“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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