An investigation by the New York Times has found radiation overdoses from CT brain perfusion scans were more prevalent and posed more serious consequences than previously thought.
According to the FDA, "patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation."
The overdoses, which first became apparent late last summer, now total over 400 at eight hospitals, six in California. Huntsville Hospital in Alabama was home to the worst case of radiation overdose at 13 times the standard level.
Patients who received the radiation overdoses reported hair loss, headaches, memory loss and confusion. Overdosed patients are also at higher risk of cancer and brain damage.
The Times investigation has created a blame game as to why patients received unnecessary amounts of radiation. Some deemed CT scan manufacturers at fault, while others held hospital technicians liable.
Most of the cases involved GE Healthcare scanners, which offered a feature that automatically adjusts the radiation level according to a patient's size and body part. According to a GE manual, as noted by the Times, the automatic feature is "a technical innovation that significantly reduces radiation dose."
Yet, at Cedars-Sinai and Glendale Adventist hospitals, "when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose--it raised it," reported the Times.
GE maintains that hospitals should have understood how to safely use the automatic feature, and that technicians didn't know how to properly administer the stroke scan.
In response, hospitals claimed GE never explained how the automatic feature works and the manufacturer failed to train hospital technicians who used its scanners.
The FDA held a 10-month inspection of CT scan overdoses and was unable to determine what went wrong, or who was to blame. After the Times report revealed the magnitude of radiation overdoses in Huntsville, Ala. the FDA is thinking of expanding its inspection there.
For more:
- read the Times report
- read this FDA press release