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Alabama schoolteacher Becky Coudert had one of the scans and then experienced symptoms of radiation sickness -- hair loss, memory loss. She's now suing GE Healthcare.  (Source: LA Times)

Over 150,000 CT perfusion scans are performed yearly, typically to diagnose strokes. The radiation poisoning reportedly occured due to lack of safeguards on Toshiba and GE Electric scanners. Hospital techs raised the amount of radiation delivered to provide better resolution.  (Source: University of Rochester)

Incidents of radiation poisoning were first reported at Cedars-Sinai hospital in California.  (Source: Academic.ru)
CT perfusion imaging devices are giving patients severe radiation poisoning

When you go in for a medical imaging procedure, you're typically made to understand that there's some risk involved.  Even mild procedures like chest X-Rays expose you to small doses of radiation that minutely increase your cancer risk.  More advanced procedures can come with larger risks.

One such procedure is the CT perfusion scan, which involves injecting an iodine tracer into the bloodstream and taking X-Rays for up to a minute of blood flow in the brain.  The procedure is commonly used to diagnose strokes.  Typically the biggest risk from the scan is an about 1 in 600 chance (according to the LA Times) of developing a brain tumor due to the radiation, which is equivalent of around 250 chest X-Rays.  That's still a lot considering that approximately 150,000 people have the scan yearly (meaning that by the LA Times' figures, approximately 250 people will get brain cancer yearly from the procedure).

However, across the country there are reports popping up of the procedure going horribly wrong and exposing patients to much higher doses of radiation. The result has been that many patients have been reporting symptoms of radiation poisoning.

Reports first popped up at the Cedars-Sinai Medical Center in Los Angeles.  The hospital informed some of its patients that they might have been exposed, but reportedly has been dragging its feet, not informing all its patients.  Now the FDA has stepped in and is investigating the mess.  The sad part is that some patients only found out about the potentially life-threatening mistake through news outlets.

One patient, Larry Biggles, says that the doctors willfully deceived him by never revealing the mistake.  He recalls flaking skin, losing clumps of hair, headaches, and blurred vision.  He recounts, "The word 'radiation' never came out of his mouth. He never said that we messed up and gave you an overdose of radiation."

Linda Morrow, a stroke victim, recalls similar irresponsibility.  She states, "He said, 'Did you have any side effects, such as reddening of the skin or hair loss.' I said no. He said, 'Well, thank you very much,' and he hung up. "I thought: 'What the hell was that?'"

Since then, the FDA has discovered other cases of possible overdoses at Glendale Adventist Medical Center in Glendale, Calif. and Providence St. Joseph Medical Center in Burbank, Calif. and at Huntsville Hospital in Huntsville, Alabama.  While the Cedars-Sinai Medical Center uses a General Electric perfusion scanner, St. Joseph uses a Toshiba model, adding an extra wrinkle to the puzzle.

According to early reports, it appears that both the Toshiba and GE scanners are configured to safe levels by technicians for the respective firms.  Hospital technicians then proceeded to modify the protocols to satisfy doctors' requests for better resolution (more radiation yielded a better image).  After patients began losing hair, the hospitals discovered their mistake, though none of them have officially admitted to making a "mistake". 

In fact Dr. Barry D. Pressman, chairman of the imaging department at Cedars-Sinai, says that the delivered radiation was no greater than that during an angioplasty.  Not only did the hospital do nothing wrong in his opinion, but they are looking to "address any side-effects that may occur, without unnecessarily alarming them."  He comments, "I sincerely regret if any patient feels that they did not receive the information they needed."

Likewise, GE and Toshiba are unwilling to take the blame for not setting stricter limits on reconfiguring the scanner settings.  Claims Arvind Gopalratnam, a spokesman for GE, "There were no malfunctions or defects in any of the GE Healthcare equipment involved."

Both the hospitals and the companies may face punishment from the FDA for their mistakes and tighter regulation -- whether or not they admit to them.  A number of patients who suffered from unexpected radiation poisoning are also looking to sue the hospitals or scanner makers.  In Alabama, Becky Coudert, a teacher in Madison County Schools, suffered from memory loss and hair loss after receiving a scan.  She's now filed a class action suit against GE Healthcare in Alabama court.  In total, the attorneys involved with the case report 15 other individuals may be added to the class. They are cooperating with attorneys in California who have over 200 patients looking to sue.  Toshiba, which manufactured the St. Joseph Medical Center scanner, may also be targeted by this new suit.

