MITA Calls for Consistent Regulation of MedicalmDevice Servicing &

Maintenance in Capitol Hill Briefing

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, DC, June 21, 2018 --(PR.com)-- 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.

The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of
medical imaging equipment manufacturers, innovators, and product developers. It represents companies
whose sales comprise more than 90 percent of the global market for advanced medical imaging
technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter
@MITAToday.-----

Page 1/2
PR.com Press Release Distribution Terms of Use
Contact Information:
Medical Imaging and Technology Alliance
Tracy Cullen
703.841.3282
Contact via Email
https://www.medicalimaging.org/

Online Version of Press Release:

You can read the online version of this press release at: https://www.pr.com/press-release/757394

Page 2/2
PR.com Press Release Distribution Terms of Use