Reuse of Medical Devices Labeled for Single-use

Statement of

David W. Feigal, M.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Department of Health and Human Services

before

the Senate Committee on Health, Education, Labor, and Pensions

June 27, 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 has re-examined its policy on this issue. 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 move forward to implement our regulatory strategy.

The public expects and the law requires all medical 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 SUDs. 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 developing an approach that will apply existing regulations to original equipment manufacturers (OEMs), third parties, and hospitals in a similar manner to minimize risks associated with reprocessed SUDs.

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. We have evaluated and conducted research. We have inspected third-party reprocessors. We have investigated reports of patient injuries. We understand that economic pressures create incentives for hospitals to reuse devices labeled for single-use and we also know that changes in technology have resulted in more devices with features that may make reprocessing difficult or impossible. Despite a lack of clear data that directly link injuries to reuse, FDA has concluded that the practice of reprocessing SUDs merits increased regulatory oversight. We are concerned because we do not yet have enough information to be certain that reprocessed SUDs are being manufactured properly, and we recognize that our medical device problem reporting systems cannot adequately capture information about potential clinical problems related to reuse. Our plan is to phase-in additional oversight based on our assessment of current practice and potential risk.

In February, we posted two draft guidance documents that pertain to the reuse of SUDs. One described a proposed risk prioritization scheme for reprocessed SUDs. The other described the Agency's proposed priorities for enforcing various regulatory requirements based on the risk associated with a reprocessed SUD. The public comment period for these documents ended on April 11, 2000, and we are now completing our analysis of the feedback we have received. In general, the comments have been very supportive of the Agency's decision to treat all reprocessors of SUDs, whether third-party firms or hospitals, in a similar manner. Some commentors asked us to phase-in our increased oversight more slowly to give hospitals a chance to become familiar with FDA requirements. Other stakeholders believe FDA is not moving quickly enough to enforce its requirements. Many stakeholders suggested we simplify the approach we had set out in the draft guidances for enforcement priorities by matching our phased-in approach to the current classification system. Let me now provide some background on reuse to put FDA's current initiatives in perspective.

BACKGROUND

The History of Reprocessing and Reuse of SUDs

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 a 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 SUDs 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 and other cardiovascular catheters. Reprocessing of these devices required more complicated decontamination and 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 SUDs subjected to reprocessing heightened concerns regarding both patient safety and a level playing field for OEMs and reprocessing firms.

The Scope of Reuse Today

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

• Surgical Saw Blades
• Surgical Drills
• Laparoscopy Scissors
• Orthodontic (metal) Braces
• Electrophysiology Catheters
• Electrosurgical Electrodes and Pencils
• Respiratory Therapy and Anesthesia Breathing Circuits
• Endotracheal Tubes
• Percutaneous Transluminal Coronary Angioplasty Catheters
• Biopsy Forceps

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

A common type of reuse in hospitals occurs when a sterile product, such as a suture, is opened during a medical procedure but not used. Typically, these are re-sterilized and re-packaged at the hospital. OEM's often provide instructions for hospitals to do so or replace the opened product with new stock. 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 several media reports of catheter tip separations, faulty cataract surgical equipment, and other problems attributed to failure of a reused SUD. A review of Medical Device Reporting (MDR) reports received by CDRH from August 19, 1996 through December 7, 1999, revealed 464 reports (out of approximately 300,000) of adverse events that could possibly be attributed to reuse of a SUD. Of these, 219 involved hemodialyzers which under certain conditions may be reused in the same patient. The remaining 245 reports spanned approximately 70 different types of products. From these 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 through the reporting system is even more challenging because the products are often not labeled as SUDs. In addition, device failures may be particularly under-reported (to manufacturers) when the hospital recognizes that the device that failed was a reprocessed 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 SUDs. Information on the difficulty of cleaning and disinfecting the devices, the effects of sterilization on materials, the efficacy of resterilization, and alteration in performance criteria have been 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 resultant 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, as well as through publications in scientific journals. 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 convened a public meeting and sponsored videoconferences on our proposed strategy. 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 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 SUDs should be regulated. Some participants believe that reprocessors should be regulated in the same manner as OEMs and that 510(k) submissions 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 which the Agency has enforced for third-party reprocessors are sufficient to ensure protection of the public health.

Participants identified the need for additional guidance on reprocessing. Suggestions included: 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 the 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 website.

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 to be used again by cleaning, repairing, or refurbishing, it is being remanufactured and the FD&C Act provides controls to address these reprocessed devices. However, up until now, FDA has not enforced its regulations in the same manner for OEMs, third-party reprocessors, and hospitals that reprocess devices.

