Rockville, MD

Workshop on Standards for Biomedical

Materials and Devices

June 13 - 14, 2001

Sponsored by: NIST

Cosponsors: AAMI, ADA, AdvaMed, ASTM, SFB, NHLB NIH

In Cooperation with: AIMBE, FDA

NISTIR 6791
Contact : Dale Hall, (301-975-5658

John Tesk, (301)-975-6799
NISTIR 6791

September 2001

U.S. DEPARTMENT OF COMMERCE

Donald L. Evans, Secretary

NATIONAL INSTITUTE OF STANDARDS

AND TECHNOLOGY

Dr. Karen H. Brown, Acting Director

U NI T E D S T A T E S OF A ME R I CA

DE P AR T MENT OF COMME R CE

Workshop on Standards for 

Biomedical Materials and Devices

U. S. DEPARTMENT OF COMMERCE

Technology Administration

National Institute of Standards

 and Technology

Gaithersburg, MD 20899-8230

1

Introduction

The Workshop on Biomedical Materials and Devices, held June 13-14, 2001, is the latest in a series of

workshops and topical meetings organized by NIST in the area of biomedical technology. The workshop

complements other recent NIST efforts to make its leadership in standards and measurements more

available to the health care industry, which accounts for about 13% of the U.S. Gross National Product

and continues to grow rapidly.

The primary goal of the workshop was to identify and prioritize standards needs in selected biomedical

materials and devices technologies as the basis for a NIST standards strategy in those areas. The

technical focus areas in this workshop,

 Biomaterials

 Tissue engineered medical devices

 Therapeutic and drug delivery systems

 Auditory diagnostic and prosthetic devices

 Manufacturing and processing of prostheses

were chosen because they are areas in which NIST currently has active projects and is prepared to

respond to the findings and recommendations of the workshop. The workshop also addressed three

crosscutting topics that are common to all of the focus areas and many other biomedical areas as well:

 Data exchange and integrity

 Sterilization

 Harmonization

A second goal of the workshop was to obtain recommendations for collaborations between NIST and

other key stakeholders in the biomedical materials and devices industry to address national and

international standards issues. NIST has a long history of effective partnerships with others in many

technical and industrial fields and has found that such arrangements can facilitate the acceptance and use

of new standards, measurement methods, and technology.

The participants for the workshop were chosen from among a core group of idea generators and decision

makers from industrial companies; organizations that shape the standards, regulatory, and research and

development environment in which those companies work; and the standards community. The findings

and recommendations in this report represent the consensus that they reached on critical standards needs

and the actions needed to address them. The workshop participants accomplished a great deal in a limited

time. The ideas and plans that were developed already represent a significant result. However, the true

success of the workshop will be measured by the actions that NIST and others subsequently take in

response to the recommendations in this report. 

The Workshop Planning Committee wishes to thank all those who organized, facilitated, and participated

in the workshop.
2

TABLE OF CONTENTS

INTRODUCTION .......................................................................................................................................................1

TABLE OF CONTENTS ............................................................................................................................................2

EXECUTIVE SUMMARY .........................................................................................................................................3

PERSPECTIVES ON THE NEEDS FOR BIOMEDICAL MATERIALS AND DEVICE STANDARDS .........5

BREAKOUT SESSION REPORTS...........................................................................................................................8

STANDARDS FOR BIOMATERIALS .....................................................................................................................9

THERAPEUTIC AND DRUG DELIVERY DEVICES .........................................................................................11

AUDITORY DIAGNOSTIC AND PROSTHETIC DEVICES..............................................................................14

MANUFACTURING OF PROSTHESES ...............................................................................................................19

TISSUE ENGINEERED MEDICAL DEVICES ....................................................................................................22

CROSSCUTTING ISSUES REPORTS...................................................................................................................26

HARMONIZATION OF STANDARDS..................................................................................................................27

APPENDICES............................................................................................................................................................36

APPENDIX: AUDITORY DIAGNOSTIC AND PROSTHETIC DEVICES.......................................................37

APPENDIX CROSSCUTTING DATA ACTION ITEMS.....................................................................................39

PARTICIPANTS LIST .............................................................................................................................................44

AGENDA....................................................................................................................................................................55

SPEAKER BIOGRAPHICAL SKETCHES ...........................................................................................................57

PLANNING COMMITTEE MEMBERS................................................................................................................59

ACKNOWLEGEMENTS AND SPECIAL THANKS............................................................................................62
3

Executive Summary

Dale Hall

Material Science and Engineering Laboratory

The biomedical materials and devices industry works in a climate of ever-higher expectations as the

demographic makeup and attitudes of the customer base evolve and technology advances in the field and

related areas. Historically, the medical device industry has been both highly innovative and strictly

regulated. The emerging relationships between standards applied for use for regulatory and trade

purposes has placed increasing importance on the development of standards for biomedical materials and

devices. The importance of standards for these purposes is evident in the three primary reasons that were

identified at the workshop as to why standards are needed today: 

 Reduced time and cost of new product introductions. Good standards can help industry to focus

on and set targets for critical product performance characteristics and to speed the approval

process. Expediting the front end of the process is crucial. Whenever possible, standards and

measurement work should be anticipatory rather than reactionary; work on the basis for a

standard can be begun before the technology is fully developed.

 Harmonization and competitiveness. Harmonization is the process of making national standards

compatible, which can cut the cost of doing business and remove impediments to international

commerce. Standards, in turn, are the common denominators that make harmonization possible.

Despite the business advantages of harmonization, consensus is not always easy, but must not be

achieved by watering down standards to the lowest common denominator. Strong international

standards can encourage convergence in national regulatory practices.

 Regulation. The work of regulators is facilitated by standards that are clear, unambiguous, and

technically rigorous. On the other hand, overly restrictive standards can stifle innovation and

leave some technological approaches either disadvantaged or infeasible. The goal is to balance

the needs for innovation and new product introduction with the need for acceptable safety levels

and public confidence. Good standards can ease the regulatory burden on industry, by reducing

the cost of compliance, and on regulators, by reducing the cost of device evaluations and

approvals.

The workshop produced clear, and in most cases, quite specific technical priorities in all of the technical

focus areas. These will not be repeated here, as they are summarized succinctly in the body of the report.

What follows here is a summary in a broader, more strategic sense, of the findings and recommendations

that emerged from the workshop. 

Although the workshop focus was on paper standards, external participants encouraged NIST to expand

its efforts in standards and standards-related work in a number of ways. Rather than defining a particular,

narrow, across-the-board standards function for NIST, workshop participants made it clear that the work

needed from NIST depended on the specific technical area and included the following:

 Standards writing and standards development; in particular, work toward consistent terminology

across standards-writing groups

 Committee leadership and participation, in both national and international standards; join

existing organizations that are meeting the needs, and form new subcommittees when necessary

 Measurement and calibration methods with high accuracy and reliability: summarize current

baseline practices and recommend and pursue further advances

 Test method validation; especially in the area of performance tests

 Databases

 Standard Reference Materials (SRMs) and other Reference Materials
4

The common denominator was the call for NIST to play to and build on its existing strengths.

Several workshop participants cited NISTís value as a neutral, objective party in technical matters. NIST

can bring unbiased public sector data into standards development and the regulatory process. When

disagreements must be resolved, NISTís long-established role of rendering sound, unbiased technical

judgments helps to give all parties the assurance of an impartial recommendation. NISTís potential value

in coordinating and convening key stakeholders in open forums, e.g., for strategy and planning, was also

cited.

NISTís value as a source of information was stressed by many of the workshop presenters. One difficulty

facing those outside NIST was the distributed nature of NISTís work on biomedical materials and

devices. Projects span several laboratories, and finding all of the relevant programmatic information can

be difficult. NIST was encouraged to develop and disseminate an inventory of all NIST activities in the

field. Such an effort should begin with, but not necessarily be limited to, NISTís website. NIST was also

encouraged to collect and make available a summary of all existing standards in the field, worldwide, i.e.,

a database of what is available and where it can be found.

Within the biomedical materials and devices community, there are a number of boards and committees

where critical issues are discussed. NIST was strongly encouraged to maintain a continuing and regular

presence on these key councils. By doing so, NIST will hear about important issues at an early stage. 

One important council is the Medical Devices Standards Board (MDSB). NIST has often attended

MDSB meetings, but has not been a full member. At the workshop, NIST committed to becoming a full

member and has subsequently done so. NISTís ability to maintain such connections has been

strengthened recently by the creation of an internal Industrial Liaison Office, and two of the principal

organizers of this workshop have joined that office, specifically to work with the health care industry.

While the workshop came to many specific recommendations, it was clear that some of the priority areas

require further definition. As a result, some of the technical focus groups recommended further meetings

and workshops to pursue those subjects. To ensure that these meetings will be action-oriented and

customer-focused, they will be co-sponsored and co-organized by NIST and external partners whenever

possible. We expect that the technical focus groups at this workshop will take proprietorship of these

meetings and will form their nuclei. 
5

Perspectives on the Needs for Biomedical Materials and Device Standards

Lisa Karam

Industrial Liaison Office

John A. Tesk

Materials Science and Engineering Laboratory

and

 Industrial Liaison Office

Dale Hall

Materials Science and Engineering Laboratory

Introductory Remarks:

The meeting was opened with a welcoming address by Karen Brown, Deputy Director and Acting

Director of NIST. Brown described the role of NIST toward improving the economy and the quality of

life in the U.S. Brown emphasized the importance of health care to the economy, saying that the U.S.

spends $1.1 trillion annually on health care, which is estimated to be 17 % of the GDP for 2002.

Leslie Smith, Director of the Materials Science and Engineering Laboratory at NIST, provided an

introduction to health related activities at NIST. He noted that of the 3000 NIST SRMs (Standard

Reference Materials) sold in 2000, approximately 10 % were health related. As an example he described

NISTís role in the development of SRMs used for cholesterol measurements. NIST efforts for

measurement methods and standards for electromagnetic fields, laser calibrations, medical materials

collaborations (with FDA), new materials for tissue engineering, and the mammography field (26 million

procedures/year for $3 B) were cited; NIST provides the standard used for 17 types of mammography

machines. The important workshop held at NIST on Nov 2-3, 2000 , dealing with the European Union In

Vitro Device Directive was noted (Beckman Coulter, Dade Behring, Abbott Laboratories, and

Ortho Clinical companies participated).

Dale Hall (NIST) explained that the workshop was being held to identify and prioritize key standards

needs in selected areas of the biomedical industry, in which NIST already has active programs on which

to build. He stated the workshop could address standards in a broad sense, including consensus paper

standards, reference materials, reference data, standardized test methods, standard practice procedures,

standardized measurements, or anything else similar. He emphasized our interest in hearing from and

responding to the industry needs on its needs, consistent with our mission, resources, and programs. It is

NISTís intent to use the workshop results as a guide in the development of future plans for addressing the

standards needs of the biomedical community.

Following the introductory remarks were a series of resource presentations.

Jack Lemons (Professor and Director of Laboratory Surgical Research, School of Medicine, Division of

Orthopaedic Surgery, University of Alabama) provided an overview of biomedical material and device

standards issues. He spoke of standards issues and a need for SRMs to serve as stable references against

which the properties of new biomaterials could be assessed. He also spoke of a need for new materials

for biomedical devices. It was his opinion that NIST could provide research infrastructure to address this

field which is evolving to devices that use ever-smaller components for their applications (measurement

resolutions are needed at the nanometer level and detection of compositions at the 10-9 % fraction levels).

For the field of orthopaedics he described a specific need for the development of a synthetic fluid that

would mimic synovial fluid, but which would not degrade under the conditions of in vitro wear testing of

materials and devices. For cardiovascular, orthopaedic, and ophthalmic devices there have been problems

with absorption, wear, and damage; standards were mentioned as needed to help assure safety, efficacy,
6

and durability. Without alluding to specific problems, he drew attention to the fact the number of tooth

implant procedures is becoming a larger fraction of all implant procedures.

John Watson (Director, Molecular Biology Program and Clinical and Molecular Medicine Program,

National Heart, Lung, and Blood Institute, NIH) addressed emerging biomedical issues. He discussed the

need for standards that have clinical relevance. New standards and guidelines are needed for data and the

use of the Internet. A big need is for implants to last a lifetime, so there is a vital need for basic research

into design, in vivo assessment of implants, retrieval, and retrieval analysis. He briefly discussed the new

NIH institute (National Institute of Biomedical Imaging and Bioengineering) and that it is the first of the

NIH institutes with an explicit mission to encourage and support the development of relevant standards

and guidelines in the field.

Don Marlowe (Director, Office of Science and Technology, FDA) covered standards and the FDA needs

for device submissions. He described how the existence of standards can help to ease some of the burden

of new device approvals through the citing of conformance, in a device approval application, to

applicable standards. There is much to be done in standards development in anticipation of future trends

in medical device technology. One of his concerns is that up-front cost containment issues can be a huge

impediment to standards development.

Bernie Liebler (Director of Technology and Regulatory Affairs, AdvaMed) gave an industrial perspective.

He noted that the medical device industry is not driven by standards; it has been, traditionally, very

highly innovative while strictly regulated. NIST has provided traceable calibrations (he mentioned

thermometers), traceable standard reference materials (for measurements, comparisons and calibrations)

and test methods and equipment. Major drivers for standards development include standards-based

EU-device approvals, globalization of markets, and strong efforts to harmonize requirements. The needs

he focused on were for patient safety, harmonization, traceability, standard materials, test methods, and

NIST participation as technical experts on standards committees. He made reference to the EU-IVD

directive (calibration materials to provide reproducibility and traceability) and round robin testing of

results. These were discussed at the Nov 2-3, 2000, workshop at NIST (Angelo, J.B. and Margolis, S.A.,

"1998 Round Robin Collaborative Study: Precision, Bias and Method Detection Limit," ASTM Research

Report for Method D 1533, no. D27-1012, 1999). He presented some industry needs for NIST action,

such as calibration standards, databases, test method validations, test/calibration methods and tools, and

standards development participation. He wanted NIST to ëcome to the tableí and specifically asked for

NIST to become a full member of the Medical Devices Standards Board (Editorial note, NIST responded

in July, following the workshop, by resuming full, voting participation, in the MDSB).

Henry Heffernan (A staff member from the Clinical Center, NIH) addressed the crosscutting issue of data.

He noted information technology as being at a critical stage with needs in the explosion of patient

information portability, security, privacy, encoding of data, and transmission. Heffernan saw NIST

expertise as essential in helping to meet these burgeoning needs. He mentioned the assemblage of a data

group for the workshop and its task to identify issues and needs for data across focus group breakout

sessions of the workshop.

Michael Scholla (Global Business Director, Tyvek Medical Packaging) addressed the crosscutting issue

of sterilization, which he believes is already a relatively mature process (internationally, in Europe and in

the US). He was speaking specifically of standards for medical device sterilization (dealt with in

ISO/TC198, CEN/TC204 and in AAMI groups among others, for over 100 standards already published ñ

many of which are recognized by the FDA). He sees needs for the development of sterilization methods

for materials of biological origins and for inactivation of prions (methods, equipment, process validation,

indicators and standards related to these are in need of development). There is a lack of an ASTM-type
7

organization in Europe for development of validated test methods, and there is no one single organization,

such as NIST, to call on for assistance.

Richard Kayser (NIST) addressed the crosscutting issue of harmonization that is, making national

standards compatible. The goal is to simplify life by facilitating mutual recognition and uniformity, and

ultimately reducing costs associated with meeting standards. He mentioned that, historically, NIST has

played a role as consultant to committees. There is a need for long-term commitment by all stakeholders

to the standards development process and a need to bring them to the table with enough data to

distinguish among methods and reach consensus based on mutual understanding.

Alan Andersen (President, National Committee for Clinical Laboratory Standards, NCCLS) talked about

biomedical materials and clinical testing. He too described the importance of determining the health

status of the patient after an implant has been placed. Standards (materials and methods) will be needed

for clinical tests that can determine, from patient monitoring, effects such as those that may arise during

the lifetime of the device, for example, from impurities leaching from an implant, leakage from silicone,

toluene diamine from polyurethane degradation, and so forth.
8

Technical focus areas: For each area, a breakout session report follows. The report represents the

consensus, not necessarily unanimous, of the participants in that session. Each focus area report responds

to what was asked for by NIST, e.g., what are the needs of the biomedical industry, in the development of

standards, to which the industry would like NIST to respond? NISTís intent is to respond to those needs,

consistent with its resources, mission, and the priorities of the needs identified, and to use this information

as an aid in the planning of future applications of its resources to assist the biomedical devices industry.

Breakout Session Reports

Breakout Session Leaders

Biomaterials:

James Burns, Genzyme, Inc. & Rebecca Bergman, Medtronic, Inc.

NIST Facilitators: Francis Wang, Bruno Fanconi - Scribe, Chad Snyder

Therapeutic and Drug Delivery Systems:

Arthur Courey, Genzyme, Inc. & Gary Strathearn, Radiance Medical Systems, Inc.

NIST Facilitators: Christopher Soares, Bert Coursey - Scribe, Brian Zimmerman

Auditory Diagnostic and Prosthetic Devices:

William Cole, Etymonic Design, Inc. & Ronald Scicluna, Argosy Electronics, Inc.

NIST Facilitators: Victor Nedzelnitsky, Jonathan Fiscus - Scribe, Victor Nedzelnitsky

Manufacturing and Processing of Prostheses:

Craig Blaschke, Biomet, Inc. & Jean (Jan) Champion, Medtronic Heart Valve, Inc.

NIST Facilitators: Howard Harary, Matthew Davies - Scribe, Ron Dixson

Tissue Engineered Medical Devices:

Peter Johnson, Tissue Informatics, Inc. & Nancy Parenteau, Organogenesis, Inc.

NIST Facilitators: Eric Amis, Lori Goldner - Scribe, Newell Washburn 
9

Standards for Biomaterials

Stephen Freiman

John Tesk

Materials Science and Engineering Laboratory

NIST

Overview

ìBiomaterials î are materials that are applied for use in medical devices that require intimate contact with

tissues and body fluids. Biomedical devices are a growing business that in 1995 was estimated at $32 B,

with a positive balance of payments in trade of $2.7 B. In 2000, the market was $42 B. Biomaterials are

finding increased use in products that replace or augment the function of body parts, for which normal

function has been lost. Devices such as orthopaedic joints, intraocular lenses, heart valves, membranes,

and pacemakers are increasing the life span and productivity of the population while improving the

quality of life for patients and their families through new designs and new or improved biomaterials.

Standards (consensus standards, standardized test methods, standard methods of analysis, reference

materials, reference data) related to the performance of biomaterials can lead to more rapid submissions

and approvals of new devices that provide benefits to patients, reduce costs to health care providers

through benchmarks for reliability of performance, and eliminate wasteful, redundant duplications of

testing of materials and devices by manufacturers. Further, standards hold the potential of helping the

United States maintain its world leading position in medical devices. Both industry and the Food and

Drug Administration (FDA) would like to see standards that would help increase the availability of new

materials for devices.