This story is only beginning to come to light as the FDA says it expects there may be similar incidents found at other hospitals that practice perfusion scans.

As the litigation piles up, hospitals are facing the unpleasant decision of whether to absolve themselves of guilt or admit to wrongdoing and try to help the patients.  Whatever their decision, hopefully the debacle will lead to tighter restrictions and more sensible administration across the country.



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Who is really liable?
By G2cool on 12/17/2009 4:34:11 PM , Rating: 1
I'm a little confused here. Am I correct in believing that the 'scanners' are radiation detectors that generate an image based on energy emitted from the isotope being injected into the blood stream? If so, then they administer more activity to increase energy output and remove the need to over amplify the signal which includes noise so the image is clearer? And the manufacturer of the scanner is liable how? It sounds very deliberate on the doctor's/radiologist's part.




RE: Who is really liable?
By siliconvideo on 12/17/2009 5:08:09 PM , Rating: 2
There is no injection of radioactive isotopes. The scanners generate x-rays that pass through the body to sensors or film. The injectables absorb some of the x-rays as they flow through the body. The absorptions are further processed by computers to increase image contrast and highlight those points that have more of the injection present.

Normal procedures are to take an x-ray and then an inject the contrast solution to highlight points of interest.


RE: Who is really liable?
By 3DoubleD on 12/17/2009 5:32:57 PM , Rating: 1
quote:
One such procedure is the CT perfusion scan, which involves injecting radioactive iodine into the blood stream and taking X-Rays for up to a minute of blood flow in the brain.

It is true that iodine is used as an x-ray contrast medium. However, there would be no reason to use a radioisotope of iodine for this purpose when normal iodine would be just as effective. Still, I suspect that you are correct and that it was an external x-ray source used with regular iodine (for contrast) and that the article (or it's source information) is just mistaken. In fact, introducing radioactive iodine into the human body is a very bad idea as it accumulates in the thyroid and quickly leads to thyroid cancer.

I should also add that ingested radioactive isotopes should be positron emitting. When a positron annihilates with an electron two gamma-rays are produced and emit at a ~180 degree angle (not exactly due to electron-positron momentum conservation, but normally really close to 180 degrees) When the 360 degree detector records two gamma-rays on opposite ends of the detector ring that data point is recorded whereas other counts are ignored as background noise. Iodine is not positron emitting, further proving it is a mistake in the article.


RE: Who is really liable?
By slawless on 12/17/2009 9:07:15 PM , Rating: 5
This is one field to which I am an expert. The Iodoine is NOT radioactive.

The CAT scanner basically consists of a large ring with an xray tube on one side and a row of detectors on the other these are rotated as you are passed thru the scanner. This creates a volume of data from which images can be reconstructed.

The Iodine is a large atom and relatively non toxic. Large atoms have electron configurations that are better for absorbing Xrays.

Xrays are usually displayed as a photographic negative. So where the Iodoine accumulates "lights up". Seeing where it goes or doesn't can be very helpful in diagnosing people


RE: Who is really liable?
By MrBlastman on 12/18/2009 12:30:57 PM , Rating: 2
What I wonder is if the scans this article references are limited to just the cerebral scans or also include thoracic scans used to image structures such as the heart and the aorta. I underwent three thoracic CT's this year--and it is a good thing that I did. If I had not, they would not have found a gigantic aneurysm in my chest that could have ruptured and well, as Bill Paxton says in Aliens, "Game over man!"

Thankfully, they found it and were able to fix it through open heart surgery. So, sometimes tests like these can be lifesaving. There are definite risks involved, however, the risk of them not finding at least my condition, would have been a one hundred percent chance of the aneuryms rupturing. So, in my case, even after hearing these statistics, the risks of the scan were far less than the alternative.

What I fear though is that there are many people who are subjected to such scans that do not need them, say for things such as back trauma, bone trauma or abdominal pain. I think in those situations an MRI should be considered as only your hydrogen atoms are being spun up and down and measured rather than subjecting you with full blown x-rays and iodine into your bloodstream.

