Few medical devices have been specifically approved for use in children. The passage of the 2007 Pediatric Medical Device Safety and Improvement Act was designed to combat the problem of approving of medical devices for use in children without pediatric testing. Despite the government’s intentions, most medical devices approved for pediatric use since the Act was passed have not been tested on children. Almost all pediatric medical devices are solely 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; however, trials don’t have to include the same type of patients that will use the device. Pediatrics also spans a very board spectrum from infant to adolescent, and even then kids can vary significantly in growth and development despite their ages.
“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,” said Brigham and Women’s Hospital and Harvard Medical School research fellow Thomas J. Hwang, one of the authors of a study published in Pediatrics earlier this year.
Four Factors that Complicate the Use of medical devices in Children:
- Depending upon the age of a child, he or she may be still growing and experiencing bodily changes that can potentially make an implanted device require adjustments.
- Children can need to use the device for longer than an adult would since they are younger and ideally live longer lives.
- The smaller size and weight of a child may make it complex or even impossible for their little bodies to hold some medical devices.
- Children are active and often get hurt and this can damage implanted devices.
Talk to Your Medical Provider
Parents must be diligent about talking to doctors about medical devices recommended for their children. When considering using a device, ask your child’s doctor whether the device is suitable for a child your child’s age and size. If your child was harmed by the implantation of a medical device, you should contact an experienced products liability lawyer today.