FDA Identifies More CT Scan Problems with Dangerous Radiation Levels

The FDA has identified at least 50 more patients who were subjected to potentially dangerous radiation overdoses during CT scans. The revelations are part of an ongoing investigation sparked by reports in October that more than 200 patients at Ceders-Sinai Medical Center in Los Angeles were subjected to overexposure to radiation.

In a statement issued Monday, the FDA issued interim recommendations to help prevent additional problems. The federal regulatory agency indicates that since their initial safety notification about the potential CT scan problems in October, they have identified additional cases where patients were exposed to excess radiation of up to eight times the expected level during CT perfusion scans.

The newest findings seem to confirm FDA suspicions that there is a widespread problem with radiation overexposure with CT brain scans. Although all of the initial 200 reports came from one hospital, the latest reports come from a number of different hospitals using different CT scanning equipment.

As a result of the CT scan radiation overexposure, some patients suffered from hair loss and erythema, according to the FDA. Erythema is redness of the skin similar to sunburn and is a common side effect of radiotherapy treatment. The agency also said that the risk is not limited to CT brain profusion scans, but applies to all CT perfusion scans, including heart scans.

The ongoing investigation is being conducted to assess the scope of the CT scan problem and to determine whether any regulatory action is required. The agency has released a list of interim recommendations for radiologists and imaging facilities to follow while its investigation continues. The interim recommendations include:

• 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 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.

At least one CT scan radiation exposure lawsuit has already been filed against Ceders-Sinai Hospital. The case, filed in October by plaintiff Trevor Reese, seeks class action status for all patients who were subjected to high levels of radiation due to incorrectly administered CT scans at the hospital over an 18 month period. Rees alleges that he suffered radiation exposure symptoms, including reddened skin, burns, hair loss, and flaking of the scalp.