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

“I’ve talked to over a hundred biomeds since the start of the crisis — all they want is to be able to fix broken equipment and protect the patients in their hospitals," said U.S. P.I.R.G. Right-to-Repair advocate Kevin O’Reilly. "By giving these frontline workers access to service materials, Sen. Wyden’s bill helps them get their job done.”

The legislation encompasses not just biomeds, but includes “any person engaged in the diagnosis of problems with respect to, or the service, maintenance, or repair, of critical medical infrastructure.” It provides relief from the copyright and patent laws to "covered service providers", which includes an owner or a licensee of a copy of service materials, or their agent.

THE (LEADER) IN MEDICAL IMAGING TECHNOLOGY SINCE 1982. SALES-SERVICE-REPAIR

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The bill imposes a duty to disclose service materials upon manufacturers of "critical medical infrastructure" so that hospitals may readily obtain service access information for medical equipment being used for diagnosis and treatment. "Critical medical infrastructure" is defined as, “a device, computer program, or other product or equipment used to provide medical services.”

Service materials when used with respect to "critical medical infrastructure" includes any information or material that the manufacturer provides "directly, indirectly or wirelessly" to technicians of the manufacturer or repair facilities authorized by the manufacturer, and includes:

• Schematics, wiring diagrams, mechanical layouts, and other pertinent data with respect to the critical medical infrastructure;
• Computer programs used in diagnosing problems or in calibrating, repairing, or maintaining the critical medical infrastructure;
• Service keys that are required to access diagnostic information or otherwise authorize repairs;
• Access to error legs that are required to diagnose required repairs;
• Preventive and corrective maintenance, inspection and repair manuals;
• Safety alerts, recalls, service bulletins, specification updates and the need for adjustments to maintain efficiency safety and convenience;
• Any other information provided to diagnose the programs with respect to service, maintain, repair, activate, certify or install;
• Training materials

Manufacturers would be required to provide, on fair and reasonable terms, access to information and tools used to diagnose problems and service. Under the legislation, the information available to a “covered service provider” would include schematics, service keys, error logs, manuals, safety alerts, recalls, specification updates and other information to diagnose problems with respect to repairing critical medical infrastructure.

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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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