<DOC> [109th Congress House Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:30528.wais] MEDICAL DEVICE SAFETY: HOW FDA REGULATES THE REPROCESSING OF SUPPOSEDLY SINGLE-USE DEVICES ======================================================================= HEARING before the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED NINTH CONGRESS SECOND SESSION __________ SEPTEMBER 26, 2006 __________ Serial No. 109-190 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpoaccess.gov/congress/ index.html http://www.house.gov/reform ______ U.S. GOVERNMENT PRINTING OFFICE 30-528 WASHINGTON : 2006 _____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512ÿ091800 Fax: (202) 512ÿ092250 Mail: Stop SSOP, Washington, DC 20402ÿ090001 COMMITTEE ON GOVERNMENT REFORM TOM DAVIS, Virginia, Chairman CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California DAN BURTON, Indiana TOM LANTOS, California ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois CHRIS CANNON, Utah WM. LACY CLAY, Missouri JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland DARRELL E. ISSA, California LINDA T. SANCHEZ, California JON C. PORTER, Nevada C.A. DUTCH RUPPERSBERGER, Maryland KENNY MARCHANT, Texas BRIAN HIGGINS, New York LYNN A. WESTMORELAND, Georgia ELEANOR HOLMES NORTON, District of PATRICK T. McHENRY, North Carolina Columbia CHARLES W. DENT, Pennsylvania ------ VIRGINIA FOXX, North Carolina BERNARD SANDERS, Vermont JEAN SCHMIDT, Ohio (Independent) BRIAN P. BILBRAY, California David Marin, Staff Director Lawrence Halloran, Deputy Staff Director Benjamin Chance, Clerk Michael Galindo, Clerk Phil Barnett, Minority Chief of Staff/Chief Counsel C O N T E N T S ---------- Page Hearing held on september 26, 2006............................... 1 Statement of: Selvey, Don, senior vice president, regulatory affairs and quality assurance, Ascent Healthcare Solutions, Inc.; Dennis J. Toussaint, director, regulatory affairs, Sterilmed, Inc.; and Stephen J. Ubl, president and CEO, Advanced Medical Technology Association.................... 39 Selvey, Don.............................................. 39 Toussaint, Dennis J...................................... 56 Ubl, Stephen J........................................... 73 Schultz, Dr. Daniel G., Director, Center for Devices and Radiological Health, Food and Drug Administration.......... 13 Letters, statements, etc., submitted for the record by: Davis, Chairman Tom, a Representative in Congress from the State of Virginia, prepared statement of................... 4 Schultz, Dr. Daniel G., Director, Center for Devices and Radiological Health, Food and Drug Administration, prepared statement of............................................... 17 Selvey, Don, senior vice president, regulatory affairs and quality assurance, Ascent Healthcare Solutions, Inc., prepared statement of...................................... 41 Toussaint, Dennis J., director, regulatory affairs, Sterilmed, Inc., prepared statement of..................... 58 Towns, Hon. Edolphus, a Representative in Congress from the State of New York, prepared statement of................... 92 Ubl, Stephen J., president and CEO, Advanced Medical Technology Association, prepared statement of.............. 75 Waxman, Hon. Henry A., a Representative in Congress from the State of California, prepared statement of................. 8 MEDICAL DEVICE SAFETY: HOW FDA REGULATES THE REPROCESSING OF SUPPOSEDLY SINGLE-USE DEVICES ---------- TUESDAY, SEPTEMBER 26, 2006, House of Representatives, Committee on Government Reform, Washington, DC. The committee met, pursuant to notice, at 10:40 a.m., in room 2157, Rayburn House Office Building, Hon. Tom Davis (chairman of the committee) presiding. Present: Representatives Tom Davis, Mica, Gutknecht, Porter, Foxx, Schmidt, Waxman, Owens, Towns, Cummings, Kucinich, and Norton. Staff present: David Marin, staff director; Larry Halloran, deputy staff director; Keith Ausbrook, chief counsel; A. Brooke Bennett, counsel; Susie Schulte, professional staff member; Michael Galindo and Benjamin Chance, clerks; Karen Lightfoot, minority communications director/senior policy advisor; Stephen Cha, minority professional staff member; Sarah Despres, minority counsel; Early Green, minority chief clerk; and Jean Gosa, minority assistant clerk. Chairman Tom Davis. I apologize for being a couple of minutes late. I want to welcome everybody to today's hearing on the Food and Drug Administration's regulation of reprocessed single-use devices. The purpose of this hearing is to assess FDA's oversight of the reprocessing industry and determine what, if any, additional measures are needed to assure reprocessed SUDs are effective and safe. FDA is responsible for approving these devices. Manufacturers choose to submit applications for single-use only designation as opposed to multi-use designation. FDA, however, allows reprocessed SUDs to be marketed if they are substantially equivalent to the original device. Many of you may not be aware that several commonly used medical devices are cleaned and resterilized to be used by hospitals more than once. Devices such as catheters, biopsy forceps, and surgical tools are often designated for one-time use, but hospitals routinely pay to have them reprocessed to cut costs and reduce medical waste. For example, new biopsy forceps can cost $60, yet reused forceps can cost as little as $15. Savings from use of reprocessed devices can be significant. Original device manufacturers have said, however, they cannot guarantee the safety of SUDs once they are reprocessed and reused. Reprocessors contend there is no sufficient or credible evidence to indicate the use of reprocessed medical devices is riskier than the use of new ones. Hospitals may save overhead costs, but what is the cost of patient's health? That is just one of the many questions we are going to ask today. The committee's interest began with a series of articles in the Washington Post that reported many instances of patient injury associated with the use of defective and unsterile reprocessed devices. Mr. Waxman and I wrote to the FDA, asking for information on device safety regulations and the adequacy of adverse event data. The FDA responded that the data in hand did not establish a clear causal link between reprocessed devices and subsequent adverse health effects, but we need to know whether that is because the reprocessed devices are safe or because MedWatch, the adverse event monitoring system, is too passive or insensitive to capture subtle but potentially deadly trends. Today's hearing will question whether FDA's current MedWatch reporting system can accurately capture adverse events resulting from reprocessed devices. We will ask FDA how new labeling requirements under the Medical Device User Fee and Modernization Act are working to help improve the MedWatch system. Effective last month, reprocessed devices are required to be stamped or tagged with a label indicating they have been reprocessed. Previously, only the packaging was required to identify the device was reprocessed, and most doctors were unaware devices were reprocessed as packaging is often removed prior to use in the operating room. Now look, I realize some of our witnesses will say it is too early to clearly determine what impact the new labeling requirement will have on adverse event reporting, and that is OK. Today's hearing will not be the committee's final look at the issue. Mr. Waxman and I have asked GAO to update its June 2000 report on SUDs. GAO's initial report found little harm from reuse but recommended additional oversight by the FDA. Because FDA regulation of the industry has increased significantly since 2000, the committee asked GAO to specifically examine the safety of SUD reprocessing, the adequacy of FDA's oversight, and how reprocessed SUDs compare to original devices. GAO has accepted this request, but they have not yet initiated work. Before we move to our first panel, I am going to express my disappointment in the original device manufacturing industry. We have no device makers testifying today because they preferred to speak through their trade association, AdvaMed. Specifically, C.R. Bard, a company from Murray Hill, NJ, was invited to testify, but they declined to appear. We would have preferred to have direct testimony from companies so they would be able to provide specific examples and commentary regarding their specific devices. Despite the committee's disappointment with the lack of original device manufacturer witnesses, we will continue our discussions with those companies. We have the reprocessors represented by SterilMed and Ascent Healthcare Solutions, the two largest companies in the business, ready to testify today, and I want to thank them for appearing. I look forward to your testimony from both panels on this important issue. [The prepared statement of Chairman Tom Davis follows:] [GRAPHIC] [TIFF OMITTED] T0528.001 [GRAPHIC] [TIFF OMITTED] T0528.002 Chairman Tom Davis. I would now recognize Mr. Waxman. Mr. Waxman. Thank you, Mr. Chairman for holding today's hearing on the safety of reprocessed medical devices. FDA's oversight of medical devices is an important issue that does not get sufficient attention. Medical devices can be as critical to a patient's care as the drugs they are prescribed. There are devices that keep the heart beating, to measure the level of oxygen in blood, to deliver pain medication, and to test blood pressure. When devices fail, there can be very serious consequences including death. Today's hearing is focused on the risks of reprocessed medical devices, but the safety risks posed by medical devices are by no means limited to reprocessed devices. One example is the recent manufacturing defects in brand new implantable cardiac defibrillators. These are devices that are implanted into people with heart problems and that can save a person's life by shocking a nonfunctioning heart back into rhythm. Even after one major manufacturer of defibrillators learned that some of its devices were flawed, the company did not inform physicians or the public, and the faulty defibrillators continued to be surgically implanted. Eventually, there was an after the fact recall, but by this time, the faulty defibrillators had already been implanted and patients were put into the position of having to live with defibrillators that could fail or undergoing another surgery to have them replaced. That is a terrible position for anyone to be in. In recent years, there has been a concerted effort to strengthen FDA regulation of reprocessed devices. A series of congressional hearings and a GAO investigation showed that this was an area that needed more regulation. FDA then asserted its jurisdiction over device reprocessors, subjecting them to the same standards as other device manufacturers, and in 2002 and in 2005, Congress imposed additional requirements on the manufacturers. The last of the new rules for reprocessed devices went into effect in August. As a result, we no longer have a regulatory scheme that allows devices to be cleaned and reused with no oversight. Under the law, reprocessed devices are actually more tightly regulated now than their single-use counterparts. I understand that the original equipment manufacturers do not like reprocessing. They have an economic concern about this practice. The practice of reprocessing cuts into their profits and often forces them to lower their prices to stay competitive. Their