[U.S. FOOD AND DRUG ADMINISTRATION]

February 10, 2000

STATEMENT BY

DAVID W. FEIGAL, M.D.

DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES


BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

COMMITTEE ON COMMERCE

U.S. HOUSE OF REPRESENTATIVES

FEBRUARY 10, 2000



INTRODUCTION

Mr. Chairman, Members of the Committee, I am Dr. David Feigal, Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am very pleased to have the opportunity to be here today to discuss the Agency's approach to the issue of reuse of medical devices labeled for single-use. As you know, FDA is currently in the process of reexamining its policy on the reuse of medical devices labeled for single-use. Our primary goal in doing so is to protect the public health by assuring that the practice of reprocessing and reusing single-use devices (SUDs) is safe and effective and based on good science. We value your interest and input as we study this complex issue and move forward to change our regulatory approach.

The public expects and the law requires all devices to be safe, effective and manufactured in accordance with Good Manufacturing Practices (GMPs). Let me say at the outset that I believe FDA does have the tools to ensure the safety, effectiveness and manufacturing quality of reprocessed single-use devices. We have been actively engaged in reuse issues for some time and our efforts have included research, outreach, inspections and compliance investigations. We are currently in the midst of crafting a new regulatory approach that will treat Original Equipment Manufacturers (OEMs), third parties and hospitals in a similar manner to minimize risks associated with reused single-use devices.

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

That being said, medical progress has been accompanied by changes in technology, resulting in more devices with features that may make reprocessing difficult or impossible. At the same time, economic pressures create incentives for reuse. Despite a lack of clear data that suggests that many injuries are occurring due to reprocessing practices, FDA has concluded that the practice of reuse of SUDs needs additional attention and controls. We recognize the limitations of our medical device problem reporting systems in capturing this information. We take the reports we do get very seriously, but at the same time, even if there were no injuries, a driving question remains: Are reprocessed SUDs being manufactured properly, that is, in accordance with the Quality Systems Regulation (QSR)?

On February 8, 2000, FDA posted on its web site two draft guidance documents that pertain to the reuse of SUDs. One describes a proposed risk categorization scheme for reprocessed SUDs. The other describes the Agency's priorities for enforcing various regulatory requirements based on the risk categorization of a reprocessed SUD. We will be publishing a Notice of Availability of the documents in the Federal Register imminently and asking for public comments on these two documents.

BACKGROUND

The History of Hospital Reuse

The practice of reusing medical devices labeled, or otherwise intended, for only one use began in hospitals in the late 1970s. Prior to this time, most medical devices were considered to be "reusable." Because most reusable devices were fabricated from glass, rubber, or metal, early reprocessing of reusable products, such as probes and surgical instruments, involved little more than hand wiping, dipping, and soaking in disinfection solutions. OEMs began to sell "single-use" medical devices as a result of market demand for disposable equipment, the development of new plastics, and the use of ethylene oxide sterilization. Hospitals began to see products labeled "single-use only" that were similar to devices that had been formerly distributed or continued to be distributed as "reusable."

The practice of reprocessing single-use devices expanded when an increasing number of hospitals decided that reuse was a cost-saving measure and when they became concerned about the amount of medical waste generated by the use of disposable devices. Hospitals started reprocessing more complex products, such as balloon angioplasty catheters and cardiac catheters. Reprocessing of these devices required more complicated decontamination sterilization procedures. As a result, an industry of third party reprocessors evolved in response to the reprocessing needs of hospitals. Expanded use of third party reprocessors and an increase in the types of single-use products subjected to reprocessing heightened concerns regarding patient safety, and equitable regulation of OEMs and reprocessing firms.

The Scope of Reuse Today

The Agency has developed a list of frequently reprocessed SUDs, which includes devices that range from the technologically simple to the complex. Examples include:

The list varies greatly in type of device, material, risk of use and severity of clinical conditions of typical use. Some products have features such as long narrow lumens, fragile plastic components, and/or unsealed electronic controls that make them very difficult to clean. Other products on the list, e.g., drill bits, are technologically less complex and are relatively easy to clean.

