of high venous pressures on dialysis and 
route for hemodialysis or plasmapheresis. 
observation ofinefficient dialysis due to recirculation 
should lead to detection ofnarrowed segments which 
Avoiding deaths from subclavian cannulation for 
can be surgically corrected before thrombosis occurs. 
hemodialysis. Tapson, J.S. and Uldall, R. Int JArtif 
Organs Sep 1983,6 (5) pp. 227-30. 
Infections associated with subclavian dialysis cathe- 
ters: the key role of nurse training. Vanherweghem, 
Infections associated with subclavianUldal1c atheters. 
J.L., Dhaene, M., Goldman, M., Stolear, J.C., Sabot, 
Sherertz, RJ., Falk, RJ., Huffman, KA, Thomann, 
J.P., Waterlot, Y., Serruys, E. and Thayse, C. Neph- 
CAa nd Mattern, WD. Arch Intern Med, 143( 11, pp. 
ron, 42 (2), pp. 116-9 (1986). The incidence of sepsis 
52-6 (Jan 1983). The incidence of UC site infection 
was not significantly greater in diabetic patients, in 
and bacteremia based was higher than the incidence 
patients with corticotherapy or in patients present- 
of infection reported with any other type of vascular 
ing an underlying systemic disease. On the contrary, 
access for hemodialysis. 
Quality Assurance Guidelines for HernodialysisD  evices  Appendix E (Cont.) 
Annotated Biblwgrmphy 
Chapter 10 
Hemodialyzer Reuse 
Release of pyrogens during clinical hemodialysis.  ministration, surveyed 1350 chronic hemodialysis 
Weingast, J.A, VanDeKerkhove, KM., Eiger, S.M.,  centers in the United Statest o ascertain practices as- 
Kluger, M.J. and Port, F.K  Trans Am Soc Artif  sociated with the reuse of disposable hemodialyzers 
Intern Organs, 31, pp. 359-62 (1985).  and the frequencyo fpyrogenicr eactions and septice- 
mia among patients.  Reusing hemodialyzers more 
Pathogenesiso ffever duringhemodialysis. Dinarello,  than 20 times and, in some instances, also using 
C.A  Contrib Nephml, 36, pp. 90-9 (1983).  manual reprocessings ystems was significantlya sso- 
ciated with clustering of pyrogenic reactions regard- 
Beta 2-microglobulink ineticsin maintenance hemodi- 
less of the type of germicide used. To detect mem- 
alysis: a comparison of conventional and high-flux 
brane leaks developing after multiple reuses, air- 
dialyzers and the effectsofdialyzerreuse. DiRaimondo, 
pressure-leak tests should be performed on all re- 
C.R. and Pollak, V.E.  Am J Kidney Dis, 13 (5), pp. 
processed hemodialyzers. 
390-5 (May 1989). To define the kinetics of beta 2M 
during hemodialysis and the effects of dialyzer re-  Effects of disinfectants in renal dialysis patients. 
processing, serum beta 2M, plasma C3a, and neutro-  Klein, E. Envhn Health Perspect, 69, pp. 45-7 (Nov 
phi1 counts were measured immediately predialysis,  1986). Overview of the risks andhazards of avariety 
15,90,a nd 180m  inutes after beginning dialysis, and  of disinfectants used in hemodialysis. 
15m  inutes postdialysis in ten chronic hemodialysis 
patients.  Complement activation and neutropenia  Effect of multiple use of dialyzers on intradialytic 
during dialysis were significantly more marked with  symptoms.  Bok, D.V.,  Pascual, L., Herberger, C., 
cuprammonium, but were not affected by reprocess-  Sawyer, R and Levin, N.W.  Pmc Clin Dial Trans- 
ing ofeither dialyzer. In-vitm adsorption ofl24I-beta  plant Forum, 10, pp. 92-9 (1980).  Patients were 
2M to polysulfone fibers was greater than to cupram-  dialyzed on new and reused dialyzers via a double 
moniurn; adsorption was not influenced by dialyzer  blind study. Incidents of many intradialytic syrnp- 
reprocessing.  tomsincluding chest pain, back pain, andnausea and 
vomiting were significantly reduced with reused 
Prevalence of nontuberculous mycobacteria in water  dialyzers as compared to new dialyzers. 
supplieso fhemodialysisc enters. Carson, L.A, Bland, 
L.A, Cusick, L.B., Favero, M.S., Bolan, G.A, Rein-  Mass transport in reused dialyzers. Gotch, F.A Pnx: 
gold, AL. and Good, R.C. Appl Envimn Microbwl, 54  Clin Dial Transplant Forum, 10, pp. 81-5 (1980). 
