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S. Hrg. 106-656 REPROCESSING OF SINGLE-USE MEDICAL DEVICES HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED SBCTH CONGRESS SECOND SESSION ON EXAMINING THE SAFETY AND EFFECTIVENESS OF CERTAIN MEDICAL DEVICES, FOCUSING ON THE PRACTICE OF REPROCESSING AND REUSING CERTAIN MEDICAL DEVICES THAT WERE DESIGNED, MANU- FACTURED, AND APPROVED BY FDA FOR USE IN A SINGLE PATIENT, DURING A SINGLE PROCEDURE JUNE 27, 2000 Printed for the use of the Committee on Health, Education, Labor, and Pensions U.S. GOVERNMENT PRINTING OFFICE 65-328CC WASHINGTON 2000 : ForsalebytheSuperintendentofDocuments,CongressionalSalesOffice U.S.GovernmentPrintingOffice,Washington,DC20402 COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS JAMES M. JEFFORDS, Vermont, Chairman JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts BILL FRIST, Tennessee CHRISTOPHERJ. DODD, Connecticut MIKE DeWINE, Ohio TOM HARKIN, Iowa MICHAEL B. ENZI, Wyoming BARBARAA. MIKULSKI, Maryland TIM HUTCHINSON, Arkansas JEFF BINGAMAN, New Mexico SUSAN M. COLLINS, Maine PAUL D. WELLSTONE, Minnesota SAM BROWNBACK, Kansas PATTY MURRAY, Washington CHUCK HAGEL, Nebraska JACK REED. Rhode Island JEFF SESSIONS, Alabama Mark E. Powden, StaffDirector Susan K. Hattan, Deputy StaffDirector J. Michael Myers, Minority StaffDirector and ChiefCounsel (II) CMS Library C2-07-13 7500 Security Blvd, Baltimore, MMt/m^JltZML^. CONTENTS STATEMENTS Tuesday, June 27, 2000 Page Jeffords, Hon. James M., Chairman, Committee on Health, Education, Labor, and Pensions, opening statement 1 Eshoo, Hon. Anna G., a Representative in Congress from the State ofCalifor- nia 2 Prepared statement 4 Feigal, David W., Jr., M.D., M.P.H., Director, Center for Devices and Radio- logical Health, Food and Drug Administration; Rockville, MD; and Janet Heinrich, Dr.Ph., R.N., Associate Director, Health, Education and Human ServicesDivision, GeneralAccountingOffice, Washington, DC 6 Prepared statements of: Dr. Feigal 9 Ms. Heinrich 16 Kennedy, Hon. Edward M., a U.S. Senator from the State ofMassachusetts, opening statement 21 Prepared statement 22 Collins, Hon. Susan M., aU.S. Senatorfrom theState ofMaine 27 Prepared statement 27 Dodd, Hon. Christopher J., a U.S. Senator from the State of Connecticut, opening statement 29 Prepared statement 30 Torrente, Josephine M., M.S., J.D., president, Association of Disposable De- vice Manufacturers, Washington, DC; John Clough, M.D., on behalf of the American Hospital Association, chair, division for health affairs, Cleve- land Clinic, Cleveland, OH; Vera Feltner, on behalf of the Association of Medical Device Reprocessors, president, Alliance Medical Corporation, Ashville, NC; and Anne Cofiell, International Association of Healthcare Central ServiceMaterialManagement, Mt. Laurel, NJ 39 Prepared statements of: Ms. Torrente 22 Dr. Clough 50 Mr. Feltner(with an attachment) 55 Ms. Cofiell 64 Tyco Healthcare, Larry Gibbons, vice president, quality assurance and regu- latoryaffairs, prepared statement 74 American College ofCardiology, prepared statement 75 NationalConsumers League, prepared statement 80 American Society ofCataractand Refractive surgery, prepared statement 82 ADDITIONAL MATERIAL Articles, publications, letters, etc.: Responses of Dr. Feigal to questions asked by Senators Jeffords, Frist, and Hutchinson 83 Responses ofDr. Heinrichto questionsasked bySenatorJeffords 90 Responses ofMs. Torrente to questions asked by SenatorFrist 92 Responses ofDr. Cloughto questions askedby SenatorFrist 94 ^Responses of Mr. Feltner to follow-up questions by Senators Jeffords andFrist 95 Six abstracts and presentations by FDA staffpresenting research results on thereuse ofsingle-use medicaldevices 97 Jeffords, Hon. James, from JosephineTorrente, datedJuly 7, 2000 Ill Comments from the Association of Disposable Device Manufacturers to the draft guidances entitled: "Reprocessing and Reuse of Single-Use Devices" 113 — — (in) ~- REPROCESSING OF SINGLE-USE MEDICAL DEVICES TUESDAY, JUNE 27, 2000 U.S. Senate, Committee on Health, Education, Labor and Pensions, Washington, DC. The committee met, pursuant to notice, at 10:05 a.m., in room SD-430, Dirksen Senate Office Building, Hon. James Jeffords, chairman ofthe committee, presiding. Present: Senators Jeffords, Frist, Collins, Kennedy, Dodd, and Reed. Also Present: Senator Durbin. Opening Statement of Senator Jeffords The Chairman. Good morning. The Committee on Health, Edu- cation, Labor, and Pensions will come to order. Welcome to the committee's hearing, "Reprocessing of Single-Use Medical Devices." I would like to extend a special welcome to our colleagues, Senator Durbin, who will be participating in the hearing a little later, and Representative Eshoo, who will be addressing the committee in a few minutes. The American public relies on the Food and Drug Administra- tion, FDA, to ensure that the medical devices used by doctors are safe and effective. Over the