The FDA Friday warned hospitals across the country about exposing patients to high doses of radiation during CT brain scans, following an investigation of errors at Cedars-Sinai Medical Center in Los Angeles.
Hospital officials told the Los Angeles Times Friday that 206 patients got eight times the regular dose of radiation during scans
used to diagnose strokes.
The hospital says they found out about the overdoses in August when a patient reported hair loss after a scan. The problem went
undetected for 18 months and other patients were also affected.
Officials determined the machine had been set to a higher level since February 2008. The FDA issued an alert, warning hospitals nationwide to review their safety procedures, but federal officials did not name Cedars-Sinai.
Here's is the statement Cedars-Sinai released Friday night:
CEDARS-SINAI MEDICAL CENTER
October 9, 2009
● CT brain perfusion scans are a special type of CT scan used in certain urgent situations – such as a suspected stroke – to identify the extent of possible blood flow problems in the brain, so that the appropriate treatment can be determined and started immediately, to prevent further damage to the brain.
● In August 2009, a patient who had previously received a CT brain perfusion scan at Cedars-Sinai contacted the medical center after noticing temporary patchy hair loss. Since this is not a common side-effect from CT brain perfusion scans, Cedars-Sinai immediately began in investigation of the equipment involved and of the protocols used for CT brain perfusion scans. No additional CT brain perfusion scans were done until the investigation was completed.
● Cedars-Sinai’s investigation found that someCT brain perfusion studies were delivering a higher dose of radiation than anticipated, which could cause temporary hair-loss or skin-reddening in some patients. Cedars-Sinai has – as a result of its investigation – instituted additional double-checks in its operations of the scanner and additional equipment protocols to ensure that this does not happen again.
● Although the temporary hair loss or skin-reddening would have occurred within 6 weeks of the CT brain perfusion scan, Cedars-Sinai began contacting 206 patients who had a CT brain perfusion scan between February 2008 and August 2009 (the time period when the machine was delivering the higher dose), in the interest of keeping them informed. Cedars-Sinai also immediately reported its findings to the California Dept. of Public Health, and continues to keep regulatory agencies informed.