State, Federal Policy Should Exempt Medical Devices from ‘Right-to-Repair’ Movement

State, Federal Policy Should Exempt Medical Devices from ‘Right-to-Repair’ Movement
State, Federal Policy Should Exempt Medical Devices from ‘Right-to-Repair’ Movement

Delaware may soon become the latest state to pass so-called “right to repair” legislation without including an exemption for medical devices. Legislators and policymakers at the state and federal levels should understand the risks that come with classifying life-saving medical devices like CT, MRI, and PET scanners with other forms of technology. While the right to repair may sound good on paper, allowing nearly anyone to service and repair highly sophisticated medical technology opens up patients, providers, and our entire healthcare system to serious risks.

Purportedly designed to help lower maintenance costs and encourage repair and replacement, right to repair legislation has been having a moment in state legislatures across the country. To date, more than two dozen states have either passed or are currently considering right to repair legislation. The overwhelming majority of these bills have carveouts for lifesaving medical devices, but not Delaware.

While there are many consumer technology and electronic products for which the right to repair ideology may not have much of a safety risk, or perhaps even be beneficial, life-saving medical devices should not be among them. These highly complex machines, including imaging scanners that use radiation or super-powered magnets, should only be serviced and maintained by regulated technicians with equally high training and a deep understanding of these kinds of technologies. Including medical devices in the types of products covered by right to repair could threaten the safety of patients and operating technicians while undermining the integrity of our health care system.

Essentially, right to repair legislation that does not include an exemption for medical devices would allow third-party independent service operators (ISOs) to service these complex pieces of technology. The trouble lies in the fact that, unlike original equipment manufacturers (OEMs), these ISOs are not held to any of the same regulatory requirements to ensure safety and uphold the highest repair standards. By law, OEMs must follow federal regulations put in place and enforced by the U.S. Food and Drug Administration (FDA); ISOs have managed to escape responsibility for following these strict standards.

Increasingly, medical device manufacturers and the health care community are raising concerns about the adverse impacts for technicians and patients that could follow from allowing unregulated ISOs to perform repairs on medical devices. When not properly serviced, highly advanced MRI machines or CT scanners can lead to a misdiagnosis for patients or even expose them to harmful radiation beyond what is medically necessary for their treatments. When lives are literally on the line, it defies logic to allow untrained, unregulated repair shops to get under the hood of such advanced, complicated machinery.

At the same time, many of the right to repair bills in state legislatures that attempt to include medical devices would require equipment manufacturers to hand over their proprietary information, including trade secrets, service manuals, copyrights, patents, and other highly sensitive documents. Doing so would not only give these unregulated service providers access to technologies for which they are not familiar or trained, it could also open the door to device malfunction or even cybersecurity risks.

Now, a new Harris poll conducted for Patients Rising Now finds that the vast majority of American consumers also have some serious misgivings about allowing third-party ISOs to perform unregulated repairs on medical devices. According to the poll, more than three-quarters (77%) of consumers agree that the FDA should regulate medical device repair conducted by either OEMs or ISOs. Moreover, nearly three out of five American consumers (59%) would be more likely to vote for a member of Congress or state legislator if they support efforts to exempt medical devices from right to repair legislation. These numbers speak for themselves.

As more states continue to weigh right to repair policies, policymakers should look to the example New York set when it became the first state in the nation to pass a right to repair law, which excluded medical devices. Notably and perhaps unsurprisingly, many state efforts to pass right to repair legislation that did not include a medical device exemption have failed, including in California, Texas, and Oklahoma. In large part, these legislative losses were due to the fact that right to repair proponents could not address concerns over how ISOs would be held to the same level of accountability as OEMs when sourcing and testing parts, following FDA safety regulations, or even investing in technician training at all.

If we are going to hold OEMs to the necessarily high standards of safety and regulation for medical device repair enforced by the FDA, then we need to hold all potential service providers, including ISOs, to that same high level of accountability. As this issue gains traction in the states, it is critical for Congress to work with the FDA to ensure the proper regulation of all medical device service providers, which calls for increasing regulatory oversight of ISOs.

The bottom line is this: there is a difference between fixing a broken laptop or iPhone and repairing advanced, highly sophisticated medical devices, including MRI machines and CT scanners. Policy decisions at the state and federal level should recognize and reflect that distinction.

Photo: fstop123, Getty Images

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