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Concerned about recent overdoses of radiation in CT perfusion scans, an FDA official urged imaging practitioners to go "back to basics" when they're performing the scans.
The advice comes after more than 250 patients in two states were exposed to excess radiation during CT perfusion brain scans.

"Until we get through whether we're dealing with errors that people are making (or) whether these are problems with the CT scanners themselves, we're saying go back to basics," said Jeffrey Shuren, MD, acting director of the FDA's Center for Devices and Radiological Health.

Shuren and colleagues released a set of interim recommendations while the agency continues to investigate cases of overexposure reported in California and Alabama.
They include:

• Imaging facilities should review their radiation dosing protocols for all CT perfusion studies to ensure that dosing is correct for each study.

• They should implement quality control procedures to ensure that protocols are followed and correct radiation is used.

• For each patient, technologists should check the CT scanner displays to make sure the radiation to be delivered is appropriate.

• If more than one study is performed during one session, practitioners should adjust the radiation dose so it is appropriate for each study.
The agency also urged imaging facilities to check whether any patients who underwent CT perfusion scans have received excess radiation.

"We're reminding (practitioners) of good practices that they should be employing routinely," said Charles Finder, MD, also of the agency's Center for Devices and Radiological Health.

The issue arose when the FDA was told of more than 200 cases of excess radiation delivered during CT perfusion brain scans at Cedars-Sinai Medical center in Los Angeles. (See CT Safety Warnings Follow Radiation Overdose Accident)
Since then, the agency has received reports of 14 cases at Glendale Adventist Medical Center, also in Los Angeles, as well as an undetermined number of cases at St. Joseph's Medical Center in Burbank, Calif., according to Simon Choi, PhD, also of the Center for Devices and Radiological Health.

Choi said the the agency is investigating reports in Alabama, too, but he did not give numbers or the name of the facility involved.

The agency said scanners made by two manufacturers, GE and Toshiba, are involved in the incidents.
Affected patients had redness of the skin and some hair loss, but potential long-term consequences include an increased risk of cancer and cataracts, Finder said.
The standard radiation dose for a CT perfusion scan is between 0.5 and 1.0 Gray, but it was reported that some patients at Cedars-Sinai got as much as 3.0 or 4.0 Gray.
According to a statement from the hospital, "there was a misunderstanding about an embedded default setting applied by the machine."

The recommendations apply to all CT perfusion imaging, since the methods involved are the same as for brain perfusion scans, the FDA said.

While the agency is probing cases in the two states, Shuren said, "we would not be surprised to find there are similar occurrences in other states."

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