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FDA Interim Recommendations on Potential Excess Radiation Exposure During CT Scans ROCKVILLE, Md -- December 8, 2009 -- As part of an ongoing investigation into cases of excess radiation during computed tomography (CT) perfusion imaging of the brain, the US Food and Drug Administration (FDA) today provided imaging facilities and practitioners with interim recommendations to help prevent additional problems. The FDA issued an initial safety notification in October after learning of 206 patients who had been exposed to excess radiation at Cedars-Sinai Medical Center, Los Angeles, California, over an 18-month period. Since then, the FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to 8 times the expected level during their CT perfusion scans. These cases so far involve more than 1 manufacturer of CT scanners. The FDA has also received reports of possible excess radiation from other states. Some of these patients reported hair loss or skin redness following their scans. On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure. These recommendations apply to all CT perfusion images, including brain and heart, as they use similar procedures and protocols. The recommendations include: · Facilities assess whether patients who underwent CT perfusion scans received excess radiation. · Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study. · Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered. · Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient. · If more than 1 study is performed on a patient during 1 imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study. The FDA continues to work with manufacturers, professional organisations, and state and local public health authorities to investigate the scope and causes of these excess exposures. The agency is also advising manufacturers to review their training for users, reassess information provided to healthcare facilities, and put into place new surveillance systems to identify problems quickly. “The FDA is making progress in the investigation of this problem,” said Jeffrey Shuren, MD, Center for Devices and Radiological Health, FDA, Rockville, Maryland. “While we do not know yet the full scope of the concern, facilities should take reasonable steps to double-check their approach to CT perfusion studies and take special care with these imaging tests.” SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version