Reprocessing Medical Devices in 
Health Care Settings: Validation 
Methods and Labeling 
Guidance for Industry and Food and 
Drug Administration Staff
 
Document issued on: March 17, 2015 
Appendix E of this guidance was updated on June 9, 2017. 
This document supersedes: Labeling Reusable Medical Devices for 
Reprocessing in Health Care Facilities: FDA Reviewer Guidance issued 
April 1996. 
The draft of this document was issued on May 2, 2011. 
For questions regarding devices regulated by the Center for Devices and Radiological Health, 
contact the Infection Control Devices Branch (INCB) at (301) 796-5580. For questions regarding 
devices regulated by the Center for Biologics Evaluation and Research (CBER), contact the 
Office of Communication, Outreach and Development at 800-835-4709 or 240-402-7800. 
 
 
 
      U.S. Department of Health and Human Services 
  Food and Drug Administration 
  Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research  Contains Nonbinding Recommendations 
 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852. Identify all comments with the docket number FDA-2011-D-0293. Comments may not be 
acted upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 1748 to identify the guidance you are requesting. 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER) 
by written request from the Office of Communication, Outreach and Development (OCOD), 
10903 New Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20993-0002, or by calling 
1-800-835-4709 or 240-402-7800, by email, ocod@fda.hhs.gov, or from the Internet at  
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm.  Contains Nonbinding Recommendations 
 
Table of Contents 
I.  INTRODUCTION .................................................................................................................1
II.  BACKGROUND...................................................................................................................2
III.  SCOPE...................................................................................................................................2
Exclusions...........................................................................................................................3
IV.  GENERAL CONSIDERATIONS FOR REUSABLE MEDICAL DEVICES................4
A.  Design of Reusable Medical Devices.........................................................................4
B.  Ensuring the Safety of Reusable Medical Devices.....................................................4
V.  GENERAL CONSIDERATIONS FOR REPROCESSING INSTRUCTIONS IN 
DEVICE LABELING ...................................................................................................................4
A.  Overview of Reprocessing ..........................................................................................5
B.  Resources for Developing Reprocessing Instructions................................................6
C.  Human Factors in Developing Reprocessing Instructions ..........................................7
VI.  FDAS SIX CRITERIA FOR REPROCESSING INSTRUCTIONS ...............................8
Criterion 1.  Labeling should reflect the intended use of the device. ................................8
Criterion 2.  Reprocessing instructions for reusable devices should advise users to 
thoroughly clean the device. ...............................................................................................9
Criterion 3.  Reprocessing instructions should indicate the appropriate microbicidal 
process for the device..........................................................................................................9
Criterion 4.  Reprocessing instructions should be technically feasible and include only 
devices and accessories that are legally marketed. ........................................................... 12
Criterion 5.  Reprocessing instructions should be comprehensive. ................................. 13
Criterion 6.  Reprocessing instructions should be understandable. ................................. 21
VII. VALIDATION OF REPROCESSING METHODS IN ACCORDANCE WITH THE 
QUALITY SYSTEM REGULATION ...................................................................................... 22
VIII. VALIDATION OF CLEANING PROCESS .................................................................. 23
A.  Validation of the Cleaning Process Using Worst-Case Testing ............................... 23
B.  Resources for Establishing Simulated Use Protocols ............................................... 27
IX.  VALIDATION OF THE FINAL MICROBICIDAL PROCESS TO PREPARE THE 
DEVICE FOR THE NEXT PATIENT ..................................................................................... 28
A.  Disinfection ............................................................................................................... 28
B.  Sterilization ............................................................................................................... 28
X.  FDA REVIEW OF REPROCESSING INSTRUCTIONS AND DOCUMENTATION 
OF REPROCESSING METHOD VALIDATION IN SUBMISSIONS ................................ 28
A.  Documentation in 510(k)s ......................................................................................... 29
B.  Documentation in PMAs, HDEs and De Novo Requests ......................................... 30
C.  Documentation in IDEs ............................................................................................. 30
APPENDIX A.  DEFINITION OF TERMS ............................................................................. 32
APPENDIX B.  OVERVIEW OF REUSABLE MEDICAL DEVICE REPROCESSING .. 35
APPENDIX C.  EXAMPLES OF STERILIZATION CYCLES USED IN HEALTH CARE 
SETTINGS................................................................................................................................... 36 Contains Nonbinding Recommendations 
 
APPENDIX D.  DESCENDING ORDER OF RESISTANCE OF MICROORGANISMS 
TO GERMICIDAL CHEMICALS ........................................................................................... 37
APPENDIX E.  DEVICES FOR WHICH A 510(K) SHOULD CONTAIN DATA TO 
VALIDATE REPROCESSING INSTRUCTIONS ................................................................. 38 Contains Nonbinding Recommendations 
 
Reprocessing Medical Devices in Health Care 
Settings: Validation Methods and Labeling 
Guidance for Industry and Food and Drug 
Administration Staff 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic. It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public. You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations. If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance. If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance. 
 
I.  Introduction 
This guidance provides recommendations for the formulation and scientific validation of 
reprocessing instructions for reusable1 medical devices. This guidance document also provides 
recommendations for the content and review of premarket notification submissions [510(k)], 
premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de 
novo requests and investigational device exemption (IDE) applications, concerning the labeling 
instructions for reprocessing reusable medical devices. Please note that exemption from 510(k) 
does not mean a device is exempt from compliance with labeling or Quality System (QS) 
requirements.  Manufacturers of 510(k)-exempt devices should follow the recommendations of 
this guidance pertaining to such requirements, unless, for example, the device is specifically 
exempted by regulation from specific QS requirements. 
Manufacturers of reusable medical devices are responsible for having labeling that bears 
adequate directions for use, including instructions on preparing a device for use. While FDA 
recognizes the critical role and responsibility of the device user community to follow the 
validated reprocessing instructions in the device labeling, the focus of this document is to 
provide guidance to medical device manufacturers in the complex activities involved in crafting 
and validating reprocessing instructions that ensure that the device can be used safely and for the 
purpose for which it is intended.  
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 
                                                 
1 While the scope of this guidance also includes single-use medical devices that are initially supplied as non-sterile 
to the user and require the user to process the device prior to its use, the majority of the devices addressed by this 
guidance are reusable devices. Accordingly, this document uses the term reusable devices for editorial 
convenience. 
1  Contains Nonbinding Recommendations 
 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
II.  Background 
Pursuant to section 502(f) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 USC 
352(f)), a device must have labeling that bears adequate directions for use. Adequate directions 
for non-prescription use include instructions on preparing a device for use.  21 CFR 801.5(g).  
Prescription devices are exempt from the adequate directions for use requirement as long as 
certain conditions are met, including that the labeling bear information for use, including 
indications, effects, routes, methods, and frequency and duration of administration, and  any 
relevant hazards, contraindications, side effects, and precautions under which practitioners 
licensed by law to administer the device can use the device safely and for the purpose for which 
it is intended...  21 CFR 801.109(c).  Because instructions on how to adequately reprocess a 
reusable device are critical to ensuring that a reusable device is appropriately prepared for its 
next lay use and that licensed practitioners can use the device safely, we interpret adequate 
reprocessing instructions to be part of providing adequate directions for use under 21 CFR 801.5 
and a condition for exemption from adequate directions for use under 21 CFR 801.109.  For 
editorial convenience, we use the phrase adequate directions for use throughout this document 
to refer to the requirements for both prescription and non-prescription devices.   
Labeling must comply with 21 CFR Part 801 and any applicable device-specific requirements 
given in Part 801; labeling for in vitro diagnostic (IVD) devices must comply with 21 CFR 
809.10. General labeling requirements for medical devices are also discussed in the guidance 
entitled Labeling Regulatory Requirements for Medical Devices available at 
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/UCM095308.pdf. 
In recent years, there has been an evolution towards more complex, reusable medical device 
designs that are more difficult to reprocess. In addition, there has been a significant advance in 
knowledge and technology involved in reprocessing reusable medical devices. This guidance 
reflects the scientific advances in these areas. Appendix A provides additional information on the 
definitions of common terms used in this guidance document. 
As additional scientific information becomes available in the field of device reprocessing, further 
revisions to this guidance may be provided. 
III.  Scope 
The scope of this guidance is limited to devices that fall into any of the four reprocessing 
situations below. 
1.  Reusable medical devices initially supplied as sterile to the user and requiring the user to 
reprocess (i.e., clean and disinfect or sterilize) the device after initial use prior to the 
subsequent patient use. 
2  Contains Nonbinding Recommendations 
 
2.  Reusable medical devices initially supplied as non-sterile to the user and requiring the 
user to process (i.e., clean, clean and disinfect, or clean and sterilize) the device for initial 
use, as well as to reprocess the device after each use. 
3.  Reusable medical devices intended to be reused only by a single patient and intended to 
be reprocessed between each use.     
4.  Single-use medical devices initially supplied as non-sterile to the user, and requiring the 
user to process the device prior to its use. 
Please note that the following sections of this guidance are not applicable to single-use devices 
initially supplied as non-sterile: 
  Section VI., Criteria 5.b  Point-of-use Processing 
  Section VI., Criteria 5.l  Reuse Life 
Exclusions 
The five situations listed below are not within the scope of this guidance, because they 
are not relevant to reusable medical devices or because they focus on the reprocessing of 
single-use devices. 
1.  Processes that are used in industrial settings for the manufacture of single-use 
medical devices that are intended to be sold sterile (For more information on this 
topic, see FDAs draft guidance Submission and Review of Sterility Information 
in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceD
ocuments/ucm109884.htm). FDAs draft guidance represents FDAs proposed 
approach on this topic.) 
2.  Processes intended to be used by reprocessors of single-use devices (See 
Medical Device User Fee and Modernization Act of 2002, Validation Data in 
Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use 
Medical Devices 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceD
ocuments/ucm071434.htm).) 
3.  Any process used for a sterile device provided without any reprocessing 
instructions from the original equipment manufacturer to permit use after the 
package has been opened. (Single-use sterile devices that do not have 
reprocessing instructions should not be reprocessed and should not be used if the 
sterile packaging has been compromised. The device should be appropriately 
discarded or returned to the manufacturer.) 
4.  Processes regarding the removal or inactivation of transmissible spongiform 
encephalopathy (TSE) agents (i.e., prions) from contaminated medical devices. 
Please note that as of the date of this guidance, FDA has not approved or cleared 
medical devices, including sterilizers, for the intended use of reducing the 
infectivity of TSE agents.  
5.  Reusable medical devices that include a component that is not initially supplied as 
sterile and between uses cannot be adequately (1) cleaned and disinfected or (2) 
cleaned and sterilized (e.g., the hand-held wireless receiver of a multi-patient use 
continuous glucose monitor (CGM)). 
3  Contains Nonbinding Recommendations 
 
This document is not intended to provide device-specific recommendations on design, testing, or 
reprocessing validation. You should also follow the recommendations in device-specific 
guidance, when available. 
  
