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Visualised: Unique device identification and global trade item number

This article was originally published in Clinica

Executive Summary

A pan-European surveillance of medical devices means that several stakeholders in the supply chain must come together to make this concept works (EU surveillance and vigilance: is a totally new oversight tool needed?, 29 June 2009)

This effort will involve not only the authorities and the medical device companies, but also partners such as system integrators and third-party logistics. Here we present a visual guide on what this concept might entail:

GTIN: Global Trade Item Number. It is a unique set of numbers used to identify any item.

The purpose: So you can retrieve pre-defined information on an item quickly. You can track and trace the movement of the item throughout the supply chain. Typically this includes the lowest level of packaging as well as higher packaging levels.

Supply chain: From the 'shopfloor' of the factory which manufacturers the item, through to the warehouses and transportation, to point-of-sale.

Point-of-sale (POS): In retail terms, the actual shopfloor. Such as the supermarket. In healthcare terms, possibly a hospital.

Who's involved in the traceability process? A general overview

Carrier/Third Party Logistics Provider (3PL)
The party responsible for the delivery or shipping of the traceable item.

Processor/Manufacturer/Primary Producer
Typically receives inputs and transforms those inputs. Could involve more than one processor, manufacturer or primary producer.

Warehouse/Distribution Centre
Responsible for the handling (may transform the traceable item) and storage of the traceable item. A warehouse could also be a third party operation that also carries out packaging or assembly processes for the manufacturer.

Retailer/Point of Sale or Service Operator
Has the final relationship with the consumer. For example, a retailer, institution, or hospitality service such as a hotel or restaurant. In healthcare context, a hospital or a research facility.

Authorities
The party legally mandated to protect the public interest.

Source: GS1

What is a traceable item?

Shipment
May contain one or more logistic unit(s)
Examples include truckload, vessel, 10 pallets of various items

Logistic unit
May contain other logistic unit(s)
May contain one or more trade item(s)
May be a trade item
Examples include pallet, container.

Trade item not crossing the POS
A trade item
Batch/lot of trade items
Serialized trade item
Examples include carton, bag

Trade item crossing the POS
Examples include consumer units

Source: GS1

Types of barcodes

EAN/UPC
Commonly used in retail at point-of-sale (POS). Ideal for high-volume scanning. Used at POS, and in logistics application, must be printed larger than the "target" size to accommodate logistics scanning.

GS1 DataBar
Used at POS; smaller than EAN/UPC in size. Can carry additional information such as serial numbers, lot numbersand expiry dates. GS1 DataBar symbols are already approved for global use on healthcare items that do not cross POS.

GS1-128
GS1-128 (UCC/EAN-128) barcodes can carry all GS1 Keys and attributes, but cannot be used to identify items crossing POS.

ITF-14
ITF-14 barcodes can only carry global trade item numbers (GTINs), can be printed directly on corrugated cartons, but cannot be used to identify items crossing POS.

GS1 DataMatrix
GS1 DataMatrix is the only "2D Matrix" symbol specified for use by GS1 and is becoming increasingly the symbol of choice for many in healthcare. Because GS1 DataMatrix requires camera-based scanners, it is currently specified for healthcare items not crossing POS and direct part marking.

Source: GS1

When to allocate a GTIN number?

Whenever any of the pre-defined characteristics of an item are different in any way that is relevant to the trading process. If any significant change is made and it is expected to distinguish a new trade item from an old trade item and use accordingly, a new GTIN should be assigned. Two products have identical ingredients and brand names but require separate GTINs as one product can be sold anywhere while the other requires a Pharmacist to distribute (because of the intended usage)

What do they mean by significant changes?

There are different packaging levels throughout the supply chain. Examples: Unit of use package, shipper or case, pallet, and so on. At each level, a different GTIN has to be used. Any packaging level that is priced or ordered or invoiced at any point in any supply chain should receive its own GTIN

GTIN Allocation Scenarios

Same product, marketed to countries with different languages. Example: One targeted for an English-speaking country; one for Spanish-speaking country. The GTIN for each market has to be different

One product, packaged in one language, for different markets, different languages. GTIN stays the same

Changes in packaging materials. Or minor artwork changes. GTIN stays the same

Promotion related to price, to run at a specific period of time. GTIN stays the same The net content changes. For example, from 100 tablets to 125 tablets. GTIN for each packaging must be different

Groupings of the same time, but in different quantities. Same GTIN

Additional pallet configurations for ordering purposes. GTIN is not normally required at the pallet level. However, if the market requires additional pallet configurations to be made available for ordering purposes, then different GTINs are required for each pallet-pattern and/or pallet-layout Source: GS1

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