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FDA investigates CT scan radiation overexposure risk

This article was originally published in The Gray Sheet

Executive Summary

FDA is conducting a safety investigation of CT brain perfusion scans performed at a single facility after learning of radiation overexposures at that location. Over an 18-month period, 206 patients at the facility received radiation doses at approximately eight times the appropriate level, in some cases resulting in hair loss and erythema, FDA says. While the event involved just one facility, "this situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure," the agency writes in an Oct. 8 initial safety notification. Hospitals and CT facilities should review CT protocols and carefully monitor radiation dose indices before and after scans, FDA says

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