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30–528 PDF 2006

MEDICAL DEVICE SAFETY: HOW FDA REGULATES

THE REPROCESSING OF SUPPOSEDLY SINGLEUSE DEVICES

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

SECOND SESSION

SEPTEMBER 26, 2006

Serial No. 109–190

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

JEAN SCHMIDT, Ohio

BRIAN P. BILBRAY, California

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

DAVID MARIN, Staff Director

LAWRENCE HALLORAN, Deputy Staff Director

BENJAMIN CHANCE, Clerk

MICHAEL GALINDO, Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

(III)

C O N T E N T S

Page

Hearing held on september 26, 2006 ..................................................................... 1

Statement of:

Selvey, Don, senior vice president, regulatory affairs and quality assurance, Ascent Healthcare Solutions, Inc.; Dennis J. Toussaint, director,

regulatory affairs, Sterilmed, Inc.; and Stephen J. Ubl, president and

CEO, Advanced Medical Technology Association ....................................... 39

Selvey, Don ................................................................................................ 39

Toussaint, Dennis J. ................................................................................. 56

Ubl, Stephen J. .......................................................................................... 73

Schultz, Dr. Daniel G., Director, Center for Devices and Radiological

Health, Food and Drug Administration ...................................................... 13

Letters, statements, etc., submitted for the record by:

Davis, Chairman Tom, a Representative in Congress from the State of

Virginia, prepared statement of ................................................................... 4

Schultz, Dr. Daniel G., Director, Center for Devices and Radiological

Health, Food and Drug Administration, prepared statement of ............... 17

Selvey, Don, senior vice president, regulatory affairs and quality assurance, Ascent Healthcare Solutions, Inc., prepared statement of .............. 41

Toussaint, Dennis J., director, regulatory affairs, Sterilmed, Inc., prepared statement of ........................................................................................ 58

Towns, Hon. Edolphus, a Representative in Congress from the State

of New York, prepared statement of ........................................................... 92

Ubl, Stephen J., president and CEO, Advanced Medical Technology Association, prepared statement of ..................................................................... 75

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of ........................................................... 8

(1)

MEDICAL DEVICE SAFETY: HOW FDA REGULATES THE REPROCESSING OF SUPPOSEDLY SINGLE-USE DEVICES

TUESDAY, SEPTEMBER 26, 2006,

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:40 a.m., in room

2157, Rayburn House Office Building, Hon. Tom Davis (chairman

of the committee) presiding.

Present: Representatives Tom Davis, Mica, Gutknecht, Porter,

Foxx, Schmidt, Waxman, Owens, Towns, Cummings, Kucinich, and

Norton.

Staff present: David Marin, staff director; Larry Halloran, deputy

staff director; Keith Ausbrook, chief counsel; A. Brooke Bennett,

counsel; Susie Schulte, professional staff member; Michael Galindo

and Benjamin Chance, clerks; Karen Lightfoot, minority communications director/senior policy advisor; Stephen Cha, minority professional staff member; Sarah Despres, minority counsel; Early

Green, minority chief clerk; and Jean Gosa, minority assistant

clerk.

Chairman TOM DAVIS. I apologize for being a couple of minutes

late. I want to welcome everybody to today’s hearing on the Food

and Drug Administration’s regulation of reprocessed single-use devices.

The purpose of this hearing is to assess FDA’s oversight of the

reprocessing industry and determine what, if any, additional measures are needed to assure reprocessed SUDs are effective and safe.

FDA is responsible for approving these devices. Manufacturers

choose to submit applications for single-use only designation as opposed to multi-use designation. FDA, however, allows reprocessed

SUDs to be marketed if they are substantially equivalent to the

original device.

Many of you may not be aware that several commonly used medical devices are cleaned and resterilized to be used by hospitals

more than once. Devices such as catheters, biopsy forceps, and surgical tools are often designated for one-time use, but hospitals routinely pay to have them reprocessed to cut costs and reduce medical waste. For example, new biopsy forceps can cost $60, yet reused

forceps can cost as little as $15. Savings from use of reprocessed

devices can be significant.

Original device manufacturers have said, however, they cannot

guarantee the safety of SUDs once they are reprocessed and reVerDate 11-MAY-2000 12:04 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 D:\DOCS\30528.TXT HGOVREF1 PsN: HGOVREF1
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used. Reprocessors contend there is no sufficient or credible evidence to indicate the use of reprocessed medical devices is riskier

than the use of new ones. Hospitals may save overhead costs, but

what is the cost of patient’s health? That is just one of the many

questions we are going to ask today.

The committee’s interest began with a series of articles in the

Washington Post that reported many instances of patient injury associated with the use of defective and unsterile reprocessed devices.

Mr. Waxman and I wrote to the FDA, asking for information on device safety regulations and the adequacy of adverse event data. The

FDA responded that the data in hand did not establish a clear

causal link between reprocessed devices and subsequent adverse

health effects, but we need to know whether that is because the reprocessed devices are safe or because MedWatch, the adverse event

monitoring system, is too passive or insensitive to capture subtle

but potentially deadly trends.

Today’s hearing will question whether FDA’s current MedWatch

reporting system can accurately capture adverse events resulting

from reprocessed devices. We will ask FDA how new labeling requirements under the Medical Device User Fee and Modernization

Act are working to help improve the MedWatch system. Effective

last month, reprocessed devices are required to be stamped or

tagged with a label indicating they have been reprocessed. Previously, only the packaging was required to identify the device was

reprocessed, and most doctors were unaware devices were reprocessed as packaging is often removed prior to use in the operating

room.

Now look, I realize some of our witnesses will say it is too early

to clearly determine what impact the new labeling requirement will

have on adverse event reporting, and that is OK. Today’s hearing

will not be the committee’s final look at the issue.

Mr. Waxman and I have asked GAO to update its June 2000 report on SUDs. GAO’s initial report found little harm from reuse

but recommended additional oversight by the FDA. Because FDA

regulation of the industry has increased significantly since 2000,

the committee asked GAO to specifically examine the safety of

SUD reprocessing, the adequacy of FDA’s oversight, and how reprocessed SUDs compare to original devices. GAO has accepted this

request, but they have not yet initiated work.

Before we move to our first panel, I am going to express my disappointment in the original device manufacturing industry. We

have no device makers testifying today because they preferred to

speak through their trade association, AdvaMed. Specifically, C.R.

Bard, a company from Murray Hill, NJ, was invited to testify, but

they declined to appear. We would have preferred to have direct

testimony from companies so they would be able to provide specific

examples and commentary regarding their specific devices. Despite

the committee’s disappointment with the lack of original device

manufacturer witnesses, we will continue our discussions with

those companies.

We have the reprocessors represented by SterilMed and Ascent

Healthcare Solutions, the two largest companies in the business,

ready to testify today, and I want to thank them for appearing.

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I look forward to your testimony from both panels on this important issue.

[The prepared statement of Chairman Tom Davis follows:]

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Chairman TOM DAVIS. I would now recognize Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman for holding today’s hearing on the safety of reprocessed medical devices.

FDA’s oversight of medical devices is an important issue that

does not get sufficient attention. Medical devices can be as critical

to a patient’s care as the drugs they are prescribed. There are devices that keep the heart beating, to measure the level of oxygen

in blood, to deliver pain medication, and to test blood pressure.

When devices fail, there can be very serious consequences including

death.

Today’s hearing is focused on the risks of reprocessed medical devices, but the safety risks posed by medical devices are by no

means limited to reprocessed devices. One example is the recent

manufacturing defects in brand new implantable cardiac

defibrillators. These are devices that are implanted into people

with heart problems and that can save a person’s life by shocking

a nonfunctioning heart back into rhythm. Even after one major

manufacturer of defibrillators learned that some of its devices were

flawed, the company did not inform physicians or the public, and

the faulty defibrillators continued to be surgically implanted.

Eventually, there was an after the fact recall, but by this time,

the faulty defibrillators had already been implanted and patients

were put into the position of having to live with defibrillators that

could fail or undergoing another surgery to have them replaced.

That is a terrible position for anyone to be in.

In recent years, there has been a concerted effort to strengthen

FDA regulation of reprocessed devices. A series of congressional

hearings and a GAO investigation showed that this was an area

that needed more regulation. FDA then asserted its jurisdiction

over device reprocessors, subjecting them to the same standards as

other device manufacturers, and in 2002 and in 2005, Congress imposed additional requirements on the manufacturers. The last of

the new rules for reprocessed devices went into effect in August.

As a result, we no longer have a regulatory scheme that allows devices to be cleaned and reused with no oversight. Under the law,

reprocessed devices are actually more tightly regulated now than

their single-use counterparts.

I understand that the original equipment manufacturers do not

like reprocessing. They have an economic concern about this practice. The practice of reprocessing cuts into their profits and often

forces them to lower their prices to stay competitive. Their agenda,

however, should not be our agenda.

The safety concerns with reprocessed devices have to be understood within the broader context of device safety. Under the FDA’s

current regulatory scheme for reprocessed devices, FDA assures us

that a reprocessed device will meet the same exact standards as

the original device. It must be just as strong and just as sterile as

it was the first time it was used. So, as we question FDA’s ability

to assure that reprocessed devices are safe and effective, as we

should, we must recognize that we are, in effect, questioning FDA’s

ability to ensure that all devices are safe and effective.

We will hear today that FDA is not devoting enough resources

to enforcing the requirements that apply to reprocessed devices. I

share these concerns.

