The FDA announced a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. They are 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 follow their recommendation 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. This website provides information on both 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.
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equipment users (e.g., physicians, radiologic technologists, and physicists), and patient advocates to discuss FDA’s draft guidance.