0
Scientific Exhibits   |    
Increasing Patient Safety and Orthopaedic Device Quality via Adverse Event Reporting Mechanisms
Michael Tanner, MS; Gloria Bradley, BSN, RN
View Disclosures and Other Information
The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2004 Dec 01;86(suppl 2):33-34
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Extract

Recent advances in orthopaedic implant development have increased the expected in vivo longevity of such devices and are the result of extensive research and development activities, including the evaluation of orthopaedic implants retrieved at the time of revision surgery1. Therefore, to help to ensure continued innovation, it is important for the hospital to appropriately notify the device manufacturer of adverse events such as implant revisions. In fact, the United States Food and Drug Administration's (FDA) Safe Medical Device Act (SMDA)2 requires the hospital to notify the device manufacturer of adverse events, and an implant revision meets the definition of an adverse event. There is generally perceived to be a low level of provider compliance with adverse event reporting requirements3, which may negatively impact patient safety. For example, higher reporting rates could lead to implant recalls being issued earlier, saving patients from an unnecessary procedure. While physicians generally agree with the importance of adverse event reporting activities4, many are unaware of the reporting tools available to them. This paper will demonstrate how adverse event reporting can affect patient safety and will identify reporting tools that are readily available to members of the health-care industry.
Figures in this Article

    First Page Preview

    View Large
    />
    First page PDF preview
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

     
    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org

    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe





    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Topic Collections
    Related Audio and Videos
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    02/19/2014
    OH - University Hospitals Case Medical Center
    11/15/2013
    LA - Ochsner Health System
    04/16/2014
    GA - Choice Care Occupational Medicine & Orthopaedics
    02/28/2014
    DC - Children's National Medical Center