| I'm just curious. I work in the automotive sector and develop hardware and software using components that are advertised as functionally safe. I use harden RTOS from vendors who claim their RTOSes are in medical devices as well as military systems. One such system is Disti (http://www.disti.com/) In the automotive field, our software is MISRA compliant, static analysis is done (Klockworks - http://www.klocwork.com/) and we follow a very strict set of guidelines outlined in ISO25119 and ISO26262 for the construction and agricultural markets. Think self driving tractors and combines. For example: A tractor traveling down a field with a combine following it a few rows over separating and chopping things into a catcher all done with one person driving. This shit can't happen where I work. Every component on our circuit boards has a MTTFd of 40 years. Hardware watchdogs can kill the system if software goes awry. Software is written to readiness level called SRL-1, SRL-2, etc... Unit tests, peer reviews, etc... Functional safety in medical devices is covered under 510(K)
(http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedur...) I find it amazingly short sited that antivirus software is even allowed on a medical device to begin with. I can't even imagine how this system even passed the easiest audit for software readiness. How is it you "go hoarse having the same conversations?" Do you not have to meet FDA compliance criteria? Are you in the US? I didn't read the whole article so I'm assuming this happened in the US. For me, we sell autonomous vehicles in the European markets where functional safety seems to be a bit more aggressive there right now for vehicles. Not sure about medical devices. |
Well... Then you should consider yourself blessed to have never had to deal with the bureaucracy of a hospital IT department and administrative staff.
Who owns the medical device? Who paid for it? If it's a glorified Windows machine and it's attaching itself to a hospitals WiFi network... Who has to use this machine? Physicians, surgeons, anesthesiologists, radiologists, other specialists, nurses, staff? All of them need to be trained on it's usage, no doubt. They don't get that training in schooling. Who provides it? This and a million other things stack up. So, well, I mean it can start to make sense how these things end up with random AV software installed on them, right?
> How is it you "go hoarse having the same conversations?" Do you not have to meet FDA compliance criteria? Are you in the US?
Yes, we are. Yes, we do "have to meet FDA compliance." I can't define "have to meet" and I work here. Of course, I'm just an engineer. We have legal, executive, and other staff for those matters. I'm sorry, I'm not trying to be an asshole... I'm just trying to be honest about where I find myself in this situation.