The maker of a life-saving radiation therapy device has patched a software bug that could cause the system’s emergency stop button to fail to stop, following an incident at a Cleveland hospital in which medical staff had to physically pull a patient from the maw of the machine.
The bug affected the Gamma Knife, a device resembling a CT scan machine that focuses radiation on a patient’s brain tumor while leaving surrounding tissue untouched. A patient lies down on a motorized couch that glides into a chamber, where 201 emitters focus radiation on the treatment area from different angles. The patient wears a specialized helmet screwed onto his skull to ensure that his head doesn’t move and expose the wrong part of the brain to the machine’s pinpoint tumor-zapping beams.
[…]
When the hospital called the company that makes the Gamma Knife, it learned that there was a “known software bug problem” affecting the unit’s couch sensors. Known, anyway, to the company, Stockholm-based Elekta AB.“Elekta was aware of the software ‘bug’ at the time of the December 2008 event and had implemented actions to correct the ‘bug’ in a future software release,” says Thomas Valentine, director of quality assurance and regulatory affairs for the Elekta’s U.S. arm, in an e-mail.
Since then, he adds, “The ‘bug’ has been corrected in software upgrades that have been implemented to all of the affected sites in the U.S. The U.S. NRC was notified of the completed status of software upgrades to correct the identified ‘bug’.”
We don’t know why “bug” is in quotes; surely this wasn’t a feature.
And then there was this:
The chief executive of Cedars-Sinai Medical Center said Thursday that he regretted the “circumstances” that subjected 206 patients to radiation overdoses and laid out reforms made since the hospital discovered that a CT scanner had been set erroneously for 18 months.
I write software and I will tell you this: There are no ‘bugs’ in software. There are only errors. Made by people. Some errors are stupid mistakes that should be caught. Others are logic errors that are a nightmare to find and fix.
And then there are the ‘business rules’ – procedures the client wants implemented in software, but riddled with contradictions and with no predictable outcome.
Nothing is perfect. Or even close. It’s a dangerous world. Be careful.
206 beta testers, not patients.
Misprint.
A doctor friend of mine calls programmers “Cheetos eating Geeks”. Mostly because of the frustration he feels with working with MS products. He doesn’t understand how unlike hardware, it’s acceptable for software to be normally “buggy”.
It’s unfortunate software developers lack hardware designers level of systematic discipline, instead; software developers routinely create “monstrosities” they can’t fully comprehend or maintain. This is why EULA agreements actually enable and foster buggy software development.
I am glad the FDA doesn’t allow medical device manufacturers a bullshit pass with EULA agreements; where, software develops are given a pass on liability. FDA strictly regulates medical devices software. Every change is documented and must be approved before implementing.
FDA regulation was born out of a massive X-ray overdose of cancer patients in the Therac-25 incident of the 1980s was caused by a software error and led to the Safe Medical Device Act of 1990 and the subsequent publication of the FDA’s QSRs in 1996, which gave software special attention. In all these cases, it was catastrophe that stimulated changes in legislation and regulation.
Theres a famous story about a hospital with higher than average death rates in the ICU. Finally, the notion was something was wrong with the pressure breathing equipment but check after check revealed nothing. Finally, a camera was set up to record the patient and the entire room. Turned out the Salvadorian Cleaning Lady would come in to mop, clean, and vacuum the area. She would unplug the breathing machine to use her vacuum.
The “glitch” was the plugs on all the machines were standard plug models. Changes were made.
What level of income is required for you to be exempt from the consequences of knowingly putting people at risk?
If they knew it was faulty but did not immediately notify client hospitals they should be arrested and charged (and sued).
That they use gamma radiation instead of safe, electromagnetic energy native to all life, goes to show how f’n clueless “modern medicine” in our
neck of the woods really is.
Thinking in terms of the physical “knife” to address a non-physical
(causal) energy imbalance, further illustrates the complete lack of understanding mainstream medicine
has of how the body works and what
causes it to malfunction.
Our “modern” Health Care system has nothing to do with “health” or “care”
should be called sick care, imo.
-the mirror image rule applies.
-s
# 6 soundwash
“That they use gamma radiation instead of safe, electromagnetic energy native to all life, goes to show how f’n clueless “modern medicine””
Hey numbnuts Gamma Radiation rays are electromagnetic radiation. It seems you are the clueless one!!!
New meaning to the blue screen of death!
# chuck Indeed. Two cases of bad procedure.
The La Times story was clear; No procedure in place and bad safety practices by staff. “CT technologists, (..), will receive extra on-the-job training.”
The word “bug” is used in place of “design fault” which is music to class action lawyers ears. Emergency stop is number one on the pass/fail acceptance testing I have done in the past. How did the machine get an install base with that fault is the real news?
Wired: “staffers hit the “emergency stop” button, expecting the couch to pull the patient out of the Gamma Knife, and the radiation shields at the mouth of the machine to automatically close. Instead, according to a report eventually filed with the Nuclear Regulatory Agency, nothing happened.”
#6 soundwash
Don’t confuse marketing with reality. Gamma Knife (a branding) is no different than Ceramic Knife (a branding also).Humm, How does one do brain surgery in your neck of the woods?
#9, That’s my question as well. E-Stops are supposed to be hardwired so when pushed, everything fails to a safe position and mode. That means power is cut, at the source, to all moving parts and control circuitry.
Hardwired. Not programmed.
And how did this thing pass a FAT or SAT? These are usually the FIRST things tested so when testing everything else, if something goes wrong, you can E-Stop without tearing up the machine.
I’ve been doing control systems for 30 years. I’ve never seen an E-Stop implemented in software. Not once.
I wonder what Jerry Pournelle (the author of Chaos Manor) will say about this? He underwent this kind of procedure about 18 months ago, with positive results so far. I suspect he’ll feel differently about this bug, since it was his head that that got irradiated.
Eventually, all of this ‘medicine’ will kill you.