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.
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