Office of Health and Industry Programs

Center for Devices and

Radiological Health

Food and Drug Administration

FY2000 Annual Report
OHIP FY2000 Annual Report, page i

FROM THE DIRECTOR

Every day, the Office of Health and Industry Programs (OHIP)

provides services that directly affect the lives of millions of

Americans. As one of the Offices within the Center for Devices and

Radiological Health (CDRH), U.S. Food and Drug Administration

(FDA), we specialize in program-based communication, education,

radiological health, mammography quality, and reduction of use error.

When thinking of OHIP’s role in CDRH, Outreach and Education

always come to mind. Outreach and education are in all aspects of

our work – whether we are producing teleconferences, training CDRH

staff, working with patients and consumers, conducting radiation

safety surveys, answering device industry questions, or writing

regulations. As we carry out our programs, we emphasize

collaboration both within and outside CDRH. Coalition building,

public participation, and information exchange allow us to obtain

appropriate input from all relevant and concerned sources and to

leverage and multiply our resources to protect the public health.

Because of the breadth of our role within CDRH, OHIP serves a wide

variety of customers, including:

• domestic and foreign manufacturers of medical devices and

radiation-emitting electronic products;

• other domestic and foreign government agencies engaged in

public health and the regulation of medical devices;

• healthcare professionals and healthcare facilities, as well as

the organizations that represent them;

• consumers and patients, including all women in the United

States who receive mammograms; and

• CDRH staff who benefit from training and professional

development activities.

We believe that each of our customers will find programs of interest

in our FY2000 Annual Report. We also believe that these programs

and our accomplishments reflect changes and improvements that have
OHIP FY2000 Annual Report, page ii

been implemented as a result of OHIP strategic planning. In 1997,

OHIP began implementation of an ambitious five-year strategic

plan. As a first step, we received specific feedback from our

customers in all of our program areas. While our customers were

generally satisfied with our services, we also received many

suggestions and comments for changes and improvements. After

listening to our customers, OHIP developed four specific goals:

• to use collaboration and cooperation whenever appropriate

to improve the quality and effectiveness of CDRH programs,

to enhance the satisfaction of our customers, and to use

CDRH resources most effectively;

• to consistently produce high quality and timely products and

services;

• to identify, develop, implement and evaluate innovative and

cost-effective approaches to accomplish vital new OHIP,

CDRH and FDA initiatives; and

• to maximize OHIP’s use and development of human and

fiscal resources.

OHIP is now in the fourth year of our strategic planning process. As

reflected in our Annual Report, OHIP’s four goals are now tightly

integrated into our programs and daily operations. During the coming

year, we will continue to update and refine our strategic plan. We will

also be concentrating our efforts on participation in the CDRH

strategic plan. As the plan is implemented, it will provide broad

principles and goals that CDRH will commit itself to over the next

several years.

During the past year, CDRH re-affirmed its

mission: to promote and protect the health of the

public by ensuring the safety and effectiveness of

medical devices and the safety of radiological

products. Next, CDRH developed a vision:

“Ensuring the health of the public throughout

the Total Product Life Cycle.”
OHIP FY2000 Annual Report, page iii

Finally, CDRH has proposed four strategic goals to fulfill the vision:

• to apply the total product life cycle model across all CDRH

activities;

• to serve as a magnet for excellence in attracting and

retaining a diverse workforce who want to help us fulfill our

public health mission;

• to manage knowledge in support of the total product life

cycle model; and

• to develop meaningful metrics to assess our continuing

impact on public health and our communication with

stakeholders.

OHIP is working with all of CDRH in the first stages of implementing

these strategic goals. We are co-leading the magnet for excellence

goal group and we lead outreach efforts inherent in all four goal

groups. Together with you, our stakeholders, we are preparing a

roadmap for the future of OHIP and for CDRH. For more detailed

information on the CDRH strategic plan, visit the CDRH website at

http://www.fda.gov/cdrh/ocd/strategic.html.

We welcome your review of OHIP’s FY2000 Annual Report and your

comments on our programs and future directions.

Sincerely,

Lireka P. Joseph, Dr. P.H.

Director, Office of Health

 and Industry Programs, CDRH
OHIP FY2000 Annual Report, page iv

TABLE OF CONTENTS

From the Director...................................................i

User Education......................................................1

Consumer Webpage....................................................................................... 1

Consumer Inquiries........................................................................................ 2

Breast Implant Information............................................................................ 2

TMJ Implants .................................................................................................. 3

Internet Sales.................................................................................................. 3

New Device Approvals................................................................................... 3

Reuse .............................................................................................................. 4

Hospital Bed Rails.......................................................................................... 6

Contacts Database ......................................................................................... 7

User Facility Reporting Bulletin.................................................................... 8

Year 2000 and FDA......................................................................................... 8

Manufacturer Support.........................................10

Small Business Activities............................................................................ 11

Assisting Manufacturers.............................................................................. 12

Device Advice Webpage ............................................................................ 14

Workshops/Presentations .......................................................................... 15

Developing Guidance for Manufacturers.................................................... 16

Accredited Persons Program...................................................................... 17

International Activities.......................................18

Foreign Manufacturers of Medical Devices................................................ 18

Regulatory Training and Assistance........................................................... 19

International Conferences .......................................................................... 19

Global Harmonization .................................................................................. 20

U.S./European Mutual Recognition Agreement......................................... 21

Radiological Health Programs............................22

Mammography Quality................................................................................. 22

MQSA Webpage ........................................................................................ 23

Assuring Quality Mammography ................................................................ 24

Improving the MQSA Program ................................................................... 25

NMQAAC ................................................................................................... 27
OHIP FY2000 Annual Report, page v

NEXT..............................................................................................................27

Annual Surveys ..........................................................................................28

NEXT Survey Results.................................................................................29

TEPRSSC.......................................................................................................31

Federal Facilities Inspections......................................................................32

Radiation Safety............................................................................................33

Reducing Use Error ............................................ 36

Human Factors .............................................................................................37

Labeling.........................................................................................................40

Patient Safety................................................................................................43

Regulations and Guidance................................. 44

Regulations ...................................................................................................44

Good Guidance Practices............................................................................46

Plain Language .............................................................................................47

FDAMA...........................................................................................................48

CDRH Staff College ............................................ 49

Training Highlights.......................................................................................49

360° Training Program .................................................................................52

Needs Assessment.......................................................................................52

Benchmarking...............................................................................................53

Teleconference/Video Production ..................... 54

Appendix............................................................. 57

Publications and Presentations ..................................................................57

OHIP Staffing and Organization ..................................................................61

Office of the Director...................................................................................61

Regulations Staff ........................................................................................61

Staff College...............................................................................................61

Division of Communication Media ..............................................................62

Division of Mammography Quality and Radiation Programs ......................62

Division of Device User Programs and Systems Analysis ..........................63

Division of Small Manufacturers Assistance...............................................63

OHIP Organization Chart..............................................................................64
OHIP FY2000 Annual Report, page vi

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OHIP FY2000 Annual Report, page 1

USER EDUCATION

CDRH regulates medical devices and radiation-emitting electronic

products that touch upon every phase of our lives. Medical devices

are an integral part of our healthcare system. Radiation-emitting

electronic products include cell phones, microwave ovens, television

sets, video display terminals and many other products that are

routinely encountered in every day life.

The users of medical devices and radiation-emitting electronic

products include patients and consumers, as well as caregivers and

healthcare professionals. As consumers, patients and device-users,

we all need accurate and up-to-date information. Providing this

information is an important part of CDRH’s public health mission.

Within CDRH, OHIP plays a key role in user education. We respond

to inquiries from individual consumers and patients, provide extensive

information on our website, and collaborate extensively with other

CDRH Offices and outside groups to prepare information on

important medical device and healthcare issues.

Consumer Webpage

Our “Consumer Page” on the CDRH website is one of our most

important tools for communicating with consumers and patients. It 4 was created in June 1999 to complement the FDA Consumer Page

http://

www.fda.gov/

cdrh/consumer/

index.shtml

Goals

1. To prepare and disseminate accurate information for consumers, patients and

others who use medical devices and radiation-emitting electronic products.

2. To respond to consumer and patient inquiries and concerns in a timely and

caring manner.
OHIP FY2000 Annual Report, page 2

(http://www.fda.gov/opacom/morecons.html). By visiting the CDRH

consumer page, you will find:

• information on the products that CDRH regulates;

• explanation of the process for obtaining FDA clearance to

market a medical device;

• information on newly approved medical devices;

• other consumer literature as well as links to other health

related government websites; and

• an easy way to automatically e-mail your questions to OHIP.

Consumer Inquiries

During FY2000, our consumer specialists responded to

approximately:

• 4,500 telephone inquiries;

• 2,000 e-mails;

• 700 letters and faxes; and

• 2,700 requests for information packages on various medical

device issues.

Breast Implant Information

We collaborated with other CDRH Offices in

preparing and distributing a brochure entitled,

“Breast Implant Risks - November 2000.”

The brochure alerts the prospective breast

implant recipient of the known consequences of

breast implant surgery. It describes fifteen

known consequences and presents pictures of

three frequent adverse outcomes. Both the

brochure on Risks as well as the FDA handbook

entitled, “Breast Implants - An Information

Update 2000” can be downloaded from the

consumer page on the CDRH website.
OHIP FY2000 Annual Report, page 3

TMJ Implants

We prepared a webpage to provide consumers with the

latest information on approved TMJ implants and those

under review. This information is important to patients

suffering extreme TMJ symptoms and to their healthcare

providers. By visiting the webpage, you will be able to

download a copy of the consumer handbook entitled “A

Consumer Information Update – November 1999.”

Internet Sales

A growing number of medical devices are available for

sale on the Internet. We prepared two articles that will

provide consumers with information about the benefits

and risks they face when purchasing medical devices

online. These articles will be available on FDA’s

webpage “Buying Medicines and Medical Products

Online.”

New Device Approvals

In October of 2000, we collaborated with other CDRH

Offices to launch a webpage for New Device Approvals.

This page includes brief, plain language information on

the most recently approved medical devices. Primarily

intended for consumers, the page links to other sources of

consumer information, Premarket Approval (PMA)

databases, and the labeling for these devices.

4

http://

www.fda.gov/

cdrh/consumer/

tmjupdate.html

4

http://

www.fda.gov/

cdrh/mda

4

http://

www.fda.gov/

oc/buyonline
OHIP FY2000 Annual Report, page 4

Reuse

Insufficient data exist

regarding the safety of

reprocessing single-use

devices (SUDs). Therefore, on

August 14, 2000, FDA

announced that it will regulate

hospitals and third parties

engaged in reprocessing SUDS in the same way that the

agency regulates device manufacturers. This policy impacts

hospitals, healthcare professionals, and the public. OHIP is

working closely with the CDRH Reuse Steering Committee

to provide up-to-date information on reuse to our stakeholders.

Our accomplishments included:

• Working with the CDRH’s Office of Systems and

Management, we created a Reuse Homepage. It includes

CDRH documents on reuse, a listing of standards relevant to

reprocessing, frequently asked questions, a calendar of

upcoming meetings at which FDA will speak on reuse,

copies of previous presentations, and e-mail capability to ask

questions or to register to receive updates on reuse. This

webpage received more than 50,000 hits in August of 2000,

making it the most popular site in FDA.

• A CDRH interactive satellite teleconference entitled,

“Proposed FDA Strategy for Reuse of Single-Use Medical

Devices” was broadcast on November 10, 1999. Industry

experts, healthcare professionals, and consumers joined in

the interactive discussion on CDRH’s proposed strategy on

SUDs. The teleconference, produced in our studio, provided

a forum for stakeholders and other interested parties to

comment and offer alternative approaches to the proposed

regulatory strategy. A second teleconference was held

December 13, 2000.

4

http://

www.fda.gov/

cdrh/reuse/

index.shtml
OHIP FY2000 Annual Report, page 5

• We provided videotaping, artwork, registration, and

administrative support for an open public meeting on reuse

held on December 14, 1999.

• Working with other CDRH staff, a one-day workshop on

the reuse of SUDs was developed and presented at the

annual meeting of the Association for the Advancement of

Medical Instrumentation in June 2000.

• A reuse packet was mailed to over 6,100 hospitals to

inform them about their new responsibilities if they

reprocess SUDs. The packet included a cover letter from the

Center Director and a copy of the August 14, 2000 guidance

document, “Guidance for Industry and for FDA Staff:

Enforcement Priorities for Single-Use Devices

Reprocessed by Third Parties and Hospitals.”

