FDA Issues Recommendations to Prevent Excess CT Radiation

Interim recommendations follow news of excess radiation exposure during CT perfusion imaging

TUESDAY, Dec. 8 (HealthDay News) -- Following news that 206 patients at Cedars-Sinai Medical Center in Los Angeles were overexposed to radiation during computed tomography (CT) perfusion imaging over an 18-month period, the U.S. Food and Drug Administration has issued interim recommendations to help prevent similar incidents.

The recommendations to facilities apply to all CT perfusion images and include determining if any patients were exposed to excess radiation during CT scans in the past, reviewing CT dosing protocols to ensure that the correct dosing is planned, and implementing quality control procedures to enforce dosing protocols. Practitioners are advised to double-check CT scanner display panels to make sure the amount of radiation to be delivered is at the appropriate level, and, for multiple studies, check that the radiation selected for each study is appropriate. Manufacturers are advised to review user training and information provided to facilities, and devise new surveillance systems.

The FDA is investigating cases of excess radiation during CT scans nationwide and is working with manufacturers, professional organizations, and public health authorities to determine the scope and causes of overexposures.

"The FDA is making progress in the investigation of this problem," said Jeffrey Shuren, M.D., acting director of the FDA's Center for Devices and Radiological Health in Silver Spring, Md. "While we do not know yet the full scope of the concern, facilities should take reasonable steps to double-check their approach to CT perfusion studies and take special care with these imaging tests."

Press Release
Initial Notification
Issue a Voluntary Report to the FDA's MedWatch

Physician's Briefing