GAO To Examine Reuse Of Single-Use Medical Devices, USA

Main Category: Medical Devices / Diagnostics
Article Date: 15 Jan 2006 - 0:00 PDT

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The Government Accountability Office on Monday announced plans to investigate the safety of the use of reprocessed medical devices designed for one-time use and FDA oversight of the practice, the Washington Post reports (Klein, Washington Post, 1/10). Reps. Thomas Davis (R-Va.), chair of the House Committee on Government Reform, and Henry Waxman (D-Calif.), ranking member of the committee, on Dec. 16, 2005, requested that FDA provide information about oversight of the use of reprocessed medical devices and that the GAO investigate the practice. The requests followed a two-part series published in the Post last December that examined reprocessed medical devices (Kaiser Daily Health Policy Report, 12/19/05). Medical device companies have said that they cannot guarantee the safety of reprocessed medical devices, but companies that reprocess devices maintain that no evidence exists to indicate such devices are less safe than new devices. The GAO investigation will expand on an agency report issued in 2000 that found "little available evidence of harm from reuse" of medical devices but stated that "reprocessing is not invariably safe and relatively little is known about the practice." Since 2000, the use of reprocessed medical devices has "grown substantially" and "is believed to be practiced in all 50 states and many of the nation's hospitals," according to the Post. Paul Anderson, a GAO spokesperson, said that the agency's health care team will conduct the investigation and that the scope and expected completion time remain undetermined.

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Dan Vukelich, deputy executive director of the Association of Medical Device Reprocessors, said, "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." According to FDA spokesperson Julie Zawisza, the agency strictly enforces regulations on companies that reprocess medical devices. She said that FDA "does not have evidence that device reuse represents a danger to health," adding, "Reusing single-use medical devices is a legal, widespread and common practice in hospitals and health care facilities driven by the need to control and reduce costs" (Washington Post, 1/10).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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