agenda, however, should not be our agenda. The safety concerns with reprocessed devices have to be understood within the broader context of device safety. Under the FDA's current regulatory scheme for reprocessed devices, FDA assures us that a reprocessed device will meet the same exact standards as the original device. It must be just as strong and just as sterile as it was the first time it was used. So, as we question FDA's ability to assure that reprocessed devices are safe and effective, as we should, we must recognize that we are, in effect, questioning FDA's ability to ensure that all devices are safe and effective. We will hear today that FDA is not devoting enough resources to enforcing the requirements that apply to reprocessed devices. I share these concerns. I want to learn how the new regulations for manufacturers of reprocessed devices are being implemented, and I hope we will do everything we can to urge FDA to be more effective bringing enforcement actions for violations of the regulations governing reprocessed devices. But we must recognize that FDA's failure to protect the public extends beyond reprocessed devices. The reality is that FDA is also not doing a good job protecting Americans from the dangers of new devices, and it is the original devices, not reprocessed ones, that cause the largest number of deaths and injuries. I issued a report in June that revealed that FDA enforcement actions have declined significantly under the Bush administration. Among FDA's regulatory centers, the Center for Devices and Radiological Health saw the biggest decline in enforcement with a 65 percent drop in the number of warning letters it issued from 2000 to 2005. This report made clear that in the last 5 years, FDA has chosen to ignore the advice of its own staff, has taken far fewer enforcement actions than in previous years, and has left the industry to police itself. In order to put the issue of reprocessed medical devices into the broader context of device safety, I requested that Dr. Peter Lurie from Public Citizen be invited to testify. For reasons that I do not understand, my request was denied. Dr. Lurie is a consumer advocate with no financial stake in this issue. He would have provided an important public health perspective to today's hearing, and it is unfortunate he was not allowed to participate. Americans rely on the FDA to make sure that the foods they eat, the drugs they take, and the devices that they need are safe and effective. Unfortunately, recent tragedies like the faulty defibrillators have shaken consumers' confidence that FDA is effectively fulfilling this role. I look forward to learning from our witnesses today steps we can take to strengthen FDA's oversight of all medical devices so that we can have this faith restored. I thank the witnesses for coming. Thank you, Mr. Chairman. [The prepared statement of Hon. Henry A. Waxman follows:] [GRAPHIC] [TIFF OMITTED] T0528.003 [GRAPHIC] [TIFF OMITTED] T0528.004 [GRAPHIC] [TIFF OMITTED] T0528.005 [GRAPHIC] [TIFF OMITTED] T0528.006 [GRAPHIC] [TIFF OMITTED] T0528.007 Chairman Tom Davis. Thank you. Any other Members wish to make opening statements? Mrs. Schmidt. Mrs. Schmidt. Thank you, Mr. Chairman. I will be brief. I really appreciate the opportunity to have this hearing today. I first became aware of the issue of using reprocessed single-use medical devices in my own district with people that had concerns over the fact that patients may not know these devices are being used, doctors may not know that these devices are being used, and the quality of them being reprocessed. I look forward to an insightful debate on this issue. The concern and the bottom line that I have is that when a patient seeks medical treatment that the best care is being provided, the safest care is being provided, and that the patient understands that when a reused device is going to be used, that they know the ramifications of that. I thank you very much for the opportunity to learn more about this. Chairman Tom Davis. Thank you very much. Any other Members wish to make opening statements? If not, we will proceed to our first panel. We have Dr. Daniel Schultz, the Director of the Center for Devices and Radiological at the Food and Drug Administration. Dr. Schultz, thank you for being here. Why don't you just remain standing, and I will swear you in. [Witness sworn.] Chairman Tom Davis. Thank you. You have a light in front of you that turns orange after 4 minutes, red after 5. Your entire statement is part of the record, and questions will be based on your entire written statement. Thanks for being with us. STATEMENT OF DR. DANIEL G. SCHULTZ, DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION Dr. Schultz. Good morning, Mr. Chairman, members of the committee. My name is Dan Schultz. I am Director of the Center for Devices and Radiological Health at the Food and Drug Administration. The safety of medical devices is of utmost importance to the agency, and I appreciate the opportunity to discuss the safety and effectiveness and manufacturing quality of reprocessed single-use devices or SUDs. My written testimony includes an overview of our regulatory authority for medical devices. FDA classifies medical devices into Class I, II, and III, based on risk, Class III being the highest risk. Currently, only Class I and II single-use device types have been cleared by FDA for reprocessing. Let me provide some background on the regulation of reprocessed devices. In August 2000, FDA issued guidance enforcement priorities for single-use devices reprocessed by third parties in hospitals. Again, this was prior to any specific legislation on this issue. It was based on a series of meetings that we held and input from stakeholders, which suggested that there was interest in having closer regulation on this topic. This guidance set forth FDA's priorities for enforcing pre- market submission and post-market requirements for manufacturers who wish to market reprocessed SUDs. The guidance document stated that any third party and hospital reprocessor should comply with requirements pertaining to registration and listing, medical device reporting, medical device tracking, medical device corrections and removals, the quality system regulation, labeling, and pre-market submission. Essentially, at that time, reprocessors were placed on the same regulatory framework as the OEMs. Prior to issuance of this guidance, reprocessors were not consistently held accountable to any of these requirements. In 2002, with enactment of MDUFMA, Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the pre-market submission of data that exceeded the requirements for OEMs. Certain reprocessed SUD types that present the greatest potential risk of infection and inadequate performance following reprocessing and that were previously exempt from pre-market submission were no longer exempt. MDUFMA also created a new type of pre-market submission called a pre-market report for Class III reprocessed SUDs that otherwise would have required a pre-market approval application. MDUFMA also required a change to FDA's MedWatch voluntary and mandatory reporting forms to identify adverse events involving reprocessed SUDs. As of August 1, 2006, MDUFMA also requires reprocessed SUDs to bear the name, abbreviation, symbol of the reprocessor, either on the device itself, on an attachment, or a detachable label. Under the FD&C Act, before introducing a device to market, manufacturers must submit a notification of 510(k) and obtain FDA clearance unless the device has been exempted. MDUFMA required FDA to identify previously exempt device types that, if processed as an SUD, would now require 510(k) submission including the submission of validation data. In addition, MDUFMA required the FDA identify SUDs already subject to 510(k) pre-market requirements but that would now also require the submission of validation data. Validation data include cleaning and sterilization and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate after the maximum number of times the device is intended to be reprocessed. On June 1, 2004, FDA issued Guidance for Industry and FDA Staff, MDUFMA 2002, Validation Data in Pre-market Notification for Reprocessed Single-Use Medical Devices. This document describes the types of validation data that FDA expects to be submitted on cleaning, sterilization, and functional performance, the timeframe for FDA's review of these submissions, and what actions the agency intends to take if it finds a reprocessed SUD to be not substantially equivalent. As of September 2006, FDA has received 200 pre-market notification submissions for reprocessed SUDs, each covering from a single to as many as several hundred device models. Approximately 67 percent have been cleared by the agency. The remaining were not cleared for reasons such as inadequate validation data, lack of necessary information from the reprocessor, withdrawal of the application, or lack of response to FDA's request for data. Just to give you some perspective on this and put it in context, of the total number of 510(k)'s that we received, approximately 88 percent of all those are cleared. Inspections serve as a bridge between pre and post-market activities. On the average, FDA has conducted inspections of reprocessor firms once every 2 years, a rate considerably higher than the one in every 4 years for OEMs. All known reprocessing firms have been inspected within the last 2 years. FDA continues to evaluate newly registered firms to confirm whether they are performing SUD reprocessing and updates its inspectional plan as required. Post-market; post-market monitoring of device-related adverse events and product problems is accomplished through the MDR system. MDR reports include deaths, serious injury, and device malfunctions. Healthcare facilities are required to report deaths suspected to be device-related to both FDA and the manufacturer/reprocessor and serious injuries to the manufacturer/reprocessor. FDA also receives voluntary reports generally from healthcare professionals through its MedWatch reporting system. CDRH receives approximately 200,000 device- related adverse event reports per year. Can I continue? Oh, sorry. As you know, on January 24, 2006, I and others briefed the committee staff about SUD reprocessing. We searched our Manufacturer and User Facility Device Experience data base for reports from October 22, 2003, which is when the MDUFMA legislation went into effect, to December 13, 2005, that were coded as adverse events associated with reprocessed SUDs. Analysis of these reports did not disclose a clear link between a reprocessed SUD and subsequent patient injury or death. In July 2006, the agency updated the search to include all reports between October 2003, and July 2006. FDA has received a total of 434 reports and, of these, approximately 65 reports involved or were suspected to involve reprocessed SUDs. These AEs may be associated with reprocessing. They may also be associated with the medical condition of the patient, the medical procedure, or other confounding factors. We are seeing that the same types of adverse events reported to be associated with the use of SUDs are similar for new, non-reprocessed devices. To learn more about how reprocessing was actually occurring from a user standpoint, we conducted a survey under our Medical Product Device Safety Network or MedSun. FDA's MedSun is comprised of over 350 hospitals