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    Active Surveillance Systems for Early Detection and Improved Recall Decision Making

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    Medical device recalls have received significant publicity regarding the timeliness and breadth of the response by the manufacturer. It has been suggested that third party oversight and enhanced public disclosure would improve the recall process. This paper discusses the limitations of passive surveillance systems and proposes new active surveillance systems to support early detection and improved recall decision making. This paper also describes additional benefits of obtaining surveillance information to support iterative design changes and product enhancements.


    recall, surveillance, medical device, implants

    Author Information:

    Tolomeo, Deborah
    Attorney, RAC, King & Spalding, LLC, Redwood Shores, CA

    Committee/Subcommittee: E08.03

    DOI: 10.1520/STP48993S