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FDA Makes Interim Recommendations to Address Concern of Excess Radiation Exposure during CT Perfusion Imaging
Date:12/7/2009

SILVER SPRING, Md., Dec. 7 /PRNewswire-USNewswire/ -- As part of an ongoing investigation into cases of excess radiation during CT perfusion imaging of the brain, the U.S. Food and Drug Administration today provided imaging facilities and practitioners with interim recommendations to help prevent additional problems.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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 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 of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one 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. 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 help 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.

These recommendations include:

  1. Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
  2. Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
  3. Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
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SOURCE U.S. Food and Drug Administration
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