Servicing Company Points To Downsides In Third-Party Servicing Bill
At a recent industry briefing to educate US congressional members about proposed legislation to mandate registration with FDA and reporting requirements for third-party servicers of devices, an equipment servicing company said a major downside of H.R. 2112 would be the burdens of having to register with both his business' home state and the federal agency, and that his firm and others already report adverse events to FDA.
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US FDA’s device center in concert with third-party servicers and original equipment manufacturers are working toward consensus on how to differentiate medtech "servicing" from "remanufacturing" activities. Progress was made at a recent workshop in laying out ways that better training and more data sharing will help.
In an interview with Medtech Insight, Bayer executive Dennis Durmis described some near-misses to patient safety involving shoddy repairs to his firm's devices. The incidents convinced him that Congress needs to pass legislation requiring all third-party servicers to register with US FDA and report adverse events to the agency.
After US FDA concluded last month that no further regulation of third-party device servicers is warranted, industry groups are going back to Congress for support. They plan to brief members of the congressional Medtech Caucus June 15 on how patients are put at risk when devices receive inadequate repairs.