You are being redirected because this document is part of your ASTM Compass® subscription.
    This document is part of your ASTM Compass® subscription.

    If you are an ASTM Compass Subscriber and this document is part of your subscription, you can access it for free at ASTM Compass

    Active Surveillance Systems for Early Detection and Improved Recall Decision Making

    Published: 01 January 2010

      Format Pages Price  
    PDF (236K) 10 $25   ADD TO CART
    Complete Source PDF (41M) 150 $55   ADD TO CART

    Cite this document

    X Add email address send
      .RIS For RefWorks, EndNote, ProCite, Reference Manager, Zoteo, and many others.   .DOCX For Microsoft Word


    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