In right to repair debate, medical devices must be protected | Column
No doctor wants to be left wondering if they can count on the results of a mammogram or from other medical devices.
An MRI machine that lets patients see peaceful nature scenes and can cut the time to take images to seconds.
An MRI machine that lets patients see peaceful nature scenes and can cut the time to take images to seconds.
Published July 28, 2023|Updated July 28, 2023

In the U.S., quality is the highest priority in the delivery of patient-centered health care. It is the reason that the American medical system, even with its challenges, remains the gold standard. With our state-of-the-art care and medical innovation, providers work together to improve, extend, and even save patients’ lives.

Jonathan Ellen
Jonathan Ellen [ Courtesy of Jonathan Ellen ]

In addition to their clinical expertise, doctors, nurses, and technical staff depend on safe, reliable, and accurate medical devices to screen, diagnose and treat patients. Without access to up-to-date and dependable medical devices, providers know less and can do less for their patients.

Meticulous upkeep is crucial when dealing with human life and well-being, and there is significant responsibility borne by the companies who make these machines, the medical professionals who operate them, and the repair processionals who fix them. To give patients peace of mind and protection, the Food and Drug Administration (FDA) mandates that manufacturers uphold “Quality System/Current Good Manufacturing Practices” that cover everything from software updates to complicated repair jobs.

Now, there is an effort in some states and in Washington, D.C., to pressure lawmakers and regulators to recognize a so-called “right to repair,” where consumers are permitted to pay any company to fix or modify a product. For many devices like cellphones or household appliances, that might make sense.

But the approach from some “right to repair” advocates is perilously broad, as it includes products like medical devices that carry more risk than typical consumer goods. If successful, sweeping right to repair policies would open up “mission critical” equipment to the increased possibility of unqualified repairs that could ultimately endanger patient and provider safety.

No doctor wants to be left wondering if they can count on the results of a mammogram, or if the tools being used to perform surgery are safe and devoid of malfunctions. It’s why there are comprehensive federal regulations and oversight on the manufacturers of these products. Compliance with medical device regulations is what creates the foundational trust our health care system is based on.

Alternatively, by allowing increased access to medical equipment by untrained or uncertified individuals, hospitals and health care institutions forfeit the manufacturers’ warranties about the dependability and trustworthiness of their products for unknown outcomes.

Expanding the “right to repair” to medical devices would also increase the liability on providers and hospitals at a time when those costs have never been higher. With medical malpractice tacking on between $50 billion and $150 billion to health care costs annually, policies that could expose our hospitals to greater risk of equipment malfunction will only increase bills for patients and insurers further. A very real risk, especially considering independent servicers are not required to report any adverse events to regulators, meaning our understanding of their impacts on these products is virtually zero.

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That’s why, as policymakers examine policy solutions to nurture competition across our economy, lawmakers and regulators must differentiate between common consumer goods, like tractors and air conditioners, versus highly specialized “mission critical” devices, like MRI scanners or robotic surgical machines.

After all, they wouldn’t want their loved ones to be forced to accept medical treatment built upon a foundation of unreliability and inaccuracy. The American people shouldn’t be, either.

Jonathan Ellen, M.D., M.S., is a pediatrician, epidemiologist and former CEO of Johns Hopkins All Children’s Hospital. He is the CEO of Connections for Health, a full-service social determinants of health (SDOH) solution for health care and pharmaceutical companies.