4 ms·

Love this take on it. That said, there's a California State Bill SB-605 "Medical Device Right to Repair Act" that's going through the motions at the moment. Med

Love this take on it. That said, there's a California State Bill SB-605 "Medical Device Right to Repair Act" that's going through the motions at the moment. Medical devices are not "basically murder weapons we kind of screwed ourselves into being reliant on". I'd like to hear what peoples' take on Medical Devices is?

archivator 5y ago
The FDA's report on third party servicing says this: > The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time. Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices. https://www.fda.gov/media/113431/download https://www.fda.gov/media/113431/download From my personal experience poking at a CPAP machine, there's nothing magical about it. All the sensors and active elements I could track down are available from the respective manufacturers in large quantities. The CPU is a freaking off the shelf STM32F4 with the jtag header still on the board. This is not some impossible to debug hyper-integrated design.
ska 5y ago
Medical devices differ more in the level of design review and testing than in the designs per se - many of them are fairly straightforward. As long as 3rd party repair a) doesn't cut corners and b) knows how to do full verification testing, it should be fine. The latter part is interesting, as public side of FDA filings doesn't have all the V&V filings. I suspect that's why FDA is less sanguine about re-manufacturing.
wiseleo 5y ago
I refurbish medical devices in California. The customer can either talk to sales or talk to me. Medical devices are a computer-controlled apparatus, and the computer. I can fix the computer without affecting the device's calibration. Devices don't break often, but their controlling computers do. The oldest devices I serviced run on Windows 3.1 and still work fine. There's a touchscreen mono CRT that runs on some custom build of Windows 3.1 in daily use at that office. I use Windows 98 daily.

archivator 5y ago

The FDA's report on third party servicing says this: > The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time. Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices. https://www.fda.gov/media/113431/download https://www.fda.gov/media/113431/download From my personal experience poking at a CPAP machine, there's nothing magical about it. All the sensors and active elements I could track down are available from the respective manufacturers in large quantities. The CPU is a freaking off the shelf STM32F4 with the jtag header still on the board. This is not some impossible to debug hyper-integrated design.

ska 5y ago

Medical devices differ more in the level of design review and testing than in the designs per se - many of them are fairly straightforward. As long as 3rd party repair a) doesn't cut corners and b) knows how to do full verification testing, it should be fine. The latter part is interesting, as public side of FDA filings doesn't have all the V&V filings. I suspect that's why FDA is less sanguine about re-manufacturing.

wiseleo 5y ago

I refurbish medical devices in California. The customer can either talk to sales or talk to me. Medical devices are a computer-controlled apparatus, and the computer. I can fix the computer without affecting the device's calibration. Devices don't break often, but their controlling computers do. The oldest devices I serviced run on Windows 3.1 and still work fine. There's a touchscreen mono CRT that runs on some custom build of Windows 3.1 in daily use at that office. I use Windows 98 daily.