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Medical Equipment Design

The Medical Equipment Design Blog is the place for conversation and discussion about medical grade materials and products, electrical and electronic equipment, computers, imaging & software, and home healthcare & diagnostics as used in the medical industry. Here, you'll find everything from application ideas, to news and industry trends, to hot topics and cutting edge innovations. This blog is inspired by the Medical Equipment Design newsletter from GlobalSpec, which you can subscribe to here.

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Equipment Error Overdose

Posted October 24, 2009 7:14 AM

Anyone can make a mistake at work, but hopefully not of this magnitude. After a California hospital changed the default settings on a CT scanner, more than 200 patients administered CT brain perfusion scans were exposed to 8x the level of normal radiation. The FDA says this case may be indicative of more widespread issues with CT quality assurance. Or is this simply a case of human error? Can such error be designed out of medical equipment?

The preceding article is a "sneak peek" from Medical Equipment Design, a newsletter from GlobalSpec. To stay up-to-date and informed on industry trends, products, and technologies, subscribe to Medical Equipment Design today.


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#1

Re: Equipment Error Overdose

10/24/2009 10:19 PM

Certainly this specific excess dosage scenario can be designed out of medical equipment. The question always comes down to cost. Not just the financial cost of expanding the safety interlock system but the added down town from false trips and the stealth cost of complacency. By trying to make any dangerous machine idiot proof, more often than not more creative idiots appear.

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#2

Re: Equipment Error Overdose

10/25/2009 12:12 AM

Not exactly the first instance.

http://en.wikipedia.org/wiki/Therac-25

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#3

Re: Equipment Error Overdose

10/25/2009 4:04 AM

Who is John Galt is exactly right. Who do we blame for the way the world is. Redfred is exactly right, the more safe we design things the more creative the idiots get. I dont know if Ayn Rand got it right in Atlas Shrugged, but what would happen if all the smart dedicated people just up and quit. I am more of a Dagny Taggart, I will stay at my post trying to save the world we are in as long as I can.

The only true solution I can see is education, too bad so many Americans who can have it merely neglect it and are satisfied living the life of Trailer Trash. Perhaps we do need some patients over-radiated to clean up the gene pool, just make sure they are offering free CT scans to the right people.



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#14
In reply to #3

Re: Equipment Error Overdose

11/09/2009 1:49 AM

the distinction between an idiot and a genius is

the a genius has boundaries

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#4

Re: Equipment Error Overdose

10/26/2009 9:21 AM

Some excellent discussion here:

http://cr4.globalspec.com/thread/44809

milo

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#5

Re: Equipment Error Overdose

10/28/2009 11:34 AM

Add a knob which requires setting the dosage before each scan. If dosage is not set, the machine won't work.

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#6
In reply to #5

Re: Equipment Error Overdose

10/28/2009 12:13 PM

They'll stick a tab off a pop can or a piece of tape to defeat that. Done it myself on conveyor belt interlocks...

milo

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#7

Re: Equipment Error Overdose

10/28/2009 12:49 PM

The problem is that no matter how idiot proof you make a device, there will be some idiot who will figure out how to defeat it, and if you automate the system too much, then you breed complacency into the operator because they come to rely on the machine making all the decisions for them and they stop checking to make sure it really is doing what they think it should be doing.

Is there a solution? I'm not sure there is. if you bury all the complexity an interlocks into the system then the operator will either be cut out of the loop completely or will not understand when there is a problem. If you leave it to a skilled operator to ensure everything is running correctly, then you are relying on the human to perform flawlessly every time.

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#8
In reply to #7

Re: Equipment Error Overdose

10/28/2009 1:11 PM

Isn't this what the real issue is in the story posted?

I think you've clobbered it!

milo

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#9
In reply to #8

Re: Equipment Error Overdose

10/28/2009 2:10 PM

My idea is that when the scan is done, the machine automatically sets dosage to 0. The knob I mentioned is connected to a many spoked wheel used to pulse an LED/photodetector setup. The machine increases the dosage depending on how many pulses it receives.

Have to talk to the wife about this. She is the medical imaging specialist in the family.

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#10
In reply to #9

Re: Equipment Error Overdose

10/28/2009 2:44 PM

and what happens when the connector to the photodiode/transistor is faulty and it generates a bunch of noise as you turn the knob generating a whole bunch of extra pulses? or a pullup resistor fails open and the shift register counting the pulses outputs the wrong number?

Therein lies the danger my friend. Nothing is or can be fool proof, and the more things you throw into the mix, the more things there are to go wrong. In fact the mathematical relationship is exponential. two failure points quadruple the likelihood of failure, three increase the likelihood by a factor of nine. and that is assuming that the failures don't interact and cascade. Many times failures are cascade failures where several minor failures, each in of themselves not terribly serious, interact and combine in unexpected ways resulting in a massive cascade failure. There have been several famous (or infamous) failures of this sort, I can think of three in the space launch business off the top of my head that resulted in total loss of the crew and/or spacecraft, and one that came mighty close.

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#11
In reply to #10

Re: Equipment Error Overdose

10/28/2009 6:25 PM

Yes! and for each one of us trying to make things foolproof, there are at least two people out there making more fools.

My wife says that there is no way that their CAT scans can generate 20 times the proper level of X-rays... but as we know, Murphy lives.

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#13
In reply to #11

Re: Equipment Error Overdose

11/05/2009 9:51 PM

Excellent example of "progress" your wife might find interesting. I installed a digital x-ray system for my dentist that uses a CCD sensor with a image intensifier/sinctillator array on top of it. the power output from the x-ray head (and therefore the patient dosage) was reduced by a factor of 10.

My doctor's office installed a "digital x-ray system" that used re-usable phosphor plates that were scanned and then reset. the dosage had to be DOUBLED to get a usable image compared to conventional film. Yes it saves storage space and cost, but at the expense of doubling the radiation dosage patients receive. So much for 'first do no harm".

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#12

Re: Equipment Error Overdose

11/05/2009 9:38 PM

You have to watch the medical system. There is a lot of this kind of stuff going on.

take drug research:

In one study conducted by the FDA itself, it was discovered that one in every five doctors investigated--doctors researching the effects of new drugs--had invented the data they reported and pocketed the fees. These are not unusual of isolated cases. John Braithwaite, a criminologist at the Australian Institute of Criminology (and also former Commissioner of Trade Practices in Australia), states: "The problem is that most fraud in clinical trials is unlikely to even be detected. Most cases which do come to public attention only do so because of extraordinary carlessness by the criminal physician."

According to Dr. Judith Jones, former Director of the Division of drug eExperience at the FDA, if a research facility obtains results that do not demonstrate the safety or effectiveness of a drug, it is not uncommon for the drug company to bury the report and continue testing elsewhere until they find a facility that tives them the results they want. Unfavorable reports are rearely published, and clinicians are pressured into keepin quiet about them.

very sad but true

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