Proprietary medical device repair harms hospitals, could threaten patients, during COVID-19 pandemic

Media Contacts

New report finds that medical device manufacturers have denied critical resources to nearly half of surveyed medical repair professionals since March


Proprietary medical device repair harms hospitals, could threaten patients, during COVID-19 pandemic

New report finds that medical device manufacturers have denied critical resources to nearly half of surveyed medical repair professionals since March

BOSTON — The coronavirus (COVID-19) pandemic is putting incredible stress on the U.S. medical system, including the equipment that is essential to diagnose and treat patients, such as ventilators. As that equipment is pressed into round-the-clock use, biomedical repair technicians face increasing pressure to maintain and repair all that equipment.

However, in too many cases, manufacturers limit access to the essential tools and information these repair experts need. A new report by the U.S. PIRG Education Fund, Hospital Repair Restrictions, details the challenges that medical professionals face as a result of device manufacturers setting up barriers to repair, and outlines steps to take to help hospitals.

The report includes a survey of 222 medical repair professionals, as well as dozens of interviews. Among the most troubling findings is how common restricted repair is — with 91.8 percent of respondents reporting that they have been denied access to service information for “critical equipment (defibrillators, ventilators, anesthesia machines, imaging equipment, etc.).”

“There is a strong financial incentive for manufacturers to restrict repair. They want to get hospitals to buy repair service contracts from the manufacturer,” said Nathan Proctor, U.S. PIRG Education Fund’s Right to Repair Campaign Director and one of the authors of the report. “Manufacturers typically charge much more for repairs than if the hospitals hire a third party or train their own technicians — but more costs aren’t the only price of proprietary repair. Delays in getting equipment running put patients at risk.”

Since March, U.S. PIRG and the U.S. PIRG Education Fund have called for manufacturers of medical devices, especially ventilators, to cooperate with biomedical technicians and provide the information, parts, and other service information needed to repair critical medical equipment. In April, a number of manufacturers responded to public outcry by releasing additional service information for ventilators.

Of the 153 survey respondents whose departments work with ventilators, 29.2 percent report that they currently (as of June 12, 2020) have ventilators that they cannot use because they lack access to parts and service information.

“Restricted access to service materials for critical health care equipment has become a growing problem that hospitals are dealing with everyday. COVID-19 has been a kind of stress test for our medical system – and unnecessary manufacturer-imposed restrictions on repair is a barrier to safe and effective care, but one of the easiest to remedy,” said Sam Jacques, VP of Clinical Engineering at McLaren Health Care.

Manufacturers claim that these restrictions are in place to ensure patient safety. However, the Food and Drug Administration (FDA), in a 2018 study, found that third-party repair carries no additional risk and, just like manufacturers, “provide high quality, safe, and effective servicing of medical devices.”

“We need to stand up and help our hospitals right now. One easy thing we can do is to remove barriers to fixing life-saving medical equipment. It’s no time to be proprietary,” said Deirdre Cummings, MASSPIRG’s legislative director.  

“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.”

“I support hospitals in California and Washington. Before our California hospitals could put the ventilators they received from the state strategic stockpile into use, we needed to perform needed routine service. Unfortunately, the manufacturer refused to work with us because we were not technically a hospital. They would not sell us the kits needed to carry out the required maintenance and did not provide us with alternatives. Ultimately, we had to send them back to the hospitals to send to the OEM, leaving our hospitals without the ventilators they needed for weeks during a tough period,” said Mike McRoberts, Senior Vice President of Business Development, MultiMedical Systems.

“Like many other biomeds, I have faced life-or-death situations where you have to fix a piece of equipment in an hour or two, or a patient will die. Our access to service materials needs to reflect that reality — we need access on demand,” said Nader Hammoud, Clinical Engineering Manager, California Association of Medical Instrumentation.

“Covid-19 crisis has shown the need for solid in-house service.  Some manufacturers were unable to get to some hospitals for service for various reasons (short staffing, canceled flights, etc.).  This was more common with rural hospitals.  This created excessive downtime which is a patient safety issue. Some manufacturers worked harder than others to help hospitals — and showed that cooperation is possible. We hope that this can continue and expand,” said Courtney Nanney, National Quality Manager, Clinical Engineering, Kentucky Association of Medical Instrumentation.