past several years, legitimate concern has been raised regarding the practice of reprocessing and reusing certain medical devices that were designed, manufactured, and approved by FDA for use in a single patient, during a single procedure. Some have argued that, in some instances, reprocessing can be a safe means to achieve financial savings in the health care sys- tem, while others have argued that the practice lacks proper oversight by FDA and presents an unreasonable risk to patient health. Last year, I was joined by a number of my colleagues from this committee in requesting the General Accounting Office, GAO, to initiate a comprehensive evaluation of this practice in the United States, so that we could put this practice into proper perspective. Senator Durbin also requested a study, and GAO agreed to answer both requests with the report that we will hear about today. We asked the GAO to look into a number of aspects of this practice, including how widespread the practice is; the economic impact; the role of the FDA; and, most importantly, what evidence can be found regarding the threat to public health associated with the practice ofreprocessed, single-use devices. (l) 2 The report that GAO will present today is largely inconclusive, but I think it raises questions about the regulatory process and the lack of information on the process and the practice. I hope that by the conclusion of today's hearing, we will have a better sense of what questions are left unanswered and what Congress and FDA can do to answer these questions; but whatever the questions and whatever the conclusion, the one question that must remain para- mount is what course of action is in the best interest of these patients? I look forward to today's testimony and to constructive interaction with our witnesses as we all try to get to the goal that we share: protecting patient safety. On our first panel this morning, we are glad to welcome Rep- resentative Anna Eshoo of California. Congresswoman Eshoo, the committee is very pleased to welcome you here today. Please pro- ceed. STATEMENT OF HON. ANNA G. ESHOO, AREPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Ms. Eshoo. Thank you and good morning to you, senator. I appreciate the invitation to come over and to testify on this important issue and to all the rest of the members of this distinguished committee who are not here yet this morning. This is something that I know that you have pursued, as other members ofthis committee have, and I am pleased to be here. I have much to say on the issue, but in the interest of brevity, I have condensed my oral statement and I ask that my full written statement be made part ofthe record. The Chairman. It will be. Ms. ESHOO. Thank you. It is estimated that as many as one in every three hospitals in our country are reusing medical devices on patients without their knowledge or consent. Reuse ofdelicate medical devices like balloon catheters and biopsy forceps have been linked to patient injuries and infections in our country. A 50-year- old woman needed surgery when two reprocessed catheters broke during a brain scan. Premature babies have suffered infections from unsterile sutures. As recently as February of this year, an elderly woman in Florida suffered significant complications when a reprocessed forceps device failed during a routine procedure to remove kidney stones. Reprocessors tell us that reprocessing is perfectly safe. They will testify today that the GAO report found little evidence that reusing devices intended for single use only causes infection or injury. What we are not told, however, is that we have very little information about the scope of patient injuries because we do not require patient consent and hospitals do not have to track whether a reused device was involved in an adverse event. We cannot say defi- nitely whether reprocessing is safe or not because there has been virtually no oversight ofthe practice over the last 20 years. FDA clearly has the authority to enforce premarket safety and effectiveness requirements, yet in my view it has essentially looked the other way. There is nothing on the books that prevents hospitals from using a reprocessed device on a patient without their knowledge or consent and nothing is required to prove that the device is safe and effective and nothing prevents a hospital from 3 charging the patient and the Federal Government through Medi- care for a new device when a second one is used. When we buy a part for our automobile, the mechanic is required to tell us if the part is new or rebuilt and we are charged accordingly. I think that our laws can do a much better job or they do a much betterjob ofcovering car parts than protecting patients. Last November, I intro—duced the Reprocess—ed Single Use Medical Device Patient Safety Act that is H.R. 3148 because I saw a failure on the part of our government and the FDA to address the safety of reprocessing in a very meaningful