National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative

Art Sedrakyan, MD, PhD; Elizabeth Paxton, MA; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Rebecca Love, MPH, RN; Danica Marinac-Dabic, MD, PhD

12/17/2014

Abstract

Nearly every American will be exposed to a medical device during his or her life, and tens of millions of people will be treated with an implantable device. However, regulatory and public health systems in the United States and internationally have critical gaps. The U.S. Food and Drug Administration (FDA) has released a national medical device postmarket surveillance plan1, in which the agency identifies as a main priority the goal of promoting the development of national and international medical device registries for selected products. Another top priority of the FDA is the creation of a unique device identification (UDI) system for medical devices in response to a 2007 federal law2.

Orthopaedic devices are a good choice for demonstrating the importance of registries and UDI implementation worldwide because they are the most commonly used devices and important for public health3. The experience of DePuy Synthes (Warsaw, Indiana) with ASR (Articular Surface Replacement) implants as well as the recalling of metal-on-metal implants in general are changing our frameworks of evaluation4,5. Coverage in The New York Times6 and articles in high-impact medical journals have highlighted the changes in public perceptions of device safety, device regulation, and available evidence5,7. The public health importance is imminent given that more than 1,100,000 joint replacements were performed in 2011 in the United States alone3. Moreover, a dramatic increase in annual volume seems to match or even outperform projections of more than three million annual joint replacement surgeries by 20308. The costs are also expected to substantially increase8.

The International Consortium of Orthopaedic Registries (ICOR) initiative was launched in 2011 to address the major gap in evidence and data related to implants. The inaugural conference was held …



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