IV.  General Considerations for Reusable Medical Devices 
A.  Design of Reusable Medical Devices 
Manufacturers of reusable devices should consider device designs that facilitate easy and 
effective cleaning, as well as any necessary disinfection or sterilization by the users. 
Some complex device designs present particular challenges to cleaning and cleaning 
validation (e.g., shaft-within-lumen configurations, elevator channels, fine channels, seals 
and mated articulating surfaces). From the earliest stages of device design and 
engineering, manufacturers should consider alternative designs to facilitate effective 
reprocessing (e.g., replace features that are challenging to reprocess with single-use parts; 
include flush ports; specify and/or provide dedicated cleaning accessories). 
B.  Ensuring the Safety of Reusable Medical Devices  
Manufacturers of reusable devices and accessories, as well as their users, have important 
roles to play in ensuring the safe and effective reprocessing of medical devices.   
Manufacturers of reusable devices should provide adequate labeling that includes 
instructions for reprocessing devices and device accessories safely and preparing them 
for reuse. In the labeling, manufacturers should identify for users the materials and 
equipment, including reprocessing supplies with part numbers, if applicable, that will be 
needed to reprocess the devices. The labeling should also clearly specify the appropriate 
material and equipment parameters to adequately reprocess the devices, as well as 
materials and equipment that are readily available to users. FDA encourages users to 
ensure that they have the facilities, equipment, and easy access to manufacturer-specified 
cleaning, sterilization/disinfection agents to implement the instructions, and that the 
instructions are followed.   
Manufacturers should maintain in the Device Master Record and/or Design History File, 
as appropriate, documentation of tests that were performed to demonstrate that the 
reprocessing instructions have been validated, are complete and understandable, and can 
reasonably be implemented by the user.  The Device Master Record must comply with 
the requirements of 21 CFR 820.181; the Design History File must comply with 
requirements of 21 CFR 820.30(j).   
V.  General Considerations for Reprocessing Instructions 
in Device Labeling 
4  Contains Nonbinding Recommendations 
 
A.  Overview of Reprocessing 
Reprocessing is defined as validated processes used to render a medical device, which 
has been previously used or contaminated, fit for a subsequent single use. These 
processes are designed to remove soil and contaminants by cleaning and to inactivate 
microorganisms by disinfection or sterilization. Reprocessing of reusable devices 
encompasses appropriate steps that begin in close proximity to the point of use of the 
device and, in general, involves the following three steps in sequence:   
1.  Point-of-Use Processing: Reprocessing begins with processing at the point of use 
(i.e., close proximity to the point of use of the device), to facilitate subsequent 
cleaning steps. We define this as point-of-use processing, which includes prompt, 
initial cleaning steps and/or measures to prevent drying of soil and contaminants 
in and on the device.  
2.  Thorough Cleaning: The device should be thoroughly cleaned after the point-of-
use processing. Generally, thorough cleaning is done in a dedicated cleaning area. 
Devices that will likely not become contaminated with pathogens during use (e.g., 
room vital signs monitor) may not require disinfection, and therefore may be 
suitable for use after cleaning only.    
3.  Disinfection or Sterilization: Depending on the intended use of the device, the 
device should be disinfected or sterilized, and routed back into use.   
A simple overview of reprocessing is presented in Figure 1. A more detailed overview of 
each reprocessing step is provided in Appendix B. 
FIGURE 1. PROCESS OVERVIEW 
Use 
Point-of-Use Processing 
(prompt, initial treatment to remove and/or 
prevent drying of soil and contaminants) 
Thorough Cleaning 
(and return to use, or) 
Disinfection  Sterilization 
(Low, Intermediate,   
or High Level) 
 
 
5  Contains Nonbinding Recommendations 
 
It is important to note that cleaning, disinfection, and sterilization are distinctly different 
processes. 
Cleaning is the physical removal of soil and contaminants; the methods and agents used 
for cleaning should be designed to remove such soil and contamination effectively. 
Effective cleaning should:  
  minimize the soil transfer from one patient to another or between uses in a single 
patient;  
  prevent accumulation of residual soil throughout the products use life; and  
  allow for successful, subsequent disinfection/sterilization steps.    
In comparison, disinfection and sterilization processes are intended to kill 
microorganisms; the methods and agents employed for disinfection and sterilization 
should be designed to achieve appropriate microbicidal effects.  Please see Appendix A 
for the definitions of disinfection and sterilization, and Section VI. Criterion 3 for 
specific information on appropriate microbicidal processes.   
Accordingly, cleaning steps should be validated separately and independently from 
disinfection or sterilization steps. 
An overview of reusable medical device processing is found in Appendix B of this 
document.  
B.  Resources for Developing Reprocessing Instructions 
The following are resources to consider when developing reprocessing instructions for 
reusable medical devices. 
1.  You should follow the labeling recommendations in device-specific guidance, 
when available. Device guidance may be found by searching FDAs Guidance 
Document Database available at 
http://www.fda.gov/RegulatoryInformation/Guidances/default.htm.  
2.  The following Technical Information Reports (TIRs) developed by the 
Association for the Advancement of Medical Instrumentation (AAMI) provide 
technical information for manufacturers and users and may be helpful when 
developing labeling instructions for reusable medical device: 
a.  AAMI TIR12, Designing, testing and labeling reusable medical devices for 
reprocessing in health care settings: A guide for medical device 
manufacturers. 
2.  AAMI TIR30, A compendium of processes, materials, test methods, and 
acceptance criteria for cleaning reusable medical devices. 
3.  We recommend you refer to the current FDA-recognized version of AAMI/ANSI 
ST81, Sterilization of medical devices - Information to be provided by the 
manufacturer for the processing of resterilizable medical devices. 
4.  We recommend you use current FDA-recognized test methods available from 
standards developing organizations (SDO). A searchable database of FDA-
6  Contains Nonbinding Recommendations 
 
recognized consensus standards is available at: 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  
5.  You should also consult any relevant clinical practice guidelines and 
recommendations for infection control published by professional societies and 
associations, standards developing organizations, and government agencies (for 
example, the Guideline for Disinfection and Sterilization in Healthcare Facilities, 
2008 from the Centers for Disease Control (CDC), available at 
http://www.cdc.gov/hicpac/pdf/guidelines/disinfection_nov_2008.pdf). 
Clinical practice guidelines, however, do not always consider or correctly address 
all FDA regulatory requirements. As an example, some professional organizations 
may recommend using disinfectants in ways that may not necessarily comply with 
FDA regulations. Compliance with FDA regulations is required. 
  
C.  Human Factors in Developing Reprocessing Instructions 
You should consider the following recommendations regarding human factors in 
developing your reprocessing instructions: 
1.  We recommend that you develop consistent reprocessing instructions across each 
of your product lines. Labeling that provides consistent methods and terminology, 
and utilizes the same document layout for all devices of a type, may help improve 
the users comprehension and adherence to the instructions. 
2.  You should address any known post-market human factors issues known to exist 
for reprocessing your device or similar devices. Examples of human factors issues 
include, but are not limited to, actions requiring substantial dexterity or strength, 
good visual acuity, or familiarity with uncommon practices. Information on post-
market issues may be found by reviewing your internal user complaint files, the 
published literature, the FDAs Medical Device Reporting (MDR) system, and 
FDA Safety Alerts and Public Health Notifications. We recommend that you refer 
to the following sources for additional information on human factors: 
a.  FDAs guidance Medical Device Use-Safety: Incorporating Human Factors 
Engineering into Risk Management 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/ucm094461.pdf). 
b.  FDAs guidance, Human Factors Principles For Medical Device Labeling 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/UCM095300.pdf). 
c.  The current FDA-recognized version of IEC Standard 62366, Medical 
Devices  Application of usability engineering to medical devices. 
d.  The current FDA-recognized version of ANSI/AAMI HE75, Human Factors 
Engineering  Design of Medical Devices.  
3.  For devices that are subject to design controls under 21 CFR 820.30, you should 
validate your reprocessing instructions to ensure that users will be able to 
successfully understand and follow them.  FDA recommends considering the 
following: 
7  Contains Nonbinding Recommendations 
 
a.  Your validation study participants should be representative of the professional 
staff that would perform these actual reprocessing procedures. If users would 
be wearing personal protective equipment (PPE), such as goggles, full-length 
face shields, heavy-duty utility gloves or liquid-resistant covering with 
sleeves, then the validation study participants should wear them as well. 
b.  Participants may use the instructions to perform an actual or simulated 
reprocessing procedure or verbally describe what they would do as they read 
the instructions. 
c.  If attributes of the use environment might affect use of the instructions and 
reprocessing of the device, they should be represented in the study. 
d.  Observing and documenting participant behavior during testing will allow you 
to assess the participants adherence to the instructions and to identify and 
understand the nature of any errors or problems that occur. 
e.  After using the instructions independently, you should ask the participants if 
they had difficulty in performing the reprocessing, and allow them to describe 
their experience. You should ask specifically about any errors, problems or 
hesitations that were observed. The participants should provide subjective 
feedback regarding any wording in the instructions that they found confusing, 
misleading, or incomplete. The participants responses and comments should 
be documented.   If you make significant changes to the instructions after 
testing them, you should validate the success of the changes at eliminating or 
reducing the problems previously identified. 
VI.  FDAs Six Criteria for Reprocessing Instructions 
Your labeling should address the six criteria below for clear reprocessing instructions, which will 
ensure users understand and correctly follow the reprocessing instructions.   
Criterion 1. Labeling should reflect the intended use of the device. 
Your labeling should include instructions for a reprocessing method that reflects the 
physical design of the device, its intended use, and the soiling and contamination to 
which the device will be subject during clinical use. Appropriate reprocessing 
instructions depend on whether the device will:   
  contact only intact skin;  
  contact intact mucosal surface; 
  contact normally sterile tissues, blood, or bodily fluids such as cerebrospinal fluid, 
peritoneal fluid, aqueous humor, etc.; 
  be subject to splatter or splash of body fluids or blood because of proximity to the 
patient, although it is not in direct contact with the patient;  
  be subject to contamination during use from contact with soiled hands of patient 
caregivers or patients; (note that both unwashed and gloved hands can carry 
organic soil as well as microorganisms to the surfaces they touch);  
  be subject to contamination by unexpected or accidental events (e.g., patient 
bleeding, incontinence, vomiting, wounds leaking through dressings); 
8  Contains Nonbinding Recommendations 
 
  be subject to reprocessing with disinfectants or other chemicals that might leave 
harmful residues, or adversely affect device materials or performance, if 
inadequately rinsed; or 
  present specific or unique risks to the patient or user. 
   
