FDA pushes to make CT diagnostic scans safer

CHICAGO (Reuters) - To cut risks to patients from excessive radiation exposure from CT diagnostic scanners, the U.S. Food and Drug Administration wants equipment makers to add safety features and do a better job of educating people who use their equipment.

The changes are meant to prevent the kind of errors that, according to the FDA, have exposed hundreds of people to toxic levels of radiation.

“Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks,” Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement on Tuesday.

CT scans deliver a much higher radiation dose than conventional X-rays. High doses of radiation can cause skin burns, cataracts, and in extreme cases cancer and death.

The FDA has been investigating states and facilities where overdoses occurred as well as equipment used in those facilities.

It found that when properly used, the CT scanners did not malfunction, and said it is likely that improper use of the scanners resulted in the overdoses.

But the equipment could be made safer, the FDA said.

It outlined its recommendations in a letter dated November 8, sent to the Medical Imaging and Technology Alliance or MITA, an industry group.

The agency recommended a change to consoles to alert the operator of a high radiation dose, extra training programs, especially for facilities that buy equipment used for brain scans; and clear instructions about the proper dose needed.

The FDA also asked that all dose-related information be collected into one section of a user manual for easy reference.

MITA said it has worked with the FDA during the past year to address the agency’s concerns and is committed to educating users and working on technologies to reduce radiation levels.

“In the end, the optimal solution will require action by all stakeholders including manufacturers, users and regulators,” the group said in a statement.

Radiation exposure became a major concern in October 2009 after the FDA said it was investigating 206 cases of patients being exposed to toxic doses of radiation during CT scans of the brain at Cedars-Sinai Medical Center in Los Angeles.

The FDA said it is now aware of at least 385 patients who received excessive radiation from CT brain perfusion scans performed at five hospitals in California and one in Alabama.

The scans produce cross-sectional images of the head that evaluate blood flow in the brain.

While unnecessary radiation exposure should be avoided, the FDA said patients should not avoid getting a medically needed CT scan.

CT equipment makers include General Electric, Toshiba Corp, Hitachi Ltd, Siemens and Philips.

Reporting by Julie Steenhuysen; Editing by Vicki Allen