A new study reveals that the majority of medical devices approved by the U.S. Food and Drug Administration (FDA) for use on children have only been tested on adults 18 years or older, with no testing done on children.
The study was conducted by researchers from Brigham and Women’s Hospital and Harvard Medical School, with the results published in Pediatrics. Researchers examined pediatric medical devices that were approved by the FDA between the years 2008 and 2011. There were 25 devices that have been approved for patients 21 years old or younger. Eleven of those devices hadn’t been tested on anyone under the age of 21 years old. And only four of those devices had actually been tested on people less than 18 years of age. To compound the problem, only three of the devices were approved to be used on anyone under the age of 18 years old. The other 22 devices were only approved by the FDA to be used on patients between the ages of 18 to 21 years of age, however these devices are routinely used physicians “off-label” in teenagers and young children since there are no alternative devices that have been approved for those age groups. The study also revealed that despite the FDA adding stipulations to the approval requiring the manufacturers to hold post-market testing, they only required three of these companies to include children in those tests. None of these tests have been completed. In a statement, one of the study’s authors wrote, “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. 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.” If you or someone in your family has been injured by the improper use of a medical device, or the use of a defective or unsafe device, contact an experienced New Braunfels personal injury attorney to find out what compensation you may be entitled to for pain and loss.