Let’s Be Serious About Right to Repair and Patient Safety

A recent editorial by the Pittsburgh Post-Gazette, discussed the introduction of right to repair legislation in the Pennsylvania State House, a bill that looks to help usher in a more repairable future. But the article incorrectly framed the consideration of extending right to repair to live saving medical devices.  

The column points to the pandemic as reason why third-party servicers need full access to these devices and only briefly points out this is a “logical exception.” This is likely due to the adverse outcomes that could arise from such permissions.

In reaction to this editorial, Peter Pitts, former Associate Commissioner of the FDA, penned a letter to the editor expressing his concerns:

In the editorial, “Pennsylvanians deserve the right to repair,” the editorial board oddly understates the dangers of extending this legislation to encompass medical devices.

The core of Right-to-Repair laws is to require innovative technology companies to make product repair information, replacement parts, and tools readily available to consumers and third-party repair shops. Should that be the case for devices such as Automated External Defibrillators and hospital ventilators? What about electrocardiograph (ECG) machines? Can physicians and patients be confident in non-FDA compliant vendors without the advanced training and technical ability to properly repair and recalibrate life-saving machines? Who could argue that “anyone can do it?”

By allowing third parties without any FDA competence to repair regulated, complicated medical devices, Right-to-Repair also opens the door to breaches in cybersecurity. According to the FDA, “Cybersecurity is a widespread issue affecting medical devices connected to the Internet, networks, and other devices.

Should an individual who lacks proper training and regulatory oversight attempt to fix a medical device and commit a grave mistake, the consequences could put patients’ lives in danger. Moreover, unregulated service providers are not obligated to report any negative incidents stemming from their work because they do not fall under the jurisdiction of the FDA.

Pennsylvania lawmakers are right to keep medical equipment in the hands of the professionals.