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 Quality System Regulation; 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 required these firms to register and list, has inspected their operations, and issued Warning Letters to third-party reprocessors when we found 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

In November of 1977, FDA issued a guidance informing hospitals that reprocess SUDs that they 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 (Compliance Policy Guide # 300.500). The Agency currently provides no active 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 can and does investigate and take appropriate action.

FDA's PROPOSED STRATEGY

As I stated earlier, FDA is reevaluating its position on the reuse of SUDs. One of the principal components of FDA's proposed strategy is 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 that it take 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. As I mentioned earlier, FDA posted its draft guidances and solicited public comment. The risk categorization scheme was our effort to prioritize the level of risk that could be posed by different reprocessed SUDs in order to reasonably allocate regulatory resources to phase-in equal enforcement of regulatory requirements for all reprocessors. The second draft guidance proposed the timing for enforcement of premarket requirements based on the level of risk assessed under the risk categorization scheme. Specifically, we stated our intention to begin to enforce premarket notification and premarket application requirements within six months of issuance of a final guidance if a reprocessed device was categorized as high risk, within 12 months if the device was categorized as moderate risk, and within 18 months if the device was categorized as low risk.

Many stakeholders who provided input on our draft guidance suggested that we simplify implementation of our policy by aligning our enforcement priorities with the actual device classification. Under that approach, FDA would enforce all premarket requirements first for those reprocessed SUDs that were Class III, then phase-in enforcement of premarket requirements for Class II and Class I reprocessed SUDs. The Agency is evaluating these suggestions and others as we finalize the guidance that will implement our policy.

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 our draft guidance or any final guidance does not and will not change the continuing obligation of third-party reprocessors to comply with those provisions of the FD&C Act. Under its draft plan, however, FDA would not immediately enforce those requirements for hospitals, in order to give them an opportunity to become familiar with the applicable regulations and procedures.

I would like to give a couple of examples of how our increased oversight 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. Within a certain period of time after the guidance becomes final, FDA will 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, tracking, and quality system manufacturing requirements. Percutaneous transluminal angioplasty (PTAC) catheters are Class III devices that we consider "high risk" under the scheme. Based on our own studies, we have determined that cleaning and sterilizing these devices are very difficult. After the final guidance is issued, FDA will actively enforce premarket requirements for hospitals and third parties that reprocess PTACs. Within a relatively short time period, FDA will enforce requirements for those hospitals and third parties to submit PMAs demonstrating that their reprocessing of PTACs 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 (reuse of those devices is already addressed in a Compliance Policy Guide), "opened-but-unused" SUDs, hemodialyzers, 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. The drafts, which relied on input from earlier public meetings, have been out for comment since February 2000 and the comment period ended on April 11, 2000. We are now completing review of the comments we received on these draft documents, and will be issuing final guidance documents in the very near future. As I noted at the outset, the Agency received strong support for its proposed regulatory strategy for third parties and hospitals that engage in the reprocessing and reuse of devices labeled for single use in the United States.

Phased-In Enforcement

In general, our stakeholders and interested parties endorsed phased-in enforcement of our strategy for applying our regulations for OEMs, third-party, and hospital reprocessors in the same manner. As soon as our final guidance issues, FDA is planning to phase-in the enforcement of regulatory requirements for third parties and hospitals that reprocess SUDs.

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 SUDs. We will be collaborating with third parties, such as JCAHO, HCFA, and other regulatory bodies that currently perform oversight of the health care sector, to assist us in implementing our 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. We plan special efforts to communicate and work with the hospital community affected by FDA's requirements for reprocessors.

SUD Labeling

We also will continue to consider 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 and 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.

General Accounting Office (GAO) Report

The Agency is pleased that Congress asked GAO to look into the practice of SUD reprocessing in the United States. We recently provided comments to GAO on the draft report. Overall, we believe the report provided a balanced analysis of a difficult issue. The draft report noted that FDA's strategy represented a reasonable approach given Agency resources. The report also stressed the need for FDA to educate hospitals about reprocessing requirements and the Agency agrees that this type of outreach effort will be essential to successful implementation. The report also highlights the need for other Federal agencies to help implement the strategy. The Agency is currently working with JCAHO to employ their expertise and resources in this area.

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. We believe we are on schedule to implement a reasonable strategy that will treat all reprocessors of SUDs in the same manner. Thank you for the opportunity to be here today. I am happy to answer any questions you may have.

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(Hypertext created by frw 2000-JUL-10)