New FDA Draft Proposal On X-Ray Imaging For Children
May 10, 2012

New FDA Draft Proposal On X-Ray Imaging For Children

Connie K. Ho for

The U.S. Food and Drug Administration (FDA) recently announced a proposal to encourage X-ray manufacturers to consider children´s safety in the development of new imaging devices.

The FDA is recommending that manufacturers who create new X-ray imaging devices include protocols and instructions for use on pediatric patients. The draft proposal by the FDA also advocates that companies who cannot demonstrate safe and effective use of the X-ray imaging devices on pediatric patients should have a label on the device that warns medical personnel against using the device on children.

The Alliance for Radiation Safety and in Pediatric Imaging (ARSPI), the FDA, and manufactures are collaborating on this new initiative to develop safety training materials on pediatric imaging radiation. According to the FDA, the X-ray machines currently only have settings for adults. The organization also has a website that includes a section on the advantages and disadvantages of imaging that has ionizing radiation, advice for parents and health care provides on how to reduce unnecessary radiation exposure, and information for the manufactures of x-ray imaging devices to consider. They are working on the project through the assistance of the Medical Imaging and Technology Alliance (MITA).

"Imaging is very important. It saves lives," commented Dr. Marta Hernanz-Schulman, chair of the American College of Radiology Pediatric Imaging Commission and a professor of radiology and pediatrics at Monroe Carell Jr. Children's Hospital at Vanderbilt (, in an article by U.S. News. "Like any tool, it needs to be used judicially; like any other tool, it's not a panacea."

Since February 2010, the FDA has worked on the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. This includes the collaboration among the ARSPA and MITA as well as the production of the website and guidance information.

"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 organized noted in a statement that was mentioned in U.S. News. "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."

The FDA believes that the X-ray imaging, such as CT, conventional X-ray, and fluoroscopy, can provide beneficial information to patients in regards to diagnosis, surgical intervention, and treatment planning. However, similarly, the X-ray imaging can cause patients to be exposed to ionized radiation. According to the FDA, the cancer risk for every unit of iodizing radiation is higher for younger patients than adults. Young adults and children, especially, have a longer lifetime for the effects of radiation to show.

“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,” noted Dr. Jeffrey Shuren, director of the FDA´s Center for Devices and Radiological Health, in a prepared statement. “Parents should engage in a discussion with their child's physician about benefits and risks of X-ray, computed tomography (CT), and fluoroscopy exams.”

Those in the medical field believe that this is a step in the right direction and that proposal will allow hospital personnel to customize dosages for each patient.

"The doses that children are getting are much, much higher than anyone realizes," remarked Radiologist Smith-Bindman in an article by USA Today. "Doses are not being appropriately reduced."

The FDA is planning a workshop in July to bring together industry; patient advocates; as well as X-ray equipment users like physicians, physicists, and radiological technologists to examine the FDA draft proposal.  The draft proposal will be open to public comments for four months, after which the guidelines become final.