• A trifold reuse brochure was prepared in a Question and

Answer format. The Joint Commission on Accreditation of

Healthcare Organizations (JCAHO) is distributing the

brochure. It will also be used at FDA exhibits nationally

and will be mailed out in answer to requests for information

about the reuse of SUDs. Copies of the brochure are also

available on the Reuse Homepage.

• To inform consumers about the new CDRH policy on reuse

of SUDs, we developed an informational letter that was

sent to 35 consumer organizations. They, in turn, were

asked to inform their membership about the new policy. We

also worked with the FDA Consumer magazine in

publishing “Reusing Medical Devices: Ensuring Safety

the Second Time Around” (September/October 2000).

4

http://

www.fda.gov/

cdrh/reuse/

trifold1.html

4

http://

www.fda.gov/

fdac/features/

2000/

500_reuse.html
OHIP FY2000 Annual Report, page 6

Hospital Bed Rails

FDA issued a Safety

Alert entitled

“Entrapment Hazard

with Hospital Bed

Side Rails” in 1995. Since then, FDA has continued

to receive reports of deaths and injuries caused by

patient entrapment between the rails of the bed and in

the gap between the mattress and side rails. To

address this complex problem, we worked with

CDRH’s Office of Surveillance and Biometrics to

create a forum for the exchange of information related

to patient entrapment associated with hospital beds.

The result was the formation of the Hospital Bed

Safety Workgroup. The Workgroup includes

representatives from the medical bed industry, national healthcare

organizations, patient advocacy groups and other federal agencies. As

the issues unfolded, possible labeling and compliance issues were

identified, so CDRH’s Office of Device Evaluation, Office of

Compliance, and Office of Science and Technology have participated

as well.

During FY2000, the Workgroup collaboratively

developed a brochure entitled, “A Guide to

Bed Safety.” The brochure discusses bed rail

patient safety, considers some of the potential

benefits and risks of using hospital bed rails,

and gives suggestions on how to meet patients’

needs without the use of bed rails. The

Workgroup is widely distributing the brochure

in hardcopy as well as through the member’s

websites.

4

http://

www.fda.gov/

cdrh/beds/

index.html
OHIP FY2000 Annual Report, page 7

The Workgroup is concurrently addressing several issues related to

the entrapment problem and its members are committed to finding a

long-term solution. In FY2000, the Workgroup began several

projects, including:

• development of a clinical guidance describing how

clinicians should approach the use of bed rails;

• review of entrapment zones in and around the bed and

development of recommended design limits for the size of

gaps;

• development of an assessment tool to determine a bed’s

compliance with the new recommendations;

• development of a decision tree to help in determining

whether to keep or replace older beds that do not meet the

recommendations; and

• widespread distribution of information on preventing

entrapment through publication in national journals and

presentations at major medical meetings.

Contacts Database

In FY2000, we began testing a “Contacts Database” to support

CDRH’s outreach programs. The database will be a tool to identify

contact information for consumers, health professionals, industry and

others interested in medical device issues. The data will be searchable

by area of interest and/or affiliation and will provide us with a rapid

means of sending information to interested organizations and

individuals. When the database is completed, members of the public

will be able to use their Web browsers to self register and indicate or

change the types of CDRH information they would like to receive.
OHIP FY2000 Annual Report, page 8

User Facility Reporting Bulletin

In the fall of 2000, we prepared the 32nd issue of the User Facility

Reporting Bulletin. First issued in 1992, the Bulletin is published

quarterly. The Bulletin provides user facilities with:

• important information on preventing adverse events with

medical devices;

• directions for reporting adverse events to the FDA; and

• feedback on reported problems.

When first published, the Bulletin had a printed circulation of over

75,000. In order to make more efficient use of resources and

technology, the Bulletin is now available solely on our website.

Year 2000 and FDA

The Year 2000 (Y2K) computer “bug” had the potential to affect

many of the products that FDA regulates. OHIP served on a CDRHwide coordinating group responsible for all Y2K issues; played a

major role in outreach to health professional organizations, healthcare

4

http://

www.fda.gov/

cdrh/

fusenews.html
OHIP FY2000 Annual Report, page 9

facilities, consumers, and manufacturers; participated in the staffing

the CDRH Y2K Emergency Operations Team that was on duty during

the rollover into the new year; and worked with other CDRH Offices

to assure that our “internal” computer systems and databases were

Y2K compliant. Our accomplishments included:

• A Public Health Notification letter was developed and sent

to the Administrators, Risk Managers, and

Biomedical/Clinical Engineers of 67,000 hospitals and

healthcare facilities in the U.S. This was followed up with

another letter in November 1999 to further encourage

facilities to complete their contingency and remediation

planning to avoid serious adverse events.

• Information on all CDRH Y2K activities was compiled into

a single, comprehensive package. These packages were

used in discussions and planning with other government and

Congressional staff. Copies were distributed to FDA’s

nationwide Public Affairs Specialists. Also, distribution was

leveraged by working with medical professional

organizations for further publication in their journals and

newsletters, notices on their webpages, copies to regional,

state and local chapters, etc.

• We provided the majority of FDA speakers and coordinated

speaker requests for a series of HCFA-sponsored outreach

meetings entitled, “Transition 2000-Y2K Readiness

Strategies for Medicare and Medicaid Providers.” The

meetings informed healthcare providers about the Y2K issue

and methods to prepare for it. Each session featured one

speaker from FDA, from a device manufacturer, and from a

healthcare facility.

• Through extensive planning, evaluation and documentation,

we assured that the database system (MPRIS) for the

mammography quality assurance program was Y2K ready.
OHIP FY2000 Annual Report, page 10

MANUFACTURER SUPPORT

Safe and effective medical devices are crucial to our healthcare

system. FDA regulated medical devices include over 100,000

different types of products in more than 1,700 product categories.

They range from simple everyday articles such as thermometers,

tongue depressors and heating pads to more complex devices such as

pacemakers, defibrillators and kidney dialysis machines. Overall,

medical devices are becoming increasingly complex. Improved, lifesaving devices are using innovations such as microprocessor control,

artificial intelligence, miniaturization and remote operation.

Members of the medical device industry are just as diverse as the

products that they manufacture:

• there are approximately 15,000 manufacturers of medical

devices worldwide;

• more than 70 percent of medical device manufacturers are

small enterprises with fewer than 50 employees; and,

• more than 40 percent of device firms manufacture abroad.

This complexity and diversity present a challenge to FDA as a

regulatory and public health agency. They also present a challenge to

the medical device manufacturers who must comply with FDA

regulations. Better communication between FDA and manufacturers

opens the door for improved understanding, provides for a better

working relationship, and results in quicker access to devices by the

public.

Goals

1. To provide technical assistance in meeting FDA requirements for medical

devices and radiation-emitting electronic products.

2. To develop informational materials and to provide accessible, efficient

channels for distributing information to manufacturers.

3. To respond to manufacturer inquiries in a comprehensive and timely manner.
OHIP FY2000 Annual Report, page 11

Small Business Activities

FDA has instituted a number of activities aimed

specifically at increasing communication with the small

business community. In addition to Small Business

Assistance Programs that reside in each of the six FDA

field offices, each Center in FDA has a special small

business unit.

Within CDRH, OHIP serves as a focus for small business

concerns. We strive to:

• identify ways in which FDA

requirements can protect and promote

the public health without being unfair

or unduly burdensome to small

business;

• encourage greater participation by

small firms in the regulatory process

itself, especially at the early stage when

comments are sought on proposals that

impact on the device industry; and

• educate CDRH staff on the needs of

medical device manufacturers and

potential problems they face in meeting FDA’s regulatory

requirements.

The specific types of assistance that we provide to small businesses

are similar to those that we provide to other domestic and foreign

manufacturers of medical devices. These are discussed in more detail

below.

General

Information

Package

We provide 2,000

General Information

Packages each year to

new companies entering

the device industry. To

obtain a copy of this

package, fax your request

to 301-443-8818.

4

http://

www.fda.gov/

ora/fed_state/

small_business/

sb_guide/

intro.html
OHIP FY2000 Annual Report, page 12

Assisting Manufacturers

The most fundamental assistance that OHIP provides to manufacturers

involves our response to individual inquiries, questions and concerns.

We do this through several mechanisms, including:

• Automated Call Center: The system used for our call

center was updated in FY1999 and work on the system

continued in FY2000. As a result of these upgrades, we

were able to implement additional customer service features

including call queuing. This advises the caller of their place

in the queue and the average wait time. While in queue the

caller hears messages about issues of interest to CDRH

stakeholders. The caller can stay on the line or select

another option, such as leaving a voice mail

or making another choice from the main

menu. This system is available year round

(see inset) and offers manufacturers the

opportunity to speak directly to a device

specialist who can answer their questions

and direct them to the needed information.

We typically receive an average of 40,000

telephone inquiries per year.

• E-mail: All of our webpages for

manufacturers include access to our e-mail

account – dsma@cdrh.fda.gov. We respond

to an average of 9,000 e-mail inquiries per

year. Although declining in numbers we

still receive an average of 2,500 written/fax inquiries per

year.

• 510(k) Status Program: We assist manufacturers in

determining the status of their pending premarket

notification applications (510(k)). Requests for this service

have decreased dramatically as CDRH eliminated the

backlog of 510(k) applications. However, we still receive

approximately 550 requests each year. The link on the left

provides instructions on using this program.

OHIP/CDRH

Division of Small

Manufacturers

Assistance

800-638-2041

301-443-6597

Automated Assistance

available 24/7

Device Specialists

available M-F

8 a.m. to 5 p.m., EST

4

http://

www.fda.gov/

cdrh/dsma/

510_stat.html
OHIP FY2000 Annual Report, page 13

• Broadcast Fax: OHIP uses an automated fax system to

rapidly distribute important CDRH information to our

industry. We also distribute information to stakeholder

organizations such as AdvaMed, RAPS and FDLI who then

provide a multiplier effect. During FY1999 and FY2000 we

distributed information on several topics, including a letter

to the medical glove industry announcing the Glove Powder

Proposal; Y2K leap year announcements; and upcoming

workshops/conferences on Reuse of single use devices.

• Facts on Demand (FOD):

FOD is an automated

answering system that allows

you to access over 1,200

CDRH publications through

your FAX machine. Almost

all of the documents available

by FOD are more easily

available from our webpage.

However, FOD is still used by

some of our stakeholders. In

FY2000 approximately 7,000

guidance documents were

obtained through this system.

• Hardcopy: OHIP is a

warehouse to over 1,000 FDA publications. Although

approximately 75 percent are accessible electronically, our

stakeholders still request hardcopies. Over the last three

years hardcopy distribution has decreased by 50 percent. In

FY2000, approximately 40,000 publications were

distributed either by hardcopy or on diskette.

• Manufacturers Assistance Webpage: Our webpage is a

comprehensive source of information for manufacturers. It

provides easy access to the services we offer, issues of

interest to manufacturers and copies of manuals and

guidance documents.

CDRH

Facts on Demand

800-899-0381

301-827-0111

Catalog available on your fax machine

after dialing the above number and:

 Press "1" to enter the system and

obtain documents

 Press "2" to obtain instructions

for using the system

 Press "INDX" (4639 on the

keypad) to request an index for

all documents.

The index can also be found at

http://www.fda.gov/cdrh/dsma/

fod.html.

4

http://

www.fda.gov/

cdrh/dsma/

dsmamain.html
OHIP FY2000 Annual Report, page 14

Device Advice Webpage

Early on, we recognized both the advantages and the

limitations of providing extensive information for

manufacturers on our website. Often, just having

“access” to all of our information doesn’t make it easy

to find the particular document or information that you

are seeking. Further, while you might find a particular

document, you might not be aware of related

documents or information.

To address these concerns, OHIP designed and implemented Device

Advice. With Device Advice, you can determine:

• whether the product you want to market is

 a radiation-emitting electronic product,

 a medical device,

 both a radiation-emitting electronic product and a

medical device, or,

 neither a radiation-emitting electronic product nor a

medical device;

• the FDA reporting requirements and standards that may

apply for a radiation-emitting electronic product;

• the classification of the product, if it is a medical device;

• the process for obtaining appropriate clearance to market the

medical device; and

• information on any other requirements that might apply to

your product.

Device Advice is an interactive system that

will guide you through the process of obtaining

FDA clearance to market a medical device and

to meet FDA requirements for radiationemitting electronic products.

4

http://

www.fda.gov/

cdrh/

devadvice
OHIP FY2000 Annual Report, page 15

Device Advice can also be used as a resource linking to

regulatory manuals, precedence correspondence,

import/export requirements, CDRH databases and a

complete index for the Code of Federal Regulations

(Title 21 CFR).

OHIP device specialists programmed the first “version” of

Device Advice in 1998. Since then, it has consistently

been one of the ten most used CDRH webpages. In

FY1999, we modified topics to include the FDA Modernization Act.