A common type of reuse in hospitals occurs when a sterile product, such as a suture, is opened during a medical procedure but not used. Typically these are re-sterilized and re-packaged at the hospital. OEM's often provide instructions for hospitals to do so. The Agency has published applicable guidance on these products and does not consider opened-but-unused SUDs to be reused devices that are within the scope of the proposed strategy.

AGENCY INVOLVEMENT IN REUSE

Reports of Patient Injuries

There have been stories in the media which have reported catheter tip separations, faulty cataract surgical equipment, and other problems attributed to failure of a reused SUD. A recent review of Medical Device Reporting (MDR) reports received by CDRH from August 19, 1996 through December 7, 1999 revealed 464 reports (out of 300,000) of adverse events that could possibly be attributed to reuse of a SUD. The 245 reports spanned approximately 70 different types of products. From this data we can discern no pattern of failures with reused SUDs that differs from patterns observed with the initial use of SUDs.

MDR reports do not enable accurate assessment of failure rates, whatever the type of device. Detecting SUD problems is even more challenging in that they are often not labeled as SUDs (other than on the original packaging). In addition, device failures may be particularly under-reported (to manufacturers) when the hospital recognizes that the device that failed was a reused SUD. Also, infections that may have resulted from an improperly reprocessed SUD may be hard to trace back to the reused device.

Research Findings

CDRH has implemented a research program to explore safety and effectiveness issues associated with the reprocessing of single-use devices. Information on difficulty of cleaning the devices, effect of sterilization on material, efficacy of resterilization, and alteration in performance criteria are all being investigated. CDRH has had the opportunity to examine SUDs after one-time use, compare them to devices that have not been used, and do simulated reuse laboratory studies. Loss of elasticity in inflatable balloons, persistence of blood and biofilms, loss of original lubricants and the effect on catheter threading, and crystallization of liquid x-ray contrast material are just some of the factors that we have examined. This research program has expanded our ability to evaluate reports, scientific studies, and comments from the healthcare community.

Hospital infection control programs rarely identify specific incidents of patient infection caused by reuse of SUDs. Our research has shown, however, that the performance of some products is degraded by the effects of biofilms and repeated use. We have presented our laboratory findings at many scientific meetings. We continue to believe that solid research by industry, academia and FDA is the best way to understand the issues that need to be addressed and to develop consensus standards for reprocessing practices.

Outreach

The Agency has conducted numerous outreach efforts to further understanding of and participation in this issue. We have organized and participated in public meetings and conducted videoconferences. We have met with individual manufacturers and reprocessors; manufacturers' and reprocessors' trade associations; the American Hospital Association; the Joint Commission of Health Care Organizations (JCAHO); the Health Care Financing Administration (HCFA); and medical professionals and some of their associations on this issue. Two meetings with broad scope that occurred in 1999 were particularly useful in furthering our understanding of this issue.

On May 5-6, 1999, FDA and the Association for the Advancement of Medical Instrumentation (AAMI) co-sponsored a conference on the practice of reprocessing and reusing SUDs. Participants included representatives of health care facilities, firms that reprocess devices, OEMs, national oversight organizations, State governments, academia, medical ethicists, and standards organizations. This provided FDA the opportunity to hear a wide range of views and concerns from individuals and organizations involved in or affected by this practice.

FDA received divergent opinions on how reprocessing and reuse of single-use devices should be regulated. Some participants believed that reprocessors should be regulated in the same manner as OEMs and that 510(k)s or Premarket Approval applications (PMAs) demonstrating the safety and effectiveness of the reprocessed device should be required. Others believe that OEMs should be required to provide instructions on how to reprocess their devices unless they can demonstrate that the device cannot be reprocessed. Still others stated that the general controls under which reprocessing is regulated currently are sufficient to ensure protection of the public health.

Participants identified the need for additional guidance on reprocessing. Among the suggestions were: standards to assure that cleaning, disinfection, and sterilization processes are validated and that reprocessing may be performed properly; a determination of what types of devices can and cannot be reprocessed; a classification scheme establishing critical, semi-critical, and non-critical categories for reprocessed devices; and clearer definitions for the terms "reuse," "reprocessing," and "resterilization."

