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(Ivanhoe Newswire) Children who undergo routine heart tests are often treated with devices that have only been approved for use in adults.
In a review of the medical records of 473 kids who underwent 595 of these procedures at Cincinnati Childrens Hospital Medical Center, 63 percent were tested with devices approved only for adults. Some procedures were more likely to be done with an adult device than others. For example, 99 percent of stent implantations were performed with an adult device. Balloon dilations were performed with an adult device 78 percent of the time.
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The use of devices approved only for adults deemed off label use by doctors is a common practice, because many devices never go through testing in children before they go on the market. These researchers believe more needs to be done to ensure more devices are tested in the pediatric population before they are used on kids.
There is a lack of regulatory oversight to assure device safety and efficacy, and industry is economically unable to refine devices for off-label pediatric applications, study author Robert Beekman, M.D., was quoted as saying. Children deserve to benefit from new and refined cardiac devices designed explicitly for their conditions.
He calls on the medical community to work more closely with the medical industry and Food and Drug Administration to make this happen.
SOURCE: Presented at the American College of Cardiology meeting, March 30, 2009
If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Melissa Medalie at mmedalie@ivanhoe.com
This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.
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