** CREDENTIALED PRESS ONLY **
WHAT:
Media Telebriefing
As part of its ongoing investigation into cases of excess radiation during CT perfusion imaging of the brain, the U.S. Food and Drug Administration is providing imaging facilities and practitioners with interim recommendations to prevent additional problems
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(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )
WHO:
-- Jeffrey Shuren, M.D., J.D., acting director, Center for Devices and Radiological Health (CDRH), FDA
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-- Simon Choi, Ph.D., network leader-radiological products, Office of Center Director, CDRH
-- Charles Finder, M.D., associate director, Division of Mammography Quality and Radiation Programs, CDRH
WHEN:
Monday, Dec. 7, 2009, 12 p.m., EST
HOW:
Reporters may dial 888-391-6809 or for international reporters, 1-212-547-0149. The password for all callers is "FDA." A replay of the briefing will be available until Dec. 14 by calling 800-925-3686 or for international reporters, 1-402-220-4149.
BACKGROUND:
The FDA first issued an initial safety notification in October after learning of 206 patients who had been exposed to excess radiation at Cedars-Sinai Medical Center in Los Angeles 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 during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. The FDA has also received reports from other states of possible excess radiation exposure during CT perfusion scans. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to take to prevent additional cases of excess exposure. These recommendations apply to all CT perfusion images, including brain and heart, because they use similar procedures and protocols.
CONTACT: Karen Riley of FDA, +1-301-796-4674, [email protected]
SOURCE U.S. Food and Drug Administration
