WASHINGTON — The Food and Drug Administration will require new safety controls on medical imaging devices and encourage development of more precise radiation dosing standards in a bid to reduce unnecessary exposure of patients to diagnostic radiation.
The agency also will promote a personal medical imaging history card that will enable patients to keep track of the number of images and the amount of radiation they receive over time, according to a medical imaging safety initiative unveiled Tuesday.
The safety push comes five months after Cedars-Sinai Medical Center in Los Angeles discovered it had accidentally exposed more than 260 patients to eight times the normal dose of radiation for CT brain scans over a period of 18 months.
Three other health care facilities, two in Los Angeles County and one in Huntsville, Ala., reported possible overdoses by imaging equipment to at least 104 people.
Those mishaps provided a nudge to FDA planning already underway for better safety protocols and more comprehensive information-gathering to determine best-practice standards, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
“We’re aware that the exposure of the American public to (diagnostic) radiation was increasing fairly dramatically over the past 20 years,” Shuren said. “These tests can provide tremendous medical benefit. We’re trying to optimize that benefit while lowering the risk.”
The FDA will hold a public meeting March 30 and 31 to collect suggestions about the kinds of new safety features and training that should be required for CT and fluoroscopic devices, Shuren said.
A CT scan is a rapid series of X-rays that results in detailed cross-sections of the body.
Possible changes include automatic calibration of radiation doses and identification of operators to track errors.
