Rep. Thomas M. Davis III (R-VA) raised concerns about the safety of reprocessed SUDs.
In January, the Government Accountability Office (GAO) said it would investigate the safety of using reprocessed single-use devices (SUDs). GAO, the investigative arm of Congress, will also examine how FDA is overseeing the issue.
The probe came in response to a request from the two senior members of the House Committee on Government Reform. Rep. Thomas M. Davis III (R–VA) is the committee chairman, and Rep. Henry A. Waxman (D–CA) is its ranking minority member. They raised the concern after reading a series of articles in the Washington Post about reprocessed SUDs.
The device industry has questioned the practice, saying it cannot vouch for the safety of reused devices designed for a single use. But the reprocessing industry says there is no evidence that reconditioning devices causes patient harm. Under the Medical Device User Fee and Modernization Act of 2002, Congress allowed FDA to establish regulations for reprocessed SUDs. FDA compelled reprocessors of certain kinds of devices to submit validation data.
GAO last issued a report on SUD reprocessing in 2000. Although it found little proof of harm to patients, it said the practice was not widely used then, and little was known about it.
“We found little indication in reports of adverse events related to medical devices that SUD reprocessing is unsafe,” that report stated. But, it added, “it is also clear that some SUDs cannot be safely reprocessed, procedures for safe reprocessing are not always followed, and the limitations of information available about SUD reprocessing argue for monitoring the practice.”
Now that FDA is monitoring the practice, the new GAO report will evaluate how well that is going.
At press time, GAO had not determined the exact scope of the investigation, nor had it set a timetable.