The Food and Drug Administration (FDA) issued an alert to hospitals nationwide, warning them to review their safety procedures for CT scans. The alert follows news of botched CT brain scans performed Cedars-Sinai Medical Center in Los Angeles, California that exposed 206 patients to excessive amounts of radiation.
While the FDA alert did not specificially mention Cedars-Sinai, the agency said it was concerned that a radiation overdosing report it received “may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion). If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects.”
According to the FDA alert, the 206 patients involved in the overdosing report had received radiation doses of 3-4 Gy to the head, rather than the expected dose of 0.5 Gy (maximum). An FDA spokesperson told the LA Times that it does not yet know what led to the overdoses at Cedars-Sinai. They may have been the result a device malfunction, or appropriate procedures may not have been followed.
According to the Associated Press, officials at Cedars-Sinai said the CT scan machine there been set at the higher level since February 2008, the Associated Press said, but the mistake had not been detected for 18 months. According to the Medical Center, the overdoses were discovered in August, when a patient reported hair loss. Other patients had also suffered hair loss and skin reddening. Cedars-Sinai has notified all patients who received the overexposure and provided resources for additional information.