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I want to learn how the new regulations for manufacturers of reprocessed devices are being implemented, and I hope we will do everything we can to urge FDA to be more effective bringing enforcement actions for violations of the regulations governing reprocessed

devices. But we must recognize that FDA’s failure to protect the

public extends beyond reprocessed devices. The reality is that FDA

is also not doing a good job protecting Americans from the dangers

of new devices, and it is the original devices, not reprocessed ones,

that cause the largest number of deaths and injuries.

I issued a report in June that revealed that FDA enforcement actions have declined significantly under the Bush administration.

Among FDA’s regulatory centers, the Center for Devices and Radiological Health saw the biggest decline in enforcement with a 65

percent drop in the number of warning letters it issued from 2000

to 2005. This report made clear that in the last 5 years, FDA has

chosen to ignore the advice of its own staff, has taken far fewer enforcement actions than in previous years, and has left the industry

to police itself.

In order to put the issue of reprocessed medical devices into the

broader context of device safety, I requested that Dr. Peter Lurie

from Public Citizen be invited to testify. For reasons that I do not

understand, my request was denied. Dr. Lurie is a consumer advocate with no financial stake in this issue. He would have provided

an important public health perspective to today’s hearing, and it is

unfortunate he was not allowed to participate.

Americans rely on the FDA to make sure that the foods they eat,

the drugs they take, and the devices that they need are safe and

effective. Unfortunately, recent tragedies like the faulty

defibrillators have shaken consumers’ confidence that FDA is effectively fulfilling this role.

I look forward to learning from our witnesses today steps we can

take to strengthen FDA’s oversight of all medical devices so that

we can have this faith restored. I thank the witnesses for coming.

Thank you, Mr. Chairman.

[The prepared statement of Hon. Henry A. Waxman follows:]

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Chairman TOM DAVIS. Thank you.

Any other Members wish to make opening statements?

Mrs. Schmidt.

Mrs. SCHMIDT. Thank you, Mr. Chairman. I will be brief. I really

appreciate the opportunity to have this hearing today. I first became aware of the issue of using reprocessed single-use medical devices in my own district with people that had concerns over the fact

that patients may not know these devices are being used, doctors

may not know that these devices are being used, and the quality

of them being reprocessed.

I look forward to an insightful debate on this issue. The concern

and the bottom line that I have is that when a patient seeks medical treatment that the best care is being provided, the safest care

is being provided, and that the patient understands that when a

reused device is going to be used, that they know the ramifications

of that.

I thank you very much for the opportunity to learn more about

this.

Chairman TOM DAVIS. Thank you very much.

Any other Members wish to make opening statements?

If not, we will proceed to our first panel. We have Dr. Daniel

Schultz, the Director of the Center for Devices and Radiological at

the Food and Drug Administration.

Dr. Schultz, thank you for being here. Why don’t you just remain

standing, and I will swear you in.

[Witness sworn.]

Chairman TOM DAVIS. Thank you.

You have a light in front of you that turns orange after 4 minutes, red after 5. Your entire statement is part of the record, and

questions will be based on your entire written statement. Thanks

for being with us.

STATEMENT OF DR. DANIEL G. SCHULTZ, DIRECTOR, CENTER

FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND

DRUG ADMINISTRATION

Dr. SCHULTZ. Good morning, Mr. Chairman, members of the committee.

My name is Dan Schultz. I am Director of the Center for Devices

and Radiological Health at the Food and Drug Administration. The

safety of medical devices is of utmost importance to the agency,

and I appreciate the opportunity to discuss the safety and effectiveness and manufacturing quality of reprocessed single-use devices or

SUDs.

My written testimony includes an overview of our regulatory authority for medical devices. FDA classifies medical devices into

Class I, II, and III, based on risk, Class III being the highest risk.

Currently, only Class I and II single-use device types have been

cleared by FDA for reprocessing.

Let me provide some background on the regulation of reprocessed

devices. In August 2000, FDA issued guidance enforcement priorities for single-use devices reprocessed by third parties in hospitals.

Again, this was prior to any specific legislation on this issue. It was

based on a series of meetings that we held and input from stakeVerDate 11-MAY-2000 12:04 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 D:\DOCS\30528.TXT HGOVREF1 PsN: HGOVREF1
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holders, which suggested that there was interest in having closer

regulation on this topic.

This guidance set forth FDA’s priorities for enforcing pre-market

submission and post-market requirements for manufacturers who

wish to market reprocessed SUDs. The guidance document stated

that any third party and hospital reprocessor should comply with

requirements pertaining to registration and listing, medical device

reporting, medical device tracking, medical device corrections and

removals, the quality system regulation, labeling, and pre-market

submission. Essentially, at that time, reprocessors were placed on

the same regulatory framework as the OEMs.

Prior to issuance of this guidance, reprocessors were not consistently held accountable to any of these requirements. In 2002, with

enactment of MDUFMA, Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the

pre-market submission of data that exceeded the requirements for

OEMs. Certain reprocessed SUD types that present the greatest

potential risk of infection and inadequate performance following reprocessing and that were previously exempt from pre-market submission were no longer exempt.

MDUFMA also created a new type of pre-market submission

called a pre-market report for Class III reprocessed SUDs that otherwise would have required a pre-market approval application.

MDUFMA also required a change to FDA’s MedWatch voluntary

and mandatory reporting forms to identify adverse events involving

reprocessed SUDs. As of August 1, 2006, MDUFMA also requires

reprocessed SUDs to bear the name, abbreviation, symbol of the reprocessor, either on the device itself, on an attachment, or a detachable label.

Under the FD&C Act, before introducing a device to market,

manufacturers must submit a notification of 510(k) and obtain

FDA clearance unless the device has been exempted. MDUFMA required FDA to identify previously exempt device types that, if processed as an SUD, would now require 510(k) submission including

the submission of validation data. In addition, MDUFMA required

the FDA identify SUDs already subject to 510(k) pre-market requirements but that would now also require the submission of validation data. Validation data include cleaning and sterilization and

functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate after the maximum

number of times the device is intended to be reprocessed.

On June 1, 2004, FDA issued Guidance for Industry and FDA

Staff, MDUFMA 2002, Validation Data in Pre-market Notification

for Reprocessed Single-Use Medical Devices. This document describes the types of validation data that FDA expects to be submitted on cleaning, sterilization, and functional performance, the timeframe for FDA’s review of these submissions, and what actions the

agency intends to take if it finds a reprocessed SUD to be not substantially equivalent.

As of September 2006, FDA has received 200 pre-market notification submissions for reprocessed SUDs, each covering from a single

to as many as several hundred device models. Approximately 67

percent have been cleared by the agency. The remaining were not

cleared for reasons such as inadequate validation data, lack of necVerDate 11-MAY-2000 12:04 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 D:\DOCS\30528.TXT HGOVREF1 PsN: HGOVREF1
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essary information from the reprocessor, withdrawal of the application, or lack of response to FDA’s request for data. Just to give you

some perspective on this and put it in context, of the total number

of 510(k)’s that we received, approximately 88 percent of all those

are cleared.

Inspections serve as a bridge between pre and post-market activities. On the average, FDA has conducted inspections of reprocessor

firms once every 2 years, a rate considerably higher than the one

in every 4 years for OEMs. All known reprocessing firms have been

inspected within the last 2 years. FDA continues to evaluate newly

registered firms to confirm whether they are performing SUD reprocessing and updates its inspectional plan as required.

Post-market; post-market monitoring of device-related adverse

events and product problems is accomplished through the MDR

system. MDR reports include deaths, serious injury, and device

malfunctions. Healthcare facilities are required to report deaths

suspected to be device-related to both FDA and the manufacturer/

reprocessor and serious injuries to the manufacturer/reprocessor.

FDA also receives voluntary reports generally from healthcare professionals through its MedWatch reporting system. CDRH receives

approximately 200,000 device-related adverse event reports per

year.

Can I continue? Oh, sorry.

As you know, on January 24, 2006, I and others briefed the committee staff about SUD reprocessing. We searched our Manufacturer and User Facility Device Experience data base for reports

from October 22, 2003, which is when the MDUFMA legislation

went into effect, to December 13, 2005, that were coded as adverse

events associated with reprocessed SUDs. Analysis of these reports

did not disclose a clear link between a reprocessed SUD and subsequent patient injury or death.

In July 2006, the agency updated the search to include all reports between October 2003, and July 2006. FDA has received a

total of 434 reports and, of these, approximately 65 reports involved or were suspected to involve reprocessed SUDs. These AEs

may be associated with reprocessing. They may also be associated

with the medical condition of the patient, the medical procedure, or

other confounding factors. We are seeing that the same types of adverse events reported to be associated with the use of SUDs are

similar for new, non-reprocessed devices.

To learn more about how reprocessing was actually occurring

from a user standpoint, we conducted a survey under our Medical

Product Device Safety Network or MedSun. FDA’s MedSun is comprised of over 350 hospitals that identify and report device problems, and this is a more active surveillance system as opposed to

the MAUDE system which is a much more passive system. Representatives from more than 50 of these facilities provided feedback

on their experience with reprocessed SUDs to FDA staff. In general, participants had a favorable view of reprocessed SUDs. There

were no reports with specific problems with SUD-related infections,

and participants did not report a greater concern with mechanical

problems associated with reprocessed SUDs compared to non-reprocessed SUDs.

