Dangerous Product Alert: Medical Devices for Children Tested in Adults

According to a recent study, almost all medical devices that have been approved for use in children were not actually tested on children first. The study “Postmarketing Trials and Pediatric Device Approvals” was published in the Pediatrics journal, and discusses how devices can be approved for pediatric use after being tested on subjects between 18–21 years old. The study was meant to see how the 2007 Pediatric Medical Device Safety and Improvement Act is working.  According to an article in Reuters, the lead author Thomas J. Hwang remarked that “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.”