UDI LUM Best Practices

HIDA and its supply chain partners have finalized a set of unique device identifier (UDI) best practices regarding lowest unit of measure (LUM) programs. These guidelines can help distributors and their trading partners comply with the Food and Drug Administration’s (FDA) UDI requirements while ensuring patient safety. Though UDI implementation presents a challenge for all parties involved, distributors and manufacturers have an opportunity to help each other and their customers. By initiating conversations around programs like low-unit-of-measure and just-in-time, distributors can offer manufacturers insights into how providers purchase, store, and use their products so appropriate solutions can be implemented. This webinar will cover:

• Key information on the requirements of UDI regulation
• Discussion on the impact of LUM programs
• Steps for discussion between supply chain partners on UDI and LUM
• Potential outcomes to the discussion between trading partners

Presenters

Mike Marchlik
VP Quality & Regulatory Compliance, Owens & Minor

Mike leads the Owens & Minor global quality and regulatory compliance organization that oversees the establishment, monitoring and management of quality and compliance systems. Prior to joining Owens & Minor, Mike was the VP Quality and Compliance for McKesson where he was accountable for all aspects of the Quality and Compliance program for the $3B Health Technology business. Mike was actively involved in industry workgroups such the public affairs and patient safety committees of the Electronic Health Records Association, the Bipartisan Policy Center initiative on oversight of health technology, and co-chair of the AAMI health technology standards committee. Before that, Mike worked at Becton Dickinson for 12 years, where he served as Worldwide Director, Quality Management. In that role, he was responsible for all aspects of quality systems for the Pre-analytical Solutions business as well as regulatory and continuous improvement programs at Becton Dickinson’s headquarters and its many manufacturing locations. While at BD, Mike was the product data process owner and a contributor to early efforts by DoD and GS1 to establish a product data synchronization process for medical devices.

Terrie Reed, MSIE
Senior Advisor for UDI Adoption, FDA

Terrie Reed, MS Industrial Engineering, has spent her career advocating for the operational integration of data standards and informatics principles into healthcare and government systems to improve the efficiency of regulatory submissions and public health reporting. Her latest role as Senior Advisor for UDI Adoption is the culmination of years of systems analysis, information science, and regulatory science experience aimed at significantly improving device evaluation and decision-making through the adoption of unique device identification (UDI) across the device ecosystem.

Dennis Black
Associate Director, Supply Chain, BD

Dennis Black has over 25 years of experience in the medical device industry and has worked in a variety of roles. He joined BD, a leading medical technology company in 1998 and currently serves as Associate Director, Supply Chain. Dennis is focused on developing and implementing supply chain solutions and related services. Other responsibilities include implementing the Unique Device Identification (UDI) regulation within BD and collaborating with select customers on strategic supply chain initiatives. Dennis currently serves on the GS1 Healthcare Global Leadership Team, the GS1 US Executive Leadership Committee, and the Strategic MarketPlace Initiatives (SMI) Board of Directors. He actively participates in several industry work groups to help solve critical healthcare challenges.