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FDA promotes radiation safety in your children

Jenny Decker RN's picture

The FDA is promoting radiation safety in your children through an initiative on reducing unnecessary imaging.

Children are more likely to have adverse risks from ionizing radiation than adults, and there are specific reasons why. The FDA has teamed up with the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) and some manufacturers of the imaging equipment to set up protocol and safety instructions for using x-rays in the pediatric populations. Another group the FDA has collaborated with on the initiative is the Medical Imaging and Technological Alliance or the MITA. The whole of these groups has worked on developing pediatric imaging and x-ray safety training materials for those professionals that are on the forefront, providing and performing these imaging services.

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Some of the issues addressed in the FDA proposal includes manufacturers designing equipment that can be specific towards the imaging of children or including instructions on the medical imaging device on how to adapt settings for pediatric patients. If this cannot be done, then a warning label should be included on the machine itself, as well as specific training for those doing the imaging. This is crucial in decreasing the risks for development of cancer in children related to the levels of ionizing radiation.

Adults require higher levels of ionizing radiation in order for a clear picture to be obtained. However, these levels are too high for children. The FDA’s Center for Devices and Radiological Health have stated that the pediatric population for the ionizing imaging should be consider birth through age 21. However, it also states that size of the person is much more important due to the ability of the body to rid itself of the radiation. Adults are able to rid themselves easier than children and children hold those levels for longer periods, thus they are at higher risk of developing cancer as a result of the imaging procedures performed in their early lives. Height and weight are the biggest factors in determining what levels would be appropriate in order to obtain the clear picture needed to diagnose and treat.

Jeffrey Shuran MD, director of the FDA’s Center for Devices and Radiological Health recommends that parents have a discussion with their physician about the benefits and the risks to determine if the imaging should be done. However, he states that the risks are relatively low in comparison to the need for diagnosis and treatment in most cases. It is wise to be aware of the benefits and risks of radiological exposure in order to make educated decisions.

A workshop is planned for July 16, 2012 to bring the whole industry of ionizing imaging together to discuss pediatric safety. This is part of the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging as a result of the 2007 law passed by Congress. This law was the FDA Amendments Act of 2007, Title III, the Pediatric Medical Device Saftey and Improvement Act (PMDSIA). This requires that information about the pediatric subpopulations that suffer from a disease or condition that requires imaging that is intended to treat, diagnose, or cure be submitted for review. Experts have maintained that many of the devices do not have the design features or labeling to note that they are inappropriate for pediatric patients. This is a great concern for benefits versus risks in children.