Representative Yvette D. Clarke
Sen. Ron Wyden, D-Ore., and Rep. Yvette D. Clarke, D-N.Y., have introduced legislation to allow trained experts to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions that are blocking needed repairs.
The Critical Medical Infrastructure Right-to-Repair Act of 2020 would allow trained repair technicians to more easily access information and tools required to complete maintenance and repair of critical medical infrastructure in preparation for and as part of a response to the current COVID-19 crisis.
Senator Ron Wyden
“There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit the U.S. in 100 years,” Wyden said. “It is just common sense to say that qualified technicians should be allowed to make emergency repairs or do preventative maintenance, and not have their hands tied by overly restrictive contracts and copyright laws, until this crisis is over.”
“As America grapples with this lethal pandemic, we are also experiencing unprecedented shortages of medical equipment,” Rep. Clarke said. “This narrowly tailored, common-sense and time-limited bill will ensure critical medical items like ventilators do not go to waste due to maintenance restrictions that have no nexus to safety. During this health crisis, we must do everything in our power to expand access to life-saving devices.”
Specifically, the bill would:
Christopher Nowak, CBET, CHP, CSCS, praised the bill. He is the senior director, information services, healthcare technology management at UHS.
“Senator Wyden and Congresswoman Clarke have introduced common sense legislation that will benefit every consumer of the American health care system,” Nowak told TechNation via email. “The right-to-repair devices that are purchased and owned by health care providers, lessors and other medical technology owners is a fundamental right. The ability to have ALL of the appropriate information, printed and electronic documents, proprietary tools and software or any other service strategies ‘baked into’ the manufacturing of a device should and must be made available to any and all owners of devices or their selected service provider of those devices.”
“The freedom for any device owner to select who services their devices, without obstacles or restrictions to documents, software or parts, is fundamental to private property rights,” he continued. “This legislation will provide a safer environment and experience for patients. Devices will have more availability and uptime for patient and caregiver needs through this legislation which will provide faster and more effective delivery of care and ultimately saving the health care consumer and American taxpayers. I look forward to the success of this legislation.”
In a prepared statement, The Medical Imaging & Technology Alliance (MITA) today expressed strong opposition to the bill.
“The legislation would give unregulated, third-party medical device service companies unfettered access to proprietary service materials and tools to maintain and repair sophisticated, highly regulated medical devices during the COVID-19 emergency. Further, the proposed legislation does not require that those servicers be held accountable to any U.S. Food and Drug Administration (FDA) regulations, such as adopting the quality management systems and safety standards that original equipment manufacturer (OEM) servicers must follow,” the statement reads.
“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.”
MITA also stated that there has not been any evidence of a qualified technician shortage. Moreover, the statement says that allowing unfettered access to software raises serious cybersecurity risks.
“The issue at hand is not that that independent servicers do not and should not have a ‘right-to-repair’ complex medical imaging systems, but rather with that right comes an inherent responsibility to have a well-implemented quality management system, file Medical Device Reports, and register with the FDA,” Hope concluded.
GE Healthcare issued a statement when TechNation asked for comment.
“GE is committed to the safe and compliant servicing of regulated medical devices. We continue to provide all appropriate access to service this equipment by our own employees, customers and third-party service providers,” the statement reads.
Rural health care and public interest advocates praised the bill.
“As COVID-19 surges across rural America, rural providers must have the rapid ability to maintain effective and operational equipment. This common-sense approach will enable rural providers caring for COVID patients to keep lifesaving equipment operating during this pandemic,” said Alan Morgan, CEO of the National Rural Health Association.
“I’ve talked to over a hundred professional medical device repairers – all they want is to be able to fix broken equipment and protect the patients in their hospitals. COVID-19 is making all they do harder, and this bill helps them get their job done. There is no reason we should tolerate manufacturers putting their own proprietary concerns over patient safety – especially during the pandemic. Passing this bill is an easy, common-sense way for the Senate to help hospitals in their time of need, and a terrific first step towards a permanent solution,” said Kevin O’Reilly, of the U.S. Public Interest Research Group.
“Since the onset of the COVID-19 pandemic in the United States, Color Of Change has pushed ventilator manufacturers to dial-back their dangerous, counterproductive repair restrictions, which have put an unnecessary strain on our medical providers’ ability to tackle the virus. For Black people especially, Senator Wyden and Representative Clarke’s bill would be a necessary protection against medical rationing in a system that has consistently neglected and harmed our communities. We commend Senator Wyden for introducing this bill and shining a light on the critical role that medical equipment manufacturers should play in the outcome of this pandemic,” said Color Of Change Vice President Arisha Michelle Hatch.
The Critical Medical Infrastructure Right-to-Repair Act has been endorsed by a wide range of health care, engineering and civil society groups:
The full bill text is available here.
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