Right to Repair Laws That Target Medical Devices Will Threaten Patient Safety

We now have another state introducing a bill that specifically targets medical devices with right-to-repair laws.

First, we wrote back in February about how Vermont was the first state this year to introduce a bill establishing the ‘right to repair’ specifically for medical devices. Then, in March, North Carolina introduced legislation that also specifically targets the right to repair for medical devices. Like Vermont’s policy, this legislation will allow unregulated servicers to perform repairs on complex medical equipment and in turn could jeopardize patient safety. 

In high-stakes environments such as operating rooms, trust in the flawless functioning of medical equipment is non-negotiable.

Devices like radiation therapy machines and advanced medical imaging systems are complex and integral to life-saving procedures. Any malfunction or error during repairs could have dire consequences for patients, potentially leading to misdiagnoses or treatment failures, or sometimes even death.

Due to their intricate features and technical specifications, medical devices require specialized knowledge for maintenance and repair. Manufacturers are bound by stringent quality systems regulated by the Food and Drug Administration (FDA), ensuring that all products meet rigorous standards both at the point of sale and during subsequent repairs.

North Carolina’s proposed “Medical Equipment Right to Repair Act,” mandates that original equipment manufacturers (OEMs) provide hospitals and independent, unregulated repair providers with access to essential support documentation, parts, and tools necessary for diagnostics, maintenance, or repairs.

However, this legislation overlooks critical concerns from patients and physicians about whether these devices will be serviced correctly outside of FDA oversight. In 2018, an FDA report highlighted approximately 4,300 instances where independent servicers, not regulated by the FDA, had performed maintenance on medical devices. Among these cases, there were 40 reported deaths, 294 serious injuries, and over 3,700 incidents of device malfunctions.

Legislators must recognize the profound implications their decisions have on patient safety. The complexities inherent in medical device technology necessitate that repairs remain under the purview of FDA-regulated professionals with the requisite expertise.

As discussions continue around these laws, policymakers must prioritize safeguarding public health over broadening repair rights indiscriminately. Ensuring that any changes do not undermine established safety protocols will be vital in maintaining trust in our healthcare systems while still exploring avenues for increased consumer rights where appropriate.