CT Overdoses at Cedars-Sinai—Perspectives from FDA and ECRI Institute
November 1, 2009 | Evaluations & Guidance
In early October, it was learned that over 200 patients at Cedars-Sinai Medical Center in Los Angeles had received serious radiation overdoses—approximately eight times the expected level. The overdoses occurred during brain perfusion computed tomography (CT) scans, which are used to diagnose suspected acute stroke.
The U.S. Food and Drug Administration (FDA) issued a Safety Investigation notification regarding this problem on October 8, 2009. In particular, FDA is concerned that the problem may be occurring unnoticed at other facilities. The notification included...