FDA to Enhance Monitoring of Medical Device Safety

February 1, 2006 -- The Food and Drug Administration is developing new guidelines to improve the monitoring of medical devices, such as surgical tools, implants, and diagnostic imaging equipment, after the devices appear on the market. Implementation of the guidelines will allow the FDA to more rapidly identify and act upon safety concerns.

Incomplete and inaccurate information interferes with FDA’s ability to quickly spot defective medical devices and report safety concerns. To improve this, FDA plans to establish universal codes for all devices approved for use on the market and will require manufacturers and hospitals to report device problems through a database instead of through current paper reporting methods.

The guidelines also include provisions that will allow FDA to better alert the public to safety issues. The agency plans to make safety information more accessible by increasing and improving Internet-based resources, as well as more quickly inform media outlets about faulty devices.

An Institute of Medicine report, Safe Medical Devices for Children, recommends similar initiatives to improve the safety of medical devices, particularly those used with children FDA should increase its interactions with industry and health professionals to better connect safety reports, electronic medical information systems, and current FDA databases, the report states. In addition, information resources on medical device safety, particularly for devices used at home, should be expanded for patients and their families.

• Safe Medical Devices for Children (2005)

• FDA News Release
• Medical Device Postmarket Transformation Initiative