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GS1 Datamatrix in Healthcare

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GS1 Datamatrix in Healthcare GS1 DataMatrix A tool to improve patient safety through visibility in the supply chain Visibility enabled by GS1 DataMatrix in Healthcare Global standards for automatic Some of these needs are being identification provide an opportunity to met, and will continue to be met, make the healthcare supply chain safer through the use of ‘traditional’ linear In France, as from the as well as more efficient and accurate. bar code data carriers, such as GS1- 1st of January 2011, Healthcare regulators and trading 128 or GS1 DataBar. However, for new regulation on the partners have realised that a global applications where they are not, GS1 traceability of human standardised identification system from Healthcare has adopted the use of GS1 pharmaceutical manufacturer to patient treatment DataMatrix as the GS1 Data Carrier (bar products requires is imperative to comply with the code symbology) solution. increasing need for product traceability a GS1 DataMatrix around the world. The healthcare industry faces major to be placed on all challenges like counterfeiting, pharmaceutical packs. The GS1 System, globally endorsed ineffective product recall, medication by the healthcare community, is errors and lack of inventory costs and the most widely used identification supply chain inefficiencies. Some system worldwide with more than 5 countries like France have already a This system will identify products with billion transactions per day. Built on a regulation in place to improve patient the GS1 Standards using the 2D foundation of identification keys (such safety through better traceability. GS1 DataMatrix as the data carrier as the Global Trade Item Number or of choice. GTIN) and attributes (such as a batch/ The EU Falsified Medicines Directive www.gs1.org/docs/healthcare/GS1- 2 lot number, expiry date, unique serial (FMD) constitutes an important step EFPIA_product_identification_vision.pdf number etc.), it is uniquely suited to in protecting patients from counterfeit meet the needs of the healthcare medicines. As a result, European The Council of Europe and its EDQM industry. pharmaceutical supply chain actors, (European Directorate for the Quality amongst others EFPIA (European of Medicines and HealthCare) have Pharmaceutical and medical device Federation of Pharmaceutical Industry also adopted a multi-level, anti- identification & marking can have very Associations) supported by GIRP counterfeiting strategy. Part of this specific needs, including: (Pharmaceutical full-line wholesalers strategy is the eTACT system: the • Encoding large amounts of variable in Europe), PGEU (Pharmaceutical EDQM anti-counterfeiting traceability or dynamic data (batch/lot number, Group of the European Union) and service for medicines. The aim of expiry date, serial number, etc.) at high EAEPC (European Association of eTACT is to ensure the traceability production speeds Euro-Pharmaceutical Companies) of individual packs of medicines • Direct part marking (e.g. marking on are developing systems enabling using mass serialisation. With surgical instruments, etc.) medicine packs to be verified at the interoperability in mind, eTACT will • Global legal and regulatory point of dispensing, with the objective follow the main standards of GS1, requirements that may dictate the to meet the requirements of the FMD. namely GTIN (Global Trade Item placement of, and data encoded in a Number) for product numbering bar code symbol as well as the specific The EFPIA solution is an end-to- and EPCIS (Electronic Product Code data carrier (bar code symbology) to end point-of-dispense coding and Information System) for interfacing be used serialisation system which allows systems. The eTACT project envisages • Traceability requirements for both pharmacists to check a unique placing a Unique Medicine Identifier pharmaceuticals and medical devices identification code on each individual (UMI), containing GTIN plus additional pack when it is dispensed to the attributes on the secondary packaging patient. These codes are generated of medicinal products in the form of a and applied by manufacturers using a 2D datamatrix barcode simple 2D data matrix barcode, which www.edqm.eu There can be no contains the GTIN (Global Trade Item visibility of an item Number), a unique serial number or asset until there and additional attributes. The scan is a standard way will reveal any duplication of data on for all stakeholders packs and will trigger the system to immediately alert the pharmacist to in the supply the possibility of a counterfeit product. chain to identify it, www.efpia.eu capture and share information about it GS1 DataMatrix – A tool to improve patient safety through visibility in the supply chain What is GS1 