In FY2000, we developed two new sections on the Investigational

Device Exemption (IDE) that include new information on meetings

with FDA, Financial Disclosure of Clinical Investigators, Institutional

Review Boards, Quality System requirements and Medical Device

Recalls (Corrections and Removals). We are currently expanding the

Premarket Approval (PMA) section.

Workshops/Presentations

During FY2000, OHIP partnered with other organizations

in presenting eight workshops for manufacturers. The

workshops allow us to meet with manufacturers face to

face and to exchange information on topics such as

regulatory requirements, Quality Systems, and import and

export requirements. Our partners in presenting the

workshops included:

• Association for the Advancement of Medical

Instrumentation (AAMI),

• Canon Communications,

• Regulatory Affairs Professional Society (RAPS),

• Food and Drug Law Institute (FDLI),

• Atlantic Food and Drug Officials (AFDO), and

• Western New York Technical Development Center.

4

http://

www.fda.gov/

cdrh/

devadvice/

365.html

4

http://

www.fda.gov/

cdrh/dsma/

workshop.html
OHIP FY2000 Annual Report, page 16

Developing Guidance for Manufacturers

In addition to facilitating manufacturers’ access to all CDRH guidance

documents, OHIP staff also prepare guidance documents in their areas

of expertise. These guidance documents may be prepared entirely

within OHIP or in collaboration with staff from other CDRH Offices.

Recent guidance documents include:

• Draft Guidance for Industry and FDA, Medical Glove

Guidance Manual. July 30, 1999

• Guidance for Industry and FDA: Regulation of Medical

Devices: Background Information for International

Officials. April 14, l999

• Draft Guidance for Staff, Industry and Third Parties:

Implementation of Third Party Programs Under the FDA

Modernization Act of 1997. June 12, 2000

• Guidance for Staff, Industry and Third Parties: Third Party

Programs Under the Sectoral Annex on Medical Devices to

the Agreement on Mutual Recognition Between the United

States of America and the European Community (MRA).

January 6, 1999

• Draft Guidance for Staff, Industry and U.S./EU CABs;

Implementation Plan for the MRA between the EU and the

USA: Confidence Building Program: Overview, Medical

Device Annex, Version 7. June 29, 2000

• Draft Guidance for Staff, Industry and U.S./EU CABs;

Implementation Plan for the MRA between the EU and the

USA: Confidence Building Program: Procedures, Medical

Device Annex, Version 7. June 29, 2000

OHIP plans to update the Premarket Notification 510(k) Regulatory

Requirements Manual in FY2001.
OHIP FY2000 Annual Report, page 17

Accredited Persons Program

OHIP administers the Accredited Persons Program for

CDRH. This program allows manufacturers to use

“Third Parties” to conduct initial review of premarket

notification (510(k)) submissions for low (Class I) to

moderate (Class II) risk devices. The Third Parties are

individuals or organizations who meet qualifications

and requirements established by FDA and who are then

“accredited” to do these reviews. This program has the

potential to provide manufacturers with more rapid clearance

decisions for their devices. At the same time, FDA would be able to

focus its resources on higher risk devices.

Both FDA and the medical device industry have been disappointed

that the Accredited Persons Program has not been used more.

Therefore, OHIP has worked closely with the Office of Device

Evaluation to significantly expand the scope of the third party

program in FY2000:

• the list of eligible devices was updated on June 12, 2000,

adding an additional 57 devices;

• in a June 12, 2000 draft guidance document we proposed a

pilot program that would make an additional 460 Class II

devices eligible for third party review;

• we worked with FDA’s Office of Regulatory Affairs to

develop an audit program for the Accredited Persons;

• we prepared a Report to Congress on the “Inclusion of

Certain Devices Within the Accredited Persons Program -

Third Party Review of Clinical Data; and

• we are currently reviewing public comments to the draft

guidance document and expect to issue final guidance early

in 2001 that will significantly expand the number of devices

eligible for the program.

Taken together, updating the list of eligible devices and

implementation of the expansion pilot program will represent more

than a 300 percent increase in the number of eligible devices.

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OHIP FY2000 Annual Report, page 18

INTERNATIONAL ACTIVITIES

The concept of a “global marketplace” is especially true in the case

of medical devices. Forty percent of approved device firms have

manufacturing facilities abroad. There are approximately 6,000

foreign establishments that export devices to the United States.

Device development studies are conducted worldwide. Postmarketing vigilance for medical device problems is a worldwide

network. The inspection methods used by national regulatory

agencies are converging.

Foreign Manufacturers of Medical Devices

During FY2000, OHIP

continued to provide

manufacturer support to

foreign firms bringing medical

devices into the United States.

In addition, there were

significant developments in

activities associated with the

Global Harmonization Task

Force and the U.S./European Mutual Recognition Agreement. Our

International Programs webpage was designed to consolidate

information on CDRH’s international activities in a single location.

Goals

1. To assure the safety and effectiveness of imported medical devices by

assisting foreign manufacturers to comply with U.S. medical device

regulations.

2. To direct U.S. firms to sources of information on foreign requirements for

medical devices.

3. To support global harmonization activities.

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OHIP FY2000 Annual Report, page 19

OHIP uses the same mechanisms to support foreign manufacturers as

those used for domestic manufacturers. During FY2000, our

assistance to foreign manufacturers included:

• answering more than 1,300 telephone inquiries;

• responding to more than 1,100 e-mails and 600 letters and

faxes; and

• mailing more than 470 information packages on various

medical device issues.

Regulatory Training and Assistance

OHIP coordinates the education of foreign governments on the U.S.

medical device regulatory process. This may involve seminars and

presentations or arrangements for more in-depth learning experiences

while at CDRH. Both OHIP and other CDRH staff participate in

these activities. During FY2000, they included:

• Brazil – presented a medical device overview;

• People’s Republic of China – ten day training program;

• Estonia – presented medical device overview;

• Ghana – presented a medical device overview;

• Japan – six-month foreign visitor training program; and

• Embassy Seminar – presented medical device regulations to

several embassy delegations.

International Conferences

As with OHIP’s educational efforts for the domestic device industry,

we also participate in international conferences to promote

compliance with U.S. medical device regulations. Recent

presentations included:

• India – Medical Gloves and Quality Systems;

• Taiwan – Medical Glove Symposium;

• Mexico – Quality Systems Workshop;

• Russia – Regulating Medical Devices in the U.S.;

• Ukraine – Regulating Medical Devices in the U.S.;

• Akron, OH – International Latex Conference;

• Long Beach, CA International Glove/Barrier Shippers

Association; and

• Washington, D.C; PAHO Conference (Pan American Health

Organization).
OHIP FY2000 Annual Report, page 20

Global Harmonization

The Global Harmonization Task Force (GHTF) is comprised of

government and industry representatives worldwide. GHTF members

are working to build an international consensus on medical device

regulatory policies and practices. The goal is to enhance public

health, promote technological innovation, and facilitate international

trade. The United States is one of five founding members and a major

partner.

OHIP coordinates CDRH participation in GHTF activities:

• In June 1999, the U.S. hosted the 7th annual meeting of the

GHTF. The meeting, chaired by CDRH, included more than

300 attendees from all of the member and observer

countries. OHIP temporarily reassigned six staff to assist in

all aspects of planning and implementing the meeting.

• OHIP led the construction of a freestanding, non-FDA

website to facilitate communications among GHTF

participants and to serve as a resource to parties interested in

GHTF activities.

• OHIP coordinated CDRH participation in the GHTF Annual

Conference held in Ottawa, Canada on

September 18-22, 2000.

• OHIP participated in the annual conference of the GHTF

Study Groups to discuss forthcoming plans for: operations

of the study groups; procedures for document review; and

discussion of an education campaign for the products of the

GHTF.

In FY2001 we will develop procedures to obtain stakeholder

comments and FDA concurrence on all GHTF documents.

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OHIP FY2000 Annual Report, page 21

U.S./European Mutual Recognition Agreement

The United States and the European Commission (EC) have signed a

mutual recognition agreement (MRA). The MRA covers a variety of

“product sectors” that include telecommunication equipment,

electromagnetic compatibility (EMC), pharmaceutical good

manufacturing practice (GMP), electrical safety, recreational craft,

and medical devices. With regards to medical devices, the MRA

relies on independent third parties from each exporting country to

audit medical device manufacturers and to conduct product reviews

according to the importing parties’ requirements. To that end, the

MRA may enhance FDA’s ability to ensure that the health and safety

of U.S. consumers are protected.

OHIP leads CDRH implementation of the medical device annex of the

MRA. Our accomplishments include:

• Together with the Commission for the European

Community, we prepared the First Annual Report on the

Medical Device Annex to the U.S./EC Mutual Recognition

Agreement. The report includes background on the MRA

and a chronology of accomplishments from May 18, 1998

through December 1, 1999.

• During FY2000, CDRH/OHIP participated in five

stakeholders meetings to provide an update on progress of

the MRA including confidence building activities and to

allow for discussions and clarification.

• OHIP issued two draft guidance documents for public

comment on October 3, 2000. These draft guidance

documents are based on draft documents prepared jointly by

the EC and the FDA (Version 7, June 29, 2000). They

describe confidence building activities and related

procedures to realize the intention of the MRA in general.

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OHIP FY2000 Annual Report, page 22

RADIOLOGICAL HEALTH PROGRAMS

Radiological health is an important part of CDRH’s public health

mission. We assure the safety of consumer and industrial radiationemitting electronic products. We promote the safe use of radiation in

medicine by reducing unnecessary radiation exposure and by

improving diagnostic image quality. However, CDRH resources for

radiological health are at an all-time low. Reallocation to medical

devices, personnel attrition and changes in product technology are just

some of the factors involved. Within CDRH, a Radiological Health

Council has been formed to revitalize our radiological health

programs. Since October 2000, OHIP’s Director has served as

chairperson of the Council. The Council is pursuing a variety of

initiatives to assure and enhance the cost-effectiveness and public

health benefits of CDRH’s radiological health programs.

Within OHIP, nearly one-third of our staff are involved in

radiological health programs. As described below, we are using third

parties, cooperative programs with the States, leveraging and other

innovative approaches to address important public health problems.

Mammography Quality

OHIP implements the Mammography Quality Standards Act of 1992

(MQSA). Congress enacted MQSA to ensure that all women have

access to quality mammography for the detection of breast cancer in

its earliest, most treatable stages.

Each year, approximately 180,000

women are diagnosed with breast

cancer. Approximately one

woman in nine will develop breast

cancer in her lifetime. Early

detection and prompt treatment of

breast cancer has been

demonstrated to reduce mortality

by one-third in women over fifty.

Mammography (x-ray examination

of the breast) is the best tool

available for the early detection of

breast cancer. It is essential that

all mammographic examinations

be of the highest quality.
OHIP FY2000 Annual Report, page 23

Under MQSA, every mammography facility must meet minimum

national quality standards. Mammography facilities include breast

clinics, radiology departments in hospitals, mobile vans, private

radiology practices, and other doctors’ offices. For each facility, an

FDA-approved accreditation body conducts a thorough review of the

mammography facility’s equipment, personnel (interpreting

physicians, radiologic technologists, and medical physicists), and

practices (including clinical image quality). The facilities that meet

quality standards are then issued an MQSA certificate. Certification

can be renewed as long as the facility remains properly accredited and

demonstrates continued compliance with MQSA quality standards

through annual inspections performed by FDA-credentialed Federal or

State inspectors. Only MQSA certified facilities can lawfully provide

mammography services.

MQSA Webpage

There are many facets to enforcement of the

Mammography Quality Standards Act. Detailed

information on all aspects of the MQSA program can be

found at the Mammography Program website. This

includes a list of all certified mammography facilities that

is searchable by zipcode or State.

Examples of documents currently available include:

• FDA’s Mammography Program: An Overview;

• Mammography Quality Standards Act;

• Federal Register Notices;

• Mammography Quality Standards Reauthorization Act of

1998;

• Mammography Matters newsletters;

Goals

1. Assure consistent availability of high quality mammographic examinations,

nationwide.

2. Update regulations and standards to reflect new technology.

3. Fulfill CDRH’s statutory obligations under the MQSA Final Rule in the most

cost-effective manner.

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OHIP FY2000 Annual Report, page 24

• policy guidance documents;

• listing of certified mammography facilities;

• Mammography Facility Performance Reports;

• Speaker’s kit: MQSA Final Regulations;

• MQSA Program Accomplishments; and

• consumer-specific information.

