FDA Announces New Program to Transform and Strengthen Medical Device Safety

In the wake of the recent and too-numerous-to-count recalls of medical devices, the FDA announced on January 20, 2006 that it is launching a new program 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 Center for Devices and Radiological Health’s (CDRH) Postmarket Transformation Initiative will better protect the public health by allowing the FDA to identify, analyze 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 system, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered,” said Dr. Scott Gottlieb, FDA’s Deputy Commissioner for Medical and Scientific Affairs. “Under the leadership of our device center’s expert staff, we are working to develop even better ways to evaluate new technologies to maximize benefits and minimize risk, including more efficient ways to develop more effective post-market systems that can support safer medical practices as well as continued innovation.”

Areas in which this initiative will focus include:

Working toward an electronic reporting system for adverse medical device events;
Unique 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 the safety of medical devices through collaborative efforts with professional organizations 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.

“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, M.D., Director, Center 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.

See CDRH’s Medical Device Postmarket Safety Program or Medical Device Postmarket Safety Program – Synopsis and Recommendations.