The only problem with MRI's? They cost a great deal. To get a single MRI scan here in the U.S. I think on average they cost between 2700.00 and 4000.00. To me, that sounds absurd for what should be a more routinely used procedure given that it is far safer than performing a CT scan. I'm not a radiologist though, so I know not exactly what they can detect better in one or the other. I will say though that if more people got MRI's, the cost would conceivably decline faster than it has been.


RE: Who is really liable?
By Oregonian2 on 12/19/2009 10:06:07 PM , Rating: 2
quote:
I should also add that ingested radioactive isotopes should be positron emitting. When a positron annihilates with an electron two gamma-rays are produced and emit at a ~180 degree angle (not exactly due to electron-positron momentum conservation, but normally really close to 180 degrees) When the 360 degree detector records two gamma-rays on opposite ends of the detector ring that data point is recorded whereas other counts are ignored as background noise. Iodine is not positron emitting, further proving it is a mistake in the article.


Unfortunately I had one of those kind of scans a few months ago. It's called a PET scan. The PET scan itself is passive (although the machine resembles a CT scanner somewhat) and in the case of mine, it's connected to a CT scanner "ahead" of it (patient goes through the CT scanner and into the PET scanner) in order to produce a "physical" image to match up the PET scan image with (PET produces a map of tissue activity, with fast growing/sugar-processing stuff being presumably cancer). The "PE" part of PET scan is Positron Emission.


RE: Who is really liable?
By 3DoubleD on 12/17/2009 5:15:41 PM , Rating: 2
While CT scans are traditionally done using a rotating x-ray source and detector, this is not always the case. By ingesting a gamma-ray emitting radioisotope, 360 degree detectors can be used to construct images of systems that are not normally opaque to x-rays. For example, consuming a radioisotope that stays in your blood stream will allow a 3D image of your circulatory system to be captured. These radioisotopes generally have a really small half life of a few days. This is why there are always shortages of supplies when 1 of 5 medical isotope reactors expectantly stops producing.

So to answer your question. I do not understand why the manufacturer of the scanner would be liable if the patients were scanned using radioisotopes. Clearly it would have been the doctor/radiologist's fault. However, that image in the article implies a directional dose from an x-ray source. In that case I would expect that the fault could be shared between both parties. That's not to say that anything could have been done by GE or Toshiba as calculating doses and exposures is extremely complicated beyond (beam intensity)x(exposure time). Medical Physics is an extremely difficult field that requires extensive post graduate education. There are very few people in this field and I wouldn't be surprised if the operator was just under qualified (eg. not a medical physicist). Only qualified people should be operating these machines and that is the Hospital's responsibility, not GE or Toshiba's.


RE: Who is really liable?
By Ard on 12/17/2009 6:41:52 PM , Rating: 2
I think that's a simple question to answer. The hospital staff and physicians are liable, provided that the equipment was functioning normally and operating within the expected safety limits. If GE's equipment conformed to all the necessary safety standards, then liability falls to the staff who modified the equipment and violated those standards.


RE: Who is really liable?
By rcsinfo on 12/17/2009 9:45:22 PM , Rating: 2
From the linked LA Times article:
quote:
The faulty scans began in February 2008 -- after the computerized protocols were modified


So it would seem to be the operator, but there has to be more to the story here. For a machine to get FDA approval it has to have hardware interlocks to prevent radiation overdose. Not only should the machine not allow the dosage, but it should shut down if it gets a dosage signal that is out of range.

This lesson was learned the hard way in the case of the famous Therac-25 radiation machine. The story is almost a universal case study for software control engineering students across all industries, not just medical.

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


RE: Who is really liable?
By Megamixman on 12/18/2009 9:49:03 AM , Rating: 2
CT Machines are used for more then just the Brain. The hardware interlocks prevent dosage from going over the maximum for the whole body.
The Brain on the other hand is a far more sensitive area then other parts of the body and there fore, the same intensity X-Ray beam will induce more dose in the Brain. A normal dose to your abdomen can be an overdose to your brain.
No Software lock can replace basic user intuition. The lady may be suing GE Healthcare, but I doubt they will be held liable for user error, especially after their machine was modified. Let's also not forget these modifications had to be FDA approved, so they share some blame if the modifications were not done right and the FDA approved them anyways.


RE: Who is really liable?
By Lerianis on 12/22/2009 4:01:55 AM , Rating: 2
Who says that they have to be FDA-approved? With all due respect, the machines themselves have to be approved.... the dosages are pretty much (outside of the absolute maximum dose) left up to the person in question who is doing the tests or buying the machine.