Criterion 2. Reprocessing instructions for reusable devices should advise 
users to thoroughly clean the device.   
Cleaning is the first step in reprocessing and should be described in the labeling as part of 
the overall reprocessing instructions. Adequate sterilization or disinfection depends on 
the thoroughness of cleaning. Instructions to the user should clearly communicate how to 
achieve thorough cleaning. Details of the cleaning procedure will vary depending on the 
complexity of the device.  
Devices with features that may result in soil retention or have features that make them 
difficult to clean, may need to be disassembled in order to be completely cleaned, unless 
the manufacturer can validate effective cleaning without disassembly (i.e., data should be 
obtained from testing soiled devices cleaned with and without disassembly for 
comparison). For such devices, instructions/diagrams for adequate disassembly should be 
included in the cleaning instructions (see Criterion 5.C. for details). 
Directions for use of the device may include the use of protective covers and sheaths to 
try to reduce the extent of cleaning needed before the device can be reused (e.g., 
bronchoscopes). If you recommend the use of protective covers, your labeling should 
include the recommendation to use only legally marketed protective covers. However, the 
cleaning instructions for your device should assume the worst-case where the device is 
used uncovered, because of the potential for loss of cover integrity during use. Unnoticed 
loss of cover integrity may result in degrees of soiling that are difficult to see but will 
present a risk to the health of the next patient unless the device is properly reprocessed.   
Flushable devices (e.g., endoscopes, laparoscopic instruments and other devices with 
flush ports) are prone to debris accumulation and should have instructions/diagrams to 
ensure proper flushing during cleaning procedures. Proper flushing of the device is 
important to remove retained soil from inside of the devices during these procedures. 
Flushing instructions/diagrams should include information on how to properly flush the 
device, the specific accessories to be used including proper size connectors for the flush 
ports, and the type and volume of flushing agent to be used to ensure thorough and 
effective cleaning of the device. 
Criterion 3. Reprocessing instructions should indicate the appropriate 
microbicidal process for the device.   
Your instructions should be consistent with current infection control principles. The 
microbicidal process recommended should be sterilization or disinfection (high, 
intermediate, or low level), depending on the intended use of the device.  
9  Contains Nonbinding Recommendations 
 
Note that whichever reprocessing method(s) is/are recommended, the compatibility of the 
device with the method(s) and the ability of the method(s) to successfully reprocess the 
device features should be validated and then stated in the instructions for use. The 
validation should demonstrate that soil and contaminants have been effectively removed 
and that the device is free of viable microorganisms. 
FDA uses the Spaulding Classification2 scheme described below for critical, semi-critical 
and non-critical devices to describe the potential risk of infection caused by the device 
and the appropriate microbicidal processes. Because the Spaulding classification does not 
address all clinical device uses and reprocessing needs in detail, we have modified it 
accordingly as described below. 
A.  Critical Devices 
Critical devices are devices that are introduced directly into the bloodstream or which 
contact a normally sterile tissue or body-space during use. There is a likelihood of 
microbial transmission and risk of infection (subclinical or clinical) if the device is 
not sterile. Users should be instructed to disassemble (if applicable), thoroughly 
clean, and sterilize critical devices after each use.   
Examples of critical devices include surgical instruments, irrigation systems for 
sterile instruments in sterile tissues, endoscopes used in sterile body cavities (such as 
laparoscopes, arthroscopes, intravascular endoscopes) and all endoscope biopsy 
accessories. 
B.  Semi-Critical Devices 
Semi-critical devices are devices that contact intact mucous membranes or non-intact 
skin. They do not ordinarily penetrate tissues or otherwise enter normally sterile areas 
of the body. Intact mucosal surfaces are relatively resistant to small numbers of 
spores. However, these devices should be reprocessed to be free from all 
microorganisms. Users should be instructed to thoroughly clean these devices and 
then reprocess them by sterilization. If the device design does not permit sterilization 
(e.g., device materials cannot withstand sterilization), then high level disinfection 
should be used. 
Examples of semi-critical devices include duodenoscopes, endotracheal tubes, 
bronchoscopes, laryngoscope blades and other respiratory equipment, esophageal 
manometry probes, diaphragm fitting rings, and gastrointestinal endoscopes.  
Heat-stable devices (e.g., rigid endoscopes) should be processed by steam 
sterilization. For heat-labile devices, available low temperature reprocessing 
                                                 
2 Spaulding, EH The role of chemical disinfection in the prevention of nosocomial infections. In: Brachman PS, 
Eickoff TC, eds Proceedings of the International Conference on Nosocomial Infections, 1970. Chicago: American 
Hospital Association, 1971:254-274 
10  Contains Nonbinding Recommendations 
 
technologies include hydrogen peroxide (H O ) sterilization, ozone (O ) sterilization, 
2 2 3
ethylene oxide (EO) sterilization3 (including device aeration) and liquid chemical 
sterilant/high level disinfectant chemical systems used to provide either liquid 
chemical sterilization or high level disinfection. High-level disinfection methods used 
in health care settings include liquid chemical sterilants used at high level disinfection 
conditions and hot water pasteurization (often used for respiratory and anesthesia 
equipment reprocessing).  
C.  Non-Critical Devices  
Non-critical devices are instruments and other devices whose surfaces contact only 
intact skin and do not penetrate it. Non-critical devices also include devices that do 
not directly contact the patient but may become contaminated with microorganisms 
and organic soil during patient care (e.g., blood, body fluids); such devices may not 
be visibly contaminated. FDA recommends thorough cleaning, then intermediate or 
low level disinfection for non-critical devices depending on the nature and extent of 
contamination. 
Examples of devices that contact only intact skin include blood pressure cuffs, 
stethoscopes, and skin electrodes. Examples of devices that have no direct patient 
contact, yet may become contaminated during patient care, include infusion pumps 
and ventilators.   
Note that some disinfectants are fairly effective cleaning agents while others are not. 
Always consider the worst-case microbes to which the device may be exposed during 
clinical use, the likelihood of significant organic soiling of the device during use, and 
the ability of the device material to repeatedly withstand disinfectant contact when 
selecting a disinfectant to validate and then recommend for use with your device.  
Also consider the products that are frequently used in health care settings when 
selecting a disinfectant to study and validate. If a product or class of products can 
damage the materials in your device, your device label should include a warning not 
to use that product or class of products to reprocess your device. 
Items contaminated with blood or body fluids, which may contain blood-borne 
pathogens, should be cleaned and then receive intermediate level disinfection with a 
product having an EPA-registered claim for activity against hepatitis B.4 Blood 
glucose meters used in healthcare settings are an example of a blood-contaminated 
device which has been a source of hepatitis B transmission during patient-to-patient 
use when not properly cleaned and disinfected after each patient and not used in strict 
compliance with glove use and hand washing after glove removal.  
Be aware that in some clinical situations (e.g., patients with Norovirus or Clostridium 
difficile infections, drug-resistant organisms, etc.), isolation precautions 
                                                 
3 EO sterilization may not be ideal for certain device types, such as duodenoscopes. 
4 Center for Disease Control and Prevention (CDC), Guideline for Disinfection and Sterilization in Healthcare 
Facilities, 2008. 
11  Contains Nonbinding Recommendations 
 
recommended for use by CDC may include the use of specific disinfectants and 
should be followed.  You should instruct the user to follow the specific EPA label 
disinfectant contact times when using the disinfectant as well as the instructions 
specified in the medical device labeling.   
Devices that will likely not become contaminated with pathogens during use (e.g., 
room vital signs monitor) may not require disinfection, and therefore may be suitable 
for use after cleaning only.  
Criterion 4. Reprocessing instructions should be technically feasible and 
include only devices and accessories that are legally marketed. 
Reprocessing instructions should be technically feasible in the intended location (e.g., 
health care setting or home use). The equipment and accessories needed to implement the 
instructions should be clearly defined (including detailed descriptions and part numbers, 
if applicable) and readily available for the users to obtain.   
The type of sterilizer, and the manufacturer-validated sterilization cycle parameters and 
accessories should be available to the users. For example, radiation sterilization is 
generally only used in manufacturing facilities. Steam sterilization is the most common 
method of sterilization used in health care settings. EO, H O , O  and liquid chemical 
2 2 3
sterilization processes are also available in some health care settings. Dry heat and 
chemical vapor sterilization are less common. 
FDA recommends that the instructions specify sterilization methods and parameters that 
are technically feasible for the user. That is, sterilization cycle parameters specified in the 
labeling for reprocessing a device should be consistent with validated sterilization cycle 
parameters for commonly available, legally marketed sterilizers. Examples of cycle 
parameters commonly found on health care steam and EO sterilizers at the time of this 
guidance are provided in Appendix C. Designing your reprocessing instructions in 
accordance with the conventional parameters represented in Appendix C provides 
assurance that your reprocessing instructions are compatible with existing essential FDA-
cleared reprocessing equipment. Information on other methods may be found in AAMI 
TIR12.  
FDAs recommendation that sterilization methods and parameters be technically feasible 
for the user has direct application to sterilization accessories. Many sterilization 
accessories used in reprocessing reusable devices in health care settings are class II 
medical devices subject to FDA premarket notification requirements. These accessories 
include sterilization wraps, pouches, cassettes, and containers; biological indicators and 
chemical indicators; and liquid chemical sterilants and disinfectants. These products 
typically receive FDA-clearance for specific process parameters or sets of parameters, 
which appear in the Intended Use sections of FDA-cleared sterilization accessories. 
Your reprocessing instructions should match these specific process parameters.  
FDA maintains a list of FDA-cleared liquid chemical sterilants and high level 
disinfectants, which is available at 
12  Contains Nonbinding Recommendations 
 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReus
ableMedicalDevices/ucm437347.htm. Designing validation protocols in accordance with 
the conventional parameters represented in this document provides assurance that your 
device is compatible with existing FDA-cleared liquid chemical sterilants and high level 
disinfectants. 
Extended Cycles 
The expression extended cycle has gained common usage to describe any 
sterilization cycle that includes specifications that deviate from those found on 
commonly used, FDA-cleared sterilizers, and for which there are limited or no FDA-
cleared sterilization accessories. Extended cycles typically include longer exposure 
times and/or higher or intermediate temperatures, which may also deviate from more 
conventional sterilization cycles. Implementation of extended cycles poses serious 
technical challenges in health care settings.  
Extended cycles are typically developed to achieve sterilization of complex devices 
or larger loads.  Recommending the use of extended cycles for larger loads or more 
complex devices in reprocessing instructions may be appropriate provided the 
appropriate accessory devices have been cleared for use with such extended cycles. 
While many sterilizers are designed with manual over-ride controls for time and 
temperature, FDA generally evaluates physical and microbiological performance 
validation data and product labeling claims for discrete cycle parameter specifications 
as part of the premarket review process for sterilizers and their accessories, including 
biological indicators, chemical indicators, and sterilization packaging.    
FDA recommends that ranges not be used for defining sterilization cycles (for 
example, 121C-132C temperature and greater or lesser than 4 minutes exposure 
time), as this implies that all intermediate values have been validated, and that there 
are FDA-cleared accessories for all the intermediate cycles.   
The Agency has accepted validated drying time specifications in the labeling that 
exceed those found on FDA-cleared sterilizers and that require manually setting the 
drying time controls. 
Criterion 5. Reprocessing instructions should be comprehensive. 
Comprehensive instructions enable the user to understand precisely how to implement the 
entire reprocessing procedure safely and effectively. There may be several acceptable 
formats for instructions.  
To ensure the reprocessing instructions are comprehensive, they should include all of the 
elements below. If any element is not applicable to your device, then you should state this 
in your premarket submission and provide a justification.  
A.  Special Accessories  
13  Contains Nonbinding Recommendations 
 
The instructions should describe any accessories that are needed for safe 
reprocessing. If the device requires any special protection during reprocessing (e.g., 
valves, plugs or stoppers to prevent ingress of harsh chemicals), they should be 
described in detail. The instructions should also identify any special tools, sizes and 
types of brushes (including custom brushes), flush port connectors and connector size 
specifications, trays, test kits, specific types of sterilization wraps or containers, and 
part numbers, if appropriate.  The instructions should also provide sufficient detail so 
that the user can purchase the correct items, including any custom cleaning 
accessories, or identify a source for the purchase of such items. 
B.  Point-of-Use Processing  
As needed, labeling should include applicable instructions for point-of-use 
processing. For example, instructions for prompt, initial cleaning steps and/or 
measures to prevent the drying of soil on the device surface prior to cleaning may be 
appropriate, as this will facilitate subsequent cleaning steps. 
In general, reprocessing procedures should minimize or eliminate delays between 
steps. Delays may create conditions favorable to microbial growth, which may 
increase the challenge to subsequent steps such as cleaning and 
disinfection/sterilization. Organic contamination may inactivate or prevent full 
penetration of a disinfectant or sterilant.   
C.  Disassembly and Reassembly 
If the device has removable parts, then reprocessing instructions should include step-
by-step instructions for disassembly and reassembly of the device to facilitate 
cleaning by the user. The equipment needed to perform these activities should be 
identified. Diagrams, photographs, illustrations and/or videos are recommended. In 
addition, the instructions should indicate the location where the user should perform 
the step (e.g., at the point of use, at the designated cleaning area).  
Disassembly and reassembly instructions should be explicit, device-specific, and 
reflect the validation activities. Expressions such as disassembly, if applicable leave 
the determination of applicability to the discretion of the user; such ambiguous 
language should not be used. If a device must be disassembled for cleaning, the 
instructions should be validated to assure that proper reassembly can be performed at 
the appropriate point in reprocessing. The labeling should provide the user with a 
validated method to verify that reassembly has been properly performed; this is to 
assure that the device is in operable condition for the next use.  Instructions should 
also specify whether to reassemble before or after sterilization. Additionally, 
disassembly and reassembly instructions should include information to visually 
inspect the device and components for wear and tear of components that cannot be 
assessed in the fully assembled configuration.   
14  Contains Nonbinding Recommendations 
 
If reassembly is to be performed by the surgeon and is described in the surgeons 
manual, then reference to this should also be made in the reprocessing instructions. 
D.  Method of Cleaning 
The labeling should provide a detailed, validated method of cleaning. The method 
may be manual or mechanical (e.g., washer, washer/disinfector, ultrasonic washer) or 
may combine the two. However, manufacturers should be aware that some small 
health care settings may not have automated cleaning equipment; therefore, validated 
manual cleaning instructions may be needed. 
Cleaning instructions should include a list of the appropriate parameters for each 
recommended method.   
For manual cleaning, the labeling should specify the duration of each processing step, 
as well as temperatures, water quality, and other necessary conditions. Repeated 
actuations, flexures, and manipulations should be specified, where appropriate, based 
on device design and validation activities. 
Similarly, for automated cleaning, the labeling should specify all processing 
conditions. The instructions should recommend equipment settings such as time, 
temperature, and maximum device load size.   
Whether the cleaning method is manual, automated, or a combination of the two, the 
labeling should contain comprehensive directions, including photographs and/or 
diagrams, if appropriate, for each cleaning, rinsing, and drying step so that users can 
accurately follow the steps or program them into the device washer or 
washer/disinfector. Recommendations for the use of detergents, enzymatic cleaners, 
and automated cleaning cycles should be consistent with the manufacturers 
directions for use for those products. 
Labeling should include surface cleaning instructions for medical devices that are at 
risk of becoming contaminated with patient materials through routine handling by 
health care workers. Even when only simple surface cleaning is recommended, the 
label should identify the suggested method, any cautions for specific locations or 
materials, any disassembly needed, and any subsequent steps.  
For a device whose internal components are not contaminated during clinical use but 
could be damaged by contact with liquids (e.g., cleaning agents, disinfectants), 
surface cleaning instructions should describe how to adequately clean the device and 
prevent contact with internal device components that are not designed for contact 
with liquids. 
E.  Cleaning Agents 
15  Contains Nonbinding Recommendations 
 
The instructions should recommend only cleaning agents or classes of agents (e.g., 
detergents such as quaternary ammonium compounds and enzymatic detergents) that 
were used during the cleaning validation studies, that have been demonstrated to be 
compatible with the device, and are effective in cleaning the device. Labeling should 
include instructions for the preparation and use of those agents (e.g., mix one ounce 
of detergent per gallon of water), or refer to the cleaning agent labeling for 
preparation and use instructions (e.g., according to the detergent manufacturers 
instructions). Labeling for use on specific medical devices should be consistent with 
the cleaning agent manufacturers instructions for use of the product.   
Certain products (e.g., some quaternary ammonium compounds and alcohols) may be 
used for both cleaning (removal of soil) and disinfection (inactivation of microbes).  
Other products are capable of only performing one of these two functions. The 
instructions for use should address both cleaning and disinfection if both are intended, 
and should be clear regarding the difference between cleaning and disinfection, and 
the products used for each step. 
F.  Rinsing 
The labeling should recommend specific directions for rinsing to remove chemical 
residues used during reprocessing; rinsing steps should be included after cleaning and 
after use of liquid chemical sterilants/high level disinfectants. Rinsing may be manual 
or mechanical. The rinsing instructions should include the type and quality of rinse 
water, duration of rinse (or, for flushes, the volume and number of repetitions), and 
temperature. You may refer to the detergent manufacturers labeling to assist in 
developing your validated rinsing instructions.  
Rinsing instructions should be validated to show that residual cleaning agents and 
liquid chemical germicides are reduced to levels that will not interfere with 
subsequent reprocessing steps and to levels that are non-toxic. Additionally, for some 
devices, the final rinse water specifications should be sufficient to remove bacterial 
endotoxins. (Note that tap water may contain endotoxins.) 
We recommend that you refer to the current version of AAMI TIR34 Water for the 
reprocessing of medical devices for more information on final rinse water quality 
and to establish the optimal water quality for final rinses, based on the intended use of 
the device. We also recommend that you refer to FDAs guidance Pyrogen and 
Endotoxins Testing: Questions and Answers 
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM310098.pdf).  
FDA generally does not recommend saline solutions as the final rinse because saline 
solutions may interfere with subsequent disinfection or sterilization steps. Saline 
rinses may also lead to corrosion on certain devices and build-up of inorganic 
residues. 
16  Contains Nonbinding Recommendations 
 
G. Lubricating Agents 
Use of lubricating agents is an effective way of extending the use life of some 
medical devices. Lubricants may reduce the friction commonly associated with metal-
on-metal movements and thereby reduce device wear and corrosion.     
If applicable, the reprocessing instructions should recommend lubricating agents, or a 
class of lubricating agents (e.g., water soluble lubricants) that are compatible with the 
medical device, its intended use, and with any subsequent processing steps such as 
sterilization. Also, labeling for the reusable device should refer to the lubricating 
agent labeling for preparation and use instructions of those agents.   
If your reprocessing instructions specify the use of lubricating agents, you should 
validate the device reprocessing methods using the lubricating agents under the 
conditions of use of the device.  
Caution should be exercised when using oil-based and silicone-based lubricants, as 
they may coat and protect surface microorganisms and reduce the effectiveness of 
certain sterilization methods, including steam and EO. They may even provide 
nutrients for microbial growth.  
H. Visual Inspection 
All routine cleaning instructions should include instructions for visual inspection, 
which may include use of magnification and adequate lighting. The instructions 
should advise the user that if the device is determined not to be visually clean at the 
end of the cleaning step, the user should either repeat the relevant previous cleaning 
steps or safely dispose of the device. 
Additionally, the visual inspection instructions should identify acceptance or failure 
criteria related to device performance (e.g., unacceptable deterioration such as 
corrosion, discoloration, pitting, cracked seals), as well as instructions to properly 
dispose of devices that fail. 
I.  Method of Disinfection or Sterilization 
For reusable devices intended to be disinfected or sterilized, reprocessing instructions 
should specify at least one validated microbicidal method for disinfection or 
sterilization.   
The type of microbicidal method would depend on the type of device to be 
reprocessed. Please refer to Criterion 3 for general considerations when selecting the 
type of microbicidal method.   
17  Contains Nonbinding Recommendations 
 
Specifications for sterilization equipment and sterilization cycle parameters vary with 
manufacturers and models. Labeling for reprocessing should identify the particular 
sterilization method and type, and list the validated cycle parameters. 
Traditional sterilization processes such as steam and EO are sufficiently well-
standardized among sterilizer manufacturers such that sterilization cycles may be 
identified by the critical cycle parameters. Accessories for these sterilization 
processes also may be identified using only the critical cycle parameters. Refer to 
Appendix C for typical parameters of sterilization cycles currently used in health care 
settings. 
The proprietary characteristics of sterilization processes using newer low-temperature 
chemical sterilization methods (e.g., H O  and O ) vary from one device 
2 2 3
manufacturer to another. Therefore, for these sterilization processes, the manufacturer 
of the device, the sterilizer model, and the specific cycle identification (name or cycle 
parameters) should be explicitly identified in the reprocessing instructions.  
Accessories for these sterilization processes should be labeled by the accessory 
manufacturer to specify sterilizer manufacturer, sterilizer model, and sterilizer cycle 
name and/or cycle parameters. 
For all methods, complete cycle specifications should include all critical cycle 
parameters and other pertinent information that identifies the cycle. For example: 
  Moist Heat/Steam  Type of cycle (dynamic air removal vs. gravity), 
exposure time, temperature, drying time 
  EO  EO concentration (and gas composition), exposure time, relative 
humidity, temperature, aeration time 
  H O  and O   Manufacturer, model, specific cycle identification per model 
2 2 3
either by name or specific cycle parameters
  Dry heat  Exposure time, temperature  
Additionally, specification of device design, packaging, and load characteristics 
should be addressed to the greatest degree possible in the labeling for the load for 
sterilization. For example: 
  Weight  Labeling should specify a maximum weight of loaded trays. You 
should follow the recommendations in the current FDA-recognized version of 
AAMI ST77 Containment devices for reusable medical device sterilization 
and the health care sterilizer specifications. 
  Materials  Labeling should warn against including incompatible materials 
within the sterilization load (e.g., cellulose incompatibility with H O  
2 2
sterilization). 
  Device Design  Labeling should recommend sterilizing only devices with 
dimensions or characteristics (e.g., lumen specifications, powered hand-
pieces) that are compatible with the labeling of the specified sterilizer and 
sterilization cycles.  
18  Contains Nonbinding Recommendations 
 
