this post was submitted on 02 Sep 2023
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Owning the device doesn't help if it requires regular maintenance and there's nobody able to do it anymore.
I mean, we should protect against that too by requiring a certain level of service. But at the very least they need to own the device and have the right to leave the device in, even if it would fail or potentially cause them harm. I pointed that out because it sounds like they wanted to leave it in and not listen to the doctors advice to remove it, but could not for some reason. The only reason I can imagine would involve someone paying for the surgery to remove it against her will is one in which she does not own the device and the alternative is being burdened with a massive debt to pay off the device.
How do you require a certain level of service when the company that made it goes out of business? Or when employees with essential knowledge leave the company? I've been working in software for a long time, and everywhere I've worked, losing someone knowledgeable about a product is a big blow to future development because a lot of important knowledge is only in their head, leaving future maintainers to do a lot of reverse engineering. Requiring documentation wouldn't work because any company that had strict enough requirements would have a very hard time hiring engineers willing to spend so much time documenting every little thing.
You require them legally to budget and plan these things and give them harsh penalties if they fail. That they need to set aside money in a way that it can't be touched if they go under. You'll likely need to hire teams at the government to help fill gaps and coordinate.
I don't think you have any idea how much money you're talking about. The fact that you're proposing it in the context of an experimental device that was probably never even marketed is just deranged. We'd still be stuck with 1950s-level technology if you had your way because nobody could afford to develop any new products that can't be made in a basic machine shop.
You asked how it might work, you didn't say it had to be practical lmao
The whole point of a clinical trial is to enroll volunteers who are willing to undergo a treatment that might not work at all and might not be available in the future even if it does work. Not only that, but you might expect to get a potential cure and end up with only a sugar pill.
If you think any of that is unreasonable, then don't enroll in a clinical trial.
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.
This, right here, is really important. We already have otherwise useful things being bricked because the software is no longer updated, or worse, the company goes bankrupt. If that's our future with brain implants, that's going to be a big problem.
Doctors remove unsafe implants and/or replace them with safer versions all the time, including devices like deep brain stimulators. I don't see why you consider this to be a big problem.
Because every surgery has risks, including simple ones. In this case, there would be no direct medical reason to do so.
There was a medical reason, the device was considered unsafe. Any experimental device is considered unsafe without monitoring, and monitoring was no longer available. That's why she chose to have it removed.
Anyone who signs up for a clinical trial knows that their treatment can be discontinued at any time, even if it is helping them. For example, if an implant is helping you but is found to be harming other people, it may be considered unsafe and you may be advised to remove it. In fact, a different article suggested that other patients were experiencing adverse effects from this experimental implant. This might even be why the company couldn't get their product approved and eventually lost funding.