124
Doctors Remove Woman’s Brain Implant Against Her Will
(futurism.com)
you are viewing a single comment's thread
view the rest of the comments
view the rest of the comments
this post was submitted on 02 Sep 2023
124 points (99.2% liked)
Science
13006 readers
18 users here now
Studies, research findings, and interesting tidbits from the ever-expanding scientific world.
Subcommunities on Beehaw:
Be sure to also check out these other Fediverse science communities:
This community's icon was made by Aaron Schneider, under the CC-BY-NC-SA 4.0 license.
founded 2 years ago
MODERATORS
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.