Medical Device Daily Washington Editor

WASHINGTON — FDA is going global on a number of fronts these days, and the unique device identifier (UDI) is part of that push, as a session in here earlier this week made clear.

Daniel Schultz, MD, director of the Center for Devices and Radiological Health, gave the Tuesday keynote address for a conference on UDI hosted by GS1 (Lawrenceville, New Jersey), a non-profit entity dedicated to the spread of standards for the conduct of business and for regulatory compliance, and Schultz made the case that given the globalization of medical device manufacturing, the effort to forge a UDI system that is truly functional must also be global.

Schultz opened his remarks by noting that "yesterday, President Obama went before the AMA [American Medical Association; Chicago] and told them he was going to fix healthcare for this country." He said he had a more modest ambition than the President of the United States, however.

"I simply want to track medical devices that are being used in patients," Schultz said. On the other hand, he also remarked that "what is surprising to me is the fact that it has taken us this long to get there," stating further that there is no time to waste. "The reality is that the time to get this done is here," he said.

The former practicing physician indicated that in his view, the iterative nature of medical devices compared to pharmaceuticals and biologics means that "the urgency is even greater than with some other types of medical products" given that "devices ... change rapidly over time."

At FDA, he said, "we need to know not only that it's a surgical tool," but also "we need to know exactly which version, which model number, it is."

That kind of detailed information will "allow us to take action where it is needed," and instead of making a general alert about a product line that emits a conspicuous safety signal via medical device reports and other routes of feedback, the appropriate regulatory activity may be restricted to a relatively small number of units.

Schultz made a point of bringing up the post-market transformation and product life-cycle paradigm now in place at CDRH. "Clearly, a big part of our effort in the past has been to look at products before they go to market," he said, but "the date that a product goes to market is ... in many ways, the beginning of the story."

The day the device goes into the real world of daily use "is when we must make our greatest effort to make sure" devices are functioning as they should. Hence, the need for "a system that allows us to identify and deal with problems quickly."

The CDRH chief reminded attendees that the UDI program was mandated as part of 2007's FDA Amendments Act and informed them that "we are in the process of drafting regulations that will allow us to get there. The question is not if, the question is not when, the question is how. How do we make it happen in a way that is meaningful," but "is not overly burdensome to industry," he said.

"Even better," Schultz said, "would be ... a system that works globally." He stated that as encouraged as he is by recent developments inside the U.S., "even more encouraging [is the] participation in this conference ... from around the world."

"A single global system for unique device identification," he said, "is our mission. That is what we hope to see happen in the not-too-distant future."

Schultz acknowledged that CDRH is working on a guidance for UDI, but was mum about an expected publication date for the draft. "We have a law in place that says FDA will do this," he said, but would say nothing more about dates other than that "FDA intends to move ahead with the regulation with all due speed and efficiency."

Jay Crowley, senior advisor for patient safety at FDA, discussed standardization for UDI, the implementation of which he promised would be no mean feat. "At 50,000 feet, UDI is simple," he said, but noted that "maybe a fifth of the hospitals have a system" for tracking and tracing the devices and drugs used in those hospitals.

As for the regulations under development at FDA, Crowley said "the difficulty we have is coming up with a regulation that is implementable." He stated that the work of getting into the details of UDI clarified some of the issues, which were not necessarily apparent to the agency at first blush. "When you deal with devices on a granular level, you discover a lot of problems you hadn't thought about before," he acknowledged.

"To us, UDI is about visibility," Crowley said. He posed the hypothetical questions that UDI will hopefully answer. "Where are devices? Which ones got used on which patients?"

UDI, he said, is "about helping us to identify specific devices" and their locations, even if it is an implantable inside a patient who is at home.

Another of the issues is facility registration and listing, which is essential to traceability for imported devices. "Import safety is a huge issue for us," Crowley said, adding that "the time we're taking [to write a guidance] is not because we can't figure what we want to do," but to make sure the issues are understood before a guidance makes it into print.

Crowley said that the formation of a UDI database promises to be "the most difficult part of this project" other than implementation. "There are going to be a lot of UDIs ... and a lot of attributes," so "we've been working on not just the structure but also the format" of the database. "We want a database that is not only accessible to people here in the U.S.," but also in other nations. "We're trying to find a minimum set of data attributes" that everyone agrees on.

One reassuring message from FDA is that the regulation will not require a track-and-trace item on every last needle and syringe ever manufactured. "Low-cost level of products" will usually need tags on the package in which the units are shipped. "Some of these things are managed by lot" rather than by unit, he said.