The breakout session on Biomaterials included sixteen (16) non-NIST participants representing a wide

spectrum of companies that included orthopaedic, heart valve, ophthalmic, and soft tissue implant

companies; the FDA; industry associations; and two highly respected biomaterials researchers who

provide leadership in the development of consensus standards. The participants identified numerous

issues related to test methods and the development of standards that they considered important for

consideration of needs on a group basis. Needs were prioritized by considering 1) clinical importance,

2) questionable results (reliability) of current test methods, 3) potential for easing of regulatory burden,

4) global impact of adoption, 5) the potential for resolving unexplained phenomena, 6) the expected

importance relevant to new technologies, and 7) the inability of individual companies to provide the

resources needed to work on the methods. 

In summary, NIST was seen as an important contributor in biomedical standards activities by serving in

the following roles:

- Provide technical support for the development of new biomaterial test methods.

- Provide technical consultation to industry and standards developing organizations

- Be a technical representative on efforts to internationalize national standards

- Conduct root cause analysis of ineffective or questionable standards. This includes

evaluations of standards and test methods that may not be optimal. 

Action Items Needed. For each of the following items, industry expressed interest in having AdvaMed

organize a 1-2 day workshop to develop a plan with action(s) required to satisfy the need identified.

NIST will initiate this activity by working with AdvaMed to form and convene a steering committee

under AdvaMed's leadership. In each case the same organizations were recognized as needed participants

in the planning of the workshops. These are: the Advanced Medical Devices Association (AdvaMed), the

FDA, NIST, ASTM, the American Dental Association, and the American Association for Medical
10

Instrumentation (AAMI). Industry participation in the planning and in the workshops was noted as being

especially important. 

 New biocompatibility test methods are needed. Existing biocompatibility tests are inadequate

because they fail to predict long-term adverse events. Unless materials cause gross cytotoxic

responses, they pass the screening tests currently defined in consensus standards. Among the key

needs are predictive biocompatibility tests to assess the effects of: long term leaching of material

components, materials on immune response, and carcinogenicity of materials.

 Accelerated life tests that can predict clinical performance of biomaterials. Numerous simulator

test methods exist that provide indications of long-term performance of a medical device, but these

are not predictors of long-term performance of the materials that are used in the device. Because of

the numerous devices and simulators used for device testing, it is virtually impossible to compare in a

meaningful way the results from one simulator test to another in order to predict the behavior of the

material in its intended application. In addition, duplications of efforts using simulator testing for

regulatory approval are required for testing according to international standards that specify test

methods/equipment that are different form those commonly found nationally. What is needed are

accelerated material tests and unifying methods of analysis that can superimpose the effects from

different test and simulator-device tests and that can be applied universally (internationally). Hence,

NIST should work toward the development of well-established test methods and then follow through,

with its technical staff and credentials, toward their inclusion in international standards.

 Methods for characterization of biomaterials and biomolecules. New applications of macro- and

bio-molecules are being found in biomedical materials and devices. The ISO 10993 series describes

testing that is required, but there is serious concern over adopting tests that are not well targeted for

the need, which is risk assessment of an implantable device. New test methods for assessing host

response, targeted to the use and pathway for eliciting response, must be developed. For example, in

consideration of the effects of a leachable component (such as uncured monomer) from a device over

long periods of time, the guidelines for tests are coming from outside of the biomedical community.

Inhalation dosage tests that were developed by the Environmental Protection Agency for airborne

toxins, or dosage tests developed by the FDA for ingestion of foods, are being used. It is clear that

inhalation and ingestion provide quite different pathways for dosing by a foreign substance. Tests are

needed that relate to long-term implantable materials, which dose through direct contact or through

the bloodstream, etc. NIST, because of its measurement and test method development expertise, is

seen as a valuable partner for cooperation in the design and validation of new test methods. 

 Develop standardized test methods for evaluation of biostability of materials. Tests for relevant

assessment of the long-term stability of materials proposed (or used) as biomaterials do not exist. The

10999 series of tests address only short term stability and need to be reviewed as to how well they

satisfy the need. NIST should be a partner in guiding root cause analysis of why existing tests may

not be appropriate. This issue was also raised in the manufacturing and processing of prostheses

breakout group report on surface finish and characterization. 

 Effects of sterilization on materials. Many methods for sterilization exist. Others are needed for

tissue engineered medical products (TEMPs). How sterilization by different methods may impact on

long term biostability, risk assessment, lifetime performance, and biocompatibility needs to be

considered. New sterilization methods are needed for TEMPs. Standardized tests for assessing the

effects of sterilization need to be developed.
11

Therapeutic and Drug Delivery Devices1

Lisa Karam

Industrial Liaison Office

Bert Coursey

Physics Laboratory

NIST

Overview

Therapeutic devices are instruments or structures that deliver pharmaceuticals, radiation, or biologics to

the body for purposes of ameliorating a disease or potential disease condition. The use of biomaterials as

delivery devices to treat disease represents a major growth market in advancing U.S. health care. Such

advances include the development of systems based on novel delivery technologies currently being

implemented by the pharmaceutical industry. Other systems, based on emerging delivery technologies,

are just beginning to be understood, and these started entering the marketplace in the late 20th century.

The field continues to grow significantly and has begun to compete with conventional means of drug

delivery for such conditions as heart disease, cancer, stroke, and diabetes, which are among the largest

crippling and fatal diseases affecting the U.S. public today. With the current acceleration in the

development of biomaterials, a plethora of potential delivery systems are either in the market, under

development, or anticipated. New measurement methods are needed to characterize the properties of

these new devices. In vitro methods must be developed for prototype designs. In vivo monitoring,

through minimally invasive methods, will be needed to evaluate the efficacy of the delivery systems.

Increasing numbers of researchers are involved in the development of new entities for the delivery of

precise, controlled dosages to specific sites of the body. Hence, for consistency in tracking the effects of

the treatments and for the health and safety of patients, there is a critical need for standards for measuring

the dose, pharmacokinetics, efficacy, and untoward effects of treatments.

This breakout session included nine non-NIST participants representing companies with interest in

delivering radiation, pharmaceuticals, or chemicals using implanted or inserted devices. These

representatives, along with others from standards organizations, determined several niches for NIST

activity in the development of standards for this segment of the biomedical industry. These niches

include: 1) exploring the trend coming out of the European Union (EU) in regulation requiring standards,

2) developing systems for determining release rates of drugs from different matrices and elimination from

the body (pharmacokinetics), 3) developing reference hydrogel or pore size standards and a standard

medium to mimic drug release in different body fluids (this would require FDA consultations), 4)

developing new standards and methods for sterilization of new and emerging materials that are

biologically based and may suffer from degradation by usual sterilization methods (maybe a series of

degradable polymers to test sterilization methods), and 5) developing standards for destructive activity

assay and dosimetry methods (or recommended practices) and transfer standards (to hospitals) for dose

measurements (material/artifactual standards) 

In summary, NIST was seen as an important contributor in biomedical standards activities by serving in

the following roles:

Providing technical support for the successful development of drug/radiation delivery methods and

devices.

- Providing unbiased technical consultation to industry and standards-developing organizations,

with adherence to rigorous use of terminology.

 1 The participants narrowed their discussion to ìTherapeutic Drug and Radiation Delivery Systems
12

- Acting as technical representatives on efforts to internationalize national standards (particularly in

view of new standards coming out of the European Union).

- Evaluating standards and test methods on an ìas neededî basis.

Action Items Needed. For each of the following items, industry expressed an interest in having either

follow-up workshops or continuing interactions with NIST in order to more clearly define the expressed

need or determine plans to satisfy the need. Standard technical methods (both physical and consensus)

were recognized as being extremely useful for assessing whether a product is safe, effective, and

reproducible in addition to providing a consistent measurement basis (prediction or comparison of clinical

outcomes) and a means for gaining acceptance of products by regulatory agencies and in foreign markets.

The needs that NIST could address or meet were rank order prioritized according to urgent, highest, high,

or moderate for the industry:

Urgent and On-Going Priority

o Material standards (national) for radio-activity

o Transfer standards for dosimetry

o Harmonization of international standards

Highest Priority

o Consistent terminology 

o Formal (written) international standards for delivery device characterization

High Priority

o Health and Safety Issues

Moderate Priority

o Activity measurements

o Dosimetry measurements

o Guidance (technical papers) for new sources, fields, applications

o Labeled materials, standards for radiopharmaceutical uptake (long-term)

 Methods and Standards for Determining Release Rates of Drugs from Different Matrices. The

scientific expertise at NIST is seen as a resource in the development of artificial reference materials

that could be used to mimic in vivo behaviors of drug release. Such materials act as in vitro models

for tracing the pharmacokinetics (elimination from the body) of pharmaceuticals that are delivered by

implanted devices (and are consequently extremely difficult to monitor). In addition, it was felt that

NIST might be in a position to develop methods that can be used to measure pharmaceuticals in

different tissues of the body (fluids, muscle, skin, etc.). Of particular use would be the development

of systems for determining release rates of drugs from different matrices for in vitro methods, such as

reference hydrogel or pore size standards; and methods of finding drugs in tissue and tracking

elimination from the body, including a standard medium to mimic drug release in different body

fluids [requires FDA consultations], other matrix and excipient materials. Container closure issues

associated with implantable infusion systems, including biocompatibility and stability also need to be

addressed. NIST can use its expertise to develop methods for determining drug/matrix compatibility;

release, absorption and elimination monitoring; and to develop test media that mimic body fluids.

Although NIST is not prepared for animal studies, in vitro and cell studies are possible (collaborative

work off-site is possible and is already being done in many cases). NIST should work toward the

development of degradable matrix and excipient test reference materials standards that can be used in

vitro in the development of products and test methods that are intended for use in vivo, as well as

methods to measure pharmaceuticals in bodily tissues.

 Methods and Standards for Determining Dose and Activity of Radiation Delivery Devices. The

FDA requires reference standards for clinical applications of inserted radiation delivery devices (such

as coronary stents and balloons, radioactive seeds for in situ therapy, etc.). The dosimetry for

measuring the activity of such devices is well defined by NIST (ìtraceabilityî). Aside from disparate
13

publications, there are no measurement standards for destructive activity assays (necessary for

activity determination), dosimetry methods, or recommended practices available for developers of

radiation delivery devices. Formal (written) standards for source and safety characterization as well

as secondary (ìtransferî) standards (material/artifactual standards to the clinical setting) for dose

measurements are needed. Historically, NIST has taken a lead role in the development of

international standards in this field, and was encouraged to continue to do so. NIST should continue

in its publication of methods used for activity and dose determinations, encourage the compilation of

these methods into documents of ìrecommended practicesî (under the auspices or organizations such

as the American Association of Physicists in Medicine, Society of Nuclear Medicine, or the Council

on Ionizing Radiation Measurements and Standards) and continue work in the development of

activity and dosimetry transfer standards for the clinical setting.

 Methods and standards for device sterilization. With new and emerging materials being developed

for implantable devices that deliver drugs and radiation, a new set of difficulties arises with regards to

sterilization. New standards and methods that can sterilize without deactivating or degrading the

device material must be developed. Current methods are not applicable, and the development of new

sterilization methods is prohibitively expensive since, in essence, a new device must be thoroughly

developed before the sterilization method can be evaluated. To ameliorate this, NIST should work on

the development of a series of standardized, degradable polymers that will be representative of the

material components used in delivery devices. These could be used for testing of new sterilization

methods, prior to full device development. The expenses and lost time associated with the full

development of a device for sterilization without material degradation would be avoided.

 NIST participation in standards writing committees. The scientific and technical expertise at

NIST is recognized as being critical to the continuing development of implanted or inserted

drug/radiation delivery devices. The fact that NIST presents an unbiased view is a large positive for

this traditionally competitive field. In addition to some of the specific needs related to physical

standards, such as better in vitro models for the body, and the determination of the

physics/mechanics of the actual delivery devices, needs within written standards were also

considered. Increased participation in the development of consensus standards by NIST scientists,

who have historically brought a rigor of terminology to the development of standards, is a way by

which standards efforts could be enhanced. Because of the increasing need for harmonization with

European standards efforts (for international marketing of devices and for international partnering in

their development), the emphasis should be on international (rather than simply national) standards.

Although industry has traditionally not been anxious to incorporate standards, trends in the

development of standards in a global regulatory environment (such as from the EU, FDA, etc.) must

be explored. NIST is encouraged to determine a need (or needs) that it could meet and then join

standards organizations that address that need (or needs). If no such activity exists, NIST could lead

toward getting the appropriate standards activity organized. NIST should cultivate relationships and

interactions with the major players in the field of standards for drug delivery and radiation delivery,

which are the standards organizations (ISO, ANSI, AAMI, NCCLS, etc.), regulatory agencies (FDA,

NRC), user communities (IEEE, AAPM, SNM, ADA, etc.), international organizations (ICRU,

WHO, DIN, IAEA) and other Federal agencies (NIH). Technical staff at NIST should work towards

increasing their participation with standards writing committees in both the national and international

arenas.
14

Auditory Diagnostic and Prosthetic Devices

Victor Nedzelnitsky

Manufacturing Engineering Laboratory

NIST

Overview

Hearing loss afflicts approximately 30 million Americans including two recent presidents (Clinton and

Reagan), and is certainly among the most frequently occurring health impairments in the U.S. Americans

of all age groups are affected, including more than 30 % of people over age 65, 14 % of people between

45 and 64, nearly 8 million people from 18 to 44, and over a million school-age children. Of the

ìtreatable population,î about 5 % to 10 % can be helped medically or surgically (including implants), and

the remaining 90 % to 95 % can significantly (but not totally) correct their hearing loss with hearing aids.

About 2 million hearing aids were sold in the U.S. in the year 2000. However, more than 16 million

Americans with substantially correctable hearing loss are not using hearing aids and would benefit from

modern aids: the Better Hearing Institute estimated (1999) that the annual cost of lost productivity, special

education, and medical care because of untreated hearing loss is $56 B. Proper diagnosis and treatment of

hearing loss is critically important for successful patient outcomes in all age groups, but is especially so

for children who have not yet acquired language. 

Auditory diagnostic and prosthetic devices include a wide variety of analog (not containing components

such as digitizers and microprocessors) instruments and, more recently, single-band and multi-frequencyband programmable digital devices containing such components and capable of digital signal processing.

The greatly enhanced features and capabilities of recent and evolving devices call for suitable standards

enabling performance specification, replicable measurements, production testing, and quality assurance,

so that manufacturers and practitioners can provide safe and effective patient outcomes. 

Eight non-NIST participants attended this session. Among the participants in this session, the numerous

manufacturers of auditory prosthetic and diagnostic devices were represented by the Chair of the Hearing

Industries Association (HIA) Technical Committee and the chairs (or other impartial representatives) of

ANSI-accredited standards committees and working groups with strong industry participation. There was

also participation from hearing instrument manufacturers and a major supplier of transducers and other

critical components to most manufacturers in the hearing industries. Other participants with major

research, clinical, and health care responsibilities, very broad experience, and knowledge in this field

came from the National Institute on Deafness and Other Communication Disorders (NIDCD) of NIH, the

Dept. of Veterans Affairs (VA), and the research arm of a private clinic that sees over 35,000 patients per

year and is one of the leading centers for auditory implants in the U.S. and the world. The Acoustical

Society of America (ASA) Standards Committee S3 Bioacoustics, referenced below, is ANSI-accredited.

Participants considered many auditory diagnostic (where diagnostic is meant broadly to include devices

used for functional assessment or screening, as well as more elaborate devices capable of diagnosing

specific causes of hearing impairment) and prosthetic devices that are, or may become, subjects of

standards activities, including:

 Various types of hearing aids (e.g., behind-the-ear, in-the-ear, in-the-canal, completely in-the-canal,

eyeglass, body, linear, compression [nonlinear], directional, programmable, and digital hearing aids), 

 Middle-ear implants, cochlear implants, and auditory brainstem implants, 

 Assistive listening devices and systems (talkerís microphone signal broadcast or propagated as FM

radio, infrared, or via ìloopingî [Faraday induction] to listenerís personal receiver),

 Ear, head, and torso simulators used in research, device design, and quality control testing, 
15

 Audiometric couplers used to calibrate and characterize earphones,

 Audiometers (pure-tone, speech, transient signals), 

 Real-ear probe-tube sound measurement systems for in situ hearing aid measurements, 

 Electroacoustical signals and transducers for auditory brainstem response (ABR) audiometry used to

predict hearing sensitivity and to assess the integrity of Cranial Nerve VIII and auditory brainstem

structures, 

 Signals and transducers for eliciting other auditory evoked potentials (AEP) usually distinguished by

their latencies of measured time-domain response,

 Instruments for measuring otoacoustic emissions (OAE), 

 Programmers/interfaces for programmable hearing aids and audiometers, 

 Devices used to determine acoustic impedance or admittance at the eardrum.

The participants identified items needed for standardization and arranged them in three priority groups.

The harmonization of ANSI and international standards is a large and essential task that has already

begun, and must be completed. Although it was considered separately during the session, and therefore

not ranked with the other items, it is of such essential importance that it has been included here in the

group with the highest priority. The listed groups and items are shown in Table 1. A list of specific

actions was developed for the items in Table 1, and is given below that table. 

TABLE 1: Prioritized list of industry needs with comparable priority within a group.

Group 1 (Highest Priority):

Harmonization of ANSI and International Standards

Clinically Useful Performance Tests for Hearing Aids

Standards on Biomaterials and Functional Performance for Active Implantable Auditory Devices

Standards for ABR Systems, Evoked Response Systems, and Otoacoustic Emission Analyzers, Especially

Regarding Infant Screening

Standardized Hearing Aid Terminology

Establishment of U.S. Positions on Standards Involving Electromagnetic Compatibility (EMC) of

Auditory Diagnostic Equipment and Hearing Aids

Group 2 (Very High Priority):

Auditory Device Data Issues

Standardized Environments for Functional Performance Testing of Hearing

Group 3 (High Priority):

Issue of Electromagnetic Interference with Audiometric Equipment in Sound Rooms

Action Items Needed:

 Proactive Participation in Harmonization of ANSI and International (Primarily IEC)

Standards. Existing standards for many auditory devices are becoming harmonized because of

ongoing activities toward, and effects of, global consolidation. The auditory device industry is now

dominated by 5 groups of which 4 are European with large presence in North America, so that

industry members now have very strong voices in the relevant ANSI and IEC working groups.

