Opinion

Why Quality, Regulated Medical Device Repair Is in Patients’ Best Interest

By Julianne Malveaux
August 13, 2020 at 5:00 am ET

Over the last several weeks, government officials and other experts have urged Americans to return to hospitals, physician offices and other outpatient facilities to get the care they need. The request, which comes after nearly three months of unprecedented delays in elective procedures and other regularly scheduled appointments, also comes as COVID-19 cases are trending upwards in almost two dozen states.

While it is crucial – especially for those who are vulnerable and dealing with long-term or chronic conditions – to ensure they catch up with non-emergent care appointments and disease screenings, it must be done in a way that maximizes safety and minimizes any potential risks. Patients deserve peace-of-mind that hospitals and physician clinics are ready for their safe return.

But for providers, ensuring safety and offering peace of mind to patients extends beyond physical distancing, heightened infection control and medical equipment sterilization. Patient safety also means ensuring advanced medical equipment, such as CT machines that use radiation or MRIs with superpowered magnets are properly serviced and maintained by qualified technicians.

Throughout the pandemic, the question of who is qualified to service advanced medical equipment has become a flash point. Exploiting early shortages of ventilators, the so-called “right to repair” movement has urged government officials to empower unregulated third-party firms to service medical devices such as ventilators, CT machines and other highly complex medical devices. While the worst fears of possible ventilator shortages were, thankfully, never fully realized, that hasn’t stopped third party service proponents to continue exploiting the crisis for their own political and business agenda.

“Right to repair” advocates consistently fail to mention that their activities aren’t regulated by the U.S. Food and Drug Administration and that they have continuously refused to adopt even minimum standards. This lack of proper oversight and regulation stands in stark contrast to the service departments of original equipment manufacturers, who are tightly regulated to ensure serviced devices meet proper quality and safety standards.

Stunningly, the FDA doesn’t even have a clear sense of how many third-party service companies are out there engaging in this unregulated maintenance of advanced medical equipment. A 2018 report from the FDA, which relied only on market data, estimated the number of third-party firms to be “between 16,000 and 20,000”—a ballpark figure at best.

Think about it for a minute: The FDA doesn’t know who might be servicing and maintaining a device that uses radiation to detect disease or involves insertion of a scope into the body. That doesn’t really engender patient peace of mind – especially in the wake of a pandemic – when non-emergent care stopped and many medical devices  sat idle. Federal regulators have a big blind spot that needs to be fixed by asking unregulated third parties to step out of the dark and take responsibility for protecting patients from potential harm.

Throughout the crisis, right to repair advocates also claimed that, due to a supposed shortage of qualified servicers, unregulated third-party servicers should be given unfettered access to the software and operating manuals of OEMs. Fortunately, these claims fell short of reality, as there was no evidence of a shortage of qualified technicians, even in areas that were hardest hit by the virus. While shortages of some advanced medical equipment were a serious challenge for many hospitals, using it to claim that a non-regulated industry should just get unmitigated access to service complex medical devices seems reckless if the servicer firm hasn’t undergone the rigorous training, implemented quality control measures or submitted reports to the federal government as required by FDA regulation.

The third-party medical device servicers have attached themselves to the broader “right to repair” campaign arguing for third-party repair of consumer electronic devices, cars and farm equipment. And while this might seem like good short-term politics – your iPhone or refrigerator isn’t as dangerous as an MRI machine.

If something goes wrong when you service a smartphone, the worst-case scenario is that it may need to be replaced. When it comes to imaging equipment, however, the stakes can be life and death. What happens if the CT scanner isn’t serviced properly and the patient receives more radiation than needed? This is exactly why OEMs are held to stringent regulations by the FDA. It’s in the best interest of patients that third-party services finally act responsibly and register with the FDA and adopt proper quality controls.

Julianne Malveaux is a D.C.-based economist and author who writes about economics, politics, gender, race and national affairs.

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