UDI Comes of Age

UDI Comes of Age

Evangeline Loh and Stewart Eisenhart

Slowly but surely, the Unique Device Identification (UDI) System topermit global identification and tracking of medical devices is moving from concept to implementation. UDI’s potential benefits are irrefutable in terms of better post-market surveillance, vigilance and other issues, but the actual implementation of such a system poses considerable logistical challenges—and requires buy-in from all major market regulators in order to properly function.

While substantial, the challenges do not appear to be an obstacle to medical device industry regulators establishing a functioning UDI system. If successful, the ramifications of such an effort will truly be significant for industry participants and regulators alike. The market regulators collectively making up the Global Harmonization Task Force (GHTF) have issued final guidelines on how national authorities should go about setting up systems that support a harmonized global UDI infrastructure, and the U.S. Food and Drug Administration (FDA) is developing draft regulations for implementation of a UDI system in the United States.

In addition, the European Commission heads a GHTF ad hoc working group developing guidelines to ensure that the FDA’s UDI proposal will be compatible across global markets. Of course, therealso is interest to ensure that the Asian Harmonization Working Party is part of the GHTF’s activities. With such heavy regulatory weight behind a global UDI system, the question of implementation increasingly becomes when, not if.

The Benefits

According to the GHTF, the European Commission and other entities, implementation of a global UDI system would greatly improve traceability of medical devices in all major markets, improve recall efforts, decrease device counterfeiting activities and boost patient safety. UDI numbers would be stored in an accessible UDI database (UDID).

The GHTF’s final guidelines issued in September are designed to address the current lack of a globally defined UDI system, and hopefully will increase the likelihood that regional efforts to implement UDI systems will effectively integrate with one another.

The guidelines list the following keyadvantages a truly global UDI system would provide:

1. Traceability of devices throughout their distribution to improve recall efforts and better manage corrective actions when necessary;

2. Identification of devices via unique codes that would be able tointegrate existing clinical, industry and regulatory databases;

3. Adverse event reporting improvements through the inclusion of UDIs in adverse event reports, providing more accurate reports as well as faster aggregation of related reports to

assist regulators;

4. Medical errors would decrease as UDI systems allow clinicians toaccess device safety data faster, and more accurately select appropriate devices for treating patients; and

5. Documentation improvements in terms of device use in electronicpatient records.

Every medical device type brought to market would be assigned a unique number created using globally accepted device identification and coding standards, according to the GHTF guidelines.

Attached to the label of a device, each unique device identifier includes two components: a Device Identifier, a code specific to a particular model of device that also serves as an access code to that device’s information in the UDID; and a Production Identifier, a code to identify units of device production (serial, lot or batch numbers can serve as Production Identifiers.)

How It Would Work

The GHTF advocates a global UDI system incorporating three main elements.

First, any UDI system established by a market regulator must adhere to a globally accepted standard. Second, UDIs should be attached either on devices themselves or on product labels. Finally, UDI data should be submitted properly to the UDID to ensure the database’s accuracy.

Other key recommendations:

• UDI system participants must ensure they each properly capture and store individual UDIs throughout their associated devices’ distribution and use time frames in order to meet traceability goals;

• UDI marking on devices should constitute an additional labeling requirement—they would not replace any other labeling information;

• Creation and maintenance of UDIs should be the responsibility of medical device manufacturers;

• Automatic Identification and Data Capture methods required by national regulators should be based on ISO standards approved by the UDI Standards Development Organization;

• Manufacturers should be responsible for submitting and updating UDI information in the UDID; and

• UDI data should include Global Medical Device Nomenclature (GMDN).

FDA Draft Rules

Following the GHTF’s publication of its UDI guidelines, the FDA is working on draft regulation to establish a UDI system in the United States. Draft rules for such an implementation in the world’s largest medical device market significantly would boost adoption rates among other market regulators. Furthermore, since the FDA participates in the GHTF, the U.S. proposal should align adequately with GHTF guidelines.

A draft rule on UDI is expected by the time this article has been published, and one year from the draft rule, a final rule promulgated. At that point, the requirement will be phased in with Class III medical devices first. The FDA will not make recommendations on the bar code system to be used, asserting that the choice between HIBC (Health Industry Bar Code) or GS1 GTIN (Global Trade Item Number) is a business decision.

One interesting comment the FDA has made about the GMDN codes is that the agency is lobbying for these codes to be publically accessible. The European Databank on Medical Devices (Eudamed), which has some functions similar to the UDI system outlined by the GHTF, became compulsory in May 2011.

Eudamed—the European medical device databank—enables European Union Competent Authorities to access data on medical devices, manufacturers, authorized representatives, certifications and other information. Importantly, Eudamed incorporates GMDN codes to support its data exchanges. The UDI is not quite required in Europe yet and hence not captured in Eudamed—though we fully expect UDI to become required, perhaps with the European Union’s recast of the Medical Devices Directives.

In Australia, proposed reforms to the medical device regulatory system also willamend the existing Australian Register of Therapeutic Goods (ARTG) database. The ARTG database is publically available and GMDN codes are required for the ARTG listings. Previously, Australian Manufacturers and Australian Sponsors entered information as device families (for Class IIb and below) without generally specifying details about the device trade names or device models. These reforms will

require ARTG listing entries include product name details.

European and Global Ramifications

Details of the FDA’s draft UDI regulation remain unknown, but how closely it hews to the GHTF guidance is a key question. If the FDA’s UDI system fits nicely within the GHTF recommendations, then that system presumably would serve as a model for the rest of the world.

UDI also magnifies the importance of the GMDN codes, and signifies its arrival as the global system to be used for medical device nomenclature.

UDI has yet to be required in Europe, but the medical device industry should anticipate its eventual introduction into the European Union. Regardless of which final iteration a global UDI system takes, medical device industry participants should expect a major impact. New labeling requirements as well as data management functions will need to be addressed, which no doubt will strain some manufacturers’ internal resources, at least in the short term following implementation.

That’s a lot to ask—especially for smaller-tier firms—but the end result of such an endeavor is too compelling to delay any longer.

Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group, an international medical device consulting firm providing regulatory, quality assurance and distribution consulting services. Evangeline can be reached at [email protected].