Subspecialty Theme Collection - April
Evidence-based orthopaedics posits the inclusion of best evidence in clinical decision-making. However, its practice is often hampered by orthopaedic implants/devices that have been introduced to the marketplace with little supportive clinical data.
The path to approval is regulated in North America by the FDA/Health Canada. The FDA faces enormous challenges and is charged with evaluating thousands of new medical devices yearly. To meet their mandate, 99% of new device applications are cleared via the 510(k) process. This emphasis on comparing new devices to pre-existing devices directs manufacturers’ resources away from issues of safety and effectiveness and towards the question of "substantial equivalence," a concern that is only important within the narrow scope of FDA regulation. As a result, many devices are approved without any clinical data while post-market surveillance is continually plagued with under-reporting.
The Canadian Orthopaedic Association’s Annual Meeting held in St. John’s, Newfoundland in July 2011 highlighted this issue in a symposium entitled, “Adverse Events and Monitoring New Implants.” With an experienced faculty of surgeons and epidemiologists (Drs. Michael McKee, Peter Kay, Robert Bourne, John Antoniou, and Dirk Stengel), we explored the challenges with the current systems for monitoring implants and proposed alternatives to maximize patient safety. Their presentations are published here as the April Subspecialty Theme Collection.
Mohit Bhandari, MD, FRCSC
Adverse Events and Monitoring New Implants – Symposium Moderator
McMaster University, Hamilton, Ontario, Canada
Articles in the Monitoring New Implants series will be available according to the schedule below, with one or more articles released each week during the month.