FDA Launches Initiative to Reduce Radiation Exposure from Medical Exams

In response to growing concerns about the side effects of radiation exposure during medical procedures, the FDA has launched a new initiative designed to reduce unnecessary exposure from CT scans, nuclear medicine studies and fluoroscopy.

The initiative, announced this month by the FDA, seeks to reduce the risk of radiation exposure from medical procedures through promotion of the safe use of medical devices, by providing support for informed clinical decision-making, and by making patients more aware of their total radiation exposure. The FDA is also considering increased requirements for computed tomography (CT) scanners and fluoroscopic devices that would call for increased safeguards and training to protect against radiation overexposure.

The agency will hold public hearings on March 30 and 31 to discuss possible new industry-wide requirements.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said the FDA’s director of it’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

The guidance comes as the FDA is investigating cases of radiation problems with CT scan procedures, after the discovery that a number of patients across the country have suffered radiation overexposure from scans performed incorrectly. The FDA released interim guidance in December for health care professionals and radiologists as it continues its investigation. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.

In many cases, patients received radiation doses to the wrong parts of the body, or were subjected to radiation several times higher than prescribed. Diversified Clinical Services, the country’s largest wound care company, treated 3,000 radiation injuries in 2009 alone.

A CT scan radiation exposure study published in December in the Archives of Internal Medicine, which studied 1,119 adults who received CT scans in San Francisco in 2008, found a high amount of variation between radiation doses, with some radiation exposure varying as much as 13-fold between scans. The study estimated that 1 in 270 women who received a CT heart scan would develop cancer, compared to 1 in 600 men.