DataMatrix? A GS1 DataMatrix bar code symbol is a • Enabling direct part marking two-dimensional (2D) matrix bar code, of trade items where labels may consisting of black and white “cells” or not be practical (small medical / modules, that can be arranged in a surgical instruments) square or rectangular matrix. • Allowing the printing of variable GS1 DataMatrix is the preferred two- information in a bar code data dimensional (2D) matrix bar code carrier, at high production rates symbology that efficiently meets all of • Providing error detection the needs of the pharmaceutical and and correction capabilities to medical device industry, by: improve the readability of bar code symbols despite irregular • Allowing the encoding and packaging or physical damage to marking of a greater amount of a label data within a smaller space Structure of GS1 DataMatrix The GS1 DataMatrix may be printed as a square or A GS1 DataMatrix can contain the following attributes : rectangular symbol made up of individual dots or squares. 3 This representation is an ordered grid of dark and light Manufacturer Product Code (GTIN) - 14 digits modules bordered by a finder pattern. The data is encoded Expiry Date - 6 digits (YYMMDD) using a series of dark or light modules based upon a Batch / lot Number - up to 20 alpha-numeric characters pre-determined module size, grid size and mathematical Unique Serial Number (randomized) - up to 20 alpha- formula. numeric characters The GS1 DataMatrix is readable omni-directionally (in a Example: Use of GS1 Standards for the identification of 360-degree orientation). products using a GS1 DataMatrix GTIN: (01) 07046261398572 Expiry: (17) 130331 Batch / lot: (10) TEST5632 S/N: (21) 19067811811 Where is it used and placed? Because of its small size and high The exact location of a GS1 DataMatrix information capacity, GS1 DataMatrix symbol on a product is determined is used in multiple industry sectors by the manufacturer who will need to including electronics, automotive, consider: aerospace and is particularly suited to healthcare. You can find it on a • The available space on the product medication or medical device package package as well as directly on medical devices. • The type of product and printing substrate (packaging material) • The intended usage of the GS1 DataMatrix (for example, will the symbol be read in an automated environment or by hand) GS1 DataMatrix – A tool to improve patient safety through visibility in the supply chain How to read it? To read the GS1 DataMatrix symbology, camera-based bar code scanners are required. Laser bar code scanners cannot read data matrix bar codes but camera-based bar code scanners can read both linear and 2D bar codes. This is the reason GS1 Healthcare published a specific position paper on camera-based scanners. For more information, please read at: www.gs1.org/docs/healthcare/GS1_HUG_ps_Camera_Based_Scanners.pdf Advantages of GS1 DataMatrix GS1 DataMatrix contains much more providing serial numbers that track DataMatrix symbol can be scanned information than a classic linear bar them throughout their entire lifetime. even if damaged, torn or printed poorly code symbol such as the GTIN (Global That can be extremely important if provided the amount of damage Trade Item Number), lot number, expiry recalls arise. does not exceed the available error date and even a unique serial number correction. which allows better traceability. Indeed, It has a sophisticated error correction 2D matrix bar code symbols capture algorithm, which can compensate for The GS1 System, the world’s most the largest amount of data in by far the lost or missing data due to extraneous accepted standards system in 4 smallest footprint. marks or partial symbol damage. With Healthcare, provides globally unique error correction, GS1 DataMatrix bar identification numbers and bar code The symbols can also be printed code symbols can recover from various marking for trade items. directly on the products themselves, types of physical damage. A GS1 GS1 DataMatrix and mobile Health Having more than one symbol on This is why GS1 Healthcare pointing to a website that could a product creates challenges in advocates for ONE bar code contain the following information: the care-giving environment, for symbol to be placed on product example: the time taken to identify packaging as a long term objective. • Packaging leaflets from medicines in which symbol to scan, the impact of electronic format the wrong symbol being scanned, In order to fulfil various needs, GS1 is • IFU (instruction for use) for medical the ability of the scanner to scan and enabling a GS1 DataMatrix that can devices – allowed in electronic decode only one symbol when in not only contain the GTIN, batch/ format in the EU close proximity to another etc., these lot number, expiry date and unique
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