Healthcare Product Identification Guideline - GS1 Canada
Healthcare AIDC:Product IdentificationCanadian Implementation Guideline andLeading PracticesFinal Draft v1.2 November 2009Healthcare AIDC: Product Identification1
Document SummaryDocument ItemCurrent ValueDocument TitleHealthcare AIDC: Product IdentificationDate Last ModifiedDate: September 23, 2009StatusPending approvalOwnerGS1 Canada : Healthcare Technical Standards Work GroupCreated ByHealthcare Product Identification Task GroupDocument Change HistoryDate ofChangeVersionChanged ByReason forChangeSummary of Change30 July, 20091.0 (Draft)Healthcare Product IDTask GroupDocument CreationCreation23 September,20091.1Healthcare Product IDTask GroupModification of wordingthroughout to align withGlobal documents.Addition of section 11Marking Grid UseWording and clarification.27 October20091.2GS1 Canada PublicAffairsBranding and language.Wording and clarification.DisclaimerWhilst every effort has been made to ensure that the guidelines to use the GS1 standards contained inthe document are correct, GS1 and any other party involved in the creation of the document HEREBYSTATE that the document is provided without warranty, either expressed or implied, of accuracy or fitnessfor purpose, AND HEREBY DISCLAIM any liability, direct or indirect, for damages or loss relating to theuse of the document. The document may be modified, subject to developments in technology, changes tothe standards, or new legal requirements. Several products and company names mentioned herein maybe trademarks and/or registered trademarks of their respective companies.Healthcare AIDC: Product Identification2
TABLE OF CONTENTSTABLE OF CONTENTS .31ACKNOWLEDGEMENTS .42EXECUTIVE SUMMARY .53INTRODUCTION .53.13.23.344.15SCOPE OF W ORK .5OUT OF S COPE.5PRODUCT MARKING G RIDS .5BASICS OF PRODUCT IDENTIFICATION .6STATIC VS. DYNAMIC DATA .6MARKING LEVEL HIERARCHY .65.1D IRECT PART MARK (DPM).65.2PRIMARY PACKAGE .75.2.1 Perforated Blister Cells .75.2.2 Non-Perforated Blister Cells .85.2.3 Pharmacy Labelled Bottles Placed in Boxes .85.3SECONDARY PACKAGE .85.3.1 All Packaged Transactional Item Levels .95.4NON-R ETAIL CASE/S HIPPERS /PALLETS .96HUMAN READABLE INTERPRETATION (HRI) .97HRI DECISION TREE .118APPLICATION IDENTIFIERS (AIS) .129SYMBOLOGY .129.19.29.39.49.5EAN/UPC .12INTERLEAVED 2 OF 5 (ITF) .13GS1-128 .13GS1 DATA BAR .14GS1 DATA MATRIX .1510SHIPPING LABEL REQUIREMENTS .1511MARKING GRID USE .15GLOSSARY 16Healthcare AIDC: Product Identification3
1 ACKNOWLEDGEMENTSThe individuals and their companies who participated in the creation, review and approval of thisdocument are:NameCompanyDon PattonJim RhodesAlberta Health ServicesMichael LoveAlberta Health ServicesAlcon CanadaRoy JamesJacques ChaputDanny TranHugo Royer-RivardEric Blanchette-Ouellet*Betty OldershawMarcel BrierleyDaniel ClarkGeorge CraigieLee-Anne Hