Medical devices have proven useful in the treatment of a variety of diseases, but few of them have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to encourage pediatric device development. Most medical devices approved for pediatric use since the Act was passed were never tested on children, according to a new study. Almost all pediatric medical devices considered had solely been tested on people age 18 and older.
The FDA requires at least one clinical trial that shows a device is safe and effective before approving it for use with patients. But the clinical trials don’t necessarily have to include the same type of patients that will be getting the device in the real world. Many in the medical and scientific community find that devices are under-tested in women, the elderly, and children, with middle-aged white males comprising the majority of study subjects.
The article’s researchers considered 25 FDA-approved medical devices for use in children. Only three of these medical devices were specifically approved for kids under 18. 15 of the 25 devices were not tested on younger patients (under age 18) at all; the rest were approved for 18- to 21-year-olds, considered by the FDA devices center to be pediatric. To make matters worse, devices approved for older children are often used “off-label” in younger children, as there are often no viable alternatives. Only three pediatric medical devices even required post-market testing on children, and none was completed.
Parents should talk to their doctors about any devices recommended for their children, and ask about how safe the product is for use in children and how much evidence there is that the device will be effective. When considering using a device, read the label and talk to your child’s doctor about whether the device is appropriate for your child’s age and size. Another consideration is your child’s ability to tolerate the device for the length of time it may be used. Once implanted, children need to take care to protect their device. Be sure to learn the specific signs of infection to watch for and other safety measures to make certain your child and their device stay safe.