Assuring Quality Mammography

Approximately 10,000 certified mammography facilities operate in

the United States, including federal and military. To be certified to

conduct mammography, each facility must be accredited by an FDAapproved accreditation body. At the end of FY2000, the five

accreditation bodies and the number of facilities they accredit were:

American College of Radiology (9,178)

State of Arkansas (71)

State of California (464)

State of Iowa (134)

State of Texas (85)

To assure mammographic quality, mammography facilities undergo

annual inspections by FDA credentialed inspectors1

. Nearly 10,000

inspections take place each year. Preliminary results from FY2000

are shown in Figure 1:

• fifty-three percent

of the

mammography

facilities had no

adverse findings;

• only four percent

of the inspections

found the most

serious type of

problems (“Level

1 finding”) –

facilities must

 

1

 The MQSA inspection program includes FDA inspections of federal facilities performing mammography.

MQSA-like inspections are also performed for the Veterans Health Administration (VHA) through an

Interagency Agreement.

Figure 1. Preliminary FY 2000 Inspection Results

Level 2

33%

Level 3

10%

No Finding

53%

Level 1

4%

• Inspectors can issue

three levels of

findings. Level 1

represents the most

serious

noncompliance with

MQSA standards.

Level 3 represents

minor

noncompliance.

• Regardless of the

level, a facility must

correct all

deficiencies found

during an inspection.
OHIP FY2000 Annual Report, page 25

correct problems or lose their certification; and

• since the beginning of the MQSA program, significant

problems at four facilities led FDA to require that patients

and physicians be notified of concerns related to the

quality of their mammographic examinations (see link to

Mammography Facility Performance Report at left). In

each case, the patients and referring physicians served by

these facilities were notified about the image quality

problems at the facilities and were advised of the health risk.

As a result, the patients and referring physicians were able to

arrange for appropriate healthcare followup. (Note: State

actions against mammography facilities are reported

separately.)

As part of its continued efforts to assist MQSA inspectors to maintain

consistent and uniform performance, FDA established an Inspector

Quality Assurance Program. This program requires inspectors to

conduct a minimum of 12 inspections yearly, obtain 15 continuing

education units in mammography-related training (MEU’s) over a

three-year period, and undergo an annual audit by an FDA MQSAcertified auditor. In FY2000, FDA completed audits of all its certified

inspectors.

Improving the MQSA Program

The mammography program strives to provide better value, improved

customer service, and improved public health. Some of the major

innovations during FY2000 are listed below.

Digital Mammography: CDRH’s Office of Device Evaluation

approved the first Full Field Digital Mammography (FFDM) system

for commercial use on January 28, 2000. Digital mammography

allows interpreting physicians to quickly and easily manipulate the

images and may reduce the need for some women to have additional

exposures. Digital units are exempt from MQSA accreditation

requirements until the accreditation bodies have developed a process

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OHIP FY2000 Annual Report, page 26

for accrediting them. However, in order for a facility to lawfully use

the FFDM system, it must:

• maintain its accreditation status for at least one screen-film

unit;

• submit an application with required information to FDA;

• ensure that any interpreting physician, medical physicist, or

radiologic technologist has eight hours of initial training in

the new modality before using it clinically;

• provide a satisfactory FFDM equipment evaluation;

• follow the manufacturer’s guidelines for quality assurance

and quality control tests; and

• receive approval from FDA.

States as Certification Agencies (“States as Certifiers”): The

States as Certifiers (SAC) Demonstration Project is in its third year.

In this project, certain key MQSA responsibilities have been

transferred successfully to the States of Illinois and Iowa. The SAC

program authorizes qualified States to certify mammography facilities

within their jurisdiction, conduct inspections, and enforce the MQSA

quality standards under FDA oversight. The proposed rule to

institutionalize the program on a national scale was published on

March 30, 2000. Final regulations are expected in 2001.

Comprehensive electronic guidance: During FY2000,

all MQSA regulatory guidance materials and documents

were compiled into the MQSA Policy Guidance Help

System (PGHS). For the first time, mammography

facilities and other interested parties have access to a

comprehensive online resource accessible through

MQSA’s webpage. Previously, this information was only

available in ten separate documents and there was no way

to search through all of the documents at once. Users of

the PGHS can search for answers to specific policy

questions through an indexed list of topics and key words. For

example, by selecting a particular subject, such as “revocation of

accreditation” or “accreditation and certification,” the user will find

the regulatory citation, any relevant guidance documents, and any

other appropriate information and references.

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OHIP FY2000 Annual Report, page 27

NMQAAC

The National Mammography Quality Assurance Advisory Committee

(NMQAAC) is a committee established by MQSA to advise FDA on

the implementation of the MQSA program. During FY1999-2000,

NMQAAC met to discuss the following important issues:

• issuance of guidance on the MQSA final regulations;

• FDA’s role in evaluating the competency of mammography

personnel;

• implementation of a demonstration project evaluating the

feasibility of performing less than annual mammography

facility inspections in high quality facilities; and

• certification of Full Field Digital Mammography facilities.

NEXT

NEXT (Nationwide Evaluation

of X-ray Trends) is a

collaborative State-Federal

survey program conducted by

the Conference of Radiation

Control Program Directors

(CRCPD) and FDA. NEXT is

the sole mechanism in the

United States for acquiring and

updating nationally

representative baseline data on

medical x-ray exposures, image

quality, and related clinical

practice.

Hands-on training for NEXT x-ray surveyors at the

National Naval Medical Center in Bethesda, Maryland

Goals

1. Develop standardized test protocols and imaging phantoms for a variety of

x-ray examinations and train State radiation control personnel in their use.

2. Determine the average radiation dose and image quality from representative

clinical x-ray examinations in the U.S.

3. Monitor trends in patient dose, image quality, and relevant clinical factors.
OHIP FY2000 Annual Report, page 28

CRCPD’s NEXT Committee serves as the steering and coordinating

group for the program, exercising general oversight and providing a

cadre of State radiation control staff who conduct the annual surveys.

OHIP provides scientific and technical support for all phases of

NEXT. This support includes training of surveyors, presentations

from CDRH staff on new technologies and survey procedures, and

hands-on surveyor training at local clinical facilities.

The NEXT program

represents a twentyseven year partnership

between FDA and the

States. Since 1998,

NEXT training for State

surveyors has been

partially supported by

the American College

of Radiology through

funding to the CRCPD.

Annual Surveys

Under NEXT, the

surveys for a given year

are directed at a single

x-ray procedure and are

conducted in a national

cross section of clinical

facilities. Thus, the

survey results for a

given year represent a

statistically valid

“snapshot” of x-ray

exposure and related

factors for that

examination in the U.S.

The table on this page

shows the status of the

1995 through 2001

NEXT surveys. During

NEXT Annual Surveys

Survey

Year

Type(s) of X-ray

Examination (N =

no. of facilities

surveyed)

FY2000

Accomplishments

1995 Abdominal and

Lumbo-sacral spine

radiography

 N=204 (abdomen)

 N=319 (l-s spine)

Tabulation and graphical

analysis of data completed,

reviewed and currently in press

by CRCPD.

1996 Upper

gastrointestinal

fluoroscopy

 N=352

Analysis completed for undertable x-ray tube systems; draft

data summary completed.

1997 Mammography*

 N=7,676 (1995)

 N=10,746 (1996)

 N=11,086 (1997)

Published major study in

Radiology on mammography in

the 1990s in the U.S. and

Canada.

1998 Pediatric radiography

 N=387

Surveys, data entry and

preliminary analysis completed.

1999 Intraoral

cephalometric, and

panoramic dental

radiography

 N=342

Surveys completed, data

entered, and analysis

proceeding.

2000 Computed

tomography (CT)

Survey protocols modified to

collect data on fluroscopic

CT**, procedures incorporate

major improvements in survey

methodology (electronic

submissions, etc.), data entry

started.

2001 Adult chest

examination

Previously surveyed in 1994,

the 2001 survey will include

procedures for new digital

imaging systems and flat panel

systems, draft protocol

completed, training dates set.

* the data used in the NEXT analysis were obtained from facility

inspections performed under the Mammography Quality Standards

Act

**There have been reports in the literature that prolonged

irradiation during fluoroscopic CT may lead to patient skin injury.

The modified protocol will collect quantitative data on the

prevalence of this procedure and associated patient exposure.
OHIP FY2000 Annual Report, page 29

each survey, various types of information are collected, including

radiographic technique factors, patient x-ray exposure, x-ray beam

quality, image quality, film processing quality and darkroom fog.

Choosing a different x-ray examination from year to year provides

data on a variety of radiographic procedures while minimizing the

workload during any one year. By repeating NEXT surveys for a

particular x-ray examination every few years, the data can be used to

identify trends or changes over the course of time.

NEXT Survey Results

OHIP prepares a comprehensive report on a given year’s data that

includes tabulations of the results and graphical summaries. These

reports are then published by the CRCPD. CRCPD publishes the

reports without conclusions or other analyses in order to make the

reports widely available and as timely as possible. Instead, the data

are available to the radiation community for their own in-depth

analysis and publication in technical journals.

During FY1999 and FY2000, OHIP published six analytical works on

the NEXT data in peer-reviewed journals and conference proceedings.

These included articles in Radiology, the Journal of the American

Dental Association, and the Proceedings of the Thirty-fifth Annual

Meeting of the National Council on Radiation Protection and

Measurements (NCRP)2

. A review of the NEXT findings was

published in a special edition of the international journal, Applied

Radiation and Isotopes in January 1999 (Vol. 50, pp. 247-259).

The uses of NEXT data and its impact are illustrated in the figure on

the next page. Data points through 1992 were generated using data

from NEXT surveys, supplemented with information from the

literature. The data since 1995 has been collected using MQSA

inspection data.

The results of the NEXT mammography surveys identified concerns

with patient dose and image quality. These were factors in ACR’s

development of its Mammography Accreditation Program in 1988 as

 

2

 Specific references as well as a list of NEXT-related presentations are included in the Appendix of this

report.
OHIP FY2000 Annual Report, page 30

well as FDA’s MQSA

regulatory program in

1992. The MQSA

inspection uses the

NEXT developed

protocol for

determining the

radiation dose and

phantom image

quality score.

As a result of NEXT

and these actions, the

radiation dose women

receive from mammography is generally lower and the image quality

is better than at any other time since we began recording such

information. Other data collected during these surveys show marked

improvement in darkroom conditions, also contributing to improved

image quality. While patient dose has been increasing slightly since

1995, that increase is primarily associated with changes in technical

measures to improve image quality.

Overall, NEXT has established baseline data and long-term trends

for seven diagnostic examinations. These data:

• provide a standard of practice against which facilities can

compare their radiation levels in order to maintain safe and

state-of-the-art radiation levels (it is a common practice for

many State x-ray surveyors to provide x-ray facilities with a

brochure so that the facility can compare its x-ray survey

results with the NEXT data);

• have been used as a standard for comparison during

inspections by the Joint Commission on Healthcare

Organizations (JCAHO); and

• are currently being adopted by the American Association of

Physicists in Medicine (AAPM) and the ACR as Reference

Values (RV) for standards of practice for patient radiation

exposure.

72 76 80 84 88 92 96 00

0

2

4

6

8

10

12

14

Phantom Score

 Mean Glandular Dose

Dose (mGy)

Year

5

6

7

8

9

10

11

12

13

14

 Phantom Score

 (w/o artifact subtraction)

Average patient dose and phantom image quality

scores during mammographic examinations.
OHIP FY2000 Annual Report, page 31

TEPRSSC

The Technical Electronic Products Radiation Safety Standards

Committee (TEPRSSC) is an important advisory committee to CDRH

and FDA. Established under the Radiation Control for Health and

Safety Act of 1968, TEPRSSC is charged with providing advice and

consultation to the Commissioner of Food and Drugs on the technical

feasibility, reasonableness, and practicality of developing performance

standards for electronic products. TEPRSSC may also recommend

electronic product radiation safety standards to the Commissioner.

FDA has performance standards for lasers, sunlamps, microwave

ovens, ultrasound medical equipment, and diagnostic x-ray systems.

In addition to these existing standards, FDA has the authority to

promulgate mandatory safety standards for a wide array of products

for which mandatory standards do not exist, such as cellular

telephones and x-ray people scanners.

OHIP provides the Executive Secretary for the committee as well as

programmatic support. Summaries of recent TEPRSSC meetings are

available on our website. During FY1999-2000, TEPRSSC

discussions included the following important health and safety issues:

• Electronic Article Surveillance Systems and their potential

interference with implanted medical devices;

• the use of ionizing radiation to scan people for concealed

weapons and other contraband;

• wireless medical telemetry and interference with medical

devices;

• the development of sunlamp standards associated with

international harmonization;

• proposed rulemaking for lasers;

• proposed amendments for computed tomography

fluoroscopy;

• NEXT computed tomography survey;

• radiological health re-engineering; and

• ultrasound diathermy.

