U.S. GOVERNMENT PRINTING OFFICE

62–970CC WASHINGTON : 2000

REUSE OF SINGLE-USE MEDICAL DEVICES

HEARING

BEFORE THE

SUBCOMMITTEE ON

OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

SECOND SESSION

FEBRUARY 10, 2000

Serial No. 106–89

Printed for the use of the Committee on Commerce

(

2

COMMITTEE ON COMMERCE

TOM BLILEY, Virginia, Chairman

W.J. ‘‘BILLY’’ TAUZIN, Louisiana

MICHAEL G. OXLEY, Ohio

MICHAEL BILIRAKIS, Florida

JOE BARTON, Texas

FRED UPTON, Michigan

CLIFF STEARNS, Florida

PAUL E. GILLMOR, Ohio

Vice Chairman

JAMES C. GREENWOOD, Pennsylvania

CHRISTOPHER COX, California

NATHAN DEAL, Georgia

STEVE LARGENT, Oklahoma

RICHARD BURR, North Carolina

BRIAN P. BILBRAY, California

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

CHARLIE NORWOOD, Georgia

TOM A. COBURN, Oklahoma

RICK LAZIO, New York

BARBARA CUBIN, Wyoming

JAMES E. ROGAN, California

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

ROY BLUNT, Missouri

ED BRYANT, Tennessee

ROBERT L. EHRLICH, Jr., Maryland

JOHN D. DINGELL, Michigan

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RALPH M. HALL, Texas

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

SHERROD BROWN, Ohio

BART GORDON, Tennessee

PETER DEUTSCH, Florida

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

RON KLINK, Pennsylvania

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

TOM SAWYER, Ohio

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

THOMAS M. BARRETT, Wisconsin

BILL LUTHER, Minnesota

LOIS CAPPS, California

JAMES E. DERDERIAN, Chief of Staff

JAMES D. BARNETTE, General Counsel

REID P.F. STUNTZ, Minority Staff Director and Chief Counsel

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

FRED UPTON, Michigan, Chairman

JOE BARTON, Texas

CHRISTOPHER COX, California

RICHARD BURR, North Carolina

Vice Chairman

BRIAN P. BILBRAY, California

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

ROY BLUNT, Missouri

ED BRYANT, Tennessee

TOM BLILEY, Virginia,

(Ex Officio)

RON KLINK, Pennsylvania

HENRY A. WAXMAN, California

BART STUPAK, Michigan

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

JOHN D. DINGELL, Michigan,

(Ex Officio)

(II)

3

C O N T E N T S

Page

Testimony of:

Feigal, David W., Director, Food and Drug Administration ......................... 9

Feltner, Vern, President, Alliance Medical Corporation ............................... 123

Fielder, John H., Professor of Philosophy, Ethics Consultant, Villanova

University ...................................................................................................... 113

Grossman, Philip .............................................................................................. 107

Lindsay, Bruce D., Associate Professor of Medicine, Washington University School of Medicine ................................................................................. 159

Maurer, Walter G., Cleveland Clinic Foundation, on behalf of American

Hospital Association ..................................................................................... 118

O’Holla, Robert H., Vice President Regulatory Affairs, Johnson & Johnson .................................................................................................................. 103

Trotter, C. Griffin, Center for Healthcare Ethics .......................................... 155

West, Laurene ................................................................................................... 100

Material submitted for the record by:

National Consumers League, prepared statement of .................................... 183

(III)

(1)

REUSE OF SINGLE-USE MEDICAL DEVICES

THURSDAY, FEBRUARY 10, 2000

HOUSE OF REPRESENTATIVES,

COMMITTEE ON COMMERCE,

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:21 a.m. in room

2322, Rayburn House Office Building, Hon. Fred Upton (chairman)

presiding.

Members present: Representatives Upton, Barton, Burr,

Whitfield, Ganske, Bryant, Bliley (ex officio), Waxman, Stupak, and

Strickland.

Also present: Representatives Eshoo and Pickering.

Staff present: Alan Slobodin, majority counsel; Anthony Habib,

legislative clerk; and John Ford, minority counsel.

Mr. UPTON. Good morning, everybody. Sorry we are a little bit

tardy starting. For those not realizing what the buzzer meant, we

had a vote. So we are all ready to start promptly at 10, and then

we had to walk over the Capitol and come back. Before I proceed

with my opening statement, I do want to ask unanimous consent

that other members of the full committee, although not on this subcommittee, be allowed to sit in, provide opening statements, and

also proceed with the question and answer period of both Dr.

Feigal and the second panel. Without objection that will be the

order of the day.

Good morning again. Today this subcommittee holds a hearing

on the reuse of medical devices, labeled and approved by the Food

and Drug Administration for single-use only. Within the last year

there has been extensive debate, both on and off the Hill regarding

the practice of reprocessing medical devices that have been designed, manufactured, and approved by the FDA for single-use

only.

As many of you know, before a device may legally enter the market, original medical device manufacturers must submit product

approval applications to FDA which may include extensive sterility

and clinical data that demonstrate the safety and efficacy of the device. The original manufacturer must also comply with the extensive FDA regulations regarding the manufacturing of the device, as

well as post-market controls that give both the FDA and the manufacturer the ability to continue to assess the safety and efficacy of

the device, and ensure that patients are adequately protected.

For patients, original device manufacturers and the FDA, this

system works. However, there is a significant and perhaps even a

dangerous, gap in FDA’s existing enforcement practices. In some

2

instances, hospitals, either using in-house facilities or third parties,

will reprocess a disposable medical device that has been approved

by FDA for use in a single patient only, and reuse the device several times on additional patients in most instances without notifying patients that the device may have already been used.

Much to my surprise I have learned that this practice includes

reusing devices that have been inserted into other patients, including biopsy forceps and catheters. This practice raises two patient

safety concerns. One, whether single-use devices can be adequately

cleaned and sterilized for use in other patients, and two, whether

attempts to clean and sterilize these devices may lead to product

failures or in any way significantly affect performance and design

specifications.

These concerns are not theoretical to me. I am alarmed by reports that there may be unsterile and contaminated medical devices on hospital shelves ready to be reused on patients. There is

the report of a broken heart catheter in a 32 year old woman that

lodged in the atrium of her heart. I am also concerned about how

one knows whether the reprocessed single-use device has been used

a second time, or an eighth time, or maybe even a tenth time. We

need to make sure that these complex, hard to clean medical devices are really sterile and functional.

These products may look fine and dandy to the naked eye, or

even one with Lasik, but under a microscope or in a patient it

could be a completely different story. I am well aware that some

hospitals and reprocessing companies take many precautions and

work very hard to produce safe and effective reprocessed single-use

medical devices. I am also aware of many studies on this issue,

some showing problems with reprocessed single-use devices, and

others indicating that single-use devices can be reprocessed and reused safely. But in the end, there seems to me to be too many questions about the risks to patients, the lack of informed consent, regulatory fairness, whether the newer and more complex devices really can be cleaned. That is why we need this hearing to help us understand the issues involved with reprocessing, to get some answers to some questions, and to assure ourselves that the FDA is

appropriately regulating the practice of reprocessing. The FDA has

acknowledged that it presently has the authority under the Federal

Food, Drug and Cosmetic Act to regulate both on a pre-market and

a post-market basis. To date, the Agency has chosen not to fully

enforce all of the statutory and regulatory requirements over reprocessing of single-use devices that original manufacturers must

comply with. Most notably, pre-market review. I look forward to

hearing directly from the Agency about how it plans to address this

issue, both now and in the future to ensure that American patients

are not unnecessarily put at risk.

I welcome particularly Dr. David Feigal of the FDA before this

subcommittee. I want to express my deep appreciation to Dr. Feigal

who only a few months ago became the Director for FDA’s Center

for Devices and has already helped lead the FDA to a reassessment

of an issue that the FDA has struggled over for many, many years.

I also want to thank Chairman Bliley for his support of this hearing and the inquiry. I also want to welcome Ms. Anna Eshoo for

raising attention to this issue, particularly with her legislation that

3

she has introduced and monitor work with her on behalf of patient

safety.

We will be hearing from outstanding witnesses on both sides of

this medical controversy. I thank all of our witnesses for taking the

time to be here, and I also want to thank the staff which has

helped us prepare, not only Mr. Alan Slobodin, but Mr. John Ford

on the Democratic side as well. And with that I will yield for an

opening statement to my friend from the great State—awesome

State—of Michigan, Mr. Stupak.

Mr. STUPAK. Thank you Mr. Chairman, and thank you for holding these very important hearings. I appreciate the hard work that

you and our colleague, Ms. Eshoo from California, have put into

this issue.

Now, Americans expect when they go to the hospital that catheters and devices used in their hospital stay are safe, effective, and

sterile. And Mr. Chairman, you commented a little bit, and I know

you have some of these with you too, but the catheter it is basically

all plastic. The little balloon on the end there. And then you have

another one over here which is a little different device but it has

a metal tip. And it is more than just plastic versus metal. I think

what we’re all looking for in these devices is to make sure that

they are sterile and safe for the patient. And I know that has been

the focus of your query here, but we have a number of these devices with us. I know you have them with you too, but I think it

gives us a good opportunity to take a look at exactly what are we

talking about.

Because Americans want to ensure that when they go to the hospital they have affordable health care at reasonable prices and

really they don’t care to pay retail all the time if there is a better

way of doing it. Today’s hearing is about striking a balance, Mr.

Chairman, between patient safety and controlling costs in our

health care system and all the devices that we use in modern medicine. But patient safety must be our first priority. Cost containment that puts patients at risk does not control costs at all. If a

patient develops an infection or has complications due to a device

malfunction, saving 50 percent on the device is no savings at all.

Even if it was, I would not want to put the lives of my wife or our

sons at risk to save a few dollars. Thus, I believe our guiding light

should really be are we ensuring patient safety.

The FDA, the Food and Drug Administration, has up until recently, had a policy of nonenforcement with respect to the singleuse requirement. In fact, medical device reprocessing has been

going on for over 20 years. However, due to the ever increasing

complexity of medical devices, much like I have shown us today,

the FDA has decided to review its enforcement policy and increase

the oversight of reprocessed devices. I know some people believe

that the FDA has taken too long to act, but I applaud the FDA for

beginning the process of ensuring that reprocessed devices will be

safe, sterile, and effective.

I want to hear about the FDA’s proposed guidance on classification and enforcement of the reprocess and reuse of single devices.

I understand that some believe the guidance goes too far, and others believe the guidance does not go far enough or quick enough.

I am interested in hearing all of these points of view. Mr. ChairVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 E:\HEARINGS\62970 pfrm08 PsN: 62970
4

man, these issues are always difficult for members up here on the

dais. We are forced to chose between competing business, patient

safety, and healthcare cost containment. I am hopeful that this

hearing will shed some light on these issues and help provide both

this committee and the FDA with input on where we go from here.

I want to once again thank you and Ms. Eshoo for your hard

work on this issue and I yield back my time, Mr. Chairman.

Mr. UPTON. Thank you.

I would also make unanimous consent request that all members

of this subcommittee be allowed to put their statements into the

record in their entirety. Without objection, that will be the rule.

Mr. Bryant from Tennessee?

Mr. BRYANT. Thank you Mr. Chairman. I would simply echo

what the two previous speakers have raised in their opening statements. And I think there are very important issues here today. I

know we have some very distinguished panelists to testify.

The issue of the economy, of why this is done is important, but

certainly the issue of safety, the issue of functionality of these

products, all are very important and I look forward to hearing testimony on both sides of the issue.

I think my main concern in reviewing this in preparation for the

hearing is with the FDA. And I am glad that, Doctor, you are here

today to open the testimony. I look forward to hearing from you.

I get a sense that the FDA is on the sidelines, and I want to know

when the FDA is going to come in and start playing on this very

important issue. And I look forward to your testimony to that effect

and would yield back my time.

Mr. UPTON. Mr. Whitfield from Kentucky?

Mr. WHITFIELD. Mr. Chairman, thank you very much and I think

all of us are looking forward to this hearing for a number of reasons, obviously, its impact on good quality and safe healthcare. Before a medical device can legally enter the market we know that

the manufacturer must demonstrate to the Food and Drug Administration is safe and effective. And I know from discussions that I

have had with other colleagues, we are disappointed by FDA’s failure to enforce existing laws and apply them to reprocessed medical

devices.

It is difficult to understand how an Agency which continually

seeks to broaden its scope of authority can leave the impression

that it is not really doing very much in this area. Yesterday we had

a hearing on safety in hospitals and in healthcare, and we talked

about the number of deaths because of mistakes made in the

healthcare delivery system. And this is a particularly important

area, and it is squarely within the jurisdiction of FDA. We all recognize the role that reprocessed medical devices play in keeping

medical care accessable by containing costs, but this is not an excuse for FDA to leave the impression and to permit unsafe medical

devices to be used in our hospitals.

Having said that, we are delighted that Dr. Feigal is here today

to talk about this issue, to let us know what he intends to do about

it, and I understand that he has been instrumental in trying to

move the Agency forward in that direction. And I, for one, am disappointed, however, that we did not have an opportunity to even

review your testimony because I guess we didn’t receive it until

5

this morning. But hopefully you will do a great job of presenting

that testimony and we thank you for being here this morning.

Mr. UPTON. Dr. Ganske from Iowa.

Mr. GANSKE. I Thank you Mr. Chairman. I will be brief. We want

to make sure that patients are getting quality care. We have medical devices that need to be safe and clean. As a medical practitioner before coming to Congress I have used disposable equipment.

I am concerned about some of the data that will be presented

today. We want to make sure that it is accurate and I think the

FDA has a role in the oversight of whether single-use medical devices can be reprocessed and used again.

There are some questions about health costs that are involved

with this. I think it would be also useful at some time, Mr. Chairman, to have the Healthcare Financing Administration present, because I am concerned about how charges are made to our Federal

system for single-use devices. For instance, does a hospital get paid

the same amount of money by Medicare if they reprocess a device

that then costs them half of what a new single-use device would

be, and are they just pocketing the difference? I am interested in

finding out how the calculations are made by HCFA for the device

component of some of the services that are being billed to the Federal Government. Maybe we will get into that today. I yield back.

Mr. UPTON. It is my understanding that the answer to that question is yes. It is a very good question. Even without their presence

here today, I think maybe members of this subcommittee can follow-up with HCFA in written form following the hearing. Mr.

Strickland, from Ohio.

Mr. STRICKLAND. No opening statement, thank you.

Mr. UPTON. Mr. Burr from North Carolina.

Mr. BURR. No opening.

Mr. UPTON. Ms. Eshoo from California.

Ms. ESHOO. Thank you very much, Mr. Chairman, and I want to

salute you for holding this very important hearing on what I think

is a critical issue that is not only before the Congress, but something that the American people deal with—patients deal with really day in and day out. I know that I am a guest of this Committee

of Investigations and Oversight, and I appreciate the hospitality,

the legislative hospitality that you have extended to me.

For those of you in the audience, I am not a member of this subcommittee and so it’s really up to the chairman to say that it is

absolutely fine for me to come and testify. I was a member of this

distinguished committee in my first term in serving on Commerce.

I come to this issue from the perspective of both legislator and a

consumer. As a legislator I have great concerns about the FDA’s

failure to require that reprocessed single-use medical devices meet

safety and effectiveness standards. It makes no sense to me that

new medical devices must meet these standards, yet the used ones

do not.

As a consumer I was horrified to learn that complex delicate devices such as cardiac balloon catheters and biopsy forceps are being

cleaned and used again on different patients. Now, this could happen to any one of us and there is not anything that is put before

the patient to ask them whether they chose to have a reprocessed

device used on them or not. So there is not any choice, there is not

6

any disclosure to the American patient today on this issue. I first

learned of this problem last August after reading reports of an outbreak of bacterial toxins in a Colorado hospital that were traced

back to reprocessed cardiac catheters. One person died from this

particular outbreak, but it raises the question of how many deaths,

or injuries occur from reprocessed devices that are unsterile or are

made less effective due to the process that they are put through to

clean them today.

FDA files on adverse outcomes from reused disposable devices

tell of reprocessed electrophysiology catheters likely weakened by

the harsh chemicals and intense temperatures required to sterilize

them breaking inside of patients. I think we should always just

keep ourselves in mind before we ever place this on a family member or anyone else. I certainly would not want that happening to

me. In one case, the tip of the catheter remained lodged in the patient’s heart requiring constant monitoring. In another the four

inch long tip traveled from the patient’s heart to his stomach. Surgeons had to open the man’s stomach to remove the tip. Premature

babies have suffered infections from unsterile sutures. A patient

was contaminated with Hepatitis B from reused biopsy forceps.

The source of this is U.S. News and World Report in their September 20, 1999 edition. It is estimated that as many as one in

every three hospitals are reusing medical devices that are designed, manufactured, and FDA approved for one use only. FDA

clearly has the authority to enforce safety and effectiveness standards. Yet in my view, after reviewing the record and seeing how

the policies are working, they have essentially looked the other way

allowing the practice to go on, within my view, very little oversight.

In fact, in a letter dated July 9, 1999, which I will submit for the

record, Mr. Chairman, with the committee’s approval, the FDA admitted that reprocessed devices are subject to all safety and effectiveness standards, but said that they had chosen not to enforce

these standards. This approach fails to ensure that devices designed for one use only can be sterilized and reused safely and effectively. That is why I introduced legislation on this issue. Mr.

Chairman, the FDA policy permits practice of withholding information from the patient that he or she is getting a previously used

device. It is also common to charge the patient and the Federal

Government through Medicare for a new device when a secondhand

one is actually being used. Now, when we buy a part for our car,

the mechanic is required to tell us if that part is new or rebuilt and

we are charged accordingly. Now, why is it that our laws are doing

a better job covering car parts than they are protecting patients in

our country?

I am very proud, Mr. Chairman, to have you join me in introducing the Reprocessed Single Use Medical Device Patient Safety

Act of 1999. The bill is H.R. 3148. The bill would ensure the protection of patients by requiring reprocessed medical devices to meet

the same standards for safety and effectiveness that new products

today must meet. When the FDA approves a device for single-use

only, that is exactly what it means—that the data submitted by the

manufacturer has to show that this device can be safely used once.

Thus, in order to avoid injuries and infections to patients, I think

that we should be requiring that those who clean devices for reuse

7

prove that it can be done safely and effectively. H.R. 3148 will increase awareness about reprocessed devices by requiring a patient’s

informed consent before that single-use medical device is used on

them, and by requiring hospitals to monitor and report injuries or

infections that occur as a result.

We have very little information about the scope of patient injuries that occur as a result of reused medical devices because patient consent is not required, and tracking is not required to determine if a reused device was involved in an adverse event. I am

pleased that the FDA has finally developed a proposed policy with

regard to reprocessing and reuse, but I am still concerned that it

is an extension of their current practice of essentially looking the

other way. In their proposed enforcement guidance they again state

that all reprocessed single use devices are subject to the same premarket requirements to prove safety and effectiveness, as new devices do, yet they do not or will not, as the way I read it, and

maybe Dr. Feigal will point this out in his testimony, enforce these

requirements unless the device is considered high risk. How will

we know whether reuse of a particular device poses a high risk to

patients without the data? Under FDA’s proposal reprocessors will

never have to submit data to prove the risk to patients of devices

that are arbitrarily determined to be moderate or low risk. Moreover, even for high risk devices, no data will be required for at

least 1 year. I understand very well the fiscal restraints that our

hospitals all over the country are under, what they are operating

under.

I have worked closely with the hospitals before I came to the

House of Representatives, and I still do today. So, I understand

very well the pressures that they work under. Between managed

healthcare and reduced Medicare reimbursements, hospitals indeed

do feel the intense pressure to cut costs wherever possible. However, we can’t put patients at risk in order to save a few dollars.

I think my colleagues that have spoken before me have really stated that quite eloquently. We have to always put patients before

profits. I know it is a struggle to do that, but I think the American

people expect our public policy to reflect that. The Reprocessed Single-use Medical Device Patient Safety Act is about putting patients

first.

I think that it is sound public policy, and I have no doubt that

today’s hearing is going to be very instructive to members of this

very important subcommittee about this issue. So I look forward to

working with you, Mr. Chairman, and the rest of the members of

this very distinguished subcommittee, all of the members of the full

committee, because this is the place where the legislation obviously

will be heard and considered. And again I thank you for your legislative hospitality in inviting me here and being able to speak to

this issue today. Thank you.

Mr. UPTON. Thank you. Mr. Pickering, do you have an opening

statement that you would like to——

Mr. PICKERING. Not at this time.

[Additional statements submitted for the record follow:]

8

PREPARED STATEMENT OF HON. TOM BLILEY, CHAIRMAN, COMMITTEE ON COMMERCE

Mr. Upton, thank you for this hearing. I am eager to get action and some answers

for the American public about the safety of reprocessing medical devices designed,

manufactured, and approved by the Food and Drug Administration for single-use

only.

I am proud of this Committee’s accomplishments in the last five years to make

the FDA a better scientific agency, one that serves the American people, promotes

innovation, and protects the public health. We have streamlined FDA procedures

and cut FDA red tape. We have made the FDA more effective.

Today’s hearing looks at reused single-use medical devices. I believe FDA has

acted with uncertainty about its own authority. For the last several years, the FDA

has sent conflicting signals about the legality and safety of reprocessing single-use

devices. The result has been that patients without their knowledge have been exposed to unknown risks from devices that were used on other patients. Thus, for

example, there is the possibility that tiny, hard-to-clean, disposable catheters used

in patients with hepatitis are being reprocessed and reused in patients without their

knowledge. That is an outrage.

But this is not all. The result of FDA uncertainty has been that the original

equipment manufacturers find their good name and liability on the line because

their disposable products have been reused without their knowledge or approval.

The result of FDA’s confused policy has helped lead to a surge of reprocessing single-use devices because hospitals and health care firms had assumed FDA’s acceptance of the practice of reprocessing.

I want the inconsistencies and uncertainties to end today. We are at long last getting some answers and actions from FDA and other interested parties. FDA’s leadership is late. I believe the FDA deserves credit for its hard work over the last several months. I hope FDA’s new policy is reasonable and protects patients.

I commend Commissioner Jane Henney and FDA Devices Director David Feigal,

both of whom came on the scene during the past year to steer FDA in a better direction on its reuse policy. I also commend Mr. Upton and Mrs. Eshoo for their leadership on this issue. I look forward to working with all concerned to give the American

people the facts and swift, common-sense action.

PREPARED STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF CALIFORNIA

Mr. Chairman, as the author of the Safe Medical Devices Act of 1990, I am

pleased that you have convened this morning’s hearing.

Ten years ago, the safety of medical devices and the practices of the device industry came into serious question. Fatal product failures like the Shiley heart valve

taught Congress and the public an important lesson—there is no substitute for

stringent FDA enforcement of rigorous standards of safety and effectiveness.

That lesson holds true today. Due in no small part to the efforts of my friend,

Senator Durbin, there is enormous interest in the regulation of reprocessed devices.

Consumer, patient and health provider groups all agree that FDA must ensure such

devices are safe and effective whether they are used once or reused.

Clearly, there are categories of use for which devices may be safely reprocessed.

Just as clearly, there have been instances of unsafe hospital practices or inadequate

safeguards on the part of reprocessors. From the written testimony submitted by

both device reprocessors and the manufacturers, it appears that they agree on the

need for rigorous FDA oversight and enforcement of risk-based standards. As a result, I am pleased that FDA has issued its new guidance document, which

prioritizes the scrutiny of reprocessed devices.

FDA clearly lacks the resources to do all it should. Last year, Senator Durbin secured an additional $1 million for the FDA to establish safety standards for reprocessed devices. But that is only a small step towards closing the widening gap between FDA’s obligations and its resources. For years, Congress has forced FDA onto

a starvation diet while we look to the agency to do more—more about tobacco, more

about online drug sales, more about drug safety, and now, more about reprocessed

devices.

FDA also lacks the authority to adequately answer basic questions about the

products it regulates. The recent IOM report on medical errors stresses the urgency

of better understanding the rates and severity of medical mistakes including medication errors. The GAO and Inspector General recently concluded that we must enhance FDA’s adverse drug event reporting system and post-market surveillance authority to help eliminate the 7,000 annual deaths from medication errors.

9

And in the case of devices, are we certain FDA has the resources to properly analyze the 100,000 reports it receives annually? And does anyone believe those reports

comprise the whole universe of device malfunctions and misadventure?

Mr. Chairman, I look forward to hearing from our witnesses. I look forward to

learning more about this important issue.

Mr. UPTON. Okay. We are ready to proceed. Dr. Feigal is our first

witness, the Director for the Center for Devices and Radiological

Health, FDA. Dr. Feigal, we welcome you to our subcommittee. We

have a long standing honored tradition of taking testimony under

oath. Do you have any objection to that? Committee rules also provide that you are entitled to counsel if you would like such. Do you

have any need to have counsel with you today?

Dr. FEIGAL. Not yet.

Mr. UPTON. Not yet.

If you could stand and raise your right hand.

[Witness sworn.]

Mr. UPTON. You are now under oath. Your testimony in its entirety is made part of the record. We would like to think that you

would sum up your testimony in about 5 minutes or so, and the

time is now yours. Welcome.

TESTIMONY OF DAVID W. FEIGAL, DIRECTOR, FOOD AND

DRUG ADMINISTRATION

Mr. FEIGAL. Thank you very much. Mr. Chairman, members of

the committee, and guests. I am pleased to be here today to discuss

our approach to the issue of reusing medical devices labeled for single-use. I would appreciate if my entire written testimony would

also be entered into the record. We value your interest and input

as we study this complex issue and move forward to change our

regulatory approach.

The public expects and the law requires that all devices be safe,

effective, and manufactured in accordance with good manufacturing practices. As you know, FDA is currently in the process of

reexamining its policy in the area of reuse of single-use devices.

Our primary goal is to protect the public health by ensuring that

reprocessed, single-use devices are safe, effective, and well manufactured. Let me say at the outset that I believe we have the regulatory tools to ensure that this will happen. We are crafting a regulatory approach that will apply equal treatment to the original

manufacturers of devices, and those who reprocess them, including

commercial reprocessing firms and hospitals. I think this approach

will assure the desired public health protection.

Just this week we posted on our Web site two draft guidance documents that pertain to the reuse of single-use devices. One describes a proposed risk categorization scheme for reprocessed devices. The other describes our enforcement priorities based on that

risk categorization scheme. We will publish a notice of availability

of these documents in the Federal Register. I realize that since we

just posted these draft guidances, they were not available for your

second panel of witnesses to review before they submitted their testimony. But we hope they will be helpful in moving this debate forward.

By way of background, let me describe how reuse has grown over

the years and why it poses a problem today that did not exist a

few decades ago. The practice of reusing medical devices intended

10

only for one use began in hospitals in the late 1970’s. Prior to that

time most medical devices were designed to be reusable. Because

most devices were made of glass, rubber, hard plastic, or metal,

early reprocessing involved little more than heat sterilization, wiping, dipping, or soaking in disinfectant. Things began to change as

a result of market demand for disposable equipment, the development of new plastics, the miniaturization of devices, and the advent of ethylene oxide sterilization.

These factors prompted the manufacturers to sell more and more

single-use only medical devices. And as a result, hospitals began to

receive products labeled single-use only that were similar to reuseable devices. In fact, outside of their packaging even today some of

them look identical to devices that had formerly been sold as reusable. The practice of reprocessing single-use devices expanded

when an increasing number of hospitals found that reuse was a

cost-saving measure and when they became concerned about the

amount of medical waste generated by the use of disposable devices. The hospitals themselves began reprocessing more complex

products such as balloon angioplasty and cardiac catheters.

Reprocessing of these devices required more complicated decontamination and sterilization procedures and as a result a new industry of third-party reprocessor evolved in response to the reprocessing needs of the hospitals. All of this has resulted in heightened

concerns about the safety and effectiveness of reused single-use devices, and about the equitable regulation of the original equipment

manufacturers and the reprocessing firms.

Where does FDA stand on this issue? We have concluded that

the practice of reuse does need additional attention and controls.

We have come to that conclusion even though we do not have clear

evidence that the reprocessing of single-use devices changes or increases the types of risks to patients beyond those posed by the

original device. We recognize that we may not have some of the evidence because our medical device reporting systems do not capture

all of the information. But patient injuries are not the only reason

for our taking action. Even without documented injury, the law

still requires that we assure that reprocessed devices are safe, effective, and manufactured properly.

I do not want to leave you with the impression that FDA is coming anew to this issue. Although we only received research reports

from the original equipment manufacturer industry within the last

year, we have been actively engaged in the reuse issue for some

time. In the past year, we have held numerous meetings and conferences with industry, health professionals, and consumers to determine the extent, magnitude, and changing nature of the practice. We have evaluated and conducted research to develop a scientific basis for addressing the issue. We have inspected thirdparty reprocessors and as a result have issued ten Warning Letters

for various violations. And, we have investigated reports of patient

injuries.

Now, let me describe what we are proposing to do in this area.

Fundamentally, our proposed strategy is based on the degree of

risk posed by the device. The primary factors we will use to determine the level of risk are the risk of infection and the risk of performance deterioration if a device is reused. There are four steps

11

in developing this regulatory system which we proposed for comment last November. First, we identified the need to develop a list

of the commonly reused single-use devices. Second, we developed a

list of the factors that will determine the degree of risk or complexity associated with reprocessing. Third, we will use this information to divide the list of commonly reprocessed single-use devices into high, moderate, and low categories of risk. And fourth,

we will develop priorities for enforcement of our regulatory requirement for hospitals and third-party reprocessors based on this category of risk.

Since announcing this strategy in November, we have made significant progress. On February 8th, we posted on our Web site two

companion draft guidance documents. One is entitled, ‘‘Reprocessing and Reuse of Single-Use Devices: A Review Prioritization

Scheme’’. It sets forth the factors that we would consider in categorizing a reprocessed device as high, moderate, or low risk. It also

includes a list of commonly reprocessed single-use devices and the

degree of risk that FDA believes each type of device poses when it

is reprocessed. The other draft guidance entitled, ‘‘Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and

Hospitals,’’ sets forth our priorities for enforcing various regulatory

requirements, based on the level of risk associated with reusing the

device.

Specifically FDA intends to begin enforcing pre-market notification and pre-market application requirements within 6 months of

issuing the final guidance if the reprocessed device is categorized

as high risk, within 12 months if the device is moderate risk, and

with 18 months if the device is low risk. I would like to close by

giving a couple examples of how this proposed risk categorization

scheme and other enforcement strategies would affect the reprocessors of various devices. Let’s take as examples oral and nasal

catheters. These are fairly simple devices. They are currently Class

I and they are exempt from pre-market notification. They would be

considered low risk under the risk categorization schemed just described.

Six months after a guidance became final, FDA would actively

enforce all post-marketing requirements for hospitals that reprocess these oral and nasal catheters, just as we currently do for manufacturers of original equipment and third-party reprocessors.

These include registration, listing, manufacturer adverse event reporting, labeling, corrections and removals, and adherence to the

quality system manufacturing requirements. At the other end of

the spectrum let’s consider the percutaneous transluminal

angioplasty catheters or intra-aortal balloon catheters, which are

Class III devices. Based on our own studies and other information,

we have determined that cleaning and sterilizing these devices is

very difficult, and so they would be considered high risk under this

scheme. Hospitals and third parties that reprocess these devices

would be required to submit to us pre-market approval applications

to demonstrate that the reprocessing of these devices results in a

product that is safe, effective, and well-manufactured.

Where do we stand right now? After the Federal Register publication of these guidances and review during the comment period,

we will issue final versions. At that point, we will be ready to enVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00015 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
12

force the regulatory scheme for third parties and hospitals that reprocess single-use devices. Mr. Chairman, let me close by saying

that although we have no clear data to indicate that people are

being harmed at a higher rate by the reuse of single-use devices,

the results of our own research and the information provided by

various stakeholders have convinced us that this growing practice

needs closer scrutiny and oversight.

We are committed to addressing this in an open and cooperative

fashion with the industries involved, the healthcare community,

the public, and of course, Congress. We want a reasonable and fairminded policy, but at the same time we want to ensure that when

a single use device is reused it doesn’t expose the patient to more

risk than a new device would have. I thank you for this opportunity to be here today. I look forward to answering any questions

that you may have.

[The prepared statement of David W. Feigal follows:]

PREPARED STATEMENT OF DAVID W. FEIGAL, DIRECTOR, CENTER FOR DEVICES AND

RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION

INTRODUCTION

Mr. Chairman, Members of the Committee, I am Dr. David Feigal, Director of the

Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am very pleased to have the opportunity to be here

today to discuss the Agency’s approach to the issue of reuse of medical devices labeled for single-use. As you know, FDA is currently in the process of reexamining

its policy on the reuse of medical devices labeled for single-use. Our primary goal

in doing so is to protect the public health by assuring that the practice of reprocessing and reusing single-use devices (SUDs) is safe and effective and based on good

science. We value your interest and input as we study this complex issue and move

forward to change our regulatory approach.

The public expects and the law requires all devices to be safe, effective and manufactured in accordance with Good Manufacturing Practices (GMPs). Let me say at

the outset that I believe FDA does have the tools to ensure the safety, effectiveness

and manufacturing quality of reprocessed single-use devices. We have been actively

engaged in reuse issues for some time and our efforts have included research, outreach, inspections and compliance investigations. We are currently in the midst of

crafting a new regulatory approach that will treat Original Equipment Manufacturers (OEMs), third parties and hospitals in a similar manner to minimize risks associated with reused single-use devices.

We have held numerous meetings and conferences with industry, health professionals, and consumers over the past several years to determine the extent, magnitude and changing nature of the practice. FDA has evaluated and conducted research to begin to develop the scientific basis for addressing the issue. We have inspected third party reprocessors and issued ten Warning Letters for various violations. We have evaluated and investigated reports of patient injuries.

That being said, medical progress has been accompanied by changes in technology, resulting in more devices with features that may make reprocessing difficult

or impossible. At the same time, economic pressures create incentives for reuse. Despite a lack of clear data that suggests that many injuries are occurring due to reprocessing practices, FDA has concluded that the practice of reuse of SUDs needs

additional attention and controls. We recognize the limitations of our medical device

problem reporting systems in capturing this information. We take the reports we

do get very seriously, but at the same time, even if there were no injuries, a driving

question remains: Are reprocessed SUDs being manufactured properly, that is, in

accordance with the Quality Systems Regulation (QSR)?

On February 8, 2000, FDA posted on its web site two draft guidance documents

that pertain to the reuse of SUDs. One describes a proposed risk categorization

scheme for reprocessed SUDs. The other describes the Agency’s priorities for enforcing various regulatory requirements based on the risk categorization of a reprocessed SUD. We will be publishing a Notice of Availability of the documents in the

Federal Register imminently and asking for public comments on these two documents.

13

BACKGROUND

The History of Hospital Reuse

The practice of reusing medical devices labeled, or otherwise intended, for only

one use began in hospitals in the late 1970s. Prior to this time, most medical devices

were considered to be ‘‘reusable.’’ Because most reusable devices were fabricated

from glass, rubber, or metal, early reprocessing of reusable products, such as probes

and surgical instruments, involved little more than hand wiping, dipping, and soaking in disinfection solutions. OEMs began to sell ‘‘single-use’’ medical devices as a

result of market demand for disposable equipment, the development of new plastics,

and the use of ethylene oxide sterilization. Hospitals began to see products labeled

‘‘single-use only’’ that were similar to devices that had been formerly distributed or

continued to be distributed as ‘‘reusable.’’

The practice of reprocessing single-use devices expanded when an increasing number of hospitals decided that reuse was a cost-saving measure and when they became concerned about the amount of medical waste generated by the use of disposable devices. Hospitals started reprocessing more complex products, such as balloon

angioplasty catheters and cardiac catheters. Reprocessing of these devices required

more complicated decontamination sterilization procedures. As a result, an industry

of third party reprocessors evolved in response to the reprocessing needs of hospitals. Expanded use of third party reprocessors and an increase in the types of single-use products subjected to reprocessing heightened concerns regarding patient

safety, and equitable regulation of OEMs and reprocessing firms.

The Scope of Reuse Today

The Agency has developed a list of frequently reprocessed SUDs, which includes

devices that range from the technologically simple to the complex. Examples include:

• Surgical Saw Blades

• Surgical Drills

• Laparoscopy Scissors

• Orthodontic (metal) Braces

• Electrophysiology Catheters

• Electrosurgical Electrodes and Pencils

• Respiratory Therapy and Anesthesia Breathing Circuits

• Endotracheal Tubes

• Balloon Angioplasty (PTCA) Catheters

• Biopsy Forceps

The list varies greatly in type of device, material, risk of use and severity of clinical conditions of typical use. Some products have features such as long narrow

lumens, fragile plastic components, and/or unsealed electronic controls that make

them very difficult to clean. Other products on the list, e.g., drill bits, are technologically less complex and are relatively easy to clean.

A common type of reuse in hospitals occurs when a sterile product, such as a suture, is opened during a medical procedure but not used. Typically these are resterilized and re-packaged at the hospital. OEM’s often provide instructions for hospitals to do so. The Agency has published applicable guidance on these products and

does not consider opened-but-unused SUDs to be reused devices that are within the

scope of the proposed strategy.

AGENCY INVOLVEMENT IN REUSE

Reports of Patient Injuries

There have been stories in the media which have reported catheter tip separations, faulty cataract surgical equipment, and other problems attributed to failure

of a reused SUD. A recent review of Medical Device Reporting (MDR) reports received by CDRH from August 19, 1996 through December 7, 1999 revealed 464 reports (out of 300,000) of adverse events that could possibly be attributed to reuse

of a SUD. The 245 reports spanned approximately 70 different types of products.

From this data we can discern no pattern of failures with reused SUDs that differs

from patterns observed with the initial use of SUDs.

MDR reports do not enable accurate assessment of failure rates, whatever the

type of device. Detecting SUD problems is even more challenging in that they are

often not labeled as SUDs (other than on the original packaging). In addition, device

failures may be particularly under-reported (to manufacturers) when the hospital

recognizes that the device that failed was a reused SUD. Also, infections that may

have resulted from an improperly reprocessed SUD may be hard to trace back to

the reused device.

14

Research Findings

CDRH has implemented a research program to explore safety and effectiveness

issues associated with the reprocessing of single-use devices. Information on difficulty of cleaning the devices, effect of sterilization on material, efficacy of resterilization, and alteration in performance criteria are all being investigated. CDRH has

had the opportunity to examine SUDs after one-time use, compare them to devices

that have not been used, and do simulated reuse laboratory studies. Loss of elasticity in inflatable balloons, persistence of blood and biofilms, loss of original lubricants and the effect on catheter threading, and crystallization of liquid x-ray contrast material are just some of the factors that we have examined. This research

program has expanded our ability to evaluate reports, scientific studies, and comments from the healthcare community.

Hospital infection control programs rarely identify specific incidents of patient infection caused by reuse of SUDs. Our research has shown, however, that the performance of some products is degraded by the effects of biofilms and repeated use.

We have presented our laboratory findings at many scientific meetings. We continue

to believe that solid research by industry, academia and FDA is the best way to understand the issues that need to be addressed and to develop consensus standards

for reprocessing practices.

Outreach

The Agency has conducted numerous outreach efforts to further understanding of

and participation in this issue. We have organized and participated in public meetings and conducted videoconferences. We have met with individual manufacturers

and reprocessors; manufacturers’ and reprocessors’ trade associations; the American

Hospital Association; the Joint Commission of Health Care Organizations (JCAHO);

the Health Care Financing Administration (HCFA); and medical professionals and

some of their associations on this issue. Two meetings with broad scope that occurred in 1999 were particularly useful in furthering our understanding of this

issue.

On May 5-6, 1999, FDA and the Association for the Advancement of Medical Instrumentation (AAMI) co-sponsored a conference on the practice of reprocessing and

reusing SUDs. Participants included representatives of health care facilities, firms

that reprocess devices, OEMs, national oversight organizations, State governments,

academia, medical ethicists, and standards organizations. This provided FDA the

opportunity to hear a wide range of views and concerns from individuals and organizations involved in or affected by this practice.

FDA received divergent opinions on how reprocessing and reuse of single-use devices should be regulated. Some participants believed that reprocessors should be

regulated in the same manner as OEMs and that 510(k)s or Premarket Approval

applications (PMAs) demonstrating the safety and effectiveness of the reprocessed

device should be required. Others believe that OEMs should be required to provide

instructions on how to reprocess their devices unless they can demonstrate that the

device cannot be reprocessed. Still others stated that the general controls under

which reprocessing is regulated currently are sufficient to ensure protection of the

public health.