that identify and report device problems, and this is a more active surveillance system as opposed to the MAUDE system which is a much more passive system. Representatives from more than 50 of these facilities provided feedback on their experience with reprocessed SUDs to FDA staff. In general, participants had a favorable view of reprocessed SUDs. There were no reports with specific problems with SUD-related infections, and participants did not report a greater concern with mechanical problems associated with reprocessed SUDs compared to non-reprocessed SUDs. I would like to emphasize, however, that one of the statements, and there was some variability in terms of the comments that we got, but one of the statements that was clear and was totally consistent was the idea that it was, that they found it necessary and desirable for FDA to have a strong oversight over this process. The agency continues to review and assess the practice of reprocessing SUDs. I have some specifics in my written summary. Just yesterday, FDA published rules amending certain classification regulations for reprocessed SUDs formerly exempt from pre-market, those previously subjected to pre-market notification, and for which validation data are now necessary in a 510(k). These amendments will help reprocessors and other stakeholders to know which devices are being reprocessed and allow them to submit the data that they need to demonstrate that their device is substantially equivalent. We have also recently updated our Web site. We have also recently initiated a dedicated post-market team to look specifically at the adverse events associated with reprocessing, and we continue to update our inspection plan to make sure that we are inspecting all of the reprocessors on a regular basis. Available data show that certain--and I emphasize the word, certain--SUDs can be reprocessed with a reasonable assurance of safety and effectiveness. FDA believes that reprocessed SUDs, that meet FDA's regulatory requirements are as safe and effective as their predicate. The law and regulations in place are designed to protect the public health by assuring that reprocessing is based on sound science. We continue to monitor the performance of these devices and to assess and refine our ability to regulate them appropriately. Mr. Chairman, I apologize for running over. Thank you again for the opportunity to address this important topic. [The prepared statement of Dr. Schultz follows:] [GRAPHIC] [TIFF OMITTED] T0528.008 [GRAPHIC] [TIFF OMITTED] T0528.009 [GRAPHIC] [TIFF OMITTED] T0528.010 [GRAPHIC] [TIFF OMITTED] T0528.011 [GRAPHIC] [TIFF OMITTED] T0528.012 [GRAPHIC] [TIFF OMITTED] T0528.013 [GRAPHIC] [TIFF OMITTED] T0528.014 [GRAPHIC] [TIFF OMITTED] T0528.015 [GRAPHIC] [TIFF OMITTED] T0528.016 [GRAPHIC] [TIFF OMITTED] T0528.017 [GRAPHIC] [TIFF OMITTED] T0528.018 [GRAPHIC] [TIFF OMITTED] T0528.019 Chairman Tom Davis. Thank you very much. I am going to start the questioning with Mr. Gutknecht. Mr. Gutknecht. Mr. Chairman, I don't have a question so much as a comment. I am delighted the FDA is taking some of these issues seriously, but I just want to make sure that we don't overstate the danger here. I just don't want consumers to believe that there is real risk. In your professional judgment, how many American consumers have been injured by some of these reused technologies? Dr. Schultz. I wish I could give you an exact count; I can't. Again, we have looked at all of the reports that have been submitted to us, most of the reports, and we were given specific authority to designate those reports as whether they are reprocessed or non-reprocessed. Unfortunately, a lot of those reports were incorrectly designated. When we looked at them specifically one by one, of those that remained, there certainly are some that could have been associated with reprocessing, but based on the data and actually the in-depth analysis of those individual reports, as I said, it is very difficult to precisely, precisely define which ones were, in fact, associated with the reprocessing versus the device or the overall procedure. I apologize for not being able to give you a more specific answer, but that is the honest answer of what we currently know. Mr. Gutknecht. My point really is, Mr. Chairman and Members, I think we have to put this in some context. The unfortunate fact is that somewhere between 6,000 and 10,000 Americans die every year in hospitals as a result of either getting the wrong medication or an infection which they actually caught while they were in the hospital. In the very rare circumstance of that infection, did that have anything to do with a reprocessed medical device? I think it is important we have this hearing, Mr. Chairman, but I think we have to put it in context. No. 1, we don't have very good data, and second, the data that we do have doesn't suggest that American consumers, American patients are at any undue risk because of the reprocessing of medical devices. I know in talking to some of the healthcare people in my district and in the State, they do want to use these because they can see significant savings rather than having to buy all new equipment. If it were up to the device manufacturers, there would be no reprocessing at all. So the only thing I would say--and I want to thank you for your testimony--is that the evidence here is pretty scant that there is real harm being done to American consumers by this technology. I yield back. Chairman Tom Davis. Thank you very much. Mr. Waxman. Mr. Waxman. Thank you, Dr. Schultz, for your presentation. As I mentioned in my opening comments, I didn't really want to restrict my comments to reprocessed devices alone because in some ways there is a blur between the two. I do want to ask you about what your office is doing regarding device safety generally. I mentioned in my opening comments the cardiac defibrillators made by Guidant. The New York Times broke the story about the Guidant pacemakers. There was little movement by your agency to look further into the company, despite reports of short circuits for years preceding this effort. Your agency, in fact, knew about these problems for years before the New York Times story. Can you explain your agency's delay in action? Dr. Schultz. Yes, we have looked at that very carefully, Mr. Waxman, because obviously it was an issue that concerned us a lot as well. One of the things that we have done over the course of the last year is to look at all the different ways that we get input regarding medical devices, and I think what we found is that we get input from a lot of different sources. We get input from patient reports. We get input from inspections. We get input from reports that manufacturers are required to submit as part of their routine post-market reporting, especially on PMA devices. I think one of the things that we have found is that it is very difficult sometimes to, what I call, connect the dots and to be able to put together the information, the patient report information, the inspectional information, and the updated manufacturing information. Mr. Waxman. Notwithstanding that, obviously you have to connect the dots before you do something, but I guess one of the sources of information is reading the newspaper because they seemed to come up with a story that connected the story in advance of the FDA. I wonder if this is part of the problem. FDA's enforcement actions have declined under the Bush administration. In fact, your Center on Devices had the greatest drop with 65 percent fewer warning letters in 2005 than in 2000. How can you explain such a sharp dropoff in enforcement during a time of increasing problems in devices such as implantable pacemakers and defibrillators? Dr. Schultz. Well, I am not sure that, I am not sure I would characterize it as increasing problems, and in terms of the 65 percent number, I don't have that number in front of me, but I certainly would take you, that that is, in fact, the number. I think that one of the things that we have been asked to do is to make sure that the warning letters that we do send out are consistent and are reviewed at higher levels to make sure that they are, in fact, consistent so that we are not sending warning letters to some companies as opposed to other companies. Other than that, I can tell you that the people that I work with and the people that are in my center are constantly looking at problems related to manufacturing and submitting appropriate, what I consider to be appropriate action items to deal with those problems. Sometimes they are warning letters. Sometimes they may be so-called untitled letters where we feel that some of those corrections can be made in other ways. Sometimes they are injunctions. Sometimes they are seizures. Mr. Waxman. Have you ever had your staff recommend enforcement action and then send it up to other higher levels than the FDA and have it turned it down? Dr. Schultz. I am sure that there are instances where warning letters have gone through different layers of review and have not gone forward. I can't tell you specifically. Mr. Waxman. Maybe you can get us some information for the record. Dr. Schultz. We can do that. We can do that. Mr. Waxman. MDUFMA required FDA to develop a list of reprocessed devices for which companies would be required to submit supplemental validation data. Can you walk us through the process FDA used to select the devices on that list? Dr. Schultz. Sure; basically, we used sort of a dual approach. One was using the so-called Spaulding criteria where we looked at the inherent risk of that particular type of device in terms of what part of the body it came in contact with. Under those criteria, there are certain types of devices that touch normally sterile parts of the body, for instance, the inside of the abdominal cavity or the chest cavity; there are other what is called semi-critical devices which touch mucosal surfaces such as the inside of the gastrointestinal tract or the inside of the respiratory tract; and then there are low risk devices which basically come in contact with intact skin. So we looked at that. We sort of used that as a starting point, and then we also looked at the device itself. There are some devices that are relatively simple and straightforward in terms of how they could be cleaned and how they could be sterilized, and we tried to gauge the complexity of the device and how difficult it would be to reprocess in conjunction with the criticality of how the device was being used. So we combined those two sets of criteria and came up with a list of what we thought were the most important, the most urgent to regulate, and then sort of worked our way down from there. Mr. Waxman. Thank you. Thank you, Mr. Chairman. Chairman Tom Davis. Thank you. Mrs. Schmidt. Mrs. Schmidt. Thank you, Mr. Chairman. I have a few questions. I think the first and the most basic that I have is I have a little trouble with if something is designed for single use, how can it be reprocessed too for dual use? Let me give you an analogy. In auto racing, there is a difference between drag cars and cars that go around and around on a track. Drag cars' engines are built for a single use, a single time, and then they get rebuilt. They are not built to go more than once. If these devices are being built to go one time, how can they be reprocessed and be safe? Dr. Schultz. OK; I am not an expert on car racing, but what I would tell you is when we look