(12), pp. 3122-5(Dec 1988). This study was conducted 
to determine the prevalence ofN!l?Man d other bacte-  Prevention of anti-N like antibodies development 
ria in water samples collected over a 13-weekp eriod  with nonformaldehyde reuse procedure. Man,N .K, 
from 115 randomly selected dialysis centers in the  Lebkiri, B., Polo, P., desainte-Lorette, E., Lemaire, 
United States. The results of this study support rec-  A and Funck-Brentano, J.L. Pm Clin Dial Truns- 
ommendationst ouse 4% HCHO or a chemical germi-  plant Forum, 10, pp. 18-21 (1980). 
cidal equivalent for disinfectingd ialyzers that are to 
Bacterial endotoxin in new and reused hemodialyz- 
be reused. 
ers: a potential cause of endotoxemia Petersen, N. J., 
Reuse of hemodialyzers. Results of nationwide sur-  Carson, LA and Favero MS.  Trans Am Soc Artif 
veillance for adverse effects.  Alter, M.J., Favero,  Intern Organs, 27, pp. 155-60 (1981). New dialyzers 
M.S., Miller, J.K, Coleman, P.J. and Bland, L.A  may contain an LAL-reactive material, but it is not 
Hepatitis Branch, Centers for Disease Control, At-  pyrogenic.  However, if reuse dialyzers are reproc- 
lanta, GA30333. JAMA, 26O(l4),p p. 2073-6 (Oct 14,  essed and stored with a disinfectantt hat contains en- 
1988). In 1986, the Centers for Disease Control, in  dotoxin, that pyrogenic material may stay in the 
collaboration with the Health Care Financing Ad-  membrane even &r  rinseout of the disinfectant. 
Quality Assurwce Guidelines for Hernodialysis Devices  E-41  Appendix E (Cont.)  Chapter 10 
Annotated Bibliography  HemodialyzerR euse 
Methods for avoiding introduction of this endotoxin  (Clinitesttablets,S chifPsreagent, Formalert Formotest) 
to the patient includes discarding the recirculating  were compared. Two methods (ScMsr eagent and 
solution to waste. Water used for dilution of germi-  Clinitest) were inadequate in detecting low concen- 
cide should be endotoxin-free.  trations of formaldehyde and were associated with 
false positives from interference by chemicals con- 
. Effect of first and subsequent use of hemodialyzers  tained in the dialysate. False positives were demon- 
on patient well-being: the rise and fall of a syndrome  strated with one (Formotest) while the other was 
associated with new dialyzer use.  Charoenpanich,  capable of detectingformaldehydec oncentrations as 
R,P ollak,V.E., Kant, KS., Robson, M.D. and Cathey,  low as4.5mgfl. Recommended to select the most sen- 
M.  Artif Organs, 11 (2), pp. 123-7 (Apr 1987). In a  sitive of these semiquantitative techniques for rou- 
single large dialysis unit in which dialyzers are  tine use and to perform regular screeningf or anti-N 
routinely subjected to multiple use, the incidence  antibodies and to periodically check formaldehyde 
rates of intradialytic symptoms during first use and  levels by the use of the highly specific Hantzsch 
reuse were compared. The results of this investiga-  reaction. 
tion suggest that subjecting dialyzers to anauto- 
mated reuse processing system before first use can  Hemodialysisn eutropenia and dialyzer reuse: role of 
markedly diminish the incidence of first-use syn-  the cleansing agent.  Gagnon, RF. and Kaye, M. 
drome.  Uremia Invest, 8 (I), pp. 17-23 (1984). As part of a 
study to evaluate the safety and efficacy of dialyzer 
Repeated use of dialyzers is safe: long-term observa-  reuse, a comparatives tudy oftwo methods ofdialyzer 
tions on morbidity and mortality in patients with  reprocessing, manual and automated,w  as conducted. 
