Unique Device Identification

Common Pitfalls in Implementing the Unique Device Identification Program

As the medical technology industry is preparing for the Unique Device Identification (UDI) initiative, package and label inspection is becoming more important than ever. On September 24, 2014, labels and packages of Class III medical devices and devices licensed under the Public Health Service Act need to conform with the UDI requirements. Although these requirements will ultimately bring many positive changes to the industry, including the ability to manage recalls and track adverse outcomes more efficiently, manufacturers face many hurdles on the way to implementation. 

UDI: Are You Ready for September 24? GS1 Healthcare US's New Head Working to Support Medical Device Manufacturers on UDI and Other Changes

Michael Innes, former Kaiser Permanente Program Director, has joined GS1 US to lead GS1 Healthcare US. PMP News Editor Daphne Allen asks for details on how he and the organization will help medical device manufacturers prepare for UDI and other upcoming regulatory changes.

Welcome to GS1 US! Can you explain what the role of GS1 Healthcare US has been, and what you hope to accomplish in leading the initiative?

Avoiding UDI Implementation Pitfalls

When getting ready for Unique Device Identification, medical device manufacturers do face a number of challenges, but they can be addressed. Debara Reese, vice president, quality and compliance for Maetrics, explored such challenges and potential solutions during the MD&M East 2014 conference, “Common Pitfalls of UDI Implementation and How to Avoid Them.”

Preparing Medical Device Packaging Professionals for UDI

Medical device packaging professionals will most likely be called upon to help their companies implement Unique Device Identification (UDI). The rule, whose effective dates begin phasing in this September, “has implications for manufacturers, who will be under regulated timelines for compliance, but it also affects device design engineers, who must now factor in labeling requirements at the earliest stages in the design of their products, and thus packaging,” reports MJ Wylie, Senior Director, Healthcare, GS1 US.

UDI Challenges Addressed at HealthPack

This September, the labeling and packaging of Class III medical devices must bear Unique Device Identification, reads FDA’s final rule.

Getting Ready for UDI at MD&M West

With initial deadlines for FDA’s Unique Device Identification rule to begin phasing in later this year, medical device manufacturers are busy studying the regulation and looking for implementation support. On February 11, attendees at Medical Design & Manufacturing West 2014 got the chance to see potential solutions on the “Get UDI Ready” show floor tour.

Specialty Label Substrates for UDI Debut

As the medical device industry begins to prepare for Unique Device Identification, FLEXcon has launched FLEXcon MedFLEX, a line of label substrates designed to meet FDA’s performance requirements. The FLEXcon MedFLEX line can support unique coding as well as comply with rub tests, the company reports. Specifically, the line is UL-certified in accordance with UL/IEC 60601-1 3rd edition marking durability rub tests, the company reports, and three of the products are UL-recognized with inks and ribbons.

FDA's Jay Crowley Joins Keynote Panel at GS1 Connect 2013

FDA's Jay Crowley will participate in a new general session keynote panel at GS1 Connect 2013 called “Held to Higher Standards: Doing Business in a Digital World.” Panelists will discuss the digital transformation taking place in business and global commerce. The panel, moderated by GS1 US President and CEO, Bob Carpenter, will include:

AIM North America Announces New Committee Leaders

AIM North America (AIM NA), the Association for Automatic Identification and Mobility in North America, reports the following new committee leaders for 2013:

  • Tom Dills, President of Elder Mountain Associates LLC (Warner Robbins, GA) will lead the UID Suppliers Alliance.
  • George Wright, IV, Vice President, Product Identification & Processing Systems Inc. (Port Chester, NY), will lead the UDI Committee.

These industry experts have been elected chair of their respective committees for one year.

Medical Device Companies Prepare To Implement Unique Device Identification

With a final rule from FDA for UDI expected this year, device makers have accelerated development of a UDI system. As a first step, “labelers” need to adopt a system for issuing UDIs from an issuing agency accredited by FDA. Support continues to grow in the supply chain for the GS1 System of Standards, embraced by early innovators pushing for a global standard for device identification and tracking.
In an interview with PMPN, Siobhan O’Bara, senior vice president, industry engagement, GS1 US discusses issues raised by manufacturers in comments on the proposed rule, and the advantages of using GS1’s system.
[Editor’s note: Siobhan O’Bara will join Jay Crowley, senior advisor patient safety, FDA, and panelists from Medtronic, GHX, and Premier speaking on Creating a Roadmap For UDI Compliance at the upcoming MD&M West trade show and conference, Feb. 11-14 in Anaheim, CA.]
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