  Chamber load  Labeling should describe the chamber load; for example, if 
the validation was conducted in an empty load or in a full worst case load.  
  Drying  Labeling should indicate that devices should be dry before they are 
packaged for sterilization. 
  Sterility Maintenance  Labeling should identify packaging that is FDA-
cleared and designed to allow adequate sterilant penetration as well as 
maintenance of sterility. Sterilization packaging should be cleared and labeled 
for the same sterilization parameters as those recommended for the devices it 
is to contain. 
J.  Reduction of Sterilant Residuals 
Labeling should include instructions for reducing sterilant residuals (e.g., by 
aeration), after processes such as sterilization by EO, hydrogen peroxide, or other 
sterilization processes that may leave sterilant residuals on the device. 
For example, for devices intended to be sterilized by EO, the labeling should 
recommend an aeration time that results in reduction of EO residuals to acceptable 
levels. For more information on EO aeration recommendations, and to establish the 
optimal aeration process specification based on the intended use of the device, we 
recommend that you refer to the current FDA-recognized version of AAMI ST41 
Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness.
For more information on acceptable levels of EO residuals, we recommend that you 
refer to the current FDA-recognized version of ANSI/AAMI/ISO 10993-7 
Biological Evaluation of Medical Devices  Part 7: Ethylene Oxide Sterilization 
Residuals. 
K. Drying 
Active device drying may reduce or eliminate recontamination of unwrapped devices 
after high level disinfection/liquid chemical sterilant reprocessing, because the 
devices will be wet at the end of reprocessing. Labeling should recommend the 
procedures that should be used to thoroughly dry the device, after processing and 
before storage, to eliminate moisture that can support the survival of contaminating 
microorganisms.  
Labeling should also recommend a validated minimum drying time specification for 
terminal sterilization methods for wrapped/contained devices. Moisture remaining on 
wrapped/contained products after sterilization could compromise the package 
integrity and performance by impairing the sterile barrier properties of the packaging 
materials and the effectiveness of the seals.  
Mid-process drying (i.e., drying after cleaning) is another important consideration, as 
moisture remaining on devices may interfere with subsequent microbicidal processes. 
If complete processing is delayed, labeling should recommend an intermediate and 
effective drying step before any delayed sterilization. 
19  Contains Nonbinding Recommendations 
 
L.  Reuse Life 
The labeling should either 1) inform the user how many times the device can be 
reused, based on testing; or 2) provide the user with a mechanism or method to 
ascertain whether the device has exceeded its use life. In the latter case, the labeling 
should identify a method to establish that the device is still within performance 
specifications, as well as instructions for appropriate disposal of devices that fail. For 
example: 
  labeling that refers to a device design feature, such as a built-in, automatic 
pre-check function; 
  labeling that identifies a performance test that should be passed prior to reuse;  
  labeling that recommends visual inspection along with acceptance or failure 
criteria (e.g., unacceptable deterioration such as corrosion, discoloration, 
pitting, cracked seals). 
Whichever method is chosen, labeling should recommend how to evaluate 
deterioration in difficult to see areas of complex devices, especially those with 
lumens (e.g., leak testing). 
Reuse life may also be addressed by validating the number of times the product can 
be reprocessed and reused, and providing this specification in the labeling. If the 
reuse life of a device is limited to a specific number of use/reprocessing cycles, the 
labeling should also describe a specific tracking method for the number of reuse 
cycles. It may be appropriate for labeling to remind the user that the specific number 
of reuse cycles is dependent on full compliance with the directions for use of the 
device. 
M. Additional Labeling Recommendations 
Devices that are initially supplied non-sterile to the user and require the user to 
sterilize the device before use should be prominently labeled "Non-sterile" directly on 
the individual device label (e.g., as opposed to only on the shipper carton) to ensure 
the non-sterile product is sterilized before use.  
Labeling should include any special warnings or precautions about the reprocessing 
procedure, when warranted. These may be related to user safety or emphasize 
conditions that could significantly alter the safety or effectiveness of reprocessing or 
the performance of the device. For example, some devices may have unsealed 
seams/crevices through which excessive liquid disinfectant could reach the interior of 
the device and damage it. In such cases, the labeling should caution users about this 
potential hazard and provide specific use instructions to prevent it, such as avoiding 
the application of excess liquid to the device.  It may also be appropriate to note 
situations where damage to the device may affect the reprocessing procedure. 
20  Contains Nonbinding Recommendations 
 
N.  Patient or Lay Use   
Devices that are intended to be maintained by a patient or lay care provider (e.g., 
family member or other) should have reprocessing instructions that are 
understandable to a lay person and can be performed at home. The equipment and 
accessories needed to implement the instructions should also be readily available in 
the intended location of use. Please also refer to FDAs guidance document 
Guidance on Medical Device Patient Labeling 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/ucm070782.htm). 
O. Reference to Guidelines or Accessory Labeling 
In addition to all of the recommendations set forth in this guidance, the reusable 
device labeling should also refer the user to the following for the purpose of 
additional education but not in lieu of validated reprocessing instructions: 
professional organizations clinical practice guidelines or clinical guidelines of the 
CDC. Please note that clinical practice guidelines, however, do not always consider 
or correctly address all FDA regulatory requirements and compliance with FDA 
regulations is required. 
Referencing the labeling of devices used in reprocessing, such as an endoscope 
washer-disinfector, may be acceptable as long as the referenced labeling is relevant 
and consistent with the reusable devices labeling. For example, labeling for an 
endoscope may refer, in part, to endoscope washer-disinfector labeling for certain 
details on scope reprocessing (e.g., placement in chamber).   
P.  Manufacturers Contact Information   
The manufacturer of the reusable device is the appropriate contact for user questions 
about the reprocessing procedures. The instructions for reusable devices should 
include a telephone number, email address, and web page address to obtain additional 
information about reprocessing the device, including questions on infection control 
procedures for the device.  
Customer service representatives of device manufacturers are often the initial point of 
contact when a device user has a question about device reprocessing. The training of 
these persons should include information on the reprocessing of devices for which 
they are responsible and the provision of information resources that they can access 
rapidly in order to provide assistance to device users. 
Criterion 6. Reprocessing instructions should be understandable. 
Reprocessing instructions should be clear, legible (i.e., reasonable font size), and 
provided in sequential order from the initial processing step through the terminal 
processing step (e.g., point-of-use processing, disassembly, cleaning, rinsing, reassembly, 
21  Contains Nonbinding Recommendations 
 
disinfection or sterilization, final rinsing after disinfection or liquid chemical sterilization, 
and post-process handling). The instructions should be written in simple language to the 
greatest extent possible. They should also be sufficiently detailed to explain the correct 
procedures for all steps. Charts, diagrams and/or device reprocessing instructions with 
pictures that can be posted in work stations, are helpful in ensuring adherence to 
reprocessing instructions. Web-posted pictures/diagrams of devices can also be helpful in 
answering user questions directly or through customer service representatives. 
Where applicable, instructions may include technique diagrams or other graphic 
representations designed to communicate recommended practices. However, any graphics 
should be accompanied by explanatory text. The instructions should be validated to 
ensure that users will be able to understand and to follow them. 
                           
VII. Validation of Reprocessing Methods in Accordance with 
the Quality System Regulation 
For class II and class III devices and select class I devices, manufacturers must establish and 
maintain procedures for validating the design of their device, which shall ensure that the device 
conforms to defined user needs and intended uses. 21 CFR 820.30(g).  Manufacturers must also 
establish and maintain procedures for monitoring and control of process parameters for validated 
processes to ensure that the specified requirements continue to be met, 21 CFR 820.75(b). 
Establishing procedures includes implementation.  21 CFR 820.3(k).  FDA interprets these 
regulations to require manufacturers to validate the design, including reprocessing instructions, 
of reusable devices to ensure that the device can be effectively reprocessed and safely reused 
over its use life, as intended.  Please note that exemption from 510(k) does not mean a device is 
exempt from compliance with labeling or Quality System (QS) requirements.  Some devices are 
specifically exempted by regulation from most QS requirements.  Manufacturers should refer to 
applicable regulations for their specific device type to determine what QS requirements apply.   
It is possible that similarities in design, materials, and other factors may allow for establishing 
product families (e.g., devices with a range of available sizes) for the purpose of minimizing 
reprocessing validation efforts. That is, it may be possible to establish that validation data for the 
most difficult to reprocess devices in a family (i.e., the worst case device or master device) 
covers devices that present an equivalent or lesser reprocessing challenge. If this method is 
utilized, all design features of the less difficult to reprocess devices in a family, such as lumen 
length and diameter, materials, configuration, and texture relevant to reprocessing challenges of 
the subject device should be evaluated and assured to be less challenging to reprocessing than the 
master device. Any changes in design or materials that could affect sterilant penetration or 
potency may result in a need to revalidate.  If a master device is used, supporting information for 
the justification should be well documented. 
For devices that are subject to design controls under 21 CFR 820.30, the device design, including 
its labeling (e.g., reprocessing instructions) is to be validated to ensure that the device conforms 
to defined user needs and intended uses and shall include testing of production units under actual 
or simulated use conditions. The human factors methods used should ensure that the 
22  Contains Nonbinding Recommendations 
 
characteristics of the user population and operating environment are considered, in accordance 
with 21 CFR 820.30(g). See Section V.C. of this guidance for more information about human 
factors in developing reprocessing instructions. 
Cleaning, disinfection and sterilization processes should be validated to provide a high degree of 
assurance that a device will consistently meet predetermined specifications, in accordance with 
21 CFR 820.75. 
VIII. Validation of Cleaning Process 
This section describes FDAs recommendations on how to comply with the QS requirements 
discussed in the previous section regarding the validation of processes designed to clean reusable 
medical devices. Although many FDA-recognized consensus standards related to medical device 
sterilization are available, limited standards or guidances are currently available regarding 
cleaning of medical devices.   
You should conduct validation activities to demonstrate: 1) that your methods (manual or 
mechanical) are adequate to allow the device to undergo further processing and to eventually be 
reused safely; and 2) that your reprocessing instructions are effective in conveying the proper 
reprocessing methods to the user.  
A.  Validation of the Cleaning Process Using Worst-Case Testing 
You should validate the cleaning process you provide in your labeling. Your validation 
activities should be based on comprehensive validation protocols that use soils that are 
relevant to the clinical use conditions of the device. These should include the worst-case 
(least rigorous) implementation of the cleaning process, medical devices that represent 
the worst-case (most challenging to reprocess and most contaminated), and at least two 
quantitative test methods that are related to the clinically relevant soil. The cleaning 
process validation protocols should specify predetermined cleaning test endpoints. These 
protocols should be designed to establish that the most inaccessible locations on your 
devices can be adequately cleaned during routine processing.   
For all testing, you should choose a justifiable number of replicate samples to support the 
validity of any instructions based on the tests being performed.   
1.  Artificial Soil, Inoculation Sites, and Simulated Use 
Implementation of a well-established, simulated use test protocol should be an 
integral part of reprocessing validation.   
a.  Artificial Soil 
The manufacturer should select an artificial test soil, the composition of which 
accurately represents materials that the device would likely be exposed to during 
23  Contains Nonbinding Recommendations 
 
