ASTM WK44529

    Work Item: ASTM WK44529 - Revision of F2943 - 13 Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty

    (What is a Work Item?)

    Active Standard: F2943 - 13

    Developed by Subcommittee: F04.22 | Committee F04 | Contact Staff Manager



    1. Rationale

    Recognizing the role variable implant package label formatting has on selection of orthopedic implants, we believe expanding this standard to include all orthopedic implants will have a significant and positive impact on patient safety. This rationale is supported by the AAOS through member surveys and anectodal observations by hospital organizations participating with this standards development. After distributing the proposed changes to the standard and soliciting feedback. The standard is being submitted for formal ballot with the following changes. See the included document for additional details


    Keywords

    end of the box; end user; implants; labels; size;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    01-02-2014

    Technical Contact:
    Kent Lowry, MD

    Item:
    012

    Ballot:
    F04 (14-01)

    Status:
    Ballot Item Approved as F2943-2014 and Pending Publication