UDI Rule Takes Final Shape as Comment Phase Nears End

Medical device makers were urged to move forward with planning for Unique Device Identification (UDI), with the issuance of a final UDI regulation System expected by May 2013, attendees heard at a UDI conference in Orlando last month.
Jay Crowley, senior advisor for FDA’s Center for Devices and Radiological Health (CDRH), said companies should not expect an extension of the 180-day comment period on the proposed rule beyond November 7.
“Submit comments. We need your help to make sure this is usable and understandable to all players,” Crowley advised the 400-plus attendees.
While the major provisions of the UDI rule are unambiguous, attendees sought clarification on aspects of the regulation and their application to specific use cases. FDA will be hammering out final rule requirements on issues including, Crowley said, an exemption process procedure.
“We received a lot of questions on whether ‘my device is exempt.’ Once the final rule is in place we can make interpretations on different devices. [But] this [regulation] applies to nearly all devices. UDI will be used by all stakeholders—distributors, GPOs, and hospitals. I wouldn’t count on a lot of exemptions—you should assume it applies to your device,” Crowley said.
General exemptions listed in the proposed rule could still be changed as well, he noted.
The rule’s proposed format for dates on device labels created “a fire storm,” Crowley reported, as device makers favored the widely-adopted ISO 8601-2004 standard that expresses the date in an all-numerical scheme.
“This is the most controversial part of the rule. We didn’t expect this. I realize for global manufacturers this is extremely problematic. We are not going down this path—we will come up with a better way to do it,” he said.
In coming weeks, FDA will publish a list of implants and life-sustaining devices for which the UDI requirement is effective two years after the final rule’s publication. Software is a medical device; the agency will come up with a way for applying the unique identifier on Health Information Technology, Crowley said.
UDIs are required on outer packaging, such as boxes and cartons, to allow identification of devices through the supply chain. “If there were no UDI on the outer packaging, the box or other type of container would need to be opened to access it, which could facilitate tampering and contribute to the very problems that the UDI system is designed to remedy,” the proposed rule reads.
“You don’t need a UDI on the final shipping container. Perhaps this needs more clarity. We look forward to comments,” Crowley said in response to an audience question.
Direct part marking (DPM) is required for certain categories of devices such as those that remain in use for extended periods of time and are likely to become separated from their labeling. The DPM can be rendered in plain text or in AIDC technology, and the DPM UDI may be different from the UDI on the label to distinguish the unpacked device from the packed device. “We recognize there are many devices that can’t be marked. We need to come up with an exception process,” Crowley said.
Presenter Tom Werthwine, global process owner, auto ID, technology and standards, Johnson & Johnson, referenced DPM in reviewing UDI implementation challenges. “If we just put human readable on the DPM, how do we identify it as the UDI? What is the survivability [of the mark] if an instrument goes through multiple sterilization cycles? [Or in the case of] an explanted implant? Look to the experts at AIM [on the DPM technology],” Werthwine said.
“What will [DPM’s] utility be in the clinical environment—will it be used in the end? Will someone be there to access it in a sterile field?” he asked.
Presenters pointed to AIM’s UDI committee as a go-to agency for information on technology options. Companies need to plan for data formatting, data carrier technology, and compatibility with scanning and data management systems of downstream partners.
“FDA in its bar code rule stipulated [the NDC number in a] linear code and is now considering matrix. We are taking the opposite approach [in allowing any AIDC technology] for the UDI rule. I think it’s the right path, but manufacturers have to be extremely aware of [their partners’ requirements and technology],” Crowley said.
Device makers need to ensure that bar codes, or RFID tags, when used, are encoded correctly according to well-documented standards, that they meet minimum print quality requirements, and are scannable, advised George Wright IV, vice president, consulting and business development, PIPS Inc., and vice chair of the AIM North America UDI Committee.
“UDI will be supported by many technologies, but you have to be cognizant of the user installed base. It is critical you talk with your supply chain partners, as the whole supply chain has to have the ability to read the code,” Wright emphasized.
“Although GS1 and HIBCC are disparate systems, they are interoperable. Scanning systems have been in place for more than a decade that can differentiate the codes and identify the product, whether it is in the GS1 or HIBCC format,” Wright said.
Device makers will decide on an FDA-accredited issuing agency, such as GS1 or HIBCC, for a UDI system, reformat production information data to the issuing agency’s format, and mark the device in manufacturing with the chosen AIDC technology. By the date the device is required to have a UDI, the device must be registered with FDA’s Global Unique Device Identification Database (GUDID).
The GUDID repository will be FDA’s source on master data for devices, enabling the agency to identify devices through distribution and use. Manufacturers must electronically submit required core attribute and administrative attribute data for each device.
Data will be submitted via FDA’s electronic submissions gateway (fda.gov/esg)—through structured on-line input or using the Health Level 7 structured product labeling (SPL) standard— or by a third party from a data pool.
Citing an early GUDID pilot in which J&J participated, Werthwine said manufacturers need to plan on what, when, and how to upload. “I had to touch eight different systems before I got all the fields filled in. You have to talk with IT to find the data and how available it is for uploading in SPL. And we will see multiple unique ID data bases—an EU requirement is coming,” Werthwine said.
Core attributes include a Global Medical Device Nomenclature (GMDN) generic name and code for the device based on the ISO 15225 GMDN standard.
Administrative attributes include a DUNS number. Company identifiers that manufacturers will obtain from Dun and Bradstreet Data Services, DUNS numbers are described as a global standard for uniquely identifying businesses. CDER has been using DUNS to identify facilities.
“This is CDRH’s first use of DUNS numbers. We are looking for an organizational DUNS as a way to distinguish an organization. We are not capturing facility level data,” Crowley said.
As a standard system for uniquely identifying devices, UDI will facilitate storage, exchange, and integration of data systems. FDA can mine population-based data sets to better understand the risk and benefits of device use for certain patient populations and indications, something “the drug side has been doing for years,” Crowley said. (See FDA’s Public workshop on use of UDI for postmarket surveillance and compliance at www.fda.gov/udi.)
“UDI can eventually support a secure supply chain as we bring in traceability to help identify counterfeit and diverted devices. That is not what we are trying to do right now, but we expect to look in this area [once the system is in place].”
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