Coalition Calling for National UDI

A patient safety coalition is again calling on the U.S. Food and Drug Administration (FDA) to create a national unique identification (UDI) system for medical devices, three years after a law was passed calling for its creation.

A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems. The number and complexity of medical devices is growing and UDIs would allow FDA to quickly identify new risks and work with industry and device users to manage these risks appropriately.

“While the Advancing Patient Safety Coalition appreciates the open and transparent process the agency has followed, the time to act is now. Therefore, we strongly urge the FDA to move the rulemaking process forward this year to implement a regulated, mandatory UDI system that is globally harmonized,” a March letter stated.

This request comes about a month after the FDA held a public workshop in Gaithersburg, Md., on Feb. 12, to hear from various stakeholders about how the pending rules should be formed. The Food and Drug Administration Amendments Act of 2007 called for the creation of a UDI.

“This is complicated, this is new,” Jay Crowley, a senior adviser for patient safety with the FDA said of creating a UDI for medical devices. “We all need to figure this out.” Crowley said that patient safety is a driving force behind creating the device identification rules.

Among the most critical decisions that need to be made are the type of identification system to use and how to handle small devices that are too small for bar codes or radio frequency identification tags. The information on marked medical devices would include details about the manufacturer, make, and model, as well as serial and lot numbers.
In 2007, there were 66,000 adverse-event reports connected to medical devices, while half of the products involved lacked any sort of identification, Crowley said.