GAO: More study needed on reuse of disposables
Public health concerns raised
Although there is little evidence that the reprocessing and reuse of "single-use" medical devices (SUDs) is a threat to public health, the practice does warrant more intensive study and oversight, the General Accounting Office (GAO) told a Senate committee recently.
"The practice of SUD reprocessing reduces the costs of medical devices for hospitals and other health care facilities, but it also raises public health concerns, primarily regarding the poten-tial risks of infection and device malfunction," GAO’s Janet Heinrich told the Senate Commit-tee on Health, Education, Labor and Pensions.
Heinrich said the GAO found evidence demonstrating the safety of reprocessing some devices, such as electrophysiology catheters. The study also found that some highly publicized reports of adverse events attributed to the reuse of SUDs "were inaccurate, did not involve the type of reprocessing discussed here, or were difficult to interpret." For example, she said, while the Food and Drug Administration (FDA) received a report of the tip of a reused electrophysiology catheter that broke off and lodged in a patient’s heart, "FDA also received two reports of similar injuries resulting from procedures with new electrophysiology catheters," Heinrich told the committee.
At the same time, she said, the dangers are more than theoretical. "It is also clear that some SUDs cannot be safely reprocessed, procedures for safe reprocessing are not always followed, and the limitation of the information available about SUD reprocessing argue for monitoring the practice," she said.
An FDA representative provided similar advice to the Senate committee. The director of the Center for Devices and Radiological Health, David Feigal, MD, outlined the agency’s proposal for oversight of the practice. "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," he said. "Our plan is to phase in additional oversight based on our assessment of current practice and potential risk."
A longtime practice
Another speaker represented the American Hospital Association. John Clough, MD, chair of health affairs at the Cleveland Clinic Foundation, told the committee that "hospitals have been reprocessing medical devices for decades. If this practice threatened patient safety, epidemiologists would have identified long ago clusters of infection developing. However, as the FDA and the GAO confirm, there is no evidence to support the notion that reprocessing is a risk to public health."
Clough also noted that original equipment manufacturers have little incentive to label devices as reusable and, in fact, have financial incentives to designate devices as "for single use."
"Manufacturers appear to use the term for single use’ as part of their labeling without justifying whether, in fact, the device can be safely reprocessed for subsequent use," he said. "In the last two years at the Cleveland Clinic, we have observed products, such as saw blades, that have been labeled historically as reusable, arriving with the for single use’ label with no observable change in the product. We believe that the recent proliferation of costly devices labeled for single use’ that have replaced viable reusable products has contributed to the strain on health care resources."
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