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FDA Calls for Reducing Unnecessary Radiation Exposure from Three Devices

 |  By jsimmons@healthleadersmedia.com  
   February 09, 2010

A new three-pronged initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures—computed tomography (CT), nuclear medicine studies, and fluoroscopy—was announced by the Food and Drug Administration (FDA) on Tuesday.

These combined procedures are considered the leading contributors to total radiation exposure in the U.S., because they use higher radiation doses than other radiographic procedures, such as standard X rays, dental X rays, and mammography, according to the FDA.

Of concern is exposing patients to ionizing radiation—a type of radiation that can increase an individual's lifetime cancer risk.

"The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years," said Jeffrey Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health, in a statement. "The goal of FDA's initiative is to support the benefits associated with medical imaging while minimizing the risks."

As the first prong of the initiative, FDA said it intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices. These requirements address safeguards in the design of their machines and provide appropriate training to support safe use by practitioners. FDA said it will hold a public meeting on March 30 31 to solicit input on what requirements to establish.

For the second part of the initiative, FDA and the Centers for Medicare and Medicaid Services will work together to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals.

FDA is recommending that healthcare professional organizations continue to develop—in collaboration with the agency—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, and capture dose information from a variety of imaging studies.

For the third prong, FDA said it is working to empower patients and increase awareness by collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be made available on the FDA's Web site, will permit 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 action follows an announcement made a week earlier by the National Institutes of Health (NIH) that its physicians will begin recording radiation doses for patients in their medical records, according to an announcement in the recent issue of the Journal of the American College of Radiology.

A radiation reporting policy has been developed at the NIH Clinical Center in Bethesda, MD, that will be used in cooperation with major equipment vendors--beginning with exposures from CT and PET/CT.

All vendors that sell imaging equipment to the clinical center will be required to "provide a routine means for radiation dose exposure to be recorded in the electronic medical record," said  David A. Bluemke, MD, the study's lead author and director of Radiology and Imaging Sciences at the Clinical Center.

In addition, radiology at NIH also will require that vendors ensure radiation exposure can be tracked by patients in their own personal health records. This approach is consistent with the American College of Radiology's and Radiological Society of North America's stated recommendation that "patients should keep a record of their X ray history."

Janice Simmons is a senior editor and Washington, DC, correspondent for HealthLeaders Media Online. She can be reached at jsimmons@healthleadersmedia.com.

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