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FDA Calls for Reducing Unnecessary Radiation Exposure from Three Devices

Janice Simmons, for HealthLeaders Media, February 9, 2010

A new three-pronged initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures—computed tomography (CT), nuclear medicine studies, and fluoroscopy—was announced by the Food and Drug Administration (FDA) on Tuesday.

These combined procedures are considered the leading contributors to total radiation exposure in the U.S., because they use higher radiation doses than other radiographic procedures, such as standard X rays, dental X rays, and mammography, according to the FDA.

Of concern is exposing patients to ionizing radiation—a type of radiation that can increase an individual's lifetime cancer risk.

"The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years," said Jeffrey Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health, in a statement. "The goal of FDA's initiative is to support the benefits associated with medical imaging while minimizing the risks."

As the first prong of the initiative, FDA said it intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices. These requirements address safeguards in the design of their machines and provide appropriate training to support safe use by practitioners. FDA said it will hold a public meeting on March 30 31 to solicit input on what requirements to establish.

For the second part of the initiative, FDA and the Centers for Medicare and Medicaid Services will work together to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals.

FDA is recommending that healthcare professional organizations continue to develop—in collaboration with the agency—diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses. A dose registry would pool data from many imaging facilities nationwide, and capture dose information from a variety of imaging studies.

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