A blog by Zoll, Kranz and Borgess, the drug and medical device advocates for safety, on the search for justice for those who suffered hip failures. Call us today TOLL FREE at (888) 841-9623 for more information or visit our DePuy ASR hip recall site.

Tuesday, April 12, 2011

Finally a U.S. National Joint Replacement Registry

Developed countries worldwide have had some form of a national registry for joint replacement, beginning as early as the late 1970s in Sweden, with most having established one by the early 2000s. In 2010, the UK National Joint Registry exceeded its millionth record in the registry, making it the largest in the world.

The benefits of such registries have been well established. For instance, the Swedish joint registry is credited as having reduced the revision rate for hip surgery in Sweden to 8%, which at the time compared to an 18% revision rate in the United States. See Herberts P, Malchau H. Long-term registration has improved the quality of hip replacement: a review of the Swedish THR Register comparing 160,000 cases. Acta Orthop Scand. 2000; 71(2):111-121; Herberts P, Malchau H. How outcome studies have changed total hip arthroplasty practices in Sweden. Clin Orthop Relat Res. 1997; (344):44-60. Further, it was the Australian Registry that first identified and raised concerns regarding the safety of DePuy ASR implants bases on its registry data.

Now, trailing behind, the US has announced the initiation of its own national registry. Reporting will be of level 1 patient data, which would include basic patient identifying information, type of procedure, date of procedure and type of implant. The pilot for the program has been started and the goal is to begin accepting level 1 data from all sources by late 2011.

However, unlike many of the similar organizations, the US Registry will be limited in its effectiveness due to several issues. First, it is not a reporting agency. This means it is not obligated to report information which may indicate a problem device to the U.S. FDA. Second, participation is on a voluntary basis. Third, there remain outstanding uncertainties with regard to information sharing and privacy issues which have not yet been determined. Having a registry is only effective if the data is compiled, shared and analyzed, and then forwarded to the US FDA when a potential problem is identified.

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