FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The U.S. Food and Drug Administration (FDA) today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These 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, dental X-rays, and mammography.

These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.

While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure. For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs.

Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and health care professional groups, the FDA 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 the FDA is announcing is expected to promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.

The FDA recommends that health care 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. Quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA’s Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records (FDA NEWS RELEASE).