FDA Calls for Reducing Unnecessary Radiation Exposure from Three Devices

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."