Institute of Medicine Findings Reinforce Need for Improved Oversight of Children's Medical Devices

Institute of Medicine Findings Reinforce Need for Improved Oversight of Children's Medical Devices

U.S. Rep. Diana DeGette (D-CO) today called on the government and manufacturers to improve oversight of children's medical devices. This comes in the wake of an Institute of Medicine (IOM) report, requested by Rep. DeGette, that found the monitoring and public reporting of children's medical devices was inadequate to ensure that the devices safe and used appropriately.

"Having worked on children's health issues for many years, it became increasingly clear that too many medical device manufacturers viewed children as simply miniature adults. Unfortunately, the Institute of Medicine found that this concern is justified," said Rep. DeGette. "The current system of FDA and industry monitoring medical devices for children falls is inadequate. While I'm still reviewing the details of the report, at the very least, it provides a basic outline of what we need to change."

The Institute of Medicine report highlighted several shortcomings in the current system, including:

• Insufficient Food and Drug Administration monitoring and public reporting of studies of children's medical devices;
• Inadequate reporting of adverse events;
• Poor coordination between doctors, medical device manufacturers and patient groups and families for monitoring of home-use medical devices;
• And the absence of a system to track children's medical devices if users need to be contacted or a recall is necessary.

The Institute of Medicine report is online at www.iom.edu/report.asp?id=28277.

http://www.house.gov/apps/list/press/co01_degette/050718b.html