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Graduated Introduction of Orthopaedic Implants: Encouraging Innovation and Minimizing Harm
Michael G. Zywiel, MD1; Aaron J. Johnson, MD2; Michael A. Mont, MD2
1 Division of Orthopaedic Surgery, University of Toronto, 100 College Street, Room 302, Toronto, ON M5G 1L5, Canada
2 Center for Joint Preservation and Replacement, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, 2401 West Belvedere Avenue, Baltimore, MD 21215. E-mail address for M.A. Mont: mmont@lifebridgehealth.org
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Nov 07;94(21):e158 1-5. doi: 10.2106/JBJS.K.01675
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There is continued pressure for the development of innovative orthopaedic surgical devices and techniques to meet the demands of increasingly younger and more active patients. However, as demonstrated by several recent orthopaedic implant withdrawals and recalls, clinically important unknown modes of failure for newly introduced devices may not become apparent for several years after widespread adoption, affecting a large number of patients. Different reasons have been implicated for this problem, including weaknesses in the United States medical device approval process, as well as deficiencies in mechanisms for postapproval implant performance monitoring. Several remedies have been proposed over the past decades. We aim to stimulate discussion concerning the adoption of orthopaedic technology by describing the concept of a graduated implant approval process for orthopaedic devices that builds on recommendations previously made by other authors; by explaining how this will benefit patients, surgeons, and device manufacturers; and by clarifying why the time has come for the orthopaedic community to reconsider the adoption of such a process.

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    Dan A. Zlotolow, MD
    Posted on December 02, 2012
    Graduated Introduction
    Shriners Hospital for Children of Philadelphia

    There are very few devices that have advanced care so dramatically that keeping them from widespread use would have been a disservice to our patients. Most devices offer an incremental improvement, at best, and could do with a limited and gradual introduction. I have been involved in the development of the Scapho-Lunate Axis Method (SLAM) for scapholunate ligament reconstruction (Arthrex, Inc.), and have learned much from the process. Despite over 40 cadaveric trials with biomechanical testing and optimization of the technique in the lab setting, we have seen that surgeons in the real world with real patients are encountering difficulties with the device. Fortunately, most of the difficulties stem from a failure to follow the surgical technique and from user error. However, this raises a serious question: if a successful outcome of a procedure requires strict adherence to the technique, yet most surgeons in real life situations for whatever reason cannot or do not follow the technique, is that device suitable for widespread introduction into the armamentarium? We have pursued a very conscious limited release of our device and have made participating in a webinar mandatory prior to allowing a surgeon to use our device. Despite this, we are seeing surgeons make the same mistakes we made early on in the cadaver lab before working out the kinks. We are now considering making a cadaver lab mandatory before release of the system. Charnley had even more strict requirements, and his hip replacement not only became reproducible, but it also changed Orthopaedics forever. As we are now learning, patience and good stewardship is the key for not only ensuring the safety of a device for our patients, but also for ensuring that well conceived but rapidly introduced devices do not end up on the rubble heap of failed implants.

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