MASSDEVICE ON CALL — The FDA launched a push to reduce children’s exposure to unnecessary radiation from X-ray imaging procedures, saying it wants manufacturers to take more responsibility for ensuring their devices are safe for kids.
The federal watchdog agency said it’s issuing draft guidance "recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients," according to a press release.
"It also 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," according to the release, which notes that the agency is collaborating with the Alliance for Radiation Safety in Pediatric Imaging and the Medical Imaging and Technology Alliance, a long-time collaborator, to formulate the new rules.
"MITA is proud to be a long-time collaborative partner with the FDA on initiatives to ensure the safe and effective use of medical imaging equipment," the group said in a press release. "Our efforts have included contributing to the development of pediatric radiation safety training materials and convening stakeholders to explore ways to prevent medical errors that involve radiation. MITA looks forward to providing comments on the guidance released today to help reduce unnecessary radiation exposure for children."
It’s all part of the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, launched in February 2010.
"The risk from a medically necessary imaging exam 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," Dr. Jeffrey Shuren, who was a radiologist before joining the FDA, said in prepared remarks. "Parents should engage in a discussion with their child’s physician about benefits and risks of X-ray, computed tomography and fluoroscopy exams."
The agency scheduled a workshop July 16 to discuss the draft guidance.
MITA
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