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OHIP FY2000 Annual Report, page 32

Federal Facilities Inspections

OHIP manages a Federal Facilities Inspection program that provides

radiation protection services to diagnostic x-ray facilities run by

various federal agencies. The federal agencies participating in this

program include:

• Department of Justice (Bureau of Prisons);

• U.S. Coast Guard;

• DOE (Department of Energy);

• HRSA (Health Resources and Services Administration); and

• NASA (National Aeronautics and Space Administration).

CDRH also has an Interagency Agreement with the Indian Health

Service to provide survey equipment, calibration services, training,

and assistance with technical issues related to radiation use and

control.

OHIP coordinates radiation surveys in these facilities with FDA’s

Office of Regulatory Affairs (ORA). ORA staff, either the FDA

Regional Radiological Health Representatives (RRHRs) or FDA x-ray

auditors, perform the actual surveys. The ORA staff have special

training and experience in radiation physics and are qualified to

provide facilities with information on how to reduce radiation

exposure during medical radiographic procedures. This information

ranges from recommending x-ray techniques to methods for

optimizing film processing and enhancing image quality. The RRHRs

are also available for phone consultation to assist facilities with other

problems that might arise in their x-ray facilities.

OHIP provides administrative support and overall coordination for the

program. This support includes negotiating Interagency Agreements

with the participating federal agencies. These Agreements fund

Goals

1. Assess federal facility compliance with the Presidential Directive of 1978,

“Radiation Protection Guidance for Federal Agencies for Diagnostic X-rays.”

2. Educate facility personnel in methods to reduce radiation exposure while

improving image quality.
OHIP FY2000 Annual Report, page 33

FDA’s program implementation for the purchasing and inventorying

of survey equipment and supplies, and for conducting surveys. Each

radiation survey is followed up with a report to the x-ray facility and

to the headquarters liaison for that federal agency. The report

contains test results, cites deficiencies if any, and makes

recommendations for improving the quality of the diagnostic x-ray

services at the facility.

Approximately 100 surveys were completed in FY2000. Most were

conducted in Bureau of Prisons or U.S. Coast Guard facilities.

Almost all surveys recommended minor changes that resulted in a

reduction in unnecessary radiation exposure and improved image

quality.

All of the participating federal agencies review these reports and

require their x-ray facilities to make changes and improvements as

recommended by the FDA. At Bureau of Prisons facilities, these

reports become an integral part of the records reviewed by auditors

from the Joint Commission on Accreditation of Healthcare

Organizations when they evaluate and accredit the facility.

Radiation Safety

In carrying out its regulatory science mission, CDRH

uses laboratories that employ radiation-emitting

products and radioactive materials. OHIP staff serve

as CDRH’s Radiation Safety Officer (RSO). The

RSO has responsibility for CDRH’s radiation safety

program to protect the health and safety of all

employees and to assure that CDRH complies with all

government regulations on the safe use of radioactive

materials.

Goals

1. Assure the safety of employees and contractors working in CDRH radiation

laboratories.

2. Assure CDRH compliance with federal regulations governing the use and

control of radiation-emitting electronic products and radioactive materials.
OHIP FY2000 Annual Report, page 34

During FY1999-2000, the RSO and OHIP accomplished the

following:

• developed and implemented a new CDRH Policy for

physical security in rooms where radioactive material is

stored;

• updated a CDRH policy on the decommissioning3 of CDRH

buildings where radioactive materials were stored or used,

and worked with other CDRH staff in decommissioning the

Wilkins Avenue building;

• updated CDRH’s inventory of electronic generators of

ionizing radiation and non-ionizing radiation used for

research purposes;

• conducted quarterly surveys of all radiation laboratories,

annual audits of all radiation programs and licensees and

unannounced surveys of CDRH radiation laboratories;

• calibrated 22 radiation survey instruments;

• conducted the annual training required of all licensed

materials users, as well as training on safety procedures for

other CDRH and contract janitorial staff who occasionally

work in radiation laboratories;

• facilitated and chaired quarterly radiation safety committee

meetings;

• amended CDRH’s Nuclear Regulatory Commission (NRC)

license from a broad to a specific license;

• disposed of approximately 200 sealed radioactive sources no

longer needed for CDRH research programs, four 55 gallon

drums of dry waste, and 40 carboys4

 of liquid radioactive

waste;

• instituted a program of bi-monthly disposal of liquid

radioactive wastes; and

• successfully passed the NRC inspection in early FY2000.

 

3

 Decommissioning is the formal process for declaring a building “free of radiation hazards” and available

for public use.

4

 A “carboy” is a term used for liquid radioactive waste containers. Each carboy typically holds from 5 to

15 gallons of liquid.
OHIP FY2000 Annual Report, page 35

During FY1999 and FY2000, there were no incidents that resulted in

harm or overexposure to individuals working in CDRH laboratories.

Our laboratory inspections and audits also indicate that we are

meeting our goals. Where minor problems or procedural violations

were identified, corrective actions have been taken and will be

monitored during future reviews.

The improvements in CDRH’s radioactive waste practices, begun in

FY1999, were particularly important accomplishments. As shown in

the following table, they have led to continuing, significant reductions

in the amounts of hazardous materials stored by CDRH. These

practices have resulted in improved radiation safety, better

accountability of radioactive materials, reduced workload for

monitoring sealed radiation sources, and reduced costs for physical

storage.

Radioactive Waste and Sealed Radiation Sources

Stored by CDRH

FY1997 FY1998 FY1999 FY2000

Containers of liquid

radioactive waste 30 40 6 1

Sealed Drums of dry

radioactive waste 3300

Drums of “Decay-inStorage” waste5 3311

Sealed radiation

sources6 200 200 3 3

 

5

 “Decay-in-Storage” – is a standard practice to store containers of short-lived radioactive waste until the

radioactive materials have decayed so that the waste can be released as non-radioactive.

6

 Does not include generally licensed sources that do not require NRC (Nuclear Regulatory Commission)

approval.
OHIP FY2000 Annual Report, page 36

REDUCING USE ERROR

People make errors all the time – it’s a (sometimes unfortunate) aspect

of being human. Errors made while using medical devices can lead to

hazards which can impact patients, family members, and professional

healthcare providers. Hazards associated with device use are a

common and serious problem. Evidence from researchers suggests

that the frequency and consequence of hazards resulting from medical

device use error far exceed those arising from device failures.

Therefore, it is essential to ensure safe and effective device use if

hazards are to be controlled effectively.

A November 1999 Institute of Medicine report, “To Err is Human –

Building a Safer Health System,” estimated that as many as 98,000

people die in any given year from medical errors that occur in

hospitals, which is more than die from motor vehicle accidents, breast

cancer, or AIDS. Though many of these errors are not related directly

to medical devices, some are, and it highlights the importance of

addressing errors with the use of medical devices.

FDA recognizes that most use errors with medical devices are not

“inevitable human error.” Rather, they are largely influenced by

device design and device labeling. OHIP seeks to promote the safe

and effective use of medical devices through our Human Factors

program, labeling efforts, and patient safety activities.

Goals

1. To support the medical device industry’s successful application of human

factors principles in order to reduce medical device use error.

2. To expand the science base and continued advocacy for the effective

communication of labeling information to patients and healthcare

professionals.
OHIP FY2000 Annual Report, page 37

Human Factors

Human Factors (HF) is a science

devoted to the interaction of

people and equipment. “Human

Factors,” “human engineering,”

“usability engineering,” and

“ergonomics” are often used

interchangeably. In the field of

medicine, the objective of Human

Factors is to improve human

performance and reduce the

likelihood of use error and patient

injury.

Human Factors has been used extensively by the military, the

transportation industry and in some consumer areas. It is now being

applied to address use error problems in medicine. Human Factors

analysis and testing should be applied throughout the entire life-cycle

of a medical device. Our Human Factors efforts impact on CDRH’s

premarket, postmarket, and field-inspection regulatory missions.

• Guidance: In July 2000, we issued a final

guidance document, “Medical Device Use

Safety: Incorporating Human Factors

Engineering into Risk Management.” It

describes how to incorporate Human Factors

techniques and theory into risk management

during the design and development of

medical devices so that intended users are

able to use medical devices safely and

effectively throughout the product life cycle.

It also facilitates review of new device

submissions and design control

documentation.

Human Factors

Considerations can

result in Medical

Devices with:

• Intuitive

operation and

low reliance on

manuals;

• Easy-to-read

displays;

• Easy-to-use

controls;

• Positive and safe

connections;

• Effective alarms;

and

• Easy repair and

maintenance.

4

http://

www.fda.gov/

cdrh/humfac/

1497.html
OHIP FY2000 Annual Report, page 38

• Webpage: We posted a

webpage on Reducing Use

Error. This page provides

CDRH staff, manufacturers and

others with comprehensive

information on the role that

Human Factors and labeling can

play in reducing use error.

• Device Reviews: We assisted CDRH’s Office of Device

Evaluation by providing Human Factors reviews for selected

medical device approval applications.

• Patient Checklist: We developed a one-page checklist,

“Make Sure the Medical Device You Choose Is Designed

for You.” Healthcare professionals and patients can use the

checklist to choose a medical device that is best for the

patient. It can easily be modified to focus on particular

devices for certain patient groups (e.g., patients with

arthritis, diabetes, or heart disease). The checklist poses

questions in three major categories for patients and

healthcare professionals to discuss:

 Do you have limitations that can affect your use of the

device?

 Is the device right for the environment where you

plan to use it?

 Are there device characteristics that can affect its

use?

• Teleconference: On June 21, 2000, we broadcast a live,

interactive satellite teleconference for risk managers and

other healthcare providers. This video teleconference used a

case study format in which a panel of risk managers

described actual incidents of medical error. They then

analyzed the incident for the audience, including lessons to

be learned about preventing and managing errors. The

audience also had the opportunity to question the panelists.

CDRH’s Office of Surveillance and Biometrics assisted us

in co-sponsoring this teleconference with The American

Society for Healthcare Risk Management (ASHRM).

4

http://

www.fda.gov/

cdrh/useerror/

you_choose_

checklist.html

4

http://

www.fda.gov/

cdrh/

useerror
OHIP FY2000 Annual Report, page 39

• Research – PROUD 2000: The Prioritization and

Reduction of Use Error in Devices 2000 project is part of

OHIP’s overall strategy to address deaths and injuries

resulting from the use of medical devices. There is still

much to be learned before we can more fully understand use

error in clinical practice. In July 2000, we completed the

first phase in which we interviewed Nurses and Risk

Managers who are actual device users. We collected

information on problematic devices, methods for analyzing

device use error, organizational influences on use error, and

overall issues that affect use error (i.e., training, staffing,

workload issues). During the next phase, we will analyze

the results and develop models to help us better understand

and prevent use error.

• International Standards: OHIP is

playing a critical role in the

development of national and

international standards that will deal

with Human Factors considerations and

medical devices (see inset). With these

efforts, we are updating existing

standards and providing new standards

that better explain how manufacturers

should perform their design activities in

an orderly manner that takes into

account the needs of device users.

When these standards are in place, they

will serve as additional Human Factors

guidance for the design of medical

devices.

• Inspections and Site Visits: We are working with FDA’s

Office of Regulatory Affairs to better understand the types

of educational and regulatory information we need to

provide manufacturers. In FY2000, we accompanied FDA

inspectors on several GMP/QSR (Good Manufacturing

Practices/Quality System Regulation) inspections of medical

device manufacturers. During directed inspections, we

observed investigations of actual adverse events related to

Human Factors-Related

Standards under Development

 ANSI/AAMI HEXX: 2000

2CDV: Volume 1, HF

Design Process and Volume

2, HF Design Principles

and Specifications

 IEC 60601 Safety Standard

for Electrical Medical

Devices

 IEC 60601-1-6 Collateral

Standard: Usability:

analysis, test, and

validation of human factors

compatibility

 ISO 14791 Risk

Management
OHIP FY2000 Annual Report, page 40

use error. During design control inspections, we gained

insight into the extent to which manufacturers were able to

include “user needs” and Human Factors in their

documentation design controls. We helped inspectors

understand how to identify and assess human factors issues

contained in complaint handling systems and device history

files. Additionally, we received practical feedback from the

inspectors on the time and resources required for them to

evaluate a manufacturer’s Human Factors processes.

• Human Factors Brochure: In FY2000, we produced a

brochure that was distributed widely at professional

meetings. The brochure briefly introduces Human Factors

in medicine, lists CDRH Human Factors activities, and gives

other information resources.

