Improving Pediatric Medical Devices with

Better Testing By Paul Barach

Paul Barach is a widely published author, researcher, and consultant in patient safety, quality improvement and human factors. As principal at J. Bara Innovation Inc., Paul Barach works with professional and academic institutions to improve the quality of health care and medical instrumentation nationwide. He has written extensively about medical device safety, pediatric sedation, alarm fatigue and safe medication administration.

Introduction

According to a study conducted by Harvard Medical School, most pediatric medical devices are not tested on children before being marketed. In fact, since the Pediatric Medical Device Safety and Improvement Act was passed by Congress in 2007, children only accounted for 10 percent of test subjects in clinical trials. The Harvard study examined 25 devices approved by the FDA between 2008 and 2011 designed to diagnose or treat conditions in patents under the age of 21.

Device Testing

The study found that of the 25 devices, the FDA approved three to treat patients under 18, and the rest were approved to treat patients under 21. However, of these devices, only four were tested on patients under 18. Since the bodies of children function differently than those of young adults, the FDA believes that companies must invest more time and effort into ensuring that medical devices are safe for children.

Conclusion