Consequently, these ANSI and IEC groups now are more effectively cooperating on harmonization

issues. For audiometers, acoustic impedance (or admittance) measurement devices, real-ear probe

measurement systems, and hearing aids, principal harmonization activities can be achieved in ANSI

(especially in Accredited Standards Committee S3 Bioacoustics and its working groups) and IEC

(especially Technical Committee 29 Electroacoustics and its working groups) standards activities,

with proactive participation by industry, NIST, and directly interested parties. Usually, the lead on

audiometric diagnostic procedures, fitting, and other clinical issues will come from audiologists, other
16

biomedical professionals, and researchers employed or supported by the industries, academic

institutions, and other government agencies with current and future representatives on these

committees and working groups. NIST should continue and extend its service in these committees

(particularly ANSI-accredited S3 Bioacoustics and IEC TC 29 Electroacoustics) and their working

groups, in close cooperation with physical scientists/engineers from industry, to resolve

harmonization issues involving physical data and measurements. 

 Participate in Study Sub-Groups of S3 Bioacoustics WG 48 Hearing Aids to Develop Clinically

Useful Performance Tests for Hearing Aids. 

There is a need for clinically useful performance tests for hearing aids. Data from existing standards

are useful for quality control purposes but frequently are not very useful clinically. Utility to the

hearing aid wearer necessarily involves performance with speech signals in the presence of varying

degrees of noise (including competing speech signals) and reverberation. Examples of specific issues

that need to be addressed are: stimulus, analysis, and data presentation issues involving speech,

speech in noise, speech in noise and reverberation, feedback suppression, etc. Directional hearing

performance and the relative positions of the hearing aid user, signal source, and noise source(s) are

also important. NIST should participate in study sub-groups of Accredited (by ANSI) Standards

Committee S3 Bioacoustics, Working Group 48 Hearing Aids. Usually, NIST and physical

scientists/engineers from industry will be most closely involved with physical measurement issues,

data, and signal processing/data analysis, while the lead on audiometric diagnostic procedures, fitting,

benefit to the patient, and other clinical issues will come from audiologists, other biomedical

professionals, and researchers employed or supported by the industries, academic institutions, and

other government agencies with current and future representatives on this working group and its subgroups.

 Organize Study Group or Workshop on Crosscutting Issues for Standards on Biomaterials and

Functional Performance for Active Implantable Auditory Devices. 

Active implantable auditory devices include middle-ear, cochlear, and brainstem implants. There is an

urgent need for these standards, which will have regulatory application. Some functional

performance issues for hearing aids are also relevant here: for example, utility to an implant user also

involves performance with speech signals in the presence of varying degrees of noise (including

competing speech signals) and reverberation. There are additional crosscutting issues critically

important for implants, for example, concerns within user communities, biocompatibility over long as

well as short time periods, device lifetimes, need for unbiased implant retrieval studies, clinically

useful performance tests, etc. NIST should organize a study group or workshop to further investigate

crosscutting issues on such devices. 

 Advise (When Requested) on Electroacoustical Measurement Issues for Standards for ABR

Systems, Evoked Response Systems, and Otoacoustic Emission Analyzers, Especially Regarding

Infant Screening. 

There is an urgent need for standardization in this area, especially regarding the growing requirements

for infant screening for hearing loss. Such screening is already mandated by a large and increasing

number of states, and is nationally recommended by NIDCD. There is existing ANSI standards work

in this area, although there is a lack of normative data, and a lack of advice and information on

physical measurements. There is not yet sufficient agreement among practitioners to establish a

consensus for standardization of procedures. The recommended role for NIST is to provide informal

technical advice regarding electroacoustical measurement issues. ANSI Working Group Chairs in this

area are to inform NIST of requests as they evolve. This can be achieved by notifying the NIST

institutional membership representatives on Accredited (by ANSI) Standards Committees

S1 Acoustics and S3 Bioacoustics, and the addition of NIST experts to working groups of these

committees as needed. 
17

 Develop Standardized Hearing Aid Terminology. 

Good communication among basic researchers, clinical researchers, practicing clinicians, design and

quality control engineers and technicians, component suppliers, programmers, dispensers of hearing

aids, purchasing agents, patients and patient advocates, and regulatory authorities is crucially

important to the improvement of hearing aids, hearing aid fitting and other clinical procedures, and

patient outcomes. Successful communication is often difficult or impossible when there is no

commonly understood or accepted terminology. Some terms are available in existing standards and

glossaries but newer terms (and sometimes inconsistencies of existing definitions) cause major

difficulties. In some cases, marketing departments are defining terminology, with obvious problems

for the field regarding clarity, correctness and consistency. To initiate this activity NIST should

contact a trade association such as the HIA, for example, (working with a trade association avoids

copyright issues and permits postings of work on unrestricted Web sites) or a standards developing

organization. 

 Name Experts on Generic Electromagnetic Compatibility (EMC) Standards to Help Establish

U.S. Positions on IEC Standards Involving EMC of Auditory Diagnostic Equipment and

Hearing Aids. 

EMC is meant here in its most general sense to include both the issue of susceptibility (immunity) of

a device to interference from radiated or conducted (e.g., via connection to the power line)

electromagnetic disturbances from other devices or sources, and the issue of radiated or conducted

disturbance produced by a device that causes interference to other devices. For establishing U.S.

positions on draft international standards involving electromagnetic compatibility (EMC) of auditory

diagnostic equipment and hearing aids, there is a need for closer involvement of NIST experts

familiar with generic international EMC standards used as normative references in these drafts. The

Technical Advisor (Victor Nedzelnitsky) to USNC (U.S. National Committee)/IEC for TC 29

Electroacoustics will ask EEEL to name experts who can comment on auditory device standards

involving EMC and references to generic EMC standards. These experts will then receive copies of

the relevant IEC TC 29 draft international standards as they appear, and can furnish comments for

inclusion in the Technical Advisorís recommendation to the Secretary, USNC/IEC for transmission as

the USNC/IEC position. 

 Provide Specific Expertise (e.g., on XML) to S3-WG 86 for Auditory Device Data Issues.

Electronic storage, transmission, and exchange of data are important to users. For example, Dept. of

Veterans Affairs (VA) is very interested in data flow from devices to patient databases, and to

electronic commerce orders for hearing aids. In an existing standards effort, there is a need for

additional expertise for certain software and input-output issues. In particular, NIST should

participate in Accredited (by ANSI) Standards Committee S3 Bioacoustics Working Group (WG) 86

Audiometric Data Structures to provide expertise in XML and related input-output issues. Len

Gallagher of ITL, NIST was asked to contact NIST management and report to the Chair (William

Cole) of S3-WG86 whether NIST could send an expert to the meeting of S3-WG86 on June 29, 2001

in Alexandria, VA. Len Gallagher did attend this meeting and offered some suggestions that seemed

to be well received by the WG. He has agreed to review any drafts produced by this WG.

 Organize a Study Group or Workshop on Standardized Environments for Functional

Performance Testing of Hearing. The absence of such standardized environments, including the

absence of reference materials (such as appropriately controlled, presented and recorded auditory

stimuli) from appropriately and adequately specified environments (degrees of noise and

reverberation, locations of signal source and noise source[s], etc.), is a significant barrier to improved

functional performance testing of hearing. This improved testing is needed for improved audiological

testing of patients and fitting of hearing aids. Improved fitting is necessary for improvements to
18

success in patient outcomes. NIST should organize a study group or workshop on this subject;

participants to consider include HIA, VA, NIH, FDA and ANSI-accredited Standards Committees;

S1, Acoustics; S3, Bioacoustics; S12, Noise; and their working groups. 

 Address the Issue of Electromagnetic Interference with Audiometric Equipment in Sound

Rooms. In busy, well-equipped clinical facilities, audiometric equipment is typically installed so that

the hearing of a patient can be examined with the patient in a very quiet sound room that isolates the

patient from excessive ambient noise sounds. Data on susceptibility (immunity) of individual items

of equipment to electromagnetic interference are limited or, most frequently, unavailable or

inapplicable due to differences (for example, in cable lengths and orientations) between test

conditions and installed conditions. Data on interfering ambient electromagnetic fields in hospitals

and clinics are also often limited or unavailable. Some diagnostic instruments (e.g., ABR systems)

are particularly susceptible because they must use electrodes to measure very small electrical

potentials that are produced by mechanoelectrical transduction and subsequent neuronal activity. The

session participants recognized that there is a need to address the issue of electromagnetic

interference with audiometric equipment in sound rooms, but could not identify who would be likely

to have the funding support and technical capability to address this issue on the national and

international levels. Currently, it is an issue for individual hospital systems and clinics to consider for

themselves. One reason that it has not been prioritized more highly is that its generic solution would

probably require a much greater level and variety of resources than would be needed to provide

significant progress toward the other standards needs cited. 
19

Manufacturing of Prostheses 

Matt Davies

Ron Dixson

Manufacturing Engineering Laboratory

NIST

Overview

The implantable prosthetics industry has three primary components: (1) artificial limbs and mechanical

aids; (2) orthopedic implants, including hip, knee, and other joint replacements; and (3) non-skeletal

implants including breast implants, heart valves, intra-ocular lenses, and implanted pacemakers. The

widespread clinical acceptance of prostheses can be illustrated by a few revealing statistics.

Approximately 245,000 knee replacements are done annually in the United States, and this number is

expected to grow rapidly as the population ages. About 50,000 substitute heart valves are implanted

annually in the United States, and this number is also growing. At present, the leading mechanical valve

design has been implanted in more than one million patients worldwide. In total, the prosthetics industry

exceeds $10B annually and is expected to grow rapidly in the next few decades; the orthopedics industry

alone has been growing steadily at 10% annually. The establishment of more comprehensive, suitable,

industry-wide, standards for manufacturing methods, inspection, and quality assurance may help to avoid

the risk of potentially disastrous failures such as have previously occurred occasionally with mechanical

heart valves, pacemakers, and orthopedic hip implants.

This breakout session included approximately nine non-NIST participants; primarily from the orthopedic

and heart valve industries. We were also fortunate to have had an orthopedic surgeon who brought a

much different and very useful perspective to the discussion. After a brainstorming session in which the

participants identified issues that NIST might address in the area of manufacturing and testing of

prosthetic devices, a rationale and some detailed action items bullets were recorded for each issue . The

participants then ranked the issues in terms of importance. A final ordered list was compiled, as shown

in Table 1. A list of specific actions was developed for the first five issues in the list, which is

summarized below.

TABLE 1: Prioritized list of industry needs. Scoring done by allowing each participant one vote on each

item: MOST IMPORTANT = 3 points, MODERATELY IMPORTANT = 2 points, and IMPORTANT =

1 point. 

Item Point Total

Reference Materials and Surfaces 18

Cleaning and Cleanliness 13

Surface Characterization 5

Medical Imaging Models 5

Dimensional Measurement 5

Non-Destructive In-Vitro/In-Vivo Testing 3

Characterize Effect of Manufacturing Process on Device Performance 2

Encouraging/Facilitating Clinician Participation in Standards Development 1
20

Action Items Needed:

 Develop Reference Materials and Reference Surfaces. In order to better understand the behavior

of implants and their interaction with the human body, it is necessary to develop standard materials

and surfaces that better allow medical researchers to design consistent experiments and interpret their

results. The most critical of these materials, identified by the focus group, were: (1) standard surfaces

and/or better surface measurement techniques for characterizing the surface finish of orthopedic

implants; (2) standard particulate debris that can be used as references against which the biological

responses of debris from retrieval experiments and in-vitro wear simulation (and other) tests can be

prepared; (3) a stable, synovial fluid analog that can be used in place of bovine serum; (4) a blood

analog(s) for accelerated, durability and performance testing of new heart valves; and (5) a bone

analog for performance evaluation of orthopaedic prostheses. NIST should work with other

organizations such as ASTM to develop these reference materials and materials analogues, beginning

by organizing a consensus committee from industry and appropriate other bodies, such as the

American Association of Orthopaedic Surgeons. To work to develop these reference materials and

material analogs. NIST would take the lead for the development of standard surfaces and in finish

characterization of implants. NIST would also lead the development of standards for wear debris.

NIST could serve a useful function by taking the lead toward the formation of alliances needed for the

development of synovial fluid, blood, and bone analogs, and could provide some of the scientific,

measurement, and engineering expertise that will be needed for development of these complex

materials.

 

 Establish Standardized Cleaning Practices for Ensuring Cleanliness. Recent incidence of

contamination of implants from unknown sources, despite adherence to good manufacturing

practices, has indicated the need for additional test/test validations/process controls and definitions of

best cleaning practices to provide 100% assurance of freedom from contamination during the

manufacturing process. To accomplish this, NIST must first organize and convene a formal or

informal committee of representatives in the field of implant manufacturing to develop a database of

current cleaning methods and then from that to codify best practices. Such an activity could help

greatly by identifying gaps in current practice and making the best methods more widely used. From

this database and prioritized list of needs, NIST would then take charge of developing the

measurement/measurement science and methods for detecting contamination of different types. NIST

would probably not lead this effort, but would seek consensus by working with bodies such as

ASTM.

 Develop Standardized Surface Characterization Methods and Tests. Surface finish and

characterization are critical for the proper functioning of implants. In orthopedic implants finish can

affect wear rates at moving interfaces and bone integration; and in heart valves, finish affects the

interaction of the blood with the implant and, potentially, mechanical failure mechanisms, although

these are at present rare. Therefore, in order to ensure accurate comparisons of experimental data, a

common description of surface finish and character across the implant industries is needed. Because

NIST has substantial expertise in the methods and technology associated with surface measurement, it

would serve a vital role to the industry by helping to define the best practices and techniques that are

applicable to the industry. Also, NIST could assist the industry by developing a

translation/organization matrix of existing surface finish standards to map existing standards to

applications in prosthetic manufacturing. Furthermore, NIST would work to develop methods that

can be used to cost-effectively monitor finish on the shop floor. To accomplish this, NIST should

sponsor a workshop on Surface Finish Measurements in the Biomedical Device Industry to better

define the issues, and then report the results of the workshop to the industrial users of surface finish

measurement equipment. NIST is uniquely positioned to take a lead role in this activity.
21

 Develop Common Methods for Improved Evaluation and Analyses of Medical Images. Medical

imaging techniques are central to the diagnosis and treatment of patients and provide invaluable tools

for the evaluation and quantification of experimental and clinical results. However, medical imaging

devices often use different methods for interpreting and presenting information, making cross

comparison more difficult. NIST could serve a vital role in this area by reviewing current practice

from a metrological and scientific viewpoint and by providing an independent technical evaluation of

current practice. NIST could also participate in a consensus committee for: (1) developing algorithms

to improve medical imaging; and (2) specifying medical artifacts for calibrating and testing medical

imaging systems (for example, the determination of the bone-flesh interface in the CT scan). The

leadership for these activities was not decided by the breakout working group. However, it would

seem that an appropriate response by NIST would be to take the lead in bringing together a critical

mass of experts to work on these issues and providing a forum through which leadership could be

assigned.

 Identify Best Practices and Reference Artifacts for Dimensional Measurements and Control,

Dimensional measurements and the maintenance of adequate part tolerances are critical to the

function of most mechanical and optical implants. This affects the wear rate of joints in orthopedic

implants and the performance of heart valves and optical devices. Furthermore in a different sense,

dimensional measurements are also important for the in-vitro measurement of medical implants for

wear or migration during their lifetime. A valuable role for NIST in this area is similar to the role

envisioned for surface finish, i.e.; to convene a workshop and develop a report summarizing best

practices and to inform the biomedical device industry about methods that could be used to monitor

part tolerance (for example, ball sphericity or dimensional deviations of a complex contoured surface)

on the shop floor. Standard surface-finish artifacts may also be extremely useful to manufacturers

and experimental clinicians by ensuring that surface definitions are widely accepted and used. NIST

is uniquely positioned to take a lead role in this activity.
22

Tissue Engineered Medical Devices

Mrunal Chapekar

Advanced Technology Program

Gregory B. V·squez

Chemical Science and Technology Laboratory

Overview

The intent of this session was to learn how NIST might assist industry in the development of standards for

Tissue Engineered Medical Products (TEMPs). TEMPs often use scaffolds, alone or in combination with

biologicals that contain animal or human cells, such as biosynthetic skins, heart valves made of scaffolds

seeded with patientís own cells etc. Development of Tissue Engineered Medical Products (TEMPs) has

been challenging due to complex and diverse interactions among a deviceís components. In 1997, a

voluntary standards effort was initiated under the auspices of the American Society for Testing and

Materials (ASTM) to develop standards for TEMPs. It is apparent from the enormous number of issues

that have evolved from the ASTM effort that there are likely to be many occasions for which NIST

involvement could be of benefit to the standards processes. This session focused on many of those issues.

It included a good representation from the industry as well as from NIST, other federal agencies,

including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), and

standards-developing organizations, such as ASTM, and the American Dental Association. Overall, there

was a significant emphasis on the need for new test method development and material characterization.

Moreover, the group felt that there was a need for a meaningful strategic role for NIST. The group

overwhelmingly urged NIST to take a leadership position, working with collaborators in industry, NIH,

FDA, clinicians, and standards organizations. 

A number of high priority issues related to the FDAís approval process. These processes are listed

separately below (bullet action items 1.x) to identify and highlight the regulatory concerns in this area and

to distinguish them from the more purely commercial/industrial interests (bullet action items 2.x).

Action Items Needed: High priority action items for NIST regarding industry needs relative to the FDA

approval process include:

 1.1 Develop rapid, highly-accurate, phenotypic determination methods (see 2.1 & 2.2). Although

it is very important for industry to have reliable and accurate phenotyping of their products, it is not

always essential for the industrial methods to be rapid. However, timely regulatory approval of

TEMPs and the establishment of good manufacturing practices will hinge upon the ability to

determine the phenotypic classification of cell types as quickly as possible. NIST should organize a

task force/group with representatives of the TEMP community to establish consensus on phenotype

determination methods. This group should then establish a plan that leads to the development of

rapid and highly accurate methods making the needed phenotypic determinations. Participants should

include NIH, FDA, industry, and academic members of the TEMP community.

 1.2 Develop methodology to characterize human-animal co-cultured TEMPs, (particularly with

respect to determining the percentage (number-fraction) of each cell type). New products are

becoming available with mixtures of cell types, and it is necessary to validate the percentage of each

type, since this may have impacts on other tests and patient responses. It may also be necessary to

address the relative distribution of mixed cell types in mixed species tissue devices. Standards and

standard methodologies that minimize damage to TEMPs are needed for assessing the percentages of

mixed species cell types and their relative distributions within engineered tissues. NIST should

organize and/or participate in a standards task force/group within the ASTM F04, Division IV
23

standards development activities. Participants should include NIH, FDA, industry, and academic

members of the TEMP community.

 1.3 Develop criteria for assessing the persistence of degradable material. Scaffold or other

materials used in TEMPs are often intended to dissolve over time while cells proliferate to repair or

replace tissues. The presence of the material may then become an impediment to an optimal

therapeutic outcome. Standardized methods are needed to measure and validate that the materials are

degrading as designed. This information will be critical for the clinical tracking of TEMPs and

determination of whether or not the patient is having or is likely to have a problem as a result of the

implanted material. NIST should organize a task force/group that will act toward establishment of the

criteria for evaluating and tracking degradable implanted materials and devices. Participants should

include NIH, FDA, industry, and academic members of the TEMP community.

