In their announcement, the European Commission said the UDI would have a three-pronged goal: enhancing post-market surveillance, reducing medical errors and fighting counterfeit products. The EC also said it envisioned a "risk-based" approach to UDI, possibly indicating Europe is taking a path similar to the FDA, where riskier devices, like implants, get labeling first.

"It's still a little vague," Karen Conway, director of industry relations at GHX, a supply chain consulting firm, told DOTmed News. "They have not provided a lot of specifics. They do say they expect to have their final directive out by 2014 and it would be a phased implementation by 2019. UDI is just one piece of that."


Still, she said in broad outline, the rules will probably resemble what the FDA has done, as European regulators were participants in the Global Harmonization Task Force, a body that sought to harmonize device rules around the world, and whose suggestions were taken into account when it came time for the FDA to draft its own UDI platform.

The difference, if any, could be in the traceability requirements, Conway said, with the Europeans likely calling for more robust "track and trace" measures to aid recalls.

Not only Europe

It's not just Europe, though. Other countries are mulling over adopting UDI, too. "China is looking very seriously at it," Conway said. Australia and some South American and Southeast Asian countries are also considering adopting the device standards, she said. "This is definitely becoming a global type of regulation."

The more countries that adopt UDI, potentially the greater the benefits. If a device is identified the same way in, say, a registry kept at Kaiser Permanente, an integrated health system in California that maintains its own device logs, and at registries in Germany, then you have much larger databases to keep track of how devices are being used and how they're performing, Conway said.

"So you're starting to not only have data in electronic medical records — 'Joe Smith got this hip replacement' — but you're also starting to have much more data around public health, 'Men over 40 receiving this particular hip have this outcome,' Conway said. "You can start doing more epidemiological work."

Here the FDA appears to agree. In a public workshop this summer, Danica Marinac-Dabic, the director of the Division of Epidemiology within agency, stressed the importance of "global capabilities" around the UDI.

"Although the focus clearly is on the national infrastructure, we would like very much to harness the resources, the data sources from around the globe," she said, according to a transcript of the workshop on the FDA's site. "As you know, medical device technology reaches markets sometimes sooner in other countries, and both in pre-market and post-market, we are very committed to be able to use that information...as we help industry to design their studies to meet approval for the FDA. "

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