an actual clinical use, and would create the greatest (worst-case) challenge to the 
cleaning process. For example, a laryngoscope is intended to provide visualization 
of the larynx as part of a medical procedure, including facilitation of tracheal 
intubation, cardiopulmonary resuscitation, and surgery in this anatomical location. 
A laryngoscope would likely be exposed to both blood and mucus. Therefore, to 
simulate a worst case cleaning challenge, the artificial test soil should be a multi-
component soil that includes substances that simulate both blood and mucus. Note 
that conducting separate cleaning validations for blood and mucus individually 
would not be representative of a worst case challenge, because the mixture of 
blood and mucus is more difficult to clean. 
The artificial test soil chosen should allow at least two clinically relevant soil 
components to be quantified for validation testing (e.g., total organic carbon, 
protein). 
FDA does not recommend the use of spore (or any other microbial marker) log 
reduction testing as a method to determine the effectiveness of the cleaning 
method. Currently, there is lack of adequate scientific evidence regarding whether 
or not the removal of bacterial spores directly correlates to the removal of clinical 
organic soil from the devices. Such testing only indicates how well a process 
reduces spore count and provides no information on any other component of 
organic soil.   
b.  Inoculation Sites 
Soil inoculations should mimic worst-case clinical use conditions. We 
recommend you use the artificial soil to inoculate the device in all locations likely 
to contact patient materials, including all locations that are difficult to clean.  
c.  Simulated Use Conditions 
Simulated use conditions for the validation studies should be considered, 
especially for devices with features at risk for the accumulation of soil with 
repeated use. In such cases, your validation studies should use devices that have 
undergone some simulated use. Your validation studies should incorporate 
multiple full use cycles and should be designed to assess the accumulation of soil 
over time. The number of simulated use cycles that you use should be 
scientifically justified. 
If the device is powered or becomes hot during clinical use, these situations 
should be replicated during simulated use testing. Examples of such devices 
include powered hand-pieces and electrosurgical instruments.  
Simulated use conditions should account for real-world use conditions to mimic 
worst-case clinical use (e.g., the worst-case duration of clinical exposure). You 
should also conduct all functional procedures (repeated articulations, flexures, 
24  Contains Nonbinding Recommendations 
 
manipulations) for which the device is intended in order to soil the device 
sufficiently to represent worst-case conditions.   
If the device is likely to be repeatedly subjected to pushing soil into a hard to 
reach area during use, validation soiling should include repeated soiling to 
adequately reproduce such a worst-case use situation. If after clinical use of the 
device, drying of soil might occur and cleaning might not be performed 
immediately after use (such as with loaner devices that will be shipped without 
adequate reprocessing), the validation methods should allow soils to dry for a 
length of time that simulates worst-case (longest duration). The control devices 
should be prepared and processed in exactly the same manner as the test devices; 
positive control devices should be soiled and negative control devices should not 
be soiled.  
2.  Validation Protocols: Documentation of Methods Designed to Test the 
Cleaning Process 
Validation protocols should support the cleaning instructions provided in your device 
labeling; they should be detailed and specific with respect to the parameters such as 
time, temperature and concentrations.  
The cleaning validation protocols should use the shortest times, lowest temperatures, 
weakest dilutions, etc., for each step of the cleaning instructions. You should perform 
a detailed, side-by-side comparison of the text of the cleaning instructions and the text 
of the validation protocols, to identify and account for all worst-case processing 
conditions.   
Examples of worst-case processing conditions: 
  If the cleaning instructions recommend a 10 to 20 minute pre-soak, the 
validation protocols should specify 10 minutes. 
  If the cleaning instructions advise the user to manually clean at 45oC  5oC, 
the validation protocols should specify cleaning at 40oC. 
  Enzymatic Detergents: In general, worst-case implies shortest times, lowest 
temperatures, etc. An exception to validation at lowest temperature would be 
enzymatic detergents, which typically have optimally effective temperature 
ranges. Validation protocols should adequately address the temperature range 
specified in the cleaning instructions for enzymatic detergents.  
  Medical Washers/Disinfectors: If your process validation uses automated 
medical washers/washer disinfectors or ultrasonic cleaners, your worst-case 
should include the extremes of the intended cycle parameters for the available 
washer/washer disinfector cycles or ultrasonic cleaners.  
  If a device consists of lumens, ports, or channels that must be flushed during 
cleaning, the validation protocol should include minimal flushing 
specifications, such as time, flush volume or flow rate, and number of 
repetitions (e.g., 10 mL flush, performed 3 times). 
25  Contains Nonbinding Recommendations 
 
3.  Testing: Test Types and Protocols 
a.  Choice of Test Types 
FDA recommends that you use at least two quantitative test methods capable of 
directly measuring clinically meaningful levels of clinically relevant soil to meet a 
relevant, predetermined cleaning endpoint. Many potential test methods exist for 
the evaluation of soil and contamination, and the effectiveness of cleaning 
processes. The AAMI TIR 30 A compendium of processes, materials, test 
methods, and acceptance criteria for cleaning reusable medical devices provides 
a summary of test methods available in the published literature. 
When choosing a test method, consideration should be given to a number of 
factors. These should include, but may not be limited to, the contaminants that the 
device is expected to come in contact with during actual clinical use (which 
should be adequately represented in the artificial soil), the test specificity for 
direct measurement of those constituents, and the sensitivity of the test methods in 
relation to the proposed cleaning endpoints.  
Regardless of the test type you choose, visual inspection of both external and 
internal surfaces should be performed during validation. 
You should provide a justification for the test types chosen, including any 
relevant documentation (e.g., FDA-recognized standard, published literature, 
instructions for use for a commercially-available assay). If your chosen test 
method deviates in any way from what is described in the provided 
documentation, then you should identify and justify each deviation. 
b.  Methods Validation 
You should validate the test methods you choose to measure residual soil. Your 
documentation of the method should include analytical sensitivity and specificity 
information, as well as predetermined cleaning endpoints, and should describe 
appropriate controls. 
The Agency recommends that your test method include the following controls: 
  Negative device control  The device should be unsoiled and undergo the 
same cleaning and extraction as test devices. The amount of residual soil 
should be at or slightly above the negative sample control.  
  Positive device control  The device should be soiled with a known 
amount of soil, but not cleaned, and residual soil extracted. The amount of 
residual soil should be equivalent to or slightly lower than the amount of 
soil placed.  Soil recovery efficiencies should be calculated and used 
during the calculations. 
26  Contains Nonbinding Recommendations 
 
  Negative sample control  Extraction is conducted with no device. This 
sample is used as a blank. 
  Positive sample control  A known amount of soil (at or slightly above the 
limit of quantitation) is added to an extraction with no device. This 
control addresses interference of the extraction fluid and extraction 
method with soil detection. 
c.  Extraction Method 
Devices should be subjected to a validated method of extraction for recovery of 
residual soil. The extraction method should be completely described for each 
device and its recovery efficiency should be determined as part of its validation. 
Exhaustive extraction and extraction using a known quantity of soil are 
commonly used methods for determining recovery efficiency. Extraction should 
sample all surfaces, including internal surfaces (such as lumens) and mated 
surfaces. The worst case challenge (most difficult to remove) components of the 
soil should be addressed in the determination of recovery efficiency testing. You 
should ensure that the extraction volume used to remove test soil from the device 
is not so large that the test marker is diluted below the level of detection for the 
assay.  
Some device designs include more complex internal structures (e.g., lumens, 
internal moving parts) that may become soiled during use, but are difficult to 
access during cleaning and extraction. Hence, cleaning methods, including 
disassembly, should be designed to access these surfaces. For such geometrically 
complex devices, all relevant internal surface areas should be sampled during both 
the extraction method validation and device cleaning validation. Thus, for 
validation studies, additional disassembly processes may be required in order to 
adequately extract residual soil from these difficult to access areas. This 
additional disassembly should rarely require disassembly beyond the basic 
elemental component units, or require their actual physical destruction. 
For devices with internal compartments that are not intended to come in contact 
with clinical soil and fluids, you should demonstrate that cleaning solutions, rinse 
water and/or patient materials will not penetrate into the internal aspects of the 
devices via incomplete seals, seams, or other internal-external contiguous air 
spaces. 
If you determine that there is a risk of clinical soil or cleaning fluid ingress, you 
should demonstrate that the cleaning methods meet the cleaning endpoints for all 
internal surfaces that become contaminated at any time during the devices use 
life. 
B.  Resources for Establishing Simulated Use Protocols 
27  Contains Nonbinding Recommendations 
 
FDA recommends the use of worst-case simulated use protocols throughout the 
validation of the cleaning process. Where applicable, clinicians should be consulted to 
determine the extent and nature of real-world, worst-case device contamination. Also, 
practicality and human factors issues should be considered when establishing your 
reprocessing protocols. 
In addition, it may be helpful to refer to the AAMI TIR 30 A compendium of processes, 
materials, test methods, and acceptance criteria for cleaning reusable medical devices, 
for additional information specifically regarding soils and soil recipes described in the 
published literature.  
IX.  Validation of the Final Microbicidal Process to Prepare 
the Device for the Next Patient 
A.  Disinfection 
FDA recommends that you validate your disinfection processes and instructions. FDA 
also recommends that you follow the recommendations in device-specific FDA guidance 
documents or any relevant FDA-recognized standards.    
B.  Sterilization  
FDA recommends that you validate as well as provide in your labeling, sterilization cycle 
specifications that are consistent with the conventional parameters presented in Appendix 
C. This is to ensure that your device is compatible with the necessary FDA-cleared 
reprocessing equipment, and the reprocessing instructions are technically feasible for 
implementation by users. For reusable devices that are intended to be used sterile, 
labeling should include a sterilization process that you have validated to attain a sterility 
assurance level (SAL) of 10-6 (or 10-3, as appropriate). 
Validation data should be generated in FDA-cleared sterilizers and with FDA-cleared 
sterilization accessories (e.g., biological indicators, physical/chemical sterilization 
process indicators, sterilization wraps). Alternatively, validation data may be generated in 
sterilizers that can show equivalent or better control of key sterilization parameters than 
FDA-cleared sterilizers. If you choose this approach, you should address differences that 
may exist between the test sterilizer and the FDA-cleared sterilizer. 
X.  FDA Review of Reprocessing Instructions and 
Documentation of Reprocessing Method Validation in 
Submissions  
All cleaning, disinfection, and sterilization methods should be validated, and validations should 
be completed prior to submission of your pre-market submission. Your reprocessing instructions 
should reflect the validated methods. FDA will review the reprocessing instructions included in 
28  Contains Nonbinding Recommendations 
 
