Survey: Medical Device Repair Professionals Fix Equipment Manufacturers Cannot Remedy

In a new survey conducted by U.S. PIRG’s sister organization, U.S. PIRG Education Fund, 67 percent of medical device repair professionals reported that they or their team fixed a device that the manufacturer could not repair. This finding undercuts manufacturers’ claim that they offer better-equipped service technicians. Manufacturers often assert that to justify restrictions on repair materials. 
 
“Manufacturers’ claim that they alone offer high-quality service is false. In fact, they are outperformed regularly by independent biomedical engineers (biomeds),” said U.S. PIRG Right to Repair Campaign Director Nathan Proctor. “Manufacturers don’t have a monopoly on quality technicians, but they are monopolistically restricting access to parts, access keys and service manuals.” 
 
As part of its Right to Repair campaign to remove barriers to repair, U.S. PIRG Education Fund has reached out to hundreds of biomeds to investigate the challenges they encounter on the job. During the COVID-19 pandemic, the demand for functional medical equipment repair has spiked. While some manufacturers make necessary materials accessible, others restrict access to necessary information, access keys, tools, manuals and diagnostic equipment for in-house or independent biomeds. 
 
“We hire from the same pool of technicians and engineers as the manufacturer,” said Ilir Kullolli, president of the American College of Clinical Engineers (ACCE) and a practicing clinical engineer in California. “There is no overall difference in qualifications or experience, and sometimes our biomeds are just better. Why shouldn’t they get access to manuals and other materials?”
 
A 2018 study published by the U.S. Food and Drug Administration (FDA) revealed that manufacturer technicians, independent servicers and in-house technicians each provide “high quality, safe, and effective servicing of medical devices.” The study said that rather than impose restrictions on third-party repair, “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.” The new finding by U.S. PIRG Education Fund underscores the FDA’s conclusion. 
 
“As on-site technicians, we have a more holistic understanding of how the equipment works with other devices in the care environment. It’s not uncommon for the manufacturer’s technician to come in, fix one problem, but break something else in a connected system because they just focus on that one device. Our ability to deliver quality patient care depends on having people who see, and can maintain, the whole system,” added Kullolli.
 
In August, Sen. Ron Wyden (OR) introduced the Critical Medical Infrastructure Right-to-Repair Act to remove manufacturer-imposed barriers to fixing medical equipment during the COVID-19 pandemic. The measure is supported by U.S. PIRG, ACCE, hundreds of biomedical professionals and a diverse group of free-market and public interest nonprofit organizations. 
 
“In-house biomeds have repeatedly outperformed manufacturers’ technicians, and functioning equipment saves lives,” said Proctor. “When manufacturers prioritize profits, patients lose.”