end-stage renal disease.  Pollak, V.E.,  Kant, KS.,  Five stable end-stage renal disease patients on cen- 
Parnell, S.L. and Levin, N.W.  Nephron, 42 (31, pp.  ter hemodialysis were evaluated as to hematological 
217-23 (1986). Through the examination of morbid-  and metabolic parameters throughout two series of 
ity and mortality figures the authors suggest that  three consecutive dialyses using first new and then 
there are no adverse long-term effects ofmultipleu se  reused dialyzersr eprocessed according to each of the 
of dialyzers.  two methods.  It would be reasonable to conclude 
from these results that amongthe various differences 
National Kidney Foundation revised standards for 
betweenthetwo~mceSSingmethods,restoratim 
reuse of hemodialyzers. Am JKidney Dis, 3 (61, pp. 
of the original level of biocompatibility of the reused 
466-8 (May 1984). The National Kidney Foundation, 
dialyzer's membrane is related to the concentration 
Inc convened a group with expertise and experience 
of the cleansing agent. 
in dialysis, including one or more physicians, nurses, 
consumers (patients), industry representatives, and  Nursing aspects of dialyzer reuse. Baldasseroni, A 
microbiologistst o formulate the described standards,  JNephml Nurs, 1( I), pp. 17-9 (Jul-Aug 1984). 
which were subsequently approved by the Executive 
Committee of the National Kidney Foundation at its  Leukopenia with different regenerated haemodialy- 
December 2,1983 meeting.  sis membranes. Ksiazek, A,S oko-Lowska,G  ., Marc- 
zewski, K and Solski J. Int Uml Nephrol, 16( 11, pp. 
Dialyzerreuse in alarge dialysisp rogram. Luehrnann,  61-7 (1984). The white blood cell count CWBC) de- 
D.,  Hirsch, D., Carlson, G., Constantini, E. and  creases during haemodialysis and was investigated 
Keshaviah, P. TransA  m Sue ArtifIntern Organs, 28,  as a bction of different dialysis membranes. Each 
pp. 76-80 (1982).  of them was used four times, applying different ster- 
ilization methods. The results indicate differences in 
Morbidity ofnondiabetich ome hemodialysispatients 
biocompatibility  between  cuprophan  and PAN 
with and without dialyzer reuse.  Siemsen, A.W., 
membranes, independent of the sterilization method 
Wong,E.G., Sugihara, J.G. andMusgrave,J .E. Tians 
employed. 
Am Soc Artif Intern Organs, 28, pp. 385-6 (1982). 
Anaphylat0xinfarmationduringhemodiatysis:mparison 
Some aspects of residual formaldehyde testing when 
of new and reused dialyzers.  Chenoweth, D.E., 
reusinghaemodialysers. Woffindin, C. and Hoenich, 
Cheung, AK, Ward, D.M. and Henderson, L.W. 
N A  Int JArtif Organs, 8 (6), pp. 313-8 (Nov 1985). 
Kidney Int, 24 (6)p p. 7704 (Dec 1983). Hemodialysis 
To assess the adequacy of quantifying residual for- 
of 11 end stage renal failure patients with new 
maldehyde concentrations when reusing, four semi- 
cuprophan hollow fiber dialyzers produced signifi- 
quantitative methods of concentration estimation 
cant leukopenia as well as increased plasma levels of 
Quality Assurance Guidelines for Hernodialysis Devices  E-42  Appendix E (Cont.)  Chapter 10 
Anndated Bibliography  Hemodiulyzer Reuse 
both C3a and C5a antigens during the initial phases  stage renal disease. The data obtained demonstrate 
of the procedure.  These observations suggest that  that membrane permeability to small solutes (urea, 
C3b deposition on the cellulosic membrane surface  creatinine, phosphate) is maintained up to thirty 
durinfirstuse markedly diminishesthe complementr  dialyzer uses. In-vitro studies confirmed this obser- 
activating potential of cuprophan dialyzers when  vation and established that clearances of larger sol- 
they are subsequently reused.  utes (vitamin B12) are also maintained over similar 
extensive dialyzer reuse. Thus, these results clearly 
Formaldehyde kinetics in reused dialyzers. Gotch,  demonstrate that prolonged dialyzer reuse in end- 
F A  and Keen, M.L.  Trans Am Soc Artif Znten  stage renal disease patients constitutes a stable form 
Organs, 29 pp. 396-401 (1983).  of renal replacement therapy provided adequate dia- 
lyzer reprocessing is applied. 
