First federal 'right to repair' legislation filed in US to help hospitals through pandemic

First federal 'right to repair' legislation filed in US to help hospitals through pandemic

August 06, 2020
Business Affairs HTM Parts And Service

“We need to do more to help the rural communities and we are hoping that there will be other steps taken to ensure that rural communities have better access," said Jason Kitchell, president of Missouri-based Universal Medical Resources.

Some detractors have said that the bill offers no answers for what happens to the service access information when the national emergency ends. However, IAMERS president Diana Upton observed that, “the hospital accrediting organization, The Joint Commission, already requires this information to be provided anyway."

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Joint Commission Standard EC.01.01.01 requires that a hospital have a library of information regarding inspection, testing and maintenance of equipment. Moreover, there are appropriate compliance/risk reasons for the Joint Commission’s requirement. Among them is the need for the hospital to address potential natural disasters. As many have recently experienced power outages with seasonal storms and bad weather, this equipment maintenance information should be available when an emergency arises. As FEMA has noted, when there is a disruption of power hospitals should have an emergency plan for restoration. (See FEMA info at p.9). Manufacturers are not always readily available during a disaster or emergency as they may be geographically unable to assist. In any event, in addition, hospitals should have choices to either use in-house biomeds or independent servicers.

This legislation addresses the elephant often in the room when manufacturers claim that they are permitted to withhold service access information as the equipment maintenance information is a trade secret. The legislation provides that the a manufacturer of critical medical infrastructure may not withhold information on the ground that disclosing the information would divulge methods or processes entitled to protection as trade secrets if that information is provided directly or indirectly to authorized dealers or service providers. Tools including software must likewise be made available on fair and reasonable terms.

Among the bill's detractors is the Medical Imaging Technology Alliance (MITA), which represents the interests of medical equipment manufacturers and argued that patient safety could be compromised by the legislation.

"While the intention of the bill's sponsors is to protect patients, the unintended consequences of this legislation would increase the risk to patient safety, said Patrick Hope, executive director of MITA. "Especially during the pandemic, we should want the most qualified, trained experts servicing essential medical equipment, not third-party servicers unknown to the FDA who are not held to any requirements."

A 2018 FDA report determined there was insufficient evidence of a safety issue with non-OEM service entities to warrant increased oversight.

About the author: Robert Kerwin is general counsel to IAMERS and has served in that capacity for over twenty-five years.


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(1)

Wayne Webster

It's a good start

August 10, 2020 10:02

The OEM's are working hard to eliminate the ISO and the medical center biomedical engineers. This Bill is the first large Congressional step in the right direction. Let's get this approved and then let's see if we can make it permanent.

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Jacob Lien

Curious about patient harm

August 17, 2020 11:21

I'm definitely curious about the inevitable scenario when an authorized service agent outside the manufacturer, with the best intentions, repairs the system inadequately and down the road results in patient harm. I'm usually not one to bring up what-ifs...and am usually an advocate for right-to-repair fights, but this seems over the top. Especially when it comes to the topic of this being extended post pandemic.

When are system warranties void?
Is biomed immediately fully responsible for the system once opened up?

Small business medical device manufacturers would be hard pressed to support anything like this when it comes to negligence from third parties effecting product support and ultimately patient safety.

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Wayne Webster

re: Curious about patient harm

August 18, 2020 02:12

In its response to Congress on this matter within the last two-years, the FDA concluded third parties “provide high-quality, safe and effective servicing of medical devices”. This outcome was as a result of a year-long study about safety of service performed by third parties. But, the larger point is that by withholding key information from commercial third parties and hospital biomedical engineers, the OEM's bring on the very safety concerns they grouse about. Therefore, one can only make a single conclusion...it's not about safety it's about eliminating the independents from the market and thus controlling all the revenue from the medical marketplace. It's time to stop monopolistic practices that result in less competition and higher costs.

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