FDA Issues CT Scan Safety Guidelines

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Interim recommendations to address concerns about patients receiving excess radiation exposure during CT perfusion imaging were released Monday by the U.S. Food and Drug Administration.

In October, the agency learned of 206 brain scan patients exposed to excess radiation at Cedars-Sinai Medical Center in Los Angeles over an 18-month period. Follow-up investigation revealed at least 50 more patients exposed to levels of radiation up to eight times higher than expected during CT perfusion scans. The cases involved CT machines made by more than one manufacturer.

Some patients exposed to excess radiation suffered hair loss or skin redness. High doses of radiation can cause cataracts and increase the risk of some types of cancer, the FDA said.

The agency's interim recommendations for imaging centers, radiologists and radiologic technologists are meant to help prevent more cases of excess patient exposure. The recommendations apply to all CT perfusion images, including brain and heart, because they use similar procedures and protocols.

The FDA recommends that:

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