UDI Efforts Stretch Worldwide

The Global Harmonization Task Force (GHTF) has released its proposal for a draft guidance on a Unique Device Identification (UDI) system that could be used around the world. The goal of the guidance is to provide a common global framework for identifying medical devices, which could facilitate recognizing recalled items and reporting specific devices involved in adverse events. Comments on the draft are welcomed through April 30.

Industry has been waiting for FDA to finalize its own regulations pertaining to Unique Device Identification, now expected before June 2011, but stakeholders should familiarize themselves with the GHTF document in the meantime. “The GHTF guidance will provide a framework for regulators, including FDA,” says Jay Crowley, senior advisor for patient safety, in FDA’s Center for Devices and Radiological Health. “That framework is a global system, technology neutral, with core attributes that are the same around the world.” (Please visit www.ghtf.org/ahwg/ahwg-proposed.html.)

Interestingly, the fact that there is no device identification standard could be a major driver. “The advantage is that UDI is new,” he says. “There are no long-entrenched embedded systems to integrate, such as regional systems like the U.S. National Drug Code or Germany’s PZN. Instead, we can collaborate to build a global approach.”

The GHTF draft calls for “medical devices . . . to be marked on the different packaging levels according to their risk class.” It discusses a “stepwise implementation process.”

FDA’s UDI regulation is expected to follow this recommendation. “We have been suggesting all along that we most likely will institute different timeframes for devices, such as having Class III devices comply within one year of publication of the final rule, Class II within three years, and Class I within five years,” explains Crowley.

Further, because some Class I devices are low-risk, low-cost devices, FDA is considering UDI on shelf packs for some of these items, rather than on the items themselves. “Some of these are not even packaged at the item level, so marking shelf packs with the UDI should be sufficient,” says Crowley.

Crowley adds that he is frequently asked about what will be required for specific devices. “We cannot identify every type of device in advance, and we won’t be able to cover every one in our rule. There will be unique situations to be addressed for individual cases, and the rule will present a process through which we can work together.”

FDA’s UDI database is under development, with a prototype expected to be ready at the end of 2011. FDA will own and maintain the database, and it is expected to hold the static portion of unique device identifiers. Variable data, such as serial numbers and lot numbers, will not be included in FDA’s database.

Stakeholders need to read the GHTF draft and provide feedback. As the draft points out, “the true benefit, in terms of patient safety, will only be achieved if all stakeholders use the globally harmonized UDI system.”