 1.4 Development of non-invasive imaging methods. Because the TEMP field is emerging, there is a

corresponding need for new, in-situ measurement methods for tracking the performance of implanted

TEMPs and to assure that they are functioning as they were intended. . This is a broad topic, relevant

to many areas. It would be useful to coordinate information about applicable techniques and

methodologies, in addition to attempting to develop new measurement methods. NIST should lead in

the organization of an interest group to track, develop and report on new measurement methods as

well as those that have been accepted by the regulatory agencies. Key participants will include FDA

and NIH as well as industrial and academic members of the TEMP community.

 1.5 Pooling of information useful for facilitating developement of TEMPs (see DATA

Crosscutting Issues section elsewhere in this workshop report).

The high priority industry action items for NIST include:

 2.1 Develop test methods for phenotype analysis and characterization. There is a need to develop

clinically relevant methods for confirmation of a phenotype of the cells that are engineered to go

through a specific differentiation pathway and for detecting changes in cells over time, in culture to

ensure consistency of cells used in TEMPs. Meeting this goal will require identification of a set of

markers per specific cell type (e.g., fibroblasts, osteoblasts) and development of inexpensive tests,

such as microarray methodology, for this task. NIST should lead in the organization of a task

force/group from the TEMP community to establish the criteria for phenotyping of cells and for

determination of the appropriate methods for these criteria. Participants should include NIH, FDA,

standards organizations, industrial trade associations, and leading researchers from industry and

academia. 

 2.2 Stem-Cell Analysis/Characterization (This is a separate, special consideration of action item

2.1). Stem cells have the potential to differentiate into cells that can develop into any of the bodyís

specific tissues/cell types. However, once a stem cell has differentiated along one pathway, it

maylose the capability for differentiation into other cell types (i.e., skin cells may not be able to

differentiate into pancreatic islet cells). Therefore, it is essential to have the most accurate

characterization possible as to whether a particular cell is still a stem cell or if it has begun

differentiation. This is a critical area of research and needs attention separately from general cellular

phenotypic characterization, because of the high potential transience of this cell type. NIST should

organize a special task force/group from the TEMP community to establish the criteria for

phenotyping of stem cells and for determination of the appropriate methods for measuring these

criteria. Participants should include NIH, FDA, industry, standards organizations, industrial trade

associations, and leading researchers from industry and academia.
24

 2.3 Develop consensus test-standards for temporary components of TEMPs; Cells, Bioactive

Agents and Solid Phase Materials. This need overlaps that of the regulatory need described in

section 1.2 for determining the percentage of cell types (human or animal) that make up a particular

TEMP. It is recognized that many of the test methods employed will need to be rapid, due to high

reactivity and, in the case of cells, developmental transience. The test methods are needed to assure

quality and optimize the TEMP development process. These standard methods could be agreed on as

a result of round-robin testing of methods that may have been developed from a variety of sources

including industrial, academic and government laboratories. Those agreed upon as a result of the

round-robin-testing will provide the advantage of being the best available. As the quickly developing

TEMPs industry changes, new tests can be quickly implemented and improved as the industry needs

them. NIST can help by leading in the organization of or participation in a round-robin-testing group

from the TEMP community to identify test methods for standardization, and for organization of

round-robin, test-validation committees. The objective will be to obtain the most accurate testing

standards available (NIST should provide the necessary technical oversight for assurance of

validation procedures.) Additionally, the test group should lead in the establishment of a

clearinghouse for accumulating tests to be considered for evaluation by the round-robin process. The

participants should include FDA, NIH, standards organizations, and industry and industrial trade

organizations, and leading academic and industrial researchers.

 2.4 Identify or develop standards for preservation of cells. While guidelines for the preservation

of cells, tissues and organs may exist, there are no existing consensus standards. Therefore, there is a

need for identifying and developing materials, standards, and standard protocols for the storage and

preservation of cells and tissues. NIST can organize a workshop to determine the current needs in

this area. The steering committee should include ASTM, FDA, American Tissue Cell Culture, and

key researchers from the TEMPs community and from the Society for Biomaterials.

 2.5 Develop biomarkers for the identification of potentially infectious agents or xenogenic cells

from co-cultures that are employed in the manufacturing of TEMPs. There is a need to develop

accurate, high-throughput assays for detection of potentially infectious agents in TEMPs (e.g., prions)

and a need for developing a rapid and highly sensitive sterility assay. Meeting this goal will require

collaboration with other federal agencies such as NIH, and with academia and the industry. NIST

should organize a task force/group from the TEMP research community to coordinate the many

activities in this area. Participants should include FDA, NIH, standards organizations, and leaders

from industry and academia.

 2.6 Develop in vitro safety and efficacy assays for individual components of a final TEMP. The

ISO 10993 biocompatibility tests pertain to biomaterials and are not optimal for assessing the safety

of combination products. To evaluate the in vitro final efficacy of an engineered device (alginateñcell

mix, bioartificial skin, or bioartificial bone combined with a growth factor) is challenging. There is a

need for novel test methods for evaluating safety and efficacy of individual components (e.g. cells,

biomaterials, biomolecules) of TEMPs and the final device. Substrate characterization is of great

importance in this regard. Development of the needed tests will be challenging and will involve

collaborations with industry, other federal agencies, and groups such as NCCLS. NIST can help by

leading in the organization of a task force/group that should coordinate the needed developmental

activities (which may be combined with Action Item 2.7, below). Participants should include FDA,

NIH, standards organizations, and leaders from industry and academia.

 2.7 Develop standard, non-cell based safety and efficacy assays (e.g. in vitro calcification model)

and reference materials for detecting residuals on TEMPS. The non-cell based assays are needed
25

to predict in vivo behavior of TEMPs. Reference materials are needed for residuals such as DMSO.

Both the validation of assay test methods and the development of models for predicting efficacy are

needed (these can work synergistically by complementary refinement to enhance the precision of

each). A collaborative effort will be needed with other federal agencies, academia and industry. 

NIST can help by leading in the organization of a task force/group to coordinate these activities

(which may be combined with Action Item 2.6, above

 2.8 Develop Genomic/Proteomic Assessments. It would be of great use if a mechanism for rapidly

annotating cells and tissues with genomic and proteomic data were available. This would allow new

cellular markers to be quickly assigned to TEMPs, for both quality control and precision

identification (i.e., production lot identification). This would require software for facilitating the

harvesting of genomic and proteomic data as well as the tools to help users map markers to cells and

tissues from any source (e.g., human, porcine, etc.). NIST should organize a workshop to establish

who, within and outside the TEMPs community, should be contributing to this effort as well as for

establishing the pertinent issues resulting from the follow-up workshop.
26

Crosscutting technical areas: These dealt with the crosscutting issues of: Harmonization of Standards

and Data in separate breakout sessions. The discussion leaders in each session wrote the reports. The

Harmonization group met after each of its members attended the first half of other technical focus-area

breakout sessions and reached consensus on the action items reported on. The data group also dispersed

itself among the technical area breakout sessions for their entire 3 hours of meeting and then met to

discuss issues that its members became aware during that time. Consensus on action items was not

reached; hence, the report contains the perceptions of various individuals of the data group regarding data

management and security needs and what they, as individuals, would like to see NIST address.

Crosscutting Issues Reports

Crosscutting Issues Session Leaders

Data - Henry Heffernan, National Institutes of Health

NIST Facilitator: Michael Hogan - Scribe, Arnold Johnson 

Harmonization - Sharon Stanford, American Dental Association

NIST Facilitator: Mary Saunders - Scribe, Belinda Collins
27

Harmonization of Standards

Belinda Collins

Office of Standards Services

NIST

Sharon Stanford

Standards Administration

American Dental Association

Overview

Harmonization of standards means development and use of a single standard that is universally acceptable

to all affected parties. Ideally, this will include compatibility with worldwide requirements of both

government and industry. Drivers for harmonization include the emergence of a global market affecting

both trade and travel, extensive regulation for the biomedical industry (sometimes with conflicting

regulations and supporting standards), and a growing body of diverse information that standards can help

to make uniform. To be effective, harmonized standards must be globally accepted, technically correct,

practical, responsive to regulatory needs, and readily accessible. 

Why should standards be harmonized? Because not harmonizing is too expensive. Harmonization avoids

the duplication of effort required to develop multiple standards. Multiple standards on the same topic

waste resources, are confusing to the users, can be expensive to conform to, and are generally

burdensome. Hence, as such standards arise from different sources, harmonization is needed as a

continuing process toward reducing them to one standard for all applications. The resulting harmonized

standard must have global acceptance. If the harmonized standard is developed by an international

organization, such as ISO and IEC, it will typically have quick global acceptance. When the standard is

used in a regulatory application, regulators, not just in the United States, but also around the world, must

also be encouraged to cite it. Finally, it must be used by the market, that is, by manufacturers, suppliers,

and customers around the world.

In the development of harmonized standards, the ideal standards process should adhere to the principles

of due process. It should be open, balanced, and involve all parties who have an interest in a particular

area. During the process, participants should consider the market relevance and any particularly

appropriate clinical relevance of the intended standard. The resulting standard should also be timely,

flexible and efficient, both in terms of initial development and on-going maintenance. 

Despite all the benefits of standardization, the standards process is often criticized as too political, too

slow and tedious, or too easily dominated by a single interest so that all voices arenít heard. Other

concerns relate to lack of adequate funding, particularly for ensuring participation of academic, consumer,

or other diverse interests in a consensus process. Finally, there is concern that the resulting standard,

being based in consensus, may be below the lowest acceptable common denominator, because too many

compromises have been made. Despite these criticisms, the harmonized standard still remains the best

way to meet market needs in both health and safety, as well as in trade and manufacturing.

To achieve a harmonized standard, interested parties must determine if a standard(s) already exists and

they may have to conduct pre-standardization research to resolve technical problems before attempting to

standardize procedures or test methods. They must find and work through an appropriate sponsoring

standards development organization (SDO) toward a consensus standard. Often validation of the standard

will require round robin testing to ensure that it will, in fact, produce the desired results.
28

In all of these steps, NIST can play an important role to facilitate the development and the use of

harmonized standards.

Proposed Roles for NIST in Harmonizing of Standards. 

 Challenge the underlying technical assumptions, such as ìsterilization is under controlî (when, in

fact, discussion at this workshop indicated that sterilization of TEMPs remains a complex problem

that needs to be solved).

 Conduct pre-normative research on technical issues so that the path to harmonized global standards is

smoothed. 

 Develop sound test methods for particular topics in conjunction with industry and government

agencies, to meet the needs of both.

 Assist in the verification of proposed test methods so that the standards developed using those test

methods are valid and reliable. 

 Facilitate not only the development, but also the use, of harmonized standards.

 Consider developing a database of all existing biomedical standards worldwide and their reference in

regulations to enable interested parties to determine the need for new standards quickly.

 Provide (or continue to provide) an open forum for discussion of industry and government needs in

standards. 

 Educate important stakeholders on the value of standards and the need for participation in developing

sound, harmonized standards. 

 Ensure that NIST staff participates at the technical level in processes that will result in internationally

accepted standards.

 Look for gaps and disharmony in the standards development process and alert stakeholders. To

achieve the roles laid out for NIST above, NIST will need more funding for scientific participation in

the standards process, including biomedical standards.

In conclusion, NIST must develop a formal, ongoing and continuing working mode with industry sectors

that involves SDOs and regulatory authorities when appropriate.
29

Data Management and Information Technology Requirements

Mike Hogan

Arnold Johnson

Information Technology Laboratory

NIST

Henry Heffernan

National Institutes of Health

Overview 

Computer-based data management and communications have become pervasive in the many specialized

segments of the nation's biomedical industry. In recognition of this fact, the NIST Workshop on

Standards for Biomedical Materials and Devices included in its design a small data group, composed of

industry and government experts experienced in data management and information technology. This

group participated in the discussions of the five breakout groups to identify the data management and

information technology requirements that were discussed in those sessions. Based on those

requirements, the data group formulated action plans for NIST to cooperate with industry in developing

the needed measurements and standards. These action plans are also intended to promote the long-term

development of standards-based information technology capabilities that will be needed for the successful

industry-wide adoption of science and technology for advanced biomedical materials and devices.

"Just-in-time" manufacturing and inventory management requires advanced data management

capabilities. The continuous need for progressive improvements in the quality and performance of

biomedical materials and devices requires new information technology (IT) approaches. The lead

position of U.S. companies in the global biomedical materials and devices markets can be helped by a

judicious selection of strategic technical support projects for advancing their data management

capabilities through standards. The following fifteen action plans will enable NIST to cooperate with

industry in designing and developing standards-based IT capabilities. 

The following fifteen action items are not prioritized. We recommend that priorities be assigned as NIST

cooperates with government and industry stakeholders on pursuing these action items. This workshop

begins a process for NIST to comprehensively cooperate with various segments of the biomedical

materials and devices industry and other federal agencies in working through strategic data

standardization issues. There are interdependencies among many of the action items, some of which are

described in the Appendix. In particular, action items 1, 2, 3, 4, 5, 12, 14, and 15 could be dealt with

together; items 8, 9, and 10 could be dealt with together. They have been described separately because

their domains do not completely overlap and describing them together would be cumbersome. In the

sense of dealing collectively with the action items there would be only six of them. Successful

implementation of one action item may require the concurrent work on one or more of the other action

items. This provides both a challenge and an opportunity for the stakeholders to work together on related

action items.

Action Items Needed:

 (1) Develop a Standard Interface to Properties of Materials Databases

Manufacturers of biomedical devices need access to publicly available information about the

physical, chemical, and performance characteristics or properties of materials used in the manufacture

of such devices. They need a standard way to represent different kinds of properties in a properties

database so that a single software application can access multiple materials databases. Collaboration

is needed by the stakeholders on a standard way to communicate with these materials
30

knowledgebases. The Oasis/ebXML/Registry (see glossary, appendix) project is developing standard

ways to query and make submissions of new data so that materials databases can interoperate. The

Oasis/ebXML/Registry specification needs specialization to fine-tune it to operate as a registry for

Properties of Materials. NIST can provide leadership for an initial meeting to coordinate standards

development, conformance test development, and implementation cooperation.

 (2) Develop Standardized Identifiers (tags) for Measurements.

Users of materials intended for biomedical applications would benefit from having materials

properties readily available with properties that have been measured by known and well understood

techniques . Manufacturers of materials intended for biomedical application would benefit from

having their products exposed to users and labeled with properties determined by independent

researchers using standardized property description formats. The biomedical materials and devices

industry needs collaboration by stakeholders on standardized tags to identify physical and chemical

measurements (e.g. the NIST/MatML project), and standard ways to represent different kinds of

properties in a properties database so that a single software application can access multiple materials

databases. Participants at the June 26-27 NIST MatML workshop can be the kernel of industry and

user participation. NIST can provide leadership for an initial meeting to coordinate standards

development, conformance test development, and implementation cooperation.

 (3) Conduct a Workshop on Standardizing Biomedical Materials Data Registry Methodology

The description of the data elements that correspond to the characterization of biomedical materials

by one organization is usually not consistent with the characterization data developed by other

organizations, which is a barrier to effective communications within the industry. An initial

workshop would enable biomedical materials and device industry representatives, materials research

and clinical quality control specialists, and interested government representatives to familiarize

themselves with the ISO/IEC 11179 Data Standardization methodology, and develop a coordinated

strategy for applying this data registry standard in a uniform way throughout the biomedical materials

and devices industry. The NIST ITL has the experience in standardizing data registries, and the

contacts with the leaders in data registry development; thus, ITL should lead in the organization of a

workshop for the biomedical materials and devices industry segments.

 (4) Provide Technical Assistance for the Development of Audiometric Data Structures.

A standardization effort already established as WG86 within ANSI-accredited Acoustical Society of

America Standards Committee S3, Bioacoustics, is combing through existing ANSI and IEC

standards, and current industrial practice, to identify appropriate data elements for construction of

higher-level data structures appropriate for the interchange of data related to Hearing Devices,

Programmers, and Test Instruments, and their use in the evaluation of human hearing. The working

group is composed of audiologists and representatives from groups that produce auditory devices, but

it has very little experience in data modeling or in the representation of data structures as XML

documents. A data representative with experience in XML and data modeling is needed to work with

domain experts of ANSI S3/WG86 to develop Audiometric Data Structures. This action item has

been partially addressed --- see Appendix regarding NIST representative meeting report from June

29, 2001, S3/WG86 meeting. Participation in this effort should include a NIST representative with

expertise in XML and data modeling, along with the current membership of ANSI S3/WG86. 

 (5) Initiate a Technical Working Group on Ontology for Clinical Responses.

Biomedical materials manufacturers, user organizations, and clinicians have a need for uniformly

classifying responses to biomaterial as well as conventional devices. The development of consensus

agreements on how these in vivo responses to biomaterials and devices are to be classified and related

to one another in a domain ontology requires an on-going Task Force or Working Group. The
31

working group, in addition to recognized representatives of the biomedical materials and devices

industry, should include scientists experienced in knowledge representation methodologies and

software systems that draw inferences from the data, and clinicians to evaluate and adopt appropriate

terminology. The objective of the working group would be to develop a plan for describing the

clinical responses of patients to biomedical materials and devices, and defining the ontological

relationships between these clinical responses in machine-interpretable formats. To facilitate the

acceptance and adoption of these ontological definitions and formats, a representative group of

clinicians and data specialists is needed to define the scope of this effort and to identify the domains

where progress could be expected to be made first. NIST can provide leadership for an initial meeting

with NIST ontology specialists to assist in defining the scope and program of work for the working

group, along with FDA and NIH participation.

 (6) Develop Data Interchange Standards among Biomedical Instruments and Implant Devices

Many devices implanted within the human body, acting as sensors to collect data, need to

communicate with instruments, databases, and expert systems located outside of the body. In addition

exterior software systems need to communicate with one another, sharing data received from sensor

devices within the body. Common high-level standard formats and data structures for interchanging

biomedical data are needed for this communication that are equally applicable for wireless data

interchange and for connected data interchange. XML is universally accepted as an appropriate

markup language for messages to be sent among cooperating software systems. The Biotechnology

Industry Organization (BIO) is cooperating with several major software vendors (e.g. Sun, IBM) to

define standard biological data structures that can be transmitted, queried, and modified by different

software systems with no loss of semantics (http://www.washtech.com/news/biotech/9972-1.html).

The BIO effort to identify data structures and a parallel effort to represent those structures as XML

documents for interchange, needs participation from interested parties. All segments of the

bio-technology industry that need to exchange structured data, and all government agencies that need

to exchange biomedical data with themselves or with industry, should be invited to participate in this

project. Whether this specific focused effort is included in the Biotechnology Industry Organization

(BIO) program as a priority that will be addressed early, needs to be determined. If it is not a priority

for the BIO project, then NIST should take the initiative toward identifying a device industry

standards development organization that will lead in this effort.

