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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.
This is why there are separate rules and standard for implantable, wearable, and supporting medical devices.
When your hacked together CPAP sends asbestos directly into your lungs because Bob from maintenance had some spare time to fix it, you’ll be crying about malpractice.