FDA launches three-pronged initiative to reduce radiation exposure

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The FDA today launched an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: CT, nuclear medicine studies and fluoroscopy.

According to the agency, these three procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard x-rays and mammography. Yet, the FDA also acknowledged that “CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning and image-guided therapies that help save lives every day.”

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

Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and healthcare professional groups, the agency is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

The three-pronged initiative will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure, according to the agency.

The FDA plans to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.

In addition, the FDA and the Centers for Medicare & Medicaid Services are collaborating to incorporate quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities, the agency says.

The FDA also 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, capturing dose information from a variety of imaging studies. The registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.