How long/why does it take hospitals months to approve surgery for a neuro-device that's been approved by the FDA for over a year?

So, myself and 2 other people are supposed to have this neuro-stimulator surgically implanted whenever our hospital gets the "approval" and legal consents all taken care of. I come to find out that there is another hospital on the other side of the highway that had this "approval" thing finished back in November 2013. I've been waiting since June 2014 for a surgery date and hospital, manufacturer of device, insurance and doctors can't give me a straight answer on this.

Any idea how I can expedite the matters? Why this is taking so long?

1 Answer

  • Bob B
    Lv 7
    5 years ago
    Best Answer

    FDA approval simply means that the device itself is cleared for use in the USA. It doesn't mean that all hospitals automatically have the training or facilities to use it, and getting those can take a while.

    For example, many nuclear isotopes are FDA approved, but they can only be used in hospitals that are capable of handling them, which not all of them are.

    Complex neurological devices aren't something any doctor can just go and implant- most likely only specialized facilities can do it. Preparing to start using it can take time. Ask your hospital when it's likely to be approved.

Still have questions? Get your answers by asking now.