Participants suggested that clinical data and experience on reuse could be obtained through hospitals' existing surveillance activities; long-term clinical studies; the establishment of a clearinghouse for data; National Institutes of Health funds and studies of reprocessing; and research by professional societies with funding provided by OEMs and reprocessors.

FDA held an open meeting, on December 14, 1999, to obtain feedback from stakeholders and interested parties on its proposed strategy on reuse of SUDs. Twenty-eight public presenters voiced a variety of concerns during the first part of the meeting, and workshops in the afternoon provided attendees with an opportunity to explore particular issues in smaller groups. An Executive Summary which describes the input we received on many aspects of this complex issue is available on our web site at http://www.fda.gov/cdrh/reuse/1214execsum.pdf.

FDA's CURRENT POLICY

As I noted at the outset, the American public expects, and the Federal Food, Drug, and Cosmetic (FD&C) Act requires, that devices be safe, effective, and manufactured in accordance with GMPs. When a SUD is prepared for reuse by cleaning, repairing, or refurbishing, it is being remanufactured and the FD&C Act provides controls to address these reprocessed devices, however, FDA has not regulated OEMs, third party reprocessors and hospitals that reprocess devices in the same manner.

Original Equipment Manufacturers (OEMs)

OEMs are subject to all requirements of the FD&C Act including: registration and listing, premarket notification and approval requirements, submission of adverse event reports under the MDR regulation, manufacturing requirements under the QSR; Labeling requirements, Medical Device Tracking, and Medical Device Corrections and Removals. The Agency has enforced all of these requirements with respect to OEMs.

Third Party Reprocessors

Third party reprocessors are subject to the same regulatory requirements as other manufacturers, including premarket requirements. As discussed previously, FDA has issued Warning Letters to third party reprocessors for various violations; however, to date, FDA has not actively enforced premarket requirements against third parties. (Note that many devices that are commonly reprocessed are exempt, by regulation, from premarket requirements.)

Hospitals

According to the Agency's Compliance Policy Guide, hospitals that reprocess single-use devices assume full liability and responsibility for their reprocessing actions and should ensure that the products are adequately cleaned and sterilized, and that device safety, effectiveness, and quality are maintained. The Agency currently provides no direct oversight or routine enforcement for in-hospital reprocessing. If a serious adverse event involving a reprocessed (or any other) device occurred in a hospital, however, FDA would conduct an investigation and take appropriate action, as necessary.

FDA's PROPOSED STRATEGY

As I stated earlier, FDA is reevaluating its position on the reuse of single-use devices. In November 1999, the Agency made a document available on its web site for public review and comment which described a proposed strategy to address reuse of SUDs. One of the principal components of FDA's proposed strategy was the establishment of agency enforcement priorities concerning regulatory requirements for third party and hospital reprocessors of SUDs. FDA proposed to prioritize its enforcement activities based on the degree of risk posed by the reprocessing. To accomplish this process, FDA proposed the following steps:

  1. develop a list of commonly-reused SUDs;

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

  3. use that list of factors to divide the list of commonly-reprocessed SUDs into three categories of risk - high, moderate, and low; and

  4. develop priorities for enforcement of regulatory requirements for hospitals and third party reprocessors, based on the category of risk.

Since the announcement of FDA's proposed strategy, FDA has made significant progress. On February 8, 2000, FDA posted on its web site two companion draft guidance documents. One is entitled, "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme." This draft guidance set forth factors we would consider in categorizing a reprocessed devices as high, moderate or low risk and includes a list of commonly-reprocessed SUDs and the degree of risk FDA believes each type of device poses when reprocessed. The other draft guidance, entitled "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals," sets forth our priorities for enforcing various regulatory requirements, based on the categorization of a device, as described in the Risk Categorization guidance.

The risk scheme guidance describes specific factors FDA would use to determine whether reprocessing posed high, medium, or low risk. This guidance has two flowcharts to help FDA and industry categorize the reprocessing risks. One flowchart addresses factors that relate to risks of infection that may accompany reprocessing. The other flowchart addresses factors that relate to risks of performance failures that may accompany reprocessing. Using these two flowcharts, FDA has categorized all currently known reused SUDS into three categories of risk -- high, medium, and low. We have clarified that the risk categorization scheme does not in any way change the classification of a device under the statute.

