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So, if you do an after-market repair on a medical device, and a patient dies as a result of poor device performance, who does the FDA usually come after, you or

So, if you do an after-market repair on a medical device, and a patient dies as a result of poor device performance, who does the FDA usually come after, you or the device manufacturer? I suspect the liability for medical device mess-ups is at least partially responsible for that situation. The tech who didn't run any diagnostics would be in serious shit if a patient died after he did nothing aside from typing in the error-clearing code on your repair. In many cases, the FDA requires the device manufacturer to maintain training records and updated repair procedures for any repair shop doing repairs on their devices. This could be the source of that error message.

marcosdumay 10y ago
> So, if you do an after-market repair on a medical device, and a patient dies as a result of poor device performance, who does the FDA usually come after, you or the device manufacturer? I don't know the answer to that question. But I do hope it is "the party that was negligent".
CaptSpify 10y ago
To be honest, I'm not sure. I was a level-of-separation away, so I never really had to worry about it personally. I'd imagine both will end up in the lawsuit, at least partially. FWIW, we did keep updated records on all the work that was done on the machine, for this exact reason. We also had to have records of passed diagnostics.
- lotu 10y ago
  I would also have to imagine that is is extremely difficult to fix an MRI such it produce incorrect scan results with being obviously broken.
  - CaptSpify 10y ago
    Right. The tests they have are pretty "by the book". Readings and diagnostics have to be pretty tight.
    - CaptSpify 10y ago
      As I can't edit the above post: Listen to wyldfire over me. My impression was that they were by the book, but I'm not an actual repair-tech
  - wyldfire 10y ago
    You'd be wrong. Source: diagnostic imaging design engineer (CT, not MR, but the hazards are similar).

marcosdumay 10y ago

> So, if you do an after-market repair on a medical device, and a patient dies as a result of poor device performance, who does the FDA usually come after, you or the device manufacturer? I don't know the answer to that question. But I do hope it is "the party that was negligent".

CaptSpify 10y ago

To be honest, I'm not sure. I was a level-of-separation away, so I never really had to worry about it personally. I'd imagine both will end up in the lawsuit, at least partially. FWIW, we did keep updated records on all the work that was done on the machine, for this exact reason. We also had to have records of passed diagnostics.

lotu 10y ago
I would also have to imagine that is is extremely difficult to fix an MRI such it produce incorrect scan results with being obviously broken.
- CaptSpify 10y ago
  Right. The tests they have are pretty "by the book". Readings and diagnostics have to be pretty tight.
  - CaptSpify 10y ago
    As I can't edit the above post: Listen to wyldfire over me. My impression was that they were by the book, but I'm not an actual repair-tech
- wyldfire 10y ago
  You'd be wrong. Source: diagnostic imaging design engineer (CT, not MR, but the hazards are similar).