Comment on Paralyzed Jockey Loses Ability to Walk After Manufacturer Refuses to Fix Battery For His $100,000 Exoskeleton

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vrek@programming.dev ⁨1⁩ ⁨month⁩ ago

This depends on the area of medical device. I work in medical device but totally different from this, mine get implanted into your body.

  1. 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.

  2. We are legally required to investigate and report any complaints(www.accessdata.fda.gov/scripts/cdrh/…/search.cfm) . If we don’t get the complaint we can’t investigate and report it.

  3. 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.

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