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Dr. Ina Trapp Roche Diagnostics
Implementation of GS1 barcode standards in a hospital laboratory - a successful case study Dr. Ina Trapp, Global UDI Change Control Manager, Roche Diagnostics 18 April 2016
Implementation of GS1 Barcode Standards in a Hospital Laboratory - A Successful Case Study Dr. Ina Trapp Global UDI Change Control Manager, Roche Diagnostics
Basic facts at a glance Founded 1896 in Basel, Switzerland Founding families still hold majority stake Employing 91,700 people Currently active in 150 countries on all continents 2015 sales of 48.1 billion Swiss francs 2015 25 million patients treated with one of Roche s top 25 selling medicines 2015 15 billion diagnostic tests performed Clear focus on healthcare Leadership in pharmaceuticals (#3)* World s largest biotech company (position #1)* with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS Leadership in in vitro diagnostics (#1) and pioneer in diabetes management Unique innovation model
Diagnostics are about gathering medical data To be transformed into actionable information Data Information Action Sample Test Result evaluation Treatment decision
Revaluing Diagnostics In vitro diagnostics testing has long been a silent champion of healthcare: IVD accounts for ~2% of worldwide healthcare spending IVD influences >60% of clinical decision-making Source: European Diagnostic Manufacturers Association (EDMA) 2009
UDI - Introduction What is Unique Device Identification? UDI stands for Unique Device Identification. UDI provides essential product identification information i.e. Identification number, lot/batch/serial number, expiry date, in a universally recognized way i.e. a barcode. (coding) The barcode is a gateway to additional information about the product that is stored in a publically accessible database. (database) Together the coding and the database make up the UDI System. UDI System coding database
UDI Labeling Requirements What is new on the label The US FDA sees UDI as a unique device identification system to adequately identify medical devices through their distribution and use. For this purpose the label of the device package must bear a UDI consisting of two parts: The Device Identifier (DI) The Production Identifier (PI) Both have to be presented on the label in human- and machine-readable form.
UDI Labeling Requirements Roche Device Identifier & Production Identifier The Device Identifier (DI) For Roche the Device Identifier is the 14 digit GS1 Global Trade Item Number (GTIN- 14). } GTIN-14 static information The Production Identifier (PI) The PI identifies the unit of production; it is mandatory only where the device is controlled in that manner. Expiration Date Lot/Batch Number Serial Number }dynamic information
UDI Barcode Type & Label Content What is printed on the label The UDI DI & PI must be applied to the label or device package of medical devices and IVDs in both plain-text (human readable) and Automatic Identification & Data Capture (AIDC / machine readable) format. For Roche this is in the form of a GS1 2D DataMatrix code. Roche Material Number (No mandatory UDI content but voluntarily printed & encoded) Lot Number (PI) REF LOT GTIN 12345678190 12345601 2014 09-24 01234567891234 GS1 2D DataMatrix (Both DI and PI must be encoded in the DataMatrix code) Expiration Date (PI) GTIN-14 (DI)
UDI - Why are we implementing it? Compliance Compliance UDI System Patient Safety Added Value With UDI we meet regulatory requirements and maintain the right to operate Increase Efficiency
UDI - Why are we implementing it? Compliance Patient Safety UDI System Increase Efficiency Patient safety Added Value With UDI we will contribute to improving patient safety by reducing errors caused by misidentification of medical devices. This is achieved by providing an easy, standardized way of identifying devices
UDI - Why are we implementing it? Compliance Added Value UDI System Patient safety Added Value With UDI we add value to our customers, because we provide easy access to harmonized product information in a public database and the tools for more efficient inventory management. Increase Efficiency
UDI - Why are we implementing it? Compliance Increase Efficiency UDI System Increase Efficiency Patient safety Added Value With the UDI barcode we improve accuracy and item verification which contributes to increased efficiency of the entire value and supply chain by having a complete picture of product traceability.
UDI - Why are we implementing it? Obligation & Opportunity Global Project: Harmonization of UDI label content across the entire Diagnostics Division at Roche. Consideration of further label changes. Not only regulatory requirement, but also a benefit for business partners and customers. Before:
UDI - Why are we implementing it? Obligation & Opportunity Global Project: Harmonization of UDI label content across the entire Diagnostics Division at Roche. Consideration of further label changes. Not only regulatory requirement, but also a benefit for business partners and customers. After:
The University Hospital Carl Gustav Carus Dresden Basic Facts 26 Clinics 4 Institutes 3 Interdisciplinary centers 52.000 Patients p.a. 1.300 In-patient beds and 95 walk-in treatment rooms 700 Physicians and 1600 Nursing staff 24/7 Laboratory testing >180 Different parameters 4.500 Samples and 23.000 measured values per day 500 Different reagents 200.000 Packages p.a. with 1500 order items
The Central Laboratory The Old Process Goods receiving: Visual check against Delivery note Batch+ Expiry Date Right amount Correlates with order? Active weekly control: Stock and expiry Purchase requisition to hospital pharmacy Discard expired products Use of product: Visual checks for Product ID Batch + Expiry Date Right amount Correlation (Instrument)
The Central Laboratory The New Paperless Process Goods receiving: Product ID (GTIN) Batch + Expiry Date Right amount Correlates with order? Use of company barcodes or relabeling Daily control online: Stock and expiry Automatic reorder (at hospital pharmacy) Discard expired products Use of product: Automatic recognition of Product ID Batch+ Expiry Date Right amount Correlation (Instrument)
The Central Laboratory The New Process in SAP Scanning the GS1 barcode maps all necessary positions to the right fields New inventory is created automatically
The Central Laboratory The New Process Goods Receiving Order List Online Paperless Inventory Label Printing (if necessary) Scanning Use of Product
UDI Harmonized Labeling Advantages for Clinical Laboratories Patient Safety Online Inventory Managemen t High Quality Standard Automatic reordering Optimization of Inventory Automatic Expiry Control
Healthcare Award 2015
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