The Food and Drug Administration (FDA) has announced a 3-pronged initiative to reduce unnecessary radiation exposure from computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures contribute the most 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. This new initiative will promote the safe use of medical imaging devices, support informed clinical decision making, and increase patient awareness of their own exposure.

While CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, they all pose risks. These types of imaging exams expose patients to ionizing radiation, which can increase the lifetime risk of cancer. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss, and cataracts. 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 unnecessary radiation exposure should be avoided. Healthcare decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.

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. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish. In addition, the FDA and the Centers for Medicare & Medicaid Services (CMS) are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.

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 website, 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 recommends that professional healthcare organizations collaborate with the FDA to develop diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.

1. Food and Drug Administration (FDA) [website]. News & Events. FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. February 9, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm200085.htm. Accessed February 23, 2010.

Posted in News Service
This entry was posted on Tuesday, February 23rd, 2010 at 12:00 pm.