A congressional briefing in Washington, D.C., was held by a panel of representatives from the Medical Imaging and Technology Alliance (MITA) on Friday, June 15, to discuss how medical device providers are regulated and how standards can be better aligned to ensure patient safety.
MITA representatives discussed that the current regulatory structure for medical device providers could lead to instances of improper servicing and therefore are in full support of Congress passing the Medical Device Servicing Safety and Accountability Act, according to a MITA news release published June 21.
Dennis Durmis, senior vice president-head if Americas region for Bayer Radiology, and Vy Tran, senior vice president of regulatory affairs and compliance for Varian, advocated passing of the Medical Device Servicing Safety and Accountability Act to ensure that all medical device servicers are held to the same quality, safety and regulatory standards and register with the FDA.
“Currently there is no basic requirement for third-party service companies to register with the FDA,” Durmis said, according to the 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.”
Miguel Machuca, executive vice president of sales for Medical Outfitters, a third party medical device serving company, also spoke at the meeting to discuss how consistent standards for device servicing can be a "win-win" for providers, servicers and patients alike, according to the new release.