Representatives from the Medical Imaging & Technology Alliance (MITA) briefed members of Congress on June 15 about the regulation of medical device servicers and how the current structure of such regulation can result in improperly serviced equipment being used by healthcare providers.
Bayer’s Dennis Durmis and Varian’s Vy Tran spoke at the briefing, advocating for the passage of the Medical Device Servicing and Accountability Act (HR 2118), bipartisan legislation first introduced by Congressmen Ryan Costello, R-Pennsylvania, and Scott Peters, D-California.
“Currently there is no basic requirement for third-party service companies to register with the FDA,” Durmis said, as quoted in a MITA press release. “As a result, it is impossible for the agency to ensure devices are correctly serviced or to even respond quickly and efficiently to adverse events should they occur.”
Medical Outfitters, a third-party medical device servicing company, was represented at the briefing by Miguel Machuca. Toni Mattoch of America’s Blood Centers also participated in the session.