FDA Investigating Radiation Overexposures During Perfusion CT Scans

The FDA has issued a statement expressing concerns that some CT brain perfusion scans may be giving patients overexposure to radiation. The regulatory agency indicates that they are working to gather more data about the situation and to understand the potential public health impact.

According to a Safety Alert issued on Thursday, the FDA indicates that several patients at an unnamed facility received radiation overdoses from multi-slice CT machines. More than 200 patients were exposed to eight times the normal amount of radiation while receiving CT brain perfusion scans for diagnosis and treatment of strokes. The incident has raised concerns that there may be a more widespread problem with radiation overexposure associated with the CT scans.

The FDA indicates that some patients suffered from hair loss and erythema as a result of the radiation overdoses. Erythema is redness of the skin similar to sunburn and is a common side effect of radiotherapy treatment. The facility has notified all patients who received overexposure.

The warning said that the agency is concerned that “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 said the magnitude of the overdoses and their effects on the patients were significant, and if similar incidents are happening at other facilities, they may be going unrecognized and unreported, leading to long-term overexposure for patients.

After gathering more data about the situation, the FDA indicates that a determination will be made about whether there are more widespread risks and the need for any actions.

In the interim, regulators are advising that all facilities performing CT scans should review their CT protocols and pay close attention to dose indices displayed on the machines’ control panels. Operators should “make sure the values displayed reasonably correspond to the doses normally associated with the protocol,” the warning stated. “Confirm this again after the patient has been scanned.”

The FDA is asking that any incidents of CT overexposure or other adverse CT events be reported to FDA’s MedWatch program.