the labeling when we review premarket submissions for reusable medical devices. If the 
proposed labeling includes reprocessing instructions that do not provide adequate directions for 
use, FDA will communicate this to the submitter of the premarket submission. In response, the 
submitter may provide revised labeling or provide a rationale (and any supporting 
documentation) to explain why the labeling is adequate.  
The documentation to be submitted to FDA for the validation of your reprocessing process and 
instructions will depend upon the type of premarket submission and device type, as described 
below. 
A.  Documentation in 510(k)s  
Review of Reprocessing Instructions 
All 510(k)s must include proposed labels and labeling sufficient to describe the device, 
its intended use, and the directions for its use.  21 CFR 807.87(e).  For a reusable medical 
device as defined in the scope of this guidance, FDA interprets this to include 
reprocessing instructions. Validation of the reprocessing instructions should be completed 
prior to submission of a 510(k).   
When evaluating a 510(k), FDA generally compares the labeling for the legally marketed 
predicate device to the proposed labeling for the new device. A description of FDAs 
510(k) decision-making process is described in FDAs guidance The 510(k) Program: 
Evaluation Substantial Equivalence in Premarket Notifications [510(k)] 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM284443.pdf#page=30). As part of this evaluation, differences in 
proposed labeling, among other product differences, can impact the assessment of 
whether two devices are substantially equivalent. However, reprocessing instructions for 
some older, legally-marketed, reusable devices may not be consistent with state-of-the-art 
science and therefore may not ensure that device is clean, disinfected, or sterile.  This 
may cause those devices to be adulterated under section 501(c) of the FDCA because its 
purity or quality fall below that which it purports or is represented to possess, or to be 
misbranded under section 502(f) of the FDCA because its labeling does not bear adequate 
directions for use or under section 502(j) of the FDCA because it is dangerous to health, 
among other possible violations. This should be taken into account when preparing 
reprocessing instructions as part of a 510(k) submission. 
Consistent with standard operating procedures for review of premarket submissions, if 
post-market experience indicates potentially unsafe reprocessing for a particular 
reprocessing method, FDA may suggest that proposed instructions utilizing such method 
for a device under review be changed to address the need for improved reprocessing 
methods to avoid adverse events of the type reported and violations of the type discussed 
in the preceding paragraph.5  
                                                 
5 SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions 
(http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm27
9288.htm).  
29  Contains Nonbinding Recommendations 
 
Review of Validation of Reprocessing Instructions 
FDA has identified a subset of medical devices that pose a greater likelihood of microbial 
transmission and represent a high risk of infection (subclinical or clinical) if they are not 
adequately reprocessed.  This identification is based on knowledge gleaned through 
MDRs; recalls; periodic outbreaks of microbial transmission or patient infection reported 
in the literature or media; reports provided by the Centers for Disease Control (CDC), the 
Veterans Administration (VA), and other health care settings; and manufacturer-initiated 
surveillance studies. These device types are listed in Appendix E. The 510(k)s for these 
devices should include protocols and complete test reports of the validation of the 
reprocessing instructions for FDA review, so that FDA has the information it needs to 
evaluate substantial equivalence.6 This includes validation of the cleaning instructions as 
well as the disinfection or sterilization instructions. The reprocessing validation data 
should demonstrate that the proposed reprocessing instructions will reprocess the subject 
device at least as well as the reprocessing instructions for the predicate device..  
For reusable medical devices not identified in Appendix E, FDA does not expect a 
complete report of the validation of the reprocessing instructions to be included in a 
510(k) submission. FDA staff may request these data, which the manufacturer should 
have on file in accordance with 21 CFR Part 820, if submission of validation data is 
recommended in a device-specific guidance or as needed to evaluate substantial 
equivalence. 
B.  Documentation in PMAs, HDEs and De Novo Requests 
A PMA, HDE or de novo request should include the protocols and complete test reports 
of the validation of the reprocessing instructions in the manufacturing and design section. 
FDA intends to review the reprocessing validation data in the same manner as the other 
manufacturing and design data. 
C.  Documentation in IDEs  
An IDE application must include a report of all prior clinical, animal, and laboratory 
testing of the device as part of the report of prior investigations.7 We interpret this to 
include a summary of the validation testing of the reprocessing instructions.  Because an 
approved IDE is not exempt from design controls under 21 CFR 820.30, we recommend 
that validation of the reprocessing instructions be complete at the time of submission of 
an IDE.   
                                                 
6 FDAs submission recommendations and review practices for 510(k)s are described in FDAs guidance The 
510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. That guidance explains 
the decision-making process FDA uses to evaluate substantial equivalence, including when submission of data may 
be necessary. 
7 21 CFR 812.27 states that the report of prior investigations shall include reports of all prior clinical, animal, and 
laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation. 
30  Contains Nonbinding Recommendations 
 
FDA intends to appropriately consider the extent of the data needed prior to the initiation 
of clinical studies to document the safety of the recommended reprocessing instructions 
for the device.  
31  Contains Nonbinding Recommendations 
 
APPENDIX A.  Definition of Terms 
The following are common terms that may be used in reprocessing instructions in device 
labeling, some of which are derived from referenced literature.8, 9, 10, 11, 12, 13 The list is not 
exhaustive. Some of the terms defined here are derived from other relevant FDA guidances and 
some terms have been defined here for the purpose of this guidance. Additional definitions of 
terms can be found in the referenced literature. 
Biological Indicator (BI): A test system containing viable microorganisms providing a defined 
resistance to a specified sterilization process. 
Cleaning: Physical removal of soil and contaminants from an item to the extent necessary for 
further processing or for the intended use.    
Design History File (DHF): A compilation of records which describes the design history of a 
finished device. (21 CFR 820.3(e)) 
Device Master Record (DMR): A compilation of records containing the procedures and 
specifications for a finished device. (21 CFR 820.3(j)) 
Disinfectant: An agent that destroys pathogenic and other kinds of microorganisms by chemical 
or physical means. A disinfectant destroys most recognized pathogenic microorganisms, but not 
necessarily all microbial forms, such as bacterial spores. 
Disinfection: A process that destroys pathogens and other microorganisms by physical or 
chemical means. Disinfection processes do not ensure the same margin of safety associated with 
sterilization processes. The lethality of the disinfection process may vary, depending on the 
nature of the disinfectant (See Appendix D), which leads to the following subcategories: 
a.  High Level Disinfection: A lethal process utilizing a sterilant under less than sterilizing 
conditions. The process kills all forms of microbial life except for large numbers of 
bacterial spores. 
b.  Intermediate Level Disinfection: A lethal process utilizing an agent that kills viruses, 
mycobacteria, fungi and vegetative bacteria, but no bacterial spores. 
                                                 
8 Pflug, I.J., Microbiology and Engineering of sterilization Processes, 7th ed. Minneapolis, Environmental 
sterilization Laboratory. 1990, Chapters 1-3. 
9 Sehulster LM, Chinn RYW, Arduino MJ et al Guidelines for environmental infection control in health care 
facilities, 2003.  
10 Occupational Safety & Health Administration, available at 
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.   
11 Association for the Advancement of Medical Instrumentation (AAMI). Sterilization of health care products-
Vocabulary.  ANSI/AAMI/ISO TIR11139:2006. 
12 Block SS, Definition of Terms In: Block SS, ed. Disinfection, Sterilization and Preservation, 5th ed. Phila: 
Lippincott Williams & Wilkins 2001:19-28. 
13 Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam 
sterilization and sterility assurance in health care facilities.  ANSI/AAMI ST79:2010 & A1:2010. 
32  Contains Nonbinding Recommendations 
 
c.  Low Level Disinfection: A lethal process utilizing an agent that kills vegetative forms of 
bacteria, some fungi, and lipid viruses. 
Germicide/Microbicide: An agent that destroys microorganisms, especially pathogenic 
organisms. Other terms with the suffix -cide (e.g., virucide, fungicide, bactericide, sporicide, 
tuberculocide) indicate an agent that destroys the microorganism identified by the prefix. 
Physical/Chemical Sterilization Process Indicator: A physical/chemical sterilization process 
indicator is a device intended for use by a health care provider to accompany products being 
sterilized through a sterilization procedure and to monitor one or more parameters of the 
sterilization process. The adequacy of the sterilization conditions as measured by these 
parameters is indicated by a visible change in the device. (21 CFR 880.2800(b)) 
Process Validation: Establishing by objective evidence that a process consistently produces a 
result or product meeting its predetermined specifications.  
Reprocessing: Validated processes used to render a medical device, which has been previously 
used or contaminated, fit for a subsequent single use. These processes are designed to remove 
soil and contaminants by cleaning and to inactivate microorganisms by disinfection or 
sterilization.   
Reusable Medical Device: A device intended for repeated use either on the same or different 
patients, with appropriate cleaning and other reprocessing between uses. 
Single-use Device (SUD): A SUD is a device that is intended for one use or on a single patient 
during a single procedure.14 
Spore (or Endospore): The dormant state of a microorganism, typically a bacterium or fungus, 
which exhibits a lack of biosynthetic activity, reduced respiratory activity, and has resistance to 
heat, radiation, desiccation and various chemical agents.  
Sterilant: An agent that destroys all viable forms of microbial life.   
Sterile: State of being free from viable microorganisms.   
Sterility Assurance Level (SAL): A SAL is the probability of a single viable microorganism 
occurring on an item after sterilization. 
Sterilization: A validated process used to render product free from viable microorganisms. 
NOTE: In a sterilization process, the nature of microbial inactivation is described as 
exponential and, thus, the survival of a microorganism on an individual item can be 
expressed in terms of probability. While this probability can be reduced to a very low 
number, it can never be reduced to zero.  
                                                 
14 Food and Drug Administration (FDA), Reprocessing of Single Use Devices, Definitions, 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-
UseDevices/ucm121090.htm (June 18, 2009). 
33  Contains Nonbinding Recommendations 
 
Sterilization Wrap: A sterilization wrap (pack, sterilization wrapper, bag, or accessories) is a 
device intended to be used to enclose another medical device that is to be sterilized by a health 
care provider. It is intended to allow sterilization of the enclosed medical device and also to 
maintain sterility of the enclosed device until used. (21 CFR 880.6850) 
34  Contains Nonbinding Recommendations 
 
APPENDIX B.  Overview of Reusable Medical Device 
Reprocessing 
As it is difficult for the health care workers responsible for reprocessing reusable devices to 
assess the amount and resistance of microbial contamination on the devices to be reprocessed, 
product labeling, professional practices, and institutional infection control procedures help guide 
the persons who are responsible for reprocessing devices.   
Proper handling and reprocessing of reusable medical devices for the next patient is done by 
carefully adhering to general reprocessing steps described in the following detailed overview, 
presented as Figure 2.  
FIGURE 2. PROCESS OVERVIEW 
 
We recommend that all reusable medical devices be designed and constructed to allow adequate 
cleaning, because if a device cannot be adequately cleaned, any subsequent disinfection or 
sterilization process may not be effective. 
Additional information on reprocessing for some specific device types, such as endoscopes and 
ultrasound transducers, is available from FDA in our database of guidance documents15 and by 
consulting specific review divisions. 
                                                 