Kidneydialysis:ambientformaldehydelevels.S mith, 
KA Jr,W  illiams, P.L.,Middendorf, P.J. andZakray-  Biocompatibility of dialysis membranes: effects of 
sek, N. Am Znd Hyg Assoc J, 45 (I), pp. 48-50 (Jan  chronic complement activation. Hakim, R.M., Fea- 
1984). Ambient levels offormaldehydei n kidney di-  ron, D.T., Lazarus, J.M. Kidney Znt, 26 (21, pp. 194 
alysis units were discussed.  Five kidney dialysis  200 (Aug 1984). Reuse decreases the capacity of the 
clinics were surveyed and air sampling was per-  cuprophane membrane to activate complement but 
formed in all major work areas. Formaldehydelevels  does not significantly alter the capacity of cellulose 
were found to be below theTLVof 1.O  part per million  acetate membranes. The extent of complement acti- 
(ppm)i n all samples and the mean ambient level was  vation paralleled the ability of these membranes to 
below 0.5 ppm.  Feasible engineering controls that  induce neutropenia Recurrent dialysis with new cu- 
would further reduce or eliminate potential em-  prophane and cellulose acetate membranes leads to 
ployee exposures were identified.  a decrease in pre-dialysisa nd "rebound leukocytosisn 
neutrophil count, as well as amore intense activation 
Microbiologic evaluation of a new glutaraldehyde- 
of complement and an enhanced endogenous clear- 
based disinfectant for hemodialysis systems.  Pe- 
ance ofproducts of complement activation. The clini- 
tersen, N.J., Carson, L.A, Doto, I.L., Aguero, S.M. 
cal sequelae of recurrent complement activation are 
and Favero, M.S. Trans Am SocArtifZntern Organs, 
discussed. 
28 pp. 287-90 (1982). Development of anti-N-like 
antibodies during formaldehyde reuse in spite of  Formaldehyde-related antibodies in hemodialysis 
adequate predialysis rinsing. Vanholder, R., Noens,  patients. Sander, S.G., Sharon, R., Bush,M., Stroup, 
L., DeSmet, R. and Ringoir, S. Am JKidney Dis Jun  M. and Sabo, B. Transfusion, 19( 6), pp. 682-7 (Nov- 
1988,ll (6) pp. 477-80.  Five of 50 patients (10%)  Dec 1979). Sera from patients dialyzed with dispos- 
became positive for anti-N-like antibodies 6 to 14  able membranes neither had anti-N-likea ctivity nor 
months &r  the start of formaldehyde reuse, indi-  agglutinated formaldehyde-treated red blood cells. 
cating that even a careful control of effluent formal-  These findings are consistent with the hypothesis 
dehyde concentration cannot prevent the occurrence  that anti-N-like reactions of hemodialysis patients' 
of this abnormality.  sera represent cross reactions of formaldehyde re- 
lated antibodies with N antigens of normal red blood 
Cuprophan reuse and intradialytic changes of lung 
cells. 
diffusion capacity and blood gases. Vanholder, R.C., 
Pauwels,R.k, Vandenbogaerde, J.F., Lamont, H.H.,  Haemolysis due to formaldehyde-induced anti-N- 
Van der Straeten, M.E.a nd Ringoir, S.M. Kidney Znt,  like antibodies in haemodialysis patients. Fassbin- 
32 (I), pp. 117-22 (Jul1987). Reuse of cuprophan  der, W., Frei, U. and Koch, KM. Klin Wochenschr, 57 
dialyzers significantly attenuated the fall in leuko-  (13), pp. 673-9 (Jul3,1979). During reuse of formal- 
cyte counts and the rise in C3a des Arg seen during  dehyde sterilized Kiil-dialysers, red cell survival was 
first use dialysis.  Drop in arterial pa02 normally  significantly reduced in patients with anti-N-like 
seen with Cuprophan dialysis was not seen when the  positive sera, when compared with 19a ntibody nega- 
dialyzer was reused.  tive control patients. Replacement of formaldehyde 
sterilized dialysers by ethylene-oxide sterilized dis- 
Dialyzer performance over prolonged reuse.  Gag- 
posable dialysers resulted in a significant increase in 
non, R.F. and Kaye, M. Clin Nephrd, 24 (11, pp. 21-  hematomit. This improvement took place, although 
7 (Jul1985). Studies were performed in patients on 
antibody titres declined only slowly. The data dem- 
maintenance hemodialysis to evaluate the role of 
onstrate that formaldehyde sterilisation of dialysers 
prolonged dialyzer reuse in the management of end- 
may cause antibody-mediatedh aemolysis contribut- 
