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FDA Working to Prevent Radiation Overdoses During CT Scans
Date:11/9/2010

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CT brain perfusion scans produce cross-sectional images of the head that evaluate blood flow in the brain. In an update released today, the FDA discussed findings of a probe into radiation overdoses in patients who received CT brain perfusion scans in hospitals located in California and Alabama.

Begun in 2009, the FDA's investigation included information from the states and facilities where radiation overdoses occurred from 2008 to Oct. 26, 2010. The agency also inspected CT scanner equipment manufacturers.

The probe indicated that CT scanners, when properly used, did not result in overdoses. However, the investigation uncovered potential enhancements to CT equipment that could reduce the likelihood of radiation overexposure if improper use occurs –  a goal of the agency's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.  

"Improving patient safety is part of our public health mission," said Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks."

Since the investigation began, the FDA is aware of at least 385 patients who received excessive radiation from CT brain perfusion scans, many undergoing the test to confirm the presence of a stroke, performed at five hospitals in California and one in Alabama.

While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks. Patients should follow their doctor's recommendations for receiving CT scans.

For more information:

Safety Investigation of CT Brain Profusion Scans: Update 12/8/
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SOURCE U.S. Food and Drug Administration
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