15 See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.   
35  Contains Nonbinding Recommendations 
 
APPENDIX C.  Examples of Sterilization Cycles Used in 
Health Care Settings  
STEAM STERILIZATION CYCLES 
Table 1. Cycle Times for Gravity-Displacement Steam Sterilization Cycles 
Exposure Time at  Exposure Time at  Exposure Time at 
Item  Minimum Drying 
121oC (250oF)  132oC (270oF)  135oC (275oF) 
Times 
Wrapped Instruments  30 minutes  15 minutes  15 - 30 minutes 
10 minutes  30 minutes 
Textile Packs  30 minutes  25 minutes  15 minutes 
10 minutes  30 minutes 
Wrapped Utensils  30 minutes  15 minutes  15 - 30 minutes 
10 minutes  30 minutes 
Nonporous items (e.g.,  3 minutes  3 minutes  0 - 1 minutes 
instruments) 
Nonporous and porous items in  10 minutes  10 minutes  0 - 1 minute 
mixed load 
Table 2. Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles 
Exposure Time at  Exposure Time at 
Item  Minimum Drying 
132oC (270oF)  135oC (275oF) 
Times 
Wrapped Instruments  4 minutes    20 - 30 minutes 
3 minutes  16 minutes 
Textile Packs  4 minutes  5 - 20 minutes 
3 minutes  3 minutes 
Wrapped Utensils  4 minutes  20 minutes 
3 minutes  16 minutes 
Nonporous items (e.g., instruments)  3 minutes  3 minutes  N/A 
Nonporous and porous items in mixed  4 minutes  3 minutes  N/A 
load 
Tables 1 and 2 modified and reprinted with permission from ANSI/AAMI ST79:2010 & A1:2010 Comprehensive guide to steam 
sterilization and sterility assurance in health care facilities. Published by the Association for the Advancement of Medical 
Instrumentation (AAMI). (C) 2012 AAMI www.aami.org. 
EO STERILIZATION CYCLES 
In general, the most common parameters are EO concentrations from 450 to 1200 milligrams per 
liter (mg/L), temperatures from 37C to 63C (99F to 145F), exposure times from 60 to 360 
minutes, and chamber humidity from 40% to 80% (ANSI/AAMI ST41:2008 Ethylene oxide 
sterilization in health care facilities: Safety and effectiveness). Other cycle parameters may be 
used if available on an FDA-cleared sterilizer. 
                       
36  Contains Nonbinding Recommendations 
 
APPENDIX D.  Descending Order of Resistance of 
Microorganisms to Germicidal Chemicals 
 
 
Most Resistant  Bacterial Spores 
 
Mycobacteria 
Nonlipid or Small Viruses 
Fungi 
Vegetative Bacteria 
 
Least Resistant  Lipid or Medium-Size Viruses 
 
 
 
 
Modified from Favero, M.S. and Bond, W.W., Chemical Disinfection of Medical and Surgical 
Materials. In: Disinfection, Sterilization, and Preservation, 5th Ed Phila: Lippincott Williams & 
Wilkins 2001: 881-917. 
37  Contains Nonbinding Recommendations 
 
APPENDIX E.  Devices for which a 510(k) Should Contain 
Data to Validate Reprocessing Instructions 
The FDA has identified a subset of medical devices that pose a greater likelihood of microbial 
transmission and represent a high risk of infection (subclinical or clinical) if they are not 
adequately reprocessed. This identification was based on knowledge gleaned through MDRs; 
recalls; periodic outbreaks of microbial transmission or patient infections reported in the 
literature or media; reports provided by the Centers for Disease Control (CDC), the Veterans 
Administration (VA), and other health care settings; and manufacturer-initiated surveillance 
studies.  
Section 3059 of the 21st Century Cures Act (Pub. L. 114-255) required FDA to publish a list of 
reusable medical devices for which validated reprocessing instructions and the validation data for 
reprocessing of the reusable device must be included in a 510(k) submission. This section also 
gives FDA the authority to determine that a 510(k) submission for these reusable devices are not 
substantially equivalent to a predicate device if the validated instructions for use and 
reprocessing validation data submitted as part of the 510(k) are inadequate.  As required under 
Section 3059 of the 21st Century Cures Act, a list of these reusable devices, categorized 
specifically by regulation and product code (Table 1 below) or by design features for certain 
device types (Table 2 below), which will require validated instructions for use and validation 
data in their premarket notifications, was published in the Federal Register (82 FR 26807) on 
June 9, 2017.  The tables below are consistent with this Federal Register Notice.   
Reprocessing instructions for medical devices should be validated. However, because of the 
greater risks to the public health posed by the devices listed below, 510(k) submissions for these 
devices should include protocols and complete test reports of the validation of the reprocessing 
instructions so that FDA has the information it needs to evaluate substantial equivalence. This 
includes validation of the cleaning instructions as well as the disinfection or sterilization 
instructions.  The reprocessing validation data should demonstrate that the proposed reprocessing 
instructions will reprocess the subject device at least as well as the reprocessing instructions for 
the predicate device.  
Table 1- Reusable Devices that Require Validation Data and Validated Reprocessing Instructions 
be Included in 510(k) Notification and upon which FDA will Determine Substantial Equivalence 
Device Type   Product  Device Name   21 CFR Section   
Code 
EOQ  Bronchoscope (flexible or rigid)  21 CFR 874.4680 
PSV  Ultrasound bronchoscope  21 CFR 892.1550 
KTI    Bronchoscope accessory  21 CFR 874.4680  
BTG  Brush, biopsy, bronchoscope (non-rigid)    21 CFR 874.4680  
Bronchoscopes (flexible or 
JEI    Claw, foreign body, bronchoscope (non-rigid)   21 CFR 874.4680  
rigid) and accessories 
JEL    Curette, biopsy, bronchoscope (rigid)  21 CFR 874.4680  
BST    Curette, biopsy, bronchoscope (non-rigid)  21 CFR 874.4680  
BWH  Forceps, biopsy, bronchoscope (non-rigid)  21 CFR 874.4680  
JEK    Forceps, biopsy, bronchoscope (rigid)  21 CFR 874.4680  
ENZ  Telescope, laryngeal-bronchial   21 CFR 874.4680  
38  Contains Nonbinding Recommendations 
 
KTR  Tube, aspirating, bronchoscope (rigid)  21 CFR 874.4680 
JEJ  Tubing, Instrumentation, bronchoscope (brush  21 CFR 874.4680 
sheath A/O aspirating) 
EOX  Esophagoscope (flexible or rigid)  21 CFR 874.4710 
GCL   Esophagoscope, general & plastic surgery  21 CFR 876.1500 
Ear, Nose, and Throat 
FDW  Esophagoscope, rigid, gastro-urology  21 CFR 876.1500 
(ENT) endoscopes and 
EOB  Nasopharyngoscope (flexible or rigid)  21 CFR 874.4760 
accessories 
EQN  Laryngoscope, nasopharyngoscope  21 CFR 874.4760 
EWY  Mediastinoscope, surgical, and accessories  21 CFR 874.4720 
Gastroenterology and  FDT  Duodenoscope and accessories, flexible/rigid  21 CFR 876.1500 
Urology Endoscopes that 
have elevator channels (not 
including accessories)  FAK  Panendoscope (gastroduodenoscope)  21 CFR 876.1500 
[e.g., duodenoscopes used 
for endoscopic retrograde 
ODF      Mini endoscope, gastroenterology-urology  21 CFR 876.1500 
cholangiopancreatography 
(ERCP)] 
FEB  Accessories, cleaning, for endoscopes  21 CFR 876.1500 
NZA  Accessories, germicide, cleaning, for  21 CFR 876.1500 
endoscopes 
Automated Reprocessors 
OUJ  High level disinfection reprocessing  21 CFR 892.1570 
for Reusable Devices 
instrument for ultrasonic transducers, mist 
 NVE  Washer, cleaner, automated, endoscope  21 CFR 876.1500 
PSW     High level disinfection reprocessing  21 CFR 892.1570 
instrument for ultrasonic transducers, liquid 
FDF  Colonoscope and accessories, flexible/rigid  21 CFR 876.1500 
FBN      Choledochoscope and accessories,  21 CFR 876.1500 
flexible/rigid 
Other Flexible 
FDA  Enteroscope and accessories  21 CFR 876.1500 
Gastroenterology and 
FDS  Gastroscope and accessories, flexible/rigid  21 CFR 876.1500 
Urology Endoscopes1 (not 
FAJ  Cystoscope and accessories, flexible/rigid  21 CFR 876.1500 
including accessories) 
FGB  Ureteroscope and accessories, flexible/rigid  21 CFR 876.1500 
ODG  Endoscopic ultrasound system,  21 CFR 876.1500 
gastroenterology-urology 
Neurological endoscopes  GWG  Endoscope, neurological  21 CFR 882.1480 
(not including accessories) 
Water-based heater-cooler  DWC  Controller, Temperature, Cardiopulmonary  21 CFR 870.4250 
systems for use in  Bypass 
operating rooms  DWJ  System, Thermal Regulating  21 CFR 870.5900 
System, Surgical,  NAY  System, Surgical, Computer Controlled  21 CFR 876.1500 
Computer Controlled  Instrument            
Instrument
Arthroscopes and  HRX    Arthroscope                  21 CFR 888.1100 
accessories2 
Laparoscopic instruments  GCJ  Laparoscope, general & plastic surgery  21 CFR 876.1500 
and accessories2 
Electrosurgical instruments  GEI    Electrosurgical, cutting & coagulation &  21 CFR 878.4400 
and accessories2  accessories 
 
1 For endoscopes that fall under these product codes, 510(k) submissions must include reprocessing  
validation data for those endoscopes which are flexible.  
2 For devices that fall under these product codes, 510(k) submissions must include reprocessing validation data if the 
device possesses any of the design features listed in Table 2 below. 
39  Contains Nonbinding Recommendations 
 
 
Table 2 
 Design Features Which May Pose a Challenge to Adequate Reprocessing for Arthroscopes, Laparoscopic 
Instruments, and Electrosurgical Instruments, and their Respective Accessories 
Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, 
bifurcated lumens, lumens with internal surfaces that are not smooth, have internal ridges or sharp angles, or are too 
small to permit a brush to pass through) 
Hinges, depressions, joints with gaps, overlapping or butted joints that result in acute angles, or ribbed or otherwise 
roughened surfaces (e.g., jaws) 
Interior device channels 
Sleeves surrounding rods, blades, activators, inserters, etc. 
Shafts within lumens  
Adjacent device surfaces between which debris can be forced or caught during use 
O-rings 
Stopcocks/Valves 
Crevices 
Fittings with very close tolerances  
Clamps that cannot be fully opened for cleaning    
Small internal parts (e.g., springs, magnets, etc.) that may become soiled 
Ridges, articulations or grooves 
Rough, irregular, discontinuous surfaces that can entrap or retain soil  
Capillary gaps  
Luer locks  
Porous materials (smooth surfaces are desirable, where possible)  
Junctions between insulating sheaths and activating mechanisms (as in certain laparoscopic instruments)  
Dead-ended chambers 
Internal movable device components such as multiple cables 
Device features that may entrap debris that can later become aerosolized (e.g., through application of power, etc.) 
Devices with these or other design features that cannot be disassembled for reprocessing 
In the future this list may be updated as additional information regarding reprocessing medical 
devices becomes available. 
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