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.
Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
41–50 of 211 posts
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#42Earlier quoted context omitted.
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
Is there a reason to believe that choosing Windows was a bad decision? The bad decision was installing antivirus software. Otherwise, most any modern OS would be fine. This machine probably shouldn't be connected to a network (if it was), the USB ports should be disabled; data can come off on burned CDs, autorun should be disabled, etc. That's how you deal with IA concerns on a standalone mission-critical system, not…
Having their software run in a Windows ecosystem that they do not have strict configuration management control over was a bad decision and on the basis of this failure report. That it did not result in patient injury or death was fortunate but is certainly not guaranteed.
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#43Earlier quoted context omitted.
This. How are these devices not running on some sort of hardened OS seen in airplanes and automotive? Medical applications are mission critical (or some variant) and should have same (or better!) certification procedures set up for correctness and security.
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…
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 planes every week of malware designed for Android phones. The malware spread to the planes only because factory employees were charging their phones with the USB port in the cockpit."
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#44Earlier quoted context omitted.
You're right. My bet is that they use windows because they want to save or get something from the machine (either to a USB drive or network) And I would have followed the same steps you mentioned. The machine could work with Windows. Windows CE might have been a better pick, so you can have things like RO filesystem, etc "There is no reason to use Windows" is, as you mentioned, not a bad decision in itself, but since…
A lot of those machines have Windows embedded in them, because a lot of doctors and nurses are really, really bad with technology and cannot use anything more complicated than Windows's familiar user interface. Training involves "OK, now use the mouse and double-click this icon on the desktop to start the program." I wish I was kidding.
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#45Is it going to take more deaths to convince people to learn from the Therac-25[1]? If you aren't designing for safety first , you have no business working on medical devices or anything else that might be a dangerous when it misbehaves. [1] http://sunnyday.mit.edu/papers/therac.pdf
I am not the parent poster, but may I ask why is this comment being down-voted? I'm not speaking for the parent, but he or she seems to be implying that medical equipment with anti-virus software with automatic updates (used as such) may potentially compromise a patient's safety, and may be indicative of further bad design practices, which could result in, at worst, death. Is this somehow off-topic, or not worthy of…
Just like the Therac-25, this isn't about a single problem (the antivirus or the race condition in the Therac-25's software). Designing for safety has to happen at all levels of design. Using Windows (or Linux, or any other complex OS) in a medical device shows that the designer wasn't even considering the safety of major parts of their design.
Designing medical devices with an OS that can be infected with malware (and thus need an antivirus) is the same kind of idiocy that puts a car's steering and brakes on the same CAN bus as the music player and emergency radio. It's a sign that the designer needs either more education or a different job before someone is injured or killed.
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#46There are kinda four flavors of machine setup I ran into while in that field: big server banks for on-site hosting (think huge enterprise VM farms, for data warehousing and record storage and virtual desktop hosting), care provider systems (think like tablets, doctor office computers, nurse workstations, room workstations), cart computers (used for things like running the sonogram or cardiogram equipment, or for other studies), and actual integrated devices (for, say, data collection).
The care provider systems are usually comically locked-down, tablets and phones having the meanest management software they can (no apps, limited connectivity, remote wiping, and so forth). Workstations tend to be centrally managed, have images pushed regularly (ha!), and often use AD and smartcards to handle authentication. One place I've seen took this a step further, and basically just booted users directly into a VM hosted on the server farms mentioned earlier. You can't use USB devices, you have highly-regulated clipboard access, and so forth--this is done to prevent HIPAA breaches. Which is kinda silly given other workarounds, but whatever makes people feel safe and the CIO happy. These workstations run some enterprise version of Windows, probably 7 Pro. Those silly-long extended service agreements you see on Microsoft? Hospitals are some of the people keeping that alive, and they will pay obnoxious amounts of money for the privilege.
The cart computers are typically like the workstations in terms of functionality, but they may have software specific to the device they're talking to. They might not be as locked down (e.g., only acting as thin clients to a remote VM), but they are still running Windows.
The device computers may run some kind of RTOS. In some cases, they'll be running a customized Windows CE installation--which is totally reasonable. There are a lot of good guarantees that that can give a development shop, least of all that they can call up Microsoft instead of StackOverflow and say "Hey, this function does x, it's documented as y, and we're paying you a lot of money, so what the fuck?". Windows Embedded (which is I think the successor, am not sure).
In all of these cases, Windows itself works pretty damned well.
It runs the software everybody needs, it has the enterprise deployment stuff figured out through decades of improvement, and really there is no reason to be scoffing at its choice.
Now, if folks have goofed up and thrown a stupid AV policy on the machine, that's a different question entirely. Health IT is full to the brim of people basically just punching a clock and being unable to get anything done in a reasonable amount of time. Sometimes, they do awesome things, but mainly they are just custodians standing between doctors and really really stupid policy decisions that seemed good at the time.
EDIT: Removed unrelated example at top.
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#47Earlier quoted context omitted.
Is there a reason to believe that choosing Windows was a bad decision? The bad decision was installing antivirus software. Otherwise, most any modern OS would be fine. This machine probably shouldn't be connected to a network (if it was), the USB ports should be disabled; data can come off on burned CDs, autorun should be disabled, etc. That's how you deal with IA concerns on a standalone mission-critical system, not…
I think you have it backwards (no disrespect intended). When you evaluate the choice of Windows you have to acknowledge that it brings with it the vulnerability of viruses and so the necessity of anti-virus software. Either you own that decision, and as part of your support your tool provides the necessary antivirus and you also insure through testing configuration management that its configured appropriately, or you…
No matter what OS you choose it is vulnerable to viruses. You and I will agree that the odds are your Windows system is much more at risk by at least an order of magnitude. But the IA people who demanded that this system run antivirus are just as likely to demand that Linux run antivirus, simply because the vulnerability theoretically exists and making that demand fulfills their CYA requirements. I've worked on standalone Linux systems that IA demanded have antivirus.
> Either you own that decision, and as part of your support your tool provides the necessary antivirus and you also insure through testing configuration management that its configured appropriately, or you choose a different option up to an including writing your own system to manage the "time critical bits".
According to the article, the software runs on the user's hardware. While they certainly could have made a decision to provide their own controlled hardware, it's entirely possible that hospital was not open to that option for cost reasons, for IT management reasons, whatever.
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#48Earlier quoted context omitted.
But when Windows is chosen because it is easier to find coders who will 'remain within the budget' (cheapcheap) and cannot even make sure the virus scanner doesn't run during procedures or at all it goes a bit too far.
According to the article, it was the hospital IT that misconfigured the antivirus, not the application developers. Is there some reason to believe this wouldn't occur on a Linux system? There are plenty of dumb IA requirements that antivirus be installed on Linux, too.
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#49/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…
correlation doesn't imply causation.... except when someone selected windows, and then made 50 other moronic decisions also. half the work done in this industry is just dealing with stupid decisions made by stupid people. i just accept this now.
I mean this quite seriously: you're hugely underestimating. Possibly unaware.
Re: Medical Equipment Crashes During Heart Procedure Because of Antivirus Scan
#50I've seen this happen time and again, where companies have some 3rd party service vendors who would install AV software on anything they can get their hand on, even a microwave or coffee machine - just to tell the client "my bill is expensive, but you can feel secure, we installed AV". I despise these folks with a passion.
The problem is not Windows. It's a lack of knowledge and understanding. Simple.
For god's sake - it's 2016 - dump the Anti Virus software. I am gonna make t-shirts this summer with this ;)