The U.S. Food and Drug Administration today took aim at three types of procedures that deliver high radiation doses: computer tomography or (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,” an agency news release said.
Accidental exposure to very high amounts of radiation can increase a person’s lifetime cancer risk as well as cause skin burns, hair loss and cataracts.
The agency intends to address unnecessary radiation exposure from certain types of medical imaging as part of a new Radiation Initiative.
Besides setting new manufacturing requirements for the makers of CT and fluoroscopic devices, the FDA also intends to start a dose registry — which will pool data from imaging facilities nationwide to “define diagnostic reference levels where they do not yet exist,” the news release said.
Though not mentioned in the FDA’s release, today’s announcement follows last month’s New York Times report about the consequences of radiation errors and last week’s call for better safety measures in giving medical radiation as well as a national database for reporting errors from the American Society for Radiation Oncology.
Read more about the FDA’s oversight of medical devices here.
“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 release said. “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.”
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