An important piece in the NYTimes today, After Stroke Scans, Patients Face Serious Health Risks, reads to me like more residue from the deregulatory era. And a triumph of technology salesman over technology training:
The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months, the agency has yet to provide a final report on what it found.
But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage.
The review also offers insight into the way many of the overdoses occurred. While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them.
The main corporate culprit is GE Healthcare (their very name is unsettling to me). Here’s an example of the finger-pointing:
At Glendale Adventist Medical Center, where Mr. Reyes and nine others were overdosed, employees told state investigators that they consulted with GE last year when instituting a new procedure to get quicker images of blood flow, state records show. But employees still made mistakes.
As a result, hospital officials said, a feature that technicians thought would lower radiation levels actually raised them. Cedars-Sinai gave a similar explanation.
“There was a lot of trust in the manufacturers and trust in the technology that this type of equipment in this day and age would not allow you to get more radiation than was absolutely necessary,” said Robert Marchuck, the Glendale hospital’s vice president of ancillary services.
GE says it’s a feature not a bug:
Normally, the more radiation a CT scan uses, the better the image. But amid concerns that patients are getting more radiation than necessary, the medical community has embraced the idea of using only enough to obtain an image sufficient for diagnosis.
To do that, GE offers a feature on its CT scanner that can automatically adjust the dose according to a patient’s size and body part. It is, a GE manual says, “a technical innovation that significantly reduces radiation dose.”
At Cedars-Sinai and Glendale Adventist, technicians used the automatic feature — rather than a fixed, predetermined radiation level — for their brain perfusion scans.
But a surprise awaited them: when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose — it raised it.
As a result, patients at Cedars-Sinai received up to eight times as much radiation as necessary, while the 10 overradiated at Glendale received four times as much, state records show.
GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had “limited utility” for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain.
GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens.
But representatives of both hospitals said GE trainers never fully explained the automatic feature.
The place where the biggest overdoses occurred was Huntsville, AL. And, in case you wondered, Alabama’s no nanny state:
The Food and Drug Administration, in trying to assess the scope and cause of the overdoses, has had to rely on state radiation control officials for information. But if Alabama is any indication, the agency is not getting a full picture.
A Huntsville Hospital spokesman, Burr Ingram, said that about 65 possible stroke patients there had been overradiated. Lawyers representing patients say the number of overdoses is closer to 100.
Nonetheless, Alabama officials say the number is actually zero since the state does not define an acceptable dosing level. “No such thing as an overdose,” said James L. McNees, director of the Alabama Office of Radiation Control.
Where would you rather be, Alabama or California?
By contrast, California officials conducted investigations, released inspection reports and have cited at least four hospitals for failing to safely irradiate patients.
While hospitals are no angels, their story sounds reasonable to me. As more stories like this emerge one can imagine citizens voting in limits on the Healthcare Industrial Complex. Even in Alabama.