Participants identified the need for additional guidance on reprocessing. Among

the suggestions were: standards to assure that cleaning, disinfection, and sterilization processes are validated and that reprocessing may be performed properly; a determination of what types of devices can and cannot be reprocessed; a classification

scheme establishing critical, semi-critical, and non-critical categories for reprocessed

devices; and clearer definitions for the terms ‘‘reuse,’’ ‘‘reprocessing,’’ and ‘‘resterilization.’’

Participants suggested that clinical data and experience on reuse could be obtained through hospitals’ existing surveillance activities; long-term clinical studies;

the establishment of a clearinghouse for data; National Institutes of Health funds

and studies of reprocessing; and research by professional societies with funding provided by OEMs and reprocessors.

FDA held an open meeting, on December 14, 1999, to obtain feedback from stakeholders and interested parties on its proposed strategy on reuse of SUDs. Twentyeight public presenters voiced a variety of concerns during the first part of the meeting, and workshops in the afternoon provided attendees with an opportunity to explore particular issues in smaller groups. An Executive Summary which describes

the input we received on many aspects of this complex issue is available on our web

site at http://www.fda.gov/cdrh/reuse/1214execsum.pdf.

15

FDA’S CURRENT POLICY

As I noted at the outset, the American public expects, and the Federal Food,

Drug, and Cosmetic (FD&C) Act requires, that devices be safe, effective, and manufactured in accordance with GMPs. When a SUD is prepared for reuse by cleaning,

repairing, or refurbishing, it is being remanufactured and the FD&C Act provides

controls to address these reprocessed devices, however, FDA has not regulated

OEMs, third party reprocessors and hospitals that reprocess devices in the same

manner.

Original Equipment Manufacturers (OEMs)

OEMs are subject to all requirements of the FD&C Act including: registration and

listing, premarket notification and approval requirements, submission of adverse

event reports under the MDR regulation, manufacturing requirements under the

QSR; Labeling requirements, Medical Device Tracking, and Medical Device Corrections and Removals. The Agency has enforced all of these requirements with respect

to OEMs.

Third Party Reprocessors

Third party reprocessors are subject to the same regulatory requirements as other

manufacturers, including premarket requirements. As discussed previously, FDA

has issued Warning Letters to third party reprocessors for various violations; however, to date, FDA has not actively enforced premarket requirements against third

parties. (Note that many devices that are commonly reprocessed are exempt, by regulation, from premarket requirements.)

Hospitals

According to the Agency’s Compliance Policy Guide, hospitals that reprocess single-use devices assume full liability and responsibility for their reprocessing actions

and should ensure that the products are adequately cleaned and sterilized, and that

device safety, effectiveness, and quality are maintained. The Agency currently provides no direct oversight or routine enforcement for in-hospital reprocessing. If a serious adverse event involving a reprocessed (or any other) device occurred in a hospital, however, FDA would conduct an investigation and take appropriate action, as

necessary.

FDA’S PROPOSED STRATEGY

As I stated earlier, FDA is reevaluating its position on the reuse of single-use devices. In November 1999, the Agency made a document available on its web site for

public review and comment which described a proposed strategy to address reuse

of SUDs. One of the principal components of FDA’s proposed strategy was the establishment of agency enforcement priorities concerning regulatory requirements for

third party and hospital reprocessors of SUDs. FDA proposed to prioritize its enforcement activities based on the degree of risk posed by the reprocessing. To accomplish this process, FDA proposed the following steps:

(1) develop a list of commonly-reused SUDs;

(2) develop a list of factors to determine the degree of risk associated with reprocessing devices;

(3) use that list of factors to divide the list of commonly-reprocessed SUDs into three

categories of risk—high, moderate, and low; and

(4) develop priorities for enforcement of regulatory requirements for hospitals and

third party reprocessors, based on the category of risk.

Since the announcement of FDA’s proposed strategy, FDA has made significant

progress. On February 8, 2000, FDA posted on its web site two companion draft

guidance documents. One is entitled, ‘‘Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme.’’ This draft guidance set forth factors we would

consider in categorizing a reprocessed devices as high, moderate or low risk and includes a list of commonly-reprocessed SUDs and the degree of risk FDA believes

each type of device poses when reprocessed. The other draft guidance, entitled ‘‘Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals,’’ sets forth our priorities for enforcing various regulatory requirements, based

on the categorization of a device, as described in the Risk Categorization guidance.

The risk scheme guidance describes specific factors FDA would use to determine

whether reprocessing posed high, medium, or low risk. This guidance has two flowcharts to help FDA and industry categorize the reprocessing risks. One flowchart

addresses factors that relate to risks of infection that may accompany reprocessing.

The other flowchart addresses factors that relate to risks of performance failures

that may accompany reprocessing. Using these two flowcharts, FDA has categorized

16

all currently known reused SUDS into three categories of risk—high, medium, and

low. We have clarified that the risk categorization scheme does not in any way

change the classification of a device under the statute.

The enforcement priority guidance bases the Agency’s timing of enforcement of

premarket requirements on the level of risk determined under the risk categorization scheme. Specifically, FDA intends to begin to enforce premarket notification

and premarket application requirements within six months of issuance of a final

guidance if the reprocessed device is categorized as high risk, within 12 months if

the device is categorized as moderate risk, and within 18 months if the device is

categorized as low risk. Although FDA has not previously enforced premarket requirements for third party reprocessors, FDA currently enforces all other requirements applicable to manufacturers against third party reprocessors. The issuance

of this draft or any final guidance will not change the continuing obligation of third

party reprocessors to comply with those provisions of the FD&C Act. FDA would not

enforce those requirements for hospitals, however, until six months from the

issuance of a final guidance document.

I would like to give a couple of examples of how this proposed risk categorization

scheme and our enforcement strategy would affect reprocessors of devices of disparate complexity and risk. Oral and nasal catheters, fairly simple devices, are currently class I and exempt from premarket notification. They would be considered

‘‘low risk’’ under the risk categorization scheme I just described. Six months after

a guidance became final, FDA would actively enforce all non-premarket requirements for hospitals that reprocess oral and nasal catheters, just as we currently do

for OEMs and third party reprocessors, including registration, listing, manufacturer

adverse event reports, labeling, corrections and removals, and quality system manufacturing requirements.

Percutaneous transluminal angioplasty catheters or intra-aortal balloon catheters,

class III, would be considered ‘‘high risk’’ under the scheme. Based on our own studies, we have determined that cleaning and sterilizing these devices are very difficult. Hospitals and third parties that reprocess these devices would be required to

submit to the Agency PMAs demonstrating that their reprocessing of these devices

is safe and effective, in addition to conforming to the general controls of the FD&C

Act.

At this time, the Agency is limiting its focus to SUD reprocessing by third parties

and hospitals. The draft SUD enforcement guidance does not apply to permanently

implantable pacemakers (the reuse of which is already addressed in a Compliance

Policy Guide), ‘‘opened-but-unused’’ SUDs, and healthcare facilities that are not hospitals.

NEXT STEPS

Issuance of Final Guidance Documents

The guidance documents I mentioned are not final, nor are they in effect at this

time. These documents incorporate comments to our proposed strategy that we received at the December 14 public meeting and written submissions. We are in the

process of publishing in the Federal Register of a notice of availability of these documents and are asking for comments. After reviewing the comments received, the

Agency will issue final guidance documents.

Phased-In Enforcement

As I have stated earlier, FDA is planning to phase in the enforcement of regulatory requirements for third parties and hospitals that reprocess SUDs. After receiving public comment on our draft guidances, including factors used to categorize

risks, and timing of our enforcement based on those risks, we will issue final guidances and begin implementation of our enforcement strategy that would regulate

OEMs, and third party and hospital reprocessors in the same manner.

Collaboration with Other Parties

The direction in which we are headed could impact significantly on the Agency’s

resources, particularly for conducting inspections of hospitals that reprocess. We will

be collaborating with third parties, such as JCAHO, HCFA and State agencies that

currently perform oversight of the health care sector to assist us in implementing

the new policy.

Outreach

We will be continuing our outreach efforts to ensure that the health care community, manufacturers, reprocessors, patients, and the public are fully aware of the

issues involving the reprocessing and reuse of SUDs. Our efforts will include talk

papers, public health notifications, and lay articles on an FDA web page.

17

SUD Labeling

We will be considering changes to the labeling of SUDs by OEMs. One option the

Agency is considering is requesting OEMs who label their devices ‘‘single-use’’ to

provide, as part of the device’s labeling, any information of which they are aware

regarding the potential risks associated with reusing their SUDs. This information

would serve as a caution to users and reprocessors who might attempt to reprocess

these SUDs.

Institute an Expanded Research Program for Reuse

The Agency has conducted several in vitro studies on reused SUDs and is considering additional studies on the effects of reprocessing. Expansion of our research efforts may facilitate collaboration with stakeholders and interested parties to conduct

more in vivo and in vitro studies.

CONCLUSION

Mr. Chairman, although we have no data to indicate that people are being injured

or put at increased risk by the reuse of SUDs, the results of our own research and

the information provided by various stakeholders have convinced us that this growing practice needs closer scrutiny and oversight. We are committed to addressing

reuse in an open and cooperative fashion with the industries involved, the health

care community, the public, and, of course, the Congress to craft a policy that is

reasonable yet effective in minimizing the risks associated with this practice. Thank

you for the opportunity to be here today. I am happy to answer any questions you

may have.

Mr. UPTON. Thank you very much. Now we will work this clock

for us. We are going to take 5 minutes each, rotating on both sides

for questions. One of the items that you used last in your testimony

was, in fact, this one right here, which is—I don’t know if I want

to take it out because then no one would be able to use it. This is

an emergency coronary artery bypass graft surgery instrument?

Mr. FEIGAL. Yes.

Mr. UPTON. And as you have indicated, it is a Class III. Okay.

Currently this could be reprocessed, is that right, without the new

regulations in place?

Mr. FEIGAL. That is correct. We have not been calling for premarket applications for reprocessors for such devices.

Mr. UPTON. But in fact this could be used more than once?

Mr. FEIGAL. Yes, that is correct.

Mr. UPTON. And under the regulations that you put on the Web

page earlier this week, if they become final then for this to be used

a second, third, or however many times, the reprocessor would

have to, in fact, demonstrate that it was absolutely clean and safe,

and there should be no problems, and it would only be used X

amount of times, is that correct? Is that basically how it is going

to work?

Mr. FEIGAL. They would need to demonstrate that their cleaning

process could assure that the product was clean and free from infection risk, and that the cleaning process did not degrade the performance of the item. The exact mechanism for doing that may involve testing and assessing the devices or tracking the number of

times a device is used. I think there is not a single answer for all

types of devices, but it would be up to the applicant to tell us that

they had a way to assure that each time that device was going to

be used that you could expect that it would perform as intended

and be safe and effective.

Mr. UPTON. Assuming that they could show that it was safe and

clean, they would have to somehow tag this so that it didn’t exceed

18

so many, whatever you defined as the number of uses, is that

right?

Mr. FEIGAL. It has to be accurately labeled. A reused product

should identify the fact that it has been reused. The hospital

should know whether it is opening something that is new or opening something that is reprocessed. I think whether each device

needs to be tracked each time it is used will vary with the type of

device. That would be one way that someone could propose that

they would control the aging of the device.

Our concern would be if someone said well, we could always use

these four times so we’ll count to four and throw it away, when in

fact, it might show degradation after the second use. So, in fact,

each time it is cleaned they need to assure that the product will

perform as expected, and that may require a different approach

than actually counting the number of uses to assure that it met

adequate performance specifications.

Mr. UPTON. How would they determine the number of uses?

Would there be a clinical trial? Would they like test it or just stand

back until they figured out when it broke down?

Mr. FEIGAL. This is one of the questions that we’ve been trying

to address with our own laboratories looking at some of the research methods. For example, a common problem with catheters.

When they are first manufactured they are coated with a lubricant

to facilitate threading. As you clean it the lubricant is stripped.

Mr. UPTON. That’s right.

Mr. FEIGAL. And so rather than finding out in patients whether

or not it is tougher to thread these things after the lubricants are

stripped, we have actually done a bit of research to try and develop

a mechanical way of measuring how smoothly something moves

through narrow spaces. This is the kind of evidence and research

we would expect the applicants to provide to address all the aspects

of why products perform well and why they are failing. The issue

of brittleness has been raised a number of times. That is another

example of something that probably can be assessed by looking at

multiple cleaning cycles and simulated use. Breakage of these fragile devices is something that even new devices are susceptible to,

and I think we can learn more about product mode failure through

this process.

Mr. UPTON. Now, in your deeming whether this should remain

a single-use or not, would you, as part of the regulations or part

of the design, would you go back to the manufacturer of this and

get their comments as well?

Mr. FEIGAL. Well, what the reprocessor is doing is taking a discarded single-use device, if you will, and using that as his starting

material. Obviously he can do a better job of assessing what he is

up against in reprocessing if he has information from the original

manufacturer. But we do not have any authority to require this. In

fact, our authority and our requirements actually protect the trade

secrets of the original manufacturers.

So, actually the burden on the reprocessor would be to show that

he could clean it, not even knowing exactly how well it was made.

We would certainly have the information in most cases ourselves

as to how it had been manufactured, but we would not be allowed

to share that with the reprocessor.

19

Mr. UPTON. Just to finish then, so it is or is not part of the process that you would have to go back to the original manufacturer

to get their comments as to whether or not this should be used a

second time?

Mr. FEIGAL. The application actually of the new manufacturer is

a trade secret as much as the application of the OEM is a trade

secret. And so that is one of the difficulties in this.

Mr. UPTON. You have got to make the judgment as to——

Mr. FEIGAL. Yes.

Mr. UPTON. [continuing] whether or not it is going to be effective

as it was the first time that it was used, and therefore you would

have some statistics that they, I would think they, would be willing

to offer to say yes or no.

Mr. FEIGAL. Yes. Well, that is why the law gives us the ability

to know all the information from both manufacturers and to consider everything we know in assessing safety and effectiveness, including all the information we have across manufacturers for multiple different types from our adverse experience reporting. There

are a lot of details, I think, that you are bringing up that are important in how this will actually work. We need to do it in a way

that both insures the public health, but also respects the trade secrets of the manufacturers who have applications before us.

Mr. UPTON. Okay. Mr. Stupak.

Mr. STUPAK. Thanks, Mr. Chairman. Is there reported cases of

infection associated with single-use instruments?

Mr. FEIGAL. I’m sorry. Could you repeat the question?

Mr. STUPAK. Single-use instruments, first time they have been

used, has there been reported cases of infection associated with

them?

Mr. FEIGAL. That would be very unusual. What is more common

is to have cases of infection reported to us from the lax cleaning

procedures of devices designed for reuse. So, for example, bronchoscopes and endoscope, there have been reports of infections that

have been spread because these devices, which are designed for

reuse, were not properly cleaned by the hospitals. So, that is the

more common type of infection that we have reported associated

with devices.

Mr. STUPAK. Those scopes though, when they are manufactured,

are they manufactured and received from the manufacturer as

being a single-use item?

Mr. FEIGAL. No. They are not. They are actually marketed with

detailed instructions for cleaning and disinfecting. And despite

that, in hospitals, we still have infections.

Mr. STUPAK. Okay. So they are manufactured, and when they

come in the package or whatever, there are instructions on how to

reprocess them for reuse and how to sterilize and take care of

them?

Mr. FEIGAL. Yes. And that information is provided by the manufacturer in their application to us so we can assess whether they

have adequate instructions for cleaning and sterilization.

Mr. STUPAK. So the sterilization, the chemical reaction, the lubricants, that is all taken into consideration if they allow it to be a

reused item?

20

Mr. FEIGAL. That is right. We have to consider all of that for reused items.

Mr. STUPAK. If I am a hospital and—it may not be a fair question

to you, but if I am at the hospital and I get a single-use item, am

I required before I use it to go through some type of sterilization,

or can I take it out of the packaging knowing I can use it immediately, or is there a requirement of the hospital to also do sterilization before they ever use a single-use item?

Dr. Feigal. Most devices that are intended for sterile use are

shipped sterile in packing that can be opened. A common challenge

for hospitals is that often devices are opened and made available

in the operating room that are not used, and then the hospitals

have to know how to repackage and re-sterilize those. The most

common product for which that occurs is sutures, but it occurs for

hip implants, all sorts of different things. So hospitals actually do

this day in, day out and have considerable skill at doing this.

Mr. STUPAK. Okay. And Doctor, the issue of alteration of performance criteria is mentioned in your description of FDA’s research on reuse issues. Could you tell us how alterations of performance criteria are handled in the draft guidance?

Mr. FEIGAL. Well, this is one of the two key factors that are identified to establish the level of risk and our level of concern about

the product. The device laws are risk-based and devices are riskstratified. We do not have the same application process for all devices. We have taken the same approach with the reusable devices

in that we will start with the products that concern us the most

and work our way out from there. Eventually we will cover them

all. But we will start with the products of greatest concern, either

because of risk of infection or difficulty in cleaning. The other factor is evidence that the material or product will not be degraded

with repeated use and cleaning.

Mr. STUPAK. What are the ones that concern you the most?

Mr. FEIGAL. The products that have delicate materials or that

were already Class III devices concern us the most. For us to even

approve them in the first place required clinical data. Many of

these devices, if you look at our prioritization scheme, are at the

top of the list. The things that are low on the list are things that

have large lumens or are made out of hard materials and are relatively straightforward to clean. There are many single use products. Many are not labeled as to why they are single use and many

of the single-use products are labeled that way for convenience. If

you look at some of the products in the low risk categories probably

relatively straightforward to clean.

Mr. STUPAK. Okay. Using one or two devices as examples, could

you give us a brief overview of the similarities and the differences

between the quality system regulations for OEMs and reprocessors?

Mr. FEIGAL. There will be none under our proposed scheme.

Whatever standard the OEM has to meet, the reprocessor has to

meet. If there are differences, the differences have to do with the

starting material. The OEM builds their device from scratch. The

reprocessor starts with a used device. So there would be differences

in the manufacturing steps, differences in some of the things that

the OEM might have to do to fabricate a device. But in terms of

21

the nature of the law and the requirements, our proposal makes

them identical. There will be a completely level playing field for

OEMs and reprocessors.

Mr. STUPAK. Okay. Well then would the guidelines then permit

significant variability among reprocessors in terms of the number

of times devices are used, reused?

Mr. FEIGAL. We will ask the reprocessors to tell us how they

know that a device addresses our concern of infection and integrity

of performance. If they can do that without counting the number

of times it is used, for example, by testing it before re-release, that

may be adequate. And I think that there will not be a single way

to safely clean and reprocess all devices. We will ask for the applications and we will review them critically. There may be times

when it will be appropriate to keep a detailed record, and others

when it may be more important to test to see how brittle the device

is, no matter how many times it has been used.

Mr. STUPAK. The reprocessors in this case would that be like the

hospitals, or could it be the manufacturer?

Mr. FEIGAL. The reprocessor is either the hospital or a thirdparty commercial reprocessor. There is, of course, some level of reprocessing that occurs, mostly in the setting of open-but-not-used

devices, that is actually done cooperatively between the original

equipment manufacturer and the hospital. So I think we are going

to see a variety of different ways that this problem is approached,

and I think some of the economic pressures will change. We may

see new partnerships develop and problem solving in some of these

areas. We would welcome research to develop reusable devices that

can be safely manufactured, and currently are only labeled singleuse for convenience or other reasons.

Mr. UPTON. We can go another round if you want?

Mr. STUPAK. Okay. Can I ask one more question? Economics I

just want to ask.

Mr. UPTON. Sure. Okay.

Mr. STUPAK. One question on economics, Dr. Ganske had brought

that up, and there is obviously a savings here, but is some of the

pressure on reprocessing because the DRGs, I mean, you get paid

a certain amount if you are doing a procedure underneath a DRG,

correct? And if you can cut the cost of doing it by using a reprocess

you would make cost benefit then would be—go to the hospital then

because you get paid an amount whether it is reused or new, correct?

Mr. FEIGAL. This is a question outside of my authority, but it is

a question I happen to know the answer to so I will be brave and

answer it for HCFA. The DRG does pay a flat fee, and in fact, one

of the questions about reuse is, ‘‘Are used devices billed individually in an itemized bill?’’ Under that system, and many other

types of systems, they are not. The hospital makes its own choice

in the equipment it purchases, the professional services it uses,

and they provide that service for that cost. And there is no representation to the third party, where the products came from or

what they were. If you want any more detail than that, I am completely out of my element so you are best to discuss this with

HCFA.

22

Mr. STUPAK. Thank you Mr. Chairman, for allowing me that last

question.

Mr. UPTON. Dr. Ganske?

Mr. GANSKE. Thanks Mr. Chairman. As a surgeon who goes oversees on surgical missions we take all of our own medical equipment

provided for free, and I am always interested in the fact that for

all the single-use tubing and equipment that we take over, that in

this country is typically just thrown away, we will frequently see

the hospital workers in these third-world countries pulling them

out of the garbage, cleaning them out, sterilizing them and using

them many, many times because they just simply cannot afford the

equipment otherwise.

It is clear to me that there are some types of single-use items

that probably can be safely cleaned, assuming that they are adequately cleaned and sterilized and reused. It also looks to me that

it is possible for us to be comparing apples to oranges. There is a

dispute between the medical manufacturers and the reprocessors.

It is fair to say that there are economic, big economic factors involved. Some would say that manufacturers will label a device a

single-use device for their own purposes so that it should be only

used once and then they have to buy another one.

There are also allegations of, and I am sure we will see some testimony today, inadequately cleaned devices. Does your organization

have any information on who has done the ‘‘inadequate cleaning’’,

for example, a lot of re-sterilization is done by individual hospitals.

They are under the auspices for doing sterilization properly, of the

JCAH, and they have protocols, but obviously if you are sterilizing

millions and millions of pieces of equipment every day, it is dependent on how thorough those pieces of equipment are cleaned. As

you pointed out in your testimony, not just for single-use items, but

for permanent items.

Mr. FEIGAL. Uh-huh.

Mr. GANSKE. Like for a steel bronchoscope that is clearly meant

to be used thousands and thousands of times, but if it is not

cleansed properly by the technician in the hospital, then it does not

matter whether it is a single-use device or a permanent device, you

have the risk of contamination. And I guess my point is this—my

question to you is have you looked at any of the data that the manufacturers are presenting that distinguishes between whether hospital contaminations after ‘‘reprocessing’’ were done by reprocessors, commercial reprocessors, as versus hospitals.

Mr. FEIGAL. The types of research submitted to us last February

by the manufacturers came from a variety of sources. Sometimes

the devices were not being sold as reprocessed devices, they were

simply devices that had been used. And the purpose of the research

was to identify the kind of condition that the device was in after

use and how use had changed it. Other types of research has actually tried to look at devices which were purported to be cleaned,

usually by third-party reprocessors. We, ourselves, have gone into

the reprocessors and done inspections and if you look through our

findings and our Warning Letters you will see the public comments

that we have made about how they do their business.

Mr. GANSKE. Well, summarize that for me.

23

Mr. FEIGAL. That industry is not terribly different than many device manufacturers, in that if you go in and look in detail at how

they follow their good manufacturing practices and their quality

systems, you find areas where they need to make improvements.

What we did not find were devices that were volatile and needed

to be seized, or products that required public health alerts, or other

types of problems.

Mr. GANSKE. When you went into those reprocessors and looked

at their results, in their reprocessed equipment sealed, ready to be

sent back, did you find pieces of tissue?

Mr. FEIGAL. We did not do those types of studies. The research

that we have done on devices has been done with single-use devices

that have been donated to us from other Federal hospitals that

were not going to reuse those devices, so we could study them. One

of the issues that addresses both the reprocessor and the hospital,

to get back to one of your earlier points, is to look and see what

the role of cleaning and reprocessing standards would be.

Certainly the OEMs are not calling for an application from hospitals on their cleaning procedure model by model, device by device,

for their reusables. We need to look and, again, our approach is to

look at the risk of the product and say which of the devices concerns us enough that we really want to see a pre-marketing application, and which are the ones for which the rigor of the quality

systems regulation and adhere to certain standards can do the job.

Mr. GANSKE. Let me give you an example of this then.

Mr. FEIGAL. Okay.

Mr. GANSKE. Let’s say you have a balloon angioplasty catheter

that has a little, you know, latex balloon on it that you put into

the coronary artery, and you blow it up, and you can crack open

a narrowing of the coronary artery. Now, are those catheters,

which are probably labeled single-use, are they being sterilized—

cleansed and sterilized in hospitals?

Mr. FEIGAL. In some hospitals, yes.

Mr. GANSKE. Okay. Now, do those hospitals have the ability to

determine whether that little latex balloon after it has been resterilized, has the same dimensions as it came from the manufacturer?

Mr. FEIGAL. We don’t know what the practice is in the hospitals,

to date, because we have not been in the hospitals. This is an issue

that needs to be addressed. There are other issues that we have

identified, such as persistence of crystallized dye in the catheters

and in the lumens.

Mr. GANSKE. Do reprocessors routinely check for that?

Mr. FEIGAL. Yes.

Mr. GANSKE. A commercial reprocessors?

Mr. FEIGAL. The reason I cannot answer that is we have not yet

asked them to file applications with us to show how they do these

things: how they clean them, what they know. What our framework

says is that they will have to tell us that in the future. That will

be our approach. We will know what they are doing, what their

standards are, and we will assess those to assure that a reprocessed device is safe and effective and manufactured to the kind of

quality we would expect of an OEM.

Mr. GANSKE. Thank you Mr. Chairman.

24

Mr. UPTON. Okay. Thank you. Mr. Strickland.

Mr. STRICKLAND. Thank you Mr. Chairman. Dr. Feigal, Boston

Scientific has done a study, which I am sure you are aware of, 35

reprocessed devices were pulled from hospital shelves and tested

for sterility. Of the 35, 25 had been reprocessed by the hospital,

and 10 by a third party. They found that 6 of the 35 were sterile.

And my question has to do with FDA research and attempt to replicate this study. I understand that FDA has attempted to replicate

the study and I would like to ask you what the results of that

study by FDA found.

Mr. FEIGAL. When we repeated the study we did not find that

the catheters would have transmitted infection. Part of the issue

comes down to the definition of what the findings were, that is,

whether we are talking about a clean but residual tissue or clean

but residual films on the forceps. Those may be other issues that

are also important to address. Where we are at this point is that

we have compared notes with Boston Scientific, we have asked to

see their methods so we can see if we can repeat the experiment

exactly the way they did it and see if we get the results. And that

is in progress. We would be happy to report back to you our findings when we complete that.

Mr. STRICKLAND. So are you telling me that there may have been

residual materials found, but that they were not found to be a

threat for infection?

Mr. FEIGAL. That is correct.

Mr. STRICKLAND. And I have also been told, and I would like for

you to deny or confirm this, that at least in one of the studies that

the devices were subject to bleach before they were examined for

being sterile or being safe. Can you tell me whether or not that is

a——

Mr. FEIGAL. I can answer that question, but I will have to submit

it as part of the record. It depends on where we got the samples.

Some of the hospitals that have been donating the equipment do

soak them in bleach to disinfect them. Bleach is a good antiviral,

virucidal agent. But I am not sure that is related.

Mr. STRICKLAND. But it does seem to be related to the validity

of the attempt to replicate the study and that is what I am getting

at.

Mr. FEIGAL. Well, that is correct. And if, in fact, we did the study

in some way that clouded the issue, we are trying to do the study

exactly the way they did it and see what we can find.

Mr. STRICKLAND. And are you saying to me now that based on

your current knowledge you cannot say that you have done a study

that, in fact, replicated the methodology of the Boston Scientific

study?

Mr. FEIGAL. Not every detail, but we tried to do it according to

our understanding of how they did the study and then when we got

the results, we compared notes with them and said well, what

might we have done different. And that is what we are trying

to——

Mr. STRICKLAND. I guess an observation I would make, if you

found materials on these reprocessed devices, that the materials

were not considered to be a danger of infection, is it possible that

25

they were not a danger of infection due to the fact that they had

been bleached?

Mr. FEIGAL. I take your point that it depends on how the materials were handled, and we should make sure that the two experiments were done the same way.

Mr. STRICKLAND. No more questions, Mr. Chairman.

Mr. UPTON. Thank you. Mr. Whitfield.

Mr. WHITFIELD. Thank you Mr. Chairman. I am sorry I missed

the testimony after saying how much I wanted to hear it. But I was

called to the House, but I will read your testimony, Dr. Feigal, and

one question I had. In the European Union, do they allow reprocessed medical devices in European countries or do you know?

Mr. FEIGAL. European device laws vary considerably from country to country. Some of the device laws do not require any type of

pre-market application and rely on quality system requirements,

and there is some effort to harmonize those. I think if we would

go country by country I think we would find countries that ignore

the problem entirely and others that have some rules about it. And

we could provide more detail as follow-up if you like. I don’t have

that information with me today.

Mr. WHITFIELD. That’s okay. Now it is my understanding that on

many of these devices the name or the initials of the original manufacturer are on the device, and then once it is reprocessed that

would still be on there.

Mr. FEIGAL. Yes. Although we heard, actually we heard on a visit

to Michigan stories of someone who was grinding off the name of

the OEM and claiming that the product was just as good as the

OEM’s product, which was a fair statement because it was the

OEM’s product, just with the name ground off, but recleaned and

reprocessed. That is right.

You usually can identify it, but I think one of the challenges for

hospitals is, if you look at some of the catheters the members of

the committee brought or that I brought today, you see there isn’t

very much room for very large lettering or detailed descriptions. So

it usually takes someone who technically knows exactly what they

are dealing with to identify the manufacturer and the model in

some of these cases.

Mr. WHITFIELD. Would that subject a reprocessor to a charge of

misbranding or not?

Mr. FEIGAL. I think it depends on what they claim. You need to

claim accurately what you have got. If you claim you have got a

reprocessed device that was originally manufactured by a specific

company, then that is the truth. Now, whether you are infringing

on their patents or other kinds of things, that would be Better

Business Law. But I think that they need to disclose what they

know about the product that is relevant for the safe and effective

use of the product.

Mr. WHITFIELD. It is my understanding that in the past the FDA

has claimed that they have been unable to find clear evidence of

adverse patient outcomes as a result of using reprocessed devices.

Is clear evidence of adverse patient outcomes the sole basis on

which the FDA would determine if there is a major public health

problem?

26

Mr. FEIGAL. No, it is not. There are times when a single serious

failure of a product can result in an FDA action to correct a product. So it is not that it takes large numbers, and it is not that we

do not have any reports. In fact, if you go through our MDR reporting system over a several year period, we have about 245 reports

of injuries associated with reused devices. The difficultly for us is

that the system does not tell us the volume of use of the product

or of the different types of problems.

And so, for example, we have reports of broken catheter tips, but

we also have 11 reports of catheter tips that broke in brand new

devices the first time they were used. And we don’t have the kind

of information and the type of system to tell whether the reused

device has a higher risk. Your other question is one that I think

is an important one, which is that the law does not just require

that the products be safe and effective. They also require that they

be well manufactured, that is, manufactured under quality system

regulations according to good manufacturing practices. So even if

they were safe enough and usually did not cause problems, we still

expect that the reprocessors and the remanufacturers of these

products will meet the same standards that we expect of the original equipment manufacturers.

Mr. WHITFIELD. Mr. Chairman, thank you. I just want to thank

Dr. Feigal for being here, and we all recognize that you have been

sort of a leader in trying to reestablish focus on this issue. And

thank you very much.

Mr. UPTON. Thank you. Mr. Bryant.

Mr. BRYANT. Thank you Mr. Chairman. Dr. Feigal, let me also

join with my colleague to thank you for what you have done in the

short time that you have been at FDA. I think everybody from hospitals to all sides of this issue are really desirous of the FDA moving on this and issuing the instructions and advice that is necessary so that we can have clarification in this issue. And I think

that is the goal of everybody. I sit here thinking what we are talking about here is reusable single-use equipment. And is that an

oxymoron or what?

Mr. FEIGAL. It sounds like it, doesn’t it?

Mr. BRYANT. Why did we ever go from reusable equipment to single-use equipment?

Mr. FEIGAL. There are a variety of different reasons. Sometimes

there was a request for disposable equipment for convenience and

it was more expensive to clean the product than it was to manufacture a disposable product. There are times when a product changes

status. It has been on the market as a multiple use and the manufacturer changes it to a single-use and it is not clear always why

that happens.

If someone is coming in for the first time it is a simpler application to have it be a disposable device than a device which is

cleaned. If they are asserting to us that it can be cleaned, they

have to include in their application the studies that show how to

clean it and that those studies do not damage the device. And so

there are probably some business decisions that at times they will

get to market more quickly with a product if it is labeled for singleuse only.

27

Mr. BRYANT. But originally wasn’t the dominant reason had been

infections and simply the safety of the product?

Mr. FEIGAL. I don’t believe that there are really very many reports with medical devices that are being reused causing infections.

The manufacturers are required to tell us what they know.

Mr. BRYANT. I mean originally, back in the 1950’s or whenever.

Mr. FEIGAL. Well, this sort of started in the 1970’s and it would

be interesting to ask some of the manufacturers who have been in

this business a long time the history from their individual companies. We can only speculate, but I think it is often many reasons.

And one of the things that we have asked for feedback about is

whether it would be useful, if a company knows that reprocessing

damages a product or that if a product is susceptible to infection

if it is reused, that they should include that information in the labeling. Now there is concern by the OEMs that that is requiring

them to say something about a use for the product they never intended and puts them at a marketing disadvantage. So we understand that. On the other hand, if it is a common practice and the

device looks very similar to devices that once their labeling is off,

their packaging is off, all look alike, then if they know their product can be damaged or made less effective that information would

be useful to the medical consumer.

Mr. BRYANT. Right. And I would assume trial lawyers to know

also.

Mr. FEIGAL. Uh-huh.

Mr. BRYANT. Did I understand you correctly to say that when a

manufacturer comes to the FDA they have to, on a single-use product, they have to provide you with instructions on how to clean it?

Mr. FEIGAL. Only if it is a multiple use. If they have a device

that is going to be reused again and again, then part of the application process is to show the performance of that device with multiple

use.

Mr. BRYANT. Okay. All right. You testified that the FDA had no

clear studies, and I think I wrote that down correctly. I am just

wondering that maybe you have been unable to find any clear evidence of adverse patient outcomes associated with the reuse of single-use devices from any source. Is the clear evidence of adverse

patient outcomes the sole basis of the FDA to determine if there

is a major public health problem? And if not, what else would the

FDA rely on?

Mr. FEIGAL. Certainly anything that resulted in patient injuries

would be an important criterion, but when we are looking at the

device we look at how complex is the cleaning process, how delicate

are the materials with which it is manufactured? Is it likely that

you are either not going to be able to clean it because you have got

lots of crevices and narrow lumens, and areas where you are going

to get residual body fluids or biofilms or even tissue?

Beyond that, even if someone can clean the device well, we look

at whether or not the cleaning process itself is likely to damage the

device and make it less effective. So the two primary criteria that

we look at is whether you can clean it in a way that makes it safe

and does not degrade the performance. So, those are the two key

issues that we have said we would use to determine our level of

28

concern with the device and how rapidly we would move it into our

priorities for taking action.

Mr. BRYANT. Given what I understand to be your testimony that

the FDA believes this issue of reusable equipment ought to have

more oversight and regulation, do you think it would be appropriate at this time that a patient should be informed ahead of time

that reprocessed equipment might be used on them?

Mr. FEIGAL. I think this is a question about which you will hear

testimony from the other panelists. When it is not in the setting

of an experimental device, then we are looking at the use of informed consent and the practice of medicine. And there are many

things that you do in the practice of medicine, such as agreeing to

surgery or agreeing to the examination of a child, where national

norms state that informed consent is appropriate in that setting.

The kinds of details, the kinds of issues that are disclosed, I think,

are part of that broader issue of informed consent relating to the

practice of medicine. And so our position as the Agency is that that

would not be something that we would consider, but it is a very

important issue for the healthcare community to address and decide what is appropriate.

Mr. BRYANT. Thank you, doctor. I see my time is up and I would

yield back.

Mr. UPTON. Mr. Burr.

Mr. BURR. Thank you Mr. Chairman.

Dr. Feigal, welcome. Do you regret the move from biologics to devices?

Mr. FEIGAL. Well, I came from drugs before that, so I am not yet

looking for my next home.

Mr. BURR. Have you figured out which direction they are sending

you yet?

Mr. FEIGAL. No. I am enjoying myself very much, thank you.

Mr. BURR. Let me take the opportunity to thank you. Since 1976,

I think, that we have had in the law the responsibilities for this

area, and I think since you got there you have taken this in a very

serious way as a safety issue and as an equity issue within the

world of OEM and reprocessors. And I think to a large degree taking into account the need that hospitals have and for that I am

very thankful. There are not too many people that would try to sort

through this. And I realize that it is a process in work. But let me

be real specific on some questions if I could.

Now, you said that under the scheme that FDA has designed,

that reprocessors would file a 510(k) application and they would

have to prove that the device was safe, effective, and well

manufacturerd. How could we expect a reprocessor to prove that it

was well manufactured?

Mr. FEIGAL. Let me start by saying that the reprocessors would

have to file the same kind of application that the OEM would have

to file for the same device. And so in some settings that would be

a PMA, in some settings it would be a 510(k), and in still other settings where the OEM is exempt from pre-market application the

reprocessor is exempt from a pre-market application. They are still

required to meet all of the other standards, including our

inspectional standards and their requirements for quality systems.

29

The cornerstone of this is that you have processes in place where

you identify where the hazards are to your product, and you identify the kind of controls that are necessary in your manufacturing

that can address those hazards, and you do it in a way that you

can document and quantify. You do not wait for them to fail and

work backwards from failure analysis, but you work forward from

the start and say there has to be integrity in this system, it has

to be a high quality system. Certainly as you get failures and complaints you feed those back in and you see why those were missed.

Mr. BURR. I think it is also safe to say that we would not design

a system that would not work, right?

Mr. FEIGAL. That is correct.

Mr. BURR. And you mentioned earlier the proprietary information and the FDA’s position on that information, and certainly this

committee has learned in the past what happens when that information leaks out of the FDA, especially as it relates to laser surgery. Let me ask you, given the need to withhold so much information about the product, is it fair to believe that they can prove the

well manufactured part, or is that just the wrong word?

Mr. FEIGAL. Well, withhold is probably the wrong word. We certainly don’t share the companies’ information with each other, but

we don’t withhold our concerns. And we can express our concerns

and what the issues are that they need to address for a product—

we learn across a whole product class what the issues are with that

product.

And we lay those out for the manufacturers and now whether

they are an OEM or a reprocessor, and those are the things they

need to address. You have allowed us in the way that you have

structured us to use all the information we have without being required to share or disclose it in order that we can meet that balance of protecting the public health but still maintaining the trade

secrets that are useful in commerce. And so that is the balance

that we need to do. It is a process that has to go device by device

and model by model to look at how this is done.

Mr. BURR. Who determines the single-use labeling?

Mr. FEIGAL. The manufacturer.

Mr. BURR. And in the absence of any request on their application, what does the FDA put on the labeling?

Mr. FEIGAL. The manufacturer does the labeling. In fact, they

have under the law the ability to actually make some changes in

the label without even informing us. It has been our practice in the

past if the manufacturer asked to label for single-use, to take that

at face value and to evaluate how it would perform with one use.

Mr. BURR. Under your proposal, would a reprocessor be required

to test every device for functionality?

Mr. FEIGAL. They have to think about the device they are dealing

with and say what are the critical performance aspects of this device and how can I assure that every time I release this device it

still meets those standards.

Mr. BURR. Are original equipment manufacturers, do they test

every device for functionality or do they batch test, do you know?

Mr. FEIGAL. It depends on the type of testing. Some types of

product testing are destructive and so you would not have any

product if you tested them all. In those kinds of settings manufacVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00033 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
30

turers typically sample. But the important thing about the way

that the law and our regulations have constructed the manufacturing process for human medical products, whether it is a drug,

biologic or device, is to emphasize the integrity of the manufacturing process. We emphasize the quality of the manufacturing

process, rather than defect analysis at the end of the game. And

we would expect that same philosophy to be adopted by re-manufacturers.

Mr. BURR. When you look at reprocessors, and I put third party

in hospitals.

Mr. FEIGAL. Yes.

Mr. BURR. Do you look at them separate? Are they different or

are they one in the same as you wrote this regulation?

Mr. FEIGAL. Our proposal is to begin treating them all the same.

Each one that is its own business entity will have a separate relationship with us.

Mr. BURR. How long does it take for 510(k) to get approval in the

FDA on average?

Mr. FEIGAL. The average is about 180 days, I believe, but there

are types of 510(k)s that are simpler and actually are approved in

as short as an average of 29 days. So it varies. But you raise an

issue that we thought about, which is how this is going to impact

our resources since the average number of reviewer hours to assess

a 510(k) is about 55. But that’s for all 510(k)s and they vary widely

in complexity. We imagine some of these would be simple, others

would be very complex.

