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Brendon Nafziger, DOTmed News Associate Editor | November 10, 2010
The U.S. Food and Drug Administration said user error was to blame, not CT scanners for radiation overdoses that affected nearly 400 patients over the last year.
In a note posted on its website, the FDA said scanners made by GE Healthcare and Toshiba America Medical Systems were not to blame for delivering the excess radiation during brain perfusion scans.
The FDA launched its investigation two years ago after reports of more than 200 patients receiving radiation overdoses during scans at Cedars Sinai Medical Center in Los Angeles, Calif. Since then, the FDA said it has uncovered 385 cases of overdoses from CT scans at five California hospitals and one in Alabama.
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The FDA has recommended a series of
safety measures to prevent future overdoses, such as implementing quality control procedures to ensure dosing protocols are followed and double-checking radiation display panels.
More information can be found here: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm
