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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