Children’s medical devices tested on adults

by

A study has found that most recently approved children’s medical devices have been tested in adults first. The study published by US journal Pediatrics, Postmarketing Trials and Pediatric Device Approvals, said that researchers found almost all of the devices had only been tested on people age 18 and older.

The study examined the type of testing that had been carried out on medical devices designed for children since an act of Congress incentivised their development in 2007.

"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 paediatric population," Thomas J Hwang, one of the study's authors, told Reuters. He is a research fellow at Brigham and Women's Hospital and Harvard Medical School.

"Without this data, it is difficult for clinicians and parents to make informed treatment decisions that weigh the risks and benefits of a particular treatment," he added.

Out of  25 medical devices that were approved by the US Food and Drug Administration (FDA) for use in patients age 21 and under between 2008 and 2011, 11 were not tested on any patients age 21 and under and only four of the devices had been tested on patients under the age of 18.

Back to topbutton