this post was submitted on 02 Sep 2023
125 points (100.0% liked)

Science

12822 readers
319 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
alyaza@beehaw.org
Gaywallet@beehaw.org
remington@beehaw.org
125
Doctors Remove Woman’s Brain Implant Against Her Will (futurism.com)
submitted 10 months ago by flumph@programming.dev to c/science@beehaw.org
68 comments fedilink hide all child comments
you are viewing a single comment's thread
view the rest of the comments
[–] ricecake@beehaw.org 4 points 10 months ago (1 children)

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.

[–] chicken@lemmy.dbzer0.com 1 points 10 months ago (1 children)

Without approval, no reputable surgeon will do anything beyond remove it.

That's fucked up then

[–] ricecake@beehaw.org 3 points 10 months ago

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.