Representatives Bill Pascrell Jr. (D-NJ) and Lloyd Doggett (D-TX) introduced a bill in the House last week that would establish a U.S. joint registry. If the registry is established, the U.S. would follow Australia, England and Sweden in creating similar databases, and physicians, payers and patients would have access to long-term outcomes and be able to detect device-related issues sooner.
Last year, the New York Times used Zimmer's Durom Cup to illustrate the need for a U.S. registry, arguing that the revision rate for the device would've been known earlier if a registry had been in place. Registry data can also play a positive role in device marketing; Smith & Nephew frequently referenced Australian data when they launched the BHR. A registry would provide unbiased data on the an entire known patient population - and companies can mine it for free.
No determinations have been made as to who would be paying for the registry, and neither the government nor industry have stepped up to fund it. A registry is a decently expensive undertaking, costing an estimated $5-$10 million each year to run. Of course, one benefit of a registry is that it could save money by demonstrating the value of one procedure over another, and in this way, the call for a registry fits into President Obama's comparative effectiveness goals. It's also unknown who would maintain the registry, though CMS is a likely choice, as is the FDA, which is already working on the Sentinel initiative for tracking drug and device performance.