at any product, whether it be a reprocessed product or a non-reprocessed product, we don't make a decision sort of before the fact as to whether or not that particular product can or can't be used in that particular manner. What we do is we say, OK, you want to do this. You want to label your product to be used in such a way. You must provide us with the data that shows that, in fact, that can happen safely and effectively. You are right; I think in some cases, there are single-use devices that cannot and should not be reprocessed. But what we have found in terms of our own review process, not what somebody tells us or doesn't tell us but in terms of our own review process is that, in fact, some devices--again, I tried to be careful in my testimony that certain devices, we believe, can be reprocessed safely and effectively--that some devices, in fact, can be used more than once if they are properly reprocessed. And we clear those devices if, and only if, the manufacturer, in this case, reprocessor, provides us with data to demonstrate that is, in fact, the case and they have to tell us, in fact, how often the device can be reprocessed safely. Mrs. Schmidt. Mr. Chairman, may I have two more questions? Chairman Tom Davis. Yes, go ahead. Mrs. Schmidt. Thank you. The second one I have is on the labeling of the devices. Dr. Schultz. Right. Mrs. Schmidt. Last winter, I had the opportunity to actually review some of these devices, and it would be very, very hard for anyone including a physician to figure out whether the device was new or reprocessed because, in some cases, there is just a little teeny dot on the instrument to note that it is a reprocessed instrument. Dr. Schultz. Right. Mrs. Schmidt. What kind of labeling do you have in place? Dr. Schultz. The new statute with regards to device labeling, as was mentioned in some of the opening comments, went into effect on August 6th. I think there was a recognition by Congress that there needed to be a clearer designation of those devices that are reprocessed versus those devices that are, in fact, being used for the first time, and that was something that needed to be done. That was part of the MDUFSA legislation, and that legislation went into effect as of August of this year. So, in terms of what was done, I can tell you that we did, in fact, that those requirements did go into effect. In terms of the outcome, what effect, and how successful that will be in terms of alleviating some of the concerns that you have heard, I think we will have to just wait and see what happens. Mrs. Schmidt. A followup, sir; what kind of label? What does this label look like that is one of these devices now? Dr. Schultz. It really depends on the device itself. This is a problem with labeling in general. Some devices can have relatively large, prominent labels if they are large devices. Some devices, the labeling is, by definition, based on the size of the device, fairly small. In those cases, there are exceptions where the label can actually be an attachment to the device as opposed to actually being imbedded in the device itself. So, again, I think what we are trying to do is take sort of a common sense approach to this to make sure that the labeling actually is legible and is of a size that people can actually see it and understand who the device manufacturer is for that particular device. Mrs. Schmidt. One final question, if I may; you said in your testimony that there is a savings aspect to this. Can you give me an indication of what the cost savings to reuse the device per procedure? Dr. Schultz. I think what I said was that in our talking to the user hospitals, that they expressed a benefit in terms of cost savings. We, at FDA, do not look at cost as one of our criteria regarding whether we clear or don't clear devices for market. We simply look at whether the device meets the criteria for safety and effectiveness. Mrs. Schmidt. Thank you, sir. Chairman Tom Davis. Mr. Towns. Mr. Towns. Thank you very much, Mr. Chairman, and thank you for holding this hearing. Dr. Schultz, do you think that the patient has the right to know that this is being reused or that they have the right to refuse the treatment with the reprocessed if they know it? What is your position on that? Dr. Schultz. Well, in terms of our authority, we clear devices based on the data that is provided to us, and once a device is clear for marketing, it is designated as a legally marketed product. So we don't discriminate between devices that are reprocessed versus those that are not reprocessed, just as if we don't discriminate between various models and various different product types. So I guess I am not trying to avoid your question. I think it is a good question. Mr. Towns. You are not answering it; you know that. Dr. Schultz. Well, I guess what I am saying is that my best understanding, is that our authority does not extend to deciding whether or not patients should be informed about reprocessing or lack of reprocessing. Our authority is to make sure that the devices, in fact, are as safe and effective as the original devices. Mr. Towns. The testimony here is very conflicting, of course. Do you feel that maybe an independent group should analyze and evaluate this because when you listen or read the testimony here, one person is saying it is great, it is no problem, and another is saying it is not. Do you think that maybe we should have some independent person to evaluate all of this? Dr. Schultz. Congressman, if I may, I would like to believe that we do, in fact, function as that independent person because frankly whether or not a device is reprocessed or whether it is an original device, I and my staff have one concern and one concern only, which is will that device perform as intended and will it provide a benefit to the patient in whom it is being used. So I can't speak to whether there ought to be another independent body looking at these questions, but I can tell you that is how we look at that. Mr. Towns. The question is: Do all hospitals report to you and indicate to you that there is a problem, if there is one, all hospitals? Dr. Schultz. All hospitals are required to report problems, and that, as I mentioned, that is under the passive reporting system that we have, the so-called MDR system. In addition to that, I mentioned that we actually, on our own initiative, instituted a survey of some of our MedSun facilities to try to get a better handle on just the kind of question that you are asking. Are there concerns? What are the concerns? Do people think that this is a good process, a bad process? Again, the responses were mixed. The responses, basically, people said no matter what the evidence shows or doesn't show, they do not believe that they should be using reprocessed devices. Even within hospitals, what we found was that there were some doctors, some parts of the hospitals, some, whether it is G.I. or cardiac may decide we will or won't allow the use of reprocessed devices. So there was a fair amount of variability. What, again, was a clear message to us was we had a responsibility to clearly identify those devices that have gone through our review process and let the hospitals know which ones have gone through the review process, which ones haven't, and inform them so that they can make up their own minds. Mr. Towns. Let me ask were you able to identify which types of hospitals traditionally use the reprocessed? Is it rural hospitals, inner city hospitals? Were you able to establish a pattern as to who would use this the most? Dr. Schultz. To the best of my knowledge, we haven't done that kind of analysis. My impression was, in participating in some of those focus group discussions, that they were hospitals of various sizes and various locations and, in fact, the MedSun program is designed specifically to include different size and different locality types of facilities. But I don't have a specific answer to your question. Mr. Towns. Let me just raise, Mr. Chairman, one more question. Chairman Tom Davis. Sure. Mr. Towns. I think it was raised earlier on the other end. Do you think it is appropriate for the FDA to approve a device as a single-use device and then turn around and approve the same device after reprocessing? Should new standards or regulations be put into place to set a standard for what is labeled as approved for a single use? In other words, I just sort of have a little problem with that. If you approve it as a single-use and then you come back, don't you feel uncomfortable with that process? Dr. Schultz. I feel that we need to look at these devices individually. As I said before, some of these devices, in fact, are labeled for single-use and cannot and should not be reprocessed. Others that have gone through our full evaluation process, and if you are interested, I can provide you some examples of what that evaluation is actually like because that may be sort of helpful in terms of understanding the kind of rigor that goes into those evaluations. I have confidence based on what I know our reviewers are doing and what kind of requirements they are setting up, that those devices that go through our full review process and full inspectional process are, in fact, going to perform as intended. Mr. Towns. With permission of the chairman, I would appreciate it if he would submit that. Chairman Tom Davis. OK; if you could try to get that to us, that would be helpful. Dr. Schultz. The specific example; sure. Mr. Towns. OK; thank you very much. Chairman Tom Davis. Mr. Cummings. Mr. Cummings. Thank you very much, Mr. Chairman. Dr. Schultz, thank you for your testimony. It has been very enlightening. I just want to go back. Who usually makes the application, a reprocessing company? Dr. Schultz. Yes, yes. Mr. Cummings. Basically, other than a hospital perhaps reporting something to you, that is how these things come to issue, is that right? In other words, is there any other way? The reprocessing company says we think this is something that can be reprocessed. You hear about a problem from a medical establishment. Dr. Schultz. Correct. Mr. Cummings. Is there any other way that it would come to your attention? Dr. Schultz. We hear about problems from the reprocessors who get reported back to them, from other parties who get reports submitted to them, and from individual hospitals and practitioners. Mr. Cummings. Let us rewind. Dr. Schultz. Yes. Mr. Cummings. So, in other words, you may approve a device for reprocessing. Dr. Schultz. Correct. Mr. Cummings. The reprocessor then discovers that someone is having a problem with the device. Dr. Schultz. Correct. Mr. Cummings. The reprocessor then has a duty to notify you. Dr. Schultz. That is correct. Mr. Cummings. When the reprocessor notifies you, what happens then? Dr. Schultz. We look at those reports, decide if there is a pattern, like we do with other adverse event reports, and then take appropriate action if, in fact, we see a pattern where a particular type of device is causing a particular type of problem. Mr. Cummings. Have we seen that happen? Dr. Schultz. We haven't. Mr. Cummings. We have not yet. Dr. Schultz. That is, part of the dilemma is that, again, we see a lot of reports. I mentioned we have seen over 400 reports of reprocessed devices. We see about 200,000 reports of all devices. And thus far, thus far--and we continue to look-- thus far, we have not seen a specific pattern that would require us to take a certain