FDA to reduce child radiation exposure

U.S. Food and Drug Administration is recommending manufacturers design new X-ray imaging devices with child safety in mind, officials say. In the draft guidance, the FDA proposes that manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective in pediatric patients should include a label on their device that cautions against use in pediatric populations, officials said. To help healthcare providers more safely use their current equipment on pediatric patients, the FDA is collaborating with the Alliance for Radiation Safety in Pediatric Imaging and manufacturers, through the Medical Imaging and Technology Alliance, to develop pediatric imaging radiation safety training materials. "When used appropriately, X-ray imaging, such as a CT, fluoroscopy, and conventional X-ray, can provide valuable information to help with diagnosis, treatment planning and surgical intervention in adults and children," a statement by the FDA said. "At the same time, these types of exams expose patients to ionizing radiation, which can be of particular concern in pediatric patients." Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement the risk posed by imaging exams is "quite small when compared to the benefit of accurate diagnosis or intervention." "There is no reason for patients who need these exams to avoid them," Shuren said. "Parents should engage in a discussion with their child's physician about benefits and risks of X-ray, computed tomography and fluoroscopy exams."