Newswatch: March 2006

FDA program aims to improve medical-device safety

The FDA (Rockville, Md) has announced 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, for both new technology and existing products.

According to FDA officials, the Postmarket Transformation Initiative of the FDA's Center for Devices & Radiological Health (CDRH) 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 healthcare and delivery system, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered," said Scott Gottlieb, MD, the 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 postmarket systems that can support safer medical practices, as well as continued innovation."

The initiative will focus on a variety of areas:

• 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 postmarket
• safety issues; and
• identifying opportunities to improve the safety of medical devices through collaborative efforts with professional organizations and the medical-device industry.

FDA officials undertook this initiative after taking a comprehensive, yearlong 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 surrounding medical devices after they reach the market.

The first step of the initiative is to review the CDRH's "Medical Device Postmarket Safety Program" report and accompanying recommendations, looking for possible ways to address areas that need improvement. Recommendations are expected next month.

For more information, visit www.fda.gov/cdrh/postmarket/mdpi.html.