Mr. BURR. I found it a little odd that in this years budget there

was four times as much money sought for tobacco out of FDA than

the issue of reprocessing of devices. And I would ask you to share

that with the Administrator when you get back that it was noticed.

Let me just ask you, under FEDMA we created the ability for

510(k)s specifically to go through a third party approval process.

Do you see this as an appropriate area for the trial of third party

approval?

Mr. FEIGAL. The way that we constructed the third party system

was to establish standards so that both the third party and the applicant would know what the review criteria were. And I think certainly that in some of the areas of very commonly used devices this

could potentially work very well with third party. We are very committed to expanding that program. We have actually put specific

proposals in this year’s budget to expand that program and whether it is expanded in the way that is proposed in the budget or not,

we are committed to seeing that program succeed. It is one of the

ways in which we can expand our scope without always doing it

with Federal workers.

Mr. BURR. Last question, Mr. Chairman. You have been there a

limited amount of time, I realize that. But in your research of this

issue, which is not new, did any point did reprocessors come to the

FDA seeking guidance or seeking the process that the FDA expected them to follow?

Mr. FEIGAL. We have met with the reprocessors, and the reprocessors actually have asked us for letters clarifying——

Mr. BURR. But prior to your passion for this issue, do the records

show that at any point that this industry——

31

Mr. FEIGAL. Yes.

Mr. BURR. [continuing] be it hospitals or be it third party reprocessors, look to the FDA for the guidance for the procedures or to

set up the procedures?

Mr. FEIGAL. Yes. That did occur, and many of the efforts actually

predated me. You have been kind to attribute as much progress to

my getting there as you have.

Mr. BURR. I thank you for your willingness. I yield back.

Mr. UPTON. I would just like to note that we will proceed with

Mr. Barton and we will take a brief recess for folks to vote. Mr.

Burr is going to be asked to come back and chair while I vote and

after that we will proceed with the other members that are here.

Mr. Barton.

Mr. BARTON. Thank you. Mr. Chairman is this 5 minute or 2

minute questions?

Mr. UPTON. You get 5 minutes, and if you want more time we

can have another round.

Mr. BARTON. No, sir, I can comply with it. I want to ask unanimous consent that my opening statement——

Mr. UPTON. It. That has already been done.

Mr. BARTON. Thank you. Doctor, we are glad to have you. I am

going to be very quick because we have a vote on. The first question I have is there any reason not to treat all manufacturers and

reprocessors the same?

Mr. FEIGAL. No. And that is why the approach that we proposed

just this week in our guidance really does take that philosophy.

Mr. BARTON. Okay. And on the informed consent issue, is there

any reason not to require informed consent for a device that is

going to be reused? Why would we not do that permanently?

Mr. FEIGAL. I think that that is a good question, but I don’t think

it is an FDA question in the same way that we don’t specify the

informed consent for putting in a hip implant or other types of

things. These are the kinds of informed consent that are done in

the practice of medicine and I think it is important to get some

consensus on whether this is one of those things, like the examination of a child or surgery where informed consent is routinely used.

But it is not something I think that is part of FDA’s purview.

Mr. BARTON. If we want to give some Congressional guidance,

the FDA would not object if we had some truth in advertising requirements so to speak that informed consent should be allowed?

If I go buy a car I want to know if it has been pre-owned, you

know, whatever I purchase I would like to know whether it is

brand new or somebody else has owned it. I mean, I would think

if you are going to put something in my body I have a right to

know that it may have been in somebody else’s body.

Mr. FEIGAL. Yes. One thing to consider is that part of our approach is to assure that the reused device will perform as well as

the original device. And I think that needs to be part of the debate

about the role of informed consent. And then beyond that there is

the issue, if informed consent is needed, do you try and do that

with labeling on the packaging or exactly what is the mechanism

for that? But I think our fundamental start was we shouldn’t be

in a position where someone has to be informed that we are using

a device on you that may not be very good.

32

Mr. BARTON. Right.

Mr. FEIGAL. We think the quality of the device is the fundamental issue, and then it makes the informed consent less of an

issue.

Mr. BARTON. Well, I have read your testimony on page 11 as you

go through the process of looking at your existing proposal. You

have a list of five steps here, or four steps. The only question I

have, what kind of procedure do you have in place for interested

parties and stakeholders to interface with the FDA?

Mr. FEIGAL. We have a comment period open now on the two

guidances that identify a list and give our proposal for risk scheme

and for an enforcement time table. And those policies will not be

made final until we have had that input. We also have had public

meetings. There have been three or four in the last year and workshops, and there are ways to address us through our Web pages,

through other types of things.

Mr. BARTON. Now, we assume that you are going to have an open

process, that if you are a remanufacturer, an original equipment

manufacturer, or an advocacy group or hospital group, you can

have an honest dialog with the FDA and the FDA will listen?

Mr. FEIGAL. Absolutely.

Mr. BARTON. Okay. Mr. Chairman, that concludes my questions.

I appreciate you holding this hearing and I will follow it very closely and work with the chairman and other interested parties on this

issue.

Mr. UPTON. I know that you will. But we will take a brief adjournment. Mr. Burr will vote, come back. We will start with the

members that have not asked questions and proceed from there. So

it will probably be about 10 minutes.

[Brief recess.]

Mr. BURR [presiding]. If I could call the hearing back to order

and ask Dr. Feigal to return to the table. I actually thought they

would finish with you before that break. As is tradition here, that

means that other members will have additional questions, so I

can’t swear to you this is the last, but the Chair would recognize

Ms. Eshoo for 5 minutes of questions.

Ms. ESHOO. Thank you Mr. Chairman. I have several questions

as you might guess, Dr. Feigal. What I want to do is to read the

questions first. My experience is I ask the first question, most of

the time is used up and then we never get to the others. So, it is

going to be up to you to divide the time judicially so that you can

answer them all. First of all, thank you for your testimony today.

I just have a couple of observations. One, in how we use the words

single-use. I think it is a real contradiction to be talking about the

reuse of single-use. If we are going to be talking about the reuse

of medical devices we should just say so. And we should establish

a national policy that guarantees patients across the country that

they are indeed safe. But to continue to use this reuse of singleuse, I really do find it to be a contradiction.

Second, most of your testimony, and I think that it was excellent.

You have been very direct, honest. You are a wonderful professional, and I am proud that you are in public service. Most of your

testimony has really been directed toward what the FDA hopes to

do—with your proposed guidelines. I want to remind members of

33

the committee that that is not in place. There is not the kind of

system that has been eluded to or spoken to during this hearing.

So here are my questions.

FDA has an approval process today for medical devices, and you

know that I have a lot of experience in that, having launched from

the Democratic side with Joe Barton on the Republican side the reforms that we brought about, as well as many members of the committee on this issue. So you have a process for medical devices that

is in place today. The PMAs, the 510(k)s, and it goes along the

lines of risk. In your proposal do you bring the same consistent

policies for the reuse of medical devices? Do your proposals contain

that?

Would the FDA oppose, would you come out against the issues

of tracking and consent? I know that you have commented on

them, but I would like to know if the FDA would oppose those—

if those directives came from the Congress. Of course, those are two

issues that are in the Bill that I have introduced. Is the Federal

Government actually paying first rate medical device prices or reused products? Is Medicare reimbursing for that? And if so, would

FDA have any voice in this or do you plan to? And can you tell us

how many times a ‘‘single use’’ device, has actually been reused?

And what exactly is FDA’s oversight today for reused products?

I am very pleased that 2 days before the hearing you have come

out with your proposed policies. I would like to think that maybe

my legislation has spurred FDA to really take this issue, not only

seriously, but to take action on it. So, if you could address yourself

to those. If you do not finish answering them, hopefully you can,

you know, get the written answers back to us. And I also, Mr.

Chairman, in my opening statement I made reference to a letter

that the FDA wrote and asked that there be unanimous consent

that that be entered into the record, and I would like that. We

didn’t do that——

Mr. BURR. Without permission, of course.

Ms. ESHOO. Thank you. Okay. He doesn’t know what I asked for,

does he? Okay. No, he does. I’m teasing. Thank you.

Mr. FEIGAL. Well, thank you for your questions. And we actually

appreciate your interest in this area and look forward to working

with you, and looking at your proposals and seeing how they fit in

the area. I began my testimony by asserting that we felt we had

the authority. We didn’t want any confusion out there that we

needed new legislation before we acted, and that we can act within

our existing authorities. And part of the reason that we are doing

this with guidance rather than regulations is that we feel our regulations have the authority for us to do this. Part of the reason for

a staged approach is because this process should not be brought to

a screeching halt with supply problems, disruption of patterns.

There are people on both sides of this issue, as you will hear today,

that we wanted to engage.

One of your fundamental questions is, will we treat everybody

the same? We will. That is one of the basic issues. One of the

things I think underlies some of the questions is that, in the past,

when we classified a device we really did not pay much attention

to whether it was single-use or multiple use. One of the things we

will have to address is whether single-use and multiple use of the

34

same device actually might in some cases even have different classifications one might be exempt but by reusing it you have changed

the safety profile. And so I think there are some issues there, but

our approach to that would be to say, what applies to the reprocessor applies to the OEMs. If it is an issue for the reprocessors,

then it is also an issue for the OEMs.

Ms. ESHOO. I didn’t hear that in your discussion of the proposals,

but if they are going to be equal, than I think that that’s a big step.

Mr. FEIGAL. On the consent, I think we don’t view that as our

responsibility for this type of consent, and it probably wouldn’t be

most effectively implemented through a change in labeling.

Ms. ESHOO. But would you oppose it, that is what I asked.

Mr. FEIGAL. I personally would not oppose it.

Ms. ESHOO. Okay. I’m not talking about personal. This is all public.

Mr. FEIGAL. Well, when I say speak personally, I mean my part

of the Agency. We could give you a more thoughtful answer about

what we see are the pros and cons to this type of approach. I think

the issue relates more to a device which is being cleaned and reused again and again, whether that is the element of consent. In

which case it would apply more broadly than if the issue is simply

that someone wanted to use a disposed of device as their starting

material to craft a new device with an application for it to be used

again. Your questions about payment are questions you need to ask

HCFA——

Ms. ESHOO. Tracking?

Mr. FEIGAL. [continuing] ask HCFA and others.

Ms. ESHOO. Tracking?

Mr. FEIGAL. Oh, and tracking.

Ms. ESHOO. I keep track, see.

Mr. FEIGAL. Yes. You do. That is good. That is the third time.

We have tracking authority in a different context for products. We

do not apply it to all products. Not even all high risk products. I

think again if this is an approach that would increase the safety

and would be the best way to make a product safe and effective,

then it would be appropriate to use it. Whether it would be the approach for all devices, I do not think would be the case. I think

there are probably some disposables that would not need to be

tracked, you would just need to look at what has happened to them

as they were being cleaned.

Ms. ESHOO. Uh-huh.

Mr. FEIGAL. The issue about the tracking and putting information into patient’s medical records, that is a practice that is commonly done with implantable devices. They are an example of a

product area where it is common for manufacturers to have a pealoff label that goes on the chart. Sometimes even the patient gets

a card if they are being tracked. So there is precedent for this. I

think what I would do is say let us take a look at the kinds of products where this makes the most sense and where it adds something. It is more cumbersome than some of the other mechanisms.

Getting hold of the right chart that has the label in it is not totally

straightforward in our medical system. And so I think we need to

make the solution fit the problem. But it is something that has

been done. It is something that we should talk about more.

35

Your one last question is, do we have a Guinness Book of World

Records for the single-use device that has been used the most

times. And probably not. I would suspect it is probably an anesthesia circuit somewhere that has been cleaned and cleaned again.

The real challenge, even for the people who clean these things, is

that there is no marking on the products themselves to indicate

that they were a disposable device for the vast majority of these

devices. And many of them look identical to the reusable devices,

and I think that is another issue that I mentioned before that we

need to deal with.

Ms. ESHOO. And what exactly is FDA’s oversight today? How

does it work? What do you actually do?

Mr. FEIGAL. Well, I am not sure I understand the question. In

terms of rolling out this framework?

Ms. ESHOO. No. I am not talking about——

Mr. FEIGAL. Or in terms of our oversight?

Ms. ESHOO. I am talking about today.

Mr. FEIGAL. Yes.

Ms. ESHOO. What is your oversight with the reuse of

manufacturer’s——

Mr. FEIGAL. Okay. What we have done today is that we are actively inspecting and looking at the manufacturing practices of the

reprocessors of——

Ms. ESHOO. Since the late 1970’s, what has the FDA’s practice

been?

Mr. FEIGAL. Well, in the late 1970’s FDA wrote a letter strongly

discouraging the practice and telling the hospitals that they accepted complete liability if they did this. Then there was a long time

period where this issue really did not get very much attention, and

I think the assumption was that not very much of that was going

on. It has really only been in the last year that there has been

more attention to this. Some of that has been economic and there

have been attempts to focus on the ethics of doing this. Some of

this has been because of patient’s insurance. Some of this has been

because of reports of injuries. Our approach is to investigate the reports of injuries, to contact the reprocessors. Some of them, when

we first contacted them didn’t think they were manufacturers. We

have let them know that they are.

Ms. ESHOO. But who do you react to? Your oversight is essentially reacting or responding to something that is——

Mr. FEIGAL. Not entirely. But it is appropriate for us to be reactive when we get a report of an injury or of a problem.

Ms. ESHOO. No. I am not suggesting that it isn’t.

Mr. FEIGAL. Yes.

Ms. ESHOO. But if that is your oversight——

Mr. FEIGAL. No. No. It’s not.

Ms. ESHOO. [continuing] I think the committee needs to——

Mr. FEIGAL. We are also being proactive. We have sought out, for

example, detailed lists of who is remanufacturing. For example, we

have identified the companies who specialize in cleaning Sharps

containers, which come in both single-use disposable and reusable

varieties, and to inspect those and look at those patterns in a very,

very narrow area. But we have not just been reactive. We have

proactively sought feedback on the approach, on how to prioritize,

36

how we begin with this problem, and we haven’t waited to go out

and inspect. We have gone out and actively engaged these companies.

Ms. ESHOO. So, you only inspect those places where items are reprocessed or the devices are reprocessed? The devices themselves

or?

Mr. FEIGAL. Our normal inspection process is to, in fact, regulate

the manufacturer who produces it and not to inspect devices.

Ms. ESHOO. I think this is a very important distinction though

to many members to hear.

Mr. FEIGAL. Well, this is also true for original equipment manufacturers. We do not inspect their devices. Now there are cases

where the device fails, where we actually bring the device into our

laboratories and work with it. In fact, if there had not been so

many samples brought by members of the committee I would have

passed out my own. And we do work with the devices themselves

in a hands on sort of way. But the fundamental way that the law

is written to regulate devices, as you know, is to really ensure the

integrity of the manufacturing process. We go in and look at the

company’s quality systems and the way that they have dealt with

the problems that have been reported to them. And that is our fundamental way of addresing the problem. This occurs more often

where there has been a specific problem with a type of product and

we have been asked to look into it.

Ms. ESHOO. Can I ask the indulgence of the chairman to ask one

more question?

Mr. BURR. Okay. One more.

Ms. ESHOO. One more?

Mr. BURR. We are going to have another round, I just want to—

for those members with additional questions.

Ms. ESHOO. Is there a problem inside the FDA relative to resources in order to wrap up this policy you may need more people

to implement it, is there, you know, to ask this publicly may not

be all that comfortable for you. But I have found with Federal

agencies that at least sometimes they are reluctant to take on more

responsibility, because as they carry out what they are directed to

do, they know that there is going to be a strain of resources, and

in my view there already is a strain at the FDA, given the very

important legislation, I think needed legislation we passed relative

to, you know, the reform on medical devices in another areas that

you have jurisdiction over.

So have you undergone or undertaken any kind of analysis of

your proposals and what that would call for monetarily inside the

Agency that you can tell us about? Because I do not want one to

get in front in the way of the other. I think that public policy has

to take precedence here, and then it is up to the Congress to deal

with what you may come forward with and say we need more to

implement this. We have done it in other instances, we have risen

to that occasion I think pretty fairly, and I think we have the capacity to do so again. But can you just touch on this?

Mr. FEIGAL. Sure. If you look at the current budget proposal that

the President announced you will not see a specific request for reprocessing in this years budget. That is for two reasons. The most

practical one is that with the long budget cycle, that budget was

37

prepared about 18 months ago. And the activities have significantly

evolved only in the last year.

Ms. ESHOO. Well, I was calling and writing in December, in the

beginning of January, so I do not necessarily agree with that, but

go ahead.

Mr. FEIGAL. In our appropriation language last year there was language that we should spend at least $1 million on the issue of

reprocessing in this year. That was not difficult for us to agree with

because our effort, even last year, was approximately that magnitude and this year it is somewhat larger than that. One of the

things that makes it difficult for us to plan is that we do not know

how many hospitals are going to decide to file pre-market applications. We do not know how many places are going to register and

list and need to be inspected.

At this point because our change in the policy is so recent, there

are not the kind of resources that we need. It has mostly been in

the area of policy development, research, and other areas. And we

have the capacity to turn and focus on an issue and not wait for

a funding cycle to catch up to a public health program. One of the

natures of FDA in general is that we are asked to prioritize risks

and act on them. And there have been decisions that have been

made in the past where this one, quite frankly, did not rise to the

top of the list and other things, such as reducing backlogs to get

products to market more quickly, implementing FDAMA and other

things got more attention. But as the committee is aware within

the last year there has been much more intense interest in this and

we have turned our resources to this problem now. We do not, yet,

have a proposal of where this is going. I think we need to hear

more from the effected parties, what their reaction is going to be,

to have an idea of the scale of what we will need. And as we need

resources we will request them.

Ms. ESHOO. Thank you. Thank you Mr. Chairman.

Mr. UPTON. You are welcome.

Mr. Pickering?

Mr. PICKERING. Mr. Chairman, thank you.

Dr. Feigal, if a device is FDA approved for single-use, why is it

possible to reuse these devices?

Mr. FEIGAL. Well, the simplest way to explain that is that there

is nothing that is illegal about using a pre-existing device as a

starting material for a new device. In fact, there is sort of a misconception that the remanufacturer is trying to restore something

identical to what the original manufacturer produced. That is not

the requirement. The requirement is that they produce a device

that is well manufactured, safe and effective for its intended use,

and that they show us that they can do that. And the difference

is that they are using a used device, they are using the components

of the used device as a starting material.

And if you look at refurbishers, particularly of more complex materials, that is not even the case that they use the entire device.

They may just salvage part of it. And so this is something that is

common, I think, throughout many industries and so long as the

device is well made, safe, and effective, there is nothing in the law

that precludes someone from doing that, despite the fact that the

manufacturer wanted it thrown away after the first use.

38

Mr. PICKERING. Yes. But does the FDA need to clarify their approval description? If it is FDA approved for single-use, but you are

saying that it is legitimate for multiple use, should you change

your labeling?

Mr. FEIGAL. Well, the manufacturer brings the labeling to us and

then we determine whether or not the product will be safe and effective as labeled. One of the complexities of the device laws is

what FDA approval means. In some cases, such as a PMA, it is an

evaluation of whether or not the product is safe and effective for

use. But more often the standard is that the device is substantially

equivalent to another device that is legally marketed. And within

that framework some of those devices are exempt from pre-market

applications and only are required to have registration and listing—actually I shouldn’t say only.

It is actually a relatively long list of things that they are required to do. But that is one of the complexities for the public to

understand. The way that the device laws have been written is

that there are a variety of standards depending on the type of the

device. The underlying principle that we are trying to apply to this

situation is to say that there should be no distinction between the

OEMs and the reprocessors. If you are manufacturing a device

from another device, that should have the same standards as if you

are manufacturing a device from first components, you know, from

scratch.

Mr. PICKERING. Now, do you give any guidelines for hospitals

who may have a device that is open but unused and then they take

precautionary steps to make sure that it is clean and sanitary? Are

you looking at any——

Mr. FEIGAL. Those types of instructions and the testing and the

adequacy, that is provided by the manufacturer. It is part of the

instructions for use. We evaluate the adequacy of those instructions

and that is a very common phenomenon. In fact, it lead to some

of the confusion when we put together some of the initial lists,

about commonly reused devices. Very many of them on the list

were things that were simply being opened in the operating room

and then being repackaged and sterilized for another day.

Mr. PICKERING. And you have no problem with that? You don’t

see a problem?

Mr. FEIGAL. It has to be done with attention to detail and that

is what the manufacturers have to assert to us that they know how

to do. So, for example, if you are reprocessing suture material, for

example, you have to know that the way that you are going to repackage and sterilize that does not damage even the packaging

which could breach the sterility of those sutures. But again, the

manufacturers have worked with the hospitals because they have

a need to do that. If we wanted to replace your hip today, in the

operating room they would open and have available for the surgeon

several different closely related sizes, because they would not be

able to know in advance which one would fit you. And rather than

charge you for all three sizes if they opened them up, they would

use the one that fit and then they would take the others back and

re-sterilize them and use them again. And we think this is a legitimate practice. It is one where the manufacturers work with the

hospitals to provide instructions on how to do this. It is a different

39

problem, I think, than the reuse of an already used single-use device.

Mr. PICKERING. Now in that context, has FDA reviewed the

cleaning processes utilized in the reprocessing of medical devices,

and if you have reviewed it, are you confident that the processes

used are effective and safe?

Mr. FEIGAL. Our first approach to this is to say that the cleaning

and the re-sterilization and the refurbishing is device and model

specific. So there is not a single standard or answer. Now, that

said, there has been tremendous interest in the device manufacturing community and in the FDA to approve standards for things

that are commonly done so that they do not have to be reinvented

for every model and every device. And so that is one of the areas

where we will be working with the people who do the cleaning to

look at those standards. These are the same issues for reusable devices, and the majority of devices are reusable. And these kinds of

issues are not new to us. The hospitals have been using the procedures on single-use devices that they have already found to work

effectively for reusable devices.

Mr. PICKERING. And when do you plan to issue further guidelines

on the cleaning process?

Mr. FEIGAL. Well, the burden is actually on the manufacturers,

on the hospitals, and the refurbishers to actually show to us that

they have cleaning processes that are adequate. That is their burden to demonstrate in the application process, just like it is for an

OEM who claims that they have a device that can be cleaned. The

OEM has to show us the evidence that validates that their process

can clean.

Mr. PICKERING. So, if the burden is on them, do they have to

demonstrate that before they can reuse?

Mr. FEIGAL. That is correct. As we roll out the enforcement strategy what we are saying is that these products, as we get to them

in order of risk, the single-use product should no longer be cleaned

until they have met the same application processes that would be

required of an OEM.

Mr. PICKERING. Now, has FDA taken a position on what is the

recommended life cycle for reprocessing of single-use devices?

Mr. FEIGAL. Again, there would not be a single answer to that.

It would vary on the device and on the model, and that is something to be determined by empiric data. There would not be a single answer for that.

Mr. PICKERING. And what empiric data do you have?

Mr. FEIGAL. Well, the data has to come from the manufacturer.

They are the ones that are claiming that they can take this singleuse device and put it back into use and have it be used effectively.

So, they need to develop the data in their application to us to show

us that they can do that.

Mr. PICKERING. Are you telling the committee today that until

that data is provided, that burden of proof is met, that the current

practice of multiple use will not be allowed on a going forward

basis?

Mr. FEIGAL. That is the guidance. The guidance gives the timeframe for the types of devices and when the applications would be

needed for those devices. And if those devices remain on the marVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00043 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
40

ket, that is what our second guidance about the compliance timeframe is all about. We are asking in the simplest terms that the

reprocessors provide the same kind of information that the manufacturers provide when they bring to market a multiple use device.

Mr. PICKERING. Mr. Chairman, I hope you forgive me for just a

couple more questions. Now, there are three issues basically here.

There is public health, public confidence, and in that confidence the

right to know. Earlier this week I sent a letter to the FDA, what

is the FDA’s position on allowing patients to know if there is a device that is being reused, is there a simple way to provide that information to patients without some type of complex regulatory

process and burden upon the providers and the doctors?

Mr. FEIGAL. The issues you bring up are intertwined. On the one

hand there is safe and effective use, and there are times when for

a patient to really make a choice, they need to actually know what

they are getting. And so there are cases, there are products, where

the information that the patient is provided is explicitly provided

in the product labeling, considered inherent in the safe and effective use of the product. There are other issues about what should

your doctor tell you when they do surgery.

Should they tell you the make and model of the machine? Should

they tell you how long they have owned it? Should they tell you the

last time it was repaired? Many of those things, I think, relate

much more to what society feels is appropriate to know to be able

to be medical consumers, and relate less to the product labeling responsibilities assigned to the FDA. I think where we would be enthusiastic about being involved is where the patient’s consent is

necessary for the safe and effective use of the product. So we would

be happy to continue to participate in these discussions, but I think

we would encourage you to really broaden the discussion to involve

the medical practice community and others who really need to implement this. If it is something that is buried in the fine print on

the product labels, which are usually attached to packaging which

is thrown away when the package is opened, that is not going to

do the patient much good. If it is the advice of Congress, if it is

the demand of the public to know about these things, then you

have to change the practice patterns of the physicians that provide

informed consent for procedures.

Mr. PICKERING. Is the FDA planning to post that type of possible

information as to possible risk of reuse or proper standards for

reuse to create the public confidence and the public knowledge?

Mr. FEIGAL. We have a Web site that is very actively used. It is

mostly used by industry. But we do have consumer parts of it and

there are some consumer products that generate a lot of interest

in our Web sites. We are more than happy to spell out in consumer’s terms the issues of these debates and our approaches and

translate some of the regulatory language of our guidance for industry so that consumers can see our vantage point on this. I think

that some of the broader issues about informed consent are things

that involve other professional groups, so we would not be the only

source, but we are certainly welcome to be a source.

Mr. PICKERING. Mr. Chairman, just one final question.

Mr. UPTON. I’ve heard that today.

41

Mr. PICKERING. And I guess this gets down to the crux of the

issue. As I talked to a friend of mine who is a cardiologist, who actually takes a persons heart into his hands and uses many of these

devices, he feels confident that they are safe and feels confident in

his use of them. In talking with the manufacturers concerns are

raised. Is this, in your opinion, driven by true health and safety

concern and risk or is this more of an economic and cost and competitive issue among manufacturers?

Mr. FEIGAL. Well, for the hospitals and the manufacturers and

the physicians who are involved with this, I think the economics

is a fact of life. It is actually not a factor that you have asked FDA

to consider when we make approvals or take regulatory actions.

And so we are bystanders on the economic issue. I think it is not

an ‘‘either/or’’ question. It is both an economic and practice of medicine issue, and an issue that affects the safety and effectiveness of

these products. You mentioned there needs to be confidence that

products are well manufactured and will perform as expected, even

if there is not a major safety problem. And that is actually in our

minds the most common problem with reusables, the integrity of

the manufacturing, not the explicit risk or safety to the patient.

Mr. PICKERING. Thank you Dr. Feigal. Thank you Mr. Chairman.

Mr. UPTON. Thank you. We are going to go to a second round.

A couple of us have a couple of questions remaining. And I wanted

to say to start off, too, Dr. Feigal, by thanking you for allowing a

member of your staff to stay for the second panel and thus being

able to address additional questions that we may have based on

that panel. A couple of things. Not counting hospitals that might

reprocess something on their own, do we know how many reprocessors there are across the country?

Mr. FEIGAL. Yes. We probably do. I think we probably have identified the majority of them. We still get referrals. Sometimes if we

visit one reprocessor he will be aware that we have not visited one

of their competitors and they may add to our lists sometimes. But

I think we actually do have pretty good knowledge. In fact, there

are even reprocessors that have filed 510(k)s with us. So it is not

that we are, you know, starting cold.

Mr. UPTON. What happens on liability on one of the devices or

instruments or whatever it may be, that may fail or perhaps has

been reprocessed? Historically what has been the case? Do they go

after the OEM? Do they go after the reprocessor? Do they go after

both? Have there been cases that have been used?

Mr. FEIGAL. You are asking something that is really outside of

FDA’s expertise. We are actually only aware of a limited number

of actions that relate to reuse. I think one of the difficulties for patients who think they have been injured by a device is that it is

very difficult for them to identify whether the device was reused

or not. Some times their physicians may not know because the devices look the same and they do not know if they are dealing with

something that has been opened and re-sterilized, or if it has been

reused before, or if it is brand new. So I think the whole scope of

that we do not really know.

Mr. UPTON. Well, as we know in the physician data bank when

there has been a judgment issued against a physician, that record

42

is kept and available to hospitals and other providers. Is there such

a log for devices that may fail or not?

Mr. FEIGAL. Not in terms of liability. Actually our interests are

broader than that. I am really out of my element talking about law,

but I will try a little bit. Liability in medical malpractice relies on

establishing negligence. We are interested in things that fail,

whether there was negligence involved or not. So, manufacturers

are required to report to us device failures that they know about.

The voluntary system by health providers has tremendous under

reporting. But if a manufacturer knows about something they have

to tell us. When we inspect them, we look at their records. So we

think that if the manufacturer knows about a device failure,

whether it is going to be involved in a suit or not, we know about

it. We are able to get those kinds of statistics.

Mr. UPTON. Would that same standard that is on the manufacturers then be under the regulations you have proposed be followed

for the reprocessors as well or not?

Mr. FEIGAL. Yes. The principle underlying all of this is that the

same requirements would be applied.

Mr. UPTON. So, if this is reprocessed and it fails——

Mr. FEIGAL. Right.

Mr. UPTON. [continuing] the reprocessor would have to file with

you all——

Mr. FEIGAL. That is right.

Mr. UPTON. [continuing] if your regulations are made in order?

Mr. FEIGAL. That is right. Even if the reprocessor is a hospital.

Mr. UPTON. Right.

Mr. FEIGAL. They would then have the kinds of mandatory responsibilities and if they have asserted to us, in an application that

they know how to reprocess those, we would treat them like any

other manufacturer.

Mr. UPTON. Good. Now, reading through your testimony that we

received last night, I think that the answer to this is yes. Is the

reprocessing of medical devices labeled for single-use without premarket submissions a violation of the Food, Drug, and Cosmetic

Act? It is a violation, is that not true? They just have not been enforced until these regulations are in place, is that right?

Mr. FEIGAL. It would be a violation of the Act if the labeling of

the product was false and misleading, or if the manufacturer was

placing into commerce a product that did not have marketing clearance or marketing approval. That is why we say we do not need

new authority. We already have the authority to require these.

Mr. UPTON. Great. And last as my light is going to light now, Mr.

Stupak had to testify before another subcommittee and he will be

back, but he asked me to ask you for him: please discuss exempt

devices and how they are dealt with under the guidance for reprocessing.

Mr. FEIGAL. Okay. Well, an exempt device is only exempt submitting a 510(k) application. They are not exempt from any of the

other standards that establish the quality of devices: registration

and listing, the device failure reporting, special controls, being subject to inspection. For exempt devices we have said the OEMs can

manufacture and not get pre-market clearance. Our proposal says

that those who remanufacture those products would also be exempt

43

from the pre-market clearance. But that is all that they are exempt

from.

Now, someone might make the case that in fact the classification

is not correct when you begin reusing certain types of devices. We

have devices that are both single use and multiple use and in almost all cases they are in the same classification. In fact, I do not

know of an exception. One of the things in this process of comment

we will be looking at is, should that be the case, or are there cases

where it is appropriate to exempt only the disposable product. If

that is the case, that would apply as much to the OEMs as the reprocessor because we want the same standard of quality no matter

who makes it.

Mr. UPTON. Thank you. Mr. Burr.

Mr. BURR. Dr. Feigal, Med-Watch is an FDA voluntary program

primarily for drugs.

Mr. FEIGAL. Yes.

Mr. BURR. It includes devices as well, doesn’t it?

Mr. FEIGAL. It includes devices, yes.

Mr. BURR. Did I just hear you earlier to say voluntary programs

do not work?

Mr. FEIGAL. No. They have under reporting for a variety of reasons, and it is true in almost every country that uses them. But

the under reporting does not mean that we do not get signals that

are very useful to us to identify the problems. What the programs

that are voluntary do not do is give us good numerators and denominators. So it is very hard for us to tell——

Mr. BURR. So, are you an advocate of a continuation of MedWatch in its current form or would you be a proponent to change

to a system that was more reliable on the indicator?

Mr. FEIGAL. Well, I think Med-Watch in its current form is very

useful and has identified problems with products that have resulted in actions.

Mr. BURR. Is that for devices, or devices and drugs?

Mr. FEIGAL. Devices and drugs.

Mr. BURR. Let me ask you if I could. Do you believe that the legislation that guides FDA requires FDA to make sure that proper

labeling follows specific products?

Mr. FEIGAL. I’m sorry. Could you say that again?

Mr. BURR. Do you believe that the legislation that guides FDA’s

work in fact requires FDA to make sure that proper labeling is assigned to all products?

Mr. FEIGAL. Yes. Yes.

Mr. BURR. Give me FDA’s reason for allowing single-use devices

to be reused and why as you as the head of the device area would

spend so much time trying to figure out a process for single-use devices to be reused, given that one of the primary roles of the FDA

is to make sure that the labeling is an accurate description of the

use of the product?

Mr. FEIGAL. Now, one of the fundamental questions is, if I own

the device can’t I do anything I want with it? That is sort of the

off label drug question rephrased for devices. If I own that device

I can’t clean it and fix it up a little bit and use it again? I am now

the owner. And our response is, the practice that has grown up in

hospitals, and certainly third parties, of taking devices and trying

44

to refurbish them, has actually turned them into, not owners of the

device, but manufacturers. And that that is the reason that they

now have to describe the integrity with which the device is manufactured and develop appropriate labeling, and adhere to the same

regulations as any other manufacturer. Part of the reason that this

process may look so tortuous is that we are aware that this is a

process that probably cannot be stopped overnight, and that is

probably a comment that you will hear debated by your next panel.

Mr. BURR. But you would not consider that the labeling of a single-use device that could pass the test of reuse was mislabeled?

You said in your opening statement, if I remember correctly.

Mr. FEIGAL. Yes.

Mr. BURR. Correct me if I am wrong, that many of the singleuse devices today are configured in the same way with the same

components as the multi use devices prior.

Mr. FEIGAL. Yes.

Mr. BURR. What, in your mind, distinguishes the difference between the multi use status that FDA agreed to and the single-use

status that FDA agreed to after the application was changed?

Mr. FEIGAL. We evaluate the claims in the label from a specific

manufacturer for a specific product and see if they have the evidence to support the claims. When it is re-manufactured, actually

the manufacturer changes. We are no longer dealing with the OEM

and his label.

Mr. BURR. Is it your interpretation then that liability would not

extend back to the original equipment manufacturer, given that

your——

Mr. FEIGAL. I am not the person to ask about tort issues.

Mr. BURR. But I am sure that the FDA has looked at that,

haven’t they?

Mr. FEIGAL. Well, and actually liability is——

Mr. BURR. I think there are some lawyers over there if I am not

mistaken.

Mr. FEIGAL. There are lawyers around here, but they are not tort

lawyers. They write regulations and things like that. But I think

this is definitely an issue you have identified for the community

that reuses devices. I do not think it is really much of a factor in

consideration of our work.

Mr. BURR. What is the definition of FDA of an already used device?

Mr. FEIGAL. That is a very good question because the variations

that we have discussed of open but unused and any used

device——

Mr. BURR. If history is any indication there will be another director at some point in the future at FDA of the device area. What

does the FDA have in place to guide them as far as this definition

so that when they come in their interpretation is not an unsterile

device that was in the OR in case it was needed.

Mr. FEIGAL. Right. Well, I think the first principle in FDA labeling is that you should say what you know. And the original manufacturer said that this is a single-use device. It is their responsibility to define when the device has been used so it is not used

again. So does that mean, for example, in the operating room when

someone may have, with their glove on, handled a couple of difVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00048 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
45

ferent hip pins to pick the right one out, that is now a used hip

pin or is that still in the open-but-unused category which——

Mr. BURR. Would it also be the original equipment manufacturer’s responsibility when they file the initial filing to tell you if this

could be reprocessed it could be used this many times based upon

our clinical studies?

Mr. FEIGAL. Yes. The type of use that they envision and the type

of use that they are claiming is safe and effective has to be described. And actually we discuss these issues in the guidance that

we have just released.

Mr. BURR. And should the original manufacturer and FDA supply guidance to the reprocessors as it relates to the reprocessing of

the device or sterilization?

Mr. FEIGAL. Our stance is that the reprocessor is a new manufacturer and so there might be a business relationship between two

manufacturers, but it is not required. The reprocessor is someone

who is taking a disposed of device as their starting material and

saying, ‘‘I can build a safe and effective and well manufactured device out of this.’’ And so it is not the OEM’s responsibility to tell

the reprocessor how to do this. If there are things which damage

these delicate devices that are commonly encountered in hospitals,

it is a little bit disingenuous for the OEMs to act like these things

will never happen. What if something was opened-but-unused and

the product is damaged by ethylene oxide? That normally would be

used in the setting of remanufacturing but, you know, we would

like to have some dialog with the OEMs about when is it appropriate for them to disclose that information in their labels.

Mr. BURR. Well, I would—again, I commend you for your willingness to jump into what is a very, very difficult thing to figure out

what the right balance is. I would encourage you to work with the

OEM manufacturers, the reprocessors, the hospitals, to work out

some of the areas that you pointed out are good questions. Because

clearly I think we are going to continue to think of some questions

that we have not thought of and I would encourage you also to

focus on the future interpretation of others by what action you take

and possibly what action Congress takes, because I think it does

have an effect on the quality of health and the cost of health in the

future. I thank the chairman. I yield back.

Mr. UPTON. Thank you. Mr. Bryant, do you have additional questions?

Mr. BRYANT. Mr. Chairman, I really don’t. I would just—it is almost entertaining to hear this discussion, not that, you know, it is

humorous or anything but we are just one giant circle and some

of the questions that are asked, and, you know, is it a single-use

item a single-use item, and reusing a single-use item, and who decides whether it is a single-use item, and then a new manufacturer

taking that item and cleaning it and saying it is now my product.

I suspect in the end it would be great to have some guidance from

you, but it seems to me that is one of the questions we have to decide is, and I don’t know.

The FDA is probably not involved in making that decision as to

whether or not this is really a single-use item. As you say, the

OEM comes to you and you accept the labeling and if they say it

is, it is. Question, why don’t they put on there this can only be

46

used one time and you do it otherwise you are subject to all kinds

of problems. They don’t want to do that, but I suspect in the end

it is going to be up to the courts of law, the trial lawyers out there,

the plaintiff’s lawyers, to litigate this. And it is going to take a few

big cases to sort things through. But there is tremendous potential

of liability here among the reprocessor, the hospitals, and maybe

even reaching back to—ingenious lawyers can reach back sometimes and find those original manufacturers, too. So, it is a complicated situation and I just again urge the FDA to move as quickly

as you can to give us all some guidance and assistance in this. And

thank you for your testimony.

Mr. UPTON. Ms. Eshoo, did you have additional questions?

Ms. ESHOO. Yes. Thank you Mr. Chairman. I would like to go

back to something, doctor, that you said just a few moments ago,

and I think that you stated earlier in your responses to questions,

and that is that the FDA considers reprocessors to be manufacturers, but your policies do not reflect this. You do not treat—if, in

fact, you consider them to be manufacturers how do you apply the

same policies that you told me earlier are applied? I think that

there is a discrepancy here. And I would also like to ask you about

enforcement. What exactly are FDA’s enforcement measures that

are brought to bear today? I mean, we could have all kinds of policies on the books. We know if they are not enforced then they are

not worth the paper they are written on, so today what are your

enforcement policies and give us examples of how you have a manifestation of the enforcement.

Mr. FEIGAL. Well, one example that I mentioned earlier is that

we have been inspecting reprocessors and we have issued them

Warning Letters for the kinds of manufacturing problems that an

OEM——

Ms. ESHOO. Is this on the enforcement side?

Mr. FEIGAL. Yes. On the enforcement side. And we have not

treated those inspections as having any different standards than

we would for any other type of manufacturer. There are many different levels of enforcement. Because we have had this policy of not

regulating this area in the past, there is a period of time when we

are going to find people who do not believe that they are regulated

by us and are putting into commerce what we consider new devices

and we will——

Ms. ESHOO. And your new guidelines, does the enforcement

change? Is it beefed up? Is it less? Is it——

Mr. FEIGAL. The new guidelines takes the principle that the enforcement will be the same for a manufacturer, whether the manufacturer is a reprocessor or if it is an original equipment manufacturer. What the guideline does is that it gives people lead time to

prepare for the change in policy, but it asks the manufacturers of

high risk or high complexity devices by our definition to come into

compliance more quickly. And that will mean having the same

standards for applications and following all the same policies that

we would expect of an original equipment manufacturer.

