Recent Sources Highlight Need to Control Pediatric Imaging Dose

October 1, 2012 | Healthcare Risk, Quality, & Safety Guidance

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Controlling the radiation dose delivered to patients during imaging procedures should be a primary focus of every radiology department, but for pediatric patients—who are at a much higher risk of developing cancer from radiation than adults are—it is absolutely critical. Controlling the dose from CT scans is especially important, since CT has a higher dose than most other imaging modalities and its use in pediatric populations is increasing worldwide. Given these concerns, pediatric dose from CT and other modalities has been the subject of increasing scrutiny. Below we summarize recent information on this topic from several sources.

FDA introduces resources to address pediatric dose risks. FDA has recently released two resources related to pediatric radiation dose. One is a draft guidance proposing that new imaging devices address dose in pediatric exams. The other is a website providing information on pediatric radiation safety. These efforts are part of the agency's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, initiated in 2010.

In May, FDA distributed for public comment a draft guidance, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm, proposing that imaging device manufacturers design their new products to address pediatric dose risks, and that they provide guidance specific to the safe imaging of pediatric patients in the labeling and instructions of all new models. Such details would be provided in 510(k) premarket notification submissions...

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