FDA proposal aims to help reduce unnecessary radiation exposure for children

The United States Food and Drug Administration (FSA) recently announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on paediatric patients. It also proposes that manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective in paediatric patients should include a label on their device that cautions against use in paediatric populations. To help health care providers more safely use their current equipment on paediatric patients, the FDA is collaborating with the Alliance for Radiation Safety in Paediatric Imaging (ARSPI) and manufacturers, through the Medical Imaging and Technology Alliance (MITA), to develop paediatric imaging radiation safety training materials. In addition, the FDA has launched a paediatric X-ray imaging website that provides information on the benefits and risks of imaging using ionising 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 ionising radiation, which can be of particular concern in paediatric patients. The cancer risk per unit dose of ionising 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 paediatric 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 Centre 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 16 July 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. Further information is available at: Draft Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications ~sU.S Food & Drug Administration, 9 May 2012

http://www.fda.gov/ ;