Ms. ESHOO. So you are maintaining that your designation of a

reprocessor as a manufacturer, as well as the OEMs that the policies that you have in place now, and the enforcement policies, are

47

exactly the same as what your proposed guidelines are? That they

are the same across the board?

Mr. FEIGAL. Once they are fully implemented, it won’t matter if

a device is manufactured or a new manufacturer is remanufacturing it. That the same standards will apply.

Ms. ESHOO. But see, I am confused, because I think that there

is—it is very confusing to me whether you are referring to proposed

guidelines and what you hope to do and what you hope to implement and/or what we have on the books today. Is it all the same?

Is there enforcement across the board whether someone is an OEM

or a reprocessor? Yes or no.

Mr. FEIGAL. No. It is not because the——

Ms. ESHOO. All right. Will there be consistency brought to both

with the proposed guidelines?

Mr. FEIGAL. Yes.

Ms. ESHOO. As well as enforcement?

Mr. FEIGAL. Yes.

Ms. ESHOO. Across the board?

Mr. FEIGAL. Yes.

Ms. ESHOO. Not just in some areas?

Mr. FEIGAL. Across the board and it will be phased in.

Ms. ESHOO. You said earlier when I asked you about standards

which is something about which I am talking about now. Today you

only inspect the place where devices are processed. Is the place

clean? Is the process a good one, is that correct?

Mr. FEIGAL. These are GMP inspections. When we inspect a reprocessor, we look at him in the same way that we look at an original equipment manufacturer. The reprocessor, to us, is a different

manufacturer than the OEM. They just have a different starting

material.

Ms. ESHOO. But you said you consider them both manufacturers.

Mr. FEIGAL. That is right.

Ms. ESHOO. So what is the difference in what you just said then

or the piece that you just mentioned? How does it affect what you

said previously?

Mr. FEIGAL. The starting material that the manufacturer makes

his product out of is different, but we treat them both as the same

kind of manufacturer with a device that is classified as the same,

with a device that has the same pre-market requirements, with a

device that has the same safety reporting requirements.

Ms. ESHOO. Well, the reason that I am asking these probing

questions is most frankly I do not think it is the same across the

board. You are saying that it might be or that it will be if you get

to implement your proposed regulations. But with new devices you

require that all sorts of data be accumulated before they ever get

to the patients, but that is not the case with the reprocessed pieces.

So I do not think that there is a consistency, with all due respect.

You are getting lots of notes on this so I must have——

Mr. FEIGAL. Yes. I am.

Ms. ESHOO. You know, by reusing the three tier risk system, the

practical effect will be that enforcement, I do not think, will be the

same across the board. FDA, I think, is sending a message to reprocessors that you are not going to enforce the same standards on

them. And that may be your direction. I do not think it is good

48

enough. Now, you talked about equipment that is the operating

room earlier, but the equipment that you referred to is not being

placed inside the patient’s body. So I do think that there is a clear

difference and that is why I think the standards really need to be

much higher. So you may want to comment on this.

Mr. FEIGAL. Let me be clear. Right now there are differences in

the way they are treated because of the policy. The guidance that

we have put forward are things which we intend to do. We are asking for comments. We have given the specific time table and told

you when we intend to do them. We have done what Congress has

consistently asked us to do with devices, and what the public has

asked us to do, which is get to the highest risk things first. Whether something is a reprocessed device or an original device, it will

have the same pre-market requirements. There will not be differences in requirements. The risk staging has more to do with how

we phase in the change in policy, than it has to do with where we

will be in 2 years, or 3 years, or whatever it takes to get there.

There will be some differences in the types of applications because

the companies building the same product are taking different paths

to build it. There still will be the same standards, whether it is an

original equipment manufacturer or a refurbisher.

Ms. ESHOO. But reprocessors do not build products, do they?

Mr. FEIGAL. Yes, they do.

Ms. ESHOO. How?

Mr. FEIGAL. They take a product that has been disposed of

and——

Ms. ESHOO. Do they reconstruct it?

Mr. FEIGAL. They do things to it——

Ms. ESHOO. They redesign it?

Mr. FEIGAL. They have to understand——

Ms. ESHOO. Or do they clean it for reuse?

Mr. FEIGAL. They may do all of those things, or it may be a simple issue of recleaning, but once they take responsibility for remanufacturing a device, they are a manufacturer with the responsibility to explain all of those things: the design and controls, the

performance standards, all of those things.

Ms. ESHOO. This is in the new policy.

Mr. FEIGAL. That is the new policy.

Ms. ESHOO. The proposed policy.

Mr. FEIGAL. The new policy is that they are no different than an

OEM.

Ms. ESHOO. That is not the case today?

Mr. FEIGAL. That is not the case today, no. We have been

very——

Ms. ESHOO. Thank you. Mr. Chairman, I would like to ask a

unanimous consent to place into the record a series of national articles that have been carried over a good deal of last year and some

from this year about this issue. Many in national publications, grey

sheets, etc., and I think it is information that is important to have

as part of the record on this.

Mr. UPTON. Without objection.

Ms. ESHOO. Thank you.

[The information follows:]

49

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

Ms. ESHOO. Thank you Doctor.

Mr. BURR. Mr. Chairman, could I ask unanimous consent for one

additional question?

Mr. UPTON. Yes, you may.

Mr. BURR. I just want to clarify one thing. If a hospital

unpackages but does not use a sterilized device, is it your position

that they are, in fact, a manufacturer when they re-sterilize it for

additional use?

Mr. FEIGAL. It depends on how it is labeled. If the original equipment manufacturer provided instructions on how to re-sterilize,

then they are using the device in one of the ways that it was intended to be used, which is to have it open and available but be

able to close it back up and sterilize it. If the hospital is doing this

for other types of products for which there are no instructions on

how to sterilize, then we are back in the area of manufacturing. In

general though, this is a practice that hospitals know very well

how to do and it is part of routine practice, and this is one of the

lower priorities on the risk scale for us to address this particular

practice of repackaging products which have been opened.

Mr. UPTON. If the gentleman will yield just 1 second, I note on

this particular device which I did not open, but somebody did

maybe. I do see a warning. This device is intended for one time use

only. Do not re-sterilize and/or reuse it as this can potentially result in a compromised device performance and the increased risk

of inappropriate sterilization and cross contamination. But if that

happened, they open this up and it goes in the trash if they do not

use it.

Mr. BURR. I guess my question would go a little deeper, given

that the hospital did not repurchase it or resell it.

Mr. FEIGAL. Right. No, that is right.

Mr. BURR. The commerce question comes in and the question of

your jurisdiction as well.

Mr. FEIGAL. Yes, that is right.

Ms. BURR. So, can you sort that out for me?

Mr. FEIGAL. Well, that does get back to the issue of where do we

get the definition of placing a device into trade. One of the factors

that we have thought about is if the hospital is charging for it more

than once, they are putting it back into trade, whether they are

using something that they own or not. But it is a complex issue.

The hospital oftentimes is acting as a third party for the physicians

that practice there. And so they, in that sense, are much more like

the third party reprocessor than they are the physician who owes

the device who wants to modify it in some way and use it in his

own practice.

Ms. BURR. But clearly based upon what you have told me, there

could be a situation where a device was never used, but it was unpacked, it needed to be re-sterilized, the manufacturer did not have

re-sterilization instructions with it, no commerce took place, but

they would still be considered a manufacturer when they repackaged it and reused it?

Mr. FEIGAL. If this was something that was a very common practice, it would be a practice that we would say needs to come under

some control, because in fact they do not know if they are damaging that product by trying to re-sterilize it. In most cases OEMs

99

will work with hospitals to provide instructions when a product can

be re-sterilized. And if they said it cannot be, I think that the hospitals are taking on the responsibilities of a manufacturer.

Ms. BURR. The FDA does not currently ask for reporting of resterilized devices, do they?

Mr. FEIGAL. No.

Ms. BURR. Okay. Thank you Mr. Chairman.

Mr. UPTON. Thank you. Well, as you can tell Dr. Feigal, I was

thinking maybe we ought to have a 2-day hearing. We appreciate

your expertise and help certainly with our subcommittee. It has

been a very good process for all of us. We look forward to seeing

the regulations made permanent so that, in fact, we do have some

enforceability that is out there. We appreciate your dialog with us,

and we look forward to working with you in the future. Again we

appreciate having a member of your staff remain to listen to the

testimony from the next panel and to be able to respond to questions that may arise. You are formally excused. Thank you.

Mr. FEIGAL. Thank you.

Mr. UPTON. Thank you.

Okay. The second panel includes these individuals, Laurene

West, R.N., Dr. Robert O’Holla, Vice President of Regulatory Affairs from Johnson & Johnson, Dr. Philip Grossman, Dr. John

Fielder, Professor of Philosophy, Ethics, at Villanova University,

Mr. Vern Feltner, President of Alliance Medical Corporation, Dr.

Bruce Lindsay, Associate Professor of Medicine at the Washington

University School of Medicine, Dr. Walter Maurer from the Cleveland Clinic on behalf of American Hospital Association, and Dr.

Griffin Trotter, Center for Healthcare Ethics at Saint Louis University.

I appreciate all of you being here this afternoon. As you may understand all of us are on multiple subcommittees. It seems like

they are all meeting today. In addition to votes on the floor, and

because this hearing has gone much longer than anticipated when

we started, members scheduled are being telescoped so we will see

a number of members coming in and out. We have a general rule

that we would like you to limit your remarks to 5 minutes. As I

am not real careful with the gavel, I will try to be a little more attentive to that clock. As you understood, I think, your testimony in

its complete form is made already part of the record as earlier

made under unanimous consent. As you may have also heard, it is

our committee practice always to take testimony under oath. Do

any of you have any objection to that? Seeing none, we also allow

under committee rules the possibility of you being represented by

counsel. Do any of you need counsel to represent you at your own

expense? And last then, if you would rise and raise your right

hand.

[Witnesses sworn.]

Mr. UPTON. Okay. You are now under oath and we will start

with Ms. West, if that is okay. Also for those behind you, particularly if you would make sure that you bring that microphone close

to you, it would be helpful for all in the room. With the clock, a

little warning light will go on with a minute to go, if that is okay.

I can change that if you do not like that, but that is the way it will

be. Ms. West, we recognize you.

100

Ms. WEST. Thank you.

Mr. UPTON. Go ahead.

STATEMENTS OF LAURENE WEST; ROBERT H. O’HOLLA, VICE

PRESIDENT REGULATORY AFFAIRS, JOHNSON & JOHNSON;

PHILIP GROSSMAN; JOHN H. FIELDER, PROFESSOR OF PHILOSOPHY, ETHICS CONSULTANT, VILLANOVA UNIVERSITY;

WALTER G. MAURER, CLEVELAND CLINIC FOUNDATION, ON

BEHALF OF AMERICAN HOSPITAL ASSOCIATION; VERN

FELTNER, PRESIDENT, ALLIANCE MEDICAL CORPORATION;

C. GRIFFIN TROTTER, CENTER FOR HEALTHCARE ETHICS;

AND BRUCE D. LINDSAY, ASSOCIATE PROFESSOR OF MEDICINE, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE

Ms. WEST. Mr. Chairman, members of the committee, I appreciate the opportunity of expressing my concerns this morning, actually this afternoon, sorry. I am here today not as a spokesperson,

not as a lobbyist for any group that is paying me, but as a classic

example of a patient who has suffered from the reuse of a singleuse device. My perspective on this pandemic healthcare issue

comes from not just being a patient, but also having been a registered nurse with a critical care certification and current licensure

for 25 years.

There are actually two ways that a single-use device can be used

twice. One is if you have an incompetent staff member who does

not follow sterile procedure and is using the device for the second

time. And then second, as we have just talked about, the sterilization of a device, excuse me, autoclaving a device, perhaps, to make

that single-use device into a multi use device. My personal example

falls into category one which comes from an incompetent staff

member not following sterile procedure. Just a little bit of history

so that you will understand why I was in this position. In 1983 I

was diagnosed with a tumor in the center of my brain and, in order

to remove that tumor, I went through a procedure which is called

a transsphenoidal hyphysectomy.

I can describe that for you, but there are some people that perhaps would prefer not the clinical aspect of that. In order to get to

that part of the brain the surgeons need to go through the bottom

of the brain. So they went through my sphenoid sinus in order to

do that. And while I was having that surgery there was a break

in sterile technique. I was exposed to and infected by the bacteria

known as staphylococcus aureus commonly known as staph. And

because that infection was acquired during a hospital stay it is referred to as a nosocomial staph infection. And I have actually battled that infection for 17 years. As the purpose of this hearing is

to describe the reuse of single-use devices, I am going to concentrate my testimony on an incident that occurred when I was ill

in 1988.

I had had two surgeries that year to remove infected bone from

both my head and my facial structure in an effort to try to prevent

Meningitis. Meningitis is where the infection is collected on the

outside of your brain. The cultures that were taken of the bacteria

in my head indicated that the bacteria had mutated to the point

that I was no longer sensitive to any antibiotic other than one

called Vancomycin which needs to be administered intravenously.

101

So, I was admitted to the hospital and what is referred to as a central line was inserted. That goes into your antecubital vein, it is

threaded up into your arm, and up into the superior venacava of

my heart.

For the first day I had a phenomenal nurse who followed sterile

procedures. She changed the needles, she changed the tubing each

time she hung the doses of Vancomycin. However, the next day I

did not have such luck. The nurse who took care of me, as she took

the needle out to end the dose, she put the needle on the table. My

thought was well, you know, that is the end of the dose. The sterile

procedure is that you would then hang a new bag, put new tubing,

put a new needle on there. She did not do either, and before I realized what she had done she had picked the needle up off the bedside table, without any cover, not even wiping it off with an alcohol

swab and then put that back into my central line which flowed directly back into my heart. Actually I would have been much better

off had I just taken care of myself at home.

My physician ordered blood cultures because we needed to know

what additional bacteria that I was now exposed to. It is flashing

red. Have I already gone 5 minutes?

Mr. UPTON. You have.

Ms. WEST. Okay. I will make this very, very quick. In order to

save my life, I went on a regime of three IV antibiotics. I have continued to suffer from that process of having had that device reused.

I will skip over just very quickly that the reuse of a vital medical

device can be a result of a bad habit, a result of not having appropriate quality assurance within a facility. However, every organization has a responsibility of maintaining a patient relationship that

allows for a sterile procedure. As we are mutating bacteria year by

year, the essentiality of sterilization is more, and more, and more

important. As patient we deserve the right to be given treatment

by trusted, trained professionals.

Very quickly I will explain that. The implementation of the 1996

Health Insurance Portability and Accountability Act known as

HIPAA-96, that was intended to standardize and simplify administrative procedures for nurses, who are currently spending 50 percent of their time taking care of paperwork. So if there is proper

implementation of the HIPAA legislation, then we then have

nurses back on the floor who can monitor, and train, and certify

and make sure that devices are not reused. Since I am over my

time, I would be happy to answer any questions that you have. I

appreciate the opportunity of sharing with you part of my story

and hope that we can find a way so that all patients have access

to quality care.

[The prepared statement of Laurene West follows:]

PREPARED STATEMENT OF LAURENE WEST

Mr. Chairman, members of the committee, my name is Laurene West. I would

like to ask that my full statement be inserted into the record of this hearing.

I am here today not as the spokesperson or lobbyist for any organization, nor for

any group that is paying me to testify—but as a classic example of a patient suffering from the results of a re-used, single use biomedical device. My perspective

on this pandemic healthcare issue is derived from being both a patient and a Registered Nurse with Critical Care Certification and Licensure for 25 years.

There are two ways in which single-use devices can be re-used; 1) staff incompetence or failure to follow sterile procedures and perhaps inadequate training 2)

102

cost containment but high risk procedures of autoclaving single-use devices to become multi-use devices.

My personal example falls into category 1—staff incompetence or failure to follow

sterile procedures and equally likely, inadequate training.

In 1983 I was diagnosed with a tumor in the center of my brain. The tumor was

surgically removed by a procedure called a Transsphenoidal Hyphysectomy. During

my surgery there was a break in sterile technique and my brain was exposed to and

infected by the bacteria staphylococcus aureus, or more commonly known as staph.

Because this infection was acquired while in the hospital, it is referred to as a

nosocomial staph infection.

As the purpose of this hearing is to describe incidents directly related to the reuse of single use devices, my testimony will concentrate on an incident in 1988

where this common, hospital wide, cost saving practice nearly took my life.

1988 was a rough year. I had two surgeries within three months trying to prevent

meningitis—which is where the lining of the brain becomes infected. The infection

in my head had traveled to my frontal sinus and the cultures revealed that the

staph had mutated so that it was no longer sensitive to any antibiotic except

Vancoymcin, which must be administered intravenously.

I was admitted to the Hospital, a central line was inserted via my antecubital

vein into the superior venacava of my heart. For my first day, I had a wonderful

nurse who followed sterile procedure correctly, used only new IV tubing and needles

as appropriate—and my temperature of 104 degrees began to decline. However, my

next nurse, a foreign national, barely able to speak English, did not follow sterile

procedure. When the current dose of Vancomycin had been infused, she took the

needle out of the mainline and laid it on the bedside table. I assumed this was her

way of reminding herself that she needed additional tubing and a new needle for

the next dose. The correct procedure for administering the next dose would have

been to hang the Vancomycin with new tubing and a new needle. However, she did

neither. Before I realized what she was doing, she re-inserted the old needle with

the old tubing into the mainline for that dose of the antibiotic. The damage was

done—I had now been contaminated with additional bacteria from the table. Within

12 hours my temperature had spiked to 108 degrees and I developed septicemia,

meaning that the infection in my head had traveled to my blood system as well.

I would have been better off taking care of myself at home.

My physician, ordered blood cultures drawn so that he could determine if there

were additional bacteria causing the increased temperature. However, my rapidly

deteriorating condition caused my doctor to immediately start a regime of three IV

antibiotics, each with exhaustive lists of negative side effects, to save my life.

I was very lucky and after weeks of therapy, recovered from the sepsis and returned to my normal battle with just the routine staph infection.

My case is only one of a vast undocumented number of similar if not worse lifethreatening stories. Most patients entering the hospital or clinic do not understand

what is happening to them and without a clinical background they do not know they

need to be cautious. They go into a facility, trusting that they will receive the best

possible care from trained and responsible professionals. They don’t know the difference between a single-use or multi-use device.

Earlier in my testimony I referred to two ways single use devices can be reused.

I suffered from professional incompetence and the failure of an allegedly trained

professional to follow appropriate procedures.

The reuse of a biomedical device could simply be the result of bad habits not recognized during training and quality assurance review. A health care organization

has constant follow-up and training responsibilities in every single patient relationship. With infection rates growing and bacteria being mutated to new forms that

are no longer sensitive to existing antibiotics, the essentiality of sterilization is of

the utmost importance for patient safety.

The implementation of the 1996 Health Insurance Portability and Accountability

Act, known as HIPAA 96’, is intended to standardize and simplify administrative

procedures, known as paperwork. Currently nurses are spending 50 percent of their

shift time on these administrative procedures. Appropriate implementation of

HIPAA 96’ would allow for greater time spent in training, practice certification and

supervision of licensed caregivers. Put nurses back on the floor taking care of patients rather than doing paperwork.

Category 2, reuse of biomedical devices as a cost containment effort, is either

sanctioned or not sanctioned by the health care organization. If the organization

chooses to reuse these devices firmly labeled as single use, they are violating the

implied sterilization warranty and putting patients at high risk of infection. This

ultimately increases patients morbidity and mortality rates.

103

This silent epidemic radiates throughout healthcare, from large acute care facilities to home health agencies and nursing homes—regardless of the owner organization. I have shared with you my own story but can give you example after example

of things that I have seen and heard from other healthcare professionals and from

the 55 million patients I represented last year on the Year 2000 Project as the National Patient Advocate.

• Autoclaving IV tubing for second and third patient use.

• Autoclaving Pacemaker wires for use on additional patients

• Saving neonatal ambu-bags and pulse oximeters without being autoclaved, to be

given to 3rd world countries.

• Subclavian guidewires autoclaved to be used on additional patients

• Suction catheters being used by multiple patients without any cleansing process

in-between patient contact.

Most caregivers are not able to document cases of increased infection, morbidity

or mortality from the re-use of single use devices as doing so would cause them to

lose their jobs.

Ladies and Gentlemen, healthcare must be driven by quality, compassion, honesty, and with respect for the rights and wishes of the individual. It must be provided by trained and competent staff.

I offer my assistance in any way possible to this committee or any organization

to help further awareness of this issue, to help better train hospital staff and make

patients more enlightened consumers.

I want to thank the members of the Committee for allowing me to testify today

and will be happy to answer any questions you may have.

Mr. UPTON. Thank you very much.

Mr. O’Holla?

TESTIMONY OF ROBERT H. O’HOLLA

Mr. O’HOLLA. Good afternoon, Mr. Chairman. Thank you. Members of the committee, my name is Robert O’Holla, I am Vice President of Regulatory Affairs for the Medical and Diagnostic Group at

Johnson & Johnson. I am also Chairman of the Association of Disposable Device Manufacturers, you have come to know as ADAM.

Mr. Chairman, I would like to thank you and Mr. Bliley for raising

the visibility of this important issue through this hearing and also

by introducing a bill along with Congresswoman Eshoo on this

issue.

I am going to do my best to control my passion for the issue this

afternoon. I have worked for approximately 30 years in the medical

device industry, and I am seriously concerned that anyone would

attempt to clean and reuse a medical device that was designed for

use in a single patient and approved by FDA for only one use. Just

as concerning, and I share the concern raised by this committee all

morning, was the apparent disinterest on the part of FDA until

very recently in this threat to the health and safety of U.S. patients. I have submitted my written testimony, but because my

time is limited, today I would like to concentrate on just one aspect: The threat that reprocessed single-use devices present to

quality healthcare for patients. The evidence for action is clear to

me. There are reports of two patients who have been blinded in one

eye, a premature baby whose foot was burned, increased pneumonia rates in children, and a 32 year old woman who we heard

about earlier this morning who has a piece of metal lodged in her

heart.

In addition, ADAM members have retrieved approximately 1,000

reprocessed devices from hospitals where they were awaiting use in

patients. The results of the tests are chilling. Approximately 75

percent of the samples collected failed either due to the presence

104

of blood and/or proteinaceous matter, bacterial contamination, functional failures, or defective packaging leading to non-sterile devices.

And I brought some pictures along so you can have some appreciation for what we found. I would like to note that these are not

unique pictures. These are representative of what we found. The

first photograph shows a piece of proteinaceous material that was

ejected from a reprocessed surgical clip applier when we fired it in

the laboratory. This is a device that is used to close bleeding blood

vessels. That piece of material is not actual size by the way. That

is about a quarter inch to an eighth inch piece of material that

would have been injected into the next patient. The interesting

thing about this is that as we tried to fire the device further, there

was so much tissue in the mechanism of this device that the device

clogged and became nonfunctional.

The second picture is in the anvil of a surgical stapler contaminated again with similar material. The next set of pictures we see

a reused electrophysiology catheter that pulled apart while inserted

in a second patient’s heart making it difficult for the doctor to remove. Last is a photograph of another electrophysiology catheter.

What we see is contamination with tissue residue. We found that

this residue was indeed one that caused a marked increase in blood

clot formation. In addition to all of this, FDA’s own data indicate

problems with the reuse of angioplasty catheters, electrophysiology

catheters, and biopsy forceps. One FDA study revealed that the

tiny tubes inside reprocessed angioplasty catheters were often

kinked and clogged with blood and cleaning chemicals. Most disturbingly, some reprocessed balloons ended up being at least one

size larger than they were supposed to be.

Now, the proponents of reprocessing have said that they do not

put patients at risk and they have no evidence that the practice is

unsafe. Yet, by simple random sampling and without any trouble

we found reused products that clearly increased the risk to patient’s health and safety. A large portion of the devices we found

were non-sterile. How many infections and more serious diseases

such as Hepatitis-C and perhaps even HIV, have been spread to

unknowing patients as a result of this practice? The sad answer to

that question is, we do not know because nobody has been looking.

There is a clear increased risk of disease transmission and functional failures. Is this an acceptable standard for medical device

performance, or are we just inviting an increase in medical errors?

It certainly is not the standard that FDA has applied to new medical devices for the last 24 years, and should not be the standard

applied to reprocessed devices. It is time that FDA enforced the full

requirements of the law so that the second, third, or sixth patient

has the exact same level of FDA protection FDA oversight provides

to devices used on the first patient. No other standard is acceptable. Thank you.

[The prepared statement of Robert H. O’Holla follows:]

PREPARED STATEMENT OF ROBERT H. O’HOLLA, VICE PRESIDENT OF REGULATORY

AFFAIRS, JOHNSON & JOHNSON

Good morning, Mr. Chairman and members of the Subcommittee. My name is

Robert O’Holla and I am Vice President of Regulatory Affairs for the Medical Devices & Diagnostics Group at Johnson & Johnson. I am also Chairman of the Association of Disposable Device Manufacturers, a trade association of single use medical

105

device manufacturers. Thank you for the opportunity to address this important patient health and safety issue. I have worked for 30 years in product development,

quality assurance, microbiology and regulatory affairs. As a long time professional

in this area, I cannot understand why anyone would believe it is acceptable to clean

and reuse a delicate, complex medical device that was designed for use in a single

patient and approved by FDA for only one use. Just as concerning is the apparent

disinterest on the part of FDA until very recently in this threat to the health and

safety of patients.

FDA has said that it is now going to regulate the practice of reprocessing. I hope

that means that FDA is now going to apply all of the provisions of the Federal Food,

Drug, and Cosmetic Act (FDC Act). No evidence of harm is needed before FDA can

and should apply the law. The FDC Act and its implementing regulations establish

a presumption that all medical devices are unsafe, and require that the safety and

effectiveness of new or substantially modified devices be affirmatively demonstrated

prior to their introduction into interstate commerce. Claiming that a single use device may be reused causes the device to be treated as a new device under FDA’s

regulatory scheme. Yet, for years FDA has chosen to ignore this clearly stated Congressional intent by allowing reprocessed single use devices to be used on patients

without requiring or reviewing the necessary data to establish their safety and effectiveness.

Risk to Patients

FDA is aware of reports of two patients who have been blinded in one eye, a premature baby whose foot was burned, a thirty-two year old woman with a piece of

metal lodged in her heart, and increased rates of pneumonia in children.

Nevertheless, FDA’s first step in regulating reused devices was to improperly shift

the burden by refusing to require that reprocessors demonstrate safety and effectiveness of their products, and suggesting instead that OEMs provide data regarding the risks associated with reprocessing. Despite this improper move, the original

equipment manufacturer (OEM) industry expended substantial effort to test reprocessed single use devices. The data from that testing, all of which has been submitted

to FDA, overwhelmingly demonstrates serious safety issues. Moreover, FDA’s Office

of Science and Technology (OST) simultaneously generated its own independent

data confirming the risks of reusing certain single use devices.

At least nineteen scientific studies involving approximately 1000 individual devices have been submitted to FDA on this topic. These studies have been conducted

by independent scientists, hospitals, OEMs and, as mentioned above, FDA’s own

laboratory personnel. Many of the devices used in these studies were obtained directly from hospital shelves where they were ‘‘ready for use’’ in seriously ill patients—patients suffering from cancer or heart disease, and requiring major abdominal, cardiovascular or thoracic surgery.

Devices studied included biopsy forceps, angioplasty balloon catheters,

electrophysiology catheters, surgical trocars, staplers, papillotomes, and other general surgical instruments. Approximately 75% of the samples studied failed, either

due to the presence of blood and/or proteinaceous matter, bacterial contamination,

non-functionality, or defective packaging. In each of seven studies of reprocessed biopsy forceps, a lack of sterility assurance was reported in over 45% of the samples

tested. This particular failure was not unexpected. As recently as last October, FDA

issued a warning letter to one of the largest commercial third-party reprocessors

specifically citing the reprocessor’s failure to adequately validate the sterilization

process. These studies also found devices with mismatched parts, a scalpel blade designed to be blunt that was, instead, sharpened, a surgical stapler contaminated by

a large piece of proteinaceous matter, and devices lacking warnings about latex content. These nineteen separate studies clearly demonstrate that reusing a single use

device may seriously compromise the integrity and subsequent safety and efficacy

of that device.

To date, FDA has failed to make public any study reports summarizing OST’s

data. Nonetheless, public presentations by OST scientists clearly indicate that these

findings include safety and effectiveness concerns with percutaneous transluminal

coronary angioplasty (PTCA) catheters, electrophysiology catheters, and biopsy forceps. One presentation revealed PTCA catheters with non-patent lumens, crimped

guidewire lumens, and plugged balloons or balloon channels. In some instances,

cleaning chemicals and blood could not be removed from the device lumens. Some

reprocessed PTCA balloons varied in size by more than 10% of the approved specifications. As a result, a cardiologist has no assurance he or she will get the particular balloon size intended for the patient.

FDA has failed to acknowledge the demonstrated patient safety risks associated

with reprocessing single use devices despite volumes of data to the contrary. ReprocVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00109 Fmt 6633 Sfmt 6621 E:\HEARINGS\62970 pfrm08 PsN: 62970
106

essing amounts to a misuse of medical devices that can only add to the nation’s preventable medical error rate. The agency’s Congressional mandate to protect the public health will not be served by reversing the burden of proof and awaiting a proven

public health disaster before taking action.

Requirements of the FDC Act

The FDC Act requires that, prior to their introduction into interstate commerce,

all new medical devices must be FDA-cleared or approved through the premarket

notification (510(k)) or premarket approval (PMA) process. This process requires

submission of data by the party that intends to market the device. For a single use

device, the OEM demonstrates that the device is safe and effective for use on a single patient in a single procedure, and the device is then cleared/approved for only

that use. Under FDA’s own rules, reprocessing significantly modifies a single use

device by changing its intended use to multiple use, creating, in effect, a ‘‘reusable’’

device. FDA requires manufacturers of single use devices that wish to market those

devices as reusable to submit a new 510(k) or PMA, including data to support the

safety and effectiveness of the device for multiple use, prior to marketing the device

for that new use.

FDA agrees that reprocessors of single use devices are manufacturers under the

FDC Act and its implementing regulations, and, as such, reprocessors are subject

to the provisions of the FDC Act that require manufacturers to obtain clearance of

a 510(k) or approval of a PMA. Despite this recognition, the agency clearly announced its intention to permit reprocessed single use devices to be marketed without its prior clearance/approval, and, to date, has subjected them only to some degree of post-market regulation. In a letter dated July 9, 1999, FDA stated that,

‘‘third-party reprocessing of devices labeled for single use is unlawful unless those

engaged in this practice comply with all regulatory requirements for manufacturers,

including premarket notification requirements.’’ However, the agency then reversed

itself by announcing in the same letter that ‘‘FDA has exercised and will continue

to exercise regulatory discretion for all premarket notification requirements.’’ This

unjustifiable use of enforcement discretion is perpetuated for many reprocessed single use devices under FDA’s recently issued strategy for regulation of single use device reprocessing.

The FDC Act requires pre-clearance of reprocessed single use devices by all device

manufacturers, whether they are OEMs or reprocessors. The Medical Device

Amendments of 1976 (MDA) were enacted for the purpose of implementing pre-market review of devices because Congress was concerned that post-marketing regulation of medical devices was inadequate to protect the public health. The design of

the MDA is consistent with Congress’ belief that post-market controls are insufficient to regulate medical devices. In today’s world of increasingly complex medical

devices and heightened concern over disease transmission, the regulatory discretion

FDA has proposed to use under its new strategy, is inconsistent with Congress’ intent. In enacting the MDA, Congress’ goal was to protect patients from unsafe and

ineffective devices, regardless of the identity of the device’s manufacturer. As such,

there is no justification for a patient to receive less protection from FDA merely because the device used for the patient’s treatment is a reprocessed single use device

rather than an FDA-cleared reusable device. FDA is, in effect, creating a de facto

exemption from the premarket review requirements for most reprocessed single use

devices ‘‘ and in doing so, is violating its Congressional mandate.

FDA’s Disparate Treatment of OEMs and Reprocessors is Illogical

FDA acknowledges that it has not regulated OEMs, third-party reprocessors, and

health care facilities in the same manner with respect to single use devices. For example, in order to market a single use surgical stapler for use in multiple patients,

an OEM must first obtain clearance of a 510(k) from FDA. A reprocessor that wishes to market that same stapler for use in multiple patients is currently free to do

so without a 510(k). Not only is this dichotomy arbitrary, it is also illogical since

only the OEM has full knowledge of the design criteria and performance specifications of the device and thus is in a far better position than the reprocessor to determine whether the device can be reused.

In the FDA’s November strategy, the agency lists the seven requirements of the

FDC Act to which OEMs must adhere: 1) registration and listing; 2) premarket notification and approval requirements; 3) submission of adverse event reports under

the Medical Device Reporting regulation; 4) manufacturing requirements under the

Quality Systems Regulation ; 5) labeling requirements; 6) Medical Device Tracking;

and 7) Medical Device Corrections and Removals. Of these requirements, FDA acknowledges that reprocessors have only been subject to four ‘‘registration and listVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00110 Fmt 6633 Sfmt 6621 E:\HEARINGS\62970 pfrm08 PsN: 62970
107

ing, QSR, labeling requirements, and MDR reporting requirements. This unequal

treatment has no justification in law.

Moreover, this unequal treatment also seriously compromises public safety. Devices are being marketed that have not been demonstrated safe and effective as required by law. FDA is effecting a double standard that lowers the burden for reprocessors as compared to OEMs. The protection of U.S. patients requires that FDA regulate all manufacturers in the same manner, regardless of whether those manufacturers are deemed OEMs or reprocessors.

Conclusion

FDA must quickly establish timelines for enforcement of the 510(k) and PMA requirements on all reprocessed single use devices. The FDC Act requires FDA to protect U.S. patients from unsafe and ineffective medical devices before they cause patient injury. Such injury has already been attributed to reprocessed single use medical devices. Proper regulation of these devices, including enforcement of the premarket submission requirements, will prevent further injury and protect patients.

Mr. UPTON. Thank you very much.

Dr. Grossman?

TESTIMONY OF PHILIP GROSSMAN

Mr. GROSSMAN. Mr. Chairman, honorable committee members,

and guests, good morning. My name is doctor——

Mr. UPTON. Good afternoon.

Mr. GROSSMAN. You are right. Good evening, actually. My name

is Dr. Grossman. I am a practicing gastroenterologist in Miami,

Florida, a Clinical Associate Professor of Gastroenterology, but I

have spent my entire adult life as a patient advocate. I want to

thank both Chairman Bliley and Upton for holding these hearings

and for inviting me to participate. Like many of you I am somewhat heartened by the recent iteration of the FDA proposals because they address many of our prior concerns, but they certainly

do not go far enough and in my opinion certainly do not get us

there fast enough, and I think the time is clearly now to act. I find

myself shaking my head in disbelief every day that this continues.

In simple terms let me explain to you what this is about. Medicine has gone through an evolution to less invasive procedures.

There have been devices that have been designed, created, and

built to foster that improved healthcare and perform a specific

task. They were not built to achieve the ability to reuse. They were

built to achieve the ability to take better care of patients. What are

the implications? They allow us to repair blocked coronary arteries

without open heart surgery. They allow us to remove benign and

malignant polyps without a laparotomy, and for the first time in

our country they allow for a national initiative to prevent colon

cancer using safe and effective techniques. But to achieve this ability their very construction is somewhat unique. They have sharp

points, they have tightly coiled wires, and they have very, very narrow lumen to permit the flexibility and mobility required in many

of these areas. This allows them to do the job, but does not necessarily allow them to be cleaned.

Imagine being at home trying to clean the inside of a swizzle

stick and then using it again. What are the consequences or the potential consequences of reuse? Infection, major concern. Lost function. If I take one of these devices in my hand to care for a patient

and it fails in the middle of the procedure, it is not a question of

dollars and give me another one. It may fail in a time and place

that causes great harm to that patient. There is risk from chemical

108

toxic injury from the reprocessing solution and finally, there is

even a risk of misdiagnosis. There is a case I am familiar with

where a patient underwent esophageal surgery for a diagnosis of

esophageal cancer, but at surgery there was no cancer. It was believed that the tissue from which the diagnosis was made was residual tissue left inside the tiny cup in the biopsy forceps, and perhaps somebody could put a picture of the biopsy forceps up.

In essence, if we permit what amounts to the recycling of medical

waste, these consequences will confront us day in and day out. I

implore you, do not be mislead by the proponents of reuse who tell

you there are no complications, there are no problems, and there

are no dead bodies. The reason is that nobody is counting, and if

you do not go looking and if you do not count, you do not find it.

There has never been a prospective study investigating patients before procedures, looking at their HIV status, their hepatitis status,

and then bringing them back every month for a year to determine

if, in fact, they have suffered a consequence. It is easy to say that

it is not there. We are creating a potential generation with infectious time bombs. The incubation period for Hepatitis-C alone is

over 6 months. These patients are not followed during that time.

If you look at the biopsy forceps that is up there, you can start to

see why these problems occur. I agree with the FDA that this is

a high-risk device. My concern that the loop hole for exemption

may allow it to escape and go beyond the protection that the law

intended.

I would like to comment on informed consent for a moment, and

that is until the FDA actually embarks on device by device review

and approval, there will be two standards of care in this country.

I believe patients have a right to know. And if the people who

think that this is so safe really believe it, I see no reason why they

should not be bragging about it. In the last group, your healthcare

workers, the unsung heros who are being exposed to unnecessary

risk by handling these contaminated devices. My conclusion would

be and my hope for this committee, the final answers may not be

in, but if reasonable doubt exists and reasonable doubt does exist,

we must err on the side of patient safety and patient well-being.

I thank you for your attention and particularly thank you for your

leadership.

[The prepared statement of Philip Grossman follows:]

PREPARED STATEMENT OF PHILIP GROSSMAN

INTRODUCTION:

My name is Philip Grossman, MD., F.A.C.P., F.A.C.G., I am a practicing Gastroenterologist in Miami, Florida, and Clinical Associate Professor of Medicine and

Gastroenterology at the University of Miami School of Medicine. I am submitting

this written testimony to address the following subject not because of any titles, but

primarily as a family man and a concerned citizen. I feel very strongly about this

issue and have traveled from Florida to provide both written and oral testimony.

I applaud your efforts to protect United States citizens.

THE PROBLEM:

The problem we are facing is the reuse of medical devices that were designed,

manufactured, tested, packaged, and labeled for the sole purpose of a single use in

a single patient. These are devices for which the very approval from the FDA is contingent upon information submitted, including the fact that these devices are to be

disposed of after a single use. Reprocessing refers to the cleaning, packaging, and

109

attempt at resterilization of a single-use medical device which was used on a patient

for its intended purpose and which will then be used again on another patient.

Some single-use medical devices, for example, biopsy forceps, are critical devices,

which, according to the Spaulding Classification, are those which routinely break

the mucus membrane, thereby coming into contact with sterile tissue or the vascular system. Critical devices carry a much higher level of risk when reused than

do non-critical or semi-critical devices, which would include endoscopes—devices

which in themselves have been associated with disease transmission even in the absence of sharp points and coiled wires. The core of this matter is not the paperwork,

labeling, or the official box these devices fit into, although these factors are important as well. Rather, the core issue is the actual reuse of single-use devices in real,

live people—husbands and wives, parents and children, brothers and sister.

The scope of this problem is broad. It encompasses a wide range of devices in multiple specialties and includes biopsy devices, cardiac catheters, and various accessrelated devices used in gastroenterology, urology, and cardiology, as well as other

specialties. This issue has become increasingly controversial as more healthcare facilities consider reuse of single-use devices as an attempted means of cost containment. According to a survey published in 1997 by ECRI, a non-profit health service

research firm, approximately one-third of healthcare facilities reused medical devices labeled for single use, and 25% more were considering the practice (Costerton).

I must be clear though that I am discussing used single use devices not single

use devices that were opened prior to a procedure and then not used. An unused

single use device presents less risk to the next patient. In a recent issue of OR Manager, 250 hospitals were surveyed on this topic. Of the devices that were being reprocessed, 80% of them were open but unused devices. Hospitals must look to the

manufacturer’s instructions to determine if these devices can be resterilized. These

are not the devices that are being discussed here. I will focus my comments on the

reuse of used single use devices.

OVERVIEW:

Devices are designed for single use only

No matter what the specialty—gastroenterology, cardiology, or urology—single-use

devices are specifically designed from inception for safety and performance. Therefore, the very design structure did not take into account the need to access all the

nooks and crannies in order to clean them. The research, development, and design

of the structure focused on a safe, effective product to be used once. An analogy to

this situation might be as follows: You are asked to design a car to take a family

of two adults three blocks from their home. However, it is only later that you find

out that this care needs to transport eight schoolchildren fifteen miles away. But

the car is six seat belts short. As with the design of the car, the design and all of

the safety features of a single-use device make is totally suitable for the purpose

for which it was created but do not automatically apply when the rules are changed.

