CT Radiation Overdoses Caused by User Error, FDA Says

Additionally, in a letter to the Medical Imaging and Technology Alliance, the major professional industry organization for manufacturers of CT scanners and other radiological imaging devices, FDA shared the results of the investigation and addressed possible CT equipment enhancements that could improve patient safety.

Among the changes under consideration:

• A console notification to alert the operator of a high radiation dose; 
• Providing particular information and training on brain-perfusion protocols to all facilities that receive base CT equipment; 

• Clarification of parameters affecting dose, along with clear instructions on how to appropriately set those parameters; and 

• Organization of all dose-related information into one section of each user manual.

Begun in 2009, FDA's investigation included information from the states and facilities where radiation overdoses occurred from 2008 to Oct. 26, 2010. The agency also inspected CT scanner equipment manufacturers. Since the investigation began, FDA learned of at least 385 patients who received excessive radiation from CT brain perfusion scans, many undergoing the test to confirm the presence of a stroke, performed at five hospitals in California and one in Alabama.

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