Advising FDA on Unique Device Identification

AIM North America has formed a new committee to address FDA’s forthcoming Unique Device Identification (UDI) proposed rule. The AIM-NA UDI committee will offer recommendations for a final rule as well as implementation models that are sensible and address the need for interoperability with other national and international unique device and unique item identification requirements. The committee is open to all AIM members; medical device manufacturers in particular are invited to join as are manufacturers and resellers of product marking and tracking solutions and related goods and services.

The committee will review and analyze existing practices and standards from UPC implementation to DOD’s IUID policy, reports Ken Koldan, chair for the UDI Initiative and also new business development manager for FLEXcon. “AIM will submit recommendations for ISO standards, but also, by creating a group, we create a louder, more unified voice during the proposed rule process. It is critical to form an industry group that focuses on the technology challenges of implementation and that is fully operational and ready to submit significant comments during the proposed rule phase of the process,” he explains.

About AIM
For more than 35 years, AIM has served as an association covering automatic identification, data collection and networking in a mobile environment. AIM members provide technologies, systems, and services that capture, manage, and integrate accurate data into larger information systems.
AIM focusing on the following tasks:

• Providing information about the application and use of all automatic identification and mobility technologies.
• Driving the adoption of international standards and their development.
• Influencing global legislative and regulatory actions that affect the use of automatic identification technologies.
• Educating end users, legislators, journalists, and consumers about the value of deploying automatic identification solutions.

Adds George Wright IV, vice president for Product Identification & Processing Systems (PIPS), who will serve as the committee’s vice chair for 2012 and assume the chairperson role for 2013: “We bring together auto ID technology providers, regulated medical device companies, U.S. regulators, and major users to work together to develop a consensus perspective on how best to address the shared needs of a broad constituency. Though underlying goals are closely aligned, different groups have different priorities. Our goal is to find common ground that meets the basic needs of all parties, keeps implementation costs at a reasonable level, and promotes rapid UDI implementation. Our hope is that through our efforts we can influence the final regulation in such a way as to make this the reality.”

AIM is working to recruit medical device manufacturers to join the committee. “Medical device manufacturers should get involved to gain a voice to ensure that their technological concerns are heard and addressed and to gain awareness of what lies ahead,” says Koldan. “They can fill the gaps in the types of information needed for the implementation to be successful. There is a lot of debate that needs to occur to form a consensus on important issues, and industry does not want to hold up FDA or the health care system.”

Over the next few months the AIM-NA UDI committee will be recruiting members and focusing on three key projects that the committee voted on as the most critical first steps:

• AIDC (i.e., Automatic Identification and Data Capture) Technology, which coordinates activities among technical groups internal and external to AIM (e.g., UID and UDI relationships).
• Communications, which takes into account member recruitment, messaging, and marketing of the committee to the AIM and non-AIM communities.
• Legislative, Implementation, and Outreach, which establishes relationships with like-minded organizations and businesses in the pursuit of successful implementations of the FDA UDI and Standardized Numerical Identification (SNI) initiatives.

“AIM’s global communities are poised to help with first hand practitioners and industry experts in various AIDC implementations,” Koldan says. In addition, “the AIM RFID Experts Group (REG) and the technical expertise of the AIM community will be drawn upon and leveraged to assist FDA as it prepares clear technical directions for use.”

The subcommittee will examine the potential of certain data carriers, such as 1-D versus 2-D and bar coding versus RFID. “The technological pros and cons will be examined and published in white papers,” says Koldan. “The AIDC Technology working group in the committee will focus heavily on this.”

Ultimately, unique identification improves logistics while driving patient safety, says Wright. “When you uniquely identify a product down the “each” – whether that is the unit of sale or the unit of use – you lay the foundation for tracking that product and ultimately being able to know to whom it was sold and where it was used. This can be invaluable for efficiently implementing product recalls and for addressing other patient safety issues.”

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