action. Mr. Cummings. Now, let me ask you this. You said something that I found very, very enlightening and interesting. You said one of the things that you are most concerned about is making sure that the reprocessed device--I am not trying to put words in your mouth, so correct me--is just as good as or just as safe as the original, is that correct? Dr. Schultz. That is correct. Mr. Cummings. Now, it is my understanding that you had 6,500 deaths associated with not reprocessed but original devices, is that correct, over the last few years? Dr. Schultz. That is the number that I heard quoted. I would have to go back and confirm that, but that is the number that I heard quoted. Mr. Cummings. Well, would you say there are thousands? Dr. Schultz. Again, you know, one of the things when we talk about deaths associated with devices, I think we have to be extremely careful, just as when we talk about deaths and adverse events associated with reprocessed devices. I think the same holds true, in general, about looking at those reports critically to see whether or not the incident in which a device was used was actually, the problem was actually caused by the device or not caused by the device. Again, I don't mean to sort of over-complicate this, but I---- Mr. Cummings. Doctor, you are not over-complicating. I understand it. I used to practice medical malpractice, so I understand. Dr. Schultz. OK. Mr. Cummings. There are all kinds of reasons. Dr. Schultz. Correct. Mr. Cummings. When you are talking about the human body, this very strong but very delicate machine, almost anything can happen. So it is hard sometimes--I understand what you are saying--to actually pinpoint something to the machine, I mean to the device. Dr. Schultz. That is correct. Mr. Cummings. All right. Let us go back very quickly and just talk about the criteria. Once you get that application, what is the criteria? Is it strength? I know you talked about the different parts of the body that it might touch. Tell me about how that--I see my time is running out--or which part of the body it touches. I want you to talk about strength of the instrument or whatever. I want you to talk about exactly what goes into the process. And one last thing, is there a situation where something may be approved to, say, use it three times? Then the reprocessor says, look, I can do something to this, and you will be able to use it 10 times. Can you just incorporate that all in your answer, please? Dr. Schultz. Let me try to work backward so that I try to cover all those. In terms of the number of times, again, the reprocessor has the option of defining how many times they believe the device can be safely reprocessed. When we do our review, we look at that number that they are proposing, and we ask a very simple question. Do you have the data to support the claim that you are making in terms of how many times that device can be used? That means that during the review process, we require that testing be done to show that the device can be used, cleaned, sterilized if necessary, and that appropriate functional testing--strength testing, bend testing, whatever type of mechanical testing our engineers tell us is appropriate for that particular use--that testing, in fact, either confirmed or didn't confirm that number of uses is appropriate. Then we will go back to the manufacturer and say, you have shown us or you haven't shown us that, in fact, that device can be used that many times. Your other question, I think was describe sort of how the review process is done. That would take a little bit longer, but let me say that, in general, we use the same set of criteria that we use for any other device, which is that we focus on those aspects of the device that relate to the way in which the device is being used. So if we are talking about a biopsy forceps, we will be looking very, very carefully at how the jaws open and close. Is it still able to capture the amount of tissue that is necessary to make a diagnosis? Is it able to bend around whatever curves it needs to bend around to get to the location that it needs to get to in order to perform optimally? Those would be the kinds of questions in addition to: Can it be cleaned, can it be disinfected in order to be able to be used safely? I don't know if that answers your question. Mr. Cummings. Thank you very much. Chairman Tom Davis. Thank you. Has FDA ever been able to establish a clear causal link between reprocessed devices and subsequent adverse health effects? Dr. Schultz. In general terms? Chairman Tom Davis. In general. Dr. Schultz. No. Chairman Tom Davis. MedWatch is the adverse event monitoring system, do you think it works well or do you think it is too passive or insensitive to capture the subtle trends? Dr. Schultz. I think it is. I think the short answer to your question, Mr. Chairman, is that we are looking very hard at the MedWatch system right now for reprocessing in particular as well as in general to see what MedWatch does well and what it doesn't do well. And I will tell you that MedWatch has been extremely useful in terms of allowing us to pick up signals. It has not been that useful in terms of helping us to analyze those signals and actually come to answer the kind of question you are asking, which is why. You gave us the MedSun program in 1995, I believe, in FDAMA, that allowed us to have a more active system where we can actually go out and ask questions and try to get specific data from various hospitals. I think that the MedWatch system, it needs to be improved. We need to do some updating in terms of getting electronic reports is one thing that I think would be extremely helpful, which would hopefully make the reports a little more consistent and also allow us to input those reports more quickly. But I think that we need to be realistic in terms of what a passive surveillance system can provide and what needs to be provided through a more active surveillance system or through ongoing studies. Chairman Tom Davis. In its written testimony, AdvaMed describes two adverse events reports that relate to FDA in 2004. These reports involve malfunction of a reprocessed heart positioner and a reprocessed endoscopic vein harvester. Did the FDA act on these reports? Dr. Schultz. The heart positioner, that question came up as to whether or not that particular type of device should fall under the unexempt provision and whether we should be regulating those. Subsequent to that, we did, in fact, include that type of device as part of the review process which, again, required the additional validation data. I can't give you a specific answer for the other one, but I certainly will go back and look at it. Chairman Tom Davis. If you can go back and check. Dr. Schultz. Yes, sir. Chairman Tom Davis. FDA, were they able to establish a causal link between the reprocessing and the adverse health effect in that? Dr. Schultz. I don't; again, the information that I got was from the MDR reports and is what I gave you. Chairman Tom Davis. Well, let me ask you this. Does FDA require tracking procedures or are the reprocessing companies required to develop those procedures as part of its validation of data requirements? Dr. Schultz. Could you be more specific when you talk about tracking? Chairman Tom Davis. You track the device. You track individual devices. Dr. Schultz. These; my best understanding, and I am going to go back and confirm this, is these do not fall under what we normally consider to be tracked devices which are usually things like pacemakers and other sort of immediately lifesaving, sustaining devices. Chairman Tom Davis. Well, then what happens when a device is recalled by an original device manufacturer? Does the FDA ensure that reprocessed devices are withdrawn from the market, or is it hard to track? Dr. Schultz. Yes, I mean these devices are considered individually. Chairman Tom Davis. Some are and some aren't is basically the answer. I guess that is where the debate lies. Dr. Schultz. I am sorry? Chairman Tom Davis. I guess that is where the debate is, reuse, where it can be dangerous and where it can't, and what should be tracked and what shouldn't and how we get into this. Thank you very much. I think we will take a 2-minute recess while we move our next panel up. Doctor, thank you. You owe us a couple answers, but I appreciate your patience. Dr. Schultz. Thank you very much. [Recess.] Chairman Tom Davis. The hearing will reconvene. We are going to now move to our second panel. We have Mr. Don Selvey, the senior vice president of Ascent Healthcare Solutions; Dennis Toussaint, the director of regulatory affairs, SterilMed; and Stephen Ubl, the president and CEO of Advanced Medical Technology Association. It is our policy that we swear you in. [Witnesses sworn.] Chairman Tom Davis. Thank you. Please be seated. I think you know the rules. Mr. Selvey, we will start with you, and we will move straight on down and then try to get to questions. Again, your entire statement is in the record. With most of your statements, we think we know where we want to go on this, so you can keep it within 5. If you really want or if you need extra time, take it, but I would like to keep them within 5 minutes, if we can, and then we will move on to questions. Thanks for being with us. STATEMENTS OF DON SELVEY, SENIOR VICE PRESIDENT, REGULATORY AFFAIRS AND QUALITY ASSURANCE, ASCENT HEALTHCARE SOLUTIONS, INC.; DENNIS J. TOUSSAINT, DIRECTOR, REGULATORY AFFAIRS, STERILMED, INC.; AND STEPHEN J. UBL, PRESIDENT AND CEO, ADVANCED MEDICAL TECHNOLOGY ASSOCIATION STATEMENT OF DON SELVEY Mr. Selvey. Thank you, Mr. Chairman, members of the committee. I am Don Selvey, the senior vice president for regulatory affairs and quality assurance at Ascent Healthcare Solutions, the Nation's largest reprocessor of single-use medical devices. Although I have more than 16 years experience in the medical device industry, I am an epidemiologist by training. Prior to my service in the medical device industry, I spent over a decade as a public health professional in Arizona, originally as a registered sanitarian and then as head of Infectious Disease/Epidemiology and later as Head of the Environmental Epidemiology program. Ascent Healthcare Soultions, headquartered in Phoenix, AZ, employs 800 persons throughout the country. Our customer base consists of approximately 1,600 hospital and surgery centers in the United States, including most of those facilities annually recognized by the U.S. News and World Report as the top hospitals in America. We only reprocess low or moderate risk medical devices such as compression sleeves, electrophysiology catheters, and orthopedic tools. We do not reprocess high risk medical devices such as implantables or devices which come into contact with the central nervous system or the brain. In fact, we estimate that we are able to reprocess only 1 to 2 percent of devices labeled for single use. The emergence of reprocessing in the United States is rooted in the meaning of the single-use label itself. Contrary to what one might think, the single-use label is not an FDA requirement. In fact, FDA does not require any device to carry a single-use label. Instead, single-use is a designation the original equipment manufacturer [OEM], chooses, and that choice is sometimes made in an effort to sell more devices, not for patient safety reasons. The truth is that a manufacturer could label an operating table as being for single use if the OEM