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UDI: Are you ready for September 24? GS1 Healthcare US's new head working to support medical device manufacturers on UDI and other changes

Daphne Allen

December 30, 2015

6 Min Read
UDI: Are you ready for September 24? GS1 Healthcare US's new head working to support medical device manufacturers on UDI and

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?

Michael Innes

Innes: GS1 Healthcare US is a dynamic and thriving collaboration that has been developed and driven by industry. As such, we have been able to work toward the adoption of open, global standards to help healthcare companies improve accuracy, speed, and efficiency in their supply chain and care delivery. Going forward, we see ourselves continuing to make contributions in three key ways:

• To help educate the industry and promote collaboration among all participants in the continuum of care delivery.
• To help implementation progress via the publication of guidelines, case studies, lessons learned, and best practices, as well as providing the experts and peer references for pilots and tests so the healthcare industry understands how to take advantage of the sweeping regulatory changes in the form of UDI Regulation and Meaningful Use to drive data standardization. 
• To innovate in the supply chain and expand its influence beyond the Materials "Dock Door" and closer to the care delivery.

How will you translate your experience as a program director for Kaiser Pemanente into a role helping pharmaceutical, medical device, provider, and patient care professionals?

Innes: At Kaiser, we evolved our traditional business trading relationships and established collaborative partnerships with our GPO and key manufacturers. Doing so was important in order to enable the supply chain organization to serve a more strategic, contributory role in helping the enterprise face regulatory and financial challenges. In addition, Kaiser Permanente owns one of the world’s largest electronic health record implementations. Coming from this environment, I have a keen grasp on how important it is to capture standardized information, including product and location identification, during the course of patient care, and how to leverage technology investments to their fullest potential. I look forward to taking what I’ve learned over the past several years and making a contribution to the growing standards movement in healthcare.

What challenges do healthcare systems face today, and what can pharmaceutical, medical device, provider, and patient care professionals do to help address those challenges?

Innes: The healthcare industry as a whole is in a time of transition. With cost pressures, reform, UDI, Meaningful Use provisions, the Triple Aim initiative (improving the individual experience of care, improving the health of populations, and reducing the per capita costs of care) and Health IT implementation, there is no shortage of “priorities" in the industry. Supply-chain data standards extend beyond the supply chain and are important to patient care and patient safety. No trading partner needs to reinvent the wheel when it comes to standards implementation. I would hope that those who are new to standards would look to those who came before, and leverage the published best practices and case examples out there. GS1 Healthcare US has a number of resources to help the industry get started, one step at a time, or to evolve to greater standards usage toward the higher goals of increased patient safety, enhanced efficiency, and reduced costs. No one should feel that they are in this exciting, transformational, and transition time alone. 

What has the Healthcare Transformation Group accomplished? Will you remain active?

Innes: The HTG has successfully collaborated with the Top 20 Supplier Partners to work on implementation of the UDI and utilize it within its organizations. Through GS1 Healthcare US, I will continue to work with HTG to communicate successful strategies and tactics for standards implementation and share those examples across the industry.

How has standardized product identification helped Kaiser Permanente?

Innes: While I was at Kaiser, one immediate benefit of standardized product information we realized is more-efficient master data management. And I think that is true at any organization that is adopting standards. Having a consistent way to identify products enables clinicians to more quickly locate the correct product at the time the product is needed, while also being able to better “see” the expiration date, accurately scan and capture the product’s attributes in the electronic health record, and have a more efficient, complete, and faster recall process. Ultimately, a consistent, standardized product identification system is about patient safety. 

What progress has been made in complying with the Unique Device Identification rule and the Drug Supply Chain Security Act, and what work is left?

Innes: The first deadline under UDI is coming up on September 24, 2014, for Class III medical devices. The manufacturers of these medical devices, for the most part, have been working toward that deadline for the better part of a year, but have known that UDI was on the horizon for years, and have, in fact, been a key part of the support behind UDI. On the provider side, while many hospitals are readying their systems to accept UDI information, still others are in the dark about how to use UDI or what they need to do to support UDI adoption. Providers should be reaching out to their key suppliers to see what timelines their supplier partners are working under to incorporate UDI on their product and device labels. Providers should also be reviewing their own technology upgrade activities in light of UDI. While doing so, they should seize opportunities to leverage existing resources to continue to learn about UDI and how they can most efficiently prepare for incorporating it. GS1 Healthcare US will support any member of the supply chain during their transition to standards-based processes, no matter where they are on the education or adoption scale. 

What should pharmaceutical, medical device, provider, and patient care professionals start doing tomorrow in terms of standardized product identification?

Innes: Make sure you understand what standards can do for you, and leverage best practices by those in the industry who have been implementing. Reach out to your business partners to find out their plans, and how you fit in. There are a lot of resources, including the GS1 US UDI resource page, that will help get you started. If you’ve already started, please share your progress with industry so that those who come behind can learn from your experience. Standards implementation is happening, right now. In the name of patient safety, it is the right thing to do.

Posted by Daphne Allen
Pharmaceutical & Medical Packaging News  

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About the Author(s)

Daphne Allen

Daphne Allen is editor-in-chief of Design News. She previously served as editor-in-chief of MD+DI and of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Daphne has covered design, manufacturing, packaging, labeling, and regulatory issues for more than 25 years.  Follow her on Twitter at @daphneallen and reach her at [email protected].

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