Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan • Hacker News Board

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

#81

Post by icegreentea » Sat, May 07, 2016, 10:05 PM UTC

kosmic_k wrote: post #28

SixSigma wrote: post #22

Earlier quoted context omitted.

List of FDA medical equipment recalls for 2016 http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm48... At least three of them are Class 1 - May cause death And all of those are software related, none run Windows http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm48... http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm48... http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm48...

That is astoundingly horrifying, especially the Class 1's which were distributed for over five years.

The bar for recall is actually relatively low. Basically, when you find a fault (somehow, maybe in regular QC in manufacturing, or something bad actually happens in the field, or some engineer is fucking around), the question is "can this affect patient safety/outcome in the field". If the answer is at all not a certain "no", then you're probably thinking recall at that point, unless you can adequately root cause and contain it.

Since the nature of "oh oops" is that they tend to affect systems in ways that are not anticipated, there's often insufficient evidence to rule out danger to patients, and therefore there's a recall.

For example, if you sold 10,000 diagnostics machines, and then discovered that because of stack up of tolerances in electrical components, something like 1 in 100,000 machines will have a fault that affects the customer safety. However, because your original analysis (during design phase) did not show this problem, you never bothered recording the actual performance characteristics of 40% of the components involved in the stack up.

Now you're in a pretty awkward situation, that could result in a recall. And it could very well by that all 100,000 machines sold are just fine.

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

#82

Post by developer2 » Sat, May 07, 2016, 10:10 PM UTC

tremon wrote: post #62

stephengillie wrote: post #44

Earlier quoted context omitted.

Windows is a familiar interface for computers. Is there a good reason for not using a familiar user interface?

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.

>> if "familiar interface" is your only requirement, I'd suggest to install a door handle or light switch

This isn't far from the truth. You'd be better of providing a console with clearly labelled buttons and switches. No operating system exposed to the user. It's not very practical to implement, let alone make changes to, but it would be more dummy proof than any desktop application.

This is also why you see a lot of kiosk-like, full-screen applications, with no ability to actually work with the desktop interface itself. A single kiosk application that cannot be alt-tabbed out of, providing screens that are easy to navigate.

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

#83

Post by sillysaurus3 » Sat, May 07, 2016, 10:11 PM UTC

Avernar wrote: post #77

"Merge says the antivirus froze access to crucial data acquired during the heart catheterization. Unable to access real-time data, the app crashed spectacularly. The company claims that they included proper instructions in their documentation, advising companies to whitelist Merge Hemo's folders in order to prevent crashes from happening, so it seems that the whole incident was nothing more than an oversight on the m…

Software shouldn't necessarily try to account for errors in that manner. Usually, the most graceful thing to do is to exit cleanly.

For example, if there is a massive amount of data, it has to be stored on disk. It's too large to keep in memory. And if the point of the program is to transform that data in real time, then it has to have access to the disk.

The antivirus basically unplugged the disk. What can it do to recover? There's nothing to be done.

It should be able to survive that situation, of course. When the disk is plugged back in, it should be able to restart without any problems. But I think that's a different kind of resiliency than what you're referring to.

In this case, the only way to recover would be to copy the frozen data to a new area of the hard drive, assuming it retained read access. But such complexities result in brittle implementations, prone to acquiring bugs. What if the disk space runs out? So you check beforehand whether there's enough space. But what if some other program starts consuming disk space in the middle of your copy operation? And so on. It's an endless spiral of design complexity.

The situation in the article seems closer to hardware failure than a design oversight.

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

#84

Post by tremon » Sat, May 07, 2016, 10:13 PM UTC

seanp2k2 wrote: post #66

tremon wrote: 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…

Oh, I didn't even mean my comment to be about Windows vs dedicated OS, at least not directly. When administered correctly and properly fenced off, using a modern Windows system is not a cardinal sin. Although I will admit that Windows 10, with its non-optional feature cadence, brings additional uncertainty.

However, I do question "it looks like Windows" as a valid rationale for what appears to be a single-purpose machine. I don't think it's likely that staff are using the operating room equipment as a desktop machine, so presumably they only care about the in-app user interface. And an application interface can be made to "look like Windows" regardless of what OS it's running on.

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

#85

Post by ams6110 » Sat, May 07, 2016, 10:14 PM UTC

ktRolster wrote: post #43

aavotins wrote: post #38

Earlier quoted context omitted.

Second this. It is terrifying to know that mission critical, medical grade software runs on a consumer operating system. Military/aerospace systems have numerous requirements and clearly defined practices and ways of developing these systems, often going through various layers of documentation and using specifically designed programming languages(like the Z programming language) to write specifications, which are the…

Then this story about viruses at a nuclear power plant won't make you feel any better: http://www.reuters.com/article/us-nuclearpower-cyber-germany... Some great quotes: "Mikko Hypponen, chief research officer for Finland-based F-Secure, said that infections of critical infrastructure were surprisingly common" "Hypponen said he had recently spoken to a European aircraft maker that said it cleans the cockpits of its p…

Sounds suspect to me. Aircraft computers are not running Android.