Quality Assurance Guidilines for Hernodialysis Devices  E-43  Appendix E (Cant.)  Chapter 10 
Annotated Biblwgmphy  Hemodialyzer Reuse 
ing to the extent of renal anaemia  This immu-  Multiple use of dialyzers: safety and efficacy. Kant, 
nohaemoly sismay be corrected, in spite of continuing  KS., Pollak, V.E., Cathey, M., Goetz, D. and Berlin, 
antibody persistance, when formaldehyde exposure  R. Kidney Int, 19 (5), pp. 728-38 (May 1981). The 
is totally avoided, or possibly when minimized.  practice of multiple use of dialyzers was examined 
over a 15-month period on all 104 patients in a 
h e d i n g so  f the National Workshop on Reuse of  chronic  maintenance hemodialysis facility.  The 
Consurnables in Hedialysis.  Sadler, J.H. Cedl.  incidence of complicationsd uring dialysis, of compli- 
Kidney Disease Coalition:W  ashington, DC (300 pp.).  cationst hat might be related to infection,a nd the rate 
ofhospitalization was not greater in the unit practic- 
Hemodialyzer Reuse: Issues & Solutwns (an AAMI 
ing multiple use as compared with the rates in the 
Analysis and Review). Association for the Advance- 
unit practicingsingleuse. Events possibly associated 
ment ofMedical Instrumentation;Arlington,VA,( 76 
with infection did not occur more frequently during 
pp.) (1985).  A review of dialyzer reuse including 
dialyses in which the dialyzerh ad been usedbetween 
cleaning, disinfection, and associated chemical haz- 
2 and 20 times than they did with the initial use ofthe 
ards, quality control, and practical considerations. 
dialyzer. With successive dialyzer use, there was no 
signzcant change in the ability to remove fluid or in 
Occupational Exposure to Formaldehyde.  29 CFR 
the dialysance of urea and creatinine.  The neu- 
Parts 1910  and 1926. Federal Register (December 4, 
tropenia that characteristically occurs early in dialy- 
1987). 
sis was substantially less with reused dialyzerst han 
with their initial use. Under the operating conditions 
Highlightso fASN Special Workshop on Reuse. Rice- 
Coplin, K and Vlchek, D. Dial & Transplant, p. 140  described, theauthors conclude thatmultiple dialyzer 
use over a 15-month period is safe, efficacious, and is 
(Mar 1987).  Discussion of several topical issues: 
not associated with an increased rate of infection, of 
alcide degredation of dialyzer membranes, sinking of 
morbidity, or of mortality. 
formaldehyde with subsequent rebound, absence of 
evidence regarding formaldehyde's carcinogenicity, 
Formation of anti-N-like antibodies in dialysis pa- 
effect of sodium hypochlorite on biocompatability 
tients: effect of different methods of dialyzer rinsing 
factor associated with reuse. 
to remove formaldehyde. Lewis, KJ., Dewar, P.J., 
Ward, M.K and Kerr, D.N. Clin Nephrol, 5 (11, pp. 
Effect of chemical germicides on the integrity of 
hemodialyzerm  embranes. Bland, LA,F avero, M.S.,  39-43 (Jan 1981). Use of formalin to sterilize dialyz- 
~rrow,G.S.,Aguero,S.M.,Searcy,B.P.andDaniel-e rs is known to be responsible for the formation of 
anti-N-iikeantibodyinlong-termhemodialysispatients. 
son, J.W.  MAIO Dam, 34 (31, p. 172-5 (Jul-Sep 
Patients dialyzed as in-patients using formalin were 
1988).  Epidemiologic investigations of bacteremia 
found to be completely free of anti-N-like antibody, 
in dialysis patients by the Centers for Disease Con- 
while among those on home dialysis, there was ahigh 
trol (CDC) identified an association with the use of 
prevalence (31%) and incidence.  The hospital pa- 
dialyzers disinfected with a specific chemical germi- 
tients were found to be receiving concentrations of 
cide. A collaborative study by the CDC and the Food 
formaldehyde less than 1m  icrograndml while those 
and Drug Administration (FDA) was conducted to 
on home dialysis received 3-13m  icrogramdml. This 
determine the effect of dialyzer disinfectants on five 
is offered as an explanation for the absence of anti-N- 
types  of  dialyzer  membranes:  three cellulosic 
antibodyi n patients usingformalin-sterilizedd ialyz- 
(Cuprophan, celluloseacetate,c uprammoniumrayon); 
ers. 
and two synthetic (polysulfone, polyacrylonitrile). 
