US Lawmaker Requests More Oversight Of Reprocessed Medical Device Industry

Main Category: Medical Devices / Diagnostics
Article Date: 14 Dec 2005 - 0:00 PDT

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Rep Rosa DeLauro (D-Conn) -- ranking member of the House Appropriations agriculture subcommittee, which oversees FDA -- on Monday requested more federal oversight of reprocessed medical devices designated for one-time use, the Washington Post reports. DeLauro made the request in response to a Post series on the issue published on Sunday and Monday. Medical device companies have raised concerns about the safety of reprocessed devices, but companies that reprocess devices maintain that "there is no credible evidence that their refurbished devices are riskier than new ones," the Post reports. Currently, FDA requires companies to register and obtain approval for each medical device that they seek to reprocess. In addition, FDA relies on physicians to report medical device malfunctions voluntarily and requires health care facilities to report patient deaths but not device malfunctions. According to DeLauro, "significant gaps remain" in FDA oversight of companies that reprocess medical devices. DeLauro called for an increased number of FDA inspectors assigned to companies that reprocess medical devices and said that she might request a congressional hearing to address the issue. She added, "Rigorous oversight of reprocessing is needed." Naomi Halpern, an attorney for the Association of Medical Device Reprocessors, said that the group "looks forward to working with Congresswoman DeLauro as she develops legislation affecting the regulation of the medical device industry." In a statement, FDA officials said that the agency "provides stringent regulatory oversight" of companies that reprocess medical devices and "will act swiftly" to address any violations (Klein, Washington Post, 12/13).

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