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Originally Published MX March/April 2006

BUSINESS NEWS

FDA Launches Medical Device Postmarket Safety Initiative

Following what FDA described as a comprehensive, year-long internal inventory of the tools used to monitor the postmarket safety of medical devices, the agency has announced that it is launching a new "postmarket transformation initiative." The program is designed to "better protect the public health by allowing FDA to identify, analyze, and act on problems more quickly, including alerting the public sooner to potential medical device issues."

In developing the program, FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) considered how postmarket safety problems are identified, how they are assessed, and how the agency responds to problems through both stakeholder communication and enforcement action. In strengthening the agency's postmarket surveillance, CDRH plans to develop the following.

  • A "culture of collaboration" for postmarket safety within CDRH.
  • World-class data sources and systems for quickly and accurately collecting, analyzing, and disseminating information about potential safety risks.
  • Enhanced risk communication efforts.
  • Improved coordination with FDA field staff.

    The transformation initiative will work to establish an electronic reporting system for adverse medical device events, develop unique ways to identify and standardize the names of medical devices, and include more device information in patient records. The program also aims to improve internal collaboration on postmarket safety issues and identify opportunities to improve the safety of medical devices through collaborative efforts with professional organizations and the medical device industry.

    Ubl

    In February, FDA met with industry association AdvaMed (Washington, DC) in the first of a series of public workshops on the postmarket safety of medical devices. "The medical technology industry is committed to providing safe and effective devices and recognizes the value of FDA's role in ensuring device safety both before and once a device is on the market," said AdvaMed president and CEO Stephen Ubl. "We welcome opportunities to work with FDA to find ways to improve and refine existing systems so that patient safety is ensured, and we offer our extensive expertise and commitment to working with FDA going forward."

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