this post was submitted on 26 Sep 2024
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I'd temper that by saying a manufacturer would need to provide a reasonable option. Some things could become dangerous or even deadly if repaired incorrectly. Or it could be dangerous or deadly to even attempt to repair it.
In the medical field when a device can only be repaired by the manufacturer then you can expect long wait times, bad repair jobs and having your own equipment sent in for repair destroyed for "safety".
We let people repair their own car's brake pads.. we shouldn't give up ownership rights for a unwarranted claim to safety. If something is potentially dangerous then making it more difficult to repair is a bad idea.
This depends on the area of medical device. I work in medical device but totally different from this, mine get implanted into your body.
I doubt many people have the knowledge to to truly troubleshoot our devices beyond what the doctor is allowed to do. We need a bunch of expensive and specialized hardware to troubleshoot.
We are legally required to investigate and report any complaints(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) . If we don't get the complaint we can't investigate and report it.
If a certain number(honestly I don't know the specific number) of complaints occur we are legally required to create a corrective action to help the patients immediately (or as soon as possible) and a preventive action to ensure it doesn't effect other patients. If a person has an issue and "repaired" it themselves they don't get counted in this and as such could cause more patients to suffer.
While I agree with right to repair I think certain things should be exempt. That said then there should be a requirement of the manufacturer to ivestigate/repair the equipment.
When a defibrillator implant incorrectly shocks a pregnant women as an edge case she has to take meds to slow her heart so it doesn't shock her. Doctors never think of the software running on it, and can't get the code because it's proprietary. People would be able to fix it, perhaps without even removing it, but can't because business. https://www.youtube.com/watch?v=easb_6LCFDI