Most FDA-Approved Medical Devices for Children Aren’t Tested on Them

A new study shows that despite some medical devices’ approval for use in children, most aren’t tested on them. Those that do may limit testing on pediatric patients.

This is in spite of efforts to increase studies on children. In 2007, Congress passed the Pediatric Medical Device Safety and Improvement Act. Yet clinical trials for these devices include just 10 percent of pediatric participants. Including children in testing not only helps show the device’s effectiveness, but also its level of safety.

In this recent study, researchers looked at high-risk medical devices marketed to children. The U.S. Food and Drug Administration (FDA) approved 84 percent of them, even with little or no testing. In fact, less than 5 percent of participants in the studies were children.

Most were heart devices, such as stents and implantable cardiac defibrillators. But they included other medical devices for spinal surgery and severe asthma. Eighty-eight percent of the class III, or high-risk, devices were tested on adults 18 and older only. This is allowed to happen because the FDA Center for Devices and Radiologic Health considers those aged 18-24 children.

Medical devices manufactured for adults but later approved for children raise safety concerns. Researchers believe physicians should take this into account when deciding to use them for treatment.

It also highlights the fact manufacturers don’t develop devices designed for children. The number of pediatric patients needing medical devices is much less than adults, but there’s still a market. Asking your physician about any trials performed using a medical device before it is used on your child is one great way to secure your child’s physical health.

Medical experts point out that it’s not just devices leaving out children in studies. They suggest that approximately 80 percent of medications don’t involve them in clinical trials.

Filing a Product Liability Claim for Injuries Sustained by a Medical Device 

Whether it’s an adult or child, any defective medical device could lead to a claim if it causes injuries. These types of product liability cases stem from defective manufacturing and/or defective designs. But they also could include off-brand marketing of the medical device. To stay apprised of recalls and defective products, sign up for our monthly newsletter, Torts and More.

Related Posts