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PHILADELPHIA, PA — In an open letter to Governor Wolf delivered by PennPIRG and signed by 518 hospital repair experts, a plea was made for manufacturers to stop withholding what technicians need to fix medical equipment including ventilators. The effort is part of PennPIRG’s Right to Repair Campaign, which aims to remove unnecessary barriers to repair that drive up costs for product owners and increase electronic waste.
“Keeping medical equipment working, whether under the stress of the COVID-19 pandemic or not, is a matter of life and death,” said Emma Horst-Martz, PennPIRG campaign associate. “With lives at stake manufacturers should not squeeze hospitals into paying extra for proprietary repairs.”
Echoing the technicians’ comments, a group of state treasurers, including Joe Torsella, sent a similar letter to manufacturers calling for them to “release all service manuals, service keys, and schematics during this crisis,” for ventilators.
“If we can aid our frontline medical personnel, and help expedite keeping devices like ventilators working, we should do so,” said Rep. Austin Davis (D-McKeesport) and prime sponsor of HB2326. “Our hospitals are working really hard, and deserve that support.”
COVID-19 has highlighted the 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.
“It is imperative that our biomedical equipment technicians have access to manufacturer-specific information to give them the necessary resources to perform repairs or maintenance on medical equipment,” said Jacqueline Boehme, MD, Resident Anesthesiologist, Brigham and Women’s Hospital. “Our technicians are trained, qualified, and experienced; with this information in hand, they will be able to decrease downtime, reduce costs, and improve patient care overall.”
“Our team of biomedical equipment technicians and clinical engineers is trained and qualified to immediately respond to and resolve equipment failures in critical situations in the over 70 operating rooms we support,” said Brian McLaughlin, Perioperative Clinical Engineering Manager at Massachusetts General Hospital. “We are impeded in our ability to do this when medical device manufacturers withhold the necessary training, documentation, and parts. This in turn results in increased cost to the hospital and delays for clinicians.”
“As a healthcare technology management professional, I believe that requiring medical device manufacturers to make service instructions, parts, software and other service tools available to medical device owners and third-party servicers is critical to the industry’s ability to ensure medical devices are to be maintained in a safe, cost-effective, competent and timely manner,” said Paul C. Monahan, Jr., Director of Quality, ISS Solutions. ISS Solutions is an Pennsylvania-based independent service organization that provides healthcare technology management services to hospitals.
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 Horst-Martz.