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Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

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Re: Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

#11

Post by lostlogin »

dpe82 wrote: post #10
lostlogin wrote: post #5

>>As a result of the Therac-25 accidents, the FDA now requires documentation on software for new medical and other products: a paper trail, in other words, that can be examined by an independent body and retraced for flaws. Anyone have any idea if this can be looked at by the end user? I'm not a radiation technologist of the flavour mentioned in the article, I'm on the diagnostic side. I use an MR scanner with numero…

GE scanner, by chance? I've heard their software is pretty terrible compared to their competitors.

I actually laughed. Yes. Latest release, flagship scanner 3T 750W. We have a few of the extra bells and whistles but not all. I'm not entirely sure which we have, as trying to run something you haven't paid for used to crash the scanner, so I'm hesitant to try some things. This bug I reported.

Re: Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

#13

Post by tokenadult »

lostlogin wrote: post #5

>>As a result of the Therac-25 accidents, the FDA now requires documentation on software for new medical and other products: a paper trail, in other words, that can be examined by an independent body and retraced for flaws. Anyone have any idea if this can be looked at by the end user? I'm not a radiation technologist of the flavour mentioned in the article, I'm on the diagnostic side. I use an MR scanner with numero…

My son the hacker used to work in the medical device industry as a summer employee while he was a student. The code he wrote for a medical device user interface was to be submitted for a line-by-line code review by the FDA. He estimated that the product would actually come to market more than three years after the summer he worked on it. And maybe that is what you are encountering--the person at the company who built in the bugs you have discovered has moved on, and doesn't work at the company anymore, and the other employees there are trying to figure out how to debug that old code and fix the problem. (Similarly, my son groused about the code in the device he was working on, which was acquired by his company from another company that had originally developed the device.) Always comment your code. You never know how long after you wrote it someone else will have to fix it, especially if the code is embedded in a medical device.

Re: Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

#14

Post by lostlogin »

tokenadult wrote: post #13
lostlogin wrote: post #5

>>As a result of the Therac-25 accidents, the FDA now requires documentation on software for new medical and other products: a paper trail, in other words, that can be examined by an independent body and retraced for flaws. Anyone have any idea if this can be looked at by the end user? I'm not a radiation technologist of the flavour mentioned in the article, I'm on the diagnostic side. I use an MR scanner with numero…

My son the hacker used to work in the medical device industry as a summer employee while he was a student. The code he wrote for a medical device user interface was to be submitted for a line-by-line code review by the FDA. He estimated that the product would actually come to market more than three years after the summer he worked on it. And maybe that is what you are encountering--the person at the company who built…

Thanks - this has been in the back of my mind and is a reason I'm trying to be patient. A 2 line message saying what was happening would remove my frustration. Usually I get a corporate speak reply with a suggestion it is my fault though. What does the FDA code review do? If it isn't catching bugs that take the scanner offline for hours at a time, what is the point?

Re: Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

#15

Post by snowwindwaves »

davidrusu wrote: post #12

I had a professor read this case study in a lecture. It amazes me that merely one programmer was trusted with building the software for a radiation beam canon.

I think a manager for a product would give as much work and responsibility to one person as possible if they say they can do it, and sometimes even when they say they don't know if they can do it but they'll try. An experienced manager might know how realistic the workload is and downsides of having only one person on task x but every manager sees the upside, fewer people = less cost.

Re: Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

#16

Post by wglb »

davidrusu wrote: post #12

I had a professor read this case study in a lecture. It amazes me that merely one programmer was trusted with building the software for a radiation beam canon.

It makes me uncomfortable as well.

But keep in mind that at that time, it may have well been the only programmer on the project, and that the manager was not likely qualified to read code.

Re: Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

#18

Post by mariodiana »

There was an article that appeared in the NY Times, a few years ago, that discusses the malfunctions of radiology equipment. There was one story, in particular, that stood out for me. It describes a, reportedly not unusual, malfunction/crash of a linear accelerator used for Intensity Modulated Radiation Therapy (IMRT):

"An error message asked [the medical physicist operating the device] if she wanted to save her changes before the program aborted. She answered yes."

How many programmers read that and cringe? I know I did. My guess is that the operating system being used for the device is some standard OS (Windows CE, maybe?) that is being repurposed to run the application and provide the GUI for the device. It's not that this is necessarily bad, but I would think the most important thing to do would be to strip the OS (or UI) of the various "user conveniences" that in a life or death situation could have all kinds of unintended consequences.

If a person is coding or doing graphic design -- or typing up cooking recipes -- and a crash happens, it's a good thing to have the opportunity to save your work. If 1 teaspoon of butter gets changed to 1 tablespoon because of some kind of data corruption, big deal. So your cookies come out terrible!

It's quite a different matter if the application is coordinating 120 moving parts to direct a radiation beam onto a human body.

The article is here:

http://www.nytimes.com/2010/01/24/health/24radiation.html?pa...

Re: Fatal Dose – Radiation Deaths linked to AECL Computer Errors (1994)

#19

Post by gwillen »

lostlogin wrote: post #11
dpe82 wrote: post #10

Earlier quoted context omitted.

GE scanner, by chance? I've heard their software is pretty terrible compared to their competitors.

I actually laughed. Yes. Latest release, flagship scanner 3T 750W. We have a few of the extra bells and whistles but not all. I'm not entirely sure which we have, as trying to run something you haven't paid for used to crash the scanner, so I'm hesitant to try some things. This bug I reported.

Perhaps it's time to forward your materials to the FDA? (Or whatever the appropriate regulator is for your device.)
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