FDA is seeking comment on a proposal that would encourage manufacturers to consider children’s safety in the design of new x-ray imaging devices. In a draft guidance, the agency recommends that manufacturers design new x-ray imaging devices with protocols and instructions addressing use on pediatric patients. The draft also proposes that manufacturers who don’t adequately demonstrate that their new x-ray imaging devices are safe and effective in pediatric patients should include a label on the device cautioning against use in pediatric populations.

An agency news release says that 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. It also says the agency has launched a pediatric x-ray imaging website with 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 on February 10, the release says.

The cancer risk per unit dose of ionizing radiation is generally higher for younger patients than adults, FDA says, 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.

A July 16 FDA workshop will bring together industry, x-ray imaging equipment users (physicians, radiologic technologists, and physicists), and patient advocates to discuss the draft guidance.