FDA Announces Initiative to Reduce Radiation Exposure From Medical Imaging

February 9, 2010—The US Food and Drug Administration (FDA) announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These are the greatest contributors to total radiation exposure within the United States population. The agency intends to hold a public meeting on March 30-31, 2010 to solicit input on what requirements to establish.

According to the agency, through the Initiative to Reduce Unnecessary Radiation Exposure From Medical Imaging, it is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure and careful optimization of the radiation dose used during each procedure.

In support of this goal, the FDA will use its regulatory authority and also collaborate with others in the Federal government and the health care professional community to:

1. Promote safe use of medical imaging devices
2. Support informed clinical decision making
3. Increase patient awareness

The FDA intends 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.

Examples of these requirements could be that these devices display, record, and report equipment settings and radiation doses, alert users when the dose exceeds a diagnostic reference level, offer training for users, and require 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 key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals that improve oversight and promote the safe use of technologies.

The agency recommends that health care professional organizations, in collaboration with the agency, continue to develop 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. This 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.

The FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card that 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. The FDA stated that it continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.