GAO to Probe Reprocessing of Single-Use Medical Devices

Congress's investigative arm said yesterday that it will investigate the safety of using reconditioned medical devices designated for one-time use and the government's oversight of the practice.

In a meeting yesterday, top officials of the Government Accountability Office agreed to open the probe in response to a request from Reps. Thomas M. Davis III (R-Va.), the chairman of the House Committee on Government Reform, and Henry A. Waxman (D-Calif.), the ranking minority member on the committee. The lawmakers' request followed a series of articles in The Washington Post examining the reuse of single-use medical devices, a growing practice called reprocessing.

"It's clearly an important safety and health issue that needs attention," said Robert White, a spokesman for Davis.

Device manufacturers say they cannot vouch for the safety of their reconditioned single-use devices, but reprocessors say there is no credible evidence that their refurbished devices are riskier than new ones. The reprocessors also say no surgery is without risk, and many hospitals cite cost savings and consider the practice safe.

The GAO's investigation will build on a report issued in 2000, when reprocessing was a nascent industry. Then, the agency "found little available evidence of harm from reuse," but also said "reprocessing is not invariably safe, and relatively little is known about the practice." Reprocessing has grown substantially since then, and it is believed to be practiced in all 50 states and many of the nation's hospitals, including several in the Washington region.

GAO spokesman Paul L. Anderson said the watchdog agency will look into the adequacy of the Food and Drug Administration's oversight of reprocessing. He said the investigation will be conducted by the GAO's health care team, although he said it has yet to define the scope of its work, including how many staffers will be involved and what their timetable will be.

Dan Vukelich, deputy executive director of the Association of Medical Device Reprocessors, said in a statement, "We're confident that the GAO will again take a thorough look at reprocessing and issue a report confirming that the industry is stringently regulated and reprocessed devices are safe."

FDA spokeswoman Julie Zawisza defended the agency's oversight of the reprocessing industry, saying it strictly enforces regulations over it. The FDA "does not have evidence that device reuse represents a danger to health," she said in a statement. "Reusing single-use medical devices is a legal, widespread and common practice in hospitals and healthcare facilities driven by the need to control and reduce costs."