RE: Who is really liable?
By aqwan135 on 12/20/09, Rating: 0
By plimogs on 12/17/2009 4:10:37 PM , Rating: 2
quote:
scanners are configured to safe levels by technicians for the respective firms. Hospital technicians then proceeded to modify the protocols to satisfy doctors' requests for better resolution (more radiation yielded a better image).


Operating medical equipment outside factory configured parameters to yield better performance at higher resolutions? Sounds like some balsy OC'ing to me!




By poundsmack on 12/17/2009 5:13:17 PM , Rating: 5
"sure you may have suffered a little radiation poisoning, but due to our overclocking efforts we got a much better picture. The graphical result was much more precise; Crysis has never looked better"


By Oregonian2 on 12/19/2009 10:09:06 PM , Rating: 2
Same folk probably overclock their CPU's at home. Similar concepts.


Minute radiation dose!!?
By AnnihilatorX on 12/18/2009 9:07:31 AM , Rating: 2
quote:
chest X-Rays expose you to small doses of radiation


Even chest X-Ray radiation is no way minute. 0.06 mSv in few seconds or so. That is nearly 1/4th the annual average natural radiation dose of 2.4 mSv/ year .




RE: Minute radiation dose!!?
By AnnihilatorX on 12/18/2009 9:08:29 AM , Rating: 2
oops sorry I missed a zero.
Damn I wish there is an edit button


RE: Minute radiation dose!!?
By AnnihilatorX on 12/18/2009 9:15:30 AM , Rating: 1
Nevertheless 1/40th is still significant.

Time has compressed by a factor of 1,050,000 from 1 year to 30 seconds, yet the does strength is only compressed by 1/40, compared to natural dose, if you see what I mean.


RE: Minute radiation dose!!?
By Lerianis on 12/22/2009 4:03:35 AM , Rating: 2
Ah, but the natural dose of radiation various depending on where you live. It can be anywhere from that very low number to a quite high number depending on where you live.


CT testing device
By jthistle on 12/17/2009 4:31:48 PM , Rating: 2
They should have been using something like this http://ldrsolutions.landauerinc.com/PRODUCTCATALOG...




RE: CT testing device
By G2cool on 12/17/2009 4:40:04 PM , Rating: 2
The product you listed would provide a record of the procedures radiation output, but it wouldn't stop people from bypassing procedures.


No radioisotope
By Slug on 12/17/2009 6:30:25 PM , Rating: 2
The scans are performed on standard modern CT scanners using standard IV iodinated contrast. No radioisotopes are used. Period.




RE: No radioisotope
By zlandar on 12/18/2009 10:40:13 AM , Rating: 2
A MRI using diffusion-weighted imaging is the gold standard to detect acute strokes. There is zero radiation involved. The hard part is having a MRI tech available at all hours to run the machine. CTs get used so frequently that nearly all hospitals need a tech staffing it at all hours.


Damned if you do...
By AssBall on 12/17/2009 4:20:44 PM , Rating: 2
Can't say I'd rather have a stroke than a brain tumor. Kind of a toss up if you ask me. Here's hoping they can fix the problem soon.




I had a brain scan...
By ol1bit on 12/21/2009 2:16:27 AM , Rating: 2
And they used an MRI. Much better, but not sure why an MRi is used sometimes, and a CT scan other...




MRI's are the way to go...
By sintaxera on 12/17/2009 10:08:46 PM , Rating: 1
If you ever get a choice as to what type of scan you get, get a MRI instead. It can do almost everything a CT scan can do, except for the lungs. Even that will be a thing of the past with the use of Xeon gas in the near future. MRI uses EMF radiation and might heat you up a bit on the inside. Especially if you are really big. But it is still so much safer than a CT, which uses ionizing radiation. So it really comes down to being heated up a bit with an MRI, or getting 100+ chest X-Rays. Of course if you're over 80, you probably won't live long enough to get cancer from it!
For the claustrophobic out there, get some relaxing meds, suck it up, and get the MRI. If you have a cochlear implant, pacemaker, nerve stimulator, etc.....well you're just out of luck, enjoy you're CT!




It's not ah toomah...
By Motoman on 12/18/2009 10:13:56 AM , Rating: 1
...oh wait, yes it is. Oops.




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