This week marks the two-year anniversary of the publication of FDA’s final Unique Device Identification rule, and with it comes compliance deadlines for the labels and packages of implantable, life-supporting, and life-sustaining devices.
Even though Unique Device Identification (UDI) requirements are now well established and the first compliance deadline (for Class III medical devices) has passed, medical device manufacturers continue to face implementation challenges. GS1 US seeks to educate MDMs and other supply chain stakeholders about UDI through a variety of means, such as the upcoming GS1 Connect 2015, webinars, workshops, and a new consulting offering, the GS1 US Advisory Services 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.
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?
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.”
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.
This September, the labeling and packaging of Class III medical devices must bear Unique Device Identification, reads FDA’s final rule.
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.
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 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: