Guest Commentary: Delaware’s right-to-repair bill needs a fix

Terry Wilcox is the co-founder and CEO of Patients Rising and Patients Rising Now.

From consumer electronics to farm equipment, “right to repair” is dominating the headlines. Proponents argue that this movement will make it easier and cheaper for consumers to fix their products.

But, unlike quick fixes for consumer products, servicing medical imaging technology requires more than just a manual, as even small repairs for medical devices require extensive training.

Medical device servicing performed by the original equipment manufacturer is regulated by the Food and Drug Administration, meaning that these companies and their servicers are required to undergo proper training, reporting and registration. In contrast, right-to-repair policies that include medical devices would permit unregulated, third-party servicers to repair highly sensitive imaging technology without registering with the administration — a requirement that even many dietary supplement manufacturers must meet — or meeting any quality, safety and regulatory requirements.

Allowing unregulated third-party actors to tinker with medical devices has significant unintended consequences and presents new and unnecessary risks to patient safety and cybersecurity. For most Americans, this is a commonsense issue. A recent Harris Poll revealed that 77% of American consumers says that the Food and Drug Administration should regulate medical device service and repair conducted by either original equipment manufacturers or independent third-party companies.

That’s why I was surprised to hear that the Delaware legislature is considering House Bill 41, a right-to-repair bill that does not explicitly exclude for medical devices. If FDA-regulated medical devices are included, this legislation will put Delaware’s patients, particularly those battling complex diseases, in harm’s way.

If the repair of a consumer electronic goes awry, it’s an inconvenience. If a medical device is improperly serviced, it puts patients at risk of serious injury or poor image quality that can lead to a delayed or missed diagnosis. Patients and their families deserve the peace of mind that medical devices work effectively and aren’t merely slapped back together by untrained, third-party servicers.

Right to repair would also jeopardize patient safety and cybersecurity by giving third-party servicers uncontrolled use of proprietary, highly technical service materials. In 2021, 108 individual ransomware attacks cost an estimated $7.8 billion and jeopardized more than 19.76 million patient records. If third-party servicers had unfettered access to this sensitive information, it would only exacerbate the risk that patient health data ends up in the wrong hands, particularly given the fact that these actors aren’t subject to the Food and Drug Administration-mandated quality management and cybersecurity processes required of original manufacturers.

Due to these risks, nearly 3 in 5 Americans said they would be more likely to vote for a member of Congress or state legislator if they supported efforts to exclude medical devices in right-to-repair legislation. Thankfully, state lawmakers are taking notice. New York’s Digital Fair Repair Act, billed as the nation’s first comprehensive “right-to-repair” law, covered a wide range of consumer electronics and gadgets but notably excluded FDA-regulated medical devices. The same is true of many other “right to repair” bills that have been introduced at the federal and state level.

As a dedicated patient advocate and executive director of Patients Rising, a nonprofit patient education and advocacy organization, I urge the Delaware legislature to listen to patient and consumer voices by exempting medical devices from its right-to-repair bill. Doing so will avoid disastrous consequences for patients who rely on lifesaving medical equipment.