 (7) Develop Round-Robin Testing Protocols for Assuring Accuracy and Precision of

Measurements. In round robin testing (see glossary, appendix) for validating and refining standards

for materials and manufacturing processes, the specifications for the statistical measures used by

different testers can be different from each other. These differences in measurement among testers

reduce significantly the confidence that can be placed in the final results of the round robin testing.

Round robin tests are often performed under the auspices of a standard protocol of a standards

organization. These form necessary rudiments for the comparisons; however, subtleties in the use (or

non use) of traceable calibration standards or in the failure to extend statistical analyses to more

robust methods may substantially reduce the value of the information that could be derived from data.

Generic protocols and tailored protocols for round-robin testing need to be developed to assure that

the appropriate numerical methods and statistical controls can be maintained throughout the roundrobin testing process. Standards development organizations, biomedical materials and devices

manufacturing firms, NIST materials scientists, manufacturing, and computational statistics personnel

should be involved. NIST statistical engineers and computational statisticians, working with the

industrial statisticians and materials standards development committees, could provide initial models

of statistical approaches that would provide examples for industry groups to follow.
32

 (8) Establish a Working Group to Develop Patient Anonymization Standards.

Just as traceability of test measurements to standard reference materials and test methods standards is

essential, so also there is a need for clinical researchers, and evaluators of materials and devices

research, to be able to trace results back to the individual patients from which the measurements and

responses were derived. Materials and devices manufacturers have a need for a uniform method for

tracking patients with devices over time that complies with applicable privacy and confidentiality

requirements. For the effective monitoring of the clinical use of biomedical materials and devices,

and for device/patient tracking over time periods, there is a need for patient anonymization standards.

An on-going Task Force or Working Group is needed to identify, evaluate and adopt the appropriate

standards. Included in the positive outcomes is expected to be the streamlining of approval processes

through acceptance of these standards by regulatory agencies, state legislatures, funding agencies,

and Institutional Review Boards (IRBs), thereby facilitating clinical trials. The working group should

include Clinicians from academia, government and the biotechnology industry, as well as data and IT

security specialists who are working in the health area. For the initial start up and definition of the

scope of this activity, NIST security standards specialists could chair the group, with support from

FDA and NIH clinical research specialists

 (9) Establish a Working Group to Develop Device/Patient Tracking Standards.

There are a number of longitudinal data tracking and coordination issues that need to be addressed for

the effective evaluation and clinical use of biomedical materials and devices. A particular need is for

device/patient tracking standards. Clinicians and device manufacturers have a need for uniformly

tracking these devices and patient responses over time, requiring a consensus on the types and

methods of data tracking. The representatives need to be recognized representatives of the data and

clinical communities to effectively facilitate the acceptance and adoption of these ontological

definitions and standards. The dimensions of the solution to this need can be determined by

assembling a representative group of device manufacturers, clinicians and data and IT security

specialists to form a Working Group on device/patient tracking standards. The working group should

include clinicians from academia, government and the biotechnology industry, along with data

specialists who are working in the health area. NIST data engineers should convene the working

group in order to define the scope and program of work of the working group, with cooperation from

FDA and NIH clinical research specialists.

 (10) Develop Standards for the Security of Data on the Measurements of Biomedical Materials

and Devices. The increasing use of information technology (IT) systems and IT-enabled devices for

electronically gathering, storing and transmitting medical data of individualís has resulted in national

rules and policies regarding the privacy and security of healthcare information such as the

Department of Health and Human Services (HHS) Health Insurance Portability and Accountability

Act of 1996 (HIPAA), and Healthcare Financing Agency (HCFA) Proposed Internet Security Policy

(HISP). Clinical researchers, evaluators and users of biomedical materials and devices capture and

use patient healthcare information, which must be protected in accordance with national laws and

regulations. Materials and devices manufacturers and users have need for standards and

measurements for protecting the integrity and confidentiality of patient data/information. A forum is

needed to address such questions as: what are the medical data privacy and security issues associated

with biomedical materials and devices; what standards are needed in this area; what Government

policies on privacy and security of medical data, (e.g., Health and Human Services (HHS) HIPAA)

must biomedical materials and devices comply with; what IT security features do biomedical devices

have, what standards must they follow, and how is compliance assessed? Participants in the forum

should include biomedical materials and device providers, clinicians, academia, government, as well

as data and information security specialists who are working in the health area. NIST can provide
33

leadership by holding an initial meeting to coordinate standards development, conformance test

development, and implementation cooperation.

 (11) Identify Internal NIST Knowledgebase and Information Expertise.

The various NIST laboratories and technical services have extensive data management and advanced

information processing expertise, but there has been little cross-unit awareness and knowledge of this

expertise, and the capabilities that this expertise can offer to the U.S. Biomedical Materials and

Devices Industry, no matter in what division or laboratory that expertise may be found. Coordination

of the NIST internal information and data expertise is needed, so that the appropriate expertise can be

identified and approached for possible collaboration and CRADA projects by organizations in the

biomedical materials and devices industries.. A series of workshops of NIST personnel that support

information handling in all NIST laboratories and programs should be held. The goal of these

workshops would be to (1) identify and categorize the expertise in information and data management

in these NIST personnel, and to catalogue the aspects of this expertise in a way that can be understood

across the NIST organizational units; (2) provide NIST personnel with an understanding of the

categories and range of complementary expertise in other NIST personnel for developing a

coordinated strategy for representing this expertise to the various industries that NIST supports with

its programs, with particular emphasis on the biomedical materials and devices industries; (3) to

communicate these information management capabilities to relevant industries where CRADA and

other cooperative programs and voluntary standards activities are conducted.

 (12) Conduct a Workshop on Ontology Technology for Nomenclatures, Biomedical Materials

Characterizations and Device Performance Characterization. A fundamental difficulty in the

characterization of biomedical materials and the performance of devices is the need to describe many

interconnected parameters and attributes in terms of how they affect the performance of the materials

and devices in different operating contexts and under different operating conditions. The semantic

interconnectedness of these data items in operational contexts can be represented in computerinterpretable forms through domain ontologies. These domain ontologies can support the

compatibility and consistency of the knowledge bases of each organization that supplies products in

the value chain of the manufacturing processes of the specialized industry segments for different

biomedical materials and devices. These domain ontologies, appropriately developed and validated

through round robin testing and refinement by firms in the industry segments is needed for the kinds

of "databases" support needed to respond to the variety of uses that the industry participants had

mentioned in the focus sections. A NIST-sponsored workshop that will be informative for

participants from the biomedical materials and devices industry segments is needed. No individual

company can develop the ontology content for its knowledge base in a sufficiently complete and

consistent manner that can assure its consistency and compatibility with the knowledge bases of other

companies in its industry category, and with the knowledge bases of the companies in its supply

chain, as well as those in its client or customer organizations. A group effort is needed. In addition,

coordinating these knowledge base developments with clinical research organizations and the

approval processes of FDA and its EU and Asian counterparts is not going to happen without a

technical support organization that is thoroughly familiar with consensus processes and is recognized

internationally, such as NIST. The workshop will provide the opportunity for identifying industry

participants in the planning and organization of the projects that will develop the domain ontologies. 

 (13) Develop Conformance Tests for the Advanced Features of SQL í99.

The biomedical industry requires that its various databases be interoperable and provide compatibility

in their management of the complex data structures used for representing properties and performance

characteristics of materials and devices. The standardization of data management features in an earlier

SQL í92 version of SQL and the development of test suites to enforce those standards proved very

useful to industry in achieving compatibility. The advanced features of the ISO/IEC database standard
34

SQL í99 contain additional capabilities helpful for managing these complex data structures;

however, conformance tests for the new features in SQL í99 do not yet exist. Many of the complex

characterizations of materials and of the performance of devices in their operational environments

need to be represented in databases in ways that can be automatically (without human examination

and interpretation) interpreted by rules in other databases. Without conformance tests,

implementation agreements, and protocols for interoperability testing, major errors can occur in

processing data structures across different databases that can result from mistaken interpretation of

database schemata across different database management systems. Database standard developers,

database systems vendors, and government agency data experts could participate in the development

of conformance tests for the advanced features of SQL í99. NIST ITL personnel were active in

development of the existing SQL í92 test suite and have experience in the complete life cycle of

conformance test suite development, and in the participatory consensus processes that are necessary

for confirming the validity of conformance test products. NIST could use this experience to act in a

limited advisory or consulting role for new initiatives from the industry.

 (14) Provide a Forum and Technical Support for the Automation of the Regulatory

Submission/Reporting Processes Manufacturers need to make submissions to various government

agencies regarding the biomedical products and devices that they manufacture. Currently it is

common practice to fill out the forms used by these agencies manually. It would save the industry

both time and effort if there were a catalog of standard government reporting forms, using a

commonly defined XML document type definition (DTD) and a standard set of basic elements for the

interchange of common information so that a manufacturerís data management software could

prepare and submit the required reports in a form that a government agency could receive and process

them, without human intervention to type and re-type or re-format the data. A forum is needed where

biomedical device manufacturers that prepare reports and the government agencies that receive them

can meet to agree on the structure and content of reporting forms. Also necessary as a catalyst for

success is participation of personnel skilled in data and process modeling and representation of data

structures in some interchange format like XML. NIST could help with creation of the appropriate

forum for such groups to present their requirements and discuss potential standardization, and NIST

personnel with experience in data modeling and data interchange, and knowledge of existing

standards, could assist in molding those requirements into candidate specifications for joint approval

by the affected groups. Participants in this project should include all agencies with submission or

reporting requirements related to biomedical devices (e.g., FDA, NIH, VA), all manufacturers subject

to submission or reporting requirements, representatives of the Clinical Data Interchange Standards

Consortium, representatives of the HCFA initiative for the U.S. Healthcare Information

Knowledgebase, NIST personnel familiar with setting up effective standardization structures, and

NIST personnel familiar with data modeling and data interchange. NIST can provide leadership for

an initial planning meeting to coordinate participation of representatives from the government

agencies, including NIST, and the manufacturer industry segments that will benefit from submission

and reporting standards.

 (15) Identify Coordination Issues between Clinical Data Standardization and Materials and

Devices Biomedical Data Requirements. Currently there is significant work being done in a

number of standards development organizations to standardize clinical data elements. As the data

requirements of the biomedical materials and devices industry become better understood, it will be

important to assure that no conflicts or incompatibilities are developed between clinical data

standards and biomedical materials and devices data agreements. The ANSI Healthcare Informatics

Standards Board (HISB) is coordinating standards development for electronic messages that include

clinical data, and is addressing the implementation agreements required for the Administrative

Simplification requirements of the Health Insurance Portability and Accountability Act (HIPAA). 
35

The ANSI Medical Devices Standards Board (MDSB) coordinates standards for medical devices. The

involvement of NIST data scientists in supporting various facets of the U.S. biomedical materials and

devices industry would provide a unique vantage point for identifying compatibility issues and bringing

these issues to the appropriate standards bodies for clarification and resolution. To accomplish this

action, NIST data scientists need to establish working relationships with various standards development

committees. 
36

Appendices
37

Appendix: Auditory Diagnostic and Prosthetic Devices 

Victor Nedzelnitsky

Manufacturing Engineering Laboratory

NIST

Overview

This Appendix furnishes some background and explanatory material regarding auditory diagnostic and

prosthetic devices. This subject is complicated because the human auditory system is complicated in its

anatomy, physiology, and function. Signal transmission and coding in the auditory system involves

complex sounds (speech, music, noise) and acoustical environments, acoustical transmission to and

reception by the external ear, sound-induced vibration of the tympanic membrane (eardrum), conduction

of mechanical vibration via the ossicles in the middle ear to the cochlea (fluid-filled inner ear),

hydromechanical frequency analysis within the cochlea, transduction to electrical potentials including

auditory nerve fiber action potentials, subsequent further nonlinear signal transmission, coding, and

processing via ascending (afferent) and also descending (efferent) neuronal pathways to and from the

brain, and binaural interactions between the left and right ears and portions of the brain. The variety of

hereditary and environmental factors, diseases and injuries that can produce ranges of damage in various

parts of the auditory system, and consequently in types and extents of hearing losses, in different

individuals at various ages, has led to the wide variety of diagnostic and prosthetic devices in this field. 

Further, the size of the auditory device industry is expected to increase significantly as a result of

(1) demographic and medical trends due to dramatic increases in the average age of populations in

industrialized nations, (2) the rapid development of new technologies resulting from the continued

integration of electrical and mechanical systems (mechatronics), advances in signal processing, improved

transducers and arrays, and miniaturization, and (3) benefits of continued basic and applied research

involving (but not limited to) signal transmission and coding in the auditory system, auditory perception

and speech reception, functional performance testing of hearing, screening and diagnosis, and prescription

(fitting) of auditory prosthetics. To illustrate, in the U.S. the elderly population (ages 65 and over) is

expected to double in the years 2000 to 2030.1

 Also, regarding recent trends in the last few decades up to

the current (2001) population, ìsome evidence points to an increase in the prevalence of hearing

impairment among persons 45-69 years of age, especially among men.î1

 Not unrelated, these same years

are expected to see a dramatic change in the number and types of technologies and devices that are

developed - custom auditory prosthetics including improved programmable and digital signal processing

hearing aids, better cochlear, middle ear, brainstem, and other auditory implants, and better metrologyintensive diagnostic devices and procedures needed for proper selection and fitting of prosthetics to better

understood, diagnosed, characterized, and measured hearing losses of patients. At present, only a small

minority (about 16%) of physicians routinely screen for hearing loss. 

Among biomedical devices, auditory devices are unusual in that they are quickly growing in importance

not only to the rapidly increasing number of the elderly, but also to all age groups including infants.

Sergei Kochkin, Ph.D., in ìFAQ About People with Hearing Lossî prepared for the Better Hearing

Institute, noted that there are ìclose to 8 million people between the ages of 18 and 44 with a hearing loss

and more than a million school aged children.î Proper diagnosis and treatment of hearing loss is critically

important for successful patient outcomes in all age groups, but is especially so for children who have not

yet acquired language. Without proper diagnosis and treatment many of these children might never

exceed the 3rd-grade educational level! 
38

Consequently, the screening of newborn infants for hearing loss is recommended nationally by the

National Institute on Deafness and Other Communication Disorders (NIDCD, an Institute of NIH), and is

legally mandated by a large and increasing number of states . According to the American SpeechLanguage-Hearing Association (ASHA), the number of states that have passed early hearing detection

and intervention (EHDI) laws has grown from 12 in 1998 to 32 in July 2000. This early screening for

hearing loss necessarily involves methods that do not require linguistic communication with the infant.

Such methods include measuring sounds produced by the auditory system called otoacoustic emissions

(OAE, which may be evoked or spontaneous), and auditory brainstem response (ABR) methods used to

predict hearing sensitivity and to assess the integrity of Cranial Nerve VIII and auditory brainstem

structures by measuring evoked potentials (electrical signals produced in the auditory system in response

to sound stimuli). These methods are also used on other patients (e.g., older children or adults),

particularly when necessary for diagnosis, or when patients are unconscious or otherwise unresponsive to

examiner-patient communication. 

Regarding the breakout session item ìAddress the Issue of Electromagnetic Interference with

Audiometric Equipment in Sound Rooms,î some additional aspects are relevant. For busy hospitals or

clinics to which patients frequently must travel considerable distances (or undergo some other hardships)

for tightly scheduled appointments, the use of electromagnetically shielded sound rooms is sometimes

considered a necessary procedure that prevents continuous or intermittent ambient electromagnetic

interference from causing invalid or misleading diagnostic instrument readings. Such interference is often

critically dependent on relatively minor details of how interconnections are made between instruments

(including cable lengths and spatial orientation), and how signal cables, power lines, or other penetrations

are carried through shielded enclosures. Consequently, the efficacy of electromagnetically shielded sound

rooms should be tested in situ after the rooms and all instrumentation have been installed and positioned

exactly as they are used. There is an existing VA procurement specification for audiometric sound rooms

that includes electromagnetic shielding specifications that are believed to be the most advanced of their

type for these rooms, but there is no comparable national or international standard.

This session has identified numerous action items that would enable NIST to build upon its current

capabilities and greatly to extend its contributions to the rapidly expanding field of standards for auditory

diagnostic and prosthetic devices. At present, NISTís Manufacturing Engineering Laboratory (MEL)

works with industry and government agencies, especially the Department of Veterans Affairs (VA), to

develop methods to measure the electroacoustical performance characteristics of various new types of

hearing aids. NIST also provides reference laboratory services (calibration and characterization of critical

audiometric measuring instruments) when requested by the U.S. Public Health Service. Other relevant

work at NIST (ITL) involves speech recognition programs and systems, natural language characteristics

of speech, and higher-level information extraction. NIST (EEEL) has extensive capabilities regarding

electromagnetic field measurements, EMC issues, and related standards development. These capabilities

and the biological and medical resources of NIH are being applied in a collaboration to study biological

effects of electromagnetic fields from cordless telephones. 

Reference: 

1. M. Desai et al., ìTrends in Vision and Hearing Among Older Americans,î Aging Trends No. 2,

Centers for Disease Control and Prevention, National Center for Health Statistics, March 2001.
39

APPENDIX CROSSCUTTING DATA ACTION ITEMS

A - SCOPE OF THE CROSSCUTTING DATA ACTION ITEMS

As stated in the overview of the data report, the action items listed assume that NIST will cooperate with

industry in providing technical support for reference materials, materials databases, test and measurement

development, and participation in appropriate standards development. The report also assumes that NIST

will continue to cooperate with the biomedical materials and devices industry segments and other federal

agencies in working through strategic technology issues as they emerge. The data group did not include

within its scope consideration of possible NIST relationships with: the Biomedical Information Science

and Technology Initiative (BISTI) that is underway at the National Institutes of Health, the new National

Institute for Biomedical Imaging and Bioengineering (NIBIB), the United States Healthcare Information

Knowledgebase (USHIK) initiative of the Health Care Financing Administration (HCFA) in cooperation

with the medical care organizations of the Department of Defense, the Department of Veterans Affairs, or

the Indian Health Service. However, a number of the recommended action items above have direct

relevance for supporting these other initiatives. 

Through participating in the discussions of the five breakout sections of the NIST Workshop on Standards

for Biomedical Materials and Devices, the data group identified relevant data standards issues and

recommended the action plans described in the body of this report. The data group recognized that there is

a need to facilitate the application of refined database technology and semantic structures to reference

databases to meet the strategic needs of the U.S. biomedical materials and devices industry segments.