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I would like to emphasize, however, that one of the statements,

and there was some variability in terms of the comments that we

got, but one of the statements that was clear and was totally consistent was the idea that it was, that they found it necessary and

desirable for FDA to have a strong oversight over this process.

The agency continues to review and assess the practice of reprocessing SUDs. I have some specifics in my written summary.

Just yesterday, FDA published rules amending certain classification regulations for reprocessed SUDs formerly exempt from premarket, those previously subjected to pre-market notification, and

for which validation data are now necessary in a 510(k). These

amendments will help reprocessors and other stakeholders to know

which devices are being reprocessed and allow them to submit the

data that they need to demonstrate that their device is substantially equivalent.

We have also recently updated our Web site. We have also recently initiated a dedicated post-market team to look specifically at

the adverse events associated with reprocessing, and we continue

to update our inspection plan to make sure that we are inspecting

all of the reprocessors on a regular basis.

Available data show that certain—and I emphasize the word, certain—SUDs can be reprocessed with a reasonable assurance of

safety and effectiveness. FDA believes that reprocessed SUDs, that

meet FDA’s regulatory requirements are as safe and effective as

their predicate. The law and regulations in place are designed to

protect the public health by assuring that reprocessing is based on

sound science. We continue to monitor the performance of these devices and to assess and refine our ability to regulate them appropriately.

Mr. Chairman, I apologize for running over. Thank you again for

the opportunity to address this important topic.

[The prepared statement of Dr. Schultz follows:]

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Chairman TOM DAVIS. Thank you very much.

I am going to start the questioning with Mr. Gutknecht.

Mr. GUTKNECHT. Mr. Chairman, I don’t have a question so much

as a comment.

I am delighted the FDA is taking some of these issues seriously,

but I just want to make sure that we don’t overstate the danger

here. I just don’t want consumers to believe that there is real risk.

In your professional judgment, how many American consumers

have been injured by some of these reused technologies?

Dr. SCHULTZ. I wish I could give you an exact count; I can’t.

Again, we have looked at all of the reports that have been submitted to us, most of the reports, and we were given specific authority to designate those reports as whether they are reprocessed

or non-reprocessed. Unfortunately, a lot of those reports were incorrectly designated. When we looked at them specifically one by one,

of those that remained, there certainly are some that could have

been associated with reprocessing, but based on the data and actually the in-depth analysis of those individual reports, as I said, it

is very difficult to precisely, precisely define which ones were, in

fact, associated with the reprocessing versus the device or the overall procedure. I apologize for not being able to give you a more specific answer, but that is the honest answer of what we currently

know.

Mr. GUTKNECHT. My point really is, Mr. Chairman and Members,

I think we have to put this in some context. The unfortunate fact

is that somewhere between 6,000 and 10,000 Americans die every

year in hospitals as a result of either getting the wrong medication

or an infection which they actually caught while they were in the

hospital. In the very rare circumstance of that infection, did that

have anything to do with a reprocessed medical device?

I think it is important we have this hearing, Mr. Chairman, but

I think we have to put it in context. No. 1, we don’t have very good

data, and second, the data that we do have doesn’t suggest that

American consumers, American patients are at any undue risk because of the reprocessing of medical devices.

I know in talking to some of the healthcare people in my district

and in the State, they do want to use these because they can see

significant savings rather than having to buy all new equipment.

If it were up to the device manufacturers, there would be no reprocessing at all.

So the only thing I would say—and I want to thank you for your

testimony—is that the evidence here is pretty scant that there is

real harm being done to American consumers by this technology.

I yield back.

Chairman TOM DAVIS. Thank you very much.

Mr. Waxman.

Mr. WAXMAN. Thank you, Dr. Schultz, for your presentation.

As I mentioned in my opening comments, I didn’t really want to

restrict my comments to reprocessed devices alone because in some

ways there is a blur between the two. I do want to ask you about

what your office is doing regarding device safety generally.

I mentioned in my opening comments the cardiac defibrillators

made by Guidant. The New York Times broke the story about the

Guidant pacemakers. There was little movement by your agency to

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look further into the company, despite reports of short circuits for

years preceding this effort. Your agency, in fact, knew about these

problems for years before the New York Times story. Can you explain your agency’s delay in action?

Dr. SCHULTZ. Yes, we have looked at that very carefully, Mr.

Waxman, because obviously it was an issue that concerned us a lot

as well.

One of the things that we have done over the course of the last

year is to look at all the different ways that we get input regarding

medical devices, and I think what we found is that we get input

from a lot of different sources. We get input from patient reports.

We get input from inspections. We get input from reports that

manufacturers are required to submit as part of their routine postmarket reporting, especially on PMA devices. I think one of the

things that we have found is that it is very difficult sometimes to,

what I call, connect the dots and to be able to put together the information, the patient report information, the inspectional information, and the updated manufacturing information.

Mr. WAXMAN. Notwithstanding that, obviously you have to connect the dots before you do something, but I guess one of the

sources of information is reading the newspaper because they

seemed to come up with a story that connected the story in advance of the FDA.

I wonder if this is part of the problem. FDA’s enforcement actions have declined under the Bush administration. In fact, your

Center on Devices had the greatest drop with 65 percent fewer

warning letters in 2005 than in 2000. How can you explain such

a sharp dropoff in enforcement during a time of increasing problems in devices such as implantable pacemakers and defibrillators?

Dr. SCHULTZ. Well, I am not sure that, I am not sure I would

characterize it as increasing problems, and in terms of the 65 percent number, I don’t have that number in front of me, but I certainly would take you, that that is, in fact, the number. I think

that one of the things that we have been asked to do is to make

sure that the warning letters that we do send out are consistent

and are reviewed at higher levels to make sure that they are, in

fact, consistent so that we are not sending warning letters to some

companies as opposed to other companies.

Other than that, I can tell you that the people that I work with

and the people that are in my center are constantly looking at

problems related to manufacturing and submitting appropriate,

what I consider to be appropriate action items to deal with those

problems. Sometimes they are warning letters. Sometimes they

may be so-called untitled letters where we feel that some of those

corrections can be made in other ways. Sometimes they are injunctions. Sometimes they are seizures.

Mr. WAXMAN. Have you ever had your staff recommend enforcement action and then send it up to other higher levels than the

FDA and have it turned it down?

Dr. SCHULTZ. I am sure that there are instances where warning

letters have gone through different layers of review and have not

gone forward. I can’t tell you specifically.

Mr. WAXMAN. Maybe you can get us some information for the

record.

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Dr. SCHULTZ. We can do that. We can do that.

Mr. WAXMAN. MDUFMA required FDA to develop a list of reprocessed devices for which companies would be required to submit

supplemental validation data. Can you walk us through the process

FDA used to select the devices on that list?

Dr. SCHULTZ. Sure; basically, we used sort of a dual approach.

One was using the so-called Spaulding criteria where we looked at

the inherent risk of that particular type of device in terms of what

part of the body it came in contact with. Under those criteria, there

are certain types of devices that touch normally sterile parts of the

body, for instance, the inside of the abdominal cavity or the chest

cavity; there are other what is called semi-critical devices which

touch mucosal surfaces such as the inside of the gastrointestinal

tract or the inside of the respiratory tract; and then there are low

risk devices which basically come in contact with intact skin.

So we looked at that. We sort of used that as a starting point,

and then we also looked at the device itself. There are some devices

that are relatively simple and straightforward in terms of how they

could be cleaned and how they could be sterilized, and we tried to

gauge the complexity of the device and how difficult it would be to

reprocess in conjunction with the criticality of how the device was

being used.

So we combined those two sets of criteria and came up with a

list of what we thought were the most important, the most urgent

to regulate, and then sort of worked our way down from there.

Mr. WAXMAN. Thank you.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you.

Mrs. Schmidt.

Mrs. SCHMIDT. Thank you, Mr. Chairman. I have a few questions.

I think the first and the most basic that I have is I have a little

trouble with if something is designed for single use, how can it be

reprocessed too for dual use?

Let me give you an analogy. In auto racing, there is a difference

between drag cars and cars that go around and around on a track.

Drag cars’ engines are built for a single use, a single time, and

then they get rebuilt. They are not built to go more than once. If

these devices are being built to go one time, how can they be reprocessed and be safe?

Dr. SCHULTZ. OK; I am not an expert on car racing, but what I

would tell you is when we look at any product, whether it be a reprocessed product or a non-reprocessed product, we don’t make a

decision sort of before the fact as to whether or not that particular

product can or can’t be used in that particular manner. What we

do is we say, OK, you want to do this. You want to label your product to be used in such a way. You must provide us with the data

that shows that, in fact, that can happen safely and effectively.

You are right; I think in some cases, there are single-use devices

that cannot and should not be reprocessed. But what we have

found in terms of our own review process, not what somebody tells

us or doesn’t tell us but in terms of our own review process is that,

in fact, some devices—again, I tried to be careful in my testimony

that certain devices, we believe, can be reprocessed safely and efVerDate 11-MAY-2000 12:04 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00035 Fmt 6633 Sfmt 6633 D:\DOCS\30528.TXT HGOVREF1 PsN: HGOVREF1
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fectively—that some devices, in fact, can be used more than once

if they are properly reprocessed. And we clear those devices if, and

only if, the manufacturer, in this case, reprocessor, provides us

with data to demonstrate that is, in fact, the case and they have

to tell us, in fact, how often the device can be reprocessed safely.

