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Senate debates hazards of reuse

Reuters Health
July 9, 2000


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Washington. Although there is little evidence that the reprocessing and reuse of single-use medical devices is a threat to public health, the practice warrants more intensive study and oversight, the General Accounting Office told a Senate committee June 27.

GAO’s Janet Heinrich told the Senate Committee on Health, Education, Labor and Pensions that the office found evidence demonstrating the safety of reprocessing some devices, such as electrophysiology catheters. It also found that some highly publicized reports of adverse events attributed to the reuse of single-use devices "were inaccurate, did not involve the type of reprocessing discussed here, or were difficult to interpret."

For example, Heinrich told the committee, although the Food and Drug Administration received a report that the tip of a reused electrophysiology catheter broke off and lodged in a patient’s heart, the "FDA also received two reports of similar injuries resulting from procedures with new electrophysiology catheters."

But the dangers are more than theoretical, Heinrich said. "It is also clear that some single-use devices cannot be safely reprocessed, procedures for safe reprocessing are not always followed, and the limitation of the information available about single-use device reprocessing argue for monitoring the practice," she said.

That view appears to be shared by the FDA, whose 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 links injuries to reuse, the FDA has concluded that the practice of reprocessing single-use devices merits increased regulatory oversight," he said. "Our plan is to phase-in additional oversight based on our assessment of current practice and potential risk."