FDA Issues Guidance Document on Pediatric Imaging

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Today the FDA released for public comment a guidance document on pediatric imaging that should help x-ray manufacturers develop devices better suited to safely imaging child patients.

Citing the inreased radiosensitivity of children as compared with that of adults, the greater timeline along which overexposure could manifest as cancer, and the potential for children to be exposed to excessive radiation when using machines calibrated principally for adults, the regulatory agency is seeking the addition of pediatric settings, labeling, displays, and software to all new equipment.

"The third point is of special concern because many pediatric imaging exams are performed in facilities lacking specialized expertise in pediatric imaging," the document reads.

The FDA was also careful to point out that although its intention is to improve pediatric imaging, "many recommendations in this guidance would also improve adult imaging (e.g., better dose display and recording; availability of default protocols and dose reduction features suitable for a broad range of sizes; instructions emphasizing clear explanations of dose reduction features and any special issues for patients that are not of average size)."