Late News: FDA delivers rule on medical device identifiers

The Food and Drug Administration delivered its final rule on a long-awaited regime to place unique identifiers on medical devices, a system that promises to improve patient safety and make hospital supply operations more efficient. But it will take another seven years to roll out the system, and much of its success depends on the voluntary participation of healthcare providers. Manufacturers will be required to assign some medical devices with a “unique device identifier,” which will include a product lot number, expiration date and manufacturing date.

The FDA will operate a publicly searchable database that will house UDI data. In addition, UDI data could be used in electronic health records, registries and insurance claims.

“Unique device identifiers will enable faster identification of product failures and more comprehensive recalls,” Josh Rising, director of Pew's medical devices initiative, said in a statement. “But the FDA's rule is just the first step. To fully realize the new system's benefits, hospitals, health plans and physicians must integrate these codes into patients' health records and insurance billing transactions.”

The Healthcare Supply Chain Association, a trade group representing group purchasing organizations, and the Premier healthcare alliance expressed disappointment with what they said was an unnecessarily long timeline. “The stakes for patients are simply too high to have to wait until 2020 for a fully operational UDI system,” said HSCA President Curtis Rooney. The FDA will use a risk-based, seven-year process to roll out the marking requirements, starting with the packaging of high-risk devices in September 2014. The Advanced Medical Technology Association says the phased rollout is necessary to accomplish such a “costly and challenging endeavor.”