|
Manufacturers asked to take their safety into account with use ofmachines, design of new scanners. By Steven Reinberg HealthDay Reporter WEDNESDAY, May 9 (HealthDay News) -- In an effort to make surechildren are not exposed to any more radiation than necessary whenthey get X-rays or CT scans, the U.S. Food and Drug Administrationhas asked the makers of these devices to factor in the safety ofpediatric patients when using existing machines and designing newones. And if the manufacturers of these scanners can't show theirequipment is safe for children, the FDA wants labels on themachines that say so. The agency released its recommendations on Wednesday, and therewill be a four-month period of public comment before the guidelinesbecome final. X-ray imaging, such as CT scans, conventional X-rays andfluoroscopy, are a valuable way of diagnosing problems anddeveloping treatments, and they can be essential before surgery,the agency noted in a statement. However, the exposure to ionizing radiation can, over time, raisethe risk of cancer, and high doses of radiation may be problematicin children. "Imaging is very important. It saves lives," said Dr. MartaHernanz-Schulman, chair of the American College of RadiologyPediatric Imaging Commission and a professor of radiology andpediatrics at Monroe Carell Jr. Children's Hospital at Vanderbiltin Nashville, Tenn. "Like any tool, it needs to be used judicially;like any other tool, it's not a panacea." "Children are not little adults," Hernanz-Schulman added. "Theirbodies are more sensitive to radiation, because they are growing,so when the cells are dividing they are more sensitive to theeffects of radiation." In addition, children actually absorb more radiation when they aregiven adult doses, she added. "Most of the effects of radiation are felt decades down the line,"Hernanz-Schulman said. The cancer risk of ionizing radiation is higher for children thanadults, and since the effects of radiation are cumulative childrenhave a longer time for the effects of radiation to show up, the FDAnoted in its statement. Also, X-ray equipment settings designed for adults can cause alarger radiation dose than needed to produce an image in children,the agency added. "The FDA is giving guidelines to manufacturers who are veryinterested in doing the right thing and providing people with whatwe need," Hernanz-Schulman said. Getting the manufacturers to make devices that can be easilyadjusted for children is a good thing. In addition, themanufacturers need to be available to educate doctors on how to usethe equipment for children, Hernanz-Schulman said. "The risk from a medically necessary imaging exam is quite smallwhen compared to the benefit of accurate diagnosis or intervention.There is no reason for patients who need these exams to avoidthem," Dr. Jeffrey Shuren, director of FDA's Center for Devices andRadiological Health, said in the statement. "Parents should engagein a discussion with their child's physician about benefits andrisks of X-ray, computed tomography (CT) and fluoroscopy exams." Parents should ask their doctor if the procedure is necessary orwhether there are different tests that can get the same informationwithout radiation, such as ultrasound or an MRI, Hernanz-Schulmanexplained. In addition, parents need to keep track of the tests done and theradiation levels used so they can show doctors when tests arerecommended and when their child is seen at different facilities,she said. The American College of Radiology recommends that parents ask theirpediatrician or other provider who orders a scan the followingquestions: How will the scan improve my child's care? Are there alternatives that don't use radiation? Is the facility accredited by the American College of Radiology? Will the radiation dose be "child-sized"? The Medical Imaging & Technology Alliance (MITA) applauded theFDA proposal. "MITA is proud to be a long-time collaborative partner with the FDAon initiatives to ensure the safe and effective use of medicalimaging equipment," the association said in a statement Wednesday."Our efforts have included contributing to the development ofpediatric radiation safety training materials and conveningstakeholders to explore ways to prevent medical errors that involveradiation. MITA looks forward to providing comments on the guidancereleased today to help reduce unnecessary radiation exposure forchildren." More information For more on imaging tests, visit the U.S. National Library of Medicine . SOURCES: Marta Hernanz-Schulman, M.D., chair, American College ofRadiology Pediatric Imaging Commission, professor, radiology andpediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt,Nashville, Tenn.; May 9, 2012, U.S. Food and Drug Administration,press release; May 9, 2012, statement, Medical Imaging &Technology Alliance Copyright © 2012 HealthDay . All rights reserved. The e-commerce company in China offers quality products such as AAA LED Flashlight , China Focusing LED Flashlight, and more. For more , please visit AA Battery LED Flashlight today!
Related Articles -
AAA LED Flashlight, China Focusing LED Flashlight,
|
