Vermont’s Misguided Medical Device Right to Repair Bill
This month Vermont introduced a new bill aimed at establishing the “right to repair” specifically for medical devices, raising serious concerns about the potential threat to quality of healthcare services and future of patient safety in the state.
The Safe Repair Project was established to help educate policymakers regarding the growing right to repair movement with an emphasis on explaining the serious implications on patient safety if complex medical equipment were to be included in laws percolating among state houses.
Medical devices are complex, highly technical equipment that often requires specialized knowledge to conduct proper maintenance. As a result, manufacturers of these products must follow federally regulated quality systems set up by the Food and Drug Administration (FDA) to help ensure that their products meet international standards when sold and when repaired.
Yet under the new bill in Vermont, independent, third party servicers that would now be allowed to access internal software and parts to repair medical devices would not be required to follow federal standards and or report adverse events that bolster transparency and oversight.
If anything, our healthcare system is the one place where servicers and repair people should be authorized and trained to perform repairs. It is a commonsense guardrail to uphold patient safety.
Look at our factsheet for the details.
While the right to repair can promote sustainability and consumer empowerment in many sectors, a diagnostic malfunction with a medical device can lead to more than just consumer inconvenience. It could lead to an incorrect diagnosis, ineffective treatment, or even jeopardize lives—especially for those in emergency situations.
When it comes to healthcare technologies, responsibly, transparency, and accountability are paramount to any small savings gained by using a third party servicer.
Now is the time to ensure policymakers hear this message: the medical devices that thousands of Vermonter patients rely on should not be subject to policies that fail to consider patients long-term safety.