Most Americans say that those who service medical and radiation-producing electronic health care equipment should be “consistently regulated,” according to a recent survey by the Medical Imaging and Technology Alliance (MITA).

The feelings reportedly apply to both original equipment manufacturers and third-party servicers.

“Although many third-party service organizations perform quality work, the lack of consistent oversight and regulation is a direct threat to millions of patients who rely on medical devices for their health,” Nelson Mendes, MITA Board Chairman and CEO of Ziehm Imaging said in a statement.

“It’s clear from this survey that Americans overwhelmingly agree with our view that FDA should extend regulatory oversight, including minimum quality, safety and regulatory requirements, to all entities servicing medical devices.”

While the FDA currently covers device servicing done by a manufacturer, third-party servicing is not currently regulated by the administration.

“Patient safety should be the top priority for all companies performing service on medical devices, and we believe the FDA should be consistent in its regulation across the space, including third-parties and original equipment manufacturers,” stated Dennis Durmis, vice president and head of commercial operations, Radiology Americas, at Bayer.

The survey looked at public assumptions about the way in which such servicing is regulated.

Among its findings:

• 90 percent of Americans agree that all medical devices should be covered by regulations, regardless of who performs the service.


• 74 percent of Americans think that, like OEMs, third-party servicers should be strictly regulated under FDA guidelines.


• 85 percent of Americans agree the government should take action to resolve concerns around third-party servicing of medical devices.


• 82 percent of Americans would think twice before seeking treatment at a facility that allows device maintenance by unregulated servicers.

The issue of third-party service and refurbishment has been an area of focus for the FDA all year, starting with a docket calling for input on the definition of these terms, and recently addressed in a Silver Spring, Maryland, workshop that drew hundreds of stakeholders together from each side of the discussion.

Two perspectives on present practices and the issues emerged at that meeting, as reported by HCB News:

OEMs, by and large, want ISOs and HTMs to be regulated in some way — not because they feel all third-parties are bad, but because the limited data that exists includes evidence that some third-parties are not providing safe service.

On the other hand, ISOs and HTMs point to the available statistics that illustrate their high level of success, and say the cost of regulations would put an unnecessary burden on the value they bring to the care system, while simultaneously strengthening OEM control and limiting competition.

“We believe many third-parties already meet the demands of Quality Service Regulations (QSR) for the value these practices bring to their business and patients,” said Tara Federici, AdvaMed's vice president of technology and regulatory affairs, arguing that, therefore, key elements of QSR could be applied to third-parties in a scalable way without disrupting the third-party value proposition.

There appears to be some consensus across the aisle that some form of standardization could benefit third-party device servicers and refurbishers, and therefore MITA's findings may not be particularly surprising. However, for the third-party industry, what's important is addressing the issue in a way that doesn't hurt companies that are providing safe and reliable service and value to their hospital customers.

"Competition is at the core of America's economy," said Katie Ambrogi, attorney advisor in the FTC's Office of Policy Planning, at the FDA workshop, "greater competition gives consumers lower prices and increased innovation." She called the health care market a "focus of FTC advocacy" and referred to an executive order issued by President Obama in April 2016 calling for increased competition and the elimination of unwarranted regulations — initiatives that would seem promising for service and refurb stakeholders.

MITA's research was conducted online earlier this month by KRC Research and incorporated answers from 1,022 members of the U.S. general public.