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www.cookmedical.com
Why do we need a standard if what we’re doing is working?
http://www.youtube.com/watch?v=g7D6pm_bLyU&feature=youtu.be
Are We There Yet? Driving data standards within the healthcare - - PowerPoint PPT Presentation
Are We There Yet? Driving data standards within the healthcare - - PowerPoint PPT Presentation
Are We There Yet? Driving data standards within the healthcare supply chain Chuck Franz UDI & Traceability for Medical Devices Munich, Germany, 25 September, 2013 www.cookmedical.com Why do we need a standard if what were doing is
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Improved Patient Safety
- Identifies: Right product, right
patient, right time
- Is scanned at the bedside
- Helps prevent medication errors
- Combats counterfeit products
- Facilitates recalls
Image source: http://www.gs1eg.org/Sectors-Healthcare-100.htm
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Improved Supply Chain Efficiency
MANUFACTURE STORAGE PATIENT PACKAGE TRANSPORT HOSPITAL
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Global Data Standards Already Exist
Apparel CPG/Grocery Foodservice Fresh Foods Healthcare Alcohol Beverage Financial Services General Merchandise Government/Public Sector Hardlines High Technology and Electronics
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An Ideal Scenario
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Government Manufacturers Payers Providers Clinicians Patients GPOs Distributors
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Multiple Standards Increase Costs
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What is a data standard?
- Data standard: A common language for trading partners to use about
products that pass through the supply chain. SAME DATA. DIFFERENT NAMES.
UDI
Unique Device Identification
GS1 Standards
Product Identification
DI
Device Identifier
GTIN
Global Trade Item Number
PI
Product Identifier
(if applicable)
AI
Application Identifier
- Expiration Date AI(17) – e.g. 141120
- Lot/Batch AI(10) – e.g. 1234AB
- Serial Number A(21) – e.g. 12345XYZ
Product identifier data will vary by medical device type and manufacturer current practice.
DI + PI = UDI GTIN or GTIN + AI(s) = UDI
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GTIN is Just a Number
Application identifier (product code) Packaging indicator Company ID Product ID Check digit Application identifier (expiration date) Expiration date Application identifier (lot number) Lot number
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GTIN is Just a Number
Application identifier (product code) Packaging indicator Company ID Product ID Check digit Application identifier (expiration date) Expiration date Application identifier (lot number) Lot number
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One Global Data Source
Distributors National Product Catalogs GPOs Hospitals and Health Systems Regional Data Centers GUDID Regulatory Agencies GDSN
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Patient Safety
- Standards should only include
information that is regulated and needed at the point of care – This information is already available to physicians and on our websites and in IFUs
- Proprietary information does not
improve patient safety
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GTIN Challenges
- Create a global product database
- Manufacturers had to change barcode labeling logic
- Cook distribution systems had to change
- EDI systems had to be altered to pass data through
all systems
- Packaging changed, resulting in going from a 1-to-1
relationship to a 1-to-many relationship between product number and packaging
- UOM changed, requiring inventory conversions
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FDA Unique Device Identification (UDI) Pilot
Helped to Identify Data Sources Developed an Automated System for Submitting Data Tested the FDA Portal for Submissions Provided Valuable Feedback about the Proposed Rule In September and October 2012, Cook participated in the FDA UDI Pilot. The purpose of the pilot was to help the FDA assess their proposed rule that would require all devices to carry a Unique Device Identifier.
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What’s Next?
http://www.youtube.com/watch?v=g7D6pm_bLyU&feature=youtu.be
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Continuing the Dialogue
Chuck Franz
Vice President & Chief Information Officer Datastandards-us@cookmedical.com
Emmet Deveroux
Director, Quality & Regulatory Affairs Datastandards-eu@cookmedical.com
Gar Murphy
Director, IT Europe Datastandards-eu@cookmedical.com
Martin Matkin
Director, Healthcare Business Solutions Europe Datastandards-eu@cookmedical.com