Labeling

Improved patient labeling on

medical devices allows the patient

or caregiver to better understand

both instructions for use and riskbenefit information. Our

accomplishments included:

• We review patient

labeling for all new

Premarket Approval (PMA) submissions and non-PMA

submissions where CDRH’s Office of Device Evaluation

feels patient labeling needs careful attention. This was the

fourth year of an inter-Office agreement for these reviews.

Our purpose is to recommend improvements to patient

labeling so that the intended patient or caregiver will better

understand both the instructions for use and the risk-benefit

information provided in the labeling. In cases where patient

labeling is not submitted, reviewers determine whether

patient labeling will contribute to reducing use error or allow

4

http://

www.fda.gov/

cdrh/humfac/

hfbrochure.html
OHIP FY2000 Annual Report, page 41

the patient to make a more informed choice concerning their

healthcare. During FY2000, we reviewed approximately 90

submissions.

Out of all reviews, 61

percent of submissions

contained patient labeling.

Twenty-two percent did

not contain patient

labeling, but we

recommended that

patient labeling be

written. Seventeen

percent did not have

patient labeling and did

not require labeling for the

patient.

• Under a contract with a Duke University expert, Model

Patient Labeling for Medical Devices is undergoing

Usability Testing. The model patient labeling for medical

devices was developed previously and includes

recommendations for both risk/benefit information and

instructions for use. This contract will compare labeling

developed according to our model with the current labeling

for a variety of devices. The results will strengthen the

scientific foundation for the CDRH policy on labeling.

• A Draft Guidance on Medical Device Patient Labeling

was issued. The guidance seeks to assist manufacturers and

CDRH reviewers in their review and evaluation of medical

device patient labeling. More understandable and usable

labeling is essential for patients, family members and other

lay persons caring for patients. The draft guidance was

issued on March 3, 2000 for public comment. The final

guidance will be issued early in 2001. Preparations are

underway to provide training for CDRH reviewers on the

final guidance.

All Product Reviews*

October 1999 - October 2000

No Patient 

Labeling 

Provided - Not 

Recommended

17%

Patient Labeling 

Provided

61%

No Patient 

Labeling 

Provided - BUT 

Recommended

22%

*Includes original submissions, supplements, and

requests for repeat reviews.
OHIP FY2000 Annual Report, page 42

• A poster presentation entitled “A Patient’s Path to

Understanding Medical Devices” was presented at two

national meetings of healthcare professionals and

stakeholders in promoting patient safety. The presentation

details the steps a patient should take to get complete

information, including labeling, about a medical device. We

developed a brochure based on the poster and are working to

make similar information available on our webpage.

• We are working with an FDA-wide Labeling Group to share

labeling and advertising/marketing research and policy

information. Working with outside experts and

stakeholders, the group is also exploring options for

leveraging activities in labeling and advertising.

Also during FY2000, OHIP used qualitative research to evaluate

labeling-related issues associated with two CDRH programs.

Qualitative research attempts to discern a target population’s

perceptions, opinions, beliefs and attitudes on a given issue or topic.

Focus groups are one of the most familiar tools used in qualitative

research. The two CDRH programs were:

• Focus Testing for Tampons: Working with CDRH’s Office

of Device Evaluation in November 1999, we coordinated a

focus group study consisting of six groups to look at tampon

usage and patient labeling. These groups explored:

 how women select tampons and the role of labeling in

tampon selection;

 women’s understanding of the tampon label hierarchy

and how they interpret the absorbency terms “light”

and “ultra”; and

 what women know about Toxic Shock Syndrome

(TSS) and the effectiveness of patient labeling in

providing TSS information.

• Focus Testing for Latex Gloves: We helped the CDRH

Glove Powder Regulation Working Group in identifying and

securing a qualitative research contractor and we provided

consultation on the preparation and conduct of focus groups

to evaluate warning messages for glove labeling.
OHIP FY2000 Annual Report, page 43

Patient Safety

In response to the November 1999 Institute of Medicine (IOM) report

on medical error, federal agencies including FDA were asked to

participate in a Quality Interagency Coordination Task Force (QuIC)

to address concerns raised in the IOM report. The goal of QuIC is to

ensure that all federal agencies that purchase, provide, study, or

regulate healthcare services are working in a coordinated way toward

the common goal of improving the quality of healthcare. QuIC

prepared a report to the President entitled “Doing What Counts for

Patient Safety: Federal Actions to Reduce Medical Errors and

Their Impact.” The report lists over 100 actions for federal agencies.

Staff from OHIP and from CDRH’s Office of Surveillance and

Biometrics coordinated CDRH’s responses for inclusion into the

QuIC report. As a result, the action list includes several items

pertaining to medical devices.

We continue to serve on three QuIC workgroups to ensure

implementation of the federal action items addressing patient safety:

• Patient and Consumer Information – addressing barriers

to effective communication with patients about quality. This

includes providing federal agencies with information to

more effectively help people understand quality issues and

how their choices influence the quality of the services they

receive. It also includes developing a common vocabulary,

or set of terms, for federal agencies to use in communicating

with patients and consumers about quality.

• Improving Information Systems – exploring how to

augment federal efforts to develop a standardized language

that will enable computerized comparisons of quality across

federal agencies. The workgroup is also examining the

potential uses of telemedicine for helping to improve quality

of care.

• Errors Workgroup – ensuring the implementation of all

action items by federal agencies and, where appropriate,

providing a forum for collaborative projects among federal

agencies.
OHIP FY2000 Annual Report, page 44

REGULATIONS AND GUIDANCE

OHIP plays an essential role in the development of all CDRH

regulations and Federal Register documents, as well as in the

management of Good Guidance Practices.

Regulations

In FY2000, OHIP lawyers and paralegal staff were instrumental in

allowing CDRH to:

• meet all statutory requirements associated with

implementation of the FDA Modernization Act of 1997

(FDAMA);

• respond to 20 citizens petitions, with no overdue petitions;

and

• publish 100 Federal Register documents. Some of the most

significant documents included:

 Postmarket Surveillance. This proposed rule would

establish procedures for FDA and manufacturers on

the postmarket surveillance requirements. This was

CDRH’s first “Plain Language” rule (see below) and

it was the first rule for which CDRH is accepting

comments on the Internet.

 510(k) -FOI rule (Freedom of Information). We

published a proposed rule to require submitters of

premarket notifications to send FDA a version of the

510(k) with trade secret and confidential commercial

information deleted. This rule, if implemented, would

save FDA the time of deleting this information when

responding to FOI requests.

Goals

1. To manage all aspects of CDRH’s regulations development process.

2. To serve as regulatory experts on CDRH teams addressing medical device or

radiological health issues.

3. To coordinate the development, review, and submission of all Federal

Register publications for CDRH, including citizen petitions.

4

http://

www.fda.gov/

cdrh/

fedregin.html
OHIP FY2000 Annual Report, page 45

 States as Certifiers. This proposed rule would

transfer aspects of FDA’s role as a Certifier of

mammography facilities to qualified States. The rule

fully implements a provision in the Mammography

Quality Standards Act (MQSA).

 Lay Summaries. CDRH issued a final rule to require

mammography facilities to send patients “lay

summaries” explaining the results of their

examination. This rule implemented a provision of

the Mammography Quality Standards Reauthorization

Act.

 The “Six Year” Rule. CDRH issued final guidance

on implementation of section 216 of FDAMA. This

section allows FDA to use data from Premarket

Approval (PMA) applications approved more than six

years earlier when approving or reclassifying devices.

 Mass Reclassification. CDRH issued a final rule to

reclassify 28 class III devices into class II. This is a

major step toward completion of the review of the

pre-1976 Class III devices.

 Apnea Monitors. CDRH withdrew its proposal to

require a mandatory standard for apnea monitors.

Instead, CDRH issued a draft 510(k) guidance

document for apnea monitors and proposed to make

this guidance document a special control for these

devices.

 Tracking Amendments. CDRH issued a proposed

rule to implement the CDRH amendments to the

tracking provisions of the Federal Food, Drug, and

Cosmetic Act.

The regulation workload in FY2000 was consistent with that of

previous years. The number of staff assigned to the regulation process

has steadily decreased. However, in order to maintain a high level of

output and quality, OHIP continued to implement improvements and

changes identified through CDRH-wide reengineering of the

regulation process.
OHIP FY2000 Annual Report, page 46

Good Guidance Practices

Good Guidance Practices (GGPs) are FDA’s policies and procedures

for developing and issuing guidance documents. Guidance documents

describe FDA’s interpretation of, or policy on, a regulatory issue.

They are typically prepared for FDA staff, applicants/sponsors and/or

the public. The GGP policy standardizes the development process for

guidance documents, provides opportunities for public comment, and

clarifies the use of guidance documents. Each FDA Center is charged

with implementing its own GGPs. OHIP leads implementation,

administration, and monitoring of GGPs within CDRH.

In FY2000, OHIP:

• Worked with the GGP coordinators across FDA to develop a

regulation on GGPs that was published on

September 19, 2000. A refresher course was given to update

all staff on the revised procedures and changes resulting

from the final regulation.

• Created and updated a comprehensive database of all

guidance documents issued by CDRH – currently, more than

607 guidance documents prepared under GGPs.

• Worked with CDRH’s Office of Systems and Management

to provide a searchable version of the database available on

the CDRH webpage.

• Updated and revised the Standard Operating Procedures

(SOP) Manual for GGPs, providing CDRH authors with

detailed instructions, templates and checklists.

• Worked with CDRH’s GGP contacts to publish an annual

listing of all guidance documents as well as quarterly

updates.

Goals

1. To provide coordination and leadership for CDRH’s GGP process.

2. To work with CDRH’s Office and Division GGP contacts to ensure that CDRH

guidance documents comply with the GGP regulation.

3. To assure easy access to CDRH guidance documents over the Internet.

4

http://

www.fda.gov/

cdrh/

ggpmain.html
OHIP FY2000 Annual Report, page 47

Plain Language

On June 1, 1998, the President

issued a directive that the federal

government's writing must be in

plain language. Basically, plain

language means that our

documents must be clear and easy

to read.

Within CDRH, OHIP is responsible for coordinating the

implementation of plain language in all of our written

communications, including regulations and guidance documents.

During FY2000, OHIP:

• continued to sponsor plain language and writing/editing

courses for CDRH staff – since these classes were first

offered in FY1999, more than 250 staff have participated in

classes for

 regulations writers,

 letter writers,

 support staff,

 reviewers and non-reviewers;

• worked with CDRH’s Office of Surveillance and Biometrics

to issue CDRH’s first proposed rule written in plain

language; and,

• continued to assure that new CDRH documents are written

in plain language and that plain language is incorporated

into existing CDRH documents as they are updated and

revised.

Goals

1. To assure that CDRH’s written communications are clear and easy to read.

2. To provide advice and assistance to CDRH staff on writing in Plain Language.

3. To provide advice and assistance to manufacturers in writing labeling in Plain

Language.
OHIP FY2000 Annual Report, page 48

FDAMA

OHIP serves as the CDRH coordinator for

implementation of the FDA Modernization Act of 1997

(FDAMA). Each of the CDRH Offices are committed

to implementing the provisions of FDAMA, as

evidenced by a record of:

• more than 24 final guidance documents and

eight final rules;

• three Reports to Congress;

• routine updates to the list of recognized consensus

standards;

• implementation and proposed expansion of the Accredited

Persons Review Program (discussed elsewhere in this

report); and

• implementation of the Least Burdensome provisions of

FDAMA.

Throughout all of these efforts, OHIP has provided support for

regulations and guidance development as well as extensive training

and education for CDRH staff on FDAMA provisions. The Least

Burdensome Provisions of FDAMA were the topic of CDRH’s first

webcast.

4

http://

www.fda.gov/

cdrh/modact/

modern.html
OHIP FY2000 Annual Report, page 49

CDRH STAFF COLLEGE

OHIP provides all CDRH employees with comprehensive

professional and technical training through our staff college. Our

products include classroom training, live satellite teleconferences,

webcasts, online coursework, and a variety of seminars and lectures.

Training Highlights

During FY2000, we provided CDRH employees with extensive

training opportunities, including: in-depth training on scientific and

technical issues; CDRH programs and policy; the use of plain

language in all CDRH communications; and training in

communication, interpersonal, and professional development skills

(see next page for examples). This training was presented in a variety

of settings and formats:

• Sixty-nine different courses were presented for more than

2,600 “students.”7 Depending upon the topic and training

objectives, individual courses can require a commitment of

from four to forty hours. The longer courses may spread

over a period several weeks.

 

7

 There were approximately 1,050 CDRH employees in FY2000. Individual employees take advantage of

several training opportunities during the year. Therefore, the number of “students” or “attendees” is greater

than the number of employees.

