[Interest] List traffic disappearing?

[Dan Allen]

Roland,

Not trying to side with anyone here, but this just got me wondering and 
I'd like to know the answer. From what you have said below and in 
previous posts, I assume Qt has been used in several medical devices by 
several different medical companies.

My question, did Qt ever claim it was safe for use in such devices? 
Especially devices that are life critical?

And also, are the device manufacturers not ultimately responsible for 
ensuring a device is safe?

I was always of the assumption there were compilers, software libraries 
etc that were medical device safe.

Apologies if these questions are stupid, I'm not a medical device 
expert. They came more from a personal concern as some of the things you 
state sound scary to me.


On 13/09/2021 15:27, Roland Hughes via Interest wrote:
>
> On 8/21/21 5:00 AM, Bernhard Lindner wrote:
>> Also one special person was banned from the list. He surely started a 
>> lot of controversies
>> and even fights but he was also responsibly for a significant part of 
>> the trafic:-)
>> Personally, I generally lost interest in Qt because I am not target 
>> audience of Qt
>> anymore. But I have no idea if other people feel this way as well.
>
> As far as I know not banned, just no reason to post. Qtc has achieved 
> its goal of getting Qt banned at most medical device companies. Been 
> involved in a lot of discussions about where everything is going now.
>
> One client had full contract from design through FDA testing and 
> manufacturing with a deep pocket client they had created devices for 
> previously. When they finished the electronic board design files they 
> told the client they wanted to use Qt for the software. That was it. 
> Client took the files and cancelled the entire project. Many many 
> millions went out the door at the mere mention of using Qt.
>
> Another end client recently finished proof-of-concept clinical trials 
> outside of the U.S. where they didn't adhere to any FDA development 
> standards. It was a non-invasive device so they could play a little 
> fast and loose. They had used Qt on a Raspberry Pi to mock things up 
> for the proof-of-concept. I told them through the service company to 
> not even look at Qt for production, but they scheduled some chats with 
> Qtc anyway.
>
> "Those guys are crazy!"
>
> Actual quote from them. Qt is no longer under consideration for any 
> current or future devices.
>
> All of the deep pocket customers have listened to the license roulette 
> shenanigans and the answer to nearly ever license question on this 
> list being "meet with your sales rep in a dark alley so they can club 
> you and take all your money."
>
> Earlier this year when this patient killing bug
>
> https://bugreports.qt.io/browse/QTBUG-12055
>
> jacked up another medical device, more than a decade after it was 
> discovered and more than eight years after people started pointing out 
> the disconnect() wasn't actually disconnecting the QFile object was 
> the absolute last straw for most. Yes, it is supposedly closed now, 
> but too little too late. Nobody is going to allow Qt to be used on 
> anything new. Mentioning you have a Qt license or want to use Qt makes 
> you a pariah in the industry.
>
> I haven't spoken to the them directly, but there is talk some of the 
> Risk Management personnel at more than one company are putting 
> together a citizen petition for the FDA.
>
> https://www.fda.gov/regulatory-information/dockets-management/instructions-submitting-citizen-petitions-cps-electronically 
>
>
> Will set heavy regulations for software being sold into medical 
> device/systems development with significant punitive, possibly 
> clinical damages for vendors selling software into this market 
> allowing patient killing bugs to exist for longer than 60 days after 
> reporting. The definition of "patient killing bug" to be any bug tied 
> to a race or abend condition like a seg-fault, stack dump, unhandled 
> exception, etc.
>
> I haven't been watching the list very closely
>
> https://www.regulations.gov/search?documentTypes=Proposed%20Rule&filter=software%20safety 
>
>
> so I haven't seen it pop up yet. Of course the trouble with that 
> database is that it is the central repository for proposed federal 
> regulations, not just the FDA.
>
> It's not just Qtc. Lots of places are trying to sell OpenSource into a 
> SAFETY environment without creating a SAFETY quality version. Versions 
> of the discussion have been going on since 2000
>
> https://www.regulations.gov/document/FDA-2000-D-0130-0005
>
> and standards get routinely updated.
>
> https://www.regulations.gov/document/FDA-2016-N-0406-0017
>
> The 2011 regulation just isn't covering everything anymore.
>
> https://www.regulations.gov/document/FDA-2008-N-0106-0032
>
> So, to answer the question, all of the contractors and developers who 
> worked for/width medical-device-in-a-box type companies who used to 
> frequent here, aren't using Qt anymore. Risk Management teams have 
> deemed use of Qt too high of a legal liability were a wrongful death 
> or other class action suit to go to trial. Having abend (known as 
> patient killing) type bugs in the bug database for years pretty much 
> does the work for the opposing legal team. Most people on a jury don't 
> write software for a living. They just hear that this list of bugs, 
> any one of which could kill their loved one in the right medical 
> device, has been known to exist for over N-years and the tool was used 
> anyway.
>