FDA investigation has uncovered more botched CT perfusion scans. A U.S. Food and Drug Administration (FDA) investigation has uncovered more botched CT perfusion scans. According to the agency, at least 50 additional patients were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. Such brain scans, said the Associated Press (AP), are a tool used to diagnose stroke.
The FDA began investigating radiation overdoses from CT perfusion scans in October after patients at Cedars-Sinai Medical Center in Los Angeles began complaining of symptoms of radiation overdose. Now, according to the AP, the FDA is investigating the use of CT scans at Glendale Adventist Medical Center and Providence St. Joseph Medical Center in Burbank, California.
Alicia Gonzalez, a spokeswoman for Glendale Adventist said the specialty scan that appears to be linked to the problem is no longer in use, said the AP. ”This procedure has been discontinued,” she said in a statement, quoted the AP. St. Joseph Medical Center had no comment, said the AP.
In October we wrote that reported complaints numbered at 206
In October we wrote that reported complaints numbered at 206, reports are now up to 260, according to the AP. Some reports have also been received from an unnamed Huntsville, Alabama hospital, said the AP.
These cases, to date, involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure that include:
- Facilities assessing whether patients who underwent CT perfusion scans received excess radiation
- Facilities reviewing their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study
- Facilities implementing quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
- Radiologic technologists checking the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
- Practitioners adjusting the radiation dose so it is appropriate for each study if more than one study is performed on a patient during one imaging session.
The FDA has not yet determined if the over exposures are a result of human error or some sort of equipment problem, reported the AP.
Although Cedars-Sinai and Glendale Adventist both use General Electric scanners, the FDA said reports have been received from other hospitals using different scanner brands, including more than one Toshiba model, explained the AP. Arevind Gopalratnam, a spokesman for GE issued a statement that said, in part, ‘there were no malfunctions or defects in any of the GE Healthcare equipment involved.”