On July 3, 2012, the FDA released a proposed rule on the unique device identification (UDI) system, ending a year-long delay in finalizing the much-anticipated safety mechanism. The 165-page comprehensive rule touches all aspects of the medical device industry.
The FDA maintains that the UDI system helps reduce the rate of death caused by faulty devices, which the agency estimates at 17,700 over the past five years. Jeffery Shuren, director of CDRH, called the UDI rule "a major game-changer."
The FDA receives numerous device-related adverse event reports, but often can’t tell what device the patient is referencing.
UDI makes aggregating reports easier, but at what time and cost to industry?
Across the board — from supplier, provider, distributor, to consumer — who is ready?
Listeners will learn what’s hidden in the rule’s 165 pages and where to start the journey to implementation.
|Bonus: Listeners will receive links to GS1’s implementation toolkits.|
Siobhan O’Bara and John Roberts of GS1 present a 90-minute audio CD/Transcript to provide clarification on creating a mandatory system of unique device identifiers.
Responding to concerns the FDA has moved too slowly on recalls in the past, the UDI system has been developed to provide a standardized way to identify devices across all information systems including electronic health records and device registries. The FDA believes it will improve the quality of medical device adverse event reporting and identify problems more quickly and efficiently.
Industry standards experts from GS1 US present a comprehensive analysis of the UDI legislation, including:
If you have responsibility for managing any portion of the order-to-cash process you will benefit from this audio CD/Transcript.
Meet Your Instructors
Siobhan O’Bara is the Vice President, Healthcare at GS1 US. Ms. O’Bara started her career in healthcare at Cardinal Health — the James W. Daly division in 1990, where she held numerous positions in marketing, purchasing and logistics operations for Cardinal’s Pharmaceutical and Medical/Surgical business in the New England market. She joined Covidien in 1996 as the Customer Service Manager for the Kendall Medical division. During her fifteen years with Covidien, she has been in corporate roles leading customer services and operations, supply chain management and information systems.
Additionally, Ms. O’Bara has led the supply chain functions at multiple Covidien divisions including: Kendall Confab Retail Group, Mallinckrodt Imaging and Pharmaceutical Sector and Nellcor Puritan Bennett Respiratory Monitoring Solutions. She has been responsible for customer services, transportation, planning, global replenishment, distribution operations and supply chain systems with expertise in acquisitions, integrations and business process development. Most recently, Ms. O’Bara joins the Industry Engagement team at GS1 US, leading the healthcare team on data standards’ development and adoption.
John Roberts, Director of Healthcare at GS1 US, is a 39-year career veteran in global healthcare logistics. Mr. Roberts has extensive experience in program management, inventory management, business, financial and resource planning, systems design and development, and product and process identification. Mr. Roberts was the program manager for the Global Location Number (GLN) Registry for Healthcare® from 2004 to 2010. He also pioneered the adoption of GS1 DataBarä, formerly known as Reduced Space Symbology, and the Composite Component symbol in U.S. Healthcare. He has authored hundreds of documents explaining the use of the GS1 System and is a recognized expert and frequent speaker at regional and global healthcare conferences.
The largest part of his healthcare career has been with the US Department of Defense activity (currently named Troop Support) charged with ensuring that the military services receive the right medical product at the right time at the right cost. His efforts materially contributed to the awarding of several commercial and government awards to this agency including two vice presidential citations or “Hammer” awards. Mr. Roberts was inducted into the Defense Logistics Agency, Defense Personal Support Center Hall of Fame in 2001 (for his contributions to improving supply chain efficiencies in global military medicine.
Most recently, Mr. Roberts was awarded the prestigious commercial “Way Paver” award for his work in promoting the use of barcodes at point of care. Mr. Roberts is currently responsible for the adoption and implementation of the goals of the 2012 Global Trade Item Number (GTIN) sunrise.
Anyone needing to gain an understanding of how UDI will need to work for them and what the roles/responsibilities for execution will be. In particular: