In July of 2012, the FDA released drafted regulations that will require the implementation of a national unique device identification (UDI) system, aiming to improve safety and efficiency in US healthcare systems. The concept of this system has the potential to be effective only if UDI is captured, stored, integrated and exchanged by all stakeholders in the US and abroad. GS1 healthcare, a diversified global healthcare group which aims to develop and implement global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies, has applauded the FDA’s steps toward improving patient safety through UDI’s. Implementing this system on a global scale is sure to be quite complex for both manufacturers and regulators and becoming a member of a Standards Development Organization such as SG1 can assist in overcoming challenges. The following presentation discusses critical points within the UDI system and highlights how the GS1 system of standards is meeting them.
- Status update and guidance on global UDI and traceability
- Understanding the intricacies of the UDI system
- Differentiating device and product indicators
- Allocation of UDI codes
- Defining what products require UDI
- Coding for product accessories/product packs
- Delegating internal responsibilities for code maintenance
- Label preparation
- Strategies and methods for internal preparation
- Potential UDI implementation timeline and compliance requirements
Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Quality Assurance
- Regulatory Affairs
Public Policy Manager
Senior Director, AIDC Healthcare
Senior Director, Industry Engagement, GDSN & GLN Service
Géraldine Lissalde-Bonnet, Public Policy Manager, GS1
Géraldine Lissalde-Bonnet is managing the GS1 Healthcare Public Policy Work Team which has the mission to lead the healthcare sector to the successful development and use of global standards. Their goal is to enhance worldwide patient safety and supply chain efficiencies through standards for AIDC (Automatic Identification and Data Capture), global data synchronization and traceability.
Ulrike Kreysa, Vice-President, Healthcare, GS1
Ulrike Kreysa manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain. Ulrike works regularly with decision makers from companies like Abbott, Medtronic, Pfizer, GE Healthcare, GSK, Johnson & Johnson, Baxter, B.Braun, Bayer, Zimmer and others to drive harmonization of standards in the implementation across the world. To achieve that she is regularly in discussions with regulatory bodies to discuss the need for a globally aligned and harmonized approach towards standards in order to avoid supply-chain inefficiencies for all healthcare stakeholders and increase patient safety.
Chuck Biss, Senior Director, AIDC Healthcare, GS1
Chuck started in the AIDC industry when he joined PSC Inc. (formerly Photographic Sciences Corporation) in 1973 and since then his focus has primarily been verification and industry standards development, as well as technical support / training and education. At GS1 he is focusing on the AIDC aspects of their healthcare initiatives on a global level as well as continuing many of his Standards activities. Until his move to GS1 Healthcare he was also a member of the AIM Global Board of Directors.
Pete Alvarez, Senior Director, Industry Engagement, GDSN & GLN Service, GS1
Peter Alvarez works with global industries on the adoption of Master Data Standards and classification and GLN in healthcare among other GS1 standards. Prior to joining GS1 in 1999, Pete worked for organizations such as National Semiconductor, Avery Dennison, Monarch Marking Systems and Spinnaker Industries among others. His experience includes Master Data Management, data quality, data synchronisation, classification, bar code applications, RFID, printing technologies, supply chain education, business development and standards development.