FDA says CT scan radiation overdoses were result of operational malfunction
The Food and Drug Administration said Tuesday that overdoses of radiation to more than 400 patients undergoing CT scans of their heads were due to operator error and called on manufacturers to make changes to prevent such mistakes in the future.
In a statement on its website and in a letter to manufacturers, the agency recommended that the companies compile all dosing information in an easily accessible form for operators and that they install a pop-up device to warn operators before they administer a dangerous overdose.
The overdoses were first observed at Cedars-Sinai Medical Center in Los Angeles, where at least 260 patients have received as much as eight times the normal radiation dose from a General Electric scanner. The hospital cited confusion over computerized instructions that control the radiation dose and scan quality.