The enforcement priority guidance bases the Agency's timing of enforcement of premarket requirements on the level of risk determined under the risk categorization scheme. Specifically, FDA intends to begin to enforce premarket notification and premarket application requirements within six months of issuance of a final guidance if the reprocessed device is categorized as high risk, within 12 months if the device is categorized as moderate risk, and within 18 months if the device is categorized as low risk. Although FDA has not previously enforced premarket requirements for third party reprocessors, FDA currently enforces all other requirements applicable to manufacturers against third party reprocessors. The issuance of this draft or any final guidance will not change the continuing obligation of third party reprocessors to comply with those provisions of the FD&C Act. FDA would not enforce those requirements for hospitals, however, until six months from the issuance of a final guidance document.

I would like to give a couple of examples of how this proposed risk categorization scheme and our enforcement strategy would affect reprocessors of devices of disparate complexity and risk. Oral and nasal catheters, fairly simple devices, are currently class I and exempt from premarket notification. They would be considered "low risk" under the risk categorization scheme I just described. Six months after a guidance became final, FDA would actively enforce all non-premarket requirements for hospitals that reprocess oral and nasal catheters, just as we currently do for OEMs and third party reprocessors, including registration, listing, manufacturer adverse event reports, labeling, corrections and removals, and quality system manufacturing requirements.

Percutaneous transluminal angioplasty catheters or intra-aortal balloon catheters, class III, would be considered "high risk" under the scheme. Based on our own studies, we have determined that cleaning and sterilizing these devices are very difficult. Hospitals and third parties that reprocess these devices would be required to submit to the Agency PMAs demonstrating that their reprocessing of these devices is safe and effective, in addition to conforming to the general controls of the FD&C Act.

At this time, the Agency is limiting its focus to SUD reprocessing by third parties and hospitals. The draft SUD enforcement guidance does not apply to permanently implantable pacemakers (the reuse of which is already addressed in a Compliance Policy Guide), "opened-but-unused" SUDs, and healthcare facilities that are not hospitals.

NEXT STEPS

Issuance of Final Guidance Documents

The guidance documents I mentioned are not final, nor are they in effect at this time. These documents incorporate comments to our proposed strategy that we received at the December 14 public meeting and written submissions. We are in the process of publishing in the Federal Register of a notice of availability of these documents and are asking for comments. After reviewing the comments received, the Agency will issue final guidance documents.

Phased-In Enforcement

As I have stated earlier, FDA is planning to phase in the enforcement of regulatory requirements for third parties and hospitals that reprocess SUDs. After receiving public comment on our draft guidances, including factors used to categorize risks, and timing of our enforcement based on those risks, we will issue final guidances and begin implementation of our enforcement strategy that would regulate OEMs, and third party and hospital reprocessors in the same manner.

Collaboration with Other Parties

The direction in which we are headed could impact significantly on the Agency's resources, particularly for conducting inspections of hospitals that reprocess. We will be collaborating with third parties, such as JCAHO, HCFA and State agencies that currently perform oversight of the health care sector to assist us in implementing the new policy.

Outreach

We will be continuing our outreach efforts to ensure that the health care community, manufacturers, reprocessors, patients, and the public are fully aware of the issues involving the reprocessing and reuse of SUDs. Our efforts will include talk papers, public health notifications, and lay articles on an FDA web page.

SUD Labeling

We will be considering changes to the labeling of SUDs by OEMs. One option the Agency is considering is requesting OEMs who label their devices "single-use" to provide, as part of the device's labeling, any information of which they are aware regarding the potential risks associated with reusing their SUDs. This information would serve as a caution to users and reprocessors who might attempt to reprocess these SUDs.

Institute an Expanded Research Program for Reuse

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

CONCLUSION

Mr. Chairman, although we have no data to indicate that people are being injured or put at increased risk by the reuse of SUDs, the results of our own research and the information provided by various stakeholders have convinced us that this growing practice needs closer scrutiny and oversight. We are committed to addressing reuse in an open and cooperative fashion with the industries involved, the health care community, the public, and, of course, the Congress to craft a policy that is reasonable yet effective in minimizing the risks associated with this practice. Thank you for the opportunity to be here today. I am happy to answer any questions you may have.

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