FDA Issues Guidance for Manufacturers to Minimize Pediatric Radiation Exposure

On Nov. 28, the U.S. Food and Drug Administration (FDA) issued guidance recommending X-ray manufacturers include dose reduction features in their equipment designs and pediatric resources when they develop and manufacture X-ray equipment. The Agency also recommended including tools that provide clear instruction on how to optimize dosage. This guidance comes as part of an effort to prevent excessive radiation exposure to patients, particularly children.

“There are two ways that children’s exposure can be reduced. The first is by ensuring that X-ray exams and procedures are only ordered when they are clinically necessary…The other way to limit exposure is to add dose reduction features to the imaging equipment itself. Special equipment settings and techniques can optimize the amount of radiation a patient receives,” writes Vasum Peiris, MD, MPH, Chief Medical Officer for Pediatrics and Special Populations, for the FDA’s Center for Devices and Radiological Health.

“Clearly, FDA does not wish to signal that children should not receive X-ray imaging exams. There are clinical questions that only X-rays, CTs and fluoroscopy can answer or can answer better than other options. But as experience has taught us, if a clinician determines that an X-ray scan is needed, it can be and should be optimized for children.”

Clinical Topics: Noninvasive Imaging, Nuclear Imaging

Keywords: X-Rays, United States Food and Drug Administration, Fluoroscopy, Radiologic Health, Radionuclide Imaging, Equipment Design, ACC Advocacy

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