Mrs. SCHMIDT. Mr. Chairman, may I have two more questions?

Chairman TOM DAVIS. Yes, go ahead.

Mrs. SCHMIDT. Thank you.

The second one I have is on the labeling of the devices.

Dr. SCHULTZ. Right.

Mrs. SCHMIDT. Last winter, I had the opportunity to actually review some of these devices, and it would be very, very hard for anyone including a physician to figure out whether the device was new

or reprocessed because, in some cases, there is just a little teeny

dot on the instrument to note that it is a reprocessed instrument.

Dr. SCHULTZ. Right.

Mrs. SCHMIDT. What kind of labeling do you have in place?

Dr. SCHULTZ. The new statute with regards to device labeling, as

was mentioned in some of the opening comments, went into effect

on August 6th. I think there was a recognition by Congress that

there needed to be a clearer designation of those devices that are

reprocessed versus those devices that are, in fact, being used for

the first time, and that was something that needed to be done.

That was part of the MDUFSA legislation, and that legislation

went into effect as of August of this year. So, in terms of what was

done, I can tell you that we did, in fact, that those requirements

did go into effect. In terms of the outcome, what effect, and how

successful that will be in terms of alleviating some of the concerns

that you have heard, I think we will have to just wait and see what

happens.

Mrs. SCHMIDT. A followup, sir; what kind of label? What does

this label look like that is one of these devices now?

Dr. SCHULTZ. It really depends on the device itself. This is a

problem with labeling in general. Some devices can have relatively

large, prominent labels if they are large devices. Some devices, the

labeling is, by definition, based on the size of the device, fairly

small. In those cases, there are exceptions where the label can actually be an attachment to the device as opposed to actually being

imbedded in the device itself.

So, again, I think what we are trying to do is take sort of a common sense approach to this to make sure that the labeling actually

is legible and is of a size that people can actually see it and understand who the device manufacturer is for that particular device.

Mrs. SCHMIDT. One final question, if I may; you said in your testimony that there is a savings aspect to this. Can you give me an

indication of what the cost savings to reuse the device per procedure?

Dr. SCHULTZ. I think what I said was that in our talking to the

user hospitals, that they expressed a benefit in terms of cost savings. We, at FDA, do not look at cost as one of our criteria regarding whether we clear or don’t clear devices for market. We simply

look at whether the device meets the criteria for safety and effectiveness.

Mrs. SCHMIDT. Thank you, sir.

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Chairman TOM DAVIS. Mr. Towns.

Mr. TOWNS. Thank you very much, Mr. Chairman, and thank

you for holding this hearing.

Dr. Schultz, do you think that the patient has the right to know

that this is being reused or that they have the right to refuse the

treatment with the reprocessed if they know it? What is your position on that?

Dr. SCHULTZ. Well, in terms of our authority, we clear devices

based on the data that is provided to us, and once a device is clear

for marketing, it is designated as a legally marketed product. So

we don’t discriminate between devices that are reprocessed versus

those that are not reprocessed, just as if we don’t discriminate between various models and various different product types.

So I guess I am not trying to avoid your question. I think it is

a good question.

Mr. TOWNS. You are not answering it; you know that.

Dr. SCHULTZ. Well, I guess what I am saying is that my best understanding, is that our authority does not extend to deciding

whether or not patients should be informed about reprocessing or

lack of reprocessing. Our authority is to make sure that the devices, in fact, are as safe and effective as the original devices.

Mr. TOWNS. The testimony here is very conflicting, of course. Do

you feel that maybe an independent group should analyze and

evaluate this because when you listen or read the testimony here,

one person is saying it is great, it is no problem, and another is

saying it is not. Do you think that maybe we should have some

independent person to evaluate all of this?

Dr. SCHULTZ. Congressman, if I may, I would like to believe that

we do, in fact, function as that independent person because frankly

whether or not a device is reprocessed or whether it is an original

device, I and my staff have one concern and one concern only,

which is will that device perform as intended and will it provide

a benefit to the patient in whom it is being used. So I can’t speak

to whether there ought to be another independent body looking at

these questions, but I can tell you that is how we look at that.

Mr. TOWNS. The question is: Do all hospitals report to you and

indicate to you that there is a problem, if there is one, all hospitals?

Dr. SCHULTZ. All hospitals are required to report problems, and

that, as I mentioned, that is under the passive reporting system

that we have, the so-called MDR system. In addition to that, I

mentioned that we actually, on our own initiative, instituted a survey of some of our MedSun facilities to try to get a better handle

on just the kind of question that you are asking. Are there concerns? What are the concerns? Do people think that this is a good

process, a bad process?

Again, the responses were mixed. The responses, basically, people said no matter what the evidence shows or doesn’t show, they

do not believe that they should be using reprocessed devices. Even

within hospitals, what we found was that there were some doctors,

some parts of the hospitals, some, whether it is G.I. or cardiac may

decide we will or won’t allow the use of reprocessed devices. So

there was a fair amount of variability.

34

What, again, was a clear message to us was we had a responsibility to clearly identify those devices that have gone through our

review process and let the hospitals know which ones have gone

through the review process, which ones haven’t, and inform them

so that they can make up their own minds.

Mr. TOWNS. Let me ask were you able to identify which types of

hospitals traditionally use the reprocessed? Is it rural hospitals,

inner city hospitals? Were you able to establish a pattern as to who

would use this the most?

Dr. SCHULTZ. To the best of my knowledge, we haven’t done that

kind of analysis. My impression was, in participating in some of

those focus group discussions, that they were hospitals of various

sizes and various locations and, in fact, the MedSun program is designed specifically to include different size and different locality

types of facilities. But I don’t have a specific answer to your question.

Mr. TOWNS. Let me just raise, Mr. Chairman, one more question.

Chairman TOM DAVIS. Sure.

Mr. TOWNS. I think it was raised earlier on the other end.

Do you think it is appropriate for the FDA to approve a device

as a single-use device and then turn around and approve the same

device after reprocessing? Should new standards or regulations be

put into place to set a standard for what is labeled as approved for

a single use?

In other words, I just sort of have a little problem with that. If

you approve it as a single-use and then you come back, don’t you

feel uncomfortable with that process?

Dr. SCHULTZ. I feel that we need to look at these devices individually. As I said before, some of these devices, in fact, are labeled

for single-use and cannot and should not be reprocessed. Others

that have gone through our full evaluation process, and if you are

interested, I can provide you some examples of what that evaluation is actually like because that may be sort of helpful in terms

of understanding the kind of rigor that goes into those evaluations.

I have confidence based on what I know our reviewers are doing

and what kind of requirements they are setting up, that those devices that go through our full review process and full inspectional

process are, in fact, going to perform as intended.

Mr. TOWNS. With permission of the chairman, I would appreciate

it if he would submit that.

Chairman TOM DAVIS. OK; if you could try to get that to us, that

would be helpful.

Dr. SCHULTZ. The specific example; sure.

Mr. TOWNS. OK; thank you very much.

Chairman TOM DAVIS. Mr. Cummings.

Mr. CUMMINGS. Thank you very much, Mr. Chairman.

Dr. Schultz, thank you for your testimony. It has been very enlightening.

I just want to go back. Who usually makes the application, a reprocessing company?

Dr. SCHULTZ. Yes, yes.

Mr. CUMMINGS. Basically, other than a hospital perhaps reporting something to you, that is how these things come to issue, is

that right? In other words, is there any other way?

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The reprocessing company says we think this is something that

can be reprocessed. You hear about a problem from a medical establishment.

Dr. SCHULTZ. Correct.

Mr. CUMMINGS. Is there any other way that it would come to

your attention?

Dr. SCHULTZ. We hear about problems from the reprocessors who

get reported back to them, from other parties who get reports submitted to them, and from individual hospitals and practitioners.

Mr. CUMMINGS. Let us rewind.

Dr. SCHULTZ. Yes.

Mr. CUMMINGS. So, in other words, you may approve a device for

reprocessing.

Dr. SCHULTZ. Correct.

Mr. CUMMINGS. The reprocessor then discovers that someone is

having a problem with the device.

Dr. SCHULTZ. Correct.

Mr. CUMMINGS. The reprocessor then has a duty to notify you.

Dr. SCHULTZ. That is correct.

Mr. CUMMINGS. When the reprocessor notifies you, what happens

then?

Dr. SCHULTZ. We look at those reports, decide if there is a pattern, like we do with other adverse event reports, and then take

appropriate action if, in fact, we see a pattern where a particular

type of device is causing a particular type of problem.

Mr. CUMMINGS. Have we seen that happen?

Dr. SCHULTZ. We haven’t.

Mr. CUMMINGS. We have not yet.

Dr. SCHULTZ. That is, part of the dilemma is that, again, we see

a lot of reports. I mentioned we have seen over 400 reports of reprocessed devices. We see about 200,000 reports of all devices. And

thus far, thus far—and we continue to look—thus far, we have not

seen a specific pattern that would require us to take a certain action.

Mr. CUMMINGS. Now, let me ask you this. You said something

that I found very, very enlightening and interesting. You said one

of the things that you are most concerned about is making sure

that the reprocessed device—I am not trying to put words in your

mouth, so correct me—is just as good as or just as safe as the original, is that correct?

Dr. SCHULTZ. That is correct.

Mr. CUMMINGS. Now, it is my understanding that you had 6,500

deaths associated with not reprocessed but original devices, is that

correct, over the last few years?

