Diagnostics & Imaging Week Washington Correspondent

GAITHERSBURG, Maryland — An FDA meeting held last week revealed a general consensus on the merits of the agency's drive to develop a unique device identification (UDI) system in the industry, but the event also provided a forum for airing continuing concerns about how to do this.

This effort is an FDA priority. That was made clear by Daniel Schultz, director of the agency's Center for Devices and Radiological Health (CDRH), noting that UDIs represent "a keystone" to broader efforts under way at the agency for improving patient safety.

Representatives of other government health bureaus, including the Center for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality (AHRQ; Washington) and the Department of Defense, also made the case for better safety outcomes, courtesy of UDIs.

Those in that camp, including some device manufacturers and hospital groups, noted that such a system would offer a range of benefits: preventing product mix-ups, thus reducing medical errors; help speed recall efforts and ensure their accuracy; combat counterfeiting by guaranteeing product pedigree; allow for better device identification in adverse events; and improve post-approval product surveillance.

"We can do a better job of surveillance of products that are on the market," said Steve Stemkowski of Premier (Charlotte, North Carolina).

But trade associations representing device manufacturers — that would bear the initial and ongoing costs of UDI — said they weren't convinced that UDI would provide a safety benefit. As a result they appeared hesitant concerning any outright mandate by the FDA to implement an identification system, citing question marks concerning the agency's authority, absent any clear benefit of patient safety.

"We'd like the FDA to prove that there are safety issues involved and that there's a necessity for it," said Jori Frahler, director of federal affairs for the Medical Device Manufacturers Association (MDMA; Washington). "We're not quite convinced that there's this need."

This view was echoed by Paul Pandiscio, who questioned the link between UDIs and safety in comments on behalf of the Advanced Medical Technology Association (AdvaMed; Washington). And Richard Eaton of the National Electrical Manufacturers Association (Rosslyn, Virginia) made the same point.

Emphasizing the need, Frahler told D&IW that drug identification systems are used in part to prevent harmful drug-drug interactions. In contrast, with devices, most patients typically receive only one, suggesting the need for a unique identifier. In addition, she said that healthcare professionals shouldn't have a difficult time recording such information in records.

Despite their concerns, the trade association speakers offered solutions for implementing UDIs.

Both MDMA and AdvaMed called for a single, globally harmonized system applicable to worldwide regulatory bodies and businesses, as did many other speakers.

Frahler noted the need for "just one" system and Pandiscio stressed a "need to define" a worldwide standard to foster UDI adoption. He is employed by Johnson & Johnson (New Brunswick, New Jersey, one of many manufacturers with internal barcoding already in place — though such systems can't be substituted, one to another.

Eaton proposed a five-year period for companies to phase in any new rules.

Frahler added that MDMA is advocating voluntary participation, but she suggested that a UDI benefit might pertain to certain devices, but not for all.

Similarly, Jim Keller of the nonprofit health services research agency ECRI (Plymouth Meeting, Pennsylvania) suggested first tackling high-profile, high-risk products before worrying about UDIs for items of much lesser consequence, such as rubber gloves or cotton balls.

The FDA's position offers flexibility, according to Larry Kessler, the director of CDRH's Office of Science and Engineering Laboratories. Noting that the agency recognizes the "enormous" scope and diversity of the device industry, he said that the FDA wouldn't "shoehorn" all companies into a single rule. "It is not clear that one size fits all," he said.

Kessler also conceded that the agency's efforts to get a sense of UDI costs have "proven a challenge."

But estimates from an outside consultant, John Eyraud, indicate that manufacturers, with the effort, could face somewhat more than $400 million in costs, even without factoring in the integration of information technology. That could add between $246 million and $2.7 billion, he said.

For hospitals, first-year investment costs could total $1.4 billion.

Several speakers pointed out that hospitals already are incurring expenses in implementing electronic health record systems, so it would make sense to piggyback a UDI system onto that effort.

A representative of the American Hospital Association (Chicago) said that group is "committed" to implementing UDIs for devices. But Kessler stressed the importance of ensuring that as hospitals and device manufacturers move forward, they are "talking the same language."

With multiple technologies available — such as bar codes and radio frequency identification — there has been concern over which is preferable. But the messenger isn't as important as the message, many speakers said.

"You have to separate the data from the data carrier," said Lu Figarella of Health Industry Business Communications Council (HIBCC; Phoenix, Arizona).

Government health agencies are keen on data that could be gleaned from tracking product usage through UDIs.

CMS' Marcel Salive said such a system would help distinguish benefits between products. "For us to pay, we'd like to see evidence of comparative effectiveness," he said. "This type of data can help us develop that evidence." Added AHRQ's Jon White: "We place a premium on information and data."

While the meeting produced no consensus on how to put a UDI system into practice, a range of voices were heard and most would presumably be in accord with Keller's assessment that universal implementation is going to be "very difficult."

That point was underscored by Leighton Hansel of Abbott (Abbott Park, Illinois), also speaking on AdvaMed's behalf: "There has to be a known strategy of where we are and where we're going."

Kessler said the FDA would accept comments on the matter through Nov. 9.

No Comments