this post was submitted on 02 Sep 2023
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True ownership would imply also having access to the code and documentation, a third party should be able to maintain it with that.
Code and documentation mean someone could theoretically maintain it, but the average consumer could not. You need someone with the knowledge, time, equipment, etc. to think it's worth their while to learn how to maintain it. In the case of a physical device that also means the ability to manufacture spare parts, some of which could be very exotic. For an experimental medical device, it also includes detailed medical knowledge that most doctors don't have. And actually working on it means being willing to take the risk of killing someone if you screw up.
I doubt the person in the article would be helped in the slightest by receiving code and documentation.
Yeah I don't think this is a coding issue. This is something on your brain and if the hardware requires maintenance you better have qualified surgeons that know and understand the device. Of that's no longer possible because the producer no longer exists then it's maybe not a bad idea to have it removed, depending on some factors of course like "how long does she have left to live" and "how much does she suffer.eithout the device".
Why would a medical device exist such that even with documentation a surgeon unaffiliated with the company cannot safely interact with it? You would think it would be a design priority for any maintenance to be straightforward and with clear instructions. I have a hard time imagining that the problem here is anything other than proprietary information being tied up in red tape.
FDA approval is contingent on so many factors that even if it was entirely open source, including all hardware design and the instructions for assembly, maintenance, and manufature it would be entirely plausible for it to lose approval if the company responsible for continued development went bankrupt.
Without approval, no reputable surgeon will do anything beyond remove it.
A device not having a clear and unambiguously documented path for addressing defects found in the future is more than sufficient reason to lose approval.
That's fucked up then
I guess I don't see how a surgeon being unwilling to do maintenance on a non-FDA approved medical device is fucked up.
If it fails to meet the criteria for being safely used in a medical context, it's irresponsible to try to maintain it.
Oh I agree with you, but that requires laws being written correctly. Healthcare being what it is currently in the USA, I very much believe that the women was better off with the device removed.
One of the articles suggests that the device was removed because the batteries were no longer available and nearing end of life.
Regardless, a surgeon is only going to maintain devices approved by the FDA or cleared for investigational use. If the company goes bankrupt then both are no longer the case.
Sounds like an FDA and battery standards problem then.
There's another article that explains that it wasn't just the battery. After the company went under, there was nobody who could provide support for the product in the event of malfunction. Removal was recommended as the safest course.
This isn't an "FDA problem". The device was investigational, which means it did not have final FDA approval. Consequently, there is no guarantee that a surgeon would have the knowledge to maintain it. Surgeons are not expected to be familiar with every experimental device, in fact most surgeons will never touch any experimental device.
And no, surgeons aren't just going to read a bunch of documentation to get up to speed. Typically, when a new product launches the manufacturer will send their technical representatives into the operating room to help troubleshoot any issues.