believed it could persuade a hospital to throw the table out after one use. To show you some of these single-use devices, I brought along some external fixation devices and some surgical tools. This, for example, is a clamp. This is a clamp. We are happy to pass those around, if you like. Here is a surgical saw blade made of stainless steel. These are the types of single-use devices we are talking about. Chairman Tom Davis. I am going to let somebody bring these up, and we will pass them around. Mr. Selvey. About two decades ago, some OEMs began to change the label on certain medical devices from reusable to single-use, in some cases, without any significant structural changes in the device that would preclude safe reuse. With this change in labeling, it became evident to many hospitals that the single-use label does not necessarily mean only single use and that certain devices designated by the original manufacturer as single-use can, in fact, be safely reprocessed. Further evidence that the single-use label does not always mean a device can only be used one time is the fact that some original manufacturers reprocess their own single-use devices. In fact, some manufacturers partner with third parties to reprocess devices that manufacturer has labeled as single-use. Today, reprocessing of devices originally labeled for single-use is standard practice in the Nation's top hospitals. Hospitals simply cannot afford to throw out devices that can be safely reprocessed. These dollars are better spent on purchasing new medical technology and preserving nursing staff. The savings generated by reprocessing can be significant. A 2000 GAO report found that for one device alone, the electrophysiology catheter, individual hospitals are saving between $200,000 and $1 million annually as a result of reprocessing. As the reprocessing industry has grown, so too has the strident opposition from the original manufacturers who see reprocessing as an increasing economic threat. The threat is two-fold. First, reprocessed devices are, on average, about half the cost of the original devices. Therefore, many hospitals choose to use reprocessed devices rather than purchase new ones. This means lower sales for original device manufacturers. Second, the very existence of reprocessing has resulted in a decrease in the price of certain new devices. Lower prices mean lower prices. Ascent hopes that this hearing today will make clear that the third party reprocessing in the United States is safe and that it is highly regulated. In fact, reprocessors are more stringently regulated than the original equipment industry. Specifically, reprocessors are required to submit validation data in our pre-market submission while the manufacturers have no such requirement. Second, certain devices that require pre- market submission for the reprocess device have no requirement for the original version of that device. And third, unlike OEMs, we reprocessors are required to place an identifying mark on the device itself, not simply on the label. Reprocessors provide a valuable service to this country's hospitals, a service that helps hospitals survive in an era of spiraling healthcare costs. Additional regulation at either the Federal or State level is not only unnecessary but also, because it would limit the ability of hospitals to use reprocessed devices, would do a disservice to America's hospitals and patients. Thank you, Mr. Chairman. [The prepared statement of Mr. Selvey follows:] [GRAPHIC] [TIFF OMITTED] T0528.020 [GRAPHIC] [TIFF OMITTED] T0528.021 [GRAPHIC] [TIFF OMITTED] T0528.022 [GRAPHIC] [TIFF OMITTED] T0528.023 [GRAPHIC] [TIFF OMITTED] T0528.024 [GRAPHIC] [TIFF OMITTED] T0528.025 [GRAPHIC] [TIFF OMITTED] T0528.026 [GRAPHIC] [TIFF OMITTED] T0528.027 [GRAPHIC] [TIFF OMITTED] T0528.028 [GRAPHIC] [TIFF OMITTED] T0528.029 [GRAPHIC] [TIFF OMITTED] T0528.030 [GRAPHIC] [TIFF OMITTED] T0528.031 [GRAPHIC] [TIFF OMITTED] T0528.032 [GRAPHIC] [TIFF OMITTED] T0528.033 [GRAPHIC] [TIFF OMITTED] T0528.034 Chairman Tom Davis. Thank you very much. Mr. Toussaint. STATEMENT OF DENNIS J. TOUSSAINT Mr. Toussaint. Thank you, Mr. Chairman. My name is Dennis Toussaint, and I am the director of regulatory affairs at SterilMed. I have been in the medical device industry for approximately 18 years. Most recently, my work has been at SterilMed. SterilMed was founded in 1997 and is a leading provider of reprocessing and repair services designed to help hospitals and other healthcare organizations generate substantial cost savings through better utilization of medical devices. As a medical device reprocessor, SterilMed cleans, tests, packages, and sterilizes previously used devices that were originally labeled for single use only. During a time of rapidly rising healthcare costs, SterilMed helps its hospital partners free up critical financial resources that can be devoted to improving their delivery of medical services while maintaining the highest possible quality of patient care at the same time. At SterilMed, I am responsible for ensuring the company's compliance with all reprocessing-related Federal, State, and local regulations. In particular, it is my responsibility to ensure compliance with the Federal Food, Drug, and Cosmetic Act and all medical device-related regulations of the Food and Drug Administration. As my colleague, Don Selvey, has just explained, reprocessors are subject to more stringent FDA regulations than OEMs are. SterilMed currently has more than 800 full-time and part- time employees throughout the country. We provide reprocessing services to approximately 1,400 healthcare facilities throughout the United States and Canada. We reprocess approximately 2 million devices per year. In that context, SterilMed currently saves hospitals over $40 million per year in device expenditures. The safety record for reprocessed medical devices is nothing short of outstanding. Of the tens of thousands of patient adverse event reports that FDA receives through its medical device reporting program [MDR] program, only a very small percentage concern reprocessed single-use devices, and the few problems that have occurred with reprocessed single-use devices appear to be quite similar to the types of problems associated with new devices. Indeed, in a recent letter from FDA to Chairman Davis regarding MDR reports filed since October 2003, to December 2005, the FDA stated expressly that it did not identify any adverse events that were actually related to the reprocessing of the SUD. A significant body of professional and scientific literature, much of it from peer review journals, further supports the conclusion that some single-use devices can safely be reprocessed. A GAO report confirms the existence of these studies. Because of the reprocessing industry's exemplary record of safety, informed hospitals and physicians support the practice of reprocessing. The GAO interviewed hospital infection control practitioners, risk management executives, and patient safety experts and found that they all reported that proper reprocessing does not pose a risk to patient health. Hospitals demand all rigorous safety standards be adhered to by third party reprocessors. Indeed, SterilMed tests or inspects every reprocessed device before it is sent out to a hospital, and this is the practice of the industry as a whole. This is in contrast to OEMs who we understand typically test only a small sampling of devices. The result is that some hospitals say they prefer using reprocessed devices over original devices because they know that each reprocessed device has been individually scrutinized. America's finest medical facilities use reprocessed medical devices, including 13 of the 14 institutions ranked by U.S. News and World Report in 2006 as the Nation's Honor Roll of Hospitals. These institutions include Massachusetts General, Brigham and Women's University Hospital, the Mayo Clinic, the Cleveland Clinic, and Johns Hopkins University. It simply makes no sense that these institutions would put their patients at risk in order to save money. To the contrary, these facilities use reprocessed devices because they have studied the issue thoroughly and have determined that reprocessing is both safe and cost-effective. Mr. Chairman, that concludes my testimony. I look forward to responding to any further questions you might have regarding these issues. [The prepared statement of Mr. Toussaint follows:] [GRAPHIC] [TIFF OMITTED] T0528.035 [GRAPHIC] [TIFF OMITTED] T0528.036 [GRAPHIC] [TIFF OMITTED] T0528.037 [GRAPHIC] [TIFF OMITTED] T0528.038 [GRAPHIC] [TIFF OMITTED] T0528.039 [GRAPHIC] [TIFF OMITTED] T0528.040 [GRAPHIC] [TIFF OMITTED] T0528.041 [GRAPHIC] [TIFF OMITTED] T0528.042 [GRAPHIC] [TIFF OMITTED] T0528.043 [GRAPHIC] [TIFF OMITTED] T0528.044 [GRAPHIC] [TIFF OMITTED] T0528.045 [GRAPHIC] [TIFF OMITTED] T0528.046 [GRAPHIC] [TIFF OMITTED] T0528.047 [GRAPHIC] [TIFF OMITTED] T0528.048 [GRAPHIC] [TIFF OMITTED] T0528.049 Chairman Tom Davis. Thank you very much. Mr. Ubl. STATEMENT OF STEPHEN J. UBL Mr. Ubl. Good morning, I would like to thank you, Mr. Chairman, and other members of the committee for holding this hearing today. AdvaMed is the world's largest trade association representing medical technology manufacturers. Our member companies produce the medical devices, diagnostic products, and health information systems that are transforming healthcare through earlier disease detection, less invasive procedures, and more effective treatments. I would like to open this morning by clarifying the basic distinction between devices sold by original equipment manufacturers, our members, and those by reprocessors. Devices that our manufacturers sell must be safe and effective. Based on their design and the data submitted, FDA clears devices designed for one-time use only as well as other devices designed for multiple use. Reprocessors, by contrast, take a device that has been cleared as safe and effective by the FDA for only one use and, after reprocessing, sell it to be used again. There are four primary messages I would like to leave with the committee about reuse of medical devices. First, reprocessing a medical device that is designed to be used once is inherently risky. It is difficult to clean and sterilize extremely small and structurally complex devices. Blood, mucous, and fecal material can accumulate during use in areas that are very difficult to access and clean. In addition, there can be debilitating effects from initial use, cleaning, and resterilization on the physical properties of the device. Materials can become brittle, sticky, or deformed. Let me illustrate these points with an example, and I think somebody will bring this to the dais for the Members to review. This is one of the technologies that was mentioned in earlier testimony. It is an EP catheter, electrophysiology catheter, and this technology is threaded through the groin of a patient, up into the heart to map the heart's electrical impulses in various parts of the heart to detect abnormalities. This device has to be rigid enough, stiff enough to actually be threaded up into the heart, yet it has to be flexible enough to make sure that it doesn't puncture the artery and it has to be flexible enough to go through the twists and turns of the artery. It also has to be sterile so as not to introduce potential infection, and it has to be sensitive enough so that when it gets to the heart, it can accurately take readings from the