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Welcome to our
29th Global GS1 Healthcare
Conference
Dr. Ina Trapp
Roche Diagnostics
Dr. Ina Trapp, Global UDI Change Control Manager, Roche Diagnostics
Implementation of GS1 barcode standards in a
hospital laboratory - a successful case study
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
• 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
Basic facts at a glance
Diagnostics are about gathering medical data
To be transformed into actionable information
ActionData
Sample
Information
Test Result
evaluation
Treatment
decision
Revaluing Diagnostics
IVD accounts for
~2%of worldwide healthcare spending
IVD influences
>60% of clinical decision-making
In vitro diagnostics testing has long been a silent champion of healthcare:
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
REF
LOT
01234567891234
12345678190
12345601
2014–09-24
GTIN
GTIN-14 (DI)
Roche Material Number
(No mandatory UDI content but voluntarily printed & encoded)
Lot Number (PI)
Expiration Date (PI)
GS1 2D DataMatrix
(Both DI and PI must be encoded in the DataMatrix code)
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.
UDI – Barcode Type & Label Content
What is printed on the label
UDI
System
Compliance
Patient Safety
Added Value
Increase Efficiency
Compliance
With UDI we meet regulatory requirements and maintain the right to operate
UDI - Why are we implementing it?
UDI
System
Compliance
Patient safety
Added Value
Increase Efficiency
Patient Safety
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?
UDI
System
Compliance
Patient safety
Added Value
Increase Efficiency
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.
UDI - Why are we implementing it?
UDI
System
Compliance
Patient safety
Added Value
Increase Efficiency
Increase Efficiency
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?
• 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
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
• 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
• 26 Clinics 4 Institutes3 Interdisciplinary centers
• 52.000 Patients p.a.
• 1.300 In-patient beds and 95 walk-in treatment rooms
• 700 Physicians and 1600 Nursing staff
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 barcodesor 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)
Scanning the GS1 barcode
maps all necessary
positions to the right fields
New inventory is created
automatically
The Central Laboratory
The New Process in SAP
The Central Laboratory
The New Process
Goods Receiving Order List OnlinePaperless
Inventory
Use of ProductLabel Printing
(if necessary) Scanning
Online Inventory
Management
Automaticreordering
Automatic Expiry Control
Optimization of Inventory
High Quality Standard
Patient Safety
UDI – Harmonized Labeling
Advantages for Clinical Laboratories
Healthcare Award 2015
Doing now what patients need next