Goals

1. To partner with all CDRH Offices in offering high quality, practical training

solutions that meet CDRH’s evolving needs and priorities.

2. To provide individual employees with management, professional development

and scientific/technical training opportunities that enhance their job

performance and maximize their career potential.
OHIP FY2000 Annual Report, page 50

• Sixty-eight seminars were

held in FY2000. 2,000

employees attended these

seminars. “Staff Updates”

are scheduled on a flexible

basis to address current or

upcoming issues.

“Science Grand Rounds”

are held monthly to keep

CDRH staff up-to-date on

the latest medical device

and radiation issues. The

speakers at our seminars

are national and

international experts from

FDA, other government

agencies, universities, and

from the medical device

industry.

• We designed, developed,

and implemented a new

training program for

CDRH support staff.

Called Pathways, it is a

voluntary three-year

training and development

program that will provide

support staff with the

knowledge and skills

needed for their continued

professional development.

Twenty-one participants

from across CDRH are

currently enrolled.

Applications are accepted

on an ongoing basis.

Examples of FY2000 Training

for CDRH Staff

• 12-week Biocompatibility course included

lectures in each type of Biocompatibility test

along with case studies to help reinforce the

information and policy presented.

• 6-session course in CDRH software policy

and review principles presented in

partnership with CDRH’s Office of Device

Evaluation and Office of Science and

Technology.

• The Clinical Trials Course was revised and

offered in modular format.

• Advanced Risk Communication training

was provided as a follow-up to the 2000 FDA

Science Forum.

• A monthly series addresses Quality

Systems Issues, including topics such as

“Six-Sigma,” Quality and Business

Management, and the Quality Management

Program instituted by FDA’s Office of

Regulatory Affairs.

• Held the 5th offering of Tissue Engineering

to provide cutting-edge information in this

technology.

• Collaborated with the Radiological Health

Reengineering Team to provide Training in

Radiation Law/Basic Radiation.

• Webcasts, with recurring playback schedule

on issues including: The Least

Burdensome Provisions of FDAMA,

CDRH Leveraging and Developing a

Strategic Vision for the Center.

• Satellite Teleconferences on issues ranging

from Best Practices in Treating Acute

Myocardial Infarction; Plain Language,

the Write Idea; to Time Management.
OHIP FY2000 Annual Report, page 51

• We increased our commitment to explore and implement

alternative training technologies that complement traditional

instructor-led classes and seminars. Teleconferences,

CDROMS, web-based online training, and webcasts allow

us to provide greater diversity in the topics that we offer as

well as greatly increasing each employee’s access to

training.

• More than thirty-two satellite teleconferences were

broadcast throughout CDRH.

• In cooperation with CDRH’s

Office of Systems and

Management, we

implemented CenterNet

Live. This uses webcast

technology to bring

important seminars, lectures

and presentations to every

desktop computer in CDRH.

Webcasting provides every

CDRH employee with the flexibility to participate in

important events “live” or at a later date through our

playback schedule.

• We provided four multimedia CDROM-based courses in

Anatomy and Physiology.

• CDRH became the first FDA Center to make SkillSoft

Corporation’s Critical Skills Library available for CDRHwide use. After pilot testing the program in FY2000, this

online (web-based) training became available to staff in

October 2000. The training library includes over 300

courses in topics such as Management, Supervision,

Teamwork, Customer Service, Project and Time

Management, Communication, Human Resources, Finance,

and Knowledge Management.
OHIP FY2000 Annual Report, page 52

• Finally, our Playback Schedule has given CDRH

employees greatly increased access to training at their

desktops and on their own schedule. Webcasts, seminars,

courses and teleconferences are being recorded and then

“archived” for later playback. Each week, our website on

CDRH’s Intranet provides employees with a schedule of

events that includes live classes and seminars and playbacks

of previously recorded events.

360° Training Program

We formed a training team to implement a continuous improvement

program, known as the 360° training program. The purpose of the

program is to ensure that courses are more rigorously designed,

developed, delivered, and assessed to ensure their quality and

relevance to program goals. This allows us to “close the loop”

between training needs assessment and course development/delivery.

In FY2000, the training team focused on needs assessment, training

impact assessment, training transfer, performance/evaluation

measurement criteria, and benchmarking.

Needs Assessment

We are working to ensure that our training programs meet the needs

of all CDRH employees, including supervisors, professionals and

support staff. During FY1999, we conducted an extensive “needs

assessment.” Many important training needs emerged and we began

addressing them in FY2000. Examples include:

• In FY2000, we developed a new course, Case Studies for

Non-Managers, that prepares employees to work

productively and proactively on CDRH programs. This

seven-session course began during fall 2000.

• Some of CDRH’s most important training needs identified

were communications, interpersonal and professional

development skills training. We formed active partnerships

with each of CDRH’s Offices, greatly increasing our course

offerings.
OHIP FY2000 Annual Report, page 53

• We instituted a continuous needs assessment program by

scheduling open houses for all CDRH Offices. The purpose

of conducting these open houses is to update the information

from the FY1999 needs assessment and to promote the

continued discussion of training needs by CDRH employees.

Benchmarking

To learn more about how other organizations provide training for their

employees, we benchmarked against ten government agencies and

private organizations. Our goal was to identify, understand and adapt

outstanding training practices and processes found outside of CDRH.

In comparison with other organizations, we confirmed that we are

doing an excellent job in a number of key areas, including needs

assessments and training evaluations. We also identified a number of

“best practices” that can be implemented in CDRH.
OHIP FY2000 Annual Report, page 54

TELECONFERENCE/VIDEO PRODUCTION

OHIP operates a broadcast

quality television studio on

behalf of CDRH and FDA.

The studio is a uniquely

powerful tool for outreach on a

wide variety of topics. The

primary medium for outreach

has become production and presentation of “live teleconferences,”

although we continue doing videotaped programming on a limited

basis.

The television studio continues to provide excellent “value” to CDRH

and FDA. Studio operations and capital expenditures, other than

personnel costs, are completely funded by chargebacks to the other

components of FDA and other government agencies sponsoring the

programming. As a result, during FY2000;

• CDRH programming was produced with minimal program

dollars.

• The same facilities and equipment used for teleconferences

and video production were available to CDRH for other

purposes:

 we provided technical video support for 27 medical

device panel meetings;

 we provided video documentation of 35 critical

CDRH meetings; and

 we downlinked 83 programs via CDRH’s fiber-optic,

closed circuit channel for staff training and

professional development available to all CDRH and

Goals

1. To provide the infrastructure and expert knowledge needed to effectively use

audio and video in support of CDRH, FDA and other government public health

programs.

2. To evaluate, recommend and support new techniques and technologies for

improved training, education and information exchange.
OHIP FY2000 Annual Report, page 55

CBER ( FDA’s Center for Biologics Evaluation and

Research) employees.

In February 2000 we

launched a

comprehensive

website for our

television and video

services. Developed

in cooperation with

CDRH’s Office of

Systems and

Management, it

provides up-to-date

information on

television programs

currently in production, programs scheduled for broadcast, and

opportunities to secure programs previously broadcast. It also

provides other PHS agencies with a greater understanding of the

facilities and services available to them.

Another important feature of our website is a “program calendar” that

provides information about, and serves as a marketing tool for,

individual CDRH/FDA teleconferences. The program calendar:

• notifies a potential audience of a scheduled event;

• creates a temporary data base of downlink sites;

• provides answers to frequently asked questions related to

downlink operations;

• allows for interactive exchange both before and after the

distance learning broadcast; and

• results in a database that significantly enhances our ability to

accurately target marketing information for all programming

activities.

Also during FY2000:

• We began exploring opportunities to deploy an HHS-wide,

multiple channel, digital service that will give all PHS

4

http://

www.fda.gov/

cdrh/ohip/

dcm
OHIP FY2000 Annual Report, page 56

agencies direct links to each other and to their constituents,

including a direct link to consumers.

• On-location video recordings of lectures, panel discussions,

training classes, and other informational programs were used

in a variety of training and learning situations, including

rebroadcast to all CDRH staff.

• Along with the Health Resources and Services

Administration, we participated in a pilot project to

disseminate television programming via digitally

compressed satellite broadcasts to personal computers.

• Fiber optic cabling was installed to provide both distribution

and programming services to the new Center for Veterinary

Medicine (CVM)/Center for Food Safety and Applied

Nutrition (CFSAN) College Park facility.

• A long-standing partnership with the Food and Drug Law

Institute (FDLI) continued to provide national training and

information dissemination on issues critical to CDRH and

other FDA Centers.

• We continued our working partnership with the Office of

Regulatory Affairs (ORA) to provide training and other

programming on a wide variety of FDA issues.
OHIP FY2000 Annual Report, page 57

APPENDIX

Publications and Presentations

OHIP’s programs may involve formal publications or presentations in

various scientific and professional settings. This listing reflects the

variety and diversity of our programs.

A Patient’s Path to Understanding Medical Devices. Presentation (poster) at the

American Academy of Family Physicians/Society of Teachers of Family

Medicine Annual Conference on Patient Education; and at the FDA/National

Patient Safety Consumer Forum. John J. Crowley, Patricia A. Kingsley.

CDRH Hot Topics for 2000 and Navigating and Retrieving Valuable

Information from the FDA Website. Presentation (booth) at The Medical Design

and Manufacturing (MD&M) East 2000 Conference, New York, NY.

William M. Sutton, Carol M. Fedorchak.

CDRH Overview. Presentation at Baltimore District Conference, Annapolis, MD.

August 21, 2000. Nancy M. Leonard.

CDRH Webpage and Overview of Medical Device Regulations. Presentations at

the Pan American Health Organization (PAHO), Washington, DC.

October 22, 1999. Frederick B. Winston, Thomas E. Cardamone,

William M. Sutton, John F. Stigi.

Central Venous Catheter Tip Placement and Catheter Occlusion. American

Journal of Surgery; 108(1):78-79 (2000). Walter L. Scott.

Challenges for FDA (in regard to electronic records and electronic signatures).

Presentation at the Drug Information Association Conference, Washington, DC.

September 13, 2000. Christine Nelson.

Condoms-Standards and Regulations. Presentation at the International

Glove/Barrier Shippers Association, Long Beach, CA. May 1, 2000.

Arthur K. Yellin.

Current Issues in Federal Sector Healthcare Law. Presentation at Medical

Jurisprudence of the Uniformed Services University of the Health Sciences

Section of Medical Jurisprudence and the Air Force Judge Advocate General

School, Bethesda, MD. May 2000. Melvin Greberman.
OHIP FY2000 Annual Report, page 58

Doses in Radiology: How and Why They Vary. Presentation at the Annual

Meeting of the National Council of Radiation Protection (NCRP), Bethesda, MD.

Orhan H. Suleiman.

Electronic Imaging in the Health Care Enterprise: Roles of the FDA.

Presentation at the American Medical Informatics Association (AMIA),

Washington, DC. November 1999. Melvin Greberman.

Electronic Records and Signatures. Presentation at AdvaMed Workshop,

Washington, DC. September 26-27, 2000. Christine Nelson.

FDA Guidance for I. V. Catheter Market Clearance. The Journal of Vascular

Access Devices; 5(3):18-19 (2000). Walter L. Scott.

FDA International Activities and FDA/EU Mutual Recognition Agreement

Update. Presentations at the Global Harmonization Task Force (GHTF) Annual

Conference, Ottawa, Canada. September 2000. Christine Nelson.

Human Factors Considerations in Infusion Pump Use Safety. Presentation at

the Infusion Pump Workshop, Minneapolis, MN. September 26-28, 2000.

John J. Crowley, Ronald D. Kaye.

Human Factors in Medical Device Use Safety: How to Meet the New

Challenges. Presentation at the International Mini-Symposium on Global

Challenges for Human Factors and Medical Systems, Conference of the

International Ergonomics Association and the Human Factors and Ergonomics

Society Annual Meeting. August 2000. Susan K. Meadows, Ronald D. Kaye,

C. Richard Sawyer, Peter B. Carstensen, Cornelia B. Rooks.

IDE Process and Expected Information in Protocols. Presentation for the U.S.

Army Medical Material Command, Bethesda, MD. October 29, 1999.

Frederick B. Winston.

Making Medical Devices Safer. Nursing Spectrum; 11A:21, 20 (1999).

Patricia A. Kingsley, C. Richard Sawyer, Peter B. Carstensen.

Mammography in the 1990’s: The United States and Canada. Radiology;

210:345-351 (1999). Orhan H. Suleiman, David C. Spelic, John L. McCrohan,

Gordon R. Symonds, Florence Houn.

Medical Glove Regulation Overview and Quality System Regulation Overview.

Presentations at the India Latex Conference, Wellington Island, Cochin, India.

