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

2.  Agenda Class Promoters Why was CLASS necessary? CLASS the Pilot and beyond….

3. Technical RFID & software development expertise with infrastructure for on-going R&D 3 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. Escalating costs of healthcare services Growing demand from regulators Trading partners need to share data to transact business & support business processes. To be efficient & effective, a common language of globally accepted standards is essential Key drivers for change “Federated Database” solution facilitates this 4

5.  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 5

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

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8.  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 8

9. 9 Innovative SMART Systems developed Use AIDC technologies Strong ROI for providers/clinics Pros Full value across entire Supply Chain unclear Lack scalability & interoperability Proprietary Lack of standards Cons Cause Supply Chain inefficiencies Inserts cost & confusion Stifles global adoption Obstacle to rapid & effective recall Net Effect of no Standards

10. 10  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. 11 Governance structure protects interests of all stakeholders Not for profit, neutral entity Ensure full representation of healthcare supply chain, influencers & key academic thought leaders Comprised of: Manufacturers GS1 GTI GHX Solution providers AutoID Labs Clinical opinion leaders (WVI et al)

12. 12  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. UHF Near Field or 2D barcode reader Hospital OR Hospital Stockroom (post sterilization if RFID) Labeling Overlabelling Stocking Point of usePost use EMR Federated database Product label bar code EPC Compliant Reader Product ID Serial # (if have) Batch/lot # Expiry date Manufacturer Product ID Serial # ( always ) Batch/lot # Expiry date Product ID Serial # Batch/lot # Expiry date Product ID Serial # Batch/lot # Expiry date Patient record Product ID Serial # Batch/lot # Expiry date Patient demographic association Product ID Serial # Batch/lot # Expiry date Phase 1

14. 14  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

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16. 16 “…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.  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 17

18. Healthcare costs are increasing Regulatory requirements exist Healthcare Industry needs to share product specific data Common language of globally accepted standards is essential Requires involvement & support of all stakeholders CLASS can facilitate this 18

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

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