FDA calls for radiation-scan safety features

WASHINGTON – To cut risks to patients from excessive radiation exposure from CT diagnostic scanners, the U.S. Food and Drug Administration wants equipment-makers to add safety features and do a better job of educating people who use their equipment.

The changes are meant to prevent the kind of errors that, according to the FDA, have exposed hundreds of people to toxic levels of radiation.

“Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks,” Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement yesterday.

CT scans deliver a much-higher radiation dose than conventional X-rays. High doses of radiation can cause skin burns, cataracts and, in extreme cases, cancer and death.

Toxic overdoses in Calif.

The FDA has been investigating states and facilities where overdoses occurred as well as equipment used in those facilities. Radiation exposure became a major concern in October 2009 after the FDA said it was investigating 206 cases of patients being exposed to toxic doses of radiation during CT scans of the brain at Cedars-Sinai Medical Center in Los Angeles.


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