Understanding the Caveats of Medical Device Repair – A Discussion

Last month, on October 24, we co-hosted a webinar with our partner Patients Rising to explore the potential implications of right-to-repair policies on patient safety. The panel talked about the various issues related to permitting unregulated entities to repair medical devices that are regulated by the Food and Drug Administration (FDA).

Peter Pitts, former FDA Associate Commissioner, and Dr. Roslyn Layton, a tech policy expert, participated in the panel discussion that spoke to the group’s network of patient advocates about the risks associated with medical device right to repair, including compromised device effectiveness, cybersecurity vulnerabilities, and the possibility of stifling innovation by reducing incentives for technology companies.

Peter Pitts honed in on the right to repair issue from a regulatory perspective. He highlighted the fatal attraction between FDA regulated medical devices and right to repair, emphasizing that of course hospitals want to get things done for cheap, but you can’t trade cost for quality.

Pitts noted that “quality is the glue that holds technology together.” Jeopardizing this quality with broad right to repair legislation will create preventable risks for patients, and in some cases, patients will be driven to lose faith in the healthcare system entirely.

On the technology side, Roslyn Layton highlighted the target-rich environment that is the hospital system and how cyberattacks towards hospitals can often be the most dangerous, citing a recent attack on a UK facility that left the hospital in the dark for nearly 40 minutes. She emphasized that “prevention is always better than treatment” and that you “can’t go back and undo the accident – it’s always better to prevent them.”

In closing remarks, Pitts stated that “[right to repair] is not a one-size-fits-all proposition” and that “consumers should want to lower costs and increase repair access, but not at the expense of quality.” Layton echoed these sentiments stating that “[medical devices] should not be grouped into these open access environments” and that “open access does not go hand-in-hand with investments and having the best and quality technology.”

As states prepare for their 2025 legislative sessions, the need for proper patient safety provisions still rings true. Any state looking to introduce right to repair to their consumers must also think about the need to keep these consumers safe from unregulated repairs in the medical field.