Radiation Overdose Prompts FDA to Issue Safety Warning

Susy Owen

Attorney

0 CommentsPrint ArticleSubscribe

The FDA issued a safety warning after 206 patients at Cedars-Sinai Medical Center in Los Angeles received eight times the necessary amount of radiation. The safety warning did not specifially name Cedars-Sinai.

The machine in question was reconfigured in February 2008 to increase the ability to see blood flow to the brain in the diagnosis of a stroke. The error was not recognized until August 2009 when a patient reported patchy hair loss.

"If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects," the safety notification added.

The FDA warned imaging facilities to review their protocols and carefully monitor the volume CT dose index and dose-length product during and after each patient's scan.

The California errors highlight an ongoing controversy over patients' increasing exposure to radiation, brought on by phenomenal growth in the number of CT procedures, said Jeff Brinker, MD, of Johns Hopkins. "This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion)," the FDA said.