July 12, 2020

Right to Repair — Medical Devices

I have been working in the medical device space for a while, including both Class II and Class III devices, and although I very much support the right to repair” movement in general, when it comes to medical devices, I have a different opinion.

There is more at stake here than what is on the surface. If you try and repair your printer and fuck it up, no big deal, you can’t print. If you try and repair a medical device without having a full and complete understanding of the device, people can be severely injured or die.

There is no answer that solves the problem given the current setup of medical device regulation, but as a start, approval can be given based on device classes perhaps.

We only have a small number of classes currently, so this most likely needs to be expanded, but given current classes, maybe something like this..?

Class I: Right to repair
Class II: Conditional Approval
Class III: Must be repaired by manufacturer

This is all swirling in my mind so I obviously don’t have the answers yet, but I do know that lumping medical devices into the same discussion as consumer electronics is a BIG mistake.

What are your thoughts?

LINKS


Medical Devices Right To Repair FDA


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