a thoughtful web.
Good ideas and conversation. No ads, no tracking.   Login or Take a Tour!
comment
kleinbl00  ·  2433 days ago  ·  link  ·    ·  parent  ·  post: FDA Wants Medical Devices to Have Mandatory Built-In Update Mechanisms

It is, but there's no "software manual" with most devices. The FDA is arguing for something like:

    This is an implantable cardioverter device (ICD). It has heartrate sensing, fibrillation sensing and a cardiological self-updating envelope. It can be updated via Bluetooth 5.0 with the password "9999."

    - Heartrate sensing is accomplished via the 2nd ring terminal of the shock/pace lead and both terminals of the pace2 lead. It uses a bla bla bla loop informed by logic from the bla blah.

    - fibrillation sensing is accomplished via both terminals on the afib lead. It uses blah blah.

    - Updating is accomplished using our software kit, available at www.acmemed.com/mr_shocky. In order to interface with the device you must have performed a chest x-ray on the patient in order to read the two-factor authentication, which changes every thirty minutes. Thump the patient hard in the chest with "shave and a haircut" and set your device to search for bluetooth device "MR_SHOCK_E". Pair using the 2FA code provided in the upper left corner of the device on the x-ray.

    - blah blah blah