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OSPIRG delivered a letter to Gov. Kate Brown Monday, signed by 326 hospital repair experts from around the country, including 6 in Oregon, calling for manufacturers to stop withholding what technicians need to fix medical equipment like ventilators. It’s part of OSPIRG’s larger Right to Repair Campaign, which aims to remove unnecessary barriers to repair that drive up costs for product owners and increase electronic waste.
“Keeping equipment working under the stress of the COVID-19 pandemic is a matter of life and death,” said Charlie Fisher, OSPIRG’s state director. “This is no time to squeeze hospitals into paying extra for proprietary repairs.”
COVID-19 is putting incredible stress on our medical system, including the work of hospital biomedical repair technicians, known as biomeds or BMETs. But in some cases, manufacturers restrict access to what biomeds need. For example, as ventilators are pressed into around-the-clock use, repair and maintenance issues increase. While some ventilator manufacturers provide service information, other manufacturers make it hard to access manuals, read error logs or run diagnostic tests.
"Time spent struggling with OEMs to obtain service information would be better spent servicing the equipment. Everyone is safer when service information is with the equipment so that any qualified technician can restore devices to optimal performance,” said Ray Marden, CEO of HTM Insight, based in Bend, “Without it, downtimes increase and the cost of ownership rises. Safety and efficiency depend on parts and technical literature being in the hands of technicians."
"This is very important to patient safety and the delivery of quality care. Access to literature, tools, and training of the equipment owners is paramount to safe future use." Ken O., an experienced biomedical engineer commented on the letter.
Manufacturers claim that these restrictions are in place to ensure safety. But in 2018, FDA found third-party repair carries no additional risk and that both they and manufacturers “provide high quality, safe, and effective servicing of medical devices.” Instead of restricting third-party repair, the FDA says “the continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.”
“Restrictions on repair aren’t about safety, as the FDA report shows -- everyone who is doing repairs is doing it carefully and safely. These restrictions are about control and about money,” said Fisher.
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