An investigation has been launched into <"http://www.yourlawyer.com/practice_areas/medical_malpractice">botched CT brain scans that were performed at Cedars-Sinai Medical Center in Los Angeles, California. On Friday, the Food and Drug Administration (FDA) issued an alert to hospitals nationwide, warning them to review their safety procedures for CT scans. However, the alert did not name Cedars-Sinai specifically.
According to the Associated Press, officials at Cedars-Sinai said on Friday that 206 patients got eight times the regular dose of radiation during CT brain scans, which are used to diagnose strokes. According to the FDA alert, patients involved in these incidents had received radiation doses of 3-4 Gy to the head, rather than the expected dose of 0.5 Gy (maximum).
The machine at Cedars-Sinai had 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.
In its alert, the FDA said it was concerned that the radiation overdosing “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.”
The FDA is encouraging every facility performing CT imaging to review its CT protocols and be aware of the dose indices normally displayed on the control panel. 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 LA Times, a statement issued by Cedars-Sinai said that since the overdosing was discovered, it had “instituted additional double-checks in its operations of the scanner and additional equipment protocols to ensure that this does not happen again.”
In addition to the FDA, the overdoses at Cedars-Sinai are being investigated by the California Department of Public Health. Depending on the outcome of the state investigation, the hospital could face restrictions on doing CT scans under its state license, LA Times said.