Many Medical Devices for Children Only Tested on Adults
Pediatric Devices Untested on Children
“Common sense would dictate that devices would be studied in the appropriate populations before they are used on the market.” – Dr. Rita F Redberg, Editor of the Journal of the American Medical Association as published by Reuters
According to Reuters, researchers analyzed testing data of all 25 medical devices approved by the U.S. Food and Drug Administration (FDA) for use in patients under the age of 21 between 2008 and 2011.
The information was gathered from the main clinical trial that was used to get each of the devices approved for the U.S. market. The researchers found that 11 of the 25 devices were never tested on any patients under the age of 21, and that only four of the devices had been tested on patients under the age of 18.
Three of the devices examined by the researchers were approved specifically for use in children under the age of 18 and the rest were approved for 18 to 21 year-olds. The FDA considers any patients under the age of 21 a pediatric patient.
Additionally, the researchers claimed that devices only approved for older adolescent patients (i.e. patients between the ages of 18 and 21) are likely used as “off-label” treatments in younger children.
While most of the devices were approved with a stipulation requiring that device makers conduct postmarket trials, only three required that children be included in the trials – none of which were every completed.
Problems with the Approval Process
“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.” – Thomas J. Hwang, research fellow with Brigham and Women’s Hospital and Harvard Medical School as published by Reuters
Dr. Katherine Bates of the Children’s Hospitals of Philadelphia, designing a medical device for children is different, and much more complex, than designing a device for adults as children are still growing and may require the device for a longer period of time.
While the FDA normally requires at least one clinical trial proving the safety and efficacy of a device before approval, clinical trials are not required to include the type of patients that will be receiving the device once it hits the market.
Further, there is an exemption from the approval requirements for devices that support or sustain life in patients with rare diseases – such devices only need to demonstrate safety and a probable benefit. Previously, such devices would not be sold for profit; however, in 2007, Congress eliminated the profit restriction for devices intended for children and set up grants for nonprofit pediatric device developers.