The disinfectants tested were 4%  formaldehyde; 
Relationshipbetweenf ormaldehyde-related antibod- 
Renalin; Cidex Dialyzer; Sporicidin HO; Warexin; 
ies and cross-reacting anti-N-like antibodies in pa- 
and RenNew-D.  Water was the control.  These 
tients undergoing chronich aemodialysis. Sharon, R 
results and those obtained from epidemiologic stud- 
JClin Path01 ,34(1), pp. 41-3 (Jan 1981). An attempt 
ies suggest that membrane integrity testing (e.g. an 
was made to determine the sequence of events lead- 
air-leak test) shouldbe an integral part of dialyzerre- 
ing to the production of two distinct antibodies in 
processing. 
patients with chronic renal failure who regularly 
undergo haemodialysis with formaldehyde reused 
Effect of multiple use of dialyzers on intradialytic 
symptoms.  Bok, D.V., Pascual, L., Herberger, C.,  dialyzers. The production of anti-formaldehyder ed 
Sawyer, R and Levin, N.W.  P m C lin Dial Trans-  cells started about six months after the beginning of 
plant Forum, 10, pp. 92-9 (19 80).  haemodialysis treatment.  Only when the titre of 
Quality Assurance Guidelines for Hernodialysis Devices  E-44  Appendix E (Cant.)  Chapter 10 
Annotated Biblwgmphy  Hemodialyzer Reuse 
these antibodies reached 64 or 128 another, appar-  at least one HBsAg-positive patient. The practice of 
ently cross-reacting, antibody appeared which re-  reusing dialyzers does not appear to be associated 
acted like an anti-N antibody. A strong direct an-  with increased risk of hepatitis B infection among 
tiglobulin reaction was found to be positive for for-  patients and staff. 
malin-treated red cells after five minutes of contact 
with specific antibody, indicating a high W t y o f  Effect of dialyzer reprocessing methods on comple- 
the antibody of the formalin-altered red cell.  ment activation and hemodialyzer-related symp 
toms. Durnler, F., Zasuwa, G. and Levin, N.W. Artif 
Effect of multiple use of dialyzers on hepatitis B  Organs, 11 (21, pp. 128-31 (Apr 1987). The effects of 
incidence in patients and staff. Favero, M.S., Deane,  different dialyzer processingmethodsa nd ofreuse on 
N., Leger, RT. and Sosin, AE. JAMA, 245 (2), pp.  complement activation and dialyzer-related symp- 
166-7 (Jan 9,1981). Data pertaining to incidence of  toms were studied in 96 maintenance hemodialysis 
hepatitis B fiom a 1976 Center for Disease Control  patients. The percentage of patients without symp- 
Study were matched with responses fiom a Renal  toms during dialysis was sigdicantly greater with 
Physicians Association survey on dialyzer reuse in  reused dialyzerst han with new dialyzers. The sever- 
the United States.  Incidence of infection of staff  ity  of  total  symptoms correlated significantly 
having atl east one HBsAg positive patient was 2.9%  (p=0.0004)w ith complement activation. The results 
incenterspracticingreusevs.3 .6%in centerspractic-  suggest that total symptoms during dialysis are 
ing single use.  Nearly all (95%) staff who became  correlated with the degree of complement activation. 
HBsAg positive were associated with centers having  However, trends in the data pertaining to chest pain 
suggest that factors other than complement activa- 
tion may be important in the pathogenesis of some 
dialyzer-related symptoms. 
Quality Assurance Guidelinesf or Hentodialysis Devices  FDA 87-4217  Proceedings of the First International Conference of Medical Devices Regulatory 
Authorities (ICMDRA) -June 2-6,1986 (PB 88-123005/AS, $25.95). 
FDA 87-4218  Have a New Medical Device? (brochure). 