December 6-8, 1999. Arthur K. Yellin, Anthony E. Rodgers.

Medical Device Update. Presentation at the Latin American Conference,

Alexandria, VA. July 11, 2000. Christine Nelson.
OHIP FY2000 Annual Report, page 59

Navigating and Retrieving Valuable Information from the FDA Website.

Presentation (booth) at The Medical Design and Manufacturing West 2000

Conference, Anaheim, CA. January 17-20, 2000. William M. Sutton.

NEXT Update. Presentation at the 31st Annual Meeting of the Conference of

Radiation Control Program Directors, Louisville, KY. David C. Spelic.

Optimization of Viewing Conditions and Phantom Image Quality Evaluations

on GE DMR and Full Field Digital Mammography System. Journal of Digital

Imaging Vol 13, No.2, Suppl 1, May 2000, pp 226-227. Kishalaya Chakrabarti,

Jerry Thomas, Richard V. Kaczmarek, Ronald W. Waynant, Michelle Loscocco.

Overview of the Division of Small Manufacturers Assistance. Presentation at

the Association of Medical Diagnostic Manufacturers Meeting, Rockville, MD.

September 20, 2000. William M. Sutton.

Overview of FDA; Design Controls Process Validation; Acceptance Activities;

and Corrective and Preventive Actions. Presentations at Association for

Advancement of Medical Instrumentation GMP Quality System Requirements

and Industry Practice Course, Roslyn, VA. February 28-March 2, 2000.

Christine Nelson.

Overview of Medical Device Regulations and Export Requirements.

Presentations at Department of Commerce Seminar, Washington, DC.

June 29, 2000. Lynne L. Rice, Thomas E. Cardamone.

Overview of US and European Medical Device Regulations. Presentation at

Department of Commerce Seminar, Russia and Ukraine. April 1-9, 2000.

Lireka P. Joseph, Lynne L. Rice.

Overview of the Quality System Regulations. Presentation at the Quality

Systems Workshop, Mexico City, Mexico. April 11-12, 2000. Joseph V. Puleo,

Christine Nelson.

Patient Dosimetry Activities in the United States: the Nationwide Evaluation of

X-ray Trends (NEXT) and Tissue Dose Handbooks. Applied Radiation and

Isotopes 50 (1999) 247-259. Orhan H. Suleiman, Stanley H. Stern,

David C. Spelic.

Phantoms Used for Evaluation of Full Field Digital Mammography Systems.

Presentation (poster) at World Congress on Medical Physics & Biomedical

Engineering, Chicago, IL. Richard V. Kaczmarek, Jerry Thomas,

Kishalaya Chakrabarti.
OHIP FY2000 Annual Report, page 60

Preference Studies of Workstation Monitor Performance. Presentation at the

Fifth International Workshop on Digital Mammography, Toronto, Canada.

June 2000. Jerry Thomas, Kishalaya Chakrabarti, Richard V. Kaczmarek,

Michelle Loscocco, Jerry Gaskill.

Preliminary Results of the 1998 Nationwide Evaluation of X-ray Trends

Pediatric Survey. Presentation at the American Association of Physicists in

Medicine Meeting, Nashville, TN. Albert E. Moyal.

Quality Control Phantoms for Full Field Digital Mammographic Systems.

Presentation at Fifth International Workshop on Digital Mammography, Toronto,

Canada. June 2000. Jerry Thomas, Kishalaya Chakrabarti,

Richard V. Kaczmarek, Michelle Loscocco, Jerry Gaskill.

Radiographic Trends of Dental Offices and Dental Schools. Journal of the

American Dental Association; Vol. 130: 1104-1110 (July 1999). Orhan H.

Suleiman, David C. Spelic, Burton J. Conway, June C. Hart, Penny R. Boyce,

Robert G. Antonsen.

Regulatory Overview; Quality Systems Inspection Technique; Corrective and

Preventive Actions; Case Studies; 21 CFR: Part 11; Electronic Records and

Signatures; Financial Disclosure for Clinical Investigators; and The 510(k)

Paradigm. Presentations at the Cooperative Workshop with Western New York

Technical Development Center, Buffalo, NY. September 26-27, 2000.

William M. Sutton; Frederick B. Winston, Joseph V. Puleo.

Regulatory Requirements for Medical Gloves and Overview of Quality Systems.

Presentations at the Medical Glove Symposium, Taipei, Taiwan.

March 27-31, 2000. Judith L. Strojny.

Results of a Nationwide Survey of Chest Radiography: Comparison with

Results of a Previous Study. Radiology; 215:891-896 (2000).

Richard V. Kaczmarek, Burton J. Conway, Robert J. Slayton, Orhan H. Suleiman.

Roles of the FDA: Telemedicine and Website Linkages. Presentations at

Mitretek Systems Seminar, McLean, VA; at Washington Metropolitan Distance

Learning Association, Washington, DC; and at University at Buffalo Schools of

Law, Medicine, and Pharmacy, Amherst, NY. Melvin Greberman.

510(k) and Registration and Listing Requirements for Medical Devices.

Presentations at the International Latex Conference, Akron, Ohio, July 25, 2000.

Arthur K. Yellin.
OHIP FY2000 Annual Report, page 61

* No longer with OHIP as of January 31, 2001

OHIP Staffing and Organization

OHIP includes the Office of the Director, two Staffs and four

Divisions.

Office of the Director

• provides overall leadership and direction

• provides administrative and ADP support to all OHIP programs

Regulations Staff

• develops and advises on the preparation of Federal Register documents,

including proposed and final regulations and notices

• coordinates the preparation, review and processing of responses to citizen

petitions

Staff College

• develops and delivers training programs, courses, seminars and lectures

• provides satellite telecasts and distance learning programs on a variety of

topics

Barr, Wes Howell, Heather D. Manny, Edward F.*

Brophy, Linda S. Jans, Ronald G. Paras, Peter

Brown, Karen M. Joseph, Lireka P. Sullenger, Deborah C.

Evans, Clifford D. Lewis, Debra Y.* Vitale, Kimberly J.

Garris, Cynthia I.

Cassis, Domini H. Noland, Bernice E. Sheehan, Joseph M.

Gilmore, Rosa M. Olson, Jean M. Wade, Jennette

Hanna, Myrna A. Ross, Ronald D.*

Brier, Marjory F. Morch, Cecile, A. Salmon, Adrienne P.*

Gerhold, Susan H. Nesseler, Steven E. Sauer, Patrice A.

Hanna, Mary R. Nakon, Kimberly K. Stewart, Laura L.

Kramer, Mark D.
OHIP FY2000 Annual Report, page 62

* No longer with OHIP as of January 31, 2001

Division of Communication Media

• produces videotapes and teleconferences – from script development to

completed program – using in-house resources

• delivers satellite productions to CDRH, FDA, and national audiences to

promote the mission and messages of CDRH and FDA

Division of Mammography Quality and Radiation Programs

• implements the Mammography Quality Standards Act, including the

certification and annual inspection of all mammography facilities

• supports collaborative activities that help protect the public from unnecessary

exposure to electronic product radiation

• administers the CDRH radiation safety office

Bailey, David W. Jefferson, Arnette L. Rose, Stanley C.

Boyce, Wallace C. Kogok, Richard A. Scimonelli, Glenn M.

Butler, Bruce E. McCleary, Robert F. Silverman, Laurie

Fatula, Robert H. Monica, Stefan F. Vinson, Jeanine M.

Frederic, Kenton P. Richards, Barbara A.

Abernethy, Scott D. Divine, Michael P. Ratskoff, Ellyce F.

Akey, Catherine L. Finder, Charles A. Robinson, Denise J.

Ali, Fiad M. Fischer, Ruth A. Shandruk, Petro

Anderson, Babette M.* Flanagan, Margaret Sheridan, Kathleen M.

Appleby, Suzanne E. Franke, Kathleen A. Sierka, Carole L.*

Ashby, Kimberly A. Friend, Wesley A. Slayton, Robert J.*

Barr, Helen J. Gunzburg, Charles R. Smith, Doris A.*

Belella, Stephanie L. Haran, Timothy J. Spelic, David C.

Bennaugh, Nancy T. Hoage, Patricia A. Stern, Stanley H.

Boyce, Penny R. Jernigan, Vickie H. Suleiman, Orhan H.

Burkhart, Roger L. Kaczmarek, Richard V. Thompson, Donald L.

Chakrabarti, Kishalaya Marks, Beverly A.* Trammell, Dennis L.

Chesemore, Kaye F. McCrohan, John L. Wandell, Evelyn P.

Chissler, Pamela G. Mourad, Walid G. Wei, Stella D.

Choy, Joanne K. Moyal, Albert E. Wynne, Nancy M.

Clingerman, Angela H. Netzer, Ruth M.*

Dennis, Malcolm M. Pack, Randy F.
OHIP FY2000 Annual Report, page 63

* No longer with OHIP as of January 31, 2001

Division of Device User Programs and Systems Analysis

• provides human factors and systems analysis to reduce use error by

evaluating device design, instructions for use, and patient labeling in

premarket and postmarket reviews

• conducts and advises on qualitative research to help construct risk messages

and analyze internal processes

• develops information and outreach for health professionals and consumers

Division of Small Manufacturers Assistance

• educates industry and helps them comply with FDA regulations

• educates consumers on medical device and radiation emitting product issues

and problems

• educates foreign governments on the U.S. regulatory process

• supports global harmonization and MRA (Mutual Recognition Agreement)

activities

Cangelosi, Robert J. McCracken, Jack E. Scott, Walter L.

Carstensen, Peter B. Meadows, Susan K. Silberberg, Paula G.

Clayton, Carol M. Mendelson, Michael Thomas, Alvin W.

Crowley, John J.* Pijar, Mary Lou Tolbert, Margaret T.

Houchins, Donna E. Rachlin, Jay A. Weiss, Ruth

Lowe, Nancy S. Rooks, Cornelia B. Wollerton, Mary Ann

Kaye, Ronald D. Sawyer, C. Richard

Kingsley, Patricia A. Seligson, Edith D.

Alderton, Bonnie J. Greberman, Melvyn Snesko, Walter M.

Alford, Ardeen S.* Leonard, Nancy M. Stellar, Barbara P.

Allen, Gene E. Lowery, Andrew* Stigi, John F.

Auerbach, Jessica B. Lucas, James E. Strojny, Judith L.

Barcome, Althea L. Nelson, Marie C. Sutton, William M.

Benesch, Bryan H.* Park, James J. Taylor, Tawana V.

Bracey, Alfred Parr, Ronald P. Watts, Crystal

Cardamone Thomas E. Pritchard, Lisa M. Weller, Phyllis S.

Carland, Deborah C. Puleo, Joseph V. Willis, Marcellus E.

Clark, Geoffrey S. Raines, Joyce A. Winston, Frederick B.

Fedorchak, Carol M. Rice, Lynne L. Yellin, Arthur K.

Freeman, Nancy J. Rodgers, Anthony E.
OHIP Organization Chart

Office of Health and Industry Programs

Director

Lireka Joseph

Deputy Director

Linda Brophy

Assistant Director for Program Operations

Cliff Evans

Division of

Communication

Media

Director, Robert McCleary

Regulations Staff

Director, Joseph Sheehan

Staff College

Director, Mark Kramer

Division of Device

User Programs

and Systems Analysis

Director, Cornelia Rooks

Division of Small

Manufacturers

Assistance

Director, John Stigi

Division of Mammography

Quality and

Radiation Programs

Director, John McCrohan

Television Design and

Development Branch

Chief, Robert Fatula

Deputy Director

Margaret Tolbert

Associate Director

Jay Rachlin

Labeling Research and

Policy Development Branch

Chief, Patricia Kingsley

Human Factors

Engineering Branch

Chief, Robert Cangelosi

Outreach and Public

Participation Branch

Chief, Alvin Thomas

Deputy Director

 Lynne Rice

Associate Director

 Al Bracey

Associate Director

 Mel Greberman

Associate Director

 Tony Rodgers

International Staff

 Chief, Chris Nelson

Technical Assistance Branch

 Chief, Joseph Puleo

Operations Branch

 Chief, Frederick Winston

Regulatory Assistance Branch

Chief, Thomas Cardamone

Deputy Director

 Helen Barr

Associate Director for

Policy & Clinical Affairs

Charles Finder

Associate Director for

Administration

 Kate Sheridan

Inspection Support Branch

 Chief, Kathleen Franke

Information Management and

Support Branch

 Chief, Tim Haran

Radiation Programs Branch

 Chief, Orhan Suleiman

Accreditation and

Certification Branch

 Chief, Ruth Fischer

Outreach and Compliance Branch

 Chief, Nancy Wynne