The US Food and Drug Administration (FDA) is launching a new programme to transform and strengthen the way it currently monitors the safety of medical devices after they reach the market, both new technology and existing products.

The FDA Centre for Devices and Radiological Health's (CDRH) Postmarket Transformation Initiative will better protect the public health by allowing the FDA to identify, analyse and act on problems more quickly, including alerting the public sooner of potential medical device issues.

"Over the next decade, medical technology innovations will fundamentally transform the health care and delivery systems, providing new solutions with medical devices that will challenge existing paradigms and revolutionise the way treatments are administered," said Dr. Scott Gottlieb, FDA's deputy commissioner for medical and scientific affairs.

"Under the leadership of our device centre's expert staff, we are working to develop even better ways to evaluate new technologies to maximize benefits and minimise risk, including more efficient ways to develop more effective post-market systems that can support safer medical practices as well as continued innovation," added Gottlieb.

This initiative will focus on working toward an electronic reporting system for adverse medical device events; unique ways to identify medical devices including standardised and globally accepted names and improve device information in patient records. It will improve internal collaboration on post market safety issues; and identify opportunities to improve the safety of medical devices through collaborative efforts with professional organisations and the medical device industry.

The FDA undertook this initiative after a comprehensive, year-long internal inventory of the tools used to monitor the safety of medical devices after they are approved. This inventory identified many areas that are working well; however, it also identified challenges associated with medical devices after they reach the market, added the release.

"With this initiative, FDA intends to improve the way it monitors the safety of medical devices and provide a strong safety net to protect public health," said Daniel Schultz, director, Centre for Devices and Radiological Health.

To guide this process, the CDRH Postmarket Transformation Leadership Team has been established consisting of senior level FDA management as well as outside consultants who are experienced in device safety and product regulation. As the first step, the team will review CDRH's Medical Device Postmarket Safety Program report and accompanying recommendations for possible ways to address areas that need improvement.

The CDRH Postmarket Transformation Leadership Team is expected to have recommendations back to CDRH within approximately four months.