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

#86

Post by tjohns » Sat, May 07, 2016, 10:14 PM UTC

zxcvcxz wrote: post #79

dlp211 wrote: post #71

Earlier quoted context omitted.

Get out of here with that nonsense. You may not be a fan of paid software, but the Windows Kernel is just as good as any FOSS kernel today in regards to stability. The Server and embedded SKUs also come with a ton of the extraneous stuff removed that one would ever be worried about. The issue here is that someone decided that a machine that should only ever be connected to an air gapped network needed anti-virus soft…

> the Windows Kernel is just as good as any FOSS kernel today in regards to stability. No it's really not. I've used Windows and Linux a lot and in 10 years of using Linux I've only twice had a kernel panic while using non-experimental software. On Windows I've had countless BSODs.

To be fair (and I'm really not a Windows fan), many of the BSODs on modern versions Windows can be attributed to shoddy third-party drivers.

And as a point of comparison, I've had tons of kernel panics on MacOS over the years, for various reasons. Sometimes defective hardware, sometimes odd software interactions, and sometimes for reasons I can't explain.

Windows has a lot of problems. The kernel itself is not really one of them.

(That said, I still wouldn't use Windows on an embedded device, much less a life-critical one. Even using Linux would give me pause in this scenario.)

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

#87

Post by ams6110 » Sat, May 07, 2016, 10:16 PM UTC

zxcvcxz wrote: post #79

dlp211 wrote: post #71

Earlier quoted context omitted.

Get out of here with that nonsense. You may not be a fan of paid software, but the Windows Kernel is just as good as any FOSS kernel today in regards to stability. The Server and embedded SKUs also come with a ton of the extraneous stuff removed that one would ever be worried about. The issue here is that someone decided that a machine that should only ever be connected to an air gapped network needed anti-virus soft…

> the Windows Kernel is just as good as any FOSS kernel today in regards to stability. No it's really not. I've used Windows and Linux a lot and in 10 years of using Linux I've only twice had a kernel panic while using non-experimental software. On Windows I've had countless BSODs.

I have BSODs on Windows too. It's almost always traceable to the graphics drivers. Nvidia software is shit.

The Windows kernel is solid. If I disable the Nvidia drivers it never crashes.

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

#88

Post by iris-digital » Sat, May 07, 2016, 10:18 PM UTC

dlp211 wrote: post #71

fiatjaf wrote: post #58

> The problem is not Windows. It's a lack of knowledge and understanding. Simple. Yes, if there was a minimum of knowledge Windows wouldn't have been used.

Get out of here with that nonsense. You may not be a fan of paid software, but the Windows Kernel is just as good as any FOSS kernel today in regards to stability. The Server and embedded SKUs also come with a ton of the extraneous stuff removed that one would ever be worried about. The issue here is that someone decided that a machine that should only ever be connected to an air gapped network needed anti-virus soft…

The kernel is not the problem with Windows on medical devices.

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

#89

Post by sathackr » Sat, May 07, 2016, 10:19 PM UTC

Avernar wrote: post #77

"Merge says the antivirus froze access to crucial data acquired during the heart catheterization. Unable to access real-time data, the app crashed spectacularly. The company claims that they included proper instructions in their documentation, advising companies to whitelist Merge Hemo's folders in order to prevent crashes from happening, so it seems that the whole incident was nothing more than an oversight on the m…

Exactly this. As I was reading the article I hoped to find this exact point in the HN comments.

The fault lies in the bad software. It could have been the indexing service, online defrag, automatic updates, or any of the other various background processes windows runs.

If it is critical software, it should be designed in a way to not fail when something non-critical malfunctions, and even the critical pieces should be built with redundancy.

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

#90

Post by symtos » Sat, May 07, 2016, 10:25 PM UTC

Blackthorn wrote: post #72

ezoe wrote: post #26

This situation is even funnier(and sadly very seriously flawed) in Japan. Medical equipment require an authorization to use. Any change to the medical equipment requires another authorization or it's prohibited. By "any change" , it includes Windows Update(it changes the system obviously). The result: they use anti-malware software to protect(or rather, believed to protect) unpatched Windows. At least one anti-malwar…

> Any change to the medical equipment requires another authorization or it's prohibited. Honestly, this isn't a bad decision. If the device was tested and certified with specific software, a software upgrade is not guaranteed to not cause a problem.

using software with known problems in order to avoid potential problems from an upgrade does not seem like a non-bad decision