Pediatric Medical Devices Often Only Tested On Adults: Study

While many high-risk medical devices are commonly used on pediatric patients, a new study indicates that many of them are never actually tested on children. 

In a report published this month in the medical journal Pediatrics, researchers reviewed 25 high-risk medical devices commonly used on children, such as stents and artificial heart valves. Although the devices were approved for use in children under 21 years of age, either through pre-market approval or through a humanitarian device exemption between 2008 to 2011, researchers determined that nearly half were never tested on patients under the age of 21.

Four out of the 25 devices were tested on patients under the age of 18, and only three were approved by the FDA for use on children under 18, but were still being prescribed for use in children nevertheless.

The remaining devices were approved for use in patients aged 18 to 21, an age group which the FDA Centers for Devices and Radiologic Health considers pediatric. Those devices are also commonly used on children younger than 18.

Of the 25 researched, 21 devices were not studied on any patients under the age of 18. The researchers analyzed data from the initial clinical trials.

Thomas J. Hwang, research fellow from Brigham and Women’s Hospital and Harvard Medical School, and the team of researchers found in most cases the clinical trials were observational; instead of more thorough randomized controlled trials.

Pre-market approval allows devices to enter the market with a stipulation that manufacturers conduct post-market trials once the devices are being used by patients.

The FDA mandated post-market studies for 19 of the devices. Most of those studies were not conducted and only three required the enrollment of pediatric patients.

Overall, researchers found very few pediatric patients were exposed to the devices prior to approval and widespread market availability. Researchers warn many devices approved for older adolescents are likely being used off-label for much younger children.

The FDA requires manufacturers show at least one clinical trial revealing the device is safe and effective before it can be used on patients.

The trials, however, do not need to include the same demographic of patient who will use the device. In many cases, pediatric devices are tested on healthy, middle aged white men.

Health experts warn against blanket use of these devices on pediatric patients, noting that children cannot be treated and prescribed in the same way as adults.

Experts say the common misconception is that children’s bodies behave just like adults, only smaller. However, a child’s body may react quite differently to different medications, devices and medical procedures based on sensitivities, height, weight, tolerance. Parents and doctors should kept that in mind when considering treatments for children, researchers warn.