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SACRAMENTO -- As the COVID-19 pandemic continues to put extreme stress on the U.S. healthcare system and workers, California introduced the Medical Device Right to Repair Act (SB 605). The bill, authored by state Sen. Susan Talamantes Eggman, would require manufacturers of critical medical equipment, such as ventilators, to provide repair parts and information to hospital technicians and other third-party servicers. The bill is co-sponsored by CALPIRG and iFixit.
Hospital biomedical repair technicians, known as biomeds, work to maintain and repair equipment, which is under near-constant use during the pandemic. Too often, however, medical equipment manufacturers deny biomeds access to the tools and manuals they need to repair equipment effectively. These barriers and delays to repair can threaten patient care and place additional strain on hospitals and healthcare workers.
A recent U.S. PIRG survey of 129 biomeds found that 76 percent of respondents, as they battled a COVID-19 case spike this winter, had been denied access to service information for critical equipment by the manufacturer and 80 percent said their hospital had unrepairable equipment because of restricted access to service keys, parts or other materials.
"By preventing fully capable, on-site biomeds from fixing medical equipment as soon as it breaks, manufacturers are hindering our healthcare system’s ability to provide life-saving care for patients,” said CALPIRG Associate Claudia Deeg. “This bill will provide much needed relief to the frontline workers charged with maintaining essential medical equipment, and ensure that our hospitals are best equipped to care for patients during this pandemic and any other health emergency.”
Manufacturers claim that these restrictions are in place for patient safety, yet the Food and Drug Administration (FDA) found in a 2018 study that third-party repair does not increase patient risk and its availability is “critical to the functioning of the U.S. healthcare system.”
“The COVID-19 pandemic has shed a light on many inequities and policy deficiencies that simply do not need to exist,” said state Senator Susan Talamantes Eggman. “Allowing greater access to repair will enable health care facilities to quickly service critical medical devices and equipment, preventing delays and improving patient care.”
In response to public outcry last spring, some manufacturers released service information for ventilators, yet significant barriers still exist. According to the U.S. PIRG survey, 90 percent of biomeds reported that the surge of COVID-19 cases had increased the need for Medical Right to Repair legislation.
“We believe that every organization that purchases and/or services medical equipment, should have the right to get trained and be able to procure parts to repair the equipment they own,”said Ilir Kullolli, president of the American College of Clinical Engineering. “This will make healthcare delivery better, faster, and safer – especially during this pandemic."
The United States is working to distribute COVID-19 vaccines that will hopefully end the pandemic sometime this year, but biomeds and policy experts say the need for medical right to repair will continue.
“Last spring, we heard countless stories from biomeds about how manufacturers are impeding their work by restricting access to medical equipment repair information,” said Kerry Maeve Sheehan, U.S. Policy Lead at iFixit. “We worked with a network of biomeds to launch a database of thousands of repair manuals for ventilators and other devices to make sure that biomeds had the resources they needed to care for patients during the pandemic, but we need our elected officials to act so manufacturers can’t continue to stand in the way.”
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