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CLASS Executive Summary Presentation
RFID In EuropePrague
March 28-31, 2011
Agenda• Class Promoters• Why was CLASS
necessary?• CLASS the Pilot and
beyond….
Information is not Power,Sharing Information is the Real Power
Technical RFID & software development expertise with infrastructure for on-going R&D
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CLASS Promoters
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
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
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Why was CLASS necessary?
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
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Pilot location – Galway Clinic (Ireland)
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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
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What problems will CLASS solve?
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
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Why now?
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What about existing solutions?
•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
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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)
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Governance of CLASS
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)
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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
UHF Near Field or 2D barcode reader
The Model Solution
Hospital ORHospital Stockroom
(post sterilization if RFID)
Labeling Overlabelling Stocking Point of use Post 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
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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
Would you prefer RFID/Barcode?
Would you be willing to share POU info with Suppliers
Do you share POU info with suppliers?
Would you make a capital investment for preferred stock control sys-tem
Keen to try Barcode
Do you feel need for Barcode
Keen to try RFID
Do you feel need for RFID
Do you have EMR
Do you use stock Tracking Software
0 1 2 3 4 5 6 7
RFID
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Barcode
No
No
No
No
No
No
No
No
No
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Clinician Survey - Preferences
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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
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 interference17
What further development is needed?
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
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To Summarise
Thank you!
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