The data group also recognized that appropriate NIST staff could undertake a number of technical support

roles in the U.S. and international standards development organizations that are actively developing

information-related standards that will affect U.S. firms in the biomedical materials and devices industry

segments, and that there is an early opportunity to accelerate the introduction of electronic interchange of

data within and between the databases of organizations in the biomedical materials and devices industry

segments and government agencies.

There are many data issues relevant to the Biomedical Devices and Materials community for anyone who

is now trying to conduct business electronically. Data issues often become an impediment to successful

electronic business deployments. Crosscutting issues with data include data acquisition, data interchange,

and data security/privacy. Solving these issues requires technically sound standards, testing, and

guidelines. There are many generic standards in place or under development for data elements, databases,

data dictionaries, knowledge representation, and data security/privacy.

NIST technical expertise in data standards and testing should be applicable to many data issues that may

be of relevance to the Biomedical Devices and Materials community.

B - INTERDEPENDENCIES AMONG ACTION ITEMS

B 1 - CHARACTERIZATION INFORMATION AND NOMENCLATURE

NIST is active in the ongoing ANSI and ISO standards work for metadata registries, using standards, such

as, ISO 11179 (Specification and Standardization of Data Elements) and ANSI X3.285 (Metamodel for

the Management of Shareable Data). A metadata registry, in which all information is defined and mapped

to physical representations in databases and e-commerce data exchange formats, assists users in the

sharing and exchange of mutually agreed information. This registry technology has unique usefulness for

clarifying the attributes and semantics of data exchanged between databases. At present there is a major
40

joint activity underway to develop a Healthcare Information Knowledgebase for the United States by

building a data registry to assist in cataloging and harmonizing data elements across organizations.

For biomedical materials and devices, to move forward in many of the activities related to data standards

and interchange it will be necessary to first address the related problem with nomenclature. For example,

the term polyethylene, can refer to a wide variety of materials with different characteristics and

performance parameters. It may not be necessary to actually come up with a standard nomenclature, but

the rules to be followed in "naming" an object, and the schema of the attributes or properties that are

required for a particular entity should be agreed upon. The main difference between what has been called

a ìnomenclatureî, ìcontrolled vocabularyî, or ìterminologyî and an ìontologyî is the degree of

definition or meaning of each of the terms included, and the capability of computer software to accurately

identify the logical implications of the use of a term in a context. Ontologies are semantically

interpretable by software. Larry Reeker, NIST ITL, has the experience in this field and the contacts with

the leaders in ontology development that will guarantee the success of an informative workshop for the

biomedical materials and devices industry segments 

For the large, complex structures of characteristics, measurements, and relationships that are needed in

reference databases for materials and devices, ontologies can relate nomenclatures/vocabularies and their

meanings with explicit, expressive, and well-defined semantic encodings that can be interpreted

accurately and precisely by computer-based inferencing software. Ontologies limit the possible other

meanings of terms to the set of meanings that are intended. Nomenclatures, controlled vocabularies, and

terminologies typically assume that humans will look at the words, names of objects, or terms and supply

the semantics through the memory recall of the human interpreter. Ontology technology is designed to

shift much of that "semantic interpretative burden" to computers and have them understand what the

terms mean. This technology enables the computer software to identify and suggest remedies for errors

of human interpretation of data. 

B 2 - DATA INTERCHANGE BETWEEN SYSTEMS AND DEVICES

For data interchange between information systems, NIST has recently developed an extended Extensible

Markup Language (XML) Test Suite in partnership with the Organization for the Advancement of

Structured Information Standards (OASIS). The XML standard provides methods for defining,

interacting with, and exchanging data for a variety of domain specific applications. NIST also has a

standard reference data program that generates sets of critically evaluated data and widely disseminates

them both as computer databases and publications.

Clinical data interchange requirements are increasing. Data interchange remains difficult and resource

intensive. Further, proprietary information must be protected, and legislative mandates (e.g., the

healthcare data interchange standards requirements of the Healthcare Insurance Portability and

Accountability Act (HIPAA)) for ensuring privacy are going into effect. Applying existing IT standards

and possibly developing new standards will be needed to achieve these goals. James Nell, in metrology

and manufacturing standards work at NIST, has worked on enterprise integration projects and standards

for many years, and is internationally recognized as a leader in coordinating the wide range of

information processing specialties and international standards for data interchange in manufacturing

enterprise activities. Based upon specific standards needs, there should be, at the very least, exploratory

meetings held to further discuss and define these needs. Participants should include organizations

involved in clinical studies and NIST. 

The following is a summary from the NIST representative to the June 29, 2001, S3/WG86 Meeting.
41

As the result of lively discussions, the Workshop on Standards for Biomedical Materials and Devices

breakout session on Auditory Diagnostic and Prosthetic Devices group asked the chair and the NIST

representative to pursue with NIST management the possibility of NIST attendance at a June 29 ANSI

S3/WG86 meeting to take a more serious look at defining an Audiology Information Model that could be

the basis of structured messages among audiologists and manufacturers of auditory devices. Such

messages usually contain data structures that describe the settings of test instruments and the curves

resulting from tests on human subjects. The June 29 S3/WG86 meeting was a success. The Audiometric

Data Structures project is now revitalized with manufacturers and audiologists in apparent agreement on a

strategy for defining a higher-level Audiology Information Model to support XML representations of

device and test instrument profiles, client evaluations, and test curve results. NIST involvement in the

future of S3/WG86 is open. The effort could be initiated under the leadership of Bill Cole, Co-chair of

S3/WG86.

B 3 - SECURITY AND PRIVACY

Legislative mandates (e.g., the healthcare data interchange standards requirements of the Healthcare

Insurance Portability and Accountability Act (HIPAA)) for ensuring privacy are going into effect. 

NIST was instrumental in developing the Common Criteria standard, ISO/IEC 15408: 1999 (Common

Criteria for Information Technology Security Evaluation), a standard for defining and measuring security

requirements in information technology (IT) security enabled products (software, firmware, hardware,

devices, etc.) and systems that are expressed in user-defined Protection Profiles or vendor-defined

Security Targets, and FIPS 140 Cryptographic Modules. NIST has been instrumental in the development

of conformance testing programs for IT security standards such as ISO/IEC 15408 Common Criteria for

IT Security Evaluation, FIPS 140 Cryptographic Modules, PKI, etc. which could be useful in supporting

the biomedical devices and materials community in complying with government regulations and

protecting medical information.

NIST also helped organize The Forum on Privacy and Security in Healthcare in November 1998. One

purpose of this Forum is to serve as venue for healthcare stakeholders to define common, user-defined IT

security requirements in the form of Common Criteria-based Protection Profiles. NIST presently has a

Draft Federal Information Processing Standard (FIPS) for the Advanced Encryption Standard (AES)

available for public review and comment. The AES specifies a cryptographic algorithm for use by U.S.

Government organizations to protect sensitive (unclassified) information. NIST also anticipates that the

AES will be widely used on a voluntary basis by organizations, institutions, and individuals outside of the

U.S. Government.

B 4 - COORDINATION WITH STANDARDS ORGANIZATIONS

In addition to the standards committees and accrediting organizations for standards development that are

active in the biomedical materials and devices sciences and technologies, a number of other standards

development organizations are actively working on data-related standards for healthcare information

services, such as HL7, X12, ASTM E31, the ANSI HISB, the SNOMED RT project, the LOINC project, the

Clinical Data Interchange Standards Consortium (CDISC), the USHIK, the NLM UMLS, and the

NCVHS. These other standards development organizations have active working relationships with

standards development organizations in other nations and at the international level. As healthcare extends

beyond national boundaries, the impact of standards becomes more critical for an organization. While

national health information standards have led the way to systems interoperability within the US, the

North American-based industry must remain cognizant of the importance of growth and harmonization

with international standards. The international standards process will have an impact, not only on the
42

healthcare standardization process within the US but also on business directly. Some relevant U.S.

standards committees are the following:

ANSI S3: Bioacoustics, which addresses hearing aids, ear and brainstem implants, and other auditory

devices. S3 has a working group WG86 on Audiometric Data Structures that wants to define and

exchange its data structures in XML.

ANSI HISB: The American National Standards Institute's Healthcare Informatics Standards Board

(ANSI HISB) provides an open, public forum for the voluntary coordination of healthcare informatics

standards among all United States' standard developing organizations. Every major developer of

healthcare informatics standards in the United States participates in ANSI HISB. The ANSI HISB has 25

voting members and more than 100 participants, including ANSI-accredited and other standards

developing organizations, professional societies, trade associations, private companies, federal agencies,

and others. The ANSI HISB meet four times a year. Please see Meeting Info for meeting information.

Please also visit the Healthcare Informatics Meeting Calendar -- listing of up-coming Healthcare

Informatics Meetings through 2001. 

ASTM Committee E31 on Healthcare Informatics: [Staff Manager: Daniel Smith (610) 832-9727]

ASTM Committee E31 on Healthcare Informatics develops standards related to the architecture, content,

storage, security, confidentiality, functionality, and communication of information used within healthcare

and healthcare decision making, including patient-specific information and knowledge. Established in

1970, E31 meets semi-annually as a committee in May and November. Members and visitors attend three

days of meetings that include technical subcommittee sessions and a plenary meeting. Some

subcommittees occasionally meet on an accelerated basis. The committee, with current membership of

approximately 270 members, currently holds jurisdiction of over 30 approved standards and additional

draft standards. Approved standards are published annually in June in the Annual Book of ASTM

Standards, Volume 14.01. 

US TAG to ISO 215: ISO TC 215 has been established to develop international health informatics

standards. Consensus on these standards will influence health informatics standards adopted in the US

and the interoperability of national and international health information exchange. Efficient exchange of

healthcare information and the interoperability of health information systems are important for industry's

viability in this expanding market. A representative should join the U.S. TAG to TC 215. 

The US TAG develops the national position, which is submitted to the TC. Membership in the TAG

provides U.S. citizens with the following benefits: 

* input into the development of the U.S. position on issues under consideration by the TC,

* opportunity to influence the work program and strategic initiatives within the TC,

* ability to affect the international standards that influence your business, 

* notification of and attendance at U.S. TAG meetings,

* access to all TAG and TC documents, including minutes, meeting notices, ballots,

* opportunity to serve as a national delegate to and U.S. expert at the TC meetings.

Glossary of Terms:

ïdata: Any representation subject to interpretation (such as through analysis or pattern matching) or to

which meaning may be assigned, such as by applying social conventions or special agreed upon codes.

Data can be processed by humans or by automatic means.

ïdata dictionary: A database or file that provides definitions for data entities. Synonymous with data

element dictionary. 
43

ïdata registry: A database containing the metadata that is necessary to clearly describe, inventory,

analyze, and classify data, providing an understanding of the meaning, representation, and identification

of each unit of data (data element), along with the registration status of the data element.

ïdata security: Computer security applied to data.

ïdata transmission: The sending of data from one place to another by means of signals over a channel.

ïinformation: The meaning that is currently assigned to data by means of the conventions applied to

these data.

ïinformation interchange: The process of sending and receiving data in such a manner that the

information content or meaning assigned to the data is not altered during the transmission.

ïknowledgebase: a database of information wherein the semantics of all data elements are described

within the database.

ïmetadata: Data about data, including their data descriptions, ownership, access paths, access rights, and

data volatility.

ïOasis/ebXML/Registry: OASIS is the Organization for the Advancement of Structured Information

Standards (http://www.oasis-open.org). It is the international, not-for-profit consortium that advances

electronic business by promoting open, collaborative development of interoperability specifications. With

the United Nations, OASIS sponsors ebXML, a global framework for electronic business data exchange.

OASIS operates XML.ORG, the non-commercial portal that delivers information on the use of XML in

industry. The XML.ORG Registry provides as an open community clearinghouse for distributing and

locating XML application schemas, vocabularies and related documents. OASIS serves as the home for

industry groups interested in developing XML specifications. OASIS technical work embraces

conformance, security, business transactions, repositories and other interoperability issues.

ïround robin test: An interlaboratory study (ILS) or ìround robinî that is utilized to generate the final

data used to support the statistical validity of the test method. Typically, a series of laboratories conduct

the same tests (a minimum of six is recommended in ASTM standard E 691).

ïontology: A database of concepts and terms, their meanings and semantic relationships to contexts,

along with the structured encodings that make it possible for a computer to interpret and draw inferences

from the definitions of the concepts and their semantic relationships.
44

Participants List
45

Eric Amis

Chief, Polymers Division

NIST

100 Bureau Drive

Mail Stop 8540

Gaithersburg, MD 20899-8540 USA

Telephone: 301/975-6681

Fax: 301/975-4252

Email: eric.amis@nist.gov

F. Alan Andersen

Director & Scientific Coordinator 

Cosmetic Ingredient Review

NCCLS

1101 17th Street, NW

Suite 310

Washington, DC 20036 USA

Telephone: 202/331-0651

Fax: 202/331-0088

Email: andersena@cir-safety.org

James Baker-Jarvis

Project Leader, Electromagnetic Properties of

Materials

NIST

325 Broadway

MS 813.01

Boulder, CO 80303 USA

Telephone: 303/497-5621

Fax: 303/497-3970

Email: jjarvis@boulder.nist.gov

Peter Barker

Research Chemist, CSTL

NIST

100 Bureau Drive

MS 8311

Gaithersburg, MD 20899-8311 USA

Telephone: 301/975-5402

Fax: 301/975-8505

Email: peter.barker@nist.gov

Al Beavan

Vice President, Process Quality

Sulzer Carbomedics

1300 East Anderson Lane

Bldg. A

Austin, TX 78752 USA

Telephone: 512/435-3200

Fax: 512/435-3700

Email: abeavan@carbomedics.com

Larry Beeman

VP, Quality Assurance & Regulatory

Sulzer Orthopedics, Inc.

9900 Spectrum Drive

Austin, TX 78717 USA

Telephone: 512/432-9410

Fax: 512/432-9501

Email: larry.beeman@sous.com

Becky Bergman

Vice President, Research Materials & Biosciences

Center

Medtronic, Inc.

6700 Shingle Creek Parkway

Brooklyn Center, MN 55430 USA

Telephone: 763/514-1323

Fax: 763/514-7514

Email: becky.bergman@medtronic.com

Cheryl Blanchard

Vice President, Research

Zimmer, Inc.

P.O. Box 708

Warsaw, IN 46581 USA

Telephone: 219/372-4467

Fax: 219/372-4266

Email: cheryl.blanchard@bms.com

Craig Blaschke

General Manager

Biomet

P.O. Box 587

56 East Bell Drive

Warsaw, IN 46581 USA

Telephone: 219/372-1682

Fax: 219/268-2742

Email: craig.blaschke@biometmail.com

Kelvin Brockbank

Senior Vice President

Organ Recovery Systems

701 East Bay Street

MSC 1119

Charleston, SC 29401 USA

Telephone: 843/514-6164

Fax: 843/722-6657

Email: kbrockbank@organ-recovery.com

Participantsí List

Workshop on Standards for Biomedical Materials and Devices

June 13-14, 2001

University System of Maryland, Rockville, MD
46

Robert Burkard

Professor

University at Buffalo

215 Parker Hall

Buffalo, NY 14214 USA

Telephone: 716/829-2001

Fax: 716/829-2980

Email: rfb@acsu.buffalo.edu

James Burns

Senior Vice President

Surgical Wound Dressings

Genzyme Corporation

One Kendall Square

Cambridge, MA 02139 USA

Telephone: 617/252-7522

Fax: 617/591-5894

Email: jim.burns@genzyme.com

Fred Cahn

Senior Fellow

Integra LifeSciences

11045 Roselle Street

Suite A

San Diego, CA 92121 USA

Telephone: 858/622-2600

Fax: 858/535-8269

Email: fcahn@integra-ls.com

Jean Champion

Director, Clinical Research & Reg. Affairs

Medtronic Heart Valves

1851 E. Deere Avenue

Santa Ana, CA 92705 USA

Telephone: 949/399-1428

Fax: 949/553-8978

Mrunal Chapekar

Technical Program Manager, ATP

NIST

100 Bureau Drive

MS 4730

Gaithersburg, MD 20899-4730 USA

Telephone: 301/975-6846

Fax: 301/548-1087

Email: mrunal.chapekar@nist.gov

Jennifer Colbert

SRM Coordinator

NIST

100 Bureau Drive

MS 2321

Gaithersburg, MD 20899-2321 USA

Telephone: 301/975-2579

Email: jennifer.colbert@nist.gov

William Cole

President

Etymonic Design, Inc.

41 Byron Ave.

Dorchester, ON N0L 1G0 CANADA

Telephone: 519/268-3313

Fax: 519/268-3256

Email: bill@etymonic.com

Belinda Collins

Director, Office of Standards Services

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-4000

Fax: 301/963-2871

Email: belinda.collins@nist.gov

Bert Coursey

Chief, Ionizing Radiation Div., Physics Lab

NIST

100 Bureau Drive, MS 8460

Gaithersburg, MD 20899-8460 USA

Telephone: 301/975-5584

Fax: 301/869-7682

Email: bert.coursey@nist.gov

Arthur Coury

Vice President R&D

Genzyme

1 Kendall Square

Bldg. 650

Cambridge, MA 02139 USA

Telephone: 617/768-8002

Fax: 617/374-7225

Tom Craig

Director, Regulatory Affairs & President, Orthopedic

Surgical Manufacturers Assn.