That’s what this problem is about.

Proponents of reprocessing may maintain that reuse is safe and vital as a measure to reduce healthcare costs; however, a preliminary FDA study uncovered dozens

of reports of infection, chemical injuries, and mechanical failures associated with

reusing equipment designed to work just once. Although reprocessing single-use devices had been widespread abroad; France has prohibited such reuse, and other

countries are looking at the issue.

Design features make cleaning/reprocessing a problem

Single-use devices have a number of common features:

1. They tend to be very small and intricate.

2. They typically have complex wiring systems, such as diagnostic wiring that carries an electronic signal for measurement, or mechanical wiring that operates

the working portion of the device much like a remote control tweezer or remote

control cane.

3. Because many of these devices are used for the purpose of removing pieces of tissue or altering tissue during a procedure, they typically have sharp points and

sharp edges.

The problem is that the very structure just described that makes the device work

so safely and effectively in its intended use is the same design that precludes the

ability to access its nooks and crannies and that encourages human debris to get

caught in tightly woven wires or on sharp points. In essence, the success of these

devices is what makes them such a risk in terms of the inability to clean them for

reuse. The basic tenet in the world of microbiology is: ‘‘If you can’t clean it, you can’t

sterilize it!!!’’

110

Devices designed to be reusable differ from reprocessed single-use devices

Manufacturers are required to conduct additional testing for devices that are intended to be reusable. They must meet FDA criteria to validate that a device can

be cleaned and resterilized multiple times. Data supporting reuse must be submitted to the FDA through the premarket notification process. FDA is not enforcing

these same regulations against reprocessors of used single use devices.

Many devices, whether labeled as single-use or reusable, may appear identical.

However, the devices may not include the same materials or internal components.

For a number of reasons, manufacturers may change the materials used in production. Changes in materials may not be obvious on visual inspection, but unless the

devices is specifically labeled ‘‘reusable,’’ the new materials may not be able to withstand the heat or chemicals required for resterilization, particularly on a repetitive

basis.

Fallacies of cost savings with reprocessing

In an effort to control costs, some hospitals have taken the position: ‘‘If a device

costs $50 and it is used just once, it costs the full $50. If a devices costs $50 and

is used ten times, it costs only $5 per use.’’ The two fallacies of this position are:

1. It reduces human risk solely into dollars per session; and

2. There are very real costs associated with processing a device for a second or subsequent use. Devices are either reprocessed in-house (at the hospital) or are

outsourced to the new industry of device reprocessors. Device reprocessors take

the devices from the hospital (much like dry cleaning) and later return them,

typically charging approximately 50% of the cost of a new device. So, it’s not

an issue of $50 vs. $0. When you factor in the cost of the reprocessor, as well

as the hospital’s cost of labor in preliminary cleaning, nursing time, as well as

plastic bags, labeling, etc., the actual costs of reprocessing increase significantly.

Devices being reused that are not intended for that function are in fact being reused at risk to the patient—as a cost saving measure. Because of the very nature

of these devices, well meaning people wanting to do a good job may still not be able

to adequately make single-use devices safe and appropriate for the next person.

Cost of failure

In addition to the issue of patient risk, there is a genuine cost, both medical and

economic, to a device which now performs at less than the standard for which it

was built. It may result in a delayed procedure, damage to other medical devices,

for example, endoscopes, higher complications, and/or greater risk to the patient as

well as the medical personnel. In fact, the entire economic issue may become lopsided beyond recognition when one actually weighs the economic cost of an injured

patient whether due to infection or device failure, against the acquisition cost of single-use devices. It may take decades to break even following such an adverse event.

DISEASE TRANSMISSION:

Reports document disease transmission

Extremely well documented reports and additional medical literature confirm that

diseases that have been transmitted from patient to patient have been tied to improperly reprocessed medical scopes and devices. Two reports documented the transmission of tuberculosis and the transmission of hepatitis. Both of these studies were

documented with DNA fingerprinting—that is, researchers were able to actually

demonstrate that the exact DNA of the organism identified from patient #1 was also

found in patient #2—on whom the same scope had been used. Scopes were implicated in these reports, and scopes do not have sharp points. If you take a tweezerlike device with a tiny spike in it and stab it into tissue, then reprocess the device

and stab it into someone else’s tissue, it does not take a leap of the imagination

to understand why disease transmission is of great concern.

A fallacy: cleaned and sterilized equals safe

Some argue that because a device is cleaned and sterilized, it is therefore safe.

This view is faulty for the following reason: some devices are constructed in a way

that make it literally impossible to properly clean. In order to clean in between wire

segments, you would have to literally unravel the device. An analogy would be: If

in order to get a pair of stretch pants properly cleaned, you have to remove the elastic before taking them to the cleaners, thus rendering them useless in the future.

When devices are reprocessed, whether in a hospital or by outside contractors,

there is a human chain of activity—that is, a series of human events where people

perform a variety of tasks. Even with well meaning and competent people doing this

task over and over, there is still a possibility for human error, which magnifies as

111

the number of steps and number of people increase. When the task involved in the

process is repetitive, tedious and arduous, the likelihood of human error along the

way is further multiplied. Everyone agrees that any human error, whether from inadequate cleaning, scrubbing, or delay, makes it impossible to properly reprocess a

device and may be the cause of disease transmission. Compare that to the patient

lucky enough to be the recipient of a first-use device—where the device comes out

of a manufacturing plant which is inspected and whose processes are regulated and

monitored by the FDA, has an established Quality Assurance process, and complies

with stringent published standards for microbiological testing. There is essentially

no concern about the possibility of error association with a repetitive human chain

because, compared to the alternative, the devices comes out assuredly sterile.

Devices may be pooled in reprocessing

If a hospital farms out its devices, hospital personnel are supposed to do a preliminary cleaning. The devices are then placed in a bag, picked up by the reprocessor, taken offsite for reprocessing, and returned. It is not uncommon for reprocessors to return a similar but not identical device. For example: You’re a reprocessor. I give you Catheter A from my hospital, and some time later you give me back

a ready-to-use Catheter A that came from a general pool of Catheter As from various facilities. My staff, over whom I have control, may have done a great job with

the preliminary cleaning of our Catheter A devices, but we got back someone else’s

catheters. Therefore our staff’s diligence might not be benefiting our patients.

Bacteria can become trapped

When human organic material—blood, stool, tissue, saliva—is allowed to stand

and crust, it forms a type of biofilm. The problem is that, in many cases, devices

sit for a period of time, waiting to be picked up. A hospital being busy or any number of factors can result in an initial delay in cleaning. This delay, as well as the

possibility of inadequate cleaning, enables the debris to form a resin that literally

seals in and therefore insulates the bacterial. (Picture the bacteria going into a

‘‘bomb shelter’’ and reemerging when ‘‘the coast is clear.’’) When the reprocessed device is returned to the hospital it has allegedly been sterilized by the reprocessor.

However, the bacteria are not effected by the sterilization process because they’ve

been ensconced in this insulating shell. The problem gets worse. When the reprocessed device is put into a patient, the shell, at body temperature, and in the presence of body fluids, starts to degrade, thereby releasing the bacteria into an innocent victim.

Devices are often used in contaminated areas of the body

In addition, the actual nature of reprocessed single-use devices lends itself to disease transmission because: (a) the majority of devices are used in the vascular system or in a contaminated area such as the urological or gastrointestinal tract, and

(b) most devices have sharp points. All of the above factors contribute to disease

transmission in reprocessed devices and enormously raise the likelihood that this

is not a safe device when used under these circumstances.

PUBLIC AWARENESS

The reason the public is not up-in-arms about the use of reprocessed devices is

that people don’t know enough about this issue, which is why this hearing is so important. Reprocessing is not an issue of greedy manufacturers; it is an issue that

the public, when informed, decries. The following data illustrate the issue of public

awareness—or lack thereof—and people’s responses when they become aware.

1. In a study called The Medical Device Reuse Awareness Study for Halsted Communications, conducted in October 1997, the following question was posed to

501 participants from Los Angeles, New York, Chicago, and Atlanta: How would

you feel if a device that by law was designed to be used once, was reused on

you or on someone you love? People responded as follows: 84% stated they

would be angry; 76% would demand an explanation; 69% would be frightened;

and 59% would ask for a guarantee that the person that the device was used

on before was healthy. Nineteen percent of the respondents from Los Angeles

stated that they would sue if they found out this happened.

2. Recently in Japan, a clinic initiated a policy in which patients were told that

there were two kinds of accessories they could use in a procedure: single use

or reprocessed. If they chose the single-use device, however, they would have

to pay an out-of-pocket premium. Everyone chose to pay the premium.

3. Some time ago the television show ‘‘Dateline’’ did a piece on the practice of

reusing some dental material—braces in particular. Following this program,

112

there was a huge outcry. Again, it was a case of the public initially not knowing, but voicing their displeasure when they found out.

4. Many studies, commissioned by original manufacturers, have been conducted by

independent sterility testing labs. In these studies, researchers took random

samples of reprocessed medical devices sitting on shelves in hospitals—ready for

use in patients. The reprocessed devices were then sent to the independent lab

for testing. In all the studies, a large number of devices were found to be contaminated with blood, body fluids, tissue, cleaning chemicals and bacteria.

These studies represented real situations, not just a theoretical concept. It was

not a case of ‘‘What do you think would be used?’’ Rather it was a case of what

would have been used, since these devices were right there on the shelf awaiting the next patient.

5. At a symposium during a meeting of the Society for Gastrointestinal Nurses and

Associates, Inc. (SGNA) held in 1998, nurses were asked the following question:

‘‘If you were a patient, what would you want used on you: single-use or reprocessed devices?’’ Unanimously, they did not want reprocessed devices. Since then,

the SGNA as an organization has published a position paper speaking out

against the practice of reprocessing. It states, ‘‘In the absence of clear regulatory guidelines for reuse of single-use devices, based on current scientifically

based literature, and taking into consideration concerns for patient safety and

ethical practice, the Society of Gastroenterology Nurses and Associates, Inc.

supports the position that critical medical devices labeled for single-use should

not be reused.’’

INFORMED CONSENT AND LIABILITY:

The outgrowth of the practice of reprocessing single-use devices raises the issues

of informed consent and liability. I believe that:

1. Ultimately the physician or physicians using the devices bear a significant liability. They are the guardian of the patient. If physicians have knowledge that the

device handed to them in any way might cause harm, they have accepted some

responsibility.

2. If a hospital makes a choice to take a legally labeled single-use device and use

it contrary to the manufacturer’s instructions, the hospital also bears responsibility.

The patient’s right to know

This also raises a question as to what the patient has the right to know and do.

Based on the above, it is my belief that, in addition to telling the patient of the risks

and benefits, potential complications, and the names(s) of the physician(s), there

should also be informed consent. It would state: ‘‘Devices that we use have been previously used in other patients. Those patients may have had infectious diseases, including AIDS and hepatitis. These devices are used contrary to manufacturer’ instruction.’’ The patient would then have the opportunity to say, ‘‘Yes, I understand;

go ahead and use the reprocessed device.’’ This, however, is obviously not being

done. I believe the practice of reprocessing of single-use devices is a significant

enough deviation that does warrant truly informed consent.

Why is information withheld?

Before conducting a procedure, I don’t hesitate to tell my patients that they have

a one in ‘‘x’’ risk of perforation, the possibility of hemorrhage, or even death. Clearly, it is not atypical to advise patients of potentially serious or even possibly fatal

events associated with procedures. So why is it that we hide information about the

risks of reprocessed devices? The answer is that physicians and hospitals are comfortable saying, ‘‘The procedure we’re doing is the best available for your condition,

while recognizing that no procedure is perfect. Here is the scientific information to

show why, given the risk/benefit ratio, it is in your best interest.’’ That is different

from trying to hide the fact that ‘‘We paid $50 for a single-use, disposable device,

but by reusing it over and over, we will save the hospital money.’’

It is as though physicians and hospitals are not informing people about using reprocessed devices and are not asking for consent because they don’t want people to

know. If they are unwilling to ask for informed consent, does that not tell the whole

story?

Do patients get equal treatment?

A patient might rightfully question, ‘‘Why do I go through life living so carefully

and avoiding risky behavior, then you expose me to the risky behavior of someone

else without telling me that the motivation is to save money for the institution?’’

Or, ‘‘Why does patient #1 get the benefit of a sterile, first-use device with no risk

113

of disease transmission while I, patient #2, get a reprocessed device?’’ There would

be no justifiable answer.

IN CONCLUSION:

I have never in my own profession or in related specialties heard a physician or

hospital say, ‘‘I think reprocessed single-use devices are better.’’ The only justification is that ‘‘it helps control costs and I think it’s OK.’’ Ardent supporters may say

that they have conducted many procedures safely with reprocessed single-use devices without hearing about resulting deaths or diseases. But, you can’t take a device apart to ensure that it’s sterile, and therefore, one doesn’t really know. We need

to be open enough to state that we have seen tremendous microbiological studies,

including DNA fingerprinting, that confirm that reprocessed devices can transmit

disease. If we err on this position, we should do so on the side of public protection. I don’t think the public is best served by waiting to form public policy until

enough victims are amassed.

You will hear from many people who will offer their legal, microbiological, and engineering perspectives. The real message you need to take away from me in my professional, life-long role as a patient advocate is that, while not dismissing the hospital or its association’s role as the patient advocate, it is perhaps the physician who

has the major advocacy role and who ultimately drives the decision.

I understand cost containment, I am not a naı ̈ve physician saying that cost

doesn’t matter. In today’s healthcare climate, we all must be mindful of cost in order

to be able to continue to deliver healthcare to the populace. In fact, I currently sit

on the board of directors of a hospital and constantly deal with cost containment.

However, understanding the need to control health care costs and making decisions

for which current information tells us that our decisions may be injurious to the patient, are hopefully—and should be—mutually exclusive.

In closing, I’d like you to ask yourselves this question: Would you want your loved

ones who had the misfortune of being ill to be in the care of a doctor or a hospital

where you sat in the waiting room and not only needed to worry about the disease

that has afflicted them, but also had to worry about the safety of the very device

used to try to bring about their wellness?

Mr. UPTON. Thank you for your final answer.

Dr. Fielder?

TESTIMONY OF JOHN H. FIELDER

Mr. FIELDER. Mr. Chairman, I am John Fielder. I am a professor

of Philosophy at Villanova University and I am here not representing any group.

Risk is the probability of harm times the severity of harm. We

know that the severity of harm, potential harm is very great. Hepatitis C, tuberculosis, and other diseases. What we do not know is

how large the probability of that harm is, however, even if you

have a low probability of harm, if the severity of harm is high, you

have a significant risk. Now, the ethics of risk are clear and they

are well established, both in ethics and law. It is the patient’s right

to be informed of the risk, informed of the benefits, the alternatives

to treatment, and to give consent. These principles are based on

the fundamental idea that persons are in charge of their lives and

it is the job of healthcare professionals to guide them in making

those decisions. Most patients are not informed that they are being

treated with devices that pose additional risk to them over a singleuse device.

Last fall I prudently got a flu shot, went down to the infirmary

at Villanova and they shot me, but I had to sign a consent form

first that told me the dangers, the benefits, and the alternatives.

So I signed it and I got my shot. And I was thinking as I was walking back that if it is appropriate for me to sign a consent form to

get a flu shot like millions of other Americans, I would sure like

to sign a consent form if somebody was going to put one of these

114

things that had been in somebody else into my body and to bite off

a piece of me to bring back for a sample. It is enlightening and constructive to try to construct a consent form for a patient who is

going to be treated with a reused device. First the risk. Okay. We

have talked about the risks, we know that there is a potential of

transmission of disease, of functional degradation, and so forth.

But what exactly are the benefits here to the patient? See, this

is where we hit the ethical brick wall. The patient is getting no

benefit by being treated with a reprocessed device. They are getting

additional risk, but they are not getting any additional benefit.

Now, you will be told that the savings from these reprocessed device will be put back into patient services and life will be better for

patients and hospitals. This may be true. But it is also true that

money might go into the pockets of investors or for-profit hospitals

as well. Also, it seems to me if this is a great benefit, put it down,

let patients decide if they want that benefit based on the risk that

the device poses.

I think the use of reprocessed devices in a present form is really

a kind of vast medical experiment that we are doing. We do not

really know the outcomes of using these extensively, we do not

really know how much disease is being transmitted, and we are

doing it without people’s knowledge and consent. And that is

wrong. We should not be doing that. A couple of other items. Fairness. I am pleased that the FDA is moving in the direction to make

the regulatory burden for the original equipment manufacturers

and the reprocessors more or less equal. That seems to be appropriate. It is simply unfair to ask one group to go through a complicated song and dance to get their device approved and not the

others. Another item I am concerned about is labeling. Many times

physicians do not know that they are using a reprocessed device.

They do not open it in the operating room. Somebody else does and

hands it to them. So when they get the device, it says Cortis, or

Boston Scientific, or whatever, and they will think they are using

an original device. I think that is unfair to the original equipment

manufacturers because that is no longer their device once it is reprocessed. And I would urge FDA and perhaps this committee if it

is appropriate, to make sure that this information about the device

is on the device so that people who are using it can tell, and so that

patients who may be damaged can use that if they want to sue for

damages.

Finally, as in all things, money is a big issue here. I know that

hospitals are under tremendous financial pressure. Some of it from

the Government, from HCFA and Medicare, some of it from insurers. One of the reasons this kind of problem pops up was that it

is very hard to treat people in hospitals and make money and to

stay afloat. I am very concerned that we create a system where

hospitals start looking for places that are ethically questionable to

save money. I would much rather have a system where they could

do their work and have adequate resources to do it, and not have

to consider this kind of practice. Thank you Mr. Chairman, I appreciate your holding hearings on this important topic.

[The prepared statement of John H. Fielder follows:]

115

1 Beauchamp, Tom, and Childress, James, Principles of Biomedical Ethics, Fourth Edition

(1994), Oxford University Press, New York. 2Faden, Ruth, and Beauchamp, Tom, A History and Theory of Informed Consent (1986), Oxford University Press, New York. 3Merritt, Katherine, Hitchins, Vicki, Woods, Terry, and Brown, Stanley, ‘‘Re-Use of Devices:

Cleaning Issues,’’ presentation at the Association for Medical Instrumentation/FDA Conference,

The Reuse of Single-Use Devices: Practice, Patient Safety, and Regulation, Crystal City, VA, May

6, 1999. This information was taken from a public presentation; FDA has not made a report

of this study publicly available. 4 Yang M, Deng X, Zhang Z, Julien M, Pelletier F, Desaulniers D, Cossette R, Teijeira FJ,

Laroche G, Guidoin R, ‘‘Are intraaortic balloons suitable for Reuse? A survey of 112 used

intraaortic balloons.’’ 1997 Artificial Organs 21(2) 121-130. 5Two of the most extensive were conducted by Ethicon Endo-Surgery, a Johnson and Johnson

Company, ‘‘Evaluation of Reprocessed Ethicon Endo-Surgery, Inc. Single-Use Medical Devices,’’

(1998) Ethicon Endo-Surgery, Cinncinnati, OH, and Muradali, Kumaree, ‘‘Report on Re-furbished Single Use Devices,’’ Cordis, a Johnson and Johnson Company, Miami Lakes, FL.

PREPARED STATEMENT OF JOHN H. FIELDER, VILLANOVA UNIVERSITY

Introduction

The patient is the ethical center of health care. All who participate in patient

care, directly or indirectly, are ethically obligated to provide adequate and appropriate care to patients and to safeguard their right to make informed health care

decisions. Patients are ill, vulnerable, dependent, and usually ignorant of the nature

of their illnesses, their treatment options, and what they mean for them. As a result, they require a greater degree of help and protection than persons who are not

ill.

Almost all health care procedures involve some risk to the patient. It is a longstanding tradition in ethics and law that patients have the right to decide what

risks to take, and health care professionals have the obligation to inform them of

the risks and benefits of alternative treatments, including nontreatment.1 Patients

are in charge of their lives, not doctors. The greater the risk, the greater the patient

protection that is needed. Formal biomedical research must meet extensive requirements concerning maximizing benefits while minimizing risks, independent review,

and informed consent.2 The concept of informed consent embodies the ethical principles of patient autonomy and provider beneficence.

Risk

From the patients’ point of view, the primary question concerns the risks posed

by the reuse of medical devices approved by FDA only for a single use. The devices

in question are those that pose the greatest risk to patients. No one worries about

the reuse of single-use compression sleeves or bedpans. It is the complex devices like

cardiac catheters, biopsy forceps, and similar devices that raise the most serious

questions of risk. These devices enter the patient’s blood stream, intestines, and

major organs where disease organisms reside. They also have tiny passages for

guide wires which may be difficult to clean and resterilize.

It is important to distinguish the two factors that are used to determine risk. Risk

is the product of the probability of harm and the severity of harm. Thus, high risk

could result from the high probability of moderate harm as well as the low probability of very serious harm. In assessing risk we must look at both the seriousness

of the potential harms as well as the likelihood of their occurrence.

In addition, we need to distinguish two kinds of harms that may result from treatment with a reused single-use device. First, diseases may be transmitted from previous patients to the patient being treated through inadequate cleaning and resterilization. Second, devices may have their functional characteristics changed as a result of cleaning, so that patients may be injured or be given less than optimal treatment. Thus we need to look at the probability and severity of harm regarding both

functional changes and disease transmission.

From my study of reuse of single-use devices, the following facts emerge:

• We know that studies of reprocessed single-use devices by FDA and others show

that some devices have debris left in them and are contaminated with fungi,

bacteria, or viruses. A study of Percutaneous Transluminal Coronary

Angioplasty (PTCA) balloon catheters found that some clean easily while others

seemed to regularly get clogged. About half the samples grew organisms in the

middle sections.3 Other studies report residual organic debris that cannot be

adequately eliminated.4 Company-sponsored studies, some by independent laboratories, confirm these results.5

• We know that reprocessing devices can result in functional changes. Another FDA

study of PTCA balloon catheters found that there were changes of up to 10%

in balloon diameter after reprocessing. Reprocessed balloons were also stickier

116

6 Brown, Stanley, Merritt, Katherine, Hitchins, Vicki, and Woods, Terry, ‘‘Effect of Use and

Simulated Reuse on Materials and PTCA Balloons and Catheters,’’ presentation at the Association for Medical Instrumentation/FDA Conference, The Reuse of Single-Use Devices: Practice, Patient Safety, and Regulation, Crystal City, VA, May 6, 1999. This information was taken from

a public presentation; FDA has not made a report of this study publicly available. 7 Bronowicki JP, Venard V, Botte C, Monhoven N, Gatin I, Chone L, Hudziak H, Rhin B,

Delanoe C, LeFaou A, Bigard MA, and Gaucher P, ‘‘Patient-to-Patient transmission of Hepatitis

C Virus During Colonoscopy,’’ New England Journal of Medicine (1997) July 24; 337(4): 237-

40. Michele TM, Cronin WA, Graham NM, Dwyer DM, Pope DS, Harrington S, Chaisson RE,

Bishai WR, ‘‘Transmission of Mycobacterium Tuberculosis by a Fiberoptic Bronchoscope. Identification by DNA Fingerprinting,’’ Journal of the American Medical Association (1997) Oct. 1;

278(13):1093-5. 8 Bahng, Susanna, VanHaln, Sonja, Nelson, Virgina, Hurvits, Edward, Roloff, Dietrich, Grady,

Elizabeth, Lewis, Cathy, ‘‘Parental Report of Pediatric Tracheostomy Care,’’ Archives of Physical

Medicine and Rehabilitation, (1998) Vol. 79; 1367-9. 9 ECRI Special Report, Reuse of Single-Use Devices: Making Informed Decisions (1996). ECRI,

Plymouth Meeting, PA., p. 1. 10 Hallermann D, Singh G. ‘‘Iatrogenic central retinal artery embolization: a complication of

cardiac catheterization.’’ Annals of Opthalmology 1984; 16:1025-27. 11MedWatch report, 3/18/99. MedWatch is a voluntary reporting system of FDA. 12Mak, Koon-Hou, Eisenberg, Mark, Plante, Sylvain, Strauss, Bradley, Arheart, Kristopher,

and Topol, Eric, ‘‘Absence of Increased In-Hospital Complications with Reused Balloon Catheters,’’ The American Journal of Cardiology (1996) Vol. 78; 717-9.

that new ones. The effects of cleaning agents on the various plastics used in

devices is materials-specific.6 The company-sponsored study (see note 5) also

found function changes in the devices they studied.

• We know that devices approved for reprocessing have been responsible for the

transmission of TB and hepatitis C during bronchoscopy and colonoscopy because of improper cleaning and sterilization.7

• We know that reprocessed devices can also transmit diseases. Sixty percent of pediatric patients treated with reused tracheostomy tubes contracted pneumonia

compared to 25% treated with new ones.8 We do not know if other diseases, particularly hepatitis C, are being transmitted because no studies have screened

patients before treatment and tested them later. A report by a well-regarded

independent organization concluded that ‘‘there is no clear evidence that reuse

of single-use medical devices is either safe or unsafe for patients.’’ 9

• We know that reprocessed devices have failed and injured patients. A patient undergoing cardiac catheterization for coronary angiography reported a sudden

loss of vision in his right eye. The procedure was stopped and an examination

of the eye revealed a green crystalline foreign body within the central retinal

artery on the optic nerve head. The catheter, approved only for a single use,

was reautoclaved, making it more friable. A fragment had broken off and traveled to the central retinal artery, occluding blood flow. Treatment of the injury

was unsuccessful and the patient was left with only light perception in his right

eye.10 In another case the tip of a reused cardiac catheter broke off and lodged

in a patient’s atrium.11

• We know that a few studies in peer-reviewed journals show that single-use and

reprocessed devices have similar rates of in-hospital adverse events. One study

in this literature is a double-blind, randomized control trial of 1,033 procedures,

of which 753 were reused PTCA balloon catheters. They found slight differences

in serious adverse complication rates, urgent coronary artery bypass surgery,

and abrupt vessel closure.12

Several conclusions can be drawn from these facts.

Changes in Functional Characteristics

Severity of Harm: Reprocessed devices can fail and cause serious injuries. Other

changes in functional characteristics can result in difficulties in treatment that may

result in injuries or additional exposure to risk.

Probability of Harm: There are only a few reports in the literature of patients

being harmed by failure of these devices, but it is likely that device failures are

underreported. Also, physicians may not recognize problems caused by reprocessing.

The probability of in-hospital adverse events does not appear to be high, but more

studies need to be done to confirm this.

This analysis suggests that the probability of harm from functional failure is likely to be low, although more good scientific evidence is needed to establish this with

reasonable certainty. I conclude that patients who are treated with reprocessed single-use devices are being subjected to a low risk of failure to function adequately.

117

13Moore v. Regents of the University of California, 51 Cal. 3d 120 (1990)

Transmission of Disease

Severity of Harm: Reprocessed devices have the potential to transmit deadly diseases; thus the severity of harm is high.

Probability of Harm: The probability of transmission of disease is unknown but

is certainly greater than zero. It also varies with the type, brand, and model of device.

The real risk is not in functional failure but in the transmission of disease. The

severity of harm is great from TB and hepatitis C, and we simply do not know much

about the probability of this happening with reprocessed single-use devices. We do

know that improper cleaning and resterilizing of used devices can transmit these

diseases, and we know that there is no manufacturer-developed and FDA-approved

protocol for cleaning them. Even if this is a low probability of harm, the severity

of the consequences creates a significant risk for patients.

Informed Consent

In cases where patients are exposed to a significant risk, ethics requires that they

be informed of the benefits of treatment, the risks, and the alternatives. This is true

even for common, low risk procedures. Last October I got a flu shot at the Villanova

University Health Center. Vaccines have a small probability of triggering an immune reaction that can cause serious illness or death. Because of this I was asked

to read and sign a consent form that informed me of the benefits of the injection,

the risks, and alternatives. The form is appended to this document.

Since patients treated with reprocessed single use devices are also exposed to a

significant risk, it is enlightening to construct a consent form for this procedure.

Imagine that you are being asked to consent to the use of a reprocessed device in

your treatment instead of an otherwise identical new, single-use device.

The form would have to state that the potential harms include the possibility of

transmission of TB and hepatitis C, very serious diseases, and possible functional

changes or failures. While some studies suggest that the probability of these events

occurring is low, we do not really know how likely they are.

What are the benefits? None to you, the patient, only to the hospital’s finances.

Note that the consent form may also have to include the fact that the hospital has

a significant financial interest in treating patients with reprocessed devices.13

What are the alternatives? Besides nontreatment and any other less invasive procedures, you could be treated with a new device at no extra cost to you and avoid

these potential complications. In effect, you are being asked to take significant risks

in your treatment for no corresponding benefit to you but to contribute to the financial health of the hospital.

To see how this works in practice, consider two patients, in 403A and 403B, both

scheduled for cardiac catheterization. The patient in 403A will be treated with a

new, single-use device and will have no risk of the infection being transmitted by

the catheter, nor will that patient or the physician have to worry about any functional changes from previous uses. In contrast, the patient in 403B is put at risk,

without any corresponding therapeutic benefit, and without the patient’s knowledge

or consent. This is simply ethically unacceptable. You cannot put people at risk

without their informed consent.

Patient Benefit

Proponents of reuse sometimes argue that savings will be passed on to patients

in the form of more and better services, but this is a weak argument. First, in forprofit hospitals those savings will, in part, be returned to investors as dividends.

Second, it is not guaranteed that any savings will directly affect the patients taking

the risk, because savings may well be applied to other hospital service areas. Third,

patients being treated with a reprocessed device may get some indirect benefit from

previous savings generated by reuse, but none from their treatment with a reprocessed device. Fourth, if these are patients’ benefits, no matter how remote, shouldn’t

they have the right to decide where they should be spent? The fact of the matter

is that it is the hospitals who benefit, and that benefit may have some indirect beneficial impact on patient care. But this does not alter the fact that any beneficial impact that accrues to a particular patient is greatly out of proportion to the risks

being taken.

Medical Experimentation

There are further ethical anomalies in the reuse of single-use devices. When you

take your flu shot, the probability of harm is reasonably well established. When you

are treated with a reprocessed device, there are substantial unknowns, especially

118

14Woltjen, Maria ‘‘Regulation of Informed Consent to Human Experimentation,’’ Loyola University of Chicago Law Journal, Vol. 17 (1986), p. 313.

concerning disease transmission. Consequently, the use of reprocessed devices is a

form of experimental treatment, providing an even stronger claim for the traditional

ethical protections, particularly informed consent.

The adequacy of consent to a pure experiment of to experimental treatment

raises more issues than consent to an established therapy simply because less

is known about the risks involved in an experimental procedure...Therefore a

prospective subject must be aware that little is known about the possible risks

and consequences...14

In the absence of adequate scientific evidence to establish the probability of harm,

particularly the transmission of disease, and in the absence of FDA-approved, device-specific protocols for cleaning, resterilizing and number of permitted uses, the

continued use of reprocessed medical devices is a large, ongoing medical experiment,

but one that lacks even the rudimentary protections to patients, particularly the requirements that risk be proportional to patient benefit and informed consent.

This raises further questions about the ethical responsibilities of all who participate in this practice—hospitals, health care professionals, and reprocessors. Because

the use of reprocessed medical devices is an unethical form of medical experimentation, then the hospitals, physicians, and other health care professionals who take

part in it are also not meeting their obligations to put patient interests first and

to uphold their right to informed consent.

Other Ethical Issues

Regulatory Fairness: Risk and patient protection are the primary ethical issues,

but there are others that need to be mentioned. Original equipment manufacturers

(OEM’s) who wish to market a reusable device must submit a validated protocol to

FDA for approval. The protocol must include scientific evidence to show that it can

be properly cleaned and resterilized, the effect of cleaning an resterilization on the

materials, functionality, and safety of the device, and the number of times it can

be reprocessed without loss of safety and effectiveness. No such regulatory burden

falls on the reprocessor, who must, at most, meet good manufacturing and quality

control standards. This is an unequal burden for which there is no adequate justification. Thus the present arrangements are unfair to OEM’s. However, FDA has

recently taken significant steps to bring reprocessed devices under greater regulatory scrutiny.

Labeling: Reprocessed devices still bear the name of the OEM on the device, but

in a real sense it is no longer theirs, since they can no longer vouch for their safety

and effectiveness. Unless there is clear information in the labeling of the reprocessed device, there is the misleading suggestion that the device has the assurance

of quality, safety, and effectiveness associated with the OEM, or that any failure is

to be attributed to the OEM.

OEM’s and Reprocessors: Are OEM’s unethical for failing to produce reusable

catheters? Critics have charged that what were once reusable devices were simply

relabeled for single use. Is this practice wrong? The FDA does not have the authority to determine what products companies may develop or what they charge for

them. It is a basic principle of our economic system that producers have a right to

decide what products they wish to market as long as they meet all legal and regulatory requirements. Unless there is some strong reason to think otherwise, OEM’s

and reprocessors are not ethically obligated to make or withhold particular products.

Conclusion

Hospitals are under severe financial pressure from payers, including Medicare

and HCFA. They are, understandably, looking for ways to cut costs and using reprocessed devices is one of them. However, this practice is, at present, ethically unacceptable because of the severity of potential harm to patients, the lack of knowledge about the probability of disease transmission, and the absence of device-specific

FDA standards for cleaning and resterilizing. It amounts to an extensive medical

experiment without patient benefit, knowledge, or consent.

It may be useful to end with the observation that it is the problem of costs that

is driving the issue of reuse of single-use medical devices. The present arrangements

encourage ethically questionable arrangements because of the pressure to cut costs

of services.

Mr. UPTON. Thank you very much.

Dr. Maurer, welcome.

119

TESTIMONY OF WALTER G. MAURER

Mr. MAURER. Thank you. Mr. Chairman, members of the committee, I am Dr. Walter Maurer, Director of Quality Management

at the Cleveland Clinic Foundation in Cleveland, Ohio. I am here

today on behalf of the American hospital Association. In addition

to being Board Certified and practicing in both the areas of internal medicine and anesthesiology, I serve as Medical Director of the

Office of Quality Management. With approximately 50,000 surgeries and more than 1.5 million outpatient visits yearly, it is my

responsibility to guide and direct our quality management team in

ensuring the highest level of patient care is provided. I also chair

the Quality Council, the Safety Coordinating Committee, and the

Joint Commission Preparation Team.

The term reuse and reprocess can encompass numerous scenarios

and they take place in multiple locations: In hospitals, ambulatory

surgical centers, and physician offices. Some hospitals utilize the

services of third party reprocessors while others reprocess within

their own facilities. In some cases, the device never touches a patient. For example, almost every day at the Cleveland Clinic we

have a surgery cancelled or postponed, sometimes after the operating room has been prepped for the procedure. That preparation

may include assembling customized procedure trays that contain

many open single-use devices, such as needles, scalpels, and syringes. I have with me here today what we term our total hip pack.

This total hip pack costs us $236. I just spent $236. This is medical

trash. Right now this is all thrown away. This is gone.

Another common scenario is the use of a low risk device, one that

does not penetrate a sterile tissue plane or mucus membrane during use, but may simply contact the patient’s skin. For instance,

the device put on a patient’s leg to promote circulation comprised

largely of plastic and fitting like a sleeve over a patient’s leg. Hospitals routinely clean, sterilize, inspect, and repackage these types

of devices. Ironically the most controversial reprocessing practice is

probably the least common for hospitals, that of cleaning, sterilizing, and repackaging a single-use, critical device after it has

been used on a patient. With constrained healthcare resources and

a heightened commitment to the environment, reprocessing does

makes sense.

I need only reiterate the slogans we now teach our children, the

three Rs of reduce, reuse, and recycle. AHA members are committed to being better stewards of the environment by pledging to

reduce, not increase waste. The AHA strongly supports the FDA’s

plan to develop a research program to help bridge the data gap between the perceived and actual safety risks associated with the

reuse of single-use devices. We must move away from anecdotal reports although they are important to look at. Research should be

directed at more complex or high-risk devices and be peer reviewed

and published for credibility. This will provide device specific scientific evidence regarding patient safety. We applaud the FDA’s

plan to develop consensus standards for the reprocessing of singleuse devices. The FDA should include all stakeholders, manufacturers, third party reprocessors, healthcare facilities, physicians, and

members of the public in developing the consensus standards.

120

At the Cleveland Clinic, for example, our cardiology

electrophysiology laboratory reprocesses diagnostic heart catheters.

These are solid tubes without hollow lumens. Each catheter is limited to five uses. First it is thoroughly cleaned by professionals in

sterile processing. It is then tested after each and every use for

electrical and mechanical safety and function and only then resterilized. Each year standard operating procedures are reviewed

and patient outcomes are assessed. The sterilization practices are

regularly reviewed and staff competency assessed. Since 1993 our

lab has had a continuous quality improvement project on any infections caused by any procedures done in that lab. Infection cases are

then reviewed with the Infectious Disease Department.

Additional oversight is provided through existing Federal and

State agencies charged with ensuring safe quality patient care. We

must restore the meaning to the term single-use. Original equipment manufacturers have little to no incentive to label their devices as reusable, and, in fact, have financial incentives to self-designate devices as single-use. In the last 2 years we have observed

products that have been historically labeled as reusable arriving

with the single-use label with no observable change in the product.

These are orthopedic saw blades. Stainless steel. There are no

small lumens in these. This is reusable. This is not. The ones that

we have started to use reprocessors of, I found out, are marked

when they come back. So we know which ones are reusable and

how many times they have been reused.

The FDA should begin to regulate the use of single-use only labels and require manufacturers to both justify labeling a device as

single-use and provide scientific data specifying any re-sterilization

or reprocessing techniques that may compromise the integrity of

the device. In conclusion, Mr. Chairman, patient safety is the first

and foremost concern of all hospitals and health systems. The AHA

believes that the FDA’s proposed strategy on the reuse of singleuse devices represents a thoughtful approach to a complex issue.

And we are pleased that the FDA has been consulting with frontline caregivers and other experts in its effort to make the standards even more meaningful. We further believe that the additional

legislation is unnecessary at this time and would only undermine

the progress that the FDA has already made. We welcome the opportunity to work with the FDA to ensure the best practices are

universally used. Thank you.

[The prepared statement of Walter G. Maurer follows:]

PREPARED STATEMENT OF WALTER MAURER, CLEVELAND CLINIC FOUNDATION, ON

BEHALF OF THE AMERICAN HOSPITAL ASSOCIATION

Mr. Chairman, I am Walter Maurer, M.D., director of quality management at the

Cleveland Clinic Foundation in Cleveland, Ohio. I am here today on behalf of the

American Hospital Association’s (AHA) nearly 5,000 hospital, health system, network, and other health care provider members. We are pleased to have the opportunity to testify on the long-standing practice of reprocessing medical devices.

The Cleveland Clinic Foundation, founded in 1921, integrates clinical and hospital

care with research and education in a private, non-profit group practice. Last year

at the Cleveland Clinic and Cleveland Clinic Florida, more than 850 physicians representing 100 medical specialties and subspecialties provided care for more than 1

million outpatient visits and close to 50,000 hospital admissions.

I have spent most of my career as a private practice internal medicine specialist

and anesthesiologist at the Cleveland Clinic with a focus on outpatient, pediatric,

and ear, nose and throat anesthesia. I also have been involved in resident education,

121

quality assurance and preoperative testing. Currently, I serve as the medical director of the Office of Quality Management. The role encompasses the hospital, its ambulatory settings including community health centers, and a long-term care facility.

With approximately 50,000 surgeries and more than 1.5 million outpatient visits

yearly, it is my responsibility to guide and direct our quality management team in

ensuring the highest level of patient care is provided. I also chair the Quality Council, the Safety Coordinating Committee and the Joint Commission Preparation

Team.

BACKGROUND

The term ‘‘reuse’’ and ‘‘reprocess’’ can encompass numerous scenarios, and they

take place in multiple locations, in hospitals, ambulatory surgical centers and physician offices. Some hospitals utilize the services of third-party reprocessors while others reprocess within their own facilities. In some cases, the device never touches a

patient. For example, almost every day at the Cleveland Clinic we have a surgery

cancelled or postponed, sometimes after the operating room has been prepped for

the procedure. That preparation may include assembling customized procedure trays

that contain many open single-use devices (SUDs), such as needles, scalpels,

sponges and syringes. What becomes of these devices when the surgery is cancelled?

Most of it would be unfortunately wasted as ‘‘medical trash’’, but because of increased environmental concerns and cost reduction initiatives, we have found that

we can safely sterilize, inspect and repackage many devices for later use.

In another scenario, often a manufacturer will ship SUDs to hospitals with separate sterilization instructions, if the manufacturer is experiencing a period of high

demand and has not had time to sterilize the SUDs prior to shipment. Hospitals

sterilize, inspect and repackage these devices too.

