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1. ok_dad+(OP)[view] [source] 2022-10-02 17:02:12
I worked in medical device quality control and so, yes, I know all about the FDA requirements for medical devices and ISO 13485. I can say, with certainty, that base Linux would not be allowed to run in a medical device in the USA. It's software of unknown provenance (SOUP) and would absolutely NOT be used as-is.
replies(6): >>smolde+M5 >>gmueck+Fb >>voakba+ud >>sarlal+OJ >>cplusp+Mi1 >>Suzura+ss2
2. smolde+M5[view] [source] 2022-10-02 17:33:08
>>ok_dad+(OP)
Makes me wonder what they run their NAS software with. Or their internal web-hosting, or their networking devices, or any of the other devices they have littered about. I'd swear on the Bible that I've seen a dentist or two running KDE 3 before...
replies(1): >>ok_dad+8h
3. gmueck+Fb[view] [source] 2022-10-02 18:05:10
>>ok_dad+(OP)
Then you should know that the use of SOUP is not so clear cut. It depends on the class of device and more specifically, on the part of the device that the software is used on. I know medical devices running SOUP operating systems like Linux. They went to some length to show that the parts running Linux and the critical functions of the device were sufficiently independent. This isolation is specifically allowed by the standards you quote.

It's even worse on things like car dashboards: some warning lights on dashboards need to be ASIL-D conformant, which is quite strict. However, developing the whole dashboard software stack to that standard is too expensive. So the common solution these days is to have a safe, ASIL-D compliant compositor and a small renderer for the warning lights section of the display while the rendering for all the flashy graphics runs in an isolated VM on standard software with lower safety requirements. It's all done on the same CPU and GPU.

replies(1): >>ok_dad+4h
4. voakba+ud[view] [source] 2022-10-02 18:17:43
>>ok_dad+(OP)
That’s an odd thing to claim. I have worked on certified medical devices that run custom Linux distribution.

Mind you, that experience also severely soured me on the quality of medical software systems, due to poor quality of the software that ran in that distribution. Linux itself was a golden god in comparison to the crap that was layered on top of it.

replies(1): >>ok_dad+ph
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5. ok_dad+4h[view] [source] [discussion] 2022-10-02 18:39:45
>>gmueck+Fb
> They went to some length to show that the parts running Linux and the critical functions of the device were sufficiently independent.

Let's not be too pedantic. You, as an experienced medical device engineer, probably knew what I meant was that they would never use Linux in the critical parts of a medical device as the OP had originally argued. Any device would definitely do all of it's functionality without the part with Linux on it.

The OP was still a major strawman, regardless of my arguments, because the Linux kernel will never be in the critical path of a medical device without a TON of work to harden it from errors and such. Just the fact that Linus' stance is as said would mean that it's not an appropriate kernel for a medical device, because they should always fail with an error and stop under unknown conditions rather than just doing some random crap.

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6. ok_dad+8h[view] [source] [discussion] 2022-10-02 18:39:59
>>smolde+M5
Those aren't medical devices.
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7. ok_dad+ph[view] [source] [discussion] 2022-10-02 18:41:20
>>voakba+ud
I'd like to hear more about that, but I assume it's much like the other poster here that described a Linux system that is a peripheral device attached to the actual medical device that does the medical shit.
replies(2): >>gmueck+yu >>voakba+bv2
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8. gmueck+yu[view] [source] [discussion] 2022-10-02 20:11:31
>>ok_dad+ph
It is not a peripheral device if it runs the UI with all the main controls, is it?
replies(1): >>ok_dad+kr1
9. sarlal+OJ[view] [source] 2022-10-02 21:52:41
>>ok_dad+(OP)
Ok, that's good for a U.S. centric view. Do you know that every medical device manufactured in China, for use in China meets the same requirements? Same for India, Russia, etc. The U.S. isn't the world and I'd be surprised if Linux weren't in use in some critical systems around the world that would be shocking for U.S. experts on those types of systems.
10. cplusp+Mi1[view] [source] 2022-10-03 02:27:35
>>ok_dad+(OP)
Surely we can “harden” Linux for this application?
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11. ok_dad+kr1[view] [source] [discussion] 2022-10-03 04:06:41
>>gmueck+yu
No, do you have a concrete example of this strawman, though?

Edit: I should also add (probably earlier too) that all my examples are specific to the USA FDA process. I'm sure some other place might not have the same rules.

replies(1): >>gmueck+YD1
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12. gmueck+YD1[view] [source] [discussion] 2022-10-03 06:32:57
>>ok_dad+kr1
I can't see how you can make out a strawman in what I said. There are medical devices where the UI is running on a processor separate from the controller in charge of the core device functions. The two are talking to each other and there is no secondary way of interacting with the controller. This lessens the requirements that are put on the part running the UI, but does not eliminate them.

I'm mostly familiar with EU rules, but as far as I know the FDA regulations follow the same idea of tiered requirements based on potential harm done.

replies(1): >>ok_dad+BS1
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13. ok_dad+BS1[view] [source] [discussion] 2022-10-03 09:03:33
>>gmueck+YD1
The UI is one of the most important parts of a machine, look at the Therac-25! The FDA regulations require a lot of effort goes into the human factors, too, and the UI definitely had to be as reliable as the rest of the device and be as well engineered as the rest.

https://www.fda.gov/medical-devices/human-factors-and-medica...

Honestly, the FDA regulations go too far vs the EU regs. The company I worked for was based in the EU and the products there were so advanced compared to our versions. Ours were all based on an original design from Europe that was approved and then basically didn’t charge for 30 years. The European device was fucking cool and had so many features, it was also capable of being carried around rather than rolled. The manufacturing was almost all automated, too, but in the USA it was not at all automated, it was humans assembling parts then recording it in a computer terminal.

14. Suzura+ss2[view] [source] 2022-10-03 13:33:33
>>ok_dad+(OP)
I am an American citizen and a former dialysis patient, now kidney transplant recipient. I have watched in-center dialysis machines reboot during treatment, show the old "Energy Star" BIOS logo, and then boot Linux...

Felt kinda bad until I thought about how well a "Linux literally killed me" headline would do on HN, but then I realized I wouldn't be able to post the article if I actually died. Such is life. Or death? One or the other.

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15. voakba+bv2[view] [source] [discussion] 2022-10-03 13:47:30
>>ok_dad+ph
These were not peripherals. We are talking devices that would be front line in an emergency room. Terrifying.
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