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Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

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Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#171

Earlier quoted context omitted.

I work for a medical devices company and I just want to say: We, specifically a few of us on the engineering staff, bring this sort of shit up constantly. I go hoarse having the same conversations over and over and over again about robustness in the face of failure, resiliency, redundancy, etc... The truth is that we're beholden to a board and an executive management team that, quite simply, doesn't give a fuck about…

It's not a decision which should be made at the level of executives though. Presumably developers are the one's estimating how long things take. (If they're not, you have even bigger problems and I'm sorry.) The time to make it safe should automatically be included in those estimates. Moreover, making it safe shouldn't be a separate part of the process. It should just be part of how you write software. It's either sa…

> Presumably developers are the one's estimating how long things take.

This is not meant as a slight: I think you're grossly unfamiliar with software development outside of engineering-driven companies.

It's pretty much a guarantee that product managers are deciding these estimates. They might confirm with the developers, but the conversation probably went something like this:

"Does 3 weeks sound about right for this?"

"No, we'll need 6"

"Why?"

"Safety checks"

"Ok, we don't have 6 weeks. I can give you 4, but we're just gonna have to make do."

Is it scary that conversation happened about a piece of medical software? Absolutely. Would I bet $1k that it happens frequently? Absolutely.

> A reputable engineer wouldn't design and build a bridge which might collapse

Rarely does a single engineer design a bridge nowadays, so corporate liability and reputation (good luck landing more contracts if your bridge collapses) is a huge factor in much of that beyond simple ethics.

I would be shocked if anything happened to Merge as a result of this, whereas a company who designed a faulty bridge would be sued into oblivion.

Further, professional engineering in the US is a whole different game that involves licensing and regulations specifically to avoid that situation. Software "engineering" has no such equivalent currently.

Pinning the blame on the peons is a sure-fire way to make sure this situation never changes.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#172
post #74

Earlier quoted context omitted.

>No matter what OS you choose it is vulnerable to viruses This may be theoretically true, but it is not practically the case. There is a reason Linux and OS X users almost never use antivirus software. Using Windows on a medical device is inexcusable. It's a heart monitor, not a game system.

Medical devices are used by humans. Humans, for some reason prefer and know Windows better. Why shouldn't the devices use Windows? Today, doctors from a hospital the other side of the country can diagnose your cancer realtime while you are still in the MRI machine, and they do it with Windows, because that's what humans know and use.

Users shouldn't be exposed to the OS here at all.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#173

Earlier quoted context omitted.

I'm with you...I can see exactly how this can happen. Unfortunately the only thing that can solve the apathetic board and executive management problem(who only see dollar signs) is the actuality, or realistic possibility, of significant financial loss, or loss of their personal freedom(prison) due to the negligence of the system. And a $10 Mil fine for a fault in something that you make $100 Mil off of is not signifi…

> Unfortunately the only thing that can solve the apathetic board and executive management problem(who only see dollar signs) is the actuality, or realistic possibility, of significant financial loss, or loss of their personal freedom(prison) due to the negligence of the system. Or developers refuse to build software without safety built in. If they can't hire anyone to build their unsafe systems, they'll have to sta…

That sounds nice...but then you will be replaced by a developer that will toe the company line. You're making 'unreasonable' demands and holding up progress. 'We can fix that with version 2.0'

If every developer on the planet suddenly had a pang of consciousness, then something like this would work.

Fortunately I have never found myself in such a position, but I have seen it many many times.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#174
post #62

Earlier quoted context omitted.

Huh? Of course there is. "Familiar interface" isn't even a functional requirement, it is only of secondary importance for any system. Actual functionality is much more important. As an aside, if "familiar interface" is your only requirement, I'd suggest to install a door handle or light switch.

Your comment may sound sarcastic on the first read, but I agree with the point; don't use Windows when what you needed could be done with a micro controller or a physical circuit. Not sure if the application here fits that at all, but I've definitely seen things like you-do-it check-outs, ATMs, billboards, etc running Windows. I would think that these systems would be much better off with something like a hardened mi…

Exactly.

If users are never meant to interact with the OS itself (airport terminals, ATMs, displays, etc.) then it makes absolutely no sense to use Windows.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#175

Earlier quoted context omitted.

It's not a decision which should be made at the level of executives though. Presumably developers are the one's estimating how long things take. (If they're not, you have even bigger problems and I'm sorry.) The time to make it safe should automatically be included in those estimates. Moreover, making it safe shouldn't be a separate part of the process. It should just be part of how you write software. It's either sa…

> Presumably developers are the one's estimating how long things take. This is not meant as a slight: I think you're grossly unfamiliar with software development outside of engineering-driven companies. It's pretty much a guarantee that product managers are deciding these estimates. They might confirm with the developers, but the conversation probably went something like this: "Does 3 weeks sound about right for this…

Oh, I'm well aware of the difficulty of negotiating with product managers over timelines.

The difference is that they never should get the decision to cut safety checks. Cutting safety checks should be as ludicrous/impossible as writing half the code of each function to cut time.

The conversation should go like this:

PM: "Does 3 weeks sound about right for this?"

Dev: "No, we'll need 6"

PM: "Why?"

Dev: "That's how long it takes to build those 6 features."

PM: "Ok, we don't have 6 weeks. I can give you 4, but we're just gonna have to make do."

Dev: "Okay, which features would you like to cut?"

> Further, professional engineering in the US is a whole different game that involves licensing and regulations specifically to avoid that situation.

I'm aware. While I don't think the majority of software developers should be certified, we should require licensing for working on safety-critical applications.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#176

Earlier quoted context omitted.

