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by scruple 3700 days ago
> I find it amazingly short sited that antivirus software is even allowed on a medical device to begin with.

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.

2 comments

Sounds like an awesome job with good engineers but neglectful and irresponsible management.

If you are only making these warnings verbally, you might want to consider emailing your immediate manager with a list of concerns. Make it as neutral as possible and ask for guidance on how they want to address the issues. But if it's on the mail server, it will be good for discovery if the worst happens, and frankly given lives are at stake you probably need to show, in writing, that you were attempting to have the issues addressed.

Who knows? That might actually get traction. Might even save someone's life!

> 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.

You are not an engineer. This is a protected term in the US and other countries. If you were a professional engineer, you would be bound by a legal and moral framework preventing you from doing work on unsafe medical equipment.

There is a good argument that there should be a software equivalent of protected engineer status for this kind of work. This kind of story should be a wake up call. I personally had no idea that critical medical equipment would be running on MS windows...

Engineer alone is not a protected term in the US. "Professional Engineer" is.

As of 2012 you can take the PE Exam for Software Engineering [1].

[1]: http://ncees.org/about-ncees/news/ncees-introduces-pe-exam-f...

Ahh, guess my info is out of date, thanks.