MITA Calls for Consistent Regulation of Medical Device Servicing & Maintenance in Capitol Hill Briefing

06.21.18

 Experts provided manufacturer, third-party servicer perspectives on medical device servicing and urged Congress to align standards on medical devices to ensure patient safety

WASHINGTON – Representatives from the Medical Imaging & Technology Alliance (MITA) held a briefing for Congressional lawmakers and staff last Friday to discuss how servicers of medical devices are regulated and how the current regulatory structure can lead to instances of improper servicing.

Panel speakers included Dennis Durmis, Senior Vice President Head of Americas Region  for Bayer Radiology; Vy Tran, Senior Vice President, Regulatory Affairs and Compliance for Varian; Miguel Machuca, Executive Vice President of Sales for Medical Outfitters; and Toni Mattoch, Director of Quality Services for America’s Blood Centers.

Dennis Durmis and Vy Tran, representing original equipment manufacturers, advocated passing of the Medical Device Servicing Safety and Accountability Act (H.R. 2118) in an effort to ensure that all medical device servicers are held to the same quality, safety, and regulatory requirements.

“Currently there is no basic requirement for third-party service companies to register with the FDA,” Durmis noted. “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.”

There is bipartisan legislation before Congress that would address these patient health and safety issues. The Medical Device Servicing and Accountability Act (H.R. 2118), sponsored by Representatives Ryan Costello (PA-6) and Scott Peters (CA-52), would require third-party servicers to register with the FDA, report deaths and serious injuries, and maintain compliant handling systems – all steps already required of original equipment manufacturers.

Medical Outfitters, a third-party device servicing company, was represented by Miguel Machuca who discussed the servicer perspective and how consistent standards for device servicing can be a win-win for providers, servicers, and patients alike.

“There are many third-party servicers out there who perform high-quality work, and who go above and beyond what’s required of them to ensure medical devices are serviced properly,” said Machuca.

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