The 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 tools and information these repair experts need, officials from the U.S. Public Interest Research Group say.
A new report by the U.S. PIRG Education Fund, titled 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 help hospitals.
The report includes a survey of 222 medical repair professionals, as well as dozens of interviews. Among the most notable findings is how common restricted repair is—with 91.8% 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,” says 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 HTM professionals 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% 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 healthcare equipment has become a growing problem that hospitals are dealing with every day,” says Sam Jacques, vice president of clinical engineering at McLaren Health Care. “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.”
“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,” adds Nader Hammoud, clinical engineering manager, California Association of Medical Instrumentation. “Our access to service materials needs to reflect that reality—we need access on demand.”
Manufacturers argue that these restrictions are in place to ensure patient safety, U.S. PIRG officials say. However, the U.S. 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,” says Nathan Proctor. “One easy thing we can do is to remove barriers to fixing life-saving medical equipment. It’s no time to be proprietary,”
A copy of the report to download is available here.