Another common scenario is the reuse of a non-critical device-one that does not

penetrate a sterile tissue plane or mucus membrane during use, but may contact

the patient’s skin. For instance, a sequential compression device, which is used on

the patient’s leg to promote circulation and avoid deep vein thrombosis, is comprised

largely of plastics and fits like a sleeve over a patient’s leg. Hospitals routinely sterilize, inspect and repackage these types of devices.

Ironically, the most discussed reprocessing practice is probably the least common

for hospitals: that of cleaning, sterilizing and repackaging a single-use, critical device after it has been used on a patient so it can be used again on another patient.

REPROCESSING MAKES SENSE

Many medical products can be safely reused. The AHA is unaware of any evidence

to demonstrate a problem with reprocessed SUDs. With constrained health care resources and a heightened commitment to the environment, reprocessing makes

sense. I need only reiterated the slogans we now teach our children—that’s the

three R’s—reduce, reuse, and recycle. AHA members are committed to being better

stewards of the environment by pledging to reduce, not increase waste. In 1998, the

AHA and the Environmental Protection Agency initiated a joint-partnership to reduce hospitals’ total waste volume by 50 percent by 2010. Responsible waste management and recent cost reduction initiatives have resulted in the discovery that

hospitals can safely sterilize, inspect, and repackage many devices for later use.

The AHA is encouraged by the Food and Drug Administration’s (FDA) decision

to provide guidance in this area to ensure and enhance patient safety, which is the

first and foremost concern of AHA members. AHA members have a great deal of

experience with reprocessed medical devices and have been working closely with the

FDA as it refines its strategy. We believe that the agency’s Proposed Strategy represents a thoughtful approach to a complex issue; it both echoes and furthers the

goals of patient safety, which we share.

The potential for device malfunctions, patient injuries, or infections related to the

reprocessing and reuse of single-use devices is a matter of great concern to hospitals

and health systems. The AHA strongly supports the FDA’s plan to develop a research program to help bridge the data gap between the perceived and actual safety

risks associated with reuse of SUDs. Such research should be directed at the more

complex or highrisk devices and be peer reviewed and published for credibility. This

will provide device-specific scientific evidence regarding patient safety.

The AHA also is encouraged by the FDA’s proposal to categorize SUDs into risk

categories, and we agree that the level of regulation for a device correspond to the

level of risk to a patient.

Furthermore, the AHA applauds the FDA’s plan to develop consensus standards

for the reprocessing of SUDs. These kinds of standards would go a long way toward

addressing the safety, and effectiveness of reprocessing. The FDA should use a

122

‘‘community best practices’’ approach for low-risk devices and a more formal FDA

interdisciplinary advisory panel for high-risk devices. The FDA should include all

stakeholders—manufacturers, third-party reprocessors, health care facilities, physicians and members of the public—in developing the consensus standards.

OVERSIGHT OF REPROCESSING

Hospitals are subject to significant regulatory and accreditation oversight by entities such as the Health Care Financing Administration, the Joint Commission on

Accreditation of Healthcare Organizations (JCAHO), state licensing authorities, and

other county and city agencies, particularly with respect to patient safety and quality of care. By contrast, only one outside source—the FDA, regulates manufacturers

and third-party reprocessors.

Hospital reprocessing activities are marked by a high degree of physician involvement, supervision and control. In many cases, a multi-disciplinary committee, such

as the infection control committee, consisting of clinical staff (physicians and nurses)

and operational staff (sterile processing, risk management, and materials management) oversees the reprocessing activities of health care facilities. This committee

monitors reprocessing quality assurance and improvement activities, recommends

strategies for improving performance, and reports such findings and recommendations to the facility’s performance improvement oversight committee, medical staff

and governing body.

Through its membership, activities and reporting structure, this type of multi-disciplinary committee meets the requirements of numerous JCAHO standards, including those for surveillance, prevention and control of infection, etc. Naturally, medical professionals and the health care facilities in which they practice have as their

primary mission quality patient care, and have in place standards, policies and procedures for reprocessing.

At the Cleveland Clinic, for example, our cardiology electrophysiology laboratory

reprocesses both non-lumen diagnostic electrophysiology catheters and non-lumen

radiofrequency ablation catheters. Each catheter is used five times or less. It is tested after each use for electrical and mechanical safety and function, and then resterilized. Each year, standard operating procedures are reviewed and patient outcomes

are assessed. The sterilization practices are regularly reviewed and staff competency

assessed. Since 1993 our lab has had a continuous quality improvement project on

any infections caused by any procedures done in the lab. Infection cases are then

reviewed with the Infectious Disease Department.

Reprocessing standards, policies and procedures, in conjunction with the quality

improvement program, are designed specifically to protect the well-being of hospital

patients. Existing nonFDA regulatory oversight, which the AHA believes includes

the components necessary to address and satisfy the FDA’s concerns in this area,

has resulted in the development of these processes.

For instance, JCAHO, during its announced and unannounced surveys, focuses

heavily on patient safety. In addition to visiting patient care and reprocessing areas

to observe infection control practices, JCAHO reviews the minutes of the infection

control committee, the medical staff executive committee, the performance improvement oversight committee and the governing body. The inspectors look for evidence

of sufficient reporting of performance improvement information and for action on

performance improvement recommendations. Failure to adequately demonstrate

compliance in these areas would result in substantial findings of noncompliance for

the facility.

RESTORE MEANING TO THE TERM ‘‘SINGLE USE’’

Original equipment manufacturers have little incentive to label devices as reusable, and, in fact, have financial incentives to self-designate devices as ‘‘single use.’’

Manufacturers appear to use the term ‘‘single use only’’ as part of their labeling

without justifying whether, in fact, the device can be safely reprocessed for subsequent use. In the last two years, we have observed products that have been historically labeled as reusable, arriving with the ‘‘single use only’’ label with no observable change in the product.

We must ensure that the label ‘‘single use only’’ is meaningful and not simply an

attempt to increase device sales. Currently, device manufacturers determine whether a device is labeled ‘‘single use.’’ However, the FDA should begin to regulate the

use of the ‘‘single use only’’ label and require manufacturers to both justify labeling

a device as ‘‘single use’’ and provide scientific data specifying any resterilization or

reprocessing techniques that compromise the integrity of the device. Manufacturers

are the repository for data on the functional specifications of their devices and know

the most about the ability of their devices to hold up to repeated cleanings and steriVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00126 Fmt 6633 Sfmt 6621 E:\HEARINGS\62970 pfrm08 PsN: 62970
123

lizations. They should share that information with those of us who use the devices,

and be actively involved in developing consensus standards.

OPENED BUT UNUSED DEVICES DESERVE SPECIAL TREATMENT

As discussed earlier, it is common practice for hospitals to reprocess open, but unused, SUDs. Many SUDs are routinely opened prior to use and are assembled as

part of customized procedure trays that contain several devices. Sterile processing

professionals assemble, wrap and sterilize these trays, which may consist of singleuse and disposable items. It is essential that hospitals be permitted to open

singleuse devices, combine them with other devices as needed for each medical procedure, and resterilize the entire tray. The creation of these trays in advance of surgeries and other procedures is designed to avoid delays in the surgical suite, create

efficiencies, and prevent subsequent infection during the procedure. Treating this

process as a ‘‘reprocessing’’ activity impedes these efforts.

As I stated earlier, any regulation should reflect the relative risk of the device

involved. Reprocessed devices that have been opened, but not used on a patient, do

not need to be part of the FDA’s guidance. Resterilization and repackaging of such

devices pose virtually no risk for patients.

There are three general areas of risk associated with reprocessing: 1. contamination of the device, if it is not properly cleaned and sterilized, could lead to infection;

2. the cleaning and/or sterilization process could harm the integrity of the device;

and 3. the repeated use of the device in subsequent procedures could harm the integrity of the device.

With respect to unused devices, the third risk is eliminated entirely. A major component of the first risk, patient crosscontamination, is also eliminated. The only possible risks, therefore, are whether the device can be adequately resterilized and if

the process of resterilization somehow harms the device. Hospitals have a great deal

of experience in sterilization of medical devices as sterilization is routinely performed on many types of devices. In fact, as mentioned earlier, it is not uncommon

for manufacturers to ship SUDs to hospitals with separate sterilization instructions.

Therefore, many providers suspect that the ‘‘single use only’’ label and ‘‘do not resterilize’’ instructions are not based on reliable scientific evidence.

CONCLUSION

Mr. Chairman, as we have already noted, patient safety is the first and foremost

concern of all hospitals and health systems. The AHA believes that the FDA’s proposed strategy on the reuse of SUDs represents a thoughtful approach to a complex

issue, and we are pleased that the FDA has been consulting with front-line caregivers and other experts in its effort to make the standards even more meaningful.

This is an important step towards the goal of assuring patient safety. For the sake

of all concerned, we commend the FDA’s efforts to move forward, with all deliberate

speed, to finalize its strategy. We further believe that additional legislation is unnecessary at this time and would only undermine the progress that FDA has already made towards developing a balanced and reasonable regulatory structure. We

welcome the opportunity to work with the FDA to ensure best practices are universally used.

Mr. UPTON. Thank you very much.

Mr. Feltner?

TESTIMONY OF VERN FELTNER

Mr. FELTNER. Good afternoon. The Association of Medical Device

Reprocessors appreciates the opportunity to present testimony regarding the reprocessing of medical devices labeled as single-use.

My name is Vern Feltner. I am President of Alliance Medical Corporation. We are a member of AMDR. AMDR is a trade association

representing the legal and regulatory interests of third party reprocessors of medical devices labeled as single-use. It is estimated

that AMDR members perform approximately 80 percent of the

third party reprocessing done in the United States. AMDR is not

here today seeking exemption from regulation and oversight. In

fact, just to the contrary. AMDR believes that a strong, rational,

FDA regulatory regime is critical to ensuring the safety of reprocVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00127 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
124

essed devices. FDA currently imposes a number of regulatory controls on third-party reprocessors, and membership in AMDR requires compliance with all applicable FDA requirements. In

AMDR’s view, protecting the patient must be of the highest priority, and accordingly FDA regulation of reprocessing must be

based on demonstrated patient safety risk and not on hypothetical

risk designed to provoke public alarm.

Unfortunately much of the opposition of reprocessing comes from

original device manufacturers who view reprocessing as an economic threat, and who stand to reap enormous financial gains by

eliminating reprocessing as an option for hospitals. Their strategy

has been to portray reprocessing as unsafe, but the facts simply do

not support their claim. The truth is that the safety record of reprocessing is excellent. As you will hear, reprocessing enjoys the

support of major hospital and physician groups, and the safety of

reprocessing has been demonstrated in numerous peer review studies and scientific studies. AMDR companies, themselves, have reprocessed over 9 million devices with very few problems. In order

to ensure the safety of their devices, AMDR members adhere to

several important safety principles, including testing every single

device before it is returned to the hospital that requested that reprocess.

The reality is that proper reprocessing of certain medical devices

labeled for single-use is absolutely safe. Manufacturers label devices as single-use, not because FDA requires a single-use designation, but because the manufacturer chooses that label. And what

we have seen again and again is a single-use label being used for

economic reasons as a way to sell more devices, and not out of a

concern for patient safety. Hospitals that discard devices that could

easily be reprocessed, are wasting resources that could be directed

toward improvement in patient access and medical technology.

Mr. Chairman, as I listened to the testimony being given I would

like to take the rest of my short period of time and set the record

straight on a couple issues that I believe are very important. First,

there seems to be a gross impression that the industry is not regulated. Nothing could be farther from the truth. Reprocessors must

comply with FDA QSRs just like manufacturers. The fact is that

FDA does not regulate all medical companies in exactly the same

way. There is a whole industry known as device servicers and refurbishers. FDA considers these companies to be manufacturers,

but pre-market review and compliance with QSRs are not required.

Second, an issue I believe that is most important and certainly of

highest concern to everyone here and that is patient safety.

This is a hard one to say, but there have been documents distributed, even to members of this committee that at best are misleading and disingenuous. At worst blatant untruths. There have

been articles commissioned and published insinuating that multitudes of patient injuries due to the use of reprocessed devices are

labeled as single-use, and that patient safety lies in using only the

new devices. Facts are stubborn things, and the facts expose the

disingenuous nature of these accusations. Public records solidly

promote the efficacy and safety of commercially reprocessed devices. As a matter of comparison between AMDR companies and

just four device manufacturers, the four that happen to be so

125

1See ‘‘America’s Best Hospitals,’’ U.S. News & World Report, July 19, 1999, at 61.

strongly fighting our industry, the facts state this. In the reporting

period from January 1997 to March 1999, 27 months, there were

three medical device reports filed concerning devices reprocessed by

AMDR companies. In the same reporting period for just these four

device manufacturers, there were in excess of 16,000 medical device reports filed, 11,827 product malfunctions reported, 2,508 patient injuries recorded, and a very unfortunate number of 163

deaths associated with the new products. Now, everyone knows

that the delivery of healthcare is not risk free. Not for one moment

am I suggesting that any of these companies market inherently unsafe products. These are good companies, good histories, made up

on the most part of good and caring people. But the facts remain

that in the 12 year history of the reprocessing industry, there

shows an excellent record, whether you judge it on its own or

whether you compare it to the OEM industry segment. I thank you

for your time.

[The prepared statement of Vern Feltner follows:]

PREPARED STATEMENT OF THE ASSOCIATION OF MEDICAL DEVICE REPROCESSORS

The Association of Medical Device Reprocessors (AMDR) appreciates the opportunity to present testimony regarding the reprocessing of medical devices labeled for

single-use. My name is Vern Feltner, and I am President of Alliance Medical Corporation. AMDR is a trade association representing the legal and regulatory interests of third-party reprocessors of medical devices labeled for single-use. It is estimated that AMDR members perform approximately 80 percent of the third-party reprocessing done in the United States. Members of AMDR serve a nationwide customer base of hospitals and outpatient surgery centers, and reprocess a limited set

of devices in several clinical areas, including perioperative, cardiology, orthopedics,

patient floor, and respiratory therapy. AMDR companies contract with hospitals in

all 50 states, and reprocessing takes place in many of the elite hospitals of our nation.1 AMDR companies very likely work with hospitals in the districts of many Subcommittee members.

AMDR is not here today seeking exemption from regulation and oversight. To the

contrary, AMDR and the reprocessing industry can only survive in a clear, rational

regulatory scheme. It is important, however, that any regulatory scheme be based

on demonstrated public safety risks and not on hypothetical risks designed to provoke public alarm. This industry is made up of people who are doctors, nurses, parents, husbands, and wives. Our families are the very ones on whom reprocessed devices will be used. If there was truly a question of increased risk to patients and,

therefore, to our families, we would not be in this business. The hospitals we serve

are populated by doctors who live and work under the Hypocratic Oath, which is

based upon the premise that patient safety must come first. In fact, the reprocessing

industry came to be as a direct result of doctors who saw the need for reprocessing.

Yes, we are a business, and yes, hospitals have bottom-lines, but that does not mean

that our motives are suspect or that reprocessed devices are inherently unsafe. All

businesses have bottom lines. AMDR members stand committed to complying with

all Food and Drug Administration (FDA) requirements applicable to third-party reprocessing. It is in AMDR’s best interest to ensure that reprocessing is a safe, rationally regulated practice that hospitals can utilize to conserve health care resources without compromising patient care.

I. HISTORY AND BACKGROUND

Over Two Decades of Successful Reprocessing. From the recent press and congressional interest, one might believe that reprocessing of medical devices labeled for

single-use is new, uncharted territory. One might also assume that reprocessing is

a haphazard practice applied indiscriminately to a garden variety of medical devices. In fact, these assumptions are entirely false. The reprocessing of certain medical devices labeled for single-use has taken place for over two decades. The American Hospital Association (AHA) calls reprocessing of ‘‘single-use’’ devices ‘‘a safe

and standard medical practice’’ that hospitals have used ‘‘for years with excellent

126

2See Attachment A for these letters. 3 All AMDR companies have been inspected by FDA in the last 12 months.

success.’’ The American College of Cardiology wrote to Congress that ‘‘there are cardiovascular specialists who have been using reprocessed catheters in their labs for

more than 20 years and cannot cite a single instance where a reprocessed catheter

has broke[n] or caused infection.’’ And the Mayo Clinic states that ‘‘for more than

20 years, the catheters used in electrophysiology procedures have been reprocessed

at Mayo and have continued to function normally without any evidence of infection.’’ 2

Hospitals originally began to reprocess for two reasons: 1) certain devices initially

labeled ‘‘reusable’’ were switched to ‘‘single-use’’ without any structural change in

the device; and 2) doctors and nurses recognized the inherent waste in discarding

certain devices after one use. The single-use designation is not based on a determination by FDA. To the contrary, the single-use label is chosen by the original

equipment manufacturers (OEMs), and, for many devices, the single-use designation

is a marketing decision, not a safety decision. AMDR believes that much of the attack on the reprocessing industry is also based on marketing concerns, not true safety concerns. The math is easy—the more devices that are reprocessed, the fewer

brand-new devices are purchased, and that much less money is made by manufacturers.

Making the Decision to Reprocess. Hospitals do not reach the decision to reprocess

lightly. Rather, they rely on committees made up of physicians, nurses, sterile processing professionals, infection control specialists, risk managers, and hospital lawyers to determine whether a specific device can and should be reprocessed. At each

AMDR company, the specific devices are carefully scrutinized in order to determine

whether they can be safely and effectively reprocessed. Because of this rigorous selection process utilized by hospitals and third-party reprocessors, only a small percentage of the thousands of medical devices used by hospitals are actually reprocessed.

II. THIRD-PARTY REPROCESSING IS AN FDA-REGULATED INDUSTRY

In the past, manufacturers have claimed that third-party reprocessing is an ‘‘unregulated’’ industry. The fact is that third-party reprocessors are currently required

to comply with a number of FDA regulatory requirements, the most significant of

which is the Quality System Regulation. The Quality System Regulation is an extensive set of quality assurance provisions governing every aspect of a reprocessor’s

operations, including production and process controls, process validation, control of

non-conforming product, and finished device acceptance. Pursuant to these Quality

System Regulation requirements, third-party reprocessors must: (1) control and

monitor production processes to ensure that a device conforms to its specifications;

(2) validate with a high degree of assurance that their reprocessing processes ensure

that specified requirements are met; and (3) establish and maintain procedures for

reprocessed device acceptance to ensure that each production run, lot, or batch

meets acceptance criteria. See 21 C.F.R. Part 820. In other words, reprocessors must

document that they have developed comprehensive systems to assure that a reprocessed device is clean, sterile, and able to perform its originally intended clinical

function. The functional testing step of reprocessing differs significantly from the

testing performed by device manufacturers: AMDR companies functionally test every

single reprocessed device before sending it back to a hospital, whereas device manufacturers test only a small sampling of their finished devices.

Third-party reprocessors must make all required Quality System Regulation information and data available for FDA inspection 3, and firms that fail to comply with

these requirements are subject to agency enforcement action. In addition to complying with Quality System Regulation requirements, third-party reprocessors also

are required to: (1) register with the agency; (2) comply with FDA labeling controls;

(3) and adhere to Medical Device Reporting (MDR) regulation requirements. Pursuant to MDR requirements, third-party reprocessors must report to FDA certain device malfunctions and device-related patient adverse events.

AMDR members reprocess three broad categories of medical devices labeled for

single-use: 1) opened devices that have never been used; 2) unopened devices whose

expiration date has passed; and 3) previously utilized devices. All three of these categories are reprocessed in compliance with the rigorous quality assurance requirements contained in FDA’s Quality System Regulation.

127

4See Attachment A. 5Letter from Dana Gruber, Chief, Infection Control Service, Brooke Army Medical Center, to

William B. Stoermer, Jr., Executive Vice President, Alliance Medical Corporation (December 29,

1999). See Attachment B.

III. THE MANUFACTURERS’ ALLEGATIONS ARE BASED ON ONE OVERRIDING CONCERN:

ECONOMICS

Manufacturers Want to Erect Economic and Regulatory Barriers to Market Competition. In AMDR’s view, there exists little, if any, factual basis for the vast majority of objections to third-party reprocessing. The major medical device manufacturers have embarked on a crusade at the federal and state level to eliminate thirdparty reprocessing. This is not a surprise. Hospitals are fully aware that the ‘‘singleuse’’ label on a medical device does not necessarily mean that it should be discarded

after one use. As the AHA noted, ‘‘In our view, the real issue is not whether reuse

is appropriate, but whether the single-use label is a complete and accurate representation of the device.’’ 4 For hospitals, proper reprocessing offers a way to maintain

the highest quality patient care, while also achieving significant cost savings.

Reprocessed Devices are More Affordable, and Market Competition Exerts Downward Pressure on the Price of New Devices. It is clear that third-party reprocessing

represents a potentially formidable economic threat to manufacturers. A future

where hospitals no longer needlessly discard certain devices labeled for single-use

could, ultimately, mean a future of lower profits for manufacturers. The fact is that

reprocessing has already had a substantial impact on the sales and profits of device

manufacturers. Indeed, every time a hospital chooses to reprocess a device rather

than purchase a new device, that means a lost sale for manufacturers. In addition,

in an effort to persuade their customers not to reprocess, manufacturers have lowered the price of their devices. Lower prices generally mean lower profits.

The experience of one hospital that utilizes third-party reprocessing services is

particularly telling. EP Technologies, Inc., a division of Boston Scientific Corporation, informed the hospital that it

would be willing to supply [the hospital] with new catheters at the price of each

returned catheter, if I (the hospital’s Chief of Infection Control Service) would

stop reprocessing... Being dumbfounded with this offer for cutting the price in

half for each new catheter, I immediately asked her (the E.P. Technologies representative) where her integrity was with keeping the price so high all this

time? She had no answers.5

Not surprisingly, the device manufacturers fail to acknowledge that their opposition

to third-party reprocessing is rooted in economics. Rather, they repeatedly assert

that their primary motivation is patient safety. While emotionally appealing, the

manufacturers’ professed interest in patient safety is disingenuous at best, misleading at worst. As set out below, third-party reprocessing is a safe, federally-regulated industry. When performed properly, third-party reprocessing poses no threat

to patient safety.

A. Manufacturers Frequently Designate a Device As ‘‘Single-Use’’ For Economic Reasons, Rather Than Out Of Concern For Patient Safety

FDA does not require manufacturers to designate certain devices as ‘‘single-use’’

only. There are no FDA regulations or formal standards distinguishing the quality

or functionality of reusable devices from single-use devices. The discretion to label

a device as single-use lies solely with the device manufacturer.

The ‘‘Single-Use’’ Label Provides Little Indication of the Product’s Useful Life. The

device manufacturers have repeatedly contended that devices labeled for single-use

must be discarded after one use because they are manufactured in such a way that

makes reuse prohibitive. As a practical matter, however, it is nearly impossible to

manufacture a medical device for ‘‘one use and only one use.’’ For example, a surgical instrument labeled for single-use does not ‘‘wear out’’ simply because it was

used in a surgical case that took three hours rather than two hours. Likewise, it

is absurd to suggest that if a scissor labeled for single-use is utilized to snip only

once in a surgical case, then its entire useful life has been exhausted. In reality,

a manufacturer’s ‘‘single-use’’ designation on a medical device provides little indication of the product’s useful life. The ‘‘single-use’’ designation more often than not

reflects a manufacturer’s decision to market a product that will lead to a needless

waste of scarce health care resources. The key issue should be the device’s

functionality. If a device labeled for single-use can be properly cleaned, packaged,

and sterilized without negatively affecting its functionality, it can, and should, be

used again.

128

6 AMDR members do not reprocess contact lenses.

7Transcript of December 11, 1998, Dateline episode at 5 (emphasis added). 8See Attachment C. 9See Attachment D. 10 Josephine Torrente, President, Association of Disposable Device Manufacturers, testimony

to Illinois State Board of Health Board Meeting and Public Hearing Regarding the Reprocessing

of Medical Devices Labeled for Single-Use, December 10, 1998. 11Letter from David W. Feigal, Director, Center for Devices and Radiological Health, FDA,

to Larry R. Pilot, McKenna & Cuneo. See Attachment E. 12Lauran Neergaard, Debate on Reuse of Medical Devices, Associated Press, August 13, 1999. 13Device & Diagnostics Letter, Vol. 26, No. 48 (Dec. 17, 1999) at 1.

Evidence that manufacturers often designate devices as single-use for economic

reasons, rather than out of a concern for patient safety, is abundant. For example,

the December 11, 1998, episode of NBC’s ‘‘Dateline’’ exposed Johnson & Johnson’s

practice of labeling as ‘‘single-use’’ contact lenses 6 that were virtually identical to

the lenses that the company had been marketing as reusable. Thus, consumers were

needlessly discarding lenses after one use. When asked why it had designated the

lenses as single-use, Johnson & Johnson stated: ‘‘If we had changed the label and

marketed for general use, then we couldn’t advertise and create this single-use,

daily disposable category. We made that decision because we felt it was a good business decision to do it that way.’’ 7

Another example is a letter written by USCI Cardiology & Radiology Products

(USCI) to a hospital explaining that, although USCI had decided to change the label

on a particular device from reusable to single-use, it had made no structural

changes to the device. Specifically, USCI stated: ‘‘[O]ur manufacturing processes of

Woven Dacron Intracardiac Electrodes have not changed. These electrodes are made

with the same materials and in the same manner they have been in the past.’’ 8 In

another example, Microvasive, a division of Boston Scientific Corporation, advised

hospitals that, although Microvasive’s hemostatic probes are labeled for single-use

only, they may be reused under certain circumstances. Specifically, the Microvasive

notice states: ‘‘BICAP Hemostatic Probes are recommended for single-use only.

However, this recommendation does not prohibit reuse under certain specific conditions . . .’’ 9

In light of the above evidence, the manufacturers’ protestations that the singleuse designation on a device is never arbitrary, and that ‘‘economics must be subordinate to this concern for proper health’’ 10 ring hollow. The reality is that some devices that carry a single-use label are suitable for reprocessing, and many are not.

Every product—whether it is labeled ‘‘single-use’’ or ‘‘reusable’’— must be assessed

individually to determine whether it can be cleaned, packaged, and sterilized without impairing functionality. Hospitals, and their doctors and nurses, should not be

forced to needlessly discard devices labeled for single-use that could be safely reprocessed. Hospitals should be free to redirect their limited resources where they are

truly needed—toward improvements in patient access and medical care.

B. When Done Properly, Third-Party Reprocessing Is Safe

The most frequently levied allegation in the manufacturers’ arsenal of scare tactics is that third-party reprocessing is unsafe. There simply is no factual basis for

this claim. The manufacturers cling desperately to this argument as a way to disguise what is, for them, an economic issue. The facts are as follows: AMDR member

companies have collectively reprocessed over 9 million devices labeled for single-use

with very few problems.

Indeed, FDA itself recently stated that it ‘‘has been unable to find clear evidence

of adverse patient outcomes associated with the reuse of a single-use device from

any source.’’ 11 Similarly, a physician with the Centers for Disease Control and Prevention remarked that he ‘‘would just be absolutely amazed if [reprocessing] is a

major health problem and the [leading hospitals] have failed to realize it.’’ 12

1. The Safety Record Of Reprocessed Devices Is Excellent—As Demonstrated By The

Handful Of MDRs And As Compared To The OEM Record

Based on FDA’s own database of device-related patient adverse events, the safety

record of reprocessing is excellent. Pursuant to the agency’s MDR regulation, hospitals must notify FDA when they learn that a device may have caused or contributed to a patient death or serious injury. 21 C.F.R. § 803.30. Every year, FDA receives over 100,000 MDR reports. Significantly, there have been only a handful of

MDR reports associated with reprocessed devices. Indeed, FDA itself recently remarked that the number of MDR reports involving reprocessed devices is ‘‘tiny’’

compared with other problems.13 Furthermore, the incidents reported in the few

MDRs involving reprocessed devices are identical to problems that have occurred in

129

14 As one example, an MDR report was submitted to FDA concerning a reprocessed

electrophysiology (EP) catheter whose tip became detached. MDR Report Number 1062310-1999-

00001. See Attachment F. However, the identical incident has been reported for new EP catheters. MDR Report Numbers 4501350000-1995-0088 and 6000087-1998-00002. See Attachment

G.15See Attachment H. 16See, e.g., Lance Williams, ‘‘Common thread in illnesses: sutures lawsuits blame postsurgical

infections on a single source,’’ San Francisco Examiner (Feb. 21, 1999); Lance Williams, ‘‘Patients wounded by infections across the country, lives have been torn by post-op complications,’’

San Francisco Examiner (Feb. 21, 1999); Lance Williams, ‘‘How suture maker kept lid on infection suits despite recall, Ethicon said product was harmless,’’ San Francisco Examiner (Feb. 22,

1999); Lance Williams, ‘‘Patients who suffered,’’ San Francisco Examiner (Feb. 22, 1999). 17See, e.g., FDA Enforcement Reports 94-43 & 95-08. 18See, e.g., Ronald Rosenberg, ‘‘Boston Scientific, FDA spar over stent,’’ The Boston Globe (October 10, 1998). 19FDA’s Center for Devices and Radiological Health issued 303 Warning Letters in 1999. See

www.fda.gov/foi/warning.htm and Thompson.com, an FDA Warning Letter Monitor. 20See Regulatory Procedures Manual at Ch. 4; FDA Office of Regulatory Affairs Warning Letter Reference Guide (October 4, 1994) at p.14. 21 As an example, we are including an FDA letter issued to an AMDR member company indicating that, in FDA’s view, the concerns raised in the Agency’s Warning Letter had been adequately addressed. See Attachment I.

new devices. Thus, it is not at all clear that these incidents were caused by reprocessing.14

There are Thousands of MDR Reports on Brand New Devices Each Year. The

OEMs have made much noise about the handful of MDRs on reprocessed devices.

Attached to my testimony is a chart of some of the MDRs for the few companies

leading the attack on reprocessing. From January 1997 to March 1999, a 27-month

period, Boston Scientific companies had a total of 2,396 MDRs. This number includes 874 injuries and 50 deaths. Johnson & Johnson companies had 11,327 MDRs,

including 1,239 injuries and 58 deaths. Mallinckrodt companies had 1,755 MDRs,

including 90 injuries and 47 deaths. Tyco companies had 552 MDRs, including 305

injuries and 8 deaths.15

As you can see, there are numerous examples of medical devices causing patient

injury during their first use. For example, a 1994 outbreak of post-surgical infections has been attributed to bacteria-contaminated sutures manufactured by

Ethicon, Inc. (Ethicon), a division of Johnson & Johnson. The contamination allegedly resulted from a malfunction in Ethicon’s sterilization system.16 Ethicon ultimately recalled 3.6 million packages of sutures.17 As another example, FDA recently

found that an improperly functioning coronary stent system manufactured by Boston Scientific Corporation had caused 26 patient injuries, and may have been a factor in the death of one individual. Boston Scientific Corporation is engaged in a recall of the defective stents.18 We cite these examples to show that the use of medical

devices is not and will likely never be 100% problem-free. That said, the reprocessing industry believes that having one injury is still one injury too many, and we

will continue to strive to make our services as safe as possible.

2. The Warning Letters Received By Certain Third-Party Reprocessors Do Not Constitute Evidence That Third-Party Reprocessing Is Unsafe

The device manufacturers also cite FDA Warning Letters received by certain

third-party reprocessors as evidence that third-party reprocessing is unsafe. Once

again, the manufacturers are not applying their own logic to themselves. While it

is true that some third-party reprocessors have been issued FDA Warning Letters,

most, if not all manufacturers have also received FDA Warning Letters. Indeed,

FDA often issues Warning Letters to device manufacturers.19

By way of background, a Warning Letter is based upon an FDA inspector’s

inspectional observations and is not independently verifiable by a court or other impartial finder of fact. A Warning Letter is informal and advisory, and constitutes

only an FDA communication that the Agency considers a violation to exist.20 Typically, the company in question addresses the concerns raised in the Warning Letter,

and FDA re-inspects the facility to ensure that any necessary changes have been

made.21

By failing to frame FDA Warning Letters in their proper perspective, and by

choosing not to disclose that manufacturers themselves often receive Warning Letters, the manufacturers clearly hope to create the impression that FDA has singled

out third-party reprocessors for some sort of special scrutiny. This is not the case.

Actually, a discussion of our receipt of Warning Letters helps prove our case—that

reprocessors are subject to FDA oversight, that oversight is active even as we sit

here. Also, what is important is that the Warning Letter recipient take the approVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00133 Fmt 6633 Sfmt 6621 E:\HEARINGS\62970 pfrm08 PsN: 62970
130

22See Attachment J for a bibliography and summary of these studies. 23 R.A. Kozarek, M.D., S.L. Raltz, R.N., M.S.N., T.J. Ball, M.D., J.J. Brandabur, M.D., ‘‘Reuse

of disposable sphincterotomes for diagnostic and therapeutic ERCP; a one-year prospective

study.’’ Gastrointestinal Endoscopy, Vol. 49 (1999) at 39. 24S.K. Roach, R.A. Kozarek, M.D., S.L. Raltz, R.N., M.S.N., and S.E. Sumida, Ph.D., ‘‘In Vitro

Evaluation of Integrity and Sterilization of Single-Use Argon Beam Plasma Coagulation Probes,’’

The American Journal of Gastroenterology, Vol. 94 (1999) at 139. 25 E.V. Platia, M.D., S. O’Donoghue, ‘‘Reuse of Pacing Catheters: a Survey of Safety and Efficacy,’’ PACE, Vol. 11 (Sept. 1988) at 1280.

priate steps to address the agency’s concerns. While AMDR members have full confidence in the safety and efficacy of their operations, they recognize that there is

always room for improvement, and they welcome FDA’s input in this regard. But,

if the suggestion that receipt of Warning Letters means that reprocessed devices are

inherently unsafe, then brand new devices should also be considered inherently unsafe. We do not believe this line of thinking is logical and urge the manufacturers

to be consistent in their application of the facts.

3. A Substantial Body Of Peer-Reviewed Scientific Literature Demonstrates The Safety Of Reprocessing

Physician and hospital groups have articulated strong support for reprocessing.

There is also a significant body of independent, peer-reviewed scientific literature

confirming the medical community’s confidence in the safety of reprocessing devices

labeled as single-use. Indeed, studies demonstrating the safety and efficacy of reprocessing have been published in a number of highly esteemed medical journals,

including Gastrointestinal Endoscopy, The American Journal of Gastroenterology,

Journal of the American College of Cardiology, Journal of Thoracic Cardiovascular

Surgery, Pacing and Clinical Electrophysiology (PACE), American Journal of Cardiology, Medical Journal of Australia, Canadian Journal of Surgery, and Canadian

Journal of Cardiology.22

As one example, Dr. Richard Kozarek, Chief of Gastroenterology at the Virginia

Mason Medical Center in Seattle, Washington, and former President of the American Society for Gastrointestinal Endoscopy, has conducted a number of independent

studies demonstrating the reusability of certain endoscopic accessories. In the area

of sphincterotomes labeled as single-use, for instance, Dr. Kozarek found that

‘‘[d]ouble channel sphincterotomes marketed as one-time-use items can be reused

safely when properly cleaned.’’ 23 Likewise, with respect to argon beam plasma coagulation (APC) probes labeled for single-use, Dr. Kozarek concluded:

The combination of manual cleaning and ETO sterilization consistently cleaned

APC probes. Ninety percent of the probes showed no sign of physical deterioration and 100% maintained their electrical activity after 10 uses. APC probes can

potentially be safely and effectively reused up to 10 times, and a significant procedural savings is possible with reuse.’’ 24

As another example, Dr. Edward V. Platia, a nationally recognized

electrophysiologist at the Washington Hospital Center in Washington, D.C., conducted an extensive multi-center study of the reuse of electrophysiology (EP) catheters, involving 14,640 EP cases and 48,075 catheter uses. Dr. Platia concluded that:

the sterilization and reuse of non-lumen, woven Dacron pacing catheters is safe,

and does not appear to result in any increase in the risk of infection. The catheters are sufficiently durable to allow them to be reused well in excess of five

times. One-time use of such catheters appears to be an unnecessary and expensive policy.25

What is, perhaps, most striking about the rigorous body of scientific evidence supporting the safety and efficacy of reprocessed devices is its dramatically superior

quality, as compared to the ‘‘studies’’ offered by the OEMs that oppose reprocessing.

Indeed, most of the ‘‘scientific evidence’’ submitted by the opponents of reprocessing

should be disregarded, as: (i) much of it was conducted by the OEMs themselves,

rather than independent entities, and, as such, is tainted by the OEMs’ clear economic incentive to portray reprocessing in a negative light; and (ii) much of it is

plagued by fundamental scientific deficiencies, such as lack of an adequate sample

size, and, as a result, cannot serve as a basis for any conclusions about the safety

of reprocessed devices.

4. Tracking And Tracing Systems For Reprocessed Devices Help Ensure Accountability And Safety

Third-party reprocessing is not conducted in a black hole where no one is accountable. There are several steps taken to ensure appropriate tracking and tracing of

each device. Once a hospital makes a determination that a specific type of device

can be reprocessed, AMDR members pick up a batch of the devices from the hosVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00134 Fmt 6633 Sfmt 6621 E:\HEARINGS\62970 pfrm08 PsN: 62970
131

pital, reprocess those devices, and return the same devices to the hospital. AMDR

members also ensure that there are numerous ways to determine whether a device

was reprocessed and to identify who the reprocessor was. For example, some reprocessors employ bar code tracking systems, which allow devices to be tracked back to

the reprocessor. Likewise, some reprocessors provide hospitals with ‘‘peel-off’’ labels,

which can be placed in a patient’s record to identify where the device was reprocessed. Therefore, it is quite easy for a doctor and a hospital to know if a reprocessed

device was used and to identify who the third-party reprocessor was.

5. Proper Reprocessing Does Not Require Access To The Manufacturer’s Specifications

One the most misleading arguments made by the manufacturers is that thirdparty reprocessors are incapable of safely reprocessing devices labeled for single-use

because they lack access to the original manufacturer’s specifications. The assertion

that the manufacturer’s specifications are required to reprocess most devices is misleading.

Access to manufacturers’ specifications is unnecessary because third-party reprocessors employ a variety of techniques to equip themselves with intimate knowledge

about the workings of every device they reprocess. For example, in addition to utilizing every publicly available source of product-related information, e.g., product labeling, marketing materials, AMDR members also use independent laboratories to

‘‘reverse engineer’’ certain devices. In addition, AMDR member companies are engaged in an ongoing dialogue with the clinical users themselves, i.e., the hospitals

and physicians, in order to understand the performance requirements for each device they reprocess.

More importantly, AMDR member companies have developed validated protocols

to ensure that every device they reprocess is safe and effective for its intended use.

If an AMDR member lacks sufficient information about a device in order to safely

reprocess it, then that device will not be reprocessed. Furthermore, as described

above, AMDR members—unlike manufacturers—perform functionality testing on

every single device that they reprocess. Thus, the manufacturers’ argument that access to the original specifications is necessary to safely reprocess devices labeled for

single-use is without merit. Indeed, if the manufacturers were correct in this

claim—and they are not—it certainly is difficult to understand why so many hospitals and doctors’ groups have endorsed the use of reprocessing.

IV. THE MANUFACTURERS’ CALL FOR ‘‘INFORMED CONSENT’’ IS SIMPLY ANOTHER PRONG

OF THEIR ECONOMIC ARGUMENT

As part of their campaign to create an ‘‘aura’’ of suspicion around third-party reprocessing, the manufacturers argue that the very doctors committed to treating

and curing the sick are keeping patients ‘‘in the dark’’ about the alleged hazards

of third-party reprocessing. Indeed, the manufacturers advocate vociferously for

mandatory ‘‘informed consent’’ regarding the use of reprocessed devices.

Although dressed up in the garb of patient safety, the manufacturers’ informed

consent argument is merely another prong of their economic agenda. Medical

ethicists state that the objective of informed consent is to arm patients with sufficient information to make a prudent judgment about their medical care. If a physician believes that the use of a certain device or procedure will increase a patient’s

risk, then the physician should disclose this to the patient. Properly done, thirdparty reprocessing presents no additional risk to patients. Because properly reprocessed devices are as safe and effective as new devices, there is no ethical basis for

requiring informed consent before the use of reprocessed devices.

Should There be Informed Consent for New Devices? It is striking that, although

they push vigorously for informed consent with respect to the reprocessing of devices

labeled for single-use, the manufacturers conspicuously avoid the obvious implications of their own argument. According to the manufacturers’ thinking, a physician

should tell a patient before using any device that has been the subject of an MDR

report, Warning Letter, or recall. Similarly, it seems only logical that the manufacturers would demand informed consent with respect to the ‘‘second use’’ of devices

that are labeled reusable. The manufacturers do not make these arguments because

they realize that informed consent regarding MDR reports, Warning Letters, and recalls would be detrimental to their own economic interests.

