por Brendon Nafziger
, DOTmed News Associate Editor | May 10, 2012
The Food and Drug Administration released draft recommendations Wednesday for manufacturers making X-ray equipment that will be used on children suggesting, among other things, that products without data showing they're safe for use with kids should be labeled accordingly.
The guidance document, which applies to traditional X-rays, mobile X-rays, CT scanners, fluoroscopy units and dental X-rays, is not legally binding, but rather reflects the agency's "current thinking" on the topic, the FDA said.
The pediatric population is especially at risk with ionizing radiation, the agency said. Youngsters are more radiosensitive than adults, and as they have more years ahead of them, there's more time for radiation-induced cancers to grow. Also, using adult settings for equipment to scan children can result in exposing these much smaller patients to more radiation than necessary to obtain good images.
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The FDA advises manufacturers looking to sell a device to be used on children to provide data showing it's safe and effective with pediatric populations. Companies that don't provide the data, or only want general marketing indications, should attach a label to the device cautioning against its use with children. According to the document, the sample label should read: "CAUTION: Not for use on patients less than approximately [insert patient size (e.g., body part thickness or height and weight appropriate to your device)]."
The agency also recommends including various features to bolster safety for use in children, such as pre-set prediatric control settings.
The FDA said it was working on an initiative to develop pediatric imaging radiation safety training manuals with the Alliance for Radiation Safety in Pediatric Imaging, which runs the "Image Gently" campaign, and MITA, a manufacturers lobby. It has also scheduled a day-long public workshop on the topic, to be held July 16 on the FDA's campus in Silver Spring, Md.
For its part, in a statement MITA said it would review the document, and that it looks forward to "ongoing cooperative efforts with the FDA."
The FDA is accepting comments on the guidance document for the next 120 days. To read the document, go here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm#6