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UDI Final Rule Still Pending

Cheryl Clark, for HealthLeaders Media, July 22, 2013

Gregory Daniels, Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform at the Brookings Institute, says that a UDI rule is "critical for assuring device safety and effectiveness." The idea is that it would work in a way similar to the National Drug Code for pharmaceutical compounds.

"On the manufacturer side there are concerns," Daniels says. "For example, are they going to be required to make sure the devices are labeled appropriately? The other stakeholders in the healthcare system, one of their big concerns is making sure the UDI is developed and documented in a way that other stakeholders can efficiently use the information.

But such a tracking system isn't that complicated, and would in essence do for life-sustaining and potentially dangerous medical devices what has already been implemented for dog food and peanut butter, a simple bar code-like marker that's linked "to a central database so that the product can be easily identified," wrote Premier's Mike Alkire, Premier's COO, in an article in Infection Control Today.

"Today, in the event that a safety problem becomes clear, a non-existent tracking system means that recalls are usually ineffective," Alkire wrote. "Recall notices go out to hospital sand healthcare facilities, but finding all the affected devices is next to impossible. Hospital materials managers have to comb through shelves of products to find a defective device. This takes tons of time, and is a manual, mistake-laden process."

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