Dr. SCHULTZ. That is the number that I heard quoted. I would

have to go back and confirm that, but that is the number that I

heard quoted.

Mr. CUMMINGS. Well, would you say there are thousands?

Dr. SCHULTZ. Again, you know, one of the things when we talk

about deaths associated with devices, I think we have to be extremely careful, just as when we talk about deaths and adverse

events associated with reprocessed devices. I think the same holds

true, in general, about looking at those reports critically to see

whether or not the incident in which a device was used was actuVerDate 11-MAY-2000 12:04 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00039 Fmt 6633 Sfmt 6633 D:\DOCS\30528.TXT HGOVREF1 PsN: HGOVREF1
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ally, the problem was actually caused by the device or not caused

by the device. Again, I don’t mean to sort of over-complicate this,

but I——

Mr. CUMMINGS. Doctor, you are not over-complicating. I understand it. I used to practice medical malpractice, so I understand.

Dr. SCHULTZ. OK.

Mr. CUMMINGS. There are all kinds of reasons.

Dr. SCHULTZ. Correct.

Mr. CUMMINGS. When you are talking about the human body,

this very strong but very delicate machine, almost anything can

happen. So it is hard sometimes—I understand what you are saying—to actually pinpoint something to the machine, I mean to the

device.

Dr. SCHULTZ. That is correct.

Mr. CUMMINGS. All right.

Let us go back very quickly and just talk about the criteria. Once

you get that application, what is the criteria? Is it strength?

I know you talked about the different parts of the body that it

might touch. Tell me about how that—I see my time is running

out—or which part of the body it touches. I want you to talk about

strength of the instrument or whatever. I want you to talk about

exactly what goes into the process.

And one last thing, is there a situation where something may be

approved to, say, use it three times? Then the reprocessor says,

look, I can do something to this, and you will be able to use it 10

times.

Can you just incorporate that all in your answer, please?

Dr. SCHULTZ. Let me try to work backward so that I try to cover

all those. In terms of the number of times, again, the reprocessor

has the option of defining how many times they believe the device

can be safely reprocessed. When we do our review, we look at that

number that they are proposing, and we ask a very simple question. Do you have the data to support the claim that you are making in terms of how many times that device can be used?

That means that during the review process, we require that testing be done to show that the device can be used, cleaned, sterilized

if necessary, and that appropriate functional testing—strength testing, bend testing, whatever type of mechanical testing our engineers tell us is appropriate for that particular use—that testing, in

fact, either confirmed or didn’t confirm that number of uses is appropriate. Then we will go back to the manufacturer and say, you

have shown us or you haven’t shown us that, in fact, that device

can be used that many times.

Your other question, I think was describe sort of how the review

process is done. That would take a little bit longer, but let me say

that, in general, we use the same set of criteria that we use for any

other device, which is that we focus on those aspects of the device

that relate to the way in which the device is being used. So if we

are talking about a biopsy forceps, we will be looking very, very

carefully at how the jaws open and close. Is it still able to capture

the amount of tissue that is necessary to make a diagnosis? Is it

able to bend around whatever curves it needs to bend around to get

to the location that it needs to get to in order to perform optimally?

37

Those would be the kinds of questions in addition to: Can it be

cleaned, can it be disinfected in order to be able to be used safely?

I don’t know if that answers your question.

Mr. CUMMINGS. Thank you very much.

Chairman TOM DAVIS. Thank you.

Has FDA ever been able to establish a clear causal link between

reprocessed devices and subsequent adverse health effects?

Dr. SCHULTZ. In general terms?

Chairman TOM DAVIS. In general.

Dr. SCHULTZ. No.

Chairman TOM DAVIS. MedWatch is the adverse event monitoring system, do you think it works well or do you think it is too passive or insensitive to capture the subtle trends?

Dr. SCHULTZ. I think it is. I think the short answer to your question, Mr. Chairman, is that we are looking very hard at the

MedWatch system right now for reprocessing in particular as well

as in general to see what MedWatch does well and what it doesn’t

do well. And I will tell you that MedWatch has been extremely useful in terms of allowing us to pick up signals. It has not been that

useful in terms of helping us to analyze those signals and actually

come to answer the kind of question you are asking, which is why.

You gave us the MedSun program in 1995, I believe, in FDAMA,

that allowed us to have a more active system where we can actually go out and ask questions and try to get specific data from various hospitals.

I think that the MedWatch system, it needs to be improved. We

need to do some updating in terms of getting electronic reports is

one thing that I think would be extremely helpful, which would

hopefully make the reports a little more consistent and also allow

us to input those reports more quickly. But I think that we need

to be realistic in terms of what a passive surveillance system can

provide and what needs to be provided through a more active surveillance system or through ongoing studies.

Chairman TOM DAVIS. In its written testimony, AdvaMed describes two adverse events reports that relate to FDA in 2004.

These reports involve malfunction of a reprocessed heart positioner

and a reprocessed endoscopic vein harvester. Did the FDA act on

these reports?

Dr. SCHULTZ. The heart positioner, that question came up as to

whether or not that particular type of device should fall under the

unexempt provision and whether we should be regulating those.

Subsequent to that, we did, in fact, include that type of device as

part of the review process which, again, required the additional

validation data.

I can’t give you a specific answer for the other one, but I certainly will go back and look at it.

Chairman TOM DAVIS. If you can go back and check.

Dr. SCHULTZ. Yes, sir.

Chairman TOM DAVIS. FDA, were they able to establish a causal

link between the reprocessing and the adverse health effect in

that?

Dr. SCHULTZ. I don’t; again, the information that I got was from

the MDR reports and is what I gave you.

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Chairman TOM DAVIS. Well, let me ask you this. Does FDA require tracking procedures or are the reprocessing companies required to develop those procedures as part of its validation of data

requirements?

Dr. SCHULTZ. Could you be more specific when you talk about

tracking?

Chairman TOM DAVIS. You track the device. You track individual

devices.

Dr. SCHULTZ. These; my best understanding, and I am going to

go back and confirm this, is these do not fall under what we normally consider to be tracked devices which are usually things like

pacemakers and other sort of immediately lifesaving, sustaining devices.

Chairman TOM DAVIS. Well, then what happens when a device

is recalled by an original device manufacturer? Does the FDA ensure that reprocessed devices are withdrawn from the market, or

is it hard to track?

Dr. SCHULTZ. Yes, I mean these devices are considered individually.

Chairman TOM DAVIS. Some are and some aren’t is basically the

answer. I guess that is where the debate lies.

Dr. SCHULTZ. I am sorry?

Chairman TOM DAVIS. I guess that is where the debate is, reuse,

where it can be dangerous and where it can’t, and what should be

tracked and what shouldn’t and how we get into this.

Thank you very much.

I think we will take a 2-minute recess while we move our next

panel up.

Doctor, thank you. You owe us a couple answers, but I appreciate

your patience.

Dr. SCHULTZ. Thank you very much.

[Recess.]

Chairman TOM DAVIS. The hearing will reconvene.

We are going to now move to our second panel. We have Mr. Don

Selvey, the senior vice president of Ascent Healthcare Solutions;

Dennis Toussaint, the director of regulatory affairs, SterilMed; and

Stephen Ubl, the president and CEO of Advanced Medical Technology Association.

It is our policy that we swear you in.

[Witnesses sworn.]

Chairman TOM DAVIS. Thank you.

Please be seated. I think you know the rules.

Mr. Selvey, we will start with you, and we will move straight on

down and then try to get to questions. Again, your entire statement

is in the record. With most of your statements, we think we know

where we want to go on this, so you can keep it within 5. If you

really want or if you need extra time, take it, but I would like to

keep them within 5 minutes, if we can, and then we will move on

to questions. Thanks for being with us.

39

STATEMENTS OF DON SELVEY, SENIOR VICE PRESIDENT, REGULATORY AFFAIRS AND QUALITY ASSURANCE, ASCENT

HEALTHCARE SOLUTIONS, INC.; DENNIS J. TOUSSAINT, DIRECTOR, REGULATORY AFFAIRS, STERILMED, INC.; AND

STEPHEN J. UBL, PRESIDENT AND CEO, ADVANCED MEDICAL TECHNOLOGY ASSOCIATION

STATEMENT OF DON SELVEY

Mr. SELVEY. Thank you, Mr. Chairman, members of the committee.

I am Don Selvey, the senior vice president for regulatory affairs

and quality assurance at Ascent Healthcare Solutions, the Nation’s

largest reprocessor of single-use medical devices. Although I have

more than 16 years experience in the medical device industry, I am

an epidemiologist by training. Prior to my service in the medical

device industry, I spent over a decade as a public health professional in Arizona, originally as a registered sanitarian and then as

head of Infectious Disease/Epidemiology and later as Head of the

Environmental Epidemiology program.

Ascent Healthcare Soultions, headquartered in Phoenix, AZ, employs 800 persons throughout the country. Our customer base consists of approximately 1,600 hospital and surgery centers in the

United States, including most of those facilities annually recognized by the U.S. News and World Report as the top hospitals in

America.

We only reprocess low or moderate risk medical devices such as

compression sleeves, electrophysiology catheters, and orthopedic

tools. We do not reprocess high risk medical devices such as

implantables or devices which come into contact with the central

nervous system or the brain. In fact, we estimate that we are able

to reprocess only 1 to 2 percent of devices labeled for single use.

