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 we’re doing is working? http://www.youtube.com/watch?v=g7D6pm_bLyU&feature=youtu.be

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

Improved Supply Chain Efficiency MANUFACTURE PACKAGE TRANSPORT HOSPITAL STORAGE PATIENT

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

An Ideal Scenario $ Providers Patients Government Manufacturers Payers Clinicians GPOs Distributors

Multiple Standards Increase Costs

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 GS1 Standards Unique Device Identification Product Identification DI GTIN Device Identifier Global Trade Item Number PI AI Product Identifier Application Identifier (if applicable) • 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. GTIN or GTIN + AI(s) = UDI DI + PI = UDI

GTIN is Just a Number Company ID Lot number Application Check Expiration identifier digit date (product code) Application identifier Packaging Product (lot number) indicator ID Application identifier (expiration date)

GTIN is Just a Number Company ID Lot number Application Check Expiration identifier digit date (product code) Application identifier Packaging Product (lot number) indicator ID Application identifier (expiration date)

One Global Data Source Hospitals and Health Systems GPOs Regional Data Centers National Product GUDID Catalogs GDSN Distributors Regulatory Agencies

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

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

FDA Unique Device Identification (UDI) Pilot 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. 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

What’s Next? http://www.youtube.com/watch?v=g7D6pm_bLyU&feature=youtu.be

Continuing the Dialogue Chuck Franz Gar Murphy Vice President & Chief Information Officer Director, IT Europe Datastandards-us@cookmedical.com Datastandards-eu@cookmedical.com Emmet Deveroux Martin Matkin Director, Quality & Regulatory Affairs Director, Healthcare Business Solutions Europe Datastandards-eu@cookmedical.com Datastandards-eu@cookmedical.com