A new study has found that most pediatric medical devices were never actually tested on children. The researchers analyzed data from the main clinical trials for 25 devices recently approved for use in patients under 21. 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.
“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. “Designing devices for children is more complex because they are still growing and may need to have the device for many decades, in contrast to older adults,” said Dr. Katherine Bates, a cardiology fellow at The Children’s Hospital of Philadelphia. Without testing the device in children, it’s impossible to say how the device will perform long term, but it can be difficult to enroll children with rare diseases in clinical trials for both practical and ethical reasons.
“Generally people in the clinical trials tend to be healthy middle-aged white men,” said Dr. Rita F. Redberg, who was not involved with the new study. “Common sense would dictate that devices would be studied in the appropriate populations before they are used on the market,” she said.
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