Product Liability

More patients exposed to excessive radiation to head

At least 250 people – 50 more than previously identified – have been exposed to excess radiation of up to eight times the expected level during CT perfusion scans, causing hair loss and skin redness, and putting them at risk of some forms of cancer, according to Food and Drug Administration (FDA) safety investigation.

The notice released this week updates a report issued in October that found that 206 patients at an unidentified facility received overdoses of radiation to the head following CT perfusion scans. Perfusion CT imaging is performed to aid in the diagnosis of stroke and other medical conditions.

The FDA’s investigation into the overdoes identified at least 50 more cases of overexposure to radiation in patients during CT perfusion scans. These cases also involve more than one manufacturer of CT scanners. As a result of the investigation, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.

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

The FDA continues to work with manufacturers, professional organizations, and state and local public health authorities to investigate the scope and causes of these excess exposures. The FDA is also advising manufacturers to review their training for users, reassess information provided to health care facilities, and put into place new surveillance systems to identify problems quickly.

“The FDA is making progress in the investigation of this problem,” said Jeffrey Shuren, M.D., acting director of the FDA’s Center for Devices and Radiological Health. “While we do not know yet the full scope of the concern, facilities should take reasonable steps to double-check their approach to CT perfusion studies and take special care with these imaging tests.”