heart. Every one of those properties can be negatively affected by reuse. Failure to completely clean and sterilize the device can potentially transfer blood-borne diseases from one patient to another. Cleaning and sterilization and use itself can affect the device's flexibility, durability, and sensitivity. No one should want a device used on a second, third, or fourth patient unless there is an ironclad assurance that it is literally as good as new after it is reprocessed. That leads to me to my second point. A reprocessed device should be held to the same rigorous standard of safety and effectiveness that FDA applies to original devices. Third, the recently enacted legislative and regulatory framework for reprocessed devices is a significant improvement. However, in our view, the public is still not adequately protected because only a limited number of reprocessed devices have been subjected to FDA review. FDA directives require that reprocessors submit validation data for only 68 or 228 device types. Yet in 50 percent of those cases, the reprocessed device was found to be not substantially equivalent to the original device or the reprocessor voluntarily withdrew the product due to lack of adequate validation data. A 50 percent failure rate is intolerable for any industry, but it is especially intolerable when it occurs with a device designed to diagnose, treat, and cure patients. AdvaMed urges FDA to review validation data for all reprocessed single-use devices. Fourth, we support the strengthened reporting and branding provisions in MDUFSA. However, it is still too early to draw conclusions as to whether these changes will adequately improve the identification reporting of adverse events associated with reprocessed devices. As has been mentioned earlier, the new labeling provision only went into effect in August. Prior to that date, providers had little ability to identify whether or not an adverse event was due to a device that had been reprocessed or one that was not. In closing, if appropriate regulations means some products will continue to be reprocessed because the practice is supported by appropriate validation data, that is acceptable. If appropriate regulation of reprocessing means some of these products can no longer be reprocessed, then patient safety will benefit from that decision. We look forward to working with the Congress and FDA to make the promise of MDUFMA a safe reality for millions of patients. Thank you for the opportunity to address the committee on this important patient safety issue. I look forward to answering any questions the committee might have. [The prepared statement of Mr. Ubl follows:] [GRAPHIC] [TIFF OMITTED] T0528.050 [GRAPHIC] [TIFF OMITTED] T0528.051 [GRAPHIC] [TIFF OMITTED] T0528.052 [GRAPHIC] [TIFF OMITTED] T0528.053 [GRAPHIC] [TIFF OMITTED] T0528.054 [GRAPHIC] [TIFF OMITTED] T0528.055 [GRAPHIC] [TIFF OMITTED] T0528.056 [GRAPHIC] [TIFF OMITTED] T0528.057 [GRAPHIC] [TIFF OMITTED] T0528.058 [GRAPHIC] [TIFF OMITTED] T0528.059 Chairman Tom Davis. Thank you. Mr. Selvey and Mr. Toussaint, let me just start. Mr. Selvey, one of the challenges of reprocessing, it seems to me, has to be the changes to technology and designs. How do you keep up with the evolving technology and designs when you are not privy to trade secret information? Mr. Selvey. Mr. Chairman, if I may? Chairman Tom Davis. Yes. Mr. Selvey. There are a couple of things that we can do to keep up with the changing in design. First off, if the design change by the original manufacturer is significant, they are required under law to notify the FDA. That becomes public information. We can monitor that and, in fact, we become aware of that. Chairman Tom Davis. You can then decide if you want to buy something new at that point to make the decision? Mr. Selvey. Correct. The other part would be the change that is made by the original manufacturer that is not a significant change; we would pick that up through our routine monitoring of the devices. Periodically, we will do revalidation of the process but even beyond that, we will do periodic things like materials testing, analysis of the devices, just to make sure that there hasn't been a relatively insignificant change that has not been reported to the Food and Drug Administration and therefore not made public. Chairman Tom Davis. I don't know how I ask this. I guess I just ask this in a generic sense. How many times can one of the single-use devices be reprocessed before it becomes unusable? Does it just depend? I gather you have a way to look at that and decide if it is usable or not. How do you decide? Mr. Selvey. Mr. Chairman, there are a couple of factors that go into it. Yes, every device does have a finite number of reprocessing cycles. Typically, for the devices that we reprocess, it is going to be somewhere between one and five cycles. The average is about three. We are going to base that on the studies that we do in order to validate our ability to clean and test and resterilize the device. There is also a certain amount of, what I refer to as, the law of diminishing return. Typically, these devices are rejected out at about a 20 percent rate. That is, when they come into us, for whatever reason, about one in five devices is not fit to go through the process. Therefore, it is in our best interest to look very carefully at whether we are going to get more than five cycles out of the device, just based on that diminishing; typically three times, usually based, well, always based on the validation studies that we have. Mr. Ubl. Mr. Chairman, may I comment on that question? Chairman Tom Davis. You may. Mr. Ubl. I think it is very, very difficult for reprocessors to keep up with those changes. Let me just give you example. This was mentioned earlier. FDA allows reprocessors to submit in bundles, sometimes covering multiple manufacturers in the same device in the hundreds. FDA would never allow original manufacturers to submit and bundle their applications in that fashion. So I think it is extremely difficult to essentially assert that these types of products have the same degree of sameness, if you will, and keep up with the rapid incremental changes in technology. Chairman Tom Davis. Mr. Selvey asserts that the reprocessing is highly regulated and probably more stringently regulated than the original equipment industry, and you seem to contradict that. Mr. Ubl. Yes, I am absolutely baffled by that assertion. Our information suggests that, in fact, they have a much lower bar, and part of that is the bundled submission that I mentioned but, in addition, the quality systems regulation, pre-clinical testing of individual components, which they obviously can't do because they don't have the proprietary information. There is a whole range of FDA regulatory authorities that apply much more acutely to original manufacturers than they do to reprocessors. Chairman Tom Davis. Why don't you guys reprocess your own stuff? Mr. Toussaint. Mr. Chairman. Chairman Tom Davis. I will give you a chance to answer in a second. Why don't your own people, your own member companies ever partner with a reprocessor to refurbish their own devices? Mr. Ubl. Why don't they? Because they don't---- Chairman Tom Davis. Yes; is it because you make more on selling new stuff? Mr. Ubl. Well, they fundamentally don't believe that a reprocessed device is their device. It is a different product, and they really question the premise of whether these technologies can be safely reprocessed. I have to go back to the comment that was made that this is about money. Reprocessing single-use devices are less than 5 percent of all device sales, 5 percent. So the assertion that this all about economics is ludicrous, absolutely ludicrous. Chairman Tom Davis. But obviously, if you can get this device to work well, I don't know why you wouldn't want to do something that costs less. They are getting squeezed every which way for health costs. If you can reprocess a device and use it cheaper, why wouldn't you? Mr. Ubl. Absolutely, and we do it all the time. Let me just clarify that FDA approves single-use devices and multiple use devices. Our members make both. Our members are trying to be responsive to what the patient needs are and what the hospital and provider needs are. So for example, a trocar is a technology that used to be made in stainless steel and is now made in plastic due to the customer demanding ease of use and disposability. So there is a tension in the marketplace, and we are trying to be as responsive as possible to providers. Chairman Tom Davis. But you would admit that if the reprocessors and the FDA can guarantee patient safety, you don't have a problem with reprocessing. Mr. Ubl. We believe that the biggest problem is that a large number of devices don't come under the FDA purview. Dr. Schultz actually mentioned two adverse events that we reported to the FDA that were not being regulated by the FDA's reprocessing authority. Chairman Tom Davis. But conceptually, if the FDA regulated them, even if they made them be single-event pieces, if they can use them and it is safe, you don't have a problem. Mr. Ubl. Conceptually, yes; I mean I think we might have some issues around bundling and some of the mechanics of how it is done. Chairman Tom Davis. You are saying if they can assure the safety, you don't have a problem; OK. Mr. Selvey, do you want to comment, or Mr. Toussaint? Mr. Toussaint. Mr. Chairman, I really need to respond to Mr. Ubl's comment about bundling. I am not sure where he is getting this, his information, but there is an FDA guidance on bundling that does apply to, not only to reprocessor but OEMs, and in that guidance document, it states specifically that it is appropriate for manufacturers to bundle devices among generic types of devices, and it defines very specifically what a generic type of device is. It is appropriate. It further states that it is appropriate to bundle devices when the differences do not reflect any changes in safety or effectiveness of the devices. So bundling is an appropriate practice. When we do choose to bundle, we do it very carefully, and we scrutinize it very carefully. When Mr. Ubl says that hundreds of devices are not tested, that is simply not correct. Chairman Tom Davis. Every time there is an adverse incident, it just hurts your industry, right? Mr. Toussaint. I am sorry, what? Chairman Tom Davis. Every time there is an adverse incident with one of these devices, it just hurts your marketability and profitability, doesn't it? Mr. Toussaint. Yes, I would say. Chairman Tom Davis. So, of course, OK. Mr. Toussaint. Yes. When we choose to bundle devices, however, it is not that we choose one device out of, say, 50 devices to test. Within the bundling, within bundling a family, for instance, all devices are tested, and that way, during the review process, if the FDA would choose to analyze each device separately, statistically and otherwise, they could do so. So in effect, it would become a separate submission. So bundling is a means to increase the efficiency of FDA review, and it allows FDA to look at devices individually along with the family of devices, the generic type of family devices they belong to. Chairman Tom Davis. How do you feel about the level of FDA regulation? Do you think it is about right at this point? Do you think you are under-regulated or over-regulated? Mr. Toussaint. Are you speaking to me, Mr. Chairman? Chairman Tom Davis. I