Whose Job Is It to Understand the Default Settings on the Devices We Make?

In the end, only the lawyers will win.

The affected patients will all die before it comes to trial, or they get any relief.

The ignorant technician who maladjusted the machine in the first place has been promoted to supervisor in charge of the CT brain perfusion scan department.

GE continues to sell lethal machines with inadequate safe guards, and the lawyers all get rich.

_{To quote a highly dignified nuclear reactor operations supervisor:} "DOH! "

"In the end, only the lawyers will win." - So true...

The affected patients cannot buy their health back, so the money won in the lawsuit will not help them remove radiation sickness.

The money the hospital looses in the lawsuit, will only cause them to hire less qualified technicians at a cheaper rate.

The money the lawyers get for the lawsuit will leave the country with them on their way to the Caribbean for their vacation. (not to mention the yacht payment)

^{Well I suppose the lawyers aren't the only ones to win... The yacht builders, charter jets, and south American prostitutes may come out ahead as well.}

It seems pretty gross to me, that a 'default' setting could be eight times the usual dose! Why on earth would the machine have those capabilities, which are dangerous and not necessary for the scans the machine is intended to perform?????

When a medical device is designed, safety assessment is a necessary part of the picture. You design it so that the patient cannot be hurt accidentally. In this case, that means you set constraints on the available power.

Eight times the necessary dose: that's not a medical device, it's a weapon.

How could it possibly run for a year without someone discovering it? In a factory I worked at, EVERY machine was checked for proper adjustments at the beginning of each shift. If ANY adjustment or value was not within prescribed limits the machine was not started until a trained maintenance technician corrected the problem.

I just can't even wrap my mind around this. That is waaaaaaaay beyond negligence.

How many episodes of 'scrubs' were required viewing before qualification for the position.

Is this part of the health care system being overhauled?

Hi all,

In my opinion is a fault of the corresponding "regulatory body" (NRC at USA, CSN at Spain.....)

They are the national responsible for radiation protection. Any device that could be an ionizing radiation source must be operated by a "licensed" operator and supervised by a "licensed" supervisor". Those "licenses" are given upon adequate training, initial qualification and periodical re-qualification.

If that's done any overdose should be punished accordingly.

Why must anybody have a driving license and operate a Co-60 source without it?

Kind regards

Actually I have been trained in radiation safety at CALTECH because I worked with it. The two organs that are very sensitive to radiation are the eyes and thyroid. When you go to the Dentist insist on a lead wrap around your thyroid and when they turn the device on close your eyes each time they take a picture.

There are other ways if you work with sources like Polonium 210 that you can inhale it or digest it. Iron 55 will shine clear across the room unless covered with a metal protection device.

It is not the only case of such criminal proofs of incompetence!

On my opinion the error was made by the designer who did not incorporate a fool proof automatic control and based on the qualification of operators the whole safety procedure.

In the industry there are regular checks for the quality of measurements and reliability of results, not the same in the medical domain. The case I know is a very sad one over 200 persons were submitted to a too high level since the controls were inadequate and nobody cared for a periodic verification.

It is as in the soft business programs are written by programmers for programmers and not for normal operators with a limited knowledge of programming. The personnel in an hospital is even trained not specialized and has not the deeper understanding of a radiation specialist or the skills of a measurement expert so that it is normal to arrive at such situations. equipment became more complex but the operator's level did not keep pace with the sophistication.

I don't believe it.

Now if you'd have told me the hospital had charged the patient ( or next of kin ) for all the extra electricity used,.......

Not being a CT operator or familiar with how one works (although it would seem the two are not necesarily mutual) I wouldn't know - but at 8 times the "intensity" wouldn't the resulting image be somehow wrong-looking?

Still, settings-wise you'd think there would be some sort of flashy red light or beepy noise whenever the machine was being "turned up to 11". My old 80's TV has an on-screen volume indicator that goes from green to red which lets you know that it's time to go visit the hearing-aid shop. Maybe this is a feature only found on household CT machines sold at Wal-Mart?

For that matter...why does the machine go that high? Are there people who have 8 times the density as average? If so, shouldn't we be breeding those people to create a more durable race of humans?

I suspect that going through the mass of a torso of a massive person might require more energy, as opposed to penetrating a sponge filled skull of say, one eighth the cross sectional area.

milo

I have some figures from a study that compares radiation dosage in a CTA procedure (that's of the heart) for people with different body mass,

"Obese patients received significantly more radiation than overweight and normal-weight patients in the non-tube current modulation groups (20.9 mSv vs 15.0 and 14.9 mSv, respectively; p < 0.0001) and in the tube current modulation groups (10.3 mSv vs 7.6 and 7.1 mSv, p < 0.0001)."

An increase from 15 to 20 mSv or from 7 to 10 mSv is a far cry from eight times the dose...

The fact that there is a dosimetry process involved in giving a CT, based on patient-specific factors like body mass, again raises the question, how could this have been let slip to the "8X" default value?

As for, why does it have so much power... body mass variation doesn't account for it.

It is always the operators responsibility no ifs ands or buts

Thanks for the thoughtful and factual answer DR Tom.

My original post was not a screed at the technology. Not a luddite.

The point was that the "people" (your "fallibility of man" point) were the weak link, and regardless of the medical physicists, checking the equipment who checked the dimbulbs who were charged with its safe and proper operation?

We are in agreement that the legal side is a waste, but again are shocked that

quis custodiet ipsos custodoes? Who is the guardian of the guards or in this case, Who is makeing sure the operators know how to operate their equipment?

Gave you a GA.

milo

Love the Quote from the Satires of Juvenal. Unless there exsisted some conspiracy by much more knowledgeable individuals, the average technical operators would not be able to detect a higher then calibated dose of radiation given by a CT machine. On plain X-rays, where film is utilized a higher dose would "white-out" the film. That leaves the manufacturers (like Toshiba, GE and et al) to produce medical devices that would give feedback that higher than normal doseses of radiation were being delivered. The FDA seems to believe that the problem with Mt Sinai's equipment is just the tip of the ice-berg. When you read the warning by the FDA, it appears that the problem is inherent to the CT medical device industry. In that case, with the advent of computerized axial tomography in the 1970's, we probably have had this problem some 30+ years. It makes your quote even more apropo. I would be leary of having CT imaging until a system wide check is completed. It's also quite interesting that the AAMP(American Association of Medical Physicists) issued a document in the fall of 2008 warning their members that there might be an inherent calibration problem with CT imaging devices. There is probably more to the story then has been made public....The truth is out there somwhere