FDA Recommends Radiation Exposure Measures For CT Manufacturers

Article preview from "The Gray Sheet" - November 15, 2010

FDA wants makers of computed tomography scanners to revamp user information materials and training programs and tweak some software/hardware components to reduce the chance of radiation overdoses to patients.

FDA Recommends Radiation Exposure Measures For CT Manufacturers

Article preview from "The Gray Sheet" - November 15, 2010

FDA wants makers of computed tomography scanners to revamp user information materials and training programs and tweak some software/hardware components to reduce the chance of radiation overdoses to patients.

FDA’s suggestions were announced Nov. 9 in tandem with findings from a year-long investigation into hundreds of cases of radiation overexposure from CT brain perfusion scans at facilities in California.

The agency determined that scanners in late-2009 incidents made by GE Healthcare and Toshiba were not at fault, but that there is room for improvement.

“FDA investigations of these companies found there were no violations of FDA laws and regulations,” the agency said. “However, FDA’s investigation did reveal improvements that industry could make to its equipment, user information and training in order to improve the safety of their equipment and reduce the likelihood of overexposures.”

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