Proposed legislation calls for a national hip and knee registry
Legislators introduced a new bill in the U.S. House of Representatives yesterday to establish a national hip and knee joint replacement registry.
If approved, the Knee and Hip Replacement Act of 2009 would create a national registry within the Agency for Health care Research and Quality at the Department of Health and Human Services to collect and analyze data on patients with hip and knee replacements. The bill calls for data collection to begin no later than 5 years after it is enacted.
The co-sponsors of the bill, Reps. Bill Pascrell Jr. (D-N.J.) and Lloyd Doggett (D-Texas), say the proposed legislation would improve the quality of patient care and cut unnecessary Medicare costs.
The Knee and Hip Replacement Act would help ensure that only the best and most effective medical devices are made available to American patients, Pascrell said in a press release. It would reduce the number of costly and complicated do-over surgeries and save taxpayers billions of dollars. It is outrageous that medical devices are being made available in America that are so lousy they have been withdrawn in markets overseas. As Congress seeks to reform health care and reduce Medicare costs, bringing higher standards to the medical device industry would be a good place to start.
Orthopedics Today Joint Reconstruction Section Editor Thomas P. Schmalzried, MD, said the challenges of data collection must be appreciated, and data interpretation is key.
While there is clearly value in a national joint registry, the limitations of registry data have to be recognized, as well as the challenges of thorough, accurate and secure data collection in the largest device market in the world, Schmalzried told Orthopedics Today.
He noted that medical tourism may also make it more difficult to track clinical outcomes.
It is an oversimplification to state that devices fail. Total joint devices today rarely suffer a gross material failure, Schmalzried said. Total joint reconstructions can require revision for a variety of reasons that include patient factors and utilization factors, as well as the biologic limitations of prosthetic joint technology. For example, a relationship has been shown in other national joint registries between patient demographics and hospital/surgeon volume for a given procedure/device and the need for revision surgery.
Furthermore, the data from different national registries for the same technology do not always match.
There have been conflicts in the outcomes reported from national joint registries and those reported from the United States, he said. Collecting the data is a good start, but the critical task is the interpretation of the data.
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