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When FDA disclosed cases of radiation overexposure at Cedars-Sinai Medical Center in Los Angeles in an October announcement, the agency hinted that additional cases might be uncovered. Now, the other shoe has dropped.


FDA has identified at least 50 additional patients, on top of the 206 previously reported, who were exposed to excess radiation during CT perfusion studies at the institution. The cases involved radiation doses up to eight times the normal levels. More than one manufacturers' scanners were used. It is still unclear whether human error or machine problems are to blame.



The investigation is ongoing and additional facilities in California have also reported radiation overdoses and are being scrutinized by the agency, including Glendale Adventist Medical Center in Glendale, Calif. and Providence St. Joseph Medical Center in Burbank, Calif. An unnamed hospital in Alabama is also under review.

Meanwhile FDA has provided imaging facilities with recommendations to curb possible problems. They 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.
4. 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.
5. If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study.

Read all the details from FDA:
CT Brain Perfusion Scans Safety Investigation: Initial Notification
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm

Read more on DOTmed:

Rad Groups Recommend Keeping a Closer Eye on CT Scan Dosage Protocols After Cedars-Sinai Fiasco
www.dotmed.com/news/story/10650

Class Action Lawsuit Filed Against Cedars-Sinai, GE
www.dotmed.com/news/story/10525

Error Leads to CT Radiation Overdose
www.dotmed.com/news/story/10467

FDA Notification of CT Radiation Overexposures
www.dotmed.com/news/story/10437