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Paralyzed Jockey Loses Ability to Walk After Manufacturer Refuses to Fix Battery For His $100,000 Exoskeleton (www.404media.co)

submitted 1 month ago by [email protected] to c/[email protected]

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Apologies for posting a pay walled article. Consider subscribing to 404. They’re a journalist-founded org, so you could do worse for supporting quality journalism.

Trained repair professionals at hospitals are regularly unable to fix medical devices because of manufacturer lockout codes or the inability to obtain repair parts. During the early days of the COVID-19 pandemic, broken ventilators sat unrepaired for weeks or months as manufacturers were overwhelmed with repair requests and independent repair professionals were locked out of them. At the time, I reported that independent repair techs had resorted to creating DIY dongles loaded with jailbroken Ukrainian firmware to fix ventilators without manufacturer permission. Medical device manufacturers also threatened iFixit because it posted ventilator repair manuals on its website. I have also written about people with sleep apnea who have hacked their CPAP machines to improve their basic functionality and to repair them.

PS: he got it repaired.

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[–] [email protected] 3 points 1 month ago (2 children)

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.

[–] [email protected] -1 points 1 month ago* (last edited 1 month ago)

A person doesn't need to study medicine or own surgical equipment to get their body repaired. Same logic applies for the repairing of their medical devices. Right to repair does mean you have to personally repair it.

2+3. I don't think that's a problem. Presumably they're already in contact with others to share information. Do that but as part of a larger, more open community.

[–] [email protected] 1 points 1 month ago* (last edited 1 month ago)

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