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The Journal of Bone and Joint Surgery (American). 2004;86:33-34
© 2004 The Journal of Bone and Joint Surgery, Inc.

Increasing Patient Safety and Orthopaedic Device Quality via Adverse Event Reporting Mechanisms

Michael Tanner, MS and Gloria Bradley, BSN, RN

Corresponding author: Michael Tanner, MS
Barnum Center, PO Box 3005, Birmingham, MI 48012-3005. E-mail
address: mgtanner@beaumonthospitals.com

The first 150 words of the full text of this article appear below.


   Introduction
 
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 . . . [Full Text of this Article]


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