February 2000 Bulletin

FDA plans strategy on reuse of devices

Targets parties who reprocess single-use devices

By Walter Gorski

Is the safety of patients who are treated with reprocessed medical devices and surgical instruments at risk?

The Food and Drug Administration (FDA) thinks the answer may be "yes" and has taken the first steps toward regulating all parties who reprocess medical devices to enhance patient safety. Under a recently released strategy proposal, the FDA plans to uniformly regulate all parties who reprocess medical devices currently labeled for only one use.

FDA’s regulatory actions will not only affect original equipment manufacturers and third-party reprocessors, but also the hospitals and clinics that reprocess medical devices. The FDA’s intentions are not aimed at banning the reuse of medical devices. Instead, the FDA’s main goal seems to be to prevent device malfunctions, patient injuries and infections relating to the reuse of single-use devices.

FDA is soliciting comments on 22 frequently used reprocessed single-use devices, including surgical saw blades, drills and drill bits and endoscopic carpal tunnel blades.

With advances in medical technology and the development of new composite materials, the reprocessing of medical devices has become commonplace and a necessity to control health care costs. No longer are health care facilities reprocessing simple instruments such as scalpels and probes. They are reprocessing more complex devices that involved advanced sterilization, servicing, packaging and reconditioning of items such as balloon angioplasty catheters and cardiac catheters.

Concern, however, has been raised because reprocessing, in some cases, has the potential to significantly change the original characteristics of the device when first manufactured, according to device manufacturers.

Fueling FDA’s efforts for regulations has been a recent Institute of Medicine (IOM) report finding that medical errors have resulted in anywhere between 44,000 to 98,000 deaths in U.S. hospitals annually. The IOM report also found that the health care industry is a decade or more behind other high-risk industries in its attention to ensuring basic safety. The IOM said the nation should set a goal of reducing medical errors by 50 percent over the next five years and recommended the FDA to increase its attention to public safety.

Additionally, several articles questioning the safety and efficacy of reprocessing medical devices have appeared in a number of national newspapers. The articles highlight adverse events where reprocessed devices have failed. In one case a cardiac catheter being used for the sixth time came apart leaving the tip lodged in the patient’s heart. In another example, a reprocessed guide-wire snapped off in a patient’s throat.

The issue of regulating the reprocessing of single use devices has faced controversy at every step thus far. Last summer, the Health Care Financing Administration created an uproar when it announced that it would not provide Medicare reimbursement for reprocessed single-use devices unless the devices meet FDA approval guidelines.

While FDA would like to implement a program fair to both the reprocessors and device manufacturers that enhances patient safety, FDA is having an increasingly difficult time developing regulations because of a lack of scientific data. Only recently has the FDA begun studying the effects of reuse. Up until this time, only partial or small outcomes surveys have been conducted on the reuse of medical devices.

A host of other controversial issues confront FDA as it moves ahead. These issues include how and who will police those subject to regulations and how various devices will be classified. Even more problematic will be the tracking of reprocessed devices.

But while patient safety may be paramount, the issue may come down to dollars and cents. In Washington, D.C., device reprocessors and manufacturers have organized on opposite sides of the issue. Both sides have launched intense lobbying efforts on Capitol Hill. The device reprocessors support moderate regulation over stakeholders and are supportive of the FDA’s regulatory goals while the device manufacturers are pressing for a ban on the reprocessing of any device labeled as single use.

Meanwhile, legislation addressing medical device reprocessing is pending in both the House of Representatives and the Senate. These legislative initiatives would place restrictions on the use of reprocessed medical devices that do not meet certain FDA standards. The legislation also would require the informed consent of patients prior to the use of reprocessed devices by physicians.

Recently, FDA specialists on reuse held a public forum to solicit input from the public and industry experts on FDA’s proposed strategy. Larry Kessler, Director of FDA’s Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics, said the CDHR is strongly seeking input from the medical community on how to regulate reprocessing activities. He hoped the FDA would be able to provide further guidance on the direction FDA would take toward regulation of the industry by the summer.

The Academy’s biomedical engineering committee and the Washington office will closely monitoring FDA’s actions and legislative measures addressing this issue and will press for results that are in the best interests of providing patients safe and effective orthopaedic care. But, due to medical, legal, ethical and economic issues surrounding the issue, as well as its complexity, final regulations could be more than two years away.

Walter Gorski is manager, government relations, AAOS Washington Office

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