In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.
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.
To help health care providers more safely use their current equipment on pediatric patients, the FDA is collaborating with the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) and manufacturers, through the Medical Imaging and Technology Alliance (MITA), to develop pediatric imaging radiation safety training materials.
The FDA has also launched a pediatric X-ray imaging website that provides information on the benefits and risks of imaging using ionizing radiation, recommendations for parents and health care providers to help reduce unnecessary radiation exposure, and information for manufacturers of X-ray imaging devices.
The guidance, website, and ongoing collaborations with ARSPI and MITA are part of FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, launched in February 2010.
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. At the same time, these types of exams expose patients to ionizing radiation, which can be of particular concern in pediatric patients.
The cancer risk per unit dose of ionizing radiation is generally higher for younger patients than adults, and younger patients have a longer lifetime for the effects of radiation exposure to manifest. Also, the use of X-ray equipment settings designed for adults can result in a larger radiation dose than necessary to produce a useful image for a smaller pediatric patient.
“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,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Parents should engage in a discussion with their child's physician about benefits and risks of X-ray, computed tomography (CT), and fluoroscopy exams.”
A workshop scheduled for July 16, 2012, will bring together industry, X-ray imaging equipment users (e.g., physicians, radiologic technologists, and physicists), and patient advocates to discuss FDA’s draft guidance.