Smith & Nephew Orthopedics

1450 Brooks Road

Memphis, TN 38116 USA

Telephone: 901/399-6142

Fax: 901/398-5146

Email: tom.craig@smith-nephew.com

John Czajkowski

Vice President, Operations

Stryker Howmedica Osteonics

359 Veterans Blvd.

Rutherford, NJ 07070 USA

Telephone: 201/507-7406

Fax: 201/507-7268

Email: jczajkowski@howost.com
47

Matthew Davies

Mechanical Engineer, MEL

NIST

100 Bureau Drive

MS 8223

Gaithersburg, MD 20899-8223

Telephone: 301/975-3521

Email: matthew.davies@nist.gov

Kyle Dennis

Deputy Director

Audiology and Speech Pathology Service

Dept. of Veterans Affairs

50 Irving Street, NW

Washington, DC 20422 USA

Telephone: 202/745-8379

Fax: 202/745-8579

Email: kyle.dennis@med.va.gov

Glenn Dill

Vice President

Theragenics Corporation

5203 Bristol Industrial Way

Burford, GA 30518 USA

Telephone: 770/271-0233

Ronald Dixson

Physicist, Precision Engineering Div., MEL

NIST

100 Bureau Drive

Mail Stop 8212

Gaithersburg, MD 20899-8212 USA

Telephone: 301/975-4399

Fax: 310/869-0822

Email: rdixson@cme.nist.gov

Amy Donahue

Chief, Hearing & Balance/Vestibular Sciences

Branch

NIDCD / NIH

6120 Executive Blvd.

EPS 400C

Rockville, MD 20892 USA

Telephone: 301/402-3458

Fax: 301/402-6251

Email: amy.donahue@nih.gov

Frederick Eichmiller

Director

ADAHF

100 Bureau Drive

Mail Stop 8546

Gaithersburg, MD 20899-8546 USA

Telephone: 301/975-6806

Fax: 301/963-9143

Email: frederick.eichmiller@nist.gov

Bruno Fanconi

Deputy Chief, Polymers Division

NIST

100 Bureau Drive

Mail Stop 8541

Gaithersburg, MD 20899-8541 USA

Telephone: 301/975-6769

Fax: 301/975-3928

Email: bruno.fanconi@nist.gov

Gary Fischman

Director & Associate Professor

University of Illinois at Chicago

UIC, College of Dentistry

Chicago, IL 60612 USA

Telephone: 312/413-1120

Jonathan Fiscus

Computer Scientist, ITL

NIST

100 Bureau Drive

Mail Stop 8940

Gaithersburg, MD 20899-8940 USA

Telephone: 301/975-3182

Fax: 301/670-0939

Email: jonathan.fiscus@nist.gov

Steve Freiman

Chief, Ceramics Division

NIST

100 Bureau Drive

Mail Stop 8520

Gaithersburg, MD 20899-8520 USA

Telephone: 301/975-6119

Fax: 301/975-5334

Stephen.freiman@nist.gov

Joe Fu

Materials Engineer, MEL

NIST

100 Bureau Drive

Mail Stop 8212

Gaithersburg, MD 20899-8212 USA

Telephone: 301/975-3495

Email: jofu@nist.gov

Chuck Furfine

Chemist

FDA

12720 Twinbrook Pkwy

HFZ-143

Rockville, MD 20852 USA

Telephone: 301/443-2536
48

Len Gallagher

Computer Scientist, ITL

NIST

100 Bureau Drive

Mail Stop 8970

Gaithersburg, MD 20899-8970 USA

Telephone: 301/975-3251

Fax: 301/948-6213

Email: lgallagher@nist.gov

Katharine Gebbie

Director, Physics Lab

NIST

100 Bureau Drive

Mail Stop 8400

Gaithersburg, MD 20899-8400 USA

Telephone: 301/975-4201

Fax: 301/975-3038

Email: gebbie@nist.gov

Leslie Gilbertson

Group Manager, Engineering Test

Zimmer, Inc.

P.O. Box 708

Warsaw, IN 46581 USA

Telephone: 219/372-4676

Fax: 219/372-4922

Email: leslie.gilbertson@bms.com

Thomas Gills

Director, Measurement Services, TS

NIST

100 Bureau Drive, MS 2000

Gaithersburg, MD 20899-2000 USA

Telephone: 301/975-2016

Email: thomas.gills@nist.gov

Lori Goldner

Physicist, PL

NIST

100 Bureau Drive, Mail Stop 8441

Gaithersburg, MD 20899-8441 USA

Telephone: 301/975-3792

Fax: 301/869-5700

Email: lori.goldner@nist.gov

David Greenspan

Vice President & Chief Technology Office

US Biomaterials Corp.

One Progress Blvd., Suite 23

Alachua, FL 32615 USA

Telephone: 386/418-1551

Fax: 386/418-1465

Email: greenspan@usbiomat.com

Robert Habig

Senior Vice President

Ampersand Medical Corp.

NCCLS

414 N. Orleans, Suite 510

Chicago, IL 60610 USA

Telephone: 312/222-9550

Fax: 312/222-9500

Email: rhabig@ampersandmedical.com

Dale Hall

Deputy Director, MSEL

NIST

100 Bureau Drive

Mail Stop 8500

Gaithersburg, MD 20899-8500 USA

Telephone: 301/975-5658

Fax: 301/975-5012

Email: dale.hall@nist.gov

Howard Harary

Acting Deputy Director, MEL

NIST

100 Bureau Drive

Mail Stop 8200

Gaithersburg, MD 20899-8200 USA

Telephone: 301/975-3401

Fax: 301/948-5668

Email: howard.harary@nist.gov

Janet Hardin-Young

Director of Technology Implementation

Organogenesis, Inc.

150 Dan Road

Canton, MA 02021 USA

Telephone: 781/401-1115

Fax: 781/401-1025

Email: jyoung@organo.com

Bob Hastings

Director of Research

DePuy

700 Orthopaedic Drive

Warsaw, IN 46581 USA

Telephone: 219/372-7438

Henry Heffernan

Catholic Chaplain

NIH

9000 Rockville Pike

Bethesda, MD 20892 USA

Telephone: 301/496-3407

Email: henry_heffernan@nih.gov
49

Michael Helmus

Vice President

Boston Scientific

One Boston Scientific

Natick, MA 01760 USA

Telephone: 508/650-8152

Fax: 508/647-2510

Email: helmusm@bsci.com

Michael Hogan

Standards Liaison, ITL

NIST

100 Bureau Drive

Mail Stop 8901

Gaithersburg, MD 20899-8901 USA

Telephone: 301/975-2926

Fax: 301/948-1784

Email: m.hogan@nist.gov

Joshua Jacobs

Inaugural Crown Family Professor of Orthopedic

Surgery

Rush Medical College

1725 W. Harrison, Suite 1063

Chicago, IL 60612 USA

Telephone: 312/850-9144

Fax: 312/243-8925

Email: jjacobs@rush.edu

Gene Jakubczak

Dow Corning Corporation

P.O. Box 994

Mail CO12272

Midland, MI 48686 USA

Telephone: 517/496-6406

Fax: 517/496-8065

Email: gene.jakubczak@dowcorning.com

Peter Johnson

President, CEO

TissueInformatics, Inc.

711 Bingham Street, Suite 202

Pittsburgh, PA 15203 USA

Telephone: 412/488-1100

Fax: 412/488-6172

Email: pcj@tissueinformatics.com

Arnold Johnson

Deputy Director for NIAP

CCEVS Validation Body, ITL

NIST

100 Bureau Drive, Mail Stop 8930

Gaithersburg, MD 20899-8930 USA

Telephone: 301/975-3247

Fax: 301/948-0279

Email: arnold.johnson@nist.gov

David Kaplan

Biological Materials Researcher

FDA

12725 Twinbrook Pkwy., HFZ-150

Rockville, MD 20852 USA

Telephone: 301/827-4754

Fax: 301/827-4904

Email: dsk@cdrh.fda.gov

Lisa Karam

Senior Technical Advisor, Health Care Sector

Industrial Liaison Office

NIST

100 Bureau Drive, MS 8462

Gaithersburg, MD 20899-8462 USA

Telephone: 301/975-5561

Fax: 301/869-7682

Email: lisa.karam@nist.gov

Rich Kayser

Director, TS

NIST

100 Bureau Drive

Mail Stop 2000

Gaithersburg, MD 20899-2000 USA

Telephone: 301/975-4500

Fax: 301/975-2183

Email: richard.kayser@nist.gov

Lothar Kleiner

Director & Senior Research Fellow

ALZA

1501 California Ave.

Palo Alto, CA 94304 USA

Telephone: 650/564-5632

Fax: 650/564-5233

Email: lothar.kleiner@alza.com

William Koch

Deputy Director, CSTL

NIST

100 Bureau Drive

Mail Stop 8300

Gaithersburg, MD 20899-8300 USA

Telephone: 301/975-8301

Fax: 301/975-3845

Email: william.koch@nist.gov

Jack Lemons

Professor 

University of Alabama

616 School of Dentistry Bldg.

SDB Box 29, UAB St.

Birmingham, AL 35294 USA

Telephone: 205/934-9206

Email: jack.lemons@ortho.uab.edu
50

Tomasz Letowski

U.S. Army Research Laboratory

AMSRL-HR-SD

Bldg. 520

APG, MD 21005 USA

Telephone: 410/278-5968

Fax: 410/278-3587

Email: trl2@arl.army.mil

Bernie Liebler

Director, Standards & Electromedical Programs

AdvaMed

1200 G Street, NW

Washington, DC 20005 USA

Telephone: 202/434-7230

Fax: 202/783-8750

Email: bliebler@advamed.org

Janice LoPresti

Sr. Engineer/Scientist

Knowles Electronics, LLC

1151 Maplewood Drive

Itasca, IL 60143 USA

Telephone: 630/285-5835

Fax: 630/250-0575

Email: janice.lopresti@knowles.com

John Lyon

Skin/Health Care Industry Director & Life Sciences

Technology Director

Dow Corning Corporation

P.O. Box 994

MS C01334

Midland, MI 48686 USA

Telephone: 989/496-1660

Fax: 989/496-6942

Email: john.lyon@dowcorning.com

Donald Marlowee

Director, Office of Science and Technology, CDRH

Food & Drug Administration

9200 Corporate Blvd., HFZ-100

Rockville, MD 20850 USA

Telephone: 301/827-4777

Fax: 301/827-4787

Email: dem@cdrh.fda.gov

D. Darin Martin

Vice President Quality Assurance/Regulatory Affairs

Symmetry Medical, Inc.

202 West Market Street

Warsaw, IN 46580 USA

Email: darinma@symmetrymedical.com

Michael Mitch

Physicist, PL

NIST

100 Bureau Drive

MS 8460

Gaithersburg, MD 20899-8460 USA

Telephone: 301/975-5491

Fax: 301/869-7682

Email: michael.mitch@nist.gov

Firas Mourtada

New Products

Guidant Vascular Intervention

8934 Kirby Drive

Houston, TX 77054 USA

Telephone: 713/218-9258

Fax: 713/218-9289

Email: fmourtad@guidant.com

Victor Nedzelnitsky

Electrical Engineer, MEL

NIST

100 Bureau Drive

Mail Stop 8221

Gaithersburg, MD 20899-8221 USA

Telephone: 301/975-6638

Fax: 310/417-0514

Email: vnedzelnitsky@nist.gov

Catherine O'Connell

Research Scientist, CSTL

NIST

100 Bureau Drive, MS 8311

Gaithersburg, MD 20899-8311 USA

Telephone: 301/975-3123

Fax: 301/975-8505

Email: catherine.oconnell@nist.gov

John O'Riordan

Director, Research

Alcon Research, Ltd.

6201 South Freeway

Fort Worth, TX 76134 USA

Telephone: 817/568-6481

Fax: 817/615-3314

Email: john.oriordan@alconlabs.com

David Pallett

Leader, Speech Group

NIST

100 Bureau Drive, MS 8940

Gaithersburg, MD 20899-8940 USA

Telephone: 301/975-2935

Email: david.pallett@nist.gov
51

Nancy Parenteau

Chief Scientific Officer

Organogenesis, Inc.

150 Dan Road

Canton, MA 02021 USA

Telephone: 781/575-0775

Fax: 781/401-1025

Email: nparenteau@organo.com

Susan Peter

Senior Manager for Bone Research

Osiris Therapeutics, Inc.

2001 Aliceanna Street

Baltimore, MD 21231 USA

Telephone: 410/522-5005

Fax: 410/522-6999

Email: speter@osiristx.com

Robert Polvani

Supervisory Physicist, MEL

NIST

100 Bureau Drive

Mail Stop 8223

Gaithersburg, MD 20899-8223 USA

Telephone: 301/975-3487

Fax: 310/975-4955

Email: robert.polvani@nist.gov

Miriam Provost

Acting Deputy Director, Division of General &

Restorative Devices

Food & Drug Administration

9200 Corporate Blvd.

CDRH/FDA HFZ-450

Rockville, MD 20850 USA

Telephone: 301/443-8517

Fax: 301/534-3076

Email: mxp@cdrh.fda.gov

Tony Ratcliffe

President & Chief

Advanced Tissue Sciences

10933 North Torrey Pines Road

La Jolla, CA 92037 USA

Telephone: 858/713-7949

Fax: 858/713-7420

Email: tony.ratcliffe@advancedtissue.com

William Regnault

Director, Division of Mechanics & Materials Science

Food & Drug Administration

9200 Corporate Blvd., HFZ-150

Rockville, MD 20850 USA

Telephone: 301/827-4748

Fax: 301/827-4853

Email: wfr@cdrh.fda.gov

Henry Rodriguez

Project Leader Biotechnology DW, CSTL

NIST

100 Bureau Drive, MS 8311

Gaithersburg, MD 20899-8311 USA

Telephone: 301/975-2578

Fax: 301/975-8505

Email: henry.rodriguez@nist.gov

Alan Rudolph

TE Program Manager

DARPA

3701 North Fairfax Drive

Arlington, VA 22203 USA

Telephone: 703/696-2240

Alan Russell

Director of McGowan Inst. For Regenerative

Medicine

University of Pittsburgh

3550 Terrace St., Suite 401

Scalfe Hall

Pittsburgh, PA 15261 USA

Telephone: 412/624-6230

Fax: 412/624-9639

Email: russel@engrng.pitt.edu

Mary Saunders

Program Chair, GSIP, Technology Services

NIST

100 Bureau Drive, Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-2396

Fax: 301/963-2871

Email: mary.saunders@nist.gov

Michael Scholla

Global Business Director

DuPont Medical Packaging

974 Centre Road, #2S20

Wilmington, DE 19805 USA

Telephone: 302/999-6744

Fax: 302/999-3788

Email: michael.h.scholla@usa.dupont.com

Ronald Scicluna

Chair, HIA Technical Committee

Argosy Electronics

10300 W. 70th Street

Eden Prairie, MN 55344 USA

Telephone: 952/826-2459

Fax: 952/942-0503

Email: ron.scicluna@argosyhearing.com
52

Charles Sherwood

President

Anika Therapeutics

160 New Boston Street

Woburn, MA 01801 USA

Telephone: 781/932-6616

Fax: 781/935-7803

Email: csherwood@anikatherapeutics.com

Nancy Shinowara

Scientific Review Administrator

NIH/CSR

6701 Rockledge Drive, MSC 7778

Bethesda, MD 20982 USA

Telephone: 301/435-1173

Fax: 301/480-2644

Email: shinowan@csr.nih.gov

Charles Sidebottom

Director, Corporate Standards

Medtronic, Inc.

710 Medtronic Pkwy., LC270

Minneapolis, MN 55432 USA

Telephone: 763/505-2599

Fax: 763/505-2613

Email: charles.sidebottom@medtronic.com

Leslie Smith

Director, MSEL

NIST

100 Bureau Drive

Mail Stop 8500

Gaithersburg, MD 20899-8500 USA

Telephone: 301/975-5658

Fax: 301/975-5012

Email: leslie.smith@nist.gov

Chad Snyder

Program Analyst

NIST

100 Bureau Drive, Mail Stop 8541

Gaithersburg, MD 20899-8541 USA

Telephone: 301/975-4526

Fax: 301/975-3928

Email: chad.snyder@nist.gov

Christopher Soares

Physicist, PL

NIST

100 Bureau Drive, MS 8460

Gaithersburg, MD 20899-8460 USA

Telephone: 301/975-5589

Fax: 301/869-7682

Email: csoares@nist.gov

Sig Soli

Vice President Technology Transfer & Head of

Human Communications 

Sciences and Devices Department

House Ear Institute

2100 W. 3rd Street, 5th Floor

Los Angeles, CA 90057 USA

Telephone: 213/353-7085

Fax: 213/413-0950

Email: ssoli@hei.org

Sharon Stanford

Director, Standards Administration

American Dental Association

211 E. Chicago Ave.

Chicago, IL 60611 USA

Telephone: 312/440-2509

Fax: 312/440-2529

Email: stanfords@ada.org

Jack Stone

Acting Group Leader, Energy Metrology, MEL

NIST

100 Bureau Drive, MS 8211

Gaithersburg, MD 20899-8211 USA

Telephone: 301/975-5638

Email: jack.stone@nist.gov

Gary Strathearn

New Products

Radiance Medical Systems

13900 Alton Parkway, Suite 122

Irvine, CA 92618 USA

Telephone: 949/595-7218

Fax: 949/457-9561

Email: gstrathearn@radiance.net

Simon Szykman

Mechanical Engineer, MEL

NIST

100 Bureau Drive

Mail Stop 8263

Gaithersburg, MD 20899-8263 USA

Telephone: 301/975-4466

Email: szykman@nist.gov

John Tesk

Coordinator, 

Biomedical Standards & Reference Materials

Senior Technical Advisor, Industrial Liaison Office

NIST

100 Bureau Drive, Mail Stop 8545

Gaithersburg, MD 20899-8545 USA

Telephone: 301/975-6799

Fax: 301/975-3928

Email: john.tesk@nist.gov
53

Eugene Troy

Senior Computer Scientist

NIST

100 Bureau Drive, Mail Stop 8930

Gaithersburg, MD 20899-8930 USA

Telephone: 301/975-3361

Fax: 301/948-0279

Email: gene.troy@nist.gov

Herman Vandenburgh

CSO ñ Chief Scientific Advisor

Cell Based Delivery, Inc.

Four Richmond Square

Providence, RI 02906 USA

Telephone: 401/454-3540

Fax: 401/454-3157

Email: vandenburgh@cellbaseddelivery.com

Gregory Vasquez

Science Advisor, CSTL

NIST

100 Bureau Drive, Mail Stop 8300

Gaithersburg, MD 20899-8300 USA

Telephone: 301/975-8308

Fax: 301/975-3845

Email: gregory.vasquez@nist.gov

Peter Waegemann

CEO & President 

Medical Records Inst.

ANSI

567 Walnut Street

Newton, MA 02460 USA

Telephone: 617/964-3923

Francis Wang

Group Leader, Biomaterials Group, Polymers Div.

NIST

100 Bureau Drive, MS 8545

Gaithersburg, MD 20899-8545 USA

Telephone: 301/975-6726

Fax: 301/975-4977

Email: francis.wang@nist.gov

Aguo Wang

Stryker Howmedica Osteonics

359 Veterans Blvd.

Rutherford, NJ 07070 USA

Telephone: 201/507-7662

Fax: 201/507-7933

Email: awang@howost.com

Newell Washburn

Research Chemist, Polymers Division

NIST

100 Bureau Drive 

MS 8542

Gaithersburg, MD 20899-8542 USA

Telephone: 301/975-4348

Email: newell.washburn@nist.gov

John Watson

Director, Clinical & Medicine

NHLBI

Two Rockledge Center, MSC 794

6701 Rockledge Dr.

Bethesda, MD 20892 USA

Telephone: 301/435-0519

Fax: 301/480-7971

Email: watsonj@nhlbi.nih.gov

Ted Wendt

Vice President, Global Regulatory & Clinical Affairs

Zimmer, Inc.

