Tuesday, April 15th, 2014
Medical devices, including artificial heart valves and other cardiac devices, which were recently approved for use by children are often only tested on adults, according to a new study. Reuters has more:
Almost all of the devices had only been tested on people age 18 and older, researchers found.
“Children are not simply ‘small adults,’ and a device found to be safe and effective in adults may have a very different safety and effectiveness profile when used in a pediatric population,” said Brigham and Women’s Hospital and Harvard Medical School research fellow Thomas J. Hwang, one of the study’s authors.
“Without this data, it is difficult for clinicians and parents to make informed treatment decisions that weigh the risks and benefits of a particular treatment,” he told Reuters Health in an email.
The new study examined what kind of testing has been done on medical devices meant for kids since an act of Congress incentivized their development seven years ago.
The researchers considered the 25 medical devices that were approved by the U.S. Food and Drug Administration (FDA) for use in patients age 21 and under between 2008 and 2011. They looked at data from the main clinical trial that was used to get each device approved.
According to those data, 11 of the 25 devices were not tested on any patients age 21 and under. Only four of the devices had been tested on patients under age 18.
Three of the devices included in the study were specifically approved for kids under 18; the rest were approved for 18- to 21-year-olds, who the FDA devices center considers pediatric. However, researchers said devices only approved for older adolescents are likely used “off-label” in younger children, as there typically aren’t any alternatives.
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