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Doctors Remove Woman’s Brain Implant Against Her Will (futurism.com)
submitted 3 years ago by to c/science@beehaw.org
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[–] 1 point 3 years ago (4 children)

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.

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  • [–] 4 points 3 years ago (2 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.

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  • [–] 1 point 3 years ago (1 child)

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

    That's fucked up then

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  • [–] 3 points 3 years 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.

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  • [–] 2 points 3 years ago

    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.

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