V. CONCLUSION

As we have demonstrated, when performed properly third-party reprocessing is

safe. Third-party reprocessors are required to comply with a host of FDA requirements. Hospitals that take advantage of the benefits of third-party reprocessing can

132

maintain the highest quality patient care, while also achieving significant cost savings. Resources saved through third-party reprocessing can be redirected toward improvements in patient access and medical technology. We believe that patient safety

is of utmost concern, but health care cost containment is also of extreme importance. In this age of rising health care costs, reprocessing is one of the few technologies that offers a solution.

133

134

135

136

137

138

139

140

141

142

143

144

145

146

147

148

149

150

151

152

153

154

155

Mr. Upton. Thank you.

Dr. Trotter?

TESTIMONY OF C. GRIFFIN TROTTER

Mr. TROTTER. Thank you. I am Griffin Trotter. I am an Assistant

Professor of Ethics and an Assistant Professor of Surgery at Saint

Louis University, Sciences Center. As a matter of record, I am not

representing any particular organization and have not received an

honorarium for this appearance. However, the Association of Medical Device Reprocessors has covered my travel and my lodging expenses. As an emergency physician and medical ethicist, my expertise is in general ethical and clinical considerations. I am not an

expert in the reprocessing of medical devices, and hence will confine my comments about safety issues to general remarks concerning clinical risks and the moral requirement for informed consent.

In clinical medicine, healthcare providers are morally obliged to

disclose significant risks pertaining to any treatment, test, or procedure that they have recommended or intend to undertake. Determining which risks count as significant for the purposes of disclosure is an important clinical challenge that is widely addressed by

the use of a material risks standard. Risks are material when they

are likely to be relevant to the decisions of reasonable patients.

When risks are very remote, disclosure is not required and, in fact,

may even detract from informed consent by inducing unreasonable

fears. Physicians or other clinicians are generally the individuals

who bear the task of disclosing risks. However, in an age of managed care, many decisions governing the practice of medicine and

its attendant risks, are determined at an institutional level. In

such instances, the moral obligation for obtaining informed consent

may shift away from the individual clinician to the institutional

provider.

156

For example, an institution that reprocesses the contents of its

suture kits may have a moral responsibility to inform clients of

thispractice, if, indeed, it was determined that the use of these kits

poses a significant risk. One problem is that it is not clear whether

the material risk standard applies or even makes sense at this

level. Informed consent in this context pertains not so much to decisions about specific treatments or procedures, but to patient’s decisions about whether or not they want to subscribe to a given

healthcare plan. The likely risk pertaining to the use of a reprocessed single-use medical device will vary depending on the nature

of the device, the previous use of the device, the reprocessing method, and the proposed manner in which the device will be reused.

These variations, along with the aforementioned intricacies that

pertain to the material risk standard, make it very difficult to articulate a uniformed requirement for informed consent. However, if

standards for reprocessing medical devices are sufficiently rigorous

to ensure that these devices may be used safely, then there is no

more requirement for informed consent.

My opinion is that if the use of reprocessed single-use medical

devices is not safe, then these devices simply should not be used.

Ensuring that the devices are safe is a far better strategy than legislating burdensome requirements for informed consent that would

amount to one more bureaucratic obstacle to the provision of a

swift, efficient, and effective response to our patients’ needs. Thank

you.

[The prepared statement of C. Griffin Trotter follows:]

PREPARED STATEMENT OF C. GRIFFIN TROTTER, CENTER FOR HEALTH CARE ETHICS, SAINT LOUIS UNIVERSITY

SUMMARY

In clinical medicine, health care providers are morally obliged to disclose significant risks pertaining to any treatment, test or procedure that they have recommended or intend to undertake. The determination of which risks count as ‘‘significant’’ for the purposes of disclosure is an important clinical challenge that is

widely addressed by the use of a ‘‘material risks’’ standard. Risks are material when

they are likely to be relevant to the decisions of reasonable patients. Physicians or

other clinicians generally disclose these risks. However, in some cases it may be

more appropriate if institutions obtain informed consent. If use of reprocessed single-use medical devices was shown to be risky, then hospitals or other corporate providers who systematically use these devices have a moral obligation to inform their

clients of this practice. On the other hand, when risks are very remote, disclosure

is not required and, in fact, may even detract from informed consent by inducing

unreasonable fears.

The likely risks pertaining to the use of a reprocessed single-use medical device

will vary, depending on the nature of the device, the previous use of the device, the

reprocessing method and the proposed manner in which the device will be reused.

These variations make it difficult to articulate a uniform requirement for informed

consent. However, if standards for reprocessing medical devices are sufficiently rigorous to ensure that these devices may be used safely, then there is no moral requirement for informed consent.

In assessing the relevant scientific data pertaining to the reuse of single-use devices, objective sources (such as the FDA and the CDC) are preferred over other

sources (such as original equipment manufacturers, reprocessors and even the news

media) that have important financial interests hinging on the interpretation of this

data.

Health care policy concerning the use of reprocessed single-use devices should be

guided by the Principle of Subsidiarity, which implies that regulatory authority and

action should be concentrated at the lowest hierarchical level of government where

there is sufficient competence. This principle points, once again, to the importance

of garnering advice from important regulatory agencies such as the FDA.

157

WRITTEN STATEMENT

Mr. Slobodin has asked me to testify about safety and policy issues associated

with the use of reprocessed single-use medical devices (abbreviated ‘‘RSUDs’’ in subsequent text). As a physician and medical ethicist, my expertise is in general ethical

and clinical considerations that may pertain to the use of these devices. I am not

an expert in the reprocessing of medical devices and, hence, will confine my comments about safety issues to general remarks concerning clinical risks and the

moral requirement for informed consent.

Valid informed consent consists of three elements: disclosure, understanding and

voluntariness. Disclosure involves the relay of relevant information (risks, anticipated benefits, costs and alternatives) about recommended medical interventions to

medical decision-makers (i.e., patients or patients’ proxies). Understanding involves

the ability of medical decision-makers to grasp the disclosed medical information

and to deliberate about choices in a manner that integrates this information with

the patient’s goals and values. Voluntariness is freedom from undue constraint.

Undue constraints include various forms of coercion, as well as emotional and social

constraints that hinder reasonable decisions.

If the proposed use of a RSUD bodes a significant risk, then this risk should be

disclosed to patients. Various standards for what ought to count as a ‘‘significant

risk,’’ requiring disclosure, have been offered. In a landmark 1972 U.S. Circuit

Court decision, Judge Spotswood G. Robinson articulated the ‘‘material risk’’ standard. According to this standard (which is now widely accepted) all material risks

should be disclosed. A risk is material ‘‘when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach

significance to the risk or cluster of risks in deciding whether or not to forgo the

proposed therapy.’’ Robinson held that serious complications that occurred in less

than 1% of cases were generally not material risks.

Robinson’s 1% standard probably does not apply for risks that could be easily

avoided. Hence, even a 0.2% additional risk posed through the use of reprocessed

medical devices may be material if the complications in question are serious and

new devices are readily available and affordable. The rationale for requiring a higher standard of disclosure in such instances would be that the risks are clinically unnecessary. Where to draw the line for disclosing such risks is debatable, and our

ultimate decision will of necessity be somewhat arbitrary (just as the standards of

statistical significance that we use in estimating risk are themselves somewhat arbitrary).

Saving money is not an adequate reason for foregoing disclosure, unless there is

an agreement (tacit or explicit) between patient and provider that the provider may

pursue cost savings whenever the risks do not exceed a certain (more generous)

threshold. The degree to which such tacit understandings operate in a managed care

environment is debatable. Physicians and/or corporate health care providers often

are not expected or required to disclose risks that may pertain when they employ

cost-saving medical technologies or protocols that are less than the best available.

For instance, hospitals with a policy of not providing pelvic ultrasounds after radiologists’ office hours are not required to post a warning on the emergency department doorway that announces this policy to patients. As another example, physicians generally are not expected to disclose whether the lab is measuring cardiac

enzymes by the traditional chromatography method or with the newer, more effective mass spectrometry method. As a practicing clinician and patient advocate, I am

more worried about these practices than I am about not disclosing the use of reprocessed medical devices, since I believe the potential risks are generally less serious

in the latter instance.

If it is determined that risks of using reprocessed medical devices are minimal,

then the process of trying to disclose these risks could actually hinder the integrity

of informed consent by promoting irrational concerns (thus constraining understanding and voluntariness). Two pitfalls pertain.

1. Patients do not generally reason statistically. Even when a risk is statistically

very remote, most patients will assume that if you mention it, then it is a clinically

significant risk. I often illustrate this point to medical students by noting that if one

pointed out the known risks of taking a bath (e.g., possible traumatic brain hemorrhage, drowning, and broken bones), then most patients unfamiliar with the process

of bathing would refuse the procedure outright, even if you explained that the cumulative serious risks were less than one in fifty thousand.

2. Patients often maintain un-warranted superstitions about the hazards of contact with others’ bodies. Members of the media who hope to turn the use of reprocessed medical devices into a high-profile health care scandal have used these superstitions as emotional leverage. Magic Johnson’s decision to quit professional basketVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00161 Fmt 6633 Sfmt 6621 E:\HEARINGS\62970 pfrm08 PsN: 62970
158

ball is an example of how concern about the transmission of AIDS is sometimes

overwrought. Even health care workers tend to be irrational about the issue of AIDS

transmission. A number of health professionals have expressed concern about occupational AIDS transmission and hope that their occupational risks can be minimized through the development of an effective AIDS vaccine. However, many of

these same health care professionals have failed to obtain immunization against

hepatitis B, despite data showing that the occupational risk of dying from hepatitis

B is far greater than it is for AIDS.

In an age of managed care, issues about the context of informed consent emerge.

Often, decisions governing the practice of medicine—and its attendant risks—are

determined at an institutional level. In such instances, the moral obligation for obtaining informed consent may shift away from the individual clinician to the institutional provider. For example, an institution that reprocesses the contents of its suture kits may bear a moral responsibility for informing clients of this practice (if

it was determined that the use of these kits poses a significant risk). One problem

is that it is not clear whether or not the material risk standard applies, or even

makes sense, at this level. Informed consent, in this context, pertains not so much

to decisions about specific treatments or procedures, but to patients’ decisions about

whether or not they want to subscribe to a given health care plan.

Several public policy implications follow from these considerations about informed

consent. First, the problem of determining the risks of using RSUDs is crucial. The

likely risks pertaining to the use of a reprocessed single-use medical device will

vary, depending on the nature of the device, the previous use of the device, the reprocessing method and the proposed manner in which the device will be reused.

These variations make it difficult to articulate a uniform requirement for informed

consent.

Second, if standards for reprocessing medical devices are sufficiently rigorous to

ensure that these devices may be used safely, then there is no moral requirement

for informed consent. One exception might be in unusual cases where patients could

be expected to have religious or other doctrinal objections to any reuse of specific

devices. But this sort of consideration applies to any device, drug or procedure, and

is best handled at a clinical level rather than through government regulations. If

significant dangers pertain despite adequate regulation, then informed consent may

be morally obligatory. It will be important to ensure that the standards of disclosure

in such cases are neither too rigorous nor too lax. Overly rigorous requirements

would result in irrational fears based on the disclosure of clinically insignificant

risks. It is also likely that overly rigorous disclosure requirements would place a bureaucratic obligation on clinicians that would impede patient care. Overly lax requirements would result in violations of the moral requirement for informed consent—in effect, exposing patients unwittingly to dangers that reasonable persons

might not approve.

Third, regulatory requirements for informed consent for the use of RSUDs should

be responsive to the context in which specific RSUDs are employed. In some instances, consent should be obtained by clinicians, in other instances the obligation

should lie with hospitals or other corporate providers.

There are also ethical issues that pertain—apart from the Principle of Informed

Consent—to the proper interpretation of risks and to the proper level of government

intervention. If the risks of using various RSUDs are to be interpreted accurately,

it is important that we obtain the best possible scientific data. Objective sources

(such as the FDA) are to be preferred over sources that have important financial

interests that hinge on the interpretation of this data. Even the news media is suspect in this regard, since they are exposed to financial incentives to find newsworthy

scandals that will arouse an emotional response from the general public. Hence,

they will be prone to exaggerate the dangers of RSUD use and to rely on anecdotal

reports of untoward effects.

Finally, health care policy concerning informed consent for the use of RSUDs

should be guided by the Principle of Subsidiarity, which implies that regulatory authority should be concentrated at the lowest hierarchical level where there is sufficient competence. This consideration enhances the rationale for looking to the FDA

for input and guidance about risks and about necessary policy adjustments. Assuming that the FDA is properly motivated to represent patients’ safety interests, the

cumulative training and expertise of FDA officials is an important asset that should

be maximally utilized.

I suspect, when all is said and done, that it will not be possible to articulate and

legislate a uniform standard for obtaining informed consent for the use of RSUDs

that is more effective or useful than general legal standards that already pertain

in clinical medicine. A more promising avenue would be to rely on the enforcement

of effective safety regulations, which would render informed consent into a moot

159

issue. The best available scientific evidence should guide the development of safety

standards. This hearing attests to the serious efforts that are being taken in order

to garner such evidence.

Mr. Upton. You get a bonus.

Mr. Lindsay?

TESTIMONY OF BRUCE D. LINDSAY

Mr. LINDSAY. Mr. Chairman and members of the subcommittee,

I am Dr. Bruce Lindsay, a cardiologist and a member of the American College of Cardiology and the North American Society of

Electrophysiology. And these organizations represent about 24,000

board certified cardiologist in the United States. I thank you for

the opportunity to testify about the safety and efficacy of reusing

electrophysiology catheters in patients who undergo procedures for

the diagnosis and treatment of heart rhythm disorders. I have

about 15 years of experience in electrophysiology and I direct the

Cardiac Electrophysiology Laboratory at Washington University in

St. Louis, where more than 1,500 diagnostic and therapeutic procedures are performed each year. In all my years of practice I have

never encountered a complication related to the reuse of an

electrophysiology catheter.

Furthermore, in my conversations with professional colleagues at

other major medical institutions, I have never heard any of them

describe this problem. I would like to emphasize that neither I nor

the organizations that I represent have any direct or indirect financial interest in the reuse of electrophysiology catheters. Our position is rooted in scientific evidence and puts concern for patient

safety as its first priority. The standard electrophysiology catheters

that we use have several electrodes used for recording electrical

signals. They cost about $500 each. In fact, some of the newer and

more advanced catheters cost $2,000 or $3,000 each. The cost of a

reprocessed catheter is generally about half the cost of a new catheter. The first electrophysiology procedures were performed more

than 30 years ago. Experience over the years has shown that

electrophysiology catheters are durable and can be re-sterilized for

reuse. The obvious motives were to reduce costs and eliminate

waste. Clearly there are ethical, medical, and legal reasons for physicians to avoid any practices that we feel would add material risk

to a procedure.

Sometimes several catheters are tried during a procedure before

an optimal catheter is identified. Sometimes a catheter, whether it

is new or reprocessed, does not have the right configuration to

reach a specific target in the heart, or may become less maneuverable over a period of time. You can see how the cost of a procedure

would escalate if we had to take catheters out and reuse them,

meaning try other catheters and change the models that we are

using. The costs begin to add up. Medicare and other third-party

payers do not increase their reimbursement irrespective of whether

we use one catheters, three catheters, or six catheters. Reprocessing is a way to help reduce the fiscal implications of using several

catheters during a single procedure. I must point out that there are

studies that have evaluated the safety of reusing electrophysiology

catheters, and these studies have involved more than 15,000 patients. And in these studies the sterility of reprocessed catheters

160

was not a concern, nor was the incidence of infection increased.

Moreover, several studies have demonstrated that the catheters are

durable enough to be reused in excess of five times. The conclusions from these studies are that the catheters appear to be stable

for reuse, that this can be done provided that they are carefully examined and that the quality assurance standards are observed. It

is an expensive policy to preclude reuse of these catheters.

You are also aware that adverse events stemming from the reuse

of medical devices are reported to the FDA. We have already heard

today that some of these reports involve not just reprocessed catheters, but new catheters. So I think it is appropriate to emphasize

that despite the reuse of hundreds of thousands of catheters, only

a few instances have been cited in which they have proved to be

faulty. We conclude that the risk to patients associated with

reusing electrophysiology catheters is very, very small relative to

the overall risk of the procedure. The risk, in fact, is so low that

it is difficult to quantify. Policies that prohibit the reuse of

electrophysiology catheters will not have an appreciable impact on

risk, but they will most certainly increase costs. In a major medical

center, the cost for example just of reusing electrophysiology catheters, the savings from that are in the range of $250,000 to

$400,000. Both the American College of Cardiology and the North

American Society of Pacing and Electrophysiology are working with

the FDA to refine additional risk adjusted standards that can be

applied to reprocessing medical devices and to clarify the criteria

for single-use labels. We urge Congress to defer to the FDA is it

perfects a regulatory strategy for the reuse of medical devices that

is based on science and emphasizes the public safety as a first priority. Mr. Chairman, I appreciate the opportunity to speak before

the committee. Thank you.

[The prepared statement of Bruce D. Lindsay follows:]

PREPARED STATEMENT OF BRUCE LINDSAY, ASSOCIATE PROFESSOR OF MEDICINE, DI- RECTOR, CLINICAL EP LABORATORY, WASHINGTON UNIVERSITY SCHOOL OF MEDI- CINE, ON BEHALF OF THE AMERICAN COLLEGE OF CARDIOLOGY

INTRODUCTION

Mr. Chairman and members of the subcommittee, I am Dr. Bruce Lindsay, a cardiologist and member of both the American College of Cardiology (ACC) and the

North American Society of Pacing and Electrophysiology (NASPE). I thank you for

the opportunity to testify before you today about the safety and efficacy of reusing

electrophysiology (EP) catheters in patients who undergo EP studies for the diagnosis or treatment of heart rhythm disorders.

Over the past several months there has been much discussion, and unfortunately

much factual distortion, about the reuse of certain medical devices. My testimony

pertains to the reuse of EP catheters and is based on more than 15 years of experience in the field of clinical EP. I direct the cardiac electrophysiology laboratory at

Washington University in St. Louis, where more than 1,500 diagnostic and therapeutic procedures are performed each year. During all these years, I have never encountered a complication related to the reuse of an EP catheter. Moreover, in my

conversations with professional colleagues at other major medical centers, I have

never heard any of them describe this problem.

The ACC and NASPE share several common objectives that promote optimal patient care, research, and education. These organizations also provide leadership in

the development of standards and guidelines and the formulation of health care policy. The interest of these two organizations in the medical reuse debate grows out

of concern for patient safety and the promotion of quality cardiovascular care for

patients. Neither I, nor the organizations that I am representing today, have any

direct or indirect financial interest in the reuse of EP catheters. The involvement

of the ACC and NASPE in this issue is rooted in scientific evidence. The ACC and

161

NASPE have been working with the Food and Drug Administration (FDA) and believe that it has also taken an approach to the issue of medical device reuse that

is based in science out of concern for patient safety.

Electrophysiology Procedures

Clinical cardiac EP studies are performed to diagnose and treat abnormal heart

rhythms referred to as arrhythmias. Typically, three to six catheters are used during these procedures. Each catheter incorporates four to 20 platinum electrodes to

record electrical signals or pace the heart. The standard EP catheters are solid

nonluminal designs, which means they do not have a hollow inner core. Some catheters have special mechanisms used to deflect the tip to help guide the catheter to

a specific target. Catheters with these deflection mechanisms are often used to deliver radiofrequency energy—a high frequency electrical current—to destroy a small

amount of tissue on the lining of the heart that has been identified as the cause

of a patient’s abnormal heart rhythm. This curative technique is referred to as an

arrhythmia ablation procedure.

The cost of catheters used to perform EP studies varies depending on the number

of electrodes, steering mechanisms, or materials used for the particular model. Diagnostic catheters range in cost from $100 to more than $1,000. Deflectable catheters

used for ablation of abnormal heart rhythms generally cost $400 to $800. Some advanced designs that provide feedback about the position and orientation of the catheter cost $2,000 to $3,000.

The first EP procedures were performed more than 30 years ago. The early experience showed that EP catheters were quite durable and could be sterilized for reuse,

as has been the practice for many surgical instruments. The obvious motives were

to reduce cost and eliminate the waste of catheters that could be reused without

compromising patient safety. The physicians who perform these studies have no direct or indirect personal financial incentives to reuse catheters, and there are ethical, medical, and legal reasons to avoid any practices that would add material risk

to EP studies. The cost of medical supplies is the responsibility of the hospital

where the procedure is performed; however, physicians often consider it their responsibility to work with hospitals to make efficient use of supplies and reduce operating costs.

Arrhythmia ablation procedures typically take three to five hours to perform. In

order to advance the EP catheters to the heart, tube-like sheaths are inserted into

the arteries and veins to provide vascular access for EP catheters. The catheters are

then inserted through the sheaths and advanced to the heart. The sheaths allow

cardiovascular specialists to remove, exchange, or reinsert the EP catheters as needed during the procedure. Sometimes catheters—new or reprocessed—must be exchanged because they do not have the necessary configuration to reach a specific

target in the heart, or because they have become less maneuverable during the

course of the procedure. Sometimes several catheters are tried during a procedure

before the optimal catheter is identified. Reprocessing allows the flexibility to use

several catheters during an EP study safely and free of fiscal concerns.

In some cases the catheter is easily positioned at the target site and is subjected

to very little manipulation. In more difficult cases a catheter may be removed and

reinserted several times during the course of a procedure and is subjected to considerably more stress when extensive efforts are required to reach the target. Because

the stresses that can be imposed on an individual catheter can vary considerably

during a study, EP catheters are manufactured to be very durable. It is their durability which makes them reprocessable. Regardless of the amount of stress imposed

on a catheter during a study, each one is carefully evaluated by the reprocessor to

determine whether it is suitable for reuse.

The number of catheters used during an EP study can have a substantial impact

on the cost of performing the study, but it does not change the level of reimbursement from Medicare or other insurance companies. When the cost of catheters exceeds the level of reimbursement, hospitals bear the loss.

Review of Published Clinical Studies

There are studies, all of which have been published in peer-reviewed scientific

medical journals, which have evaluated the safety of reusing catheters for EP studies. All have found no evidence that the sterility of reprocessed catheters is a concern or that the incidence of infection is increased. The results of four clinical studies are summarized:

1. The results of a study of 12 medical centers were published in the medical journal Pacing and Clinical Electrophysiology in 1988. The study looked at the safety

of reusing catheters. The incidence of infection related to a total of 14,640 EP procedures involving 48,075 catheter uses was reported. At three centers, catheters were

162

automatically discarded after a single use. These centers carried out 1,245 EP procedures using 3,125 catheters. At the other nine centers, catheters were sterilized for

reuse. There were 13,395 procedures using 44,950 catheters in the reuse group. The

incidence of bacteremia (blood borne infection) and superficial skin infection at the

site of catheter insertion is shown below.

Table 1: Incidence of Infection During EP Studies.

Group Bacteremia Superficial Skin

Single Use Catheters ....................................................................................................................... 1 (0.03%) 1 (0.03%)

1,245 studies

3,125 catheters

Reused Catheters ............................................................................................................................ 8 (0.018%) 1 (0.002%)

13,395 studies

44,950 catheters

The authors of the study concluded that sterilization and reuse of the catheters

employed in this study did not result in any increase in the risk of infection. They

felt the catheters were sufficiently durable to be reused well in excess of five times,

and that one-time use of such catheters appeared to be a medically unnecessary and

expensive policy to adopt.

2. Similar results in a prospective study were published in the Journal of the

American College of Cardiology in 1987. The study evaluated catheter reuse over a

five-year period during which 178 catheters were used 1,576 times for 847 EP procedures. Detailed records of catheter testing and use were maintained. No complications were encountered during the study period. All reused catheters functioned for

cardiac pacing and recording of cardiac electrical signals. Surveillance cultures and

biologic indicators revealed that adequate sterilization procedures were used. The

authors concluded that EP catheters may be safely reused provided a thorough

cleaning, testing and record-keeping system is instituted. They also concluded that

the practice of reusing catheters would result in substantial cost savings to hospitals.

3. The studies mentioned above were conducted in patients undergoing diagnostic

EP studies before the advent of deflectable catheters and arrhythmia ablation procedures. A study published in the Journal of the American College of Cardiology in

1993 prospectively investigated the time course of electrical, physical and mechanical changes in ablation catheters to determine the affect of reuse on safety and efficacy. The study included 69 ablation catheters made by a single manufacturer that

were used in 336 procedures. Testing of physical integrity consisted of visual and

stereoscopic (X30 magnification) examination of handle function, catheter shaft and

the deflectable tip. Specific attention was paid to the ablation electrode attachment

to the catheter shaft, and the ablation tip electrode was scrutinized for pitting. The

electrical integrity of the catheters was measured by electrical resistance from the

handle connector to the recording rings and to the tip electrode. Deflection and

torque measurements were made to assess mechanical integrity.

During the course of this study 36 catheters (52 percent) were rejected at some

point because of mechanical or electrical failure. Eighteen catheters were repeatedly

sterilized and eleven of the catheters were used 10 or more times. The most common

reasons for catheter rejection were tip electrode glue separation after an average of

4.3 uses and loss of deflection after an average of five uses. Electrical discontinuity

was observed after an average of 10 uses. There was no significant decrease in catheter torquing ability that determines the steering responsiveness of the catheter.

The medical records of 140 patients who had arrhythymia ablation procedures in

this study revealed only one case (0.7 percent) of local infection at the insertion site

that was treated effectively by antibiotics. There were no other complications.

The authors of the study concluded that the catheter model used in this study

could be reused an average of five times. They recommended that after each use

catheters be carefully examined under magnification with special attention to the

tip electrode. They also recommended that the catheters be tested for deflection and

electrical integrity after each use.

4. Another study published in the American Journal of Cardiology in 1994 looked

at the effects of reprocessing on mechanical integrity, sterility, and chemical residuals. The study was part of an internal quality review process conducted by a hospital to establish and validate an institutional policy for reuse. A total of 12 commercially available catheters from two manufacturers were analyzed. Eleven of the

catheters were randomly selected from the catheter inventory of the clinical EP labVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00166 Fmt 6633 Sfmt 6621 E:\HEARINGS\62970 pfrm08 PsN: 62970
163

oratory after being used one to four times. They were manually cleaned, repackaged,

and gas sterilized with ethylene oxide. To assess the sterility of reused catheters,

three were cut into two-inch segments, placed in bacterial culture media, and incubated for five days. Six of the catheters were analyzed for chemical residuals after

gas sterilization. Two catheters were examined for evidence of component failure.

Visual inspection and microscopy were used to determine mechanical integrity of

the catheter surface, and x-ray inspection was performed to assess interior structures.

The results showed no bacterial growth detected on any of the cultures. which indicated that reprocessed EP catheters are effectively sterilized. The chemical analysis demonstrated that the concentrations of ethylene oxide detected in extraction

liquid exceeded standards established by the FDA. Microscopic examination of reprocessed catheters demonstrated inconsequential metal and fiber particulates on

the catheter surface and at some electrode-catheter interfaces. The shaft of the catheters and the electrodes remained intact. There was no evidence of electrical discontinuity, and the integrity of internal structures was confirmed by x-ray inspection.

The authors concluded that, with sterilization techniques frequently used by hospitals, the potential for chemical residual contamination might exist after sterilization with ethylene oxide. Based on these results the hospital changed its policy to

single use. It should be noted that the hospital subsequently resumed multiple use

of catheters that were reprocessed by a commercial vendor whose chemical residuals

after reprocessing met FDA standards.

Medical Device Reports

Medical Device Reports (MDRs) submitted to the FDA contain information about

three cases involving EP catheters. One case involved a reprocessed catheter. The

other two occurred with new single-use catheters. It is appropriate to emphasize

that despite the reuse of hundreds of thousands of catheters, only one MDR has

been submitted to the FDA that involved a reused catheter. The reports are summarized below:

• A new deflectable ablation catheter was being positioned in the right atrium when

the catheter tip was noted to be detached and wedged in the coronary sinus.

The patient was observed overnight and discharged the following day without

any reported symptoms.

• A small fragment of the distal tip in proximity to the electrode side of a new catheter broke away and the fragment could not be located. Further details are not

available.

• A reprocessed orthogonal EP catheter was used without incident until it was removed from the heart. The physician felt some resistance during removal of the

catheter. A subsequent x-ray showed a small electrode fragment lodged in the

wall of the right atrium. It was presumed that a single platinum electrode

mounted on the surface of the catheter might have been compromised during

reprocessing. The surgical consultant decided that removal of the fragment was

not indicated and the patient remained free of symptoms.

Impact of Reuse Policies on Physicians, Hospitals, and Patients

Most EP laboratories are staffed and administered by hospital employees. The

cost of supplies and maintenance for EP laboratories is also paid from hospital

budgets. The physicians’ motive to reuse EP catheters has arisen from their experience that the catheters are durable and can be safely used for several procedures

without posing an increased risk to the patient. As such, it would be a waste to discard EP catheters after a single use.

The risk to patients associated with reusing EP catheters is inconsequential relative to the overall risk of these procedures. The risk is, in fact, so low that it is

difficult to quantify. Policies that prohibit the reuse of EP catheters will not have

an appreciable impact on the risks of these procedures, but they will certainly increase the costs.

The cost savings realized by hospitals that reuse EP catheters depend on the volume of procedures and whether catheters are reprocessed internally or through a

commercial reprocessing company. As a general rule, reprocessing companies charge

50 percent of the original cost of the catheter each time the catheter is reprocessed.

Allowing for an 85 to 90 percent pass rate for each reprocessing cycle for a maximum of six uses per catheter (resterilized a maximum of five times), hospitals can

reduce their catheter costs by about 35 percent. At large medical centers these

measures may lead to cost savings in the range of $250,000 to $400,000. At smaller

medical centers the total savings would be substantially less, but for both large and

164

small hospitals this practice is a significant cost-reducing measure at a time of escalating costs and declining reimbursement.

Development of Policies For Reuse of Medical Devices

The FDA has proposed a strategy to address the reuse of medical devices currently labeled for single use. This policy was developed in response to the concern

that a device’s performance, safety, specifications, or intended use might be compromised during reprocessing procedures. The policy would be applicable to both

commercial reprocessors and hospitals that engage in these activities. The FDA’s

strategy categorizes levels of risk presented by reprocessing and reusing single-use

devices. Factors that would influence the risk category of a specific device include

the complexity of procedures associated with reprocessing, the actual and potential

risk for infection should the device be reused, and the quality and extent of published data on reprocessing for that device. The agency would consider ‘‘high-risk’’

devices to be products that may pose significant public heath risk to patients and

users after reprocessing. It is anticipated that the FDA would enforce all of the

agency’s regulatory requirements, including premarket requirements, for high-risk

devices. The FDA has indicated that it would also enforce applicable premarket requirements for ‘‘moderate-risk’’ devices to ensure that the reprocessed device remains as safe and effective as a device that has never been used.

The FDA is examining the criteria used to label a device as ‘‘single-use.’’ The new

policy would potentially clarify or justify manufacturers’ need for ‘‘single-use’’ labels.

The FDA has also questioned the need for informed consent when it is anticipated

that reprocessed devices might be used during a procedure.

Summary

The ACC and NASPE support the position that reuse of EP catheters is a safe

and cost-effective practice provided that these devices are meticulously cleaned,

sterilized, and inspected in accordance with accepted standards of practice. Both organizations are working with the FDA to refine additional risk adjusted standards

that can be applied to reprocessing medical devices and to clarify the criteria for

single-use labels. We urge Congress to defer to the FDA as it perfects a regulatory

strategy for the reuse of medical devices that is based on science and emphasizes

public safety as the first priority. We firmly believe that no further congressional

action is required at this time.

Mr. UPTON. Well, thank you all very much for your testimony

and as folks could tell we wanted a diverse range of opinions and

we got them. I compliment the staff, Mr. Ford and Mr. Slobodin.

A couple of things. This is an enormously complex issue and Dr.

Ganske, as an example, will be able to come back to discuss. He

is one of the physicians that serves on this subcommittee. I know

that the FDA regulations that they put out for comment only really

came out this week. There has been a lot of talk about them in recent days, weeks. And Ms. Eshoo’s bill has been out there for a little while as well.

I am wondering if any of you at the table have actually looked

at the regulations that came out earlier this week, and might make

some comment or indicate whether you are going to comment on

them. And if so, maybe give us an advance in terms of where you

think they are strong enough, where you think they may be too

weak. Or maybe you do not think we need them at all or whether

this is exactly the right direction that we are going to head. And

I will just start, Mr. Lindsay. And if you have not had a chance

to see them, I certainly understand. We understand. I appreciate

your comments maybe in writing at some point if you, in fact, you

do make those comments known.

Mr. LINDSAY. I just received the documents yesterday and was

taking care of patients until late in the day, so I have not reviewed

them. But I have spoken to people at the FDA this week, and we

have talked about some of the common ground that as a professional organization we feel that we have with the FDA in trying

165

to address this problem. Physicians have no reason to use devices

that are unsafe. It just makes our lives miserable and it is not why

we went into medicine. Our interest is in protecting patients and

in trying to help them, and we would like to work with the FDA

to tackle this in a responsible way.

Mr. UPTON. So, you do not have a verdict yet whether or not it

is the right course?

Mr. LINDSAY. From what I have read I think that it is a workable solution and one that will protect the public interest. I think

it is one that would prohibit the recycling of certain devices that

are not safe to reuse. I think it would permit the reuse of devices

that can be safely reprocessed, and I think that is a reasonable approach to take.

Mr. UPTON. Dr. Trotter?

Mr. TROTTER. I too have not been able to review the written revisions by the FDA. I do think that it is important that we focus on

the FDA recommendations. One of the things I appreciate about all

the attention that was given to the FDA today is I consider them

to be a relatively objective source. I think some of the other parties

involved on both sides may have financial conflicts of interests that

could implicitly or explicitly affect their testimony. I think there is

less of that then on the FDA.

Mr. UPTON. You want to stay on the topic. The clock is ticking

on me, too.

Mr. TROTTER. Okay.

Mr. UPTON. Mr. Feltner.

Mr. FELTNER. Yes. It is AMDR’s view that FDA regulation of reprocessing is necessary, critical to ensuring the safety of reprocessed devices, and the patients. We believe that the current FDA

regulatory regime which emphasizes compliance with QSRs is wellsuited to meeting public health. We do not really believe that the

pre-market review scheme proposed is necessary, but if there is a

reason, and there is an assessment, and there are relevant facts

that determine a pre-market review is necessary, we support it and

we are willing to work and look forward to working with FDA on

any path that it chooses.

Mr. UPTON. Dr. Maurer, and actually before you answer, I would

just like to know what the difference was. You showed those saw

blades that you said were recyclable. What was the other device

that looked like a——

Mr. MAURER. Both of these are saw blades.

Mr. UPTON. Oh, they are? Okay. I did not see the other end of

it.

Mr. MAURER. It has been coming for years and years.

Mr. UPTON. You had it covered up with your thumb.

Mr. MAURER. And it shows up on our door——

Mr. UPTON. I just saw the wrench.

Mr. MAURER. [continuing] you could be paralyzed. Same blade.

Mr. UPTON. Okay. Okay. I just saw the wrench at the other end

when you——

Mr. MAURER. Put it with the other saws.

Mr. UPTON. So that is—all right. All right. Go ahead and answer

the——

166

Mr. MAURER. Well again, we have not had much time to look at

it. I looked at it briefly. I think the major thing that comes out of

it, just on a cursory review, is it’s got to be the same across the

board. I think when you first read it, it looks like it is directed

purely at hospitals and reprocessors. We have free standing inventory, surgery centers, we have physician offices, we have a lot of

people that are going to reuse these devices, and it has got to be

a level playing field or we are going to have patient problems.

Mr. UPTON. Do you all at the Cleveland Clinic, actually keep

track then of the number of times that things are reprocessed?

Mr. MAURER. Absolutely. You would have to be or we would not

be able to limit it to five and those that come back from the reprocessor have a mark on them. Half of the ones we sent out, they

threw away because after they looked at them they felt they were

unacceptable and we do not get charged for that when they throw

them away.

Mr. UPTON. Dr. Fielder.

Mr. FIELDER. I very much like the direction that the FDA is moving. I did have a chance to look at the documents, but not terribly

carefully. One of the things that, from an ethical standpoint, is important about their proposal is that they are going to have patient

assurance that these devices can be cleaned and sterilized that is

based upon an objective third party review rather than simply on

what the manufacturers say, or on GMPs and quality assurance.

And that is very important for patients.

Mr. UPTON. Dr. Grossman.

Mr. GROSSMAN. Yes. I’m sorry. I have had a chance to review

them and have four specific areas. First, I think they are very commendable in that they do level the playing field and for the first

time will force the production of reliable data, and that should be

commended. Some of the specific devices, I think, probably should

be in higher categories and I think that will probably evolve under

their scheme up. The exemption issue concerns me because the

very biopsy device I showed, although I am not an attorney, clearly, the reason for it in the past would be to allow similar devices.

But in fact, if it would allow that kind of device with a sharp point

to skate through and bypass the safeguards, clearly that would

need to be tightened up. My last comment is again, the plea. This

issue has been alive for longer than today. My concern is I start

to see 6 months to 12 months to 18 months, a notice period. I do

not know how much more it could be tightened, but that would

clearly be a plea.

Mr. UPTON. Mr. O’Holla?

Mr. O’HOLLA. Yes. I have also had an opportunity to read them

in between everything else I was doing this week, and I think FDA

has come a long way, certainly from where they were 18 months

ago. Certainly where they were even in November, and I would like

to thank this committee and its members because I think it is a

result of the attention you have paid to that issue that has caused

some of that movement. I do, however, think there is one problem

area where we need to talk with FDA a little more, and that is the

area of exemptions raised by Dr. Grossman. The exemptions currently for medical devices did not take into consideration the risks

associated with reuse and cleaning. I think, therefore, those exempVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00170 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
167

tions should not stand for a prolonged period of time. We are going

to have to figure out how can we deal with that issue and make

sense out of the scheme. But I think we are headed in the right

direction. I think the nice part is, nobody has to believe me and nobody has to believe them. We will have a referee.

Mr. UPTON. Ms. West.

Ms. WEST. I think the recommendation certainly show progress.

My concern is that it does not cover staff incompetence and question how they would be able to implement that without having

someone on the floor continually for quality assurance.

Mr. UPTON. Thank you. Mr. Stupak, you ready or do you want

me to come back to you?

Mr. STUPAK. Thank you Mr. Chairman. Dr. Lindsay, if the FDA

is going to set a standard for a number of times the device is reused, how do you establish this number? Is there a community or

an acceptable medical practice standard for a device established by

ACC or NASPE or would it vary from hospital to hospital? Would

the standard include a level of device integrity below which the

catheter is discarded? How do you track and account for the number of times that the individual catheter has been reused? What

happens if the numbers exceed it? I know there are a lot of questions there, but I am just trying to get it on the record.

Mr. LINDSAY. First of all the tracking is easy in that any catheter

that is reused has a tag on it. It is a serial number and it is

tracked by the reprocessor. So that there are limits that are set on

that. Many hospitals with regard to electrophysiology catheters

have set a limit of five reuses based on some information that is

available from the literature. In some cases catheters in these studies have been used 10 or 15 times, but we do not want to push it

to its limit because at that point I think you could have a greater

risk for a breakdown. But certainly somewhere in the maximum of

five seems reasonable. Now, having said that let me make it clear

that not all catheters make it to five.

Each cycle, at least with our reprocessor, each cycle about 80 percent, 85 percent of the catheters will make it through that cycle

and the others do not. They do not make the cut. So, I think that

the criteria that are used has to be the same at each hospital or

at each reprocessor. We cannot have divergent criteria.

Mr. STUPAK. So whether a catheter makes the cut, that is up to

the reprocessor?

Mr. LINDSAY. That depends on the inspection and the testing

that is done. So they examine it for nicks and electrical integrity,

things that might potentially compromise it. Now, the other part

of that question is that as catheter designs evolve, and the catheters we use today are different than they were say 10 or 15 years

ago. It may be that with the newer designs, some of the designs

will not be suitable for reprocessing. They may have sensors in

them that would preclude reprocessing. We have that, for example,

for some of the catheters that cost $2,000 or $3,000. They have sensors built into them that cannot be reprocessed. In other cases they

may have mechanisms that may not lend themselves to reprocessing. So I think that one of the challenges before us is to identify

these catheters, to look at their mechanisms, to look at the materials that they are made of, and decide whether they can safely be

168

reprocessed and used in patients in such a way that nobody has

any question whatsoever about the integrity of that product.

