Majority of Pediatric Medical Devices Not Tested on Children | Shapiro, Washburn & Sharp

A recent study by researchers from Brigham and Women’s Hospital and Harvard Medical School has uncovered the majority of pediatric medical devices approved by the U.S. Food and Drug Administration (FDA) are only tested on adults.

The study examined the records of 25 different medical devices that had been approved for children between the years 2008 through 2011. The data revealed that 11 medical devices had never been tested on any patients age 21 and under and only four of the devices had been tested on patients who were under the age of 18.




Only three of the devices had actually been approved by the FDA for children under the age of 18. The rest of the products were approved only for 18 to 21 year old patients. However, because the FDA considers this age group (18 to 21) as pediatric, many of these devices are used “off-label” in younger children. “Off-label” means the device is being used in a manner not specified in the FDA’s approval. The reason given for using an off-label device on a young child is because there is no alternative device to use.

Almost all of the devices received FDA approval with a stipulation that the manufacturer conduct testing post-market to determine its level of safety. The agency required only three of the devices actually be tested on children. However, the study found that no testing on any of these devices had ever been done after FDA approval.

If you or a loved one has been injured from a defective medical device or other defective product, contact a Virginia personal injury attorney to find out what legal recourse you may have for pain and loss.