Reps. Davis, Waxman Ask FDA For More Information About Oversight Of Reused Medical Devices

Main Category: Medical Devices / Diagnostics
Article Date: 20 Dec 2005 - 10:00 PDT

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Reps Thomas Davis (R-Va), chair of the... House Committee on Government Reform, and Henry Waxman (D-Calif.), ranking member of the committee, on Friday requested that FDA provide information about oversight of reprocessed medical devices designated for one-time use and that the Government Accountability Office investigate the practice, the Washington Post reports. The requests follow a two-part series published in the Post on Dec. 11 and Dec. 12 that examined reprocessed medical devices and a call for more FDA oversight of the practice by Rep. Rosa DeLauro (D-Conn.) on Dec. 12. In a letter to FDA, Davis and Waxman requested that FDA provide detailed information on agency oversight of reprocessed medical devices, such as steps taken to ensure that such devices are "safe and efficacious" (Klein, Washington Post, 12/17). In a letter to GAO, the lawmakers requested that the agency investigate the safety of reprocessed medical devices and the adequacy of FDA oversight (CQ HealthBeat, 12/16). GAO spokesperson Paul Anderson said that the agency will respond to the request within one week. FDA declined to comment on the issue (Washington Post, 12/17).

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