> Unfortunately the only thing that can solve the apathetic board and executive management problem(who only see dollar signs) is the actuality, or realistic possibility, of significant financial loss, or loss of their personal freedom(prison) due to the negligence of the system. Or developers refuse to build software without safety built in. If they can't hire anyone to build their unsafe systems, they'll have to sta…

That sounds nice...but then you will be replaced by a developer that will toe the company line. You're making 'unreasonable' demands and holding up progress. 'We can fix that with version 2.0' If every developer on the planet suddenly had a pang of consciousness, then something like this would work. Fortunately I have never found myself in such a position, but I have seen it many many times.

That's why we should probably require engineering certifications for working on safety-critical software. Working on such software should require demonstrating a certain level of knowledge and upholding a code of ethics.

I generally oppose certification for engineers, but solving collective action dilemmas like this and saving lives in the process is exactly where it would help.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#177

/rant/ I can't tell you how many times we've chased down field problems that ultimately were the result of antivirus scans. It's been so bad, that one of the first questions we now ask when we get a tool-down report is "is there antivirus running and what is the configuration?" Bringing Windows into the architecture of any type of capital equipment control system is a bane. A scourge. I mean to say, it really is a mi…

This This machines costs hundreds of thousands of dollars. There should be no excuse for using Windows. None. I would not be surprised if the "antivirus" thing was some PHB requirement

Windows ( at least 7 & XP) can be stripped down to something approximating a properly running system. This isn't easy.

Having an anything-critical Windows machine on the open Internet might not be such a wonderful idea.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#178

Earlier quoted context omitted.

> Presumably developers are the one's estimating how long things take. This is not meant as a slight: I think you're grossly unfamiliar with software development outside of engineering-driven companies. It's pretty much a guarantee that product managers are deciding these estimates. They might confirm with the developers, but the conversation probably went something like this: "Does 3 weeks sound about right for this…

Oh, I'm well aware of the difficulty of negotiating with product managers over timelines. The difference is that they never should get the decision to cut safety checks. Cutting safety checks should be as ludicrous/impossible as writing half the code of each function to cut time. The conversation should go like this: PM: "Does 3 weeks sound about right for this?" Dev: "No, we'll need 6" PM: "Why?" Dev: "That's how lo…

> The conversation should go like this:

I think you're missing the end to that conversation:

>PM: "Ok, we don't have 6 weeks. I can give you 4, but we're just gonna have to make do."

> Dev: "Okay, which features would you like to cut?"

PM: We can't cut any of them. We need features A,B,C in the product and we need it in 4 weeks.

Here we insert a rant from the PM about one of the following:

1) Leadership

2) Hard work

3) Threats about job security

4) Recalling that one time you delivered something ahead of schedule so why is this different

5) I see you getting up to get coffee at least twice a day so stop goofing off and get it done

I think you're vastly overestimating how much power/control said Dev has over the whole process at these sorts of companies.

Sure, they can quit, but if they felt empowered to quit they probably wouldn't be there in the first place: I don't think anyone's busting down the door to work at MedicalBusinessTM.

> we should require licensing for working on safety-critical applications.

Fully agreed, though with some misgivings.

Incorporating safety-critical software into the "professional engineering" spectrum would almost certainly require some things that are seen as near-heresy to the software community, like requiring a 4-year degree from an ABET-accredited program.

Still, I agree.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#179

Earlier quoted context omitted.

> Presumably developers are the one's estimating how long things take. This is not meant as a slight: I think you're grossly unfamiliar with software development outside of engineering-driven companies. It's pretty much a guarantee that product managers are deciding these estimates. They might confirm with the developers, but the conversation probably went something like this: "Does 3 weeks sound about right for this…

Oh, I'm well aware of the difficulty of negotiating with product managers over timelines. The difference is that they never should get the decision to cut safety checks. Cutting safety checks should be as ludicrous/impossible as writing half the code of each function to cut time. The conversation should go like this: PM: "Does 3 weeks sound about right for this?" Dev: "No, we'll need 6" PM: "Why?" Dev: "That's how lo…

I agree with your sentiment 100%, but if you insist on doing things safely while your colleagues do not, you might get a reputation for being slow and be earmarked for replacement. Perhaps it's worth losing a job over, but your replacement will cut corners so the net effect is patients unsafe + you have no job. It feels reminiscent of the prisoner's dilemma.

Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan

#180

Earlier quoted context omitted.

Oh, I'm well aware of the difficulty of negotiating with product managers over timelines. The difference is that they never should get the decision to cut safety checks. Cutting safety checks should be as ludicrous/impossible as writing half the code of each function to cut time. The conversation should go like this: PM: "Does 3 weeks sound about right for this?" Dev: "No, we'll need 6" PM: "Why?" Dev: "That's how lo…

> The conversation should go like this: I think you're missing the end to that conversation: >PM: "Ok, we don't have 6 weeks. I can give you 4, but we're just gonna have to make do." > Dev: "Okay, which features would you like to cut?" PM: We can't cut any of them. We need features A,B,C in the product and we need it in 4 weeks. Here we insert a rant from the PM about one of the following: 1) Leadership 2) Hard work…

I've managed to push back on PMs many times by redirecting them to trade between time and features (so they still feel like they're in control). That being said, you're right that I would never work somewhere that treats developers so porly.

> Incorporating safety-critical software into the "professional engineering" spectrum would almost certainly require some things that are seen as near-heresy to the software community, like requiring a 4-year degree from an ABET-accredited program.

The vast majority of software isn't safety-critical, so there would still be plenty of opportunities for developers who don't fit into rigid modes.

I 100% oppose having accreditations for all developers.

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