Active Surveillance Systems for Early Detection and Improved Recall Decision Making

    Volume 6, Issue 10 (November 2009)

    ISSN: 1546-962X

    CODEN: JAIOAD

    Published Online: 22 October 2009

    Page Count: 7


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

    (Received 30 October 2008; accepted 8 September 2009)

    Abstract

    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.


    Paper ID: JAI102204

    DOI: 10.1520/JAI102204

    ASTM International is a member of CrossRef.

    Author
    Title Active Surveillance Systems for Early Detection and Improved Recall Decision Making
    Symposium Presented at the ASTM Second Symposium on Fatigue and Fracture of Medical Metallic Materials and Devices, 2008-05-07
    Committee E08