FDA 87-4221  Regulatory Requirements for Devices for the Handicapped (PB 88-123013/AS, 
$12.95). 
FDA 87-4222  An Introduction to Medical Device Regulations (pamphlet). 
FDA 87-4223  Classifying Your Medical Devices (brochure). 
FDA 87-4224  In Vitro Diagnostic Devices:  Guidance for the Preparation of 510(k) Submissions 
(PB 88-121801/AS, $14.95). 
FDA 88-4160  Import and Export - Regulatory Requirements for Medical Devices (August 
1988)(GPO 017-012-00336-2, $2.25) (PB 89-121859/AS, $13.95). 
FDA 88-4225  Review and Summary of Hemodialysis System Investigative Reports from 
California, the District of  Columbia, Massachusetts and Ohio (PB 88-121793/AS, 
$19.95). 
FDA 88-4226  Medical Device Reporting Questions and Answers (February 1988) (PB 88- 
192737/AS, $14.95). 
FDA 88-4227  Export of Medical Devices:  A Workshop Manual (September 1988) (GPO 017-012- 
00338-9, $10.00) (PB 89-119663/AS, $28.95). 
FDA 88-4228  Import of Medical Devices: A Workshop Manual (September 1988) (Supersedes FDA 
83-4167) (GPO 017-012-00337-1, $8.50) (PB 89-119671/AS, $21.95). 
FDA 88-4229  Applications of DNA Probes for the Diagnosis of Human Infectious Diseases:  An 
Overview (September 1988) (PB 89-120497/AS, $15.95). 
FDA 89-4158  Premarket Notification:  510(k) - Regulatory Requirements for Medical Devices 
(November 1988) (GPO 017-012-00342-7, $3.75) (PB 89-145312/AS, $15.95). 
FDA 89-4159  Investigational Device Exemptions - Regulatory Requirements for Medical Devices 
(May 1989) (Supersedes FDA 83-4159) (GPO 017-012-00346-0, $5.00) (PB 90- 
128927, $23.00). 
FDA 89-4165  Regulatory Requirements for Medical Devices - A Workshop Manual - Fourth 
Edition (May 1989) (Supersedes FDA 85-4165) (GPO 017-012-00344-3, $18.00) (PB 
89-215388/AS, $36.95). 
FDA 89-4203  Labeling - Regulatory Requirements for Medical Devices (May 1989) (Supersedes 
FDA 86-4203) (GPO 017-012-00345-1, $2.75) (PB 90-131418/AS, $17.00). 
FDA 89-4231  Nursing and Technology:  Moving Into the 21st Century - Conference Proceedings - 
May 16-18,1988 - Annapolis, MD (April 1989) (GPO 017-015-00237-3, $6.00) (PB 90- 
100710/AS, $21.95). 
FDA 89-4232  Yorick: The CDRH Bionic Skeleton (pamphlet). 
FDA 89-4234  A Manual on Water Treatment for Hemodialysis (July 1989) (PB 90-121211/AS, 
$31.00). 
FDA 90-4219  Medical Devices Standards Activities Report (Supersedes FDA 87-4219) (PB 90- 
180134/AS, $23.00). 
FDA 90-4235  Device Recalls:  A Study of Quality problems (January 1990) (PB 90-181272/AS, 
$15.00). 
FDA 90-4237  The Device Priority Model:  Development and Applications (October 1989) (PB 90- 
165937/AS, $17.00). 
FDA 90-4238  Replacement and Repair of the Visual System:  I.  Visual Prosthetics  11.  Retinal 
Transplants - A Review (October 1989) (PB 90-181298/AS, $17.00). 
FDA 90-4239  Condoms and Sexually Transmitted Diseases - Especially AIDS (booklet). 
FDA 90-4240  AIDS-Information for the Dialysis Patient (pamphlet). 
FDA 90-4241  AIDS-Information for the Dialysis Health Professional (pamphlet).  U.S. DEPARTMENT OF 
HEALTH AND HUMAN SERVICES  SPECIAL FOURTH CLASS RATE 
POSTAGE AND FEES PAID 
Public Health Service  PHSlFDA 
Food and Drug Administration  PERMIT NO. G-285 
Center for Devices and Radiological Health 
Rockville, Maryland 20857 
OFFICIAL BUSINESS 
PENALTY FOR PRIVATE USE, $300