way. The bill ensures the protection of patients by requiring reprocessed medical devices to meet the same safety and effectiveness standards that new products must meet. H.R. 3148 will also increase awareness about reprocessed devices by requiring a patient's informed consent before a single use medical device may be used on them and also requiring hospitals to monitor and report injuries or infections that occur as a result. When FDA approves the device for single use only, that is exactly what it means, that the data submitted by the manufacturer has shown that this device can be safely used one time only. Thus, a company that reprocesses the device and reuses it multiple times should be required to inform the patient that they are not getting what the label advertises. These labels should mean exactly what they say: single use means single use. A reprocessed single-use device is a multiple use device and the label should say so. Ifnot, patients, in my view, should be informed and their consent requested. I am encouraged that FDA has finally developed a proposed policy requiring premarket approval for all reprocessed devices. How- ever, I remain concerned that they may not follow through with this approach. I understand that in recent speeches that FDA officials have indicated that the agency will not require PMAs or 510(k)s to demonstrate that the devices can be safely and effectively reprocessed multiple times. If, in fact, there is backtracking, I would call that into question. I am concerned that it is yet another indication that the agency will not bring about true enforcement of the data requirements on reprocessors and I think that that is not good for patient care and quality care in our Nation. The GAO report raises significant questions in my view about the safety of reprocessing and the need for meaningful oversight of the practice. One, without premarket approval, how do we ensure that all reprocessed devices undergo carefully controlled reprocessing? How do we determine which single-use devices can be reprocessed safely and which ones cannot? Should we leave it up to the very industry that obviously its bottom line is a profit, which we We recognize? respect that in our country, but I do not think that that is good enough. Without informed consent and tracking, how will we know when reprocessed devices have been used safely or not? Mr. Chairman, I look forward to working with you. You have given great leadership on this issue with the rest of this distinguished committee to finding a thoughtful solution that will be effective for the American people and also that the industry, I might say, will be able to go out and be able to say with great confidence 4 that these devices by the very process of approval are safe for patients and the hospitals that use them across our Nation. So I thank you for this generous invitation to testify and I look forward to moving this legislation forward. The Chairman. Well, thank you very much. You stated the problem very astutely and accurately, and we look forward to working with you. We have several witnesses this morning who will give us more information. And if the FDA adequately regulates this process so that safety is guaranteed, do you think informed consent is still necessary? Ms. Eshoo. I think it is a very important point to raise and I raised it in the legislation because most frank—ly there is not anything on the books. I am pleased that the FDA that there is some movement. But I think if there is not a process by which the patient, the consumer, so to speak, is guaranteed that they are safe, then I think the consent has already been given by the government, so to speak, that they can stand behind the product. But there is not anything today, and that is very disturbing. It is very disturbing, and there is an irony that these devices are called single-only use, but it does not live up to the advertising. So I think that we have a ways to go on this, and I know that people, the industry, do not like the informed consent. I do not like to alarm people and I think that anyone that goes into the hospital, whatever it is, their anxiety level is probably raised. Whether someone is going to wave a label before then is questionable and I think that to layer on something else in terms of their anxiety to say that what is going to be used on them is questionable do they want it used or not? But the fact ofthe matter is is that today these devices are being used. They do not know the status ofthem, and I think that as legislators, we are casting the light on this and that we can do much, much better in this country. Certainly the incidences that have occurred are serious enough to warrant our stepping in legislatively. So I think that if we can cover all the other bases, that maybe informed consent will go away, but I think that we still have a ways to go before we achieve that. The Chairman. Thank you very much. Ms. Eshoo. Thank you. The