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CLASS Executive Summary Presentation RFID In Europe Prague March 28-31, 2011

CLASS Executive Summary Presentation RFID In Europe Prague March 28-31, 2011. Information is not Power, Sharing Information is the Real Power. Agenda Class Promoters Why was CLASS necessary? CLASS the Pilot and beyond…. CLASS Promoters.

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CLASS Executive Summary Presentation RFID In Europe Prague March 28-31, 2011

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  1. CLASS Executive Summary Presentation RFID In Europe Prague March 28-31, 2011

  2. Information is not Power,Sharing Information is the Real Power • Agenda • Class Promoters • Why was CLASS necessary? • CLASS the Pilot and beyond….

  3. CLASS Promoters Technical RFID & software development expertise with infrastructure for on-going R&D Implementation of GS1 Standards for Unique Identification & Automatic Data Capture using Barcodes and RFID in Ireland Clinical test-bed and end-user involvement in system development

  4. Why was CLASS necessary?

  5. Pilot location – Galway Clinic (Ireland) • 146-bed Private hospital • Approx.16,000 acute & elective surgical & medical admissions yearly • Over 900 physicians and allied health professionals • Full range of surgical services; endovascular, cardiac surgery, etc. • Hybrid endovascular suite; state of the art facilities; Robotic surgery. • Over 8,000 surgeries; 2,000 Cath lab procedures yearly

  6. What problems will CLASS solve? Per capita healthcare spending and how it relates to Average Life Expectancy in the top 30 countries worldwide with the highest life expectancy rates

  7. What problems will CLASS solve?

  8. Why now? • Healthcare costs escalating • Threat of counterfeit devices • Regulatory Bodies working on Unique Device Identifier (UDI) • Key drivers for change, • Only addressed by adoption of agreed standards for product id & data sharing • To do nothing, will ultimately • Cost more • Take longer

  9. What about existing solutions?

  10. Objectives of CLASS • Delivery of real-time visibility of medical devices • Support innovative Solution providers • Global standards-based approach across the entire supply chain • Use of open standards for unique product identification & data sharing • Federated database (GHX) to store information • EPCIS (GS1Visibility Network) to share information • Application of Automatic Identification and Data Capture (AIDC) and Electronic Data Exchange technologies. • Standardised label format (sGTIN) / 2-D DataMatrix (ECC 200) / RFID (EPC Gen 2)

  11. Governance of CLASS

  12. What’s different about CLASS Solution? • Based on open GS1/EPCglobal standards • Provides interoperability essential for mass adoption. • Copes with different data carrier/capture technologies • Proposes federated database • facilitate exchange of transactional data • for providers and manufacturers • up to point of use data capture. • Based on Clinical input & best practices • Provides non-partisan certification service to ensure solutions comply with the standards

  13. The Model Solution Phase 1 Overlabelling Labeling Stocking Point of use Post use Manufacturer Hospital OR Hospital Stockroom (post sterilization if RFID) Product label bar code UHF Near Field or 2D barcode reader EMR EPC Compliant Reader • Product ID • Serial # (if have) • Batch/lot # • Expiry date • Product ID • Serial # • Batch/lot # • Expiry date • Patient record • Product ID • Serial # • Batch/lot # • Expiry date • Product ID • Serial # • Batch/lot # • Expiry date • Product ID • Serial # (always) • Batch/lot # • Expiry date Federated database • Product ID • Serial # • Batch/lot # • Expiry date • Patient demographic association

  14. Phase 1 Findings • Tagged over 660 high-value endovascular products (guide-wires, stents, balloons, etc.) • Successfully demonstrated system • Could be deployed across multiple manufacturers based on existing, global standards • Could be seamlessly integrated into current clinical workflow practices • Did not impact on medical equipment as a result of the UHF RFID CLASS Label

  15. Clinician Survey - Preferences 30

  16. Clinician Survey - Comments • “…With shrinking reimbursement rates in the US, we cannot afford to waste resources. When can we start?...” • Gary M. Ansel, MD, • Care Riverside Methodist Hospital, Columbus, Ohio. • “…We need to track products between various centers within our medical group and many of these are in different cities across the United States. Why isn’t this available already?...” • Sam S. Ahn, MD, FACS, MBA, • University Vascular Associates and DFW Vascular Group

  17. What further development is needed? • Phase 1 • Model system successfully deployed in clinical setting. • Phase 2 • Implement in a number of “Centres of Excellence” • Concentrated in one geographical region (Boston, Tokyo, etc) • Mixture of RFID and/or barcodes • Inclusive model • Speeds roll-out • Adheres to principal of open standards • Allows leeway for technology to develop • Further research to better understand RF interference

  18. To Summarise

  19. Further Information kevin.mcguinness@georgiatech.ie jim.bracken@gs1ie.org niamhmhynes@gmail.com www.vascular.ie

  20. Kindly supported by

  21. Thank you!

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