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FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Press releases may be edited for formatting or style | February 10, 2010
Focus on radiation in imaging
The U.S. Food and Drug Administration has 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.

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 FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.

However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. 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.
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"The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years," said Jeffrey Shuren, M.D., J.D., 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."

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.