Chairman. A pleasure having you with us, and we look forward to working with you. [The prepared statement ofMs. Eshoo follows:] Prepared StatementofRepresentative Eshoo Thank you, Mr. Chairman and Senator Kennedy for holding today's hearing on theveryimportantissue ofreuse ofsingle-use medical devices. I come to this issue from the perspective ofboth a legislator and a consumer. As a legislator, I have grave concerns about the FDA's failure to date to enforce meaningful safety and effectiveness requirements for reprocessed single-use devices. I question the logic of requiring new medical devices to meet basic patient safety standards yet failingto require the same standards forreprocessed and reused ones. As a consumer, I'm horrified to know that complex, delicate devices, such as car- diac balloon catheters and biopsy forceps, are being cleaned and used again on dif- ferentpatients with little proofthatitcanbe done safely. Reuse of delicate medical devices, like balloon catheters and biopsy forceps, has been linked to patient infection and injury. As recently as February of this year, an elderly woman in Florida suffered significant complications when a reprocessed forceps device failed duringa routineprocedure to remove kidney stones. Duringthe — 5 procedure, the grasping forceps broke offand lodged in the patient's ureter, cutting offaccess to the bladder. The attending physician was forced to conduct emergency surgery to remove the failed device and reattach the patient's bladder. The patient has since suffered significant complications and has had to undergo farther surgical procedures toremoveunhealed scartissue in herbladder. The patient's daughter, Ms. Georgia Abernathy, suspected that the grasping forceps used on her mother may have been reprocessed and that repeated sterilizing and reuse fatigued the device to the point of failure. It's only because Ms. Aber- nathy, employed by a manufacturer of single-use devices, is aware of the dangers of reprocessing, that she investigated. For more than two weeks, Ms. Abernathy questioned hospital personnel about whether the hospital uses reprocessed grasping forceps. Finally, they admitted that they do use reprocessed single-use devices on patients without their knowledge and that the device that was used on Ms. Abernathy's mother was, in fact, reprocessed. Ifnot for Ms. Abernathy's tenacity and familiarity with the risks ofinfection and device failure that accompany reprocessing, she would never have known that a reprocessed device was involved in her mother's injury. Most patients are unaware that reprocessing even occurs. Most situations like the one experienced by Ms. Abernathy's mother are neitherinvestigated norreported. The reprocessors here today will tell you that reprocessing is perfectly safe. They will say that the GAO report found little evidence that reprocessing and reusing devices intended for single use only cause infection or injury. What they won't tell you however, is that we have very little information about the scope ofpatient injuries. Of course there's little evidence. We don't require patient consent and hospitals don't have to track whether a reused device was involved in an adverse event. We can't say definitively whether reprocessing is safe or not because there's been vir- tuallyno oversight ofthe practice forthe past 20 years. We don't even know the extent to which reprocessing occurs. It's estimated that as many as one in every three hospitals are reusing single-use devices and none are required to report whether a reprocessed device was involved in an adverse event. FDA doesn't even know ofall the reprocessors that exist. According to the GAO report, FDA suspects there are third-party reprocessors that have never even reg- istered with them. FDA clearly has the authority to enforce safety and effectiveness standards, yet ithas looked the otherway, allowing this practice to go on with verylittle oversight. In fact, in a letter dated July 9, 1999, FDA admitted that reprocessing a medical device constitutes re-manufacturing a device and, as such, is subject to the same pre-market safety and effectiveness standards as original equipment. Yet, to date FDAhas chosen not to enforce these standards. Today, there is nothing on the books that prevents hospitals from using a reprocessed device on a patient without their knowledge or consent. Nothing is required to prove that the device is safe and effective. And nothing prevents a hospital from chargingthepatient and the Federal governmentthrough Medicarefora new device when a secondhand one is used. When we buy a part for our car, the mechanic is required to tell us ifthe part is new orrebuilt and we are charged accordingly. Why is it that our laws are doing a betterjob covering car parts than they do protecting patients? Until recently, FDA's primary reason for not enforcing these standards was the increased regulatory burden. I find this an irresponsible and fully