By Kenneth Moritsugu / For The Herald
It’s no secret that technology is rapidly transforming the way we approach health care.
Doctors today are equipped with tools that are improving outcomes at virtually every stage of treatment and care. These advances hold tremendous promise. They also demand rigorous oversight to ensure patient safety.
This word of caution may seem obvious enough, but it bears reminding as lawmakers across the country now consider so-called “right to repair” legislation. Such bills have been considered in at least 40 state houses. In Olympia, policymakers introduced such legislation in the 2024 session.
Right-to-repair bills seek to require electronics manufacturers to publicly provide the parts and instructions to fix their devices. For some industries, like smartphones or commercial equipment, this makes sense. It reduces manufacturers’ ability to gouge prices for repairs after the point of sale. Why take your broken tablet to the Genius Bar when a handyman with the right parts can fix it cheaper?
That logic may hold up for phones, household products and even some industrial equipment. It sure seems to fit the prevalent political appetite for more consumer protections. But it would be dangerous to lump medical equipment under the same umbrella as everyday items.
Modern health care tools are unique. Even the slightest miscalibration can have serious consequences. Unlike a smartphone or a piece of manufacturing equipment, which, if serviced incorrectly, might cause some headaches, an erroneously serviced medical device can be a matter of life and death.
Health care equipment is highly regulated, and appropriately so. Devices are thoroughly scrutinized and tested before ever being installed in a patient setting. The process is intended to identify and correct any defects that could have an adverse effect during operation. Even then, each medical device has, on average, 6.2 vulnerabilities; about 40 percent of which occur toward the end of the equipment’s life cycle.
Allowing manufacturers of these devices to withhold and control proprietary parts and instructions offers patients some safety guarantee. It ensures repairs are completed by a qualified professional specifically trained for the job with continuing quality control and oversight. In the event a piece of equipment is serviced incorrectly, it’s clear who the responsible and accountable party is and how to initiate corrective action to improve outcomes and patient safety.
The same cannot be said if health care equipment is subjected to right-to-repair laws. There would be few, if any, controls to ensure that a repair technician has the necessary training, expertise and oversight to work on a device. And as a nearly two decade long user of an insulin pump coupled with a continuous glucose monitor, I am professionally and personally aware of and extremely sensitive to the criticality of having reputable servicers handle any modifications or repairs.
A 2018 study found more than 4,300 adverse events caused by devices repaired, replaced or serviced by third-party servicers. But the true stats are likely even higher since third parties are not required to report an incident to the Food and Drug Administration, the federal agency charged with overseeing quality of these devices.
Invariably, those figures would likely increase even more with less regulatory supervision.
The stakes are even higher as equipment becomes ever more connected. Today’s health care devices stream patient information in real time. Each machine is a potential entry point for hackers to exploit. One must ask, how can we ensure our guards are up when even the slightest coding error by an unqualified repair tech could create a backdoor for bad actors?
Fortunately, some states that passed right-to-repair laws excluded medical equipment. They wisely understood the unique nature of the industry and the need for sufficient oversight.
As a former U.S. surgeon general, it was my job to foster public trust in our health care system by ensuring clear and consistent guidance and resources. I spent nearly four decades of my career in public health with that mission; to ensure that patients from all walks of life can have confidence in the doctors and medical professionals.
That’s why I strongly urge lawmakers to keep right-to-repair legislation far away from the health care device space. These perhaps well-intentioned bills would have costly results for patients’ safety and lives.
Congress would be wise to pass legislation to prevent states from inadvertently veering into dangerous territory. In reality, that’s probably not practical. It is incumbent then on our state elected leaders to realize that “right to repair” might work for common consumer products, but it should have no place in our hospitals and doctors’ offices.
Dr. Kenneth Moritsugu is a master of public health, a fellow of the American College of Preventive Medicine, a retired rear admiral for the U.S. Public Health Service, former acting U.S. Surgeon General and chair of the Together for Safer Roads Expert Panel.
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