345 E. Main Street

Warsaw, IN 46581 USA

Telephone: 219/372-4113

Fax: 219/372-4605

Email: ted.wendt@bms.com

Kathleen White

Director of QA & Regulatory Affairs

Polymer Tech Group

2810 7th Street

Berkeley, CA 94710 USA

Telephone: 510/841-8800

Email: KWhite@polymertech.com

Yi-Ren Woo

St. Jude Medical

One Lillehei Plaza

St. Paul, MN 55117 USA

Telephone: 651/481-7739

Email: ywoo@sjm.com

Wayne Wozniak

Director of Guidelines and Standards

American Dental Association

211 E. Chicago Avenue

Chicago, IL 60611 USA

Telephone: 312/440-2503

Fax: 312/440-2536

Email: wozniakw@ada.org
54

Brian Zimmerman

Research Chemist, Physics Lab

NIST

100 Bureau Drive, MS 8462

Gaithersburg, MD 20899-8462 USA

Telephone: 301/975-5191

Fax: 301/869-7682

Email: brian.Zimmerman@nist.gov
55

Standards for Biomedical Materials and Devices Workshop

June 13 ñ 14, 2001

University System of Maryland - Shady Grove Center 

AGENDA

Wednesday Afternoon, June 13

12:00 PM- 1:00 PM Registration and Lunch

Biomedical Standards Resource Presentations

1:00 Welcome

Karen Brown Acting Director, NIST

1:15 NIST's Role in Biomedical Science and Technology - An Overview 

Leslie Smith Director, Materials Science and Engineering Laboratory, NIST

1:30 Objectives of the Workshop 

Dale Hall Deputy Director, Materials Science and Engineering Laboratory, NIST

1:40 Overview of Biomedical Material & Device Standards Issues

Jack Lemons Professor and Director of Laboratory Surgical Research, School of Medicine 

Division of Orthopedic Surgery, University of Alabama Birmingham

2:15 Emerging Biomedical Issues

John Watson Director, Molecular Biology Program and Clinical and Molecular Medicine Program,

National Heart, Lung, and Blood Institute, NIH

2:35 Standards and the FDA Needs for Device Submissions

Don Marlowee Director, Office of Science and Technology, FDA

2:55 An Industrial Perspective

Bernie Liebler Director of Technology and Regulatory Affairs, AdvaMed (Speaker)

Jim Benson Executive Vice President of Technology and Regulatory Affairs, AdvaMed

3:15 Break

Crosscutting Issues (Data/Sterilization/Harmonization)

3:35 Data

Henry Heffernan Staff, Clinical Center , NIH

3:45 Sterilization

Michael Scholla Global Business Director, Tyvek Medical Packaging

3:55 Harmonization

Richard Kayser Director, Technology Services, NIST

4:05 Biomedical Materials and Clinical Testing

Alan Andersen President, National Committee for Clinical Laboratory Standards

4:25 Instructions for Thursdayís Sessions

John Tesk Coordinator, Biomaterial Standards and Reference Materials, Polymers Division, 

Materials Science and Engineering Laboratory, NIST

4:40 Adjourn

6:00 Cash Bar, Reception, and Dinner at Quality Suites Hotel
56

Thursday, June 14

8:00 AM Coffee & Pastries

8:30 Instructions for Breakout Sessions

8:40 Disperse to Breakout Session Rooms

Breakout Sessions

8:50 AMñ 12:00 PM Focus Area Breakout Sessions: Chairs & Co-Chairs,

 Biomaterials: James Burns, Genzyme, Inc. & Rebecca Bergman, Medtronic, Inc.

 NIST Facilitators: Francis Wang, Bruno Fanconi - Scribe, Chad Snyder

 Therapeutic and Drug Delivery Systems: Arthur Courey, Genzyme, Inc. & Gary Strathearn, Radiance

Medical Systems, Inc.

 NIST Facilitators: Christopher Soares, Bert Coursey - Scribe, Brian Zimmerman

 Auditory Diagnostic and Prosthetic Devices: William Cole, Etymonic Design, Inc. & Ronald Scicluna Argosy

Electronics, Inc.

 NIST Facilitators: Victor Nedzelnitsky, Jonathan Fiscus - Scribe, Victor Nedzelnitsky

 Manufacturing and Processing of Prostheses: Dane Miller, Biomet, Inc. & Jan Ann Champion,

Medtronic Heart Valve, Inc.

 NIST Facilitators: Howard Harary, Matthew Davies - Scribe, Ron Dixson

 Tissue Engineered Medical Devices: Peter Johnson, Tissue Informatics, Inc. & Nancy Parenteau,

Organogenesis, Inc.

 NIST Facilitators: Eric Amis, Lori Goldner - Scribe, Newell Washburn 

10:20 AMñ12:00 PM Breakaway Sessions 

 Data - Henry Heffernan, National Institutes of Health

 NIST Facilitator: Michael Hogan - Scribe, Arnold Johnson

 Harmonization - Sharon Stanford, American Dental Association

 NIST Facilitator: Mary Saunders - Scribe, Belinda Collins

Breaks Taken as Needed (Coffee etc., available from 10:00 AM to 11:00 AM)

12:00 PM Lunch

1:00 Full Assembly

Breakout Session Reports with 5 minute Discussions

Peter Johnson, Tissue Informatics, Inc., Chair

Joshua Jacobs, Rush Presbyterian St. Luke's Hospital, Co-Chair

Dale Hall, NIST, Convenor

1:00  Biomaterials

1:20  Tissue Engineered Medical Devices

1:40  Therapeutic and Drug Delivery Devices

2:00  Manufacturing and Processing of Devices

2:20  Auditory Diagnostic and Prosthetic Devices

Cross Cutting Breakaway Session Reports

2:40  Data

2:55  Harmonization

Discussions & Refinements of Issues and Priorities

3:10 NIST Facilitators: Stephen Freiman & Bruno Fanconi

3:40  Action Items: Dale Hall, NIST

4:00  Summary: Leslie Smith, NIST

4:10  Adjourn
57

Speaker Biographical Sketches

Workshop on Standards for Biomedical Materials and Devices

Rockville, MD

June 13-14, 2001

Karen H. Brown is the acting director and deputy director of NIST. Brown came to NIST as deputy director in

January 1999. Previously she was a Distinguished Engineer at IBM Microelectronics in Hopewell Junction, N.Y.

Her 22-year career at IBM concentrated on solving problems in semiconductor lithography and microelectronics.

Brown also served (on assignment from IBM) as director of lithography for SEMATECH from 1994-1998. She has

a proven track record in management, having successfully met the challenges of moving ideas from the laboratory

into manufacturing. A native of Schenectady, N.Y., Brown holds a B.A. in chemistry and in history, and a Ph.D. in

chemistry from the University of Rochester.

Leslie E. Smith is director of the Materials Science and Engineering Laboratory at NIST. Dr. Smith joined NIST in

1969 and worked extensively on interfacial phenomena of polymers. In particular, he has investigated the

measurement of the conformation of adsorbed polymers and the relationship of adsorbed polymers to

biocompatibility of synthetic implants. Dr. Smith is currently responsible for a comprehensive program of

fundamental research of measurement methods, standards, and scientific concepts to support the U.S. industrial

production and use of materials. Dr. Smith received his B.S. in chemistry at the Case Institute of Technology, and

his Ph.D. in chemistry at the Catholic University of America.

Dale E. Hall is the deputy director of the Materials Science and Engineering Laboratory at NIST. During his years

at NIST he has had several responsibilities, including chief of the Office of Intelligent Processing of Materials.

Before joining NIST, he worked in industry for 14 years in electrochemistry and advanced materials development,

including seven years at the International Nickel Company as principal scientist. He received his BS, cum laude, in

chemistry, and his Ph.D. in physical chemistry from Rensselaer Polytechnic Institute. He is a former president of

The Electrochemical Society.

Jack Lemons holds degrees of Associate in Engineering, Bachelors and Masters in Metallurgical Engineering, and a

Doctorate in Materials Science from the University of Florida. After employment as a Director of Physical

Metallurgy at Southern Research Institute he was an Assistant Professor of Interdisciplinary Studies at Clemson

University. This was followed by a NIH sponsored fellowship in Medicine and Dentistry in 1970-73 at the

University of Alabama at Birmingham with academic promotion to full professor in 1976. Dr. Lemons served as

Chair of the Department of Biomaterials from 1978-1990 with transition to Professor and Director of Laboratory

Surgical Research for the Departments of Prosthodontics and Biomaterials in Dentistry and the Division of

Orthopaedic Surgery in Medicine since 1990. Publications and presentations exceed 600 including four books, and

he has served as chair for more than 140 studentsí graduate committees. Research focus has been on biomaterial

and biomechanical properties as they relate to the biocompatibility of implant devices. He has provided leadership in

numerous standards related capacities with organizations that include the ASTM, the American Dental Association,

the American Association of Orthopaedic Surgeons, and the Society for Biomaterials

John T. Watson is the Director Clinical and Molecular Medicine, Division of Heart and Vascular Diseases,

National Heart, Lung, and Blood Institute, National Institutes of Health. Dr. Watson came to NIH in 1976 from the

University of Texas Health Science Center where he was Chairman of the Graduate Study Program in Biomedical

Engineering and Assistant Professor of Surgery and Physiology. He has bachelor's (Univ. Of Cincinnati) and

master's (Southern Methodist Univ.) degrees in mechanical engineering and earned a doctorate in physiology from

the University of Texas at the Southwestern Medical School. Dr. Watson experience includes 10 years in industry,

10 years in academia, and 24 years in the public sector. His research interests include medical implant design and

science, biomaterials, imaging and heart failure. He is a Founding Fellow of the American Institute of Medical and

Biological Engineering and a member of the National Academy of Engineering.

Donald E. Marlowe is the Director, Office of Science and Technology, Center for Devices and Radiological Health

(CDRH), Food and Drug Administration (FDA). He directs the CDRH laboratory programs in areas of electronics,

computer science, materials science, mechanical engineering, toxicology, bioeffects, and physics. He is currently

Chairman of the Board for the American Society for Testing and Materials (ASTM). Mr. Marlowee received an
58

A.B. in Physics (1964), a B.M.E. (1964) and a M.S.E. in Solid Mechanics from Catholic University (1966). He

holds several technical committee assignments and professional society memberships, including the American

Society of Mechanical Engineers, the Association for the Advancement of Medical Instrumentation, and the

American Society for Testing and Materials.

Bernie Liebler is Director, Technology & Regulatory Affairs at AdvaMed. As a member of the Technology and

Regulatory Affairs Department, he is responsible for the technical aspects of standards, testing, and certification issues

relating to medical devices. He is the Technical Advisor for the U.S. Advisory Groups for IEC TC 62 and SC 62A,

international standards committees preparing horizontal standards for the safety of electrical medical devices. He also

addresses quality assurance, biomaterials, software, and other regulatory issues. He received a B.S. in Physics from the

City College of New York and an M.A. in Nuclear Physics from the State University of New York at Stony Brook.

James S. Benson is the Executive Vice President, Technology and Regulatory Affairs at the Advanced Medical

Technology Association (AdvaMed). He is the lead strategist for the Associationís regulatory agenda, which

included the passage of the Biomaterials Access Assurance Act of 1998 and the FDA Modernization Act of 1997.

Prior to joining AdvaMed, Mr. Benson held various positions at the Food and Drug Administration, including

Acting FDA Commissioner (1990), FDA Deputy Commissioner (1988-1991) and Director for the Center for

Devices and Radiological Health (1991-1992). Mr. Benson serves on the National Academy of Sciences Roundtable

on Bioengineering and on the National Cancer Institute's Technology Evaluation Committee. He is a fellow of the

American Institute of Medical and Biological Engineering (AIMBE). He is on the board of advisors to the Food and

Drug Law Institute (FDLI). Past appointments include Board of Trustees of the American Society for Artificial and

Internal Organs and the Institute of Medicine's Roundtable on Research and Development of Drugs, Biologics, and

Medical Devices. Mr. Benson received a B.S. degree in Civil Engineering from the University of Maryland and an

M.S. degree in Nuclear Engineering from the Georgia Institute of Technology.

Henry G. Heffernan, currently on the staff of the NIH Clinical Center, has nearly 30 years of experience in the

development of information technology standards, and in the development of medical information systems. With an

academic background in economics, he participated in early efforts to refine CLIA requirements before the

legislation, and in defining requirements for the reliability and safety of the software systems. Improving biomedical

computing infrastructure capabilities is a current

focus of interest and effort.

Michael H. Scholla is Global Business Manager within DuPont Nonwovens with responsibility for the TYVEK(R)

Medical. His diverse research background includes activation of cryptic genes, biological nitrogen fixation,

antimicrobial polymer additives, and laser induced antimicrobial activity in polymers. His research has focused on

issues affecting sterile package integrity and the microbial barrier properties of porous medical packaging materials.

He holds key positions on several industry committees including Co-chair of the US technical advisory group for

ISO TC198/WG7 on medical packaging; Chair of the Sterilization Task Force and Chair of the Standards Task

Force for the Advanced Medical Technology Association; the Association for the Advancement of Medical

Instrumentation International Standards Committee and Co-chair of the Packaging Committee. Dr. Scholla was

awarded BS and MS degrees in Microbiology from the University of Central Florida and his Ph.D. from North

Carolina State University.

Richard F. Kayser is the Director of Technology Services at the National Institute of Standards and Technology.

Dr. Kayser joined the National Bureau of Standards in May 1976 as a National Science Foundation Postdoctoral

Fellow and joined the Thermophysics Division as a permanent staff member one year later. He became chief of the

Thermophysics Division in May 1989 and chief of the Physical and Chemical Properties Division in 1996. Dr.

Kayser received a Sc.B. in chemistry from Brown University in 1973 and a Ph.D. in chemistry from Rice University

in 1976.

F. Alan Andersen is Director and Scientific Coordinator, Cosmetic Ingredient Review (CIR), an independent group

tasked with assessing the safety of individual chemicals used in cosmetics. Prior to joining CIR in 1993,

Dr. Andersen was Acting Director, Office of Device Evaluation, and Director, Office of Science and Technology,

Center for Devices and Radiological Health. Currently, he is President of the NCCLS, a organization of volunteers

from industry, the professions, and government that develops standards for clinical testing. Dr. Andersen received

his B.S. from Muhlenberg College and his M.S. and Ph.D. from Penn State.
59

Workshop on Standards for Biomedical Materials and Devices

Planning Committee Members

Eric Amis, Materials Science and Engineering Laboratory, NIST

Mrunal Chapekar, Advanced Technology Program, NIST*

Jennifer Colbert, Technology Services, NIST

Belinda Collins, Technology Services, NIST

Bert Coursey, Physics Laboratory, NIST*

Matthew Davies, Manufacturing Engineering Laboratory, NIST*

Marc Derosiers, Physics Laboratory, NIST

Ronald Dixson, Manufacturing Engineering Laboratory, NIST*

Stephen Freiman, Materials Science and Engineering Laboratory, NIST* ++

Gradimir Georgevich, Advanced Technology Program, NIST

Dale Hall, Materials Science and Engineering Laboratory, NIST#

Michael Hogan, Information Technology Laboratory, NIST*

Sherena Johnson, Technology Services, NIST

Lisa Karam, Physics Laboratory & Industrial Liaison Office, NIST*

William Koch, Chemical Science and Technology Laboratory, NIST

Jeanniece May, Technology Services, NIST

Victor Nedzelnitsky, Manufacturing Engineering Laboratory, NIST*

Joanne Overman, Technology Services, NIST

Ronald Powell, Electronics and Electrical Engineering Laboratory, NIST

William Regnault, Office of Science and Technology, FDA

Mary Saunders, Technology Services, NIST

John Tesk, Materials Science and Engineering Laboratory & Industrial Liaison Office, NIST* +

Gregory Vasquez, Chemical Sciences and Technology Laboratory, NIST*

Angela Hight Walker, Physics Laboratory, NIST

Michael Welch, Chemical Science and Technology Laboratory, NIST

# Workshop Convenor * Focus Area Champion + Chair, Planning Committee ++ Co-Chair, Planning Committee
60

NIST Acknowledges the Contributions Provided by Special Consultants to the

Planning Committee

Jim Benson

Executive Vice President, Technology and Regulatory Affairs,

Advanced Medical Technology Association

1200 G Street, NW, Suite 400

Washington, D.C. 20005-3814,

Tel: (202) 783-8700

Fax: (202) 783-8750

jbenson.@himanet.com

Robert Britain

Vice President, Medical Standards

National Electrical Manufacturers Association

1300 North 17th St., Suite 1847

Rosslyn, VA, 22209

Tel: (703) 831-3259

Bob_britain@nema.org

Frederick Eichmiller

Director, Paffenbarger Research Center

Polymers Division

National Institute of Standards and Technology

100 Bureau Drive, Mail Stop 8546

Gaithersburg, MD 20899

Tel: (301) 975-6813

frederick.eichmiller@nist.gov

Bernie Liebler

Director, Technology Regulatory Affairs

Advanced Medical Technology Association

1200 G Street, NW, Suite 400

Washington, DC 20005

Tel: (202) 434-7230

Fax: (202) 783-8750

blieber@himamnet.com

Don Marlowe

Director, Office of Science and Technology &

Chairman, Board of Directors of ASTM

Food and Drug Administration

FDA/CDRRIOST (HFZ-150)

9200 Corporate Blvd.

Rockville MD 20850

Tel: (301) 827-4777

dem@cdrh.fda.gov
61

Kevin W. OíConnor

Executive Director

The American Institute for Medical and Biological Engineering

1901 Pennsylvania Avenue NW, Suite 401

Washington, D.C. 20006

Tel: (202) 496-9660

Fax: (202) 466-8489

kwoaimbedc@aol.com

William Regnault

Director, Division of Mechanics and Materials Science

Office of Science and Technology

Food and Drug Administration

9200 Corporate Blvd.

Rockville MD 20850

Tel: (301) 827-4748

wfr@cdrh.fda.gov

Sharon S. Stanford

Standards Coordinator &

Chairperson, Medical Devices Standards Board of ANSI

American Dental Association

610 E. Chicago Ave

Chicago IL 60606

Tel: (312) 440-2509

stanfors@ada.org

John T. Watson

Director, Molecular Biology Program &

Clinical and Molecular Medicine Program

National Heart, Lung, and Blood Institute

National Institutes of Health

Rockledge 2, Room 9178

Bethesda, MD 20892

Tel: (301) 435-0513

Fax: (301) 480-1336

e-mail: jw53f@nih.gov

Theresa Zuraski

Vice President, Standards

Association for the Advancement of Medical Instrumentation

1110 N Glebe Road, Suite 220

Arlington, VA 2220 1-4795

Tel: (703) 525-4890, Xtn. 209

Tzuraski@AAM1.org
62

The Planning Committee Wishes To Express Its Gratitude For The Special

Assistance Provided by The Following NIST Employees:

Karen Barklcy

Materials Science and Engineering Laboratory

Denise Cockerham

Technology Services

Laura Hanlon

Materials Science and Engineering Laboratory

Denise Herbert

Program Office

Joan Hill

Materials Science and Engineering Laboratory

Patrick Looney

Chemical Sciences and Technology Laboratory/Program Office

Michael Kaufman

Material Science and Engineering Laboratory

Robyn Smith

Manufacturing Engineering Laboratory