FDA’s Unique Identifier Program Has Benefits, Drawbacks

The Food and Drug Administration’s proposed rule that most medical devices distributed in the United States carry a unique device identifier (UDI) may help prevent adverse events and streamline recall processes.

Edward Buthusiem, who until last year was general counsel of Kavo Kerr Group, the dental medical device arm of multinational firm Danaher Corp., and recently joined Berkeley Research Group of Emeryville, Calif., as a director and member of the firm’s Health Analytics Practice, said the proposed rule will likely have little impact on the day-to-day activities of otolaryngologists and other specialists, but the long-term implications could be positive. “From a safety standpoint, from an adverse event standpoint and from a recall standpoint, having the ability to uniformly track a device to a particular manufacturer and a particular distributor should facilitate the recall process,” he said.

The Background

The UDI system began in 2007, when Congress passed legislation to develop rules for a system that would identify medical devices uniquely. The FDA defines a UDI as “a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.”

In tow with the UDI, the FDA is building a database that will include a standard set of basic identifying elements for each marker. Most of the information will be publicly available so that both physicians and users will have access to it. Neither the UDI nor the FDA’s database will contain patient information.

The FDA expects the final rule to be released in mid 2013. When fully implemented, the FDA said the UDI may improve reporting and analysis of adverse events, reduce medical errors, enhance device analysis and provide a more uniform process to more effectively manage medical device recalls. It may also spur a uniform global identification system for medical devices.

A Move to Thwart Counterfeiting

Another potential benefit, Buthusiem said, is the implementation of a system that would address counterfeit medical devices. In 2010, the World Health Organization reported that some 8 percent of devices in circulation were counterfeit and, last year, U.S. Customs and Border Protection seized counterfeit medical devices and pharmaceutical products valued at $83 million, according to massdevice.com, an online journal that covers the medical device field.

Buthusiem said many counterfeits, especially those designed to imitate small devices like the ones that treat sleep apnea or help with voice restoration, are impressively deceptive, so a system of identifiers that could not be falsely replicated would be important. “Small devices that are easily knocked off tend to get knocked off,” he said. “Typically, these counterfeits are so good, so close to the original, they will appear to be authentic to the naked eye.”

Challenges for Manufacturers

While the FDA has pushed the rule as a boon, Buthusiem said the downside encompasses the “time, effort and expense” of crafting UDIs. For some devices, it could mean more expensive labeling or manufacturing processes. The Medical Device Manufacturers Association (MDMA) agrees and has continued to lobby for flexibility in the rule. Buthusiem said that because the rule rolls out in phases for seven years after publication of the final rule this spring, there is time to continue those discussions.

“This transition will require the medical technology industry to spend significant resources to comply,” the MDMA wrote to the FDA last fall. “With smaller companies facing a looming medical device tax, increased user fees and a reduction in venture capital investment, allowing as much flexibility and time to comply is critical.”