unacceptable failure on the part ofFDA to ensure patient safety. I understand that FDA has a lot on its plate. However, patient safetymust always come first. I introduced the Reprocessed Single-Use Medical Device Patient Safety Act (HR 3148) because I saw a real failure on the part ofFDA to address the safety ofre- processingin a meaningful way. Mybill ensures the protection ofpatients by requiring reprocessed medical devices to meet the same safety and effectiveness standards that new products must meet. HR 3148 will also increase awareness about reprocessed devices by requiring a patient's informed consent before a single-use medical device may be used on them and requiring hospitals to monitor and report injuries orinfections thatoccuras a result. When FDA approves a device for single-use only, that's exactly what it means that the data submitted by the manufacturer has shown that this device can be safely used once. Thus, a company that reprocesses the device and reuses itmultiple times should be—required to inform the patient that they aren't getting what the label advertises a single-use, disposable device. These labels should mean exactly what they say. Single-use means you can only use it once. A reprocessed single-use device is a multiple use device and the label should say so. Ifnot, patients should be told and theirconsent obtained. 6 I'm encouraged that FDA has finally developed a proposed policy with regard to reprocessing and reuse. However, I'm concerned that their willingness to properly regulate the industry continues to evolve at an erratic pace. In their proposed enforcement guidance, FDA stated that while all reprocessed single use devices are subject to the same pre-market safety and effectiveness requirements as new devices, FDA wouldn't enforce these requirements unless the device was considered "high risk." Following numerous questions about the logic ofrequiring one to show whether reuse of a particular device poses a "high risk" to patients without the data, FDA suddenly changed its proposal to include all single-use devices—just in time for a Commerce Committeehearing. FDA's new draft guidance states that they will require premarket approval for all reprocessed devices. However, I understand that in recent speeches, FDA officials have indicated that FDA will not require PMAs or 510(k)s to demonstrate that the devices can be safely and effectively reprocessed multiple times. This recent backtracking calls into question FDA's motivation to properly regulate reprocessing. I'm concerned that it's yet another indication that FDA plans to delay true enforcement ofthe data requirements on reprocessors foras longas possible. I understand the fiscal constraints hospitals are under. Between managed health care and reduced Medicare reimbursements, hospitals feel intense pressure to cut costs whereverpossible. However, we can't continue puttingpatients at risk in orderto save a few dollars. Wemustputpatientsbeforeprofits. TheReprocessed SingleUseMedical Device Pa- tient SafetyActis aboutputtingpatients first. I lookforward toworkingwithyou, Mr. Chairman, andwiththerestofthe distinguished Committee members to find a thoughtful solution to this problem. Thank you. The Chairman. Our next witness will be Dr. David Feigal rep- resenting the U.S. Food and Drug Administration. Dr. Feigal re- ceived his M.D. from Stanford University Medical School and an M.P.H. from the University ofCalifornia, Berkeley. Dr. Feigal joined the Food and Drug Administration in 1992, heading the Division of Anti-Viral Drug Products, a position he held until 1997. In the fall of 1997, he moved to the Center for Bio- logics Evaluation and Research as the Medical Deputy Director. Dr. Feigal is currently the Director ofthe Center for Devices and Radi- ological Health, the center with regulatory responsibility over medical devices. Dr. Feigal, we are pleased to have you with us, and ifyou would like to introduce the person with you, I would appreciate it. Dr. Feigal. Actually I believe it is the witness after me. The Chairman. Oh, okay. I will do that. Dr. Feigal. OK. Good. The Chairman. All right. Go right ahead. Just testing you to see how alert you were. [Laughter.] Dr. Feigal. OK. Good. Yeah. Well, we are adding new staff all the time. I have to check. [Laughter.] STATEMENTS OF DAVID W. FEIGAL, JR., M.D., M.P.H., DIREC- TOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION; ROCKVTLLE, MD; AND JANET HEINRICH, DR.PH., R.N, ASSOCIATE DIRECTOR, HEALTH, EDUCATION AND HUMAN SERVICES DIVISION, GENERALACCOUNTING OFFICE, WASHINGTON, DC Dr. Feigal. Well, Mr. Chairman, I am pleased to be here today to discuss our approach to the issue ofreissuing medical devices la- beled for single use. We value your interest and input as we move forward to change our regulatory approach. Our primary goal is to protect the public health by assuring that reprocessed single-use devices are safe, effective and well manufactured.