FDA initiative to reduce unnecessary radiation exposure

The US FDA unveiled an initiative to reduce unnecessary radiation exposure from 3 types of medical imaging procedures that are the greatest contributors to total radiation exposure within the United States: computed tomography (CT), nuclear medicine studies, and fluoroscopy.

The FDA initiative has 3 goals: to promote the safe use of medical imaging devices; to support informed clinical decision-making; and to increase patients' awareness of their exposure. The agency expects to issue target requirements for manufacturers of CT and fluoroscopic devices to incorporate safeguards into the design of their machines, to develop safer technologies, and to provide appropriate training to support safe use. Some examples might be requiring that devices display, record, and report equipment settings and radiation dose or an alert when the dose exceeds a diagnostic reference level.

In addition, FDA and CMS are collaborating to incorporate key quality assurance practices into mandatory accreditation. The FDA also recommends that healthcare professional organizations continue to develop diagnostic radiation reference levels for medical imaging procedures and to increase efforts to develop national registries for radiation doses.

FDA unveils initiative to reduce unnecessary radiation exposure from medical imaging [press release]. February 9, 2010. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm200085.htm. Accessed March 11, 2010.