Nearly 70 percent of more than 200 medical repair professionals surveyed by U.S. PIRG Education Fund, U.S. PIRG’s sister organization, say that their hospital has had to “delay a patient procedure because [they] were waiting on a manufacturer service representative to fix a device.”
Time can be of the essence for many medical procedures, so these delays undermine the quality of care. While many hospitals had issues with the timeliness of proprietary equipment repair before the COVID-19 pandemic spread widely in March, the coronavirus has exacerbated the issue by restricting travel and outside access to medical facilities. Meanwhile, medical device manufacturers regularly refuse to provide on-site repair professionals with necessary materials such as service manuals, access keys and spare parts to complete repairs on their own.
“By restricting access to repair, manufacturers can endanger patients who might not get access to critical procedures when they need them,” said Anne Marie Green, associate with U.S. PIRG’s Right to Repair campaign. “A lot is said about how manufacturer repair restrictions run up the cost of healthcare, but they can also result in patient care being delayed by weeks or months. That’s absurd and unacceptable.”
Hospitals typically have in-house repair technicians, known as biomeds, who are qualified to service medical equipment. Because they are on-site, hospital biomeds can service equipment quicker, with less downtime.
“It is always life or death in the hospital. I have been brought into the hospital in the middle of night and told ‘If you don’t get the device up and running in an hour or two, that patient will die,’ ” said Nader Hammoud, who is with the California Medical Instrumentation Association and manages a biomedical engineering team in a California hospital. “Putting patients first means manufacturers must cooperate with the hospital biomedical staff, and make access keys and service materials available.”
Manufacturers tend to charge significantly more for repair service, and profit from restricting the repair of their devices to their authorized technicians. Many of the equipment companies defend this practice by claiming that these restrictions are done to prevent safety issues.
But these restrictions cause safety issues of their own. U.S. PIRG Education Fund released a report in July detailing the difficulties manufacturers impose on hospitals when it comes to repair. Out of the 222 biomeds surveyed, nearly half said they had been denied access to “critical repair information” by manufacturers since the beginning of the COVID-19 pandemic in March.
One based in Texas said the hospital was “at the whim of a vendor who says they’re not coming in because of COVID-19. And we have equipment down and we have patients that still keep coming, and it was tumultuous.”
“If medical equipment manufacturers truly prioritized patient care, they would empower hospitals to repair the equipment they own,” said Green.
To address damaging repair restrictions during the COVD-19 pandemic, Sen. Ron Wyden (OR) introduced a bill in August, supported by U.S. PIRG, that would require manufacturers to provide access to critical service materials.
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