FDA strengthens device monitoring
Following a 12-month examination of the way medical devices are monitored for safety after approval, the USA’s Food and Drug Administration (FDA) has launched a new programme to ‘transform and strengthen’ current monitoring of new technology as well as existing products.
The FDA Center for Devices and Radiological Health’s (CDRH) Postmarket Transformation Initiative aims to identify, analyse and act on problems more quickly, and alert the public sooner about potential medical device issues.
The Initiative will focus on: Developing an electronic reporting system for adverse medical device events; ways to identify medical devices including standardized and globally accepted names; ways to improve device information in patient records; improved internal collaboration on post market safety issues; and identifying opportunities to improve medical device safety via collaborative efforts with professional organizations and the medical device industry.
Initially, the CDRH’s Medical Device Postmarket Safety Program report, and accompanying recommendations for possible ways to address areas that need improvement, will be reviewed.
This article was published on 03/01/2006