The emergence of reprocessing in the United States is rooted in

the meaning of the single-use label itself. Contrary to what one

might think, the single-use label is not an FDA requirement. In

fact, FDA does not require any device to carry a single-use label.

Instead, single-use is a designation the original equipment manufacturer [OEM], chooses, and that choice is sometimes made in an

effort to sell more devices, not for patient safety reasons. The truth

is that a manufacturer could label an operating table as being for

single use if the OEM believed it could persuade a hospital to

throw the table out after one use.

To show you some of these single-use devices, I brought along

some external fixation devices and some surgical tools. This, for example, is a clamp. This is a clamp. We are happy to pass those

around, if you like. Here is a surgical saw blade made of stainless

steel. These are the types of single-use devices we are talking

about.

Chairman TOM DAVIS. I am going to let somebody bring these up,

and we will pass them around.

Mr. SELVEY. About two decades ago, some OEMs began to change

the label on certain medical devices from reusable to single-use, in

some cases, without any significant structural changes in the device that would preclude safe reuse. With this change in labeling,

it became evident to many hospitals that the single-use label does

40

not necessarily mean only single use and that certain devices designated by the original manufacturer as single-use can, in fact, be

safely reprocessed. Further evidence that the single-use label does

not always mean a device can only be used one time is the fact that

some original manufacturers reprocess their own single-use devices. In fact, some manufacturers partner with third parties to reprocess devices that manufacturer has labeled as single-use.

Today, reprocessing of devices originally labeled for single-use is

standard practice in the Nation’s top hospitals. Hospitals simply

cannot afford to throw out devices that can be safely reprocessed.

These dollars are better spent on purchasing new medical technology and preserving nursing staff. The savings generated by reprocessing can be significant. A 2000 GAO report found that for

one device alone, the electrophysiology catheter, individual hospitals are saving between $200,000 and $1 million annually as a

result of reprocessing.

As the reprocessing industry has grown, so too has the strident

opposition from the original manufacturers who see reprocessing as

an increasing economic threat. The threat is two-fold. First, reprocessed devices are, on average, about half the cost of the original devices. Therefore, many hospitals choose to use reprocessed devices

rather than purchase new ones. This means lower sales for original

device manufacturers. Second, the very existence of reprocessing

has resulted in a decrease in the price of certain new devices.

Lower prices mean lower prices.

Ascent hopes that this hearing today will make clear that the

third party reprocessing in the United States is safe and that it is

highly regulated. In fact, reprocessors are more stringently regulated than the original equipment industry. Specifically, reprocessors are required to submit validation data in our pre-market

submission while the manufacturers have no such requirement.

Second, certain devices that require pre-market submission for the

reprocess device have no requirement for the original version of

that device. And third, unlike OEMs, we reprocessors are required

to place an identifying mark on the device itself, not simply on the

label.

Reprocessors provide a valuable service to this country’s hospitals, a service that helps hospitals survive in an era of spiraling

healthcare costs. Additional regulation at either the Federal or

State level is not only unnecessary but also, because it would limit

the ability of hospitals to use reprocessed devices, would do a disservice to America’s hospitals and patients.

Thank you, Mr. Chairman.

[The prepared statement of Mr. Selvey follows:]

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Chairman TOM DAVIS. Thank you very much.

Mr. Toussaint.

STATEMENT OF DENNIS J. TOUSSAINT

Mr. TOUSSAINT. Thank you, Mr. Chairman.

My name is Dennis Toussaint, and I am the director of regulatory affairs at SterilMed. I have been in the medical device industry for approximately 18 years. Most recently, my work has been

at SterilMed.

SterilMed was founded in 1997 and is a leading provider of reprocessing and repair services designed to help hospitals and other

healthcare organizations generate substantial cost savings through

better utilization of medical devices. As a medical device reprocessor, SterilMed cleans, tests, packages, and sterilizes previously

used devices that were originally labeled for single use only. During a time of rapidly rising healthcare costs, SterilMed helps its

hospital partners free up critical financial resources that can be devoted to improving their delivery of medical services while maintaining the highest possible quality of patient care at the same

time.

At SterilMed, I am responsible for ensuring the company’s compliance with all reprocessing-related Federal, State, and local regulations. In particular, it is my responsibility to ensure compliance

with the Federal Food, Drug, and Cosmetic Act and all medical device-related regulations of the Food and Drug Administration. As

my colleague, Don Selvey, has just explained, reprocessors are subject to more stringent FDA regulations than OEMs are.

SterilMed currently has more than 800 full-time and part-time

employees throughout the country. We provide reprocessing services to approximately 1,400 healthcare facilities throughout the

United States and Canada. We reprocess approximately 2 million

devices per year. In that context, SterilMed currently saves hospitals over $40 million per year in device expenditures.

The safety record for reprocessed medical devices is nothing short

of outstanding. Of the tens of thousands of patient adverse event

reports that FDA receives through its medical device reporting program [MDR] program, only a very small percentage concern reprocessed single-use devices, and the few problems that have occurred

with reprocessed single-use devices appear to be quite similar to

the types of problems associated with new devices. Indeed, in a recent letter from FDA to Chairman Davis regarding MDR reports

filed since October 2003, to December 2005, the FDA stated expressly that it did not identify any adverse events that were actually related to the reprocessing of the SUD.

A significant body of professional and scientific literature, much

of it from peer review journals, further supports the conclusion that

some single-use devices can safely be reprocessed. A GAO report

confirms the existence of these studies. Because of the reprocessing

industry’s exemplary record of safety, informed hospitals and physicians support the practice of reprocessing. The GAO interviewed

hospital infection control practitioners, risk management executives, and patient safety experts and found that they all reported

that proper reprocessing does not pose a risk to patient health.

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Hospitals demand all rigorous safety standards be adhered to by

third party reprocessors. Indeed, SterilMed tests or inspects every

reprocessed device before it is sent out to a hospital, and this is the

practice of the industry as a whole. This is in contrast to OEMs

who we understand typically test only a small sampling of devices.

The result is that some hospitals say they prefer using reprocessed

devices over original devices because they know that each reprocessed device has been individually scrutinized.

America’s finest medical facilities use reprocessed medical devices, including 13 of the 14 institutions ranked by U.S. News and

World Report in 2006 as the Nation’s Honor Roll of Hospitals.

These institutions include Massachusetts General, Brigham and

Women’s University Hospital, the Mayo Clinic, the Cleveland Clinic, and Johns Hopkins University. It simply makes no sense that

these institutions would put their patients at risk in order to save

money. To the contrary, these facilities use reprocessed devices because they have studied the issue thoroughly and have determined

that reprocessing is both safe and cost-effective.

Mr. Chairman, that concludes my testimony. I look forward to responding to any further questions you might have regarding these

issues.

[The prepared statement of Mr. Toussaint follows:]

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Chairman TOM DAVIS. Thank you very much.

Mr. Ubl.

STATEMENT OF STEPHEN J. UBL

Mr. UBL. Good morning, I would like to thank you, Mr. Chairman, and other members of the committee for holding this hearing

today.

AdvaMed is the world’s largest trade association representing

medical technology manufacturers. Our member companies produce

the medical devices, diagnostic products, and health information

systems that are transforming healthcare through earlier disease

detection, less invasive procedures, and more effective treatments.

I would like to open this morning by clarifying the basic distinction between devices sold by original equipment manufacturers, our

members, and those by reprocessors. Devices that our manufacturers sell must be safe and effective. Based on their design and the

data submitted, FDA clears devices designed for one-time use only

as well as other devices designed for multiple use. Reprocessors, by

contrast, take a device that has been cleared as safe and effective

by the FDA for only one use and, after reprocessing, sell it to be

used again.

There are four primary messages I would like to leave with the

committee about reuse of medical devices.

First, reprocessing a medical device that is designed to be used

once is inherently risky. It is difficult to clean and sterilize extremely small and structurally complex devices. Blood, mucous,

and fecal material can accumulate during use in areas that are

very difficult to access and clean. In addition, there can be debilitating effects from initial use, cleaning, and resterilization on the

physical properties of the device. Materials can become brittle,

sticky, or deformed.

Let me illustrate these points with an example, and I think

somebody will bring this to the dais for the Members to review.

This is one of the technologies that was mentioned in earlier testimony. It is an EP catheter, electrophysiology catheter, and this

technology is threaded through the groin of a patient, up into the

heart to map the heart’s electrical impulses in various parts of the

heart to detect abnormalities.

This device has to be rigid enough, stiff enough to actually be

threaded up into the heart, yet it has to be flexible enough to make

sure that it doesn’t puncture the artery and it has to be flexible

enough to go through the twists and turns of the artery. It also has

to be sterile so as not to introduce potential infection, and it has

to be sensitive enough so that when it gets to the heart, it can accurately take readings from the heart.

Every one of those properties can be negatively affected by reuse.

Failure to completely clean and sterilize the device can potentially

transfer blood-borne diseases from one patient to another. Cleaning

and sterilization and use itself can affect the device’s flexibility, durability, and sensitivity. No one should want a device used on a

second, third, or fourth patient unless there is an ironclad assurance that it is literally as good as new after it is reprocessed.

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That leads to me to my second point. A reprocessed device should

be held to the same rigorous standard of safety and effectiveness

that FDA applies to original devices.