Mr. STUPAK. Thank you. Dr. Maurer, in keeping with that same

line of thought, in your testimony you talked about the fact there

is a five time use limit for reprocessed non-aluminum diagnostic

electrophysiology catheters. Would you outline for the committee

how the clinic tracks the five times use to assure that is not exceeded? What mechanisms are in place that you use? Should it be

accidentally exceeded? And is this a model for tracking limited

reuse utilized on a hospital wide basis?

Mr. MAURER. Well, it is important to understand there is very

little of this done. I mean, more sterile processing and so forth, I

mean, 99.9 percent is with reusables. Scissors and clamps in ORs.

So we are not, you know, just striking out on this.

Mr. STUPAK. True.

Mr. MAURER. This is a very small amount. I would echo what Dr.

Lindsay says. We follow the same things. These are nationally published studies that are peer reviewed and have been around for

years. We track them by serial numbers, there is a log kept, we

have continuous quality improvement and statistical process control that is applied to these entire departments, not just in the reprocessing of catheters. It looks at all their infections, and all staff

competency, and the review that has to occur on a regular basis.

We are required to do this for Joint Commission. Believe me, when

they come they bare down on this and if there is any problem,

there is a root cause analysis done by us before Joint Commission

does come and we have to show them that root cause analysis. So

it is very stringent. I mean, you have got to understand, we physicians do not get any money from this. Can you imagine what it

takes for us to grab a reprocessed device. We require that there be

good quality control before we touch that and stick it in a patient.

Mr. STUPAK. Sure, but then a question I asked earlier about

DRGs. I mean, DRGs source will only pay so much for a procedure.

Now, if I can use a reprocessed catheter I am going to save some

money, and the pressure on the hospitals, and clinics, and everyone

else to keep within that amount, I mean, you know, we talk about

these things, but there is also a responsibility here for the rest of

us up on this side of the dias when we start putting on these standards or what we are saying has to be done. DRGs limited amount

payment leads to this reuse.

Mr. MAURER. Yes. We charge less, and we so note that in the

record that it is a reused device. I do.

Mr. STUPAK. But if it is a DRG, I mean, you get paid the same

for the DRG whether you use reprocessed or not.

Mr. MAURER. That’s true. That’s true. But that charging less

than when the DRG gets reevaluated by HCFA they will note that.

And if it has become a standard thing that everyone reprocesses it,

then they feel within their rights in terms of being budget neutral

to cut back on that where they want to give money elsewhere.

Mr. STUPAK. I do not have any more for now.

Mr. UPTON. You are out of time.

Mr. STUPAK. Okay. Thanks.

Mr. UPTON. We are going to have another round though, I promise. Mr. Bryant.

169

Mr. BRYANT. Thank you Mr. Chairman. Dr. Trotter, on the issue

of informed consent I kind of, first of all I want to apologize for

being late. We have been in a prescription drug meeting right next

door, and I missed, I think, the first four or five panelists testimony. But I did come in and Dr. Trotter you had mentioned something in your testimony about informed consent and when it would

be appropriate. And as I recall it was based on, I think, the degree

of risk involved, that being determined by I assume a physician,

would determine whether or not the patient ought to be informed.

And if I hear what you are saying that overall the gist of your testimony is that for a reprocessed medical equipment there should

not be an informed consent by the patient?

Mr. TROTTER. That would be the end result that I would recommend. My opinion was that we ought to ensure that these reprocessed single-use devices are safe, safe enough so that there

would not be a significant risk, and therefore informed consent

would be a moot point.

Mr. BRYANT. And how do you do that? How do you ensure that

they are that safe? You as a physician cannot do it, can you?

Mr. TROTTER. No. No, I cannot do it as a physician. I did read

H.R. 3148 and I noticed though that many of the devices that I use

I guess I count as the reprocessor. For instance, a stethoscope

would count as a critical Class I device since I put it in unsterile

areas of the body like the oscula and the inframamillary fold every

time I examine a patient. So if something like a stethoscope, if that

sort of risk was something where we required informed consent,

then I guess, you know, I would need to be more involved in that

sort of manner. But in fact, the specific requirements for ensuring

the safety of some of these more complicated devices are far beyond

my scope.

Mr. BRYANT. Yes. That should be at least the FDA’s responsibilities?

Mr. TROTTER. Yes.

Mr. BRYANT. Okay. Dr. Lindsay, on reviewing some of the information here I find that the Association for Operating Room Nurses

has developed a different policy from the one you expressed and the

one that is endorsed by your American College of Cardiology and

that is that in essence that unless the hospital can demonstrate the

patient’s safety and the medical devices effectiveness and integrity

are not compromised, that reprocessing is not recommended by

that Operating Room Nurses’ Association. Do you have any comments on that?

Mr. LINDSAY. I think some of this may reflect the different types

of devices that are reused. The American College of Cardiology and

NASPE are not advocating that all devices be reused, and some of

it may depend on what kind of things they come in contact with.

That is a different group than nurses, for example, that work in

cardiac catheterization and electrophysiology laboratories. I do not

know that a lot of these devices clearly should not be used. I think

there are some things in gastroenterology that probably should not

be reused. And there may be some areas in cardiology that we have

touched on today that they should not be reused. But that is what

we have to examine carefully.

170

Mr. BRYANT. I would like to just throw this question open to anyone who would like to answer. I think some of you have touched

on this already in other questions, but my question would be what

more, beyond these two letters that the FDA has sent out, what

more can they do now to advise and instruct or anything else the

FDA can do to help ensure the safety of patients in this area of

using reprocessed, I almost said repossessed, reprocessed medical

equipment.

Mr. UPTON. You are thinking of NAPA auto parts.

Mr. BRYANT. We were talking about body parts a minute ago.

Yes, doctor.

Mr. MAURER. Well, I think they have already done quite a bit.

I have looked at their conferences that many on this committee

have attended and given their views to, and they have taken views

from everyone. I just think they need to continue to collect data,

now that it is time to get the studies of large groups of patients

that are peer reviewed and published, that have the chance of appropriate criticism of the design of the study and the results, and

we get the data out in the open and let the public know that we

are doing our job at looking at this on a scientific basis.

Mr. UPTON. Very quickly, one more.

Mr. O’Holla?

Mr. O’HOLLA. Yes. I think the FDA has done a great job in getting everybody’s comments together and looking at the available

data. You know, peer review is not the standard that FDA uses to

establish safety and efficacy. I think it is time for FDA to act. They

have already said that this is a device by device decision. The big

studies are not necessary to make the device decisions. They need

to act. They may need to act more quickly than they have published this week and start looking at the applications that show the

particular device that the surgeon is grabbing tomorrow is safe.

Mr. BRYANT. Anyone else? I thought I saw a hand go up. Okay.

Well, thank you very much, and I yield back the balance of my

time.

Mr. UPTON. Thank you. I wish all members were able to spend

the time like you have, Ms. Eshoo. Maybe you should think about

getting off one of those other subcommittees and we will find a vacancy over here.

Ms. ESHOO. There are several people here that would not want

me to.

Mr. UPTON. Go ahead.

Ms. ESHOO. Thank you very much, Mr. Chairman. I want to

make a couple of observations before I ask questions of this very

distinguished panel. A few barbs have been thrown around that the

effort underway to take an even closer look at reprocessing, what

that means relative to the public health and whether we have policies in place that speak to the best of what we could do. These are

all very legitimate questions that are being asked. And I think that

the, I know that the intent here, my intent of submitting the legislation was not to favor one group or another. Now, around here,

you know, you punch the pillow, you put a dent in it, but there is

always something else that pops up. I remember going back to FDA

reform where medical device manufacturers were not happy with

what I placed on the table because it was very stringent and it did

171

not always meet with what they wanted to do. There were some

people involved in that debate that wanted to destroy the FDA.

They did not want an FDA around. Now today I hear so many complimentary things said about the FDA and I welcome that.

I think it is important to the American people, and I reminded

my colleagues during that debate that if they were to say otherwise

they were frightening the American people. The American people

want an Agency that is going to be a top watchdog that will step

between whatever interests are out there and their interests. I

think today by the questions that have been asked by my colleagues on both sides of the aisle, that you have all figured out that

we are here for the public interest. So, you know, always in all of

these issues someone’s ox seems to be gored or the perception is

that. I am here for the public interest and I think everyone here

on the committee is as well. So I would hope that you would keep

that in mind. I really want to work with everyone.

I really believe that the reason that all of these proposed guidelines were bragged about today, and I think it is terrific that they

have proposed guidelines, is because we have pushed, and pushed,

and pushed. That is what my colleagues and I are supposed to do.

Because every 2 years our constituents hold us responsible for

what we have done or have not done. So I think it is a very important background for each one of the people that comprise this very

distinguished panel. Just one more observation, and that is in all

of the research we did before we ever thought of writing legislation,

yes each side has some studies, but the FDA does not on behalf of

the public which raises another question. Of course an organization

is going to bring information forward that is going to be favorable

to what they do. I would be all over you, questioning you, why you

had not done that. But the fact of the matter is, is that the public

agency that is supposed to be guarding the best interests of the

public health has not done that. Nor do the regulations, so to

speak, or the guidelines, or whatever they have in place do not

bring that about.

That is a big, deep, dark hole as far as I am concerned because

we have to have a public yardstick by which we measure these

things. I think it is important for organizations to do it. Certainly

I will take that into consideration, but I want you to know that I

think that at the top the absence of that kind of information, I

think, is somewhat alarming and we need to do something about

that. Now, I would like to go to Dr. Maurer, thank you for being

here representing the American Hospital Association. I am very familiar with the Joint Commission standards because I chaired a

hospital board of directors. So I know what those standards are,

but I also know that as someone at this end of the table said that

there really is a patchwork quilt throughout the country of what

some hospitals may do, what some other hospitals may not. My

question to you is do you pass the savings on of the reuse of a single-use device onto the patient or to Medicare?

Mr. MAURER. Well, like I said we charge less. It all depends on

whether the patient——

Ms. ESHOO. Where does the savings go though? Does it go to the

patient or does it go—if it is a HCFA issue——

172

Mr. MAURER. Whoever is paying the bill. If Medicare is paying

the bill on a Medicare patient, the savings goes to Medicare.

Ms. ESHOO. Then it goes to Medicare.

Mr. MAURER. If the patient does not pay anything, we cannot impart savings to him.

Ms. ESHOO. If it is a private insurance, do you pass it up to the

private insurers?

Mr. MAURER. Yes. Yes. The charge is made.

Ms. ESHOO. You do? And that is a consistent standard across the

country or is it just where you are?

Mr. MAURER. That I do not know. I can only speak for what I

do.

Ms. ESHOO. All right.

Mr. MAURER. And what my hospital does.

Ms. ESHOO. Well, I think the committee members need to keep

that in mind. In your testimony you said, to go with the FDA’s proposed guidelines, you have not read them thoroughly, but you said

we do not need the bill. Have you read the bill?

Mr. MAURER. I have read the bill.

Ms. ESHOO. All right. Now, if you have not read the others and

you compare and contrast the two, how can you come to that conclusion? I mean, I have said to the American Hospital Association,

California Hospital Association, I stand ready to work with you. So

it is a little disturbing to me because you have been my partner

in so many things, and I have a deep regard for what you do and

fought very hard, by the way, for the BBA refinements to take

place because hospitals were really getting it across the country.

Why would you say in your testimony not having read one, but

read the other, to go with the one that you really have not read

but disregard the one that you had.

Mr. MAURER. No. What I meant was, I have read the bill. I think

the bill actually does exactly what you said it did. It is a wake-up

call. This needs to be looked at. But all the bill can do is one thing.

The FDA has a continuous regulatory process which they are putting in place. Which conceptually as we have heard today I fully

agree with. In a cursory review of what I got less than 12 hours

ago I have some concerns, but that is the regulatory process which

will go on and on years and years after you and I are doing something else.

Ms. ESHOO. Well, good laws do too as well.

Mr. MAURER. Exactly.

Ms. ESHOO. So thank you very much. To—let’s see who it was.

I do not have a name. Is it Dr. Trotter? I think if you read page

four again of the bill’s language, it really applies to devices that are

inserted into the body. And to take that, to pull that out of context

I think is, well, I mean as the author of the legislation I can say

it is somewhat unfair. If we need to go back and say that in a better way we will do that. But it was never intended, you know. I

am a legislator, I am a politician. I do not consider myself a fool.

I simply would not do that legislatively, because it is not necessary.

So I just want to correct that.

Let me ask one more question and that is to Mr. O’Holla, and

I want to thank you. Even though I am not asking all of you questions, I would like to thank you all for what you have brought forVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00176 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
173

ward today. In your view should any single-use device be reprocessed without a 510(k)? This has gone on back and forth today and,

you know, I think that I would like to have this set down for the

record. For instance, if a new device is exempt, it is all around

these exemptions and the consistency. Now, I heard Dr. Feigal say

that under the proposed guidelines that there would be total consistency, and yet I do not hear a consistency of comments from the

varying views that are a part of this panel in agreement that there

will be consistency. So would you comment on that where a new

device is exempt from pre-market requirements, should not the reprocessed one be exempt as well?

Let me just add a little asterisk to this. For those of you that

cannot stand what I am doing, you must think that I am regulation

happy. I am not. But I do think and if anyone ever wanted to go

back and track this and we have talked about tracking today, in

all of the years of my public service, both in County government

and now here in the House of Representatives, there are two places

where I think, regardless of what level of government we are at,

that we have to have absolutely the highest standards when it

comes to public safety and when it comes to public health. People

cannot do these things for themselves. They simply cannot. They

are reliant upon either very sound regulations and laws that are

put into place. So, would you comment on this.

Mr. O’HOLLA. I am glad you asked that question, because I also

got confused this morning, but I have worked it out in my mind

and I hope I can clarify it for the members here. There are exemptions for new devices in two categories. There are exemptions for

the disposable devices, and there are exemptions for reusable devices. For certain kinds of devices both of those are lumped together. So we have three different kinds. If a disposable device has

been exempted, it has never been taken into consideration the risks

associated with the reuse of that disposable device. That exemption

does not address those risks and should not hold. If an exemption

holds for a reusable device, it has been exempted based upon the

fact that the device was designed to be reusable. It still does not

take into consideration the risks associated with reusing a singleuse device. So, my comment to the committee would be, be very

careful about these exemptions. They have not taken the risks into

consideration. They should not stand.

Ms. ESHOO. Thank you.

Mr. O’HOLLA. Does that help?

Ms. ESHOO. It does help. Thank you.

Mr. O’HOLLA. Okay.

Ms. ESHOO. It is clarifying and it is an important part of the

record. Thank you to all of you and to Mr. Chairman.

Mr. UPTON. Thank you. I have got a number of questions left and

I know Mr. Stupak is back and so I would expect the same as well.

What is the number of single-use devices that are reprocessed

about, percentage wise? Mr. O’Holla? Mr. Maurer, at the Cleveland

Clinic?

Mr. MAURER. I can comment at our institution. We have just

done a recent review of that. It is very hard to give an exact percentage, but of all devices that go through sterile processing, and

that is what we are talking about. I think, you know, Ms. Eshoo’s

174

comment is: Let us get away from this reuse of single-use devices.

We are talking about sterile processing of devices, period. It is less

than 1 percent, maybe even less than 1⁄10th of a percent.

Mr. UPTON. Mr. Feltner?

Mr. FELTNER. Yes. Overall it is very small. In fact, on the list

that FDA published of commonly reprocessed devices, AMDR members do not do half of them.

Mr. UPTON. Well, that is my other question. In fact, I was going

to ask Dr. Maurer, you know, as I look at—and you are a terrific

witness. The Cleveland Clinic is up at the very top, so we are glad

that you are here and I know my hospitals of Michigan are very

good as well, and I am anxious to see exactly what they are doing.

But of the devices that you watch over, how many of them will be

sent out to one of the AMDR member versus what you do in-house?

Mr. MAURER. Most of the reprocessing is in-house. When it gets

down to a critical device, the saw blades like I showed you, we send

out. Now, the electrophysiology catheters, what if you were better

at that. They are contained within the department of

electrophysiology, there are trained people there, we have looked at

them, we have continuous process control upon them. You have got

to remember in terms of sterile processing, hospitals have done

that ever since they opened their doors hundreds of years ago and,

you know, Halsted decided that things should be sterile. That we

should wear gloves. Hospitals do that, they are professionals in

that. The people are trained. You cannot walk into those areas unless you are supposed to be there.

Mr. UPTON. And Mr. Feltner, as your organization brings things

in, and obviously some things fail, what percentage of that? I

mean, obviously if the average of——

Mr. FELTNER. It varies by product as you—I mean, saw blades,

for instance. I mean, you cannot drop one and break it generally,

but other products you could. So I would say we have some products as high as 60 percent rejection. Other products as low as 10

percent rejection. But I think there is something here that I am not

comfortable that we are all speaking in the same language, because

here is the thing.

Mr. UPTON. I know there are a lots of oranges and apples here.

Mr. FELTNER. Yes. One thing though that is very important that

we have common language on. I am hearing a lot of concern that

these devices that we are talking about I could not possibly think

of having a device put in my body that was in the body of a previous person. Well, then you better never go to a hospital because

every procedure that I have ever seen, someplace in that procedure

is a product, whether it is reprocessed, or reusable, or new, that

has been used on another patient. So what we are really saying is

oops, I did not mean to say that I meant to say if it is single-use.

Mr. UPTON. Well, this happened. Yes.

Mr. FELTNER. Now, what we are saying then is we have two different standards of sterility. We have two different standards of

cleanliness. One for a product marked single-use, and one for a

product marked reusable. Well, that does not make any sense because the standard for validating the sterility of either product is

the same. So, I think we have to look at this. Once a product is

out of the package it has to meet the same standard. We were talkVerDate 11-MAY-2000 13:34 Aug 23, 2000 Jkt 063453 PO 00000 Frm 00178 Fmt 6633 Sfmt 6602 E:\HEARINGS\62970 pfrm08 PsN: 62970
175

ing about which one would be exempt. The example just talked

about. One of Dr. Maurer’s saw blades would be exempt and one

would not. Why? Because the manufacturer chose to label one single-use. It just so happened he sold the same one as reusable last

week. Which one do you exempt?

Mr. UPTON. When an AMDR member rejects a product, is there

some reporting of that? Do they go back to the OEM?

Mr. FELTNER. We manifest everything that we must turn that

into medical waste or hazardous waste.

Mr. UPTON. Right. Right. But do you report back to the original

manufacturer or to the FDA?

Mr. FELTNER. Oh, yes. Sure. Well, not back to the manufacturer.

No. We report back to the hospital who sent it to us. See, that is

another thing I want to make sure we understand. Hospitals who

send products to us only get their products back. These are never

owned by us. We do not sell products.

Mr. UPTON. Right. I understand.

Mr. FELTNER. So when they send us 50 saw blades and we reject

five, they know that. We send them back and say we rejected five

of these. We are shipping you 45 back.

Mr. UPTON. Well, what happens with devices that are used on

someone with a disease like Hepatitis or HIV, what happens to

those—are those automatically out of the stream? Are they reprocessed still? What type of——

Mr. MAURER. Well, I can tell you, we have a policy in terms of

sterilization that is the same for everything, because you do not

know who has the Hepatitis.

Mr. UPTON. Right.

Mr. MAURER. It was spoke about here that it may take 6 months

to develop.

Mr. UPTON. But what if you do know that somebody has that?

What if you do know that somebody has HIV, are any of those

products that might have been used in that individual’s body? Are

they still processed with maybe more care? I mean, what happens?

Mr. MAURER. The processing is the same. The processing will kill

HIV. It has got to because you do not know if they have it. It has

got to. Now, to be frank, when I am in an operating room and I

know the patient has got HIV, yes. I double glove and, you know,

obviously that is just normal. But we cannot rely on that, so our

processing has to be enough to kill that bug, no matter if we knew

it or not.

Mr. UPTON. As I go back to, and I am going to use, you know,

one of Mr. O’Holla’s, I guess it is the lower picture there which is

the tip of a catheter, is that what that is?

Mr. O’HOLLA. Ablation catheter, yes.

Mr. UPTON. Ablation residue, and I presume that this device that

you came back to get had been reprocessed, right?

Mr. O’HOLLA. Yes, it had.

Mr. UPTON. So it was not perfect.

Mr. O’HOLLA. That is right.

Mr. UPTON. And if that individual whose residue is still there,

in fact, had HIV or something else infection like that, it would be

more than trouble?

Mr. O’HOLLA. I would think so.

176

Mr. MAURER. Two things. You have got to look at what the process is that delivered that to the physician. You know, it is probably

not a good process. You also have to remember that residue does

not always equal infection as was shown in some of the studies.

Mr. O’HOLLA. Right.

Mr. MAURER. Now, it is yucky. I agree and it should not be there

and I would not want it in me. Okay. Absolutely. But you have got

to look at the process. That is a good quality control. If that is coming out, the process needs to be looked at. The process needs to be

improved, but do not throw out the baby with the bath water. We

are not going to throw out reprocessing because the process is bad.

That is where the data needs to come from, from the FDA, and

that the processes are certified as not producing that product.

Mr. UPTON. Well, I guess as us novices sit up here on this dais,

we want something that is going to work so that that does not happen.

Mr. MAURER. That is true.

Mr. UPTON. And we want some good housekeeping seal or something along those lines to ensure the safety to the patients, as well

as to the hospital workers that are using those particular products.

My time has expired here so I guess I go to Mr. Stupak.

Mr. STUPAK. Thank you Mr. Chairman. Dr. Fielder, in delineating patient alternatives, you used the example of offering a patient the choice between a used or reprocessed SUD with no difference in the cost to the patient. Would it follow then that a patient should be offered the same choice in a situation of two brand

new devices, or one that costs the hospital less and at a smaller

potential risk?

Mr. FIELDER. If I was a patient and they came at me and I had

a choice between a new single-use device and a reprocessed one, I

would take the new one, sure.

Mr. STUPAK. Sure. But I am saying should they be offered that

choice?

Mr. FIELDER. Yes, they should.

Mr. STUPAK. Okay.

Mr. FIELDER. Because it is an alternative treatment.

Mr. STUPAK. But on two new ones, where one would cost less,

both new, if there is one cost——

Mr. FIELDER. If there is no significant difference in risk, then

that is the choice of the physician and the hospital. In the case of

reprocessed devices, there is a significant risk. That crud that you

see on the ablation catheter could be Hepatitis C that you are

going to put into somebody else, so that is a risk. We do not know

how high the risk is, but it is a risk.

Mr. STUPAK. If you have two new devices, brand new, and the

question assumes a small potential risk with using one or the

other, the patient should be made aware of that, right?

Mr. FIELDER. Not necessarily. I mean, there has to be some kind

of, I mean, there is some risk in everything.

Mr. STUPAK. Sure.

Mr. FIELDER. And there is some level, as Dr. Trotter was saying,

that the Courts have used the idea that material risk, is this something that the patient would want to know as part of his or her

decision to have this treatment? So there is a kind of floor or level

177

beyond which the risks are so remote that that does not really matter and people need not to be informed. They need to be informed

if this is part of their decision in their lives and in their healthcare.

And I think the fact that we do not have a well controlled cleaning

and sterilization process that has been approved by FDA, means

that there is a significant risk that people ought to know about so

they can decide if they want to go along.

Mr. UPTON. Mr. Feltner?

Mr. FELTNER. Yes. That is not entirely correct because all of the

processes in commercial reprocessing are validated and the FDA

has standards for sterilization validation. Now, if we ask or have

the doctor get patient consent for every product that has been used,

are we going to get patient consent for every reusable product?

Every product has a life. We just do not happen to know what it

is. I have seen $4,000 instruments sold as reusable break on the

first case. They were not meant to be disposable. They just happened to be that time. So we never know. Well, we say oh, take

this out of circulation because next time it is going to break. We

do not know that. So all of these products that are being reprocessed should they have patient consent as well?

Mr. STUPAK. Well, should a patient be asked their consent on

whether they want a new one or reprocessed one?

Mr. FELTNER. If we do that we will run out of money by 7 this

evening.

Mr. MAURER. Let me explain a little bit about patient consent because I do it every day. Every day I do anesthesia on somebody,

I have to consent that patient. Okay. These people are very nervous. They are coming in for surgery on their bodies. Okay. What

they want is quality care delivered to them in a safe environment.

That is all our jobs here is to make sure that the regulatory, that

the laws, that the FDA, that the licensing to be a physician, is done

properly. Okay. I consent them for the serious parts of their procedure that they need to consent to. Okay. I tell you, to shirk our duties and think that somehow the consent issue is the primary one

and that is going to solve this, is not going to work. Okay. We

should consent patients. We should inform them, but when the risk

is very low, and that is the thing that we are arguing here on either side, is how high is the risk. When the risk is very low and

that risk is documented by valid data, then let us not confuse the

issue with consent.

Ms. WEST. Excuse me. I want to know if there is a reused device

going to be put into my body. I have suffered for 17 years because

a C-arm was reused when they originally did the surgery on my

head. And whether we run out of money or not, then we need to

find another way to do that. But as a patient, I want to know if

I am being given a reused or a clean device. And then in addition

to that, I need to ask to be excused as I am supposed to be over

at the Senate at 3 and I apologize for this, but my opinion is that

I want to know. And I have many years of experience because I

was not told, I was not given the option and everybody should be

given the option.

Mr. STUPAK. Dr. Maurer, if I may, just a point of clarification on

a question and answer with Ms. Eshoo. Maybe I misunderstood it.

178

But I understand that, Ms. West, you can go. Right, Mr. Chairman,

she can go?

Mr. UPTON. Yes.

Mr. STUPAK. I understand that the Cleveland Clinic passes along

savings of reprocessing to the government and the patient, but

where does the Cleveland Clinic reduce cost by reprocessing? I got

the impression that there was a reduced cost that was passed on

to the patient and the Government, so where does the Cleveland

Clinic reduce the cost by reprocessing?

Mr. MAURER. Well, if you reduce the cost and you deliver the

same quality, you increase your value. And that is reflected in your

market share because you then, the patients come to you more because you are delivering better value. So that is where the advantage is.

Mr. STUPAK. Okay. So it is not, that is value to the Cleveland

Clinic then?

Mr. MAURER. That is right. Now in some instances, in terms of

going out in the marketplace and then negotiating a managed care

contract, if we can do it at a lower cost, we offer a lower managed

care contract, as long as we deliver the same quality and can certify that quality to the people that are paying us, and we get the

contract.

Mr. STUPAK. Okay.

Mr. UPTON. Dr. Ganske.

Mr. GANSKE. Thanks Mr. Chairman. I want to go back to a question I asked Dr. Feigal, and it looks to me like we have a cardiologist on this panel, and I apologize for not being here earlier, but

I had some other meetings I had to be at. We have somebody from

the reprocessors, and the manufacturers. And now Dr. Maurer, are

you representing the American Hospital Association?

Mr. MAURER. I have been asked to come here on their behalf,

yes.

Mr. GANSKE. Okay. Let us go to this situation where we have a

catheter used for balloon angioplasty to crack open a stenosis in a

coronary artery. That little balloon, you know, is made of an inflatable material. It is manufactured, in my understanding to under a

certain pressure go to a certain size, there are different techniques

for sterilization, one of which though is a heat sterilization. The

other would be a gas, but then you are also dependent on very meticulous cleansing, manual cleansing. I want to know specifically,

does this panel think that the average hospital, I am not saying

some hospitals cannot, but the average hospital, can they re-sterilize those catheters, and I am not talking about the reprocessors.

I will get to that in a minute. But the average hospital, can they

re-sterilizing that balloon catheter, with a proper sophistication, to

be able to certify that after multiple uses this catheter is up to par.

Mr. MAURER. Well, I can tell you that I cannot comment nationally, and I do not have the data on it, but in my hands, when I

open a Swan-Ganz catheter with a balloon on it, even if I do not

put it into the patient it goes in the trash. We do not even re-sterilize those that are open and not used because we have that concern.

Mr. GANSKE. So it is a Swan-Ganz?

179

Mr. MAURER. Well, it has got a balloon on it. That is what I have

in my hands.

Mr. GANSKE. All right. I am talking about are balloon

angioplasty catheters reuse?

Mr. MAURER. We do not reuse those at the Cleveland Clinic, no.

Mr. GANSKE. Are they reused, do you think they are reused anywhere?

Mr. MAURER. You can ask our cardiologist.

Mr. GANSKE. Yes.

Mr. LINDSAY. I’m Dr. Lindsay. There are some hospitals that

reuse these catheters. My hospital does not, and I have some reservations about whether the data would support reusing those. I

think there are some of these devices that probably should not be

used. And I think as the FDA looks at them, that is one of the devices that I have questions about.

Mr. GANSKE. Mr. Feltner, what would your response on that be?

Mr. FELTNER. Some AMDR members reprocess balloon catheters,

and when they do they use FDA published guidelines that assure

bio-compatibility and physical testing. One company I know that is

an AMDR member, they tested over 8,000 balloon catheters before

they ever shipped their first one back to the hospital. And I am told

now that they have processed over 3,000 without an incident.

This——

Mr. GANSKE. Does this require some special type of technology

and expertise to do that?

Mr. FELTNER. Oh, yes. It will require special technology, special

equipment, but I think here what we are really getting to

though——

Mr. GANSKE. Let me just ask you.

Mr. FELTNER. Yes.

Mr. GANSKE. Do you think the average hospital has that type of

technology or equipment to do?

Mr. FELTNER. I would not think, and I use the word think, I

would not think that today many hospitals would have all that

equipment, but this is where we really need to zero in on the answer here. And the answer is process. Validation. I am aware of a

major institution reprocessing in-house pace makers from cadavers.

Now, that sends a little hair up my back when I first heard that

and I heard no. If the process is right, if the cleaning is validated,

if the sterilization is validated, and the functional testing is to a

standard that could be validated, the process is good. Now, many

companies may chose, or many hospitals may chose not to reprocess a product simply because of our litigious society. There are certain products that maybe the risk of a legal problem is greater

than the possible return of the market.

Mr. GANSKE. Okay. Well, let me just follow this. I want an answer from everyone on the panel on this. Is the panel in consensus

that at least for some types of single-use products that the re-sterilization should be done, not by hospitals, but only by certifiable reprocessors?

Mr. MAURER. The hospitals could get certified if they had enough

volume to get all the same equipment.

Mr. GANSKE. Okay. But they would have to go through a—that

for some types of single-use products they ought to go through FDA

180

certification process. Is there any disagreement with that on this

panel?

Mr. GROSSMAN. I would disagree because I think that the FDA

themselves are saying that what they are going to finally focus on

is the data that not what the process might have led to, but what

actually happened. Because that is the burden they put when these

products are originally created. The Office of Science and Technology recently did a study they presented publicly in May looking

at the kind of catheters to which you refer. Took them from Walter

Reed instead of discarding them in the garbage and performed

functional testing and showed that they were a disaster. They were

a disaster. The balloons changed compliance, changed shape, became sticky, so I think since——

Mr. GANSKE. So, you are agreeing with me?

Mr. GROSSMAN. Well, I am saying I do not think the process will

protect it by saying you have handled it well. I think the FDA then

needs to actually go to the device and say now that it has been

processed, we are going to say that it is safe and effective just like

we did when it was new.

Mr. GANSKE. Well, right. I am assuming that if it is

processed——

Mr. GROSSMAN. Oh, okay.

Mr. GANSKE. That if it is processed that the process certification

says that it works, not that you can just have a sterile one—but

now it inflates to 3 millimeters instead of 2.5. Okay.

Mr. GROSSMAN. Yes.

Mr. GANSKE. So, at least the entire panel is in consensus that

there are probably some sophisticated devices that are in use that

it would be inappropriate for a hospital to be reprocessing and

sterilizing themselves unless they have some extraordinary reprocessing/processing capability, and that these are items that could be

identified by the FDA. Is that fair?

Mr. MAURER. It out to be a functional definition. I worry about

location because things change over time. You know, so I think it

is a functional definition. If you cannot meet the standard, then

you should not be doing it no matter who you are.

Mr. GANSKE. Yes.

Mr. O’HOLLA. Congressman Ganske, I do not know if FDA can

actually identify those a priority. I know that FDA can make a

judgment about those if the person who wanted to do the act came

to FDA and said I am going to reprocess this particular device this

way and here is the data that shows it is safe and effective. I think

they can evaluate that. I think you may be asking them to do an

impossible task to identify a priority which devices can and cannot

be done, because they do not know what people will be doing to

them.

Mr. GANSKE. Okay. Let me get to my second question. And you

know, pictures like this are disturbing to all of us, but matters of

thoroughness, of cleansing can vary between let’s say hospitals and

professional reprocessors. Is there anyone that would disagree with

that?

Mr. MAURER. Well, I think it can vary hospital to hospital. It can

vary reprocessor to reprocessor.

181

Mr. GANSKE. Right. But how many reprocessors are there in the

country?

Ms. ESHOO. They do not know.

Mr. FELTNER. I cannot really say. I hear some stories that are

amazing. I do not know if they are—somebody said there are 23.

If there are, I do not know who they are. There are three major

processors that are members of AMDR. I think that as FDA implements the proposed guidelines, they would all have to register, and

then we would definitely know who they were. We have cooperated

with FDA in giving them all the companies that we know of.

Mr. GANSKE. Well, are were talking about less than 20?

Mr. FELTNER. Oh, yes. Yes. Yes.

Mr. GANSKE. Okay. And how many hospitals are there in the

country?

Mr. FELTNER. Six thousand, roughly.

Mr. GANSKE. It would be a lot easier to oversee whether less

than 20 reprocessors are doing their job properly than to be thinking about looking at, for single-use devices, particularly the ones

that can be identified as problematic, 6,000 hospitals. Does not that

seem reasonable?

Mr. MAURER. On the surface, yes. Okay. But you have got to

watch because, you know, hospitals have very good sterile processing departments and quality control systems in place, and those

are well set up. They are supervised by Joint Commission and

State health boards, and it is not just the FDA that is getting in

on this. You know, processing and sterile processing has been

around for years.

Mr. GANSKE. I understand. I am a surgeon. I have worked with

instruments all my life.

Mr. MAURER. You know what I am talking about. We have got

to look at those ones which are borderline, and we do not have the

data on, and if they require functionally specialized techniques and

the hospital cannot deliver that specialized technique, then a specialized person needs to do it. And if that is a reprocessor, then so

be it.

Mr. GANSKE. I agree. Thank you. Thank you Mr. Chairman.

Mr. UPTON. Thank you. Ms. Eshoo, do you have additional questions?

Ms. ESHOO. Yes. Mr. Chairman, I would like to make a request

and that is that if Dr. Maurer for the committee’s record could submit to us copies of the hospital’s billings that show the rates that

are billed to HCFA when a reused device is used versus the other.

Because I think it will show, you know, it is a demonstration and

an example of the billing. And I also think that when we look at

these things that are submitted for the record that we understand

that while you may be doing that at your hospital, we do not know

what is happening at others.

Mr. MAURER. We can do that.

[The following was received for the record:]

182

183

Ms. ESHOO. And I think that this patchwork quilt of issues has

really been nailed down with me today. That we have some reprocessors that are absolutely terrific. The gentlemen that represents

them as a trade association cannot tell us how many there are in

the country. We do not know how many hospitals adhere to the

high standards that Dr. Maurer has talked about, nor do we have

information and data that has been collected by the FDA, not the

associations and the groups around all of this. They simply have

not tracked and collected the data that we could weigh and measure in a hearing like this. So, it is a patchwork quilt. I think that

there are some problems out there. We do not know in the reuse

of these devices if, in fact, the record that we know about

anecdotally is the best record of all. I mean, maybe that is the perfect good news. It is not perfect, but there is a lot of good news in

it because people with legitimacy can say well, we do not have that

many problems in the country. But do we really know that? So I

think that this hearing was designed, or really offered us, what

Congressional investigation and oversight is really meant to be. It

has answered some questions, it has raised others, and because of

each one of you I think that we are going to move on and keep examining this, at least I will. So thank you very much. And thank

you again, Mr. Chairman, for allowing me to be here today and for

the legislative courtesies that have been extended to me, and your

patience as well. Thank you.

Mr. UPTON. Thank you. Again, I appreciate all of your testimony

and your answers. We would be most interested in the future as

you comment back to the FDA with regard to the regulations that

they put out. You have done a fine job today and you are formerly

now excused. Thank you.

[Whereupon, at 2:58 p.m., the subcommittee was adjourned, to

reconvene at the call of the Chair.]

[Additional material submitted for the record follows:]

PREPARED STATEMENT OF NATIONAL CONSUMERS LEAGUE

The National Consumers League is a national, nonprofit consumer advocacy organization founded in 1899 to represent consumers in the marketplace and workplace.

NCL commends the Subcommittee on Oversight and Investigations for holding this

hearing. As you examine the complex issue of medical device reprocessing, we want

to bring to your attention important consumer implications of this issue.

NCL believes that Congress must do all that it can to assure that the Food and

Drug Administration is doing its job to protect public health. We believe that the

Commerce Committee is moving in the right direction as it investigates and oversees FDA’s regulation of medical device reprocessing. The safety of medical device

reprocessing must be the overriding concern of Congress, the FDA, hospitals, and

physicians. Clearly, no amount of health care cost savings can be justified if safety

is compromised.

In our view, the medical device reprocessing debate concerns two very different

interests: the interests of consumers who expect safe health care practices and the

interests of the medical device manufacturers who are working very hard to eliminate competition.

First and foremost are the interests of consumers. Through appropriate regulation, FDA must assure that medical device reprocessing is safe. Consumers must

have confidence that when a reprocessed medical device is used in a procedure, it

will perform as safely and effectively as it would on its first use. Consumers should

be assured that they will not experience an infection or health complication because

a device was reprocessed.

Once it is determined, through sound science, that medical device reprocessing

can be safely performed and is adequately regulated, then and only then should the

cost savings that such a practice provides be considered. Faced with overwhelming

184

cost pressures, hospitals are increasingly reducing staff and scaling back on the procedures they will perform. For many consumers, the result has been lower quality

and less affordable health care. Measures that can help control health care costs

must be encouraged but should never be considered if patient care is compromised.

As you know, medical device reprocessing is a practice aimed at reducing costs

associated with medical devices labeled as ‘‘single use’’ or ‘‘disposable’’ by the manufacturer. We understand that many hospitals have been reprocessing ‘‘single use’’

devices for years and that a number of hospital and physician groups have sent letters to Congress expressing confidence in the safety and effectiveness of reprocessed

devices.

FDA has a strong tradition of protecting the public health based on sound science.

As FDA reviews its regulatory approach for medical device reprocessing, we expect

the agency to continue this tradition. Even though there has not been any significant evidence of a public health hazard to date, FDA should be thorough and vigilant in its regulation of device reprocessing and should take a strong regulatory posture that is systematic, based on science and based on risk. If effectively enforced,

FDA’s current regulatory regime affords consumers appropriate protection. FDA’s

Quality System Regulation, which governs the reprocessing of medical devices by

third parties, is similar to good manufacturing practice regulations and sets forth

requirements designed to assure that reprocessed medical devices are clean, sterile,

and functional. Through inspection, FDA must assure compliance with all of the

QSR requirements, including process validation, acceptance activities, internal audits, personnel training, storage, and complaint handling. By requiring those engaged in the reprocessing of medical devices to withstand the scrutiny of FDA inspection, consumers can have assurance that reprocessed medical devices are clean,

sterile, and functional.

We understand that FDA is reviewing its policy to require premarket review of

reprocessed medical devices. To date, the agency has not believed premarket review

is necessary to protect the public health. If risk warrants premarket review for certain device reprocessing, FDA should require it. NCL also believes consumers deserve more information about the risks and benefits with all health practices, including procedures that involve using all devices. FDA should work with consumer

and patient advocates to ensure that the messages patients receive are accurate and

thorough. To that end, statutory requirements for informed consent—in consumer

friendly language to assure that the consumer understands—should be more broadly

applied so that consumers may assess the relative risks of a procedure or a particular device. The FDA should require that all significant risks trigger an informed

consent requirement. In this way, consumers will receive relevant information, communicated both orally and in writing in consumer friendly language, and the information that they receive will be put in the proper context with respect to their own

health care regimen.

As mentioned, the issue of medical device reprocessing touches on two different

interests: the interests of consumers and the interests of the medical device manufacturers. As the Subcommittee studies the safety of medical device reprocessing, we

urge you to take note of the strong opposition to reprocessing voiced by the manufacturers of ‘‘single use’’ devices. You should be aware that the term ‘‘single use’’

is a term that is chosen by the manufacturer of the device; it is not required by

the FDA. There is a clear economic incentive to label devices as ‘‘single use’’ in order

to sell more devices.

As Congress considers the issue of medical device reprocessing, it should make

sure that FDA has a sound science-based regulatory procedure for medical device

reprocessing in place that will protect the public health and assure consumers that

the devices used for their health care are safe and effective.

Æ