am. I am going to ask all three of you that. Mr. Toussaint. About the entire MDUFMA regulation, I think it is entirely over-regulated. I think many of these devices that require additional validation were previously cleared in the year 2000 or even prior to that and contain much of the data that submissions contain today, and I believe this is simply that the requirements that are required today of SVS submissions are a result of the pressure put on OEMs, so we are not allowed to process devices. Chairman Tom Davis. Mr. Ubl, you don't agree with that? Mr. Ubl. I absolutely don't agree. I think the practice is under-regulated. Again, FDA only regulates 68 types of technologies out of a possible 228. AdvaMed has provided to the FDA two types of technologies that have had adverse events associated with them. They, in turn, have extended their regulatory umbrella to those types of technologies. We wonder how many other technologies are out there that are at risk to patients. I know for my family, I certainly wouldn't want to trust a reprocessor to tell me how many uses. Chairman Tom Davis. Well, let me ask you another question. Do you think the OEMs are too regulated or not regulated enough? Mr. Ubl. I think there are appropriate regulations of original manufacturers. Chairman Tom Davis. OK. Mr. Toussaint. Mr. Chairman, I really need to respond to one other comment from Mr. Ubl. Chairman Tom Davis. Now, I am going to get to Mr. Gutknecht. Sure, we will let you respond. Let me give Mr. Gutknecht 10 minutes. Go ahead. Mr. Gutknecht. Well, I just want one real quick question. If this is so dangerous, you, both Mr. Selvey and Mr. Toussaint, your product liability or your liability insurance must be just sky-high. Mr. Selvey. Mr. Gutknecht, that is an important distinction. We do carry liability insurance, in fact, at the same level or an even higher level than some of the original manufacturers. Although we are not trying to compete with the manufacturers, we are trying to make our hospital customers very comfortable with our level of coverage. The reality is that despite having reprocessed something on the order of 15 million devices since our inception, we have never been sued by a patient, by a hospital, claiming that we produced an adverse event in a patient. In a litigious society, I think maybe that says something. Mr. Toussaint. I don't know what our insurance rates are at SterilMed, but I can say the same thing that Mr. Selvey has said, and that is that we have never been sued by a hospital, a patient, or had any other litigious event occur against our company. Mr. Gutknecht. So it is fair to say that both your insurance companies and your customers are satisfied with the quality of the products that you are putting out there. Mr. Ubl. Can I comment on that, Congressman? In some ways, reprocessing is flying under the radar. The reason there haven't been suits by patients or by providers is because, as has been mentioned by FDA and in my testimony, there is not adequate branding so that practitioners and patients even know that a reprocessed device is being used. So, until we have well-established branding, tracking, reporting, and so forth, we are not going to know what the true impact is. Mr. Gutknecht. Well, with all due respect, I have heard those siren songs before about drugs coming in from Canada, and the evidence is that a whole lot more Americans die every year from drugs that are purchased in the United States. Mr. Ubl. This is very different than a pill, Congressman. This is coming in contact with blood, tissue, and even the heart. Mr. Gutknecht. I understand, and I will reclaim my time, thank you. The point really is if this was as dangerous as some would have us believe, we would have massive lawsuits and, more importantly, the market for these devices, in my judgment, would dry up. I have talked to some of my hospital people. I have talked to some of my doctors about this very issue, and their general view is this is much ado about very little. I yield back my time. Chairman Tom Davis. Mrs. Schmidt. Mrs. Schmidt. Thank you, Mr. Chairman. I have a couple of questions for the panel. The first regards the bundling. I am very concerned about the bundling because I don't think it allows the FDA to have a clear review of each and every device. Would you be amenable? Frankly, I am not concerned about the ease of the FDA doing their job. The point is we have to have FDA doing the right job. Would any of you be adverse to not allowing the bundling and to force the FDA to look at each and every application on its own merit without bundling these devices? Mr. Selvey. Mrs. Schmidt, may I take a crack at that? Bundling is a prime example of much ado about nothing. As Mr. Toussaint has said, there is an FDA guidance on bundling for both OEMs and for reprocessors. But there is a very practical aspect here. When we put together a 510(k) and it goes to a reviewer who is not used to seeing bundled submissions, they have not been trained in bundled submissions, honestly, the reviewer doesn't know what to do with a bundled submission. We do not put together bundled submissions. I am not sure what Mr. Ubl is complaining about, but aside from some of the very early submission that we did back in the year 2000 that caused much heartburn and grief among the reviewers at the FDA, we stopped bundling. We haven't bundled a submission in a very long time. So to answer your question very directly, we would have no issue at all with doing away with bundling. It simply is not an issue for us in this industry. Mrs. Schmidt. In the matter of time, could I have a yes or no from either one of you because I have another question? Mr. Ubl. I am delighted to hear that response. The only comment that I would make is it is important for the committee to understand we are not just talking about a family of technologies made by one manufacturer. What they are bundling is across manufacturers making a similar product which is why it is so disturbing to us. Mr. Toussaint. Mr. Chairman, why that statement is somewhat incorrect is after each family, even though we bundle across families, for each family we provide separate validation data on that family. So each family is tested independently. Whether they are bundled together in a single submission or in multiple submissions, they still undergo the same review process. Mrs. Schmidt. Mr. Chairman, another question; one of my other concerns is the ability for the patient to know whether they are getting an original product or a reused product. Would any of you; just a yes or no answer with no comment, be in agreement that in the future, if it is a reused product, the patient will know up-front that it is going to be used, yes or no? Mr. Selvey. No. Mr. Toussaint. No. Mr. Cummings. Yes, we would support patient informed consent. Mrs. Schmidt. OK, thank you very much. Mr. Toussaint. Mr. Chairman. Chairman Tom Davis. Yes, go ahead. Mr. Toussaint. I have another comment I feel I must address by Mr. Ubl, and that was his comment regarding the 50 percent rate as being totally unobjectionable as devices not being safe enough and effective. I am not sure where that rate comes from, but I believe it is a total distortion of facts. I believe that rate comes from the fact that when reprocessors originally had to submit SVSes on a number of products, we received a number of NFC determinations or requests for additional information. This in no way implied that the devices were not safe and effective. In fact, let me read to you a quote from an FDA colleague about this matter. Larry Spears, the Deputy Director of the Office of Compliance at the FDA Center for Devices and Radiological Health stated that any reference to the specific devices that can no longer be legally marketed as being dangerous or unsafe is incorrect. Although some devices were found through review by our Office of Device Evaluation to be non-substantially equivalent to a previously marketed device, this does not mean they are unsafe or ineffective. Mr. Ubl. Mr. Chairman. Mr. Toussaint. When you receive an NFC letter, that is a request by FDA that you need to submit further information, further validation data, or other information. It does not mean that the devices at that point cannot be deemed substantially equivalent. During that period of time, many SVS submissions were submitted to FDA, and FDA was working through the process as well as the manufacturer. So it is not unexpected that we would receive NFC letters and FDA would be, would send out such letters and ask for additional information. There are other factors that relate to that 50 percent figure. It may be simply that the manufacturer chose not, after receiving such a letter, decided, chose not to provide that additional information because it was too, not feasibly cost- effective. Mr. Ubl. I promise to be really quick, Mr. Chairman, but let us just look at FDA's testimony to this committee. They say 33 percent of the time when the reprocessor submits their application, it was not substantially equivalent. That means it is taken off the shelf. I will grant you that it seems like approval rates have improved since we have been using the 50 percent rate, but a third of the time, they are submitting applications that are not meeting the test by FDA. This, to us, tells us that not only should they be looking at the devices they are looking at now but the additional types of technologies that are currently under FDA's purview. Chairman Tom Davis. All right; anything else? Mr. Toussaint. No; I would just like to respond to that comment as well. Chairman Tom Davis. Go ahead and get going. Go ahead. Mr. Toussaint. Just that the 33 percent simply means that we need to provide additional validation data. It doesn't mean the devices are not substantially equivalent, nor does it mean that---- Mr. Ubl. Does it mean they are off the shelf? Chairman Tom Davis. Is this stuff properly categorized so you know how many times it has been used, just for the record, as you keep it, or do you just examine it and say, yes, this looks good? Mr. Toussaint. I am sorry. I didn't understand the question. Chairman Tom Davis. Every time you reuse a medical device, is it logged in that this is the third time or the fourth time or the second time it has been used, or do you just kind of look at it and decide if it meets criteria or not? Mr. Toussaint. I would say we generally look at it and decide if it meets criteria. Chairman Tom Davis. So it is not necessarily logged in, and you have that record of how many times it is has been used? Mr. Toussaint. Well, we certainly have. You are talking about specific devices? Chairman Tom Davis. Yes. Mr. Toussaint. Certainly, we have a record of how many times a device has been used. Chairman Tom Davis. Anything else? We are going to vote, and I want to let the panel go. This is to be continued. Obviously, we don't have a consensus here, but I appreciate everybody's testimony and being able to make the case. The committee will continue to look at this further. Thank you. [Whereupon, at 12:17 p.m., the committee was adjourned.] [The prepared statement of Hon. Edolphus Towns follows:] [GRAPHIC] [TIFF OMITTED] T0528.060 [GRAPHIC] [TIFF OMITTED] T0528.061 [GRAPHIC] [TIFF OMITTED] T0528.062 [GRAPHIC] [TIFF OMITTED] T0528.063 [GRAPHIC] [TIFF OMITTED] T0528.064 [GRAPHIC] [TIFF OMITTED] T0528.065 [GRAPHIC] [TIFF OMITTED] T0528.066 [GRAPHIC] [TIFF OMITTED] T0528.067 <all>