Oct. 27, 2023
Former Congressman Al Wynn
(TriceEdneyWire.com) - In state legislatures across the country the “right to repair” movement is gaining momentum. Thirty-three states and Puerto Rico considered right to repair legislation during the 2023 legislative session. And while this might be a good idea for some products, policymakers should oppose any attempts to weaken regulated safety requirements for repairing life-saving and life-enhancing medical devices. Patient safety is too great a risk.
In theory, expanding repair options might seem like a good idea. It is the democratization of product repair. And certainly, there are many industries in which this is the right path forward.
In fact, advocates for this movement notched a symbolic win in California after tech giant Apple unexpectedly supported a bill that would require electronics companies to provide more access to the parts and instructions to fix their products.
What the right to repair movement ignores though is that not all product classes are created equal. And a one-size-fits-all solution is not a real solution, especially when it comes to regulated products like medical devices.
Medical devices are an important part of the healthcare services industry. Every single person has been helped by a medical device – whether it’s an EKG machine, a defibrillator, dialysis pump, x-ray machine, or any of the other more than 24,000 devices that medical professionals use every day.
Now imagine if that device didn’t work.
It is this risk that should give policymakers considering these right to repair laws pause. Given the influence medical devices have on public welfare, do we really want to introduce more risk? Risk that could impact functionality?
During my time in the House of Representatives, I served on the Subcommittee on Health whose jurisdiction included oversight over the U.S. Food and Drug Administration (FDA), the agency in charge of the effective regulation of these devices to guarantee their quality and safety. I know firsthand the diversity and sophisticated nature of these products. By granting broad, open access by repair shops unregulated by the FDA, we could be undermining device integrity maintained by the whole regulatory system.
Essentially, if a smartphone or tablet malfunctions from a bad repair job, there’s sure to be some headaches, but you’ll survive. On the other hand, if a sophisticated medical device experiences the same type of error because a hospital chose unregulated repair options, it can be a matter of life or death.
It is also important to consider possible unintended consequences this type of policy might have on underserved and racial minority communities, which are most often among the truly disadvantaged.
One report from researchers with UCLA, Johns Hopkins and Harvard shows that hospitals with a large share of African American patients have significant funding disparities and receive lower payments for care from programs like Medicare. Unfortunately, these facilities are the ones that will most likely use the unregulated repair option to fit necessary maintenance into tight budgets. Therefore, we could be unintentionally putting our community on the front lines of the increased risk a broad right to repair policy would enable.
Cutting corners in the medical field should never be an option. A 2016 study by the National Library of Medicine found that cutting corners was a “common practice” that contributes to adverse outcomes. That’s simply unacceptable.
Albert R. Wynn is a former member of the U.S. House of Representatives, representing Maryland’s 4th Congressional District. While in the House, he served as a member of the Subcommittee on Health.