From the August 2018 issue of HealthCare Business News magazine

The time has come for Congress to ensure that all imaging and other device servicers meet the same high regulatory and quality standards. The bipartisan Medical Device Servicing Safety and Accountability Act (H.R. 2118) requires third-party servicers to register with the FDA, report information about adverse events, and maintain a complaint handling system. This legislation would be a much-needed step in the right direction. It is essential that repairs or maintenance performed by non-OEM entities be held to the same quality, safety, and regulatory requirements, including FDA oversight.

Fortunately for patients, laudable third-party servicers do indeed perform quality work that meets safety standards – which is all the more reason why they should register with the FDA and participate in existing federal data collection and trend analysis efforts. Doing so would not only help promote high-quality standards that will benefit the entire industry, but is also the right thing to do for patients and the viability of their businesses.


Without FDA oversight of third-party servicers, we likely will not learn about device issues unless or until an adverse event has occurred, or the owner, operator, or a third-party servicer reports it to an OEM. In the absence of regulation, OEMs will continue to have to step up to fix a failed device. This repair is likely slowed as they have to work backward to try to document what work might already have been done by unregistered servicers. OEM servicers need to baseline the status of the device so that they can proceed, confidently empowered with the latest knowledge of the rapid advances in technology for the imaging field.

In the wake of an FDA report that relies on incomplete data, the imaging community is more hopeful than ever that Congress will fix these issues legislatively. We are confident that requiring third-parties to register with the FDA, report serious problems or injuries, and maintain complaint handling systems will only improve the quality of care that American healthcare consumers deserve. It is time to end this waiting game and actively address these very real risks once and for all.

About the author: Patrick Hope is the executive director of the Medical Imaging & Technology Alliance (MITA).

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August 2018 Magazine

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