The FDA's three-prong initiative is intended to promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of medical radiation. The FDA plans to use its existing authority to regulate medical imaging devices, and will also collaborate with other federal agencies and healthcare professional groups.
Pointing out that the amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH), stated that the goal of the FDA's initiative is to support the benefits associated with medical imaging while minimizing the risks.
In a press release, the FDA stated that "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."
The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate safeguards into scanner design, develop safer technologies, and provide appropriate training to support safe use by practitioners. The agency cited as examples a requirement that scanners display, record, and report equipment settings and radiation dose, as well as a requirement that medical devices be able to capture and transmit radiation dose information to a patient's electronic medical record and national dose registries.
The FDA also announced that it intends to hold a public meeting March 30 and 31 at its Silver Spring, MD, headquarters to solicit input on requirements to establish in connection with the initiative.
The FDA's initiative comes as the U.S. House of Representatives is preparing to hold hearings on the issue of medical radiation. The hearings were originally scheduled for February 10 but have been postponed due to snowy weather in Washington, DC.
By Cynthia E. Keen
AuntMinnie.com staff writer
February 9, 2010
Congress sets hearing to review medical radiation, February 8, 2010
NIH tells scanner suppliers to include radiation monitoring, February 1, 2010
FDA finds new cases of radiation overexposure, December 7, 2009
NEJM study: Imaging procedures, radiation growing, August 26, 2009
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