Third, the recently enacted legislative and regulatory framework

for reprocessed devices is a significant improvement. However, in

our view, the public is still not adequately protected because only

a limited number of reprocessed devices have been subjected to

FDA review. FDA directives require that reprocessors submit validation data for only 68 or 228 device types.

Yet in 50 percent of those cases, the reprocessed device was

found to be not substantially equivalent to the original device or

the reprocessor voluntarily withdrew the product due to lack of

adequate validation data. A 50 percent failure rate is intolerable

for any industry, but it is especially intolerable when it occurs with

a device designed to diagnose, treat, and cure patients. AdvaMed

urges FDA to review validation data for all reprocessed single-use

devices.

Fourth, we support the strengthened reporting and branding provisions in MDUFSA. However, it is still too early to draw conclusions as to whether these changes will adequately improve the

identification reporting of adverse events associated with reprocessed devices. As has been mentioned earlier, the new labeling provision only went into effect in August. Prior to that date, providers

had little ability to identify whether or not an adverse event was

due to a device that had been reprocessed or one that was not.

In closing, if appropriate regulations means some products will

continue to be reprocessed because the practice is supported by appropriate validation data, that is acceptable. If appropriate regulation of reprocessing means some of these products can no longer be

reprocessed, then patient safety will benefit from that decision.

We look forward to working with the Congress and FDA to make

the promise of MDUFMA a safe reality for millions of patients.

Thank you for the opportunity to address the committee on this important patient safety issue. I look forward to answering any questions the committee might have.

[The prepared statement of Mr. Ubl follows:]

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Chairman TOM DAVIS. Thank you.

Mr. Selvey and Mr. Toussaint, let me just start.

Mr. Selvey, one of the challenges of reprocessing, it seems to me,

has to be the changes to technology and designs. How do you keep

up with the evolving technology and designs when you are not

privy to trade secret information?

Mr. SELVEY. Mr. Chairman, if I may?

Chairman TOM DAVIS. Yes.

Mr. SELVEY. There are a couple of things that we can do to keep

up with the changing in design. First off, if the design change by

the original manufacturer is significant, they are required under

law to notify the FDA. That becomes public information. We can

monitor that and, in fact, we become aware of that.

Chairman TOM DAVIS. You can then decide if you want to buy

something new at that point to make the decision?

Mr. SELVEY. Correct.

The other part would be the change that is made by the original

manufacturer that is not a significant change; we would pick that

up through our routine monitoring of the devices. Periodically, we

will do revalidation of the process but even beyond that, we will do

periodic things like materials testing, analysis of the devices, just

to make sure that there hasn’t been a relatively insignificant

change that has not been reported to the Food and Drug Administration and therefore not made public.

Chairman TOM DAVIS. I don’t know how I ask this. I guess I just

ask this in a generic sense. How many times can one of the singleuse devices be reprocessed before it becomes unusable? Does it just

depend?

I gather you have a way to look at that and decide if it is usable

or not. How do you decide?

Mr. SELVEY. Mr. Chairman, there are a couple of factors that go

into it. Yes, every device does have a finite number of reprocessing

cycles. Typically, for the devices that we reprocess, it is going to be

somewhere between one and five cycles. The average is about

three. We are going to base that on the studies that we do in order

to validate our ability to clean and test and resterilize the device.

There is also a certain amount of, what I refer to as, the law of

diminishing return. Typically, these devices are rejected out at

about a 20 percent rate. That is, when they come into us, for whatever reason, about one in five devices is not fit to go through the

process. Therefore, it is in our best interest to look very carefully

at whether we are going to get more than five cycles out of the device, just based on that diminishing; typically three times, usually

based, well, always based on the validation studies that we have.

Mr. UBL. Mr. Chairman, may I comment on that question?

Chairman TOM DAVIS. You may.

Mr. UBL. I think it is very, very difficult for reprocessors to keep

up with those changes. Let me just give you example. This was

mentioned earlier. FDA allows reprocessors to submit in bundles,

sometimes covering multiple manufacturers in the same device in

the hundreds. FDA would never allow original manufacturers to

submit and bundle their applications in that fashion. So I think it

is extremely difficult to essentially assert that these types of prodVerDate 11-MAY-2000 12:04 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00089 Fmt 6633 Sfmt 6633 D:\DOCS\30528.TXT HGOVREF1 PsN: HGOVREF1
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ucts have the same degree of sameness, if you will, and keep up

with the rapid incremental changes in technology.

Chairman TOM DAVIS. Mr. Selvey asserts that the reprocessing

is highly regulated and probably more stringently regulated than

the original equipment industry, and you seem to contradict that.

Mr. UBL. Yes, I am absolutely baffled by that assertion. Our information suggests that, in fact, they have a much lower bar, and

part of that is the bundled submission that I mentioned but, in addition, the quality systems regulation, pre-clinical testing of individual components, which they obviously can’t do because they

don’t have the proprietary information. There is a whole range of

FDA regulatory authorities that apply much more acutely to original manufacturers than they do to reprocessors.

Chairman TOM DAVIS. Why don’t you guys reprocess your own

stuff?

Mr. TOUSSAINT. Mr. Chairman.

Chairman TOM DAVIS. I will give you a chance to answer in a

second.

Why don’t your own people, your own member companies ever

partner with a reprocessor to refurbish their own devices?

Mr. UBL. Why don’t they? Because they don’t——

Chairman TOM DAVIS. Yes; is it because you make more on selling new stuff?

Mr. UBL. Well, they fundamentally don’t believe that a reprocessed device is their device. It is a different product, and they really question the premise of whether these technologies can be safely

reprocessed.

I have to go back to the comment that was made that this is

about money. Reprocessing single-use devices are less than 5 percent of all device sales, 5 percent. So the assertion that this all

about economics is ludicrous, absolutely ludicrous.

Chairman TOM DAVIS. But obviously, if you can get this device

to work well, I don’t know why you wouldn’t want to do something

that costs less. They are getting squeezed every which way for

health costs. If you can reprocess a device and use it cheaper, why

wouldn’t you?

Mr. UBL. Absolutely, and we do it all the time. Let me just clarify that FDA approves single-use devices and multiple use devices.

Our members make both. Our members are trying to be responsive

to what the patient needs are and what the hospital and provider

needs are. So for example, a trocar is a technology that used to be

made in stainless steel and is now made in plastic due to the customer demanding ease of use and disposability. So there is a tension in the marketplace, and we are trying to be as responsive as

possible to providers.

Chairman TOM DAVIS. But you would admit that if the reprocessors and the FDA can guarantee patient safety, you don’t have

a problem with reprocessing.

Mr. UBL. We believe that the biggest problem is that a large

number of devices don’t come under the FDA purview. Dr. Schultz

actually mentioned two adverse events that we reported to the

FDA that were not being regulated by the FDA’s reprocessing authority.

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Chairman TOM DAVIS. But conceptually, if the FDA regulated

them, even if they made them be single-event pieces, if they can

use them and it is safe, you don’t have a problem.

Mr. UBL. Conceptually, yes; I mean I think we might have some

issues around bundling and some of the mechanics of how it is

done.

Chairman TOM DAVIS. You are saying if they can assure the safety, you don’t have a problem; OK.

Mr. Selvey, do you want to comment, or Mr. Toussaint?

Mr. TOUSSAINT. Mr. Chairman, I really need to respond to Mr.

Ubl’s comment about bundling. I am not sure where he is getting

this, his information, but there is an FDA guidance on bundling

that does apply to, not only to reprocessor but OEMs, and in that

guidance document, it states specifically that it is appropriate for

manufacturers to bundle devices among generic types of devices,

and it defines very specifically what a generic type of device is. It

is appropriate. It further states that it is appropriate to bundle devices when the differences do not reflect any changes in safety or

effectiveness of the devices. So bundling is an appropriate practice.

When we do choose to bundle, we do it very carefully, and we

scrutinize it very carefully. When Mr. Ubl says that hundreds of

devices are not tested, that is simply not correct.

Chairman TOM DAVIS. Every time there is an adverse incident,

it just hurts your industry, right?

Mr. TOUSSAINT. I am sorry, what?

Chairman TOM DAVIS. Every time there is an adverse incident

with one of these devices, it just hurts your marketability and profitability, doesn’t it?

Mr. TOUSSAINT. Yes, I would say.

Chairman TOM DAVIS. So, of course, OK.

Mr. TOUSSAINT. Yes. When we choose to bundle devices, however,

it is not that we choose one device out of, say, 50 devices to test.

Within the bundling, within bundling a family, for instance, all devices are tested, and that way, during the review process, if the

FDA would choose to analyze each device separately, statistically

and otherwise, they could do so.

So in effect, it would become a separate submission. So bundling

is a means to increase the efficiency of FDA review, and it allows

FDA to look at devices individually along with the family of devices, the generic type of family devices they belong to.

Chairman TOM DAVIS. How do you feel about the level of FDA

regulation? Do you think it is about right at this point? Do you

think you are under-regulated or over-regulated?

Mr. TOUSSAINT. Are you speaking to me, Mr. Chairman?

Chairman TOM DAVIS. I am. I am going to ask all three of you

that.

Mr. TOUSSAINT. About the entire MDUFMA regulation, I think

it is entirely over-regulated. I think many of these devices that require additional validation were previously cleared in the year

2000 or even prior to that and contain much of the data that submissions contain today, and I believe this is simply that the requirements that are required today of SVS submissions are a result

of the pressure put on OEMs, so we are not allowed to process devices.

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Chairman TOM DAVIS. Mr. Ubl, you don’t agree with that?

Mr. UBL. I absolutely don’t agree. I think the practice is underregulated. Again, FDA only regulates 68 types of technologies out

of a possible 228. AdvaMed has provided to the FDA two types of

technologies that have had adverse events associated with them.

They, in turn, have extended their regulatory umbrella to those

types of technologies. We wonder how many other technologies are

out there that are at risk to patients.

I know for my family, I certainly wouldn’t want to trust a reprocessor to tell me how many uses.

Chairman TOM DAVIS. Well, let me ask you another question. Do

you think the OEMs are too regulated or not regulated enough?

Mr. UBL. I think there are appropriate regulations of original

manufacturers.

Chairman TOM DAVIS. OK.

Mr. TOUSSAINT. Mr. Chairman, I really need to respond to one

other comment from Mr. Ubl.

Chairman TOM DAVIS. Now, I am going to get to Mr. Gutknecht.

Sure, we will let you respond. Let me give Mr. Gutknecht 10 minutes. Go ahead.

Mr. GUTKNECHT. Well, I just want one real quick question. If this

is so dangerous, you, both Mr. Selvey and Mr. Toussaint, your

product liability or your liability insurance must be just sky-high.

Mr. SELVEY. Mr. Gutknecht, that is an important distinction. We

do carry liability insurance, in fact, at the same level or an even

higher level than some of the original manufacturers. Although we

are not trying to compete with the manufacturers, we are trying to

make our hospital customers very comfortable with our level of coverage. The reality is that despite having reprocessed something on

the order of 15 million devices since our inception, we have never

been sued by a patient, by a hospital, claiming that we produced

an adverse event in a patient. In a litigious society, I think maybe

that says something.

Mr. TOUSSAINT. I don’t know what our insurance rates are at

SterilMed, but I can say the same thing that Mr. Selvey has said,

and that is that we have never been sued by a hospital, a patient,

or had any other litigious event occur against our company.

Mr. GUTKNECHT. So it is fair to say that both your insurance

companies and your customers are satisfied with the quality of the

products that you are putting out there.

Mr. UBL. Can I comment on that, Congressman?

In some ways, reprocessing is flying under the radar. The reason

there haven’t been suits by patients or by providers is because, as

has been mentioned by FDA and in my testimony, there is not adequate branding so that practitioners and patients even know that

a reprocessed device is being used. So, until we have well-established branding, tracking, reporting, and so forth, we are not going

to know what the true impact is.

Mr. GUTKNECHT. Well, with all due respect, I have heard those

siren songs before about drugs coming in from Canada, and the evidence is that a whole lot more Americans die every year from drugs

that are purchased in the United States.

Mr. UBL. This is very different than a pill, Congressman. This

is coming in contact with blood, tissue, and even the heart.

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Mr. GUTKNECHT. I understand, and I will reclaim my time, thank

you.

The point really is if this was as dangerous as some would have

us believe, we would have massive lawsuits and, more importantly,

the market for these devices, in my judgment, would dry up. I have

talked to some of my hospital people. I have talked to some of my

doctors about this very issue, and their general view is this is much

ado about very little.

I yield back my time.

Chairman TOM DAVIS. Mrs. Schmidt.

Mrs. SCHMIDT. Thank you, Mr. Chairman.

I have a couple of questions for the panel. The first regards the

bundling. I am very concerned about the bundling because I don’t

think it allows the FDA to have a clear review of each and every

device. Would you be amenable? Frankly, I am not concerned about

the ease of the FDA doing their job. The point is we have to have

FDA doing the right job.

Would any of you be adverse to not allowing the bundling and

to force the FDA to look at each and every application on its own

merit without bundling these devices?

Mr. SELVEY. Mrs. Schmidt, may I take a crack at that?

Bundling is a prime example of much ado about nothing. As Mr.

Toussaint has said, there is an FDA guidance on bundling for both

OEMs and for reprocessors.

But there is a very practical aspect here. When we put together

a 510(k) and it goes to a reviewer who is not used to seeing bundled submissions, they have not been trained in bundled submissions, honestly, the reviewer doesn’t know what to do with a bundled submission. We do not put together bundled submissions. I am

not sure what Mr. Ubl is complaining about, but aside from some

of the very early submission that we did back in the year 2000 that

caused much heartburn and grief among the reviewers at the FDA,

we stopped bundling. We haven’t bundled a submission in a very

long time.

So to answer your question very directly, we would have no issue

at all with doing away with bundling. It simply is not an issue for

us in this industry.

Mrs. SCHMIDT. In the matter of time, could I have a yes or no

from either one of you because I have another question?

Mr. UBL. I am delighted to hear that response. The only comment that I would make is it is important for the committee to understand we are not just talking about a family of technologies

made by one manufacturer. What they are bundling is across manufacturers making a similar product which is why it is so disturbing to us.

Mr. TOUSSAINT. Mr. Chairman, why that statement is somewhat

incorrect is after each family, even though we bundle across families, for each family we provide separate validation data on that

family. So each family is tested independently. Whether they are

bundled together in a single submission or in multiple submissions,

they still undergo the same review process.

Mrs. SCHMIDT. Mr. Chairman, another question; one of my other

concerns is the ability for the patient to know whether they are

getting an original product or a reused product. Would any of you;

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just a yes or no answer with no comment, be in agreement that in

the future, if it is a reused product, the patient will know up-front

that it is going to be used, yes or no?

Mr. SELVEY. No.

Mr. TOUSSAINT. No.

Mr. CUMMINGS. Yes, we would support patient informed consent.

Mrs. SCHMIDT. OK, thank you very much.

Mr. TOUSSAINT. Mr. Chairman.

Chairman TOM DAVIS. Yes, go ahead.

Mr. TOUSSAINT. I have another comment I feel I must address by

Mr. Ubl, and that was his comment regarding the 50 percent rate

as being totally unobjectionable as devices not being safe enough

and effective. I am not sure where that rate comes from, but I believe it is a total distortion of facts. I believe that rate comes from

the fact that when reprocessors originally had to submit SVSes on

a number of products, we received a number of NFC determinations or requests for additional information. This in no way implied

that the devices were not safe and effective.

In fact, let me read to you a quote from an FDA colleague about

this matter. Larry Spears, the Deputy Director of the Office of

Compliance at the FDA Center for Devices and Radiological Health

stated that any reference to the specific devices that can no longer

be legally marketed as being dangerous or unsafe is incorrect. Although some devices were found through review by our Office of

Device Evaluation to be non-substantially equivalent to a previously marketed device, this does not mean they are unsafe or ineffective.

Mr. UBL. Mr. Chairman.

Mr. TOUSSAINT. When you receive an NFC letter, that is a request by FDA that you need to submit further information, further

validation data, or other information. It does not mean that the devices at that point cannot be deemed substantially equivalent. During that period of time, many SVS submissions were submitted to

FDA, and FDA was working through the process as well as the

manufacturer. So it is not unexpected that we would receive NFC

letters and FDA would be, would send out such letters and ask for

additional information.

There are other factors that relate to that 50 percent figure. It

may be simply that the manufacturer chose not, after receiving

such a letter, decided, chose not to provide that additional information because it was too, not feasibly cost-effective.

Mr. UBL. I promise to be really quick, Mr. Chairman, but let us

just look at FDA’s testimony to this committee. They say 33 percent of the time when the reprocessor submits their application, it

was not substantially equivalent. That means it is taken off the

shelf. I will grant you that it seems like approval rates have improved since we have been using the 50 percent rate, but a third

of the time, they are submitting applications that are not meeting

the test by FDA. This, to us, tells us that not only should they be

looking at the devices they are looking at now but the additional

types of technologies that are currently under FDA’s purview.

Chairman TOM DAVIS. All right; anything else?

Mr. TOUSSAINT. No; I would just like to respond to that comment

as well.

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Chairman TOM DAVIS. Go ahead and get going. Go ahead.

Mr. TOUSSAINT. Just that the 33 percent simply means that we

need to provide additional validation data. It doesn’t mean the devices are not substantially equivalent, nor does it mean that——

Mr. UBL. Does it mean they are off the shelf?

Chairman TOM DAVIS. Is this stuff properly categorized so you

know how many times it has been used, just for the record, as you

keep it, or do you just examine it and say, yes, this looks good?

Mr. TOUSSAINT. I am sorry. I didn’t understand the question.

Chairman TOM DAVIS. Every time you reuse a medical device, is

it logged in that this is the third time or the fourth time or the

second time it has been used, or do you just kind of look at it and

decide if it meets criteria or not?

Mr. TOUSSAINT. I would say we generally look at it and decide

if it meets criteria.

Chairman TOM DAVIS. So it is not necessarily logged in, and you

have that record of how many times it is has been used?

Mr. TOUSSAINT. Well, we certainly have. You are talking about

specific devices?

Chairman TOM DAVIS. Yes.

Mr. TOUSSAINT. Certainly, we have a record of how many times

a device has been used.

Chairman TOM DAVIS. Anything else?

We are going to vote, and I want to let the panel go.

This is to be continued. Obviously, we don’t have a consensus

here, but I appreciate everybody’s testimony and being able to

make the case. The committee will continue to look at this further.

Thank you.

[Whereupon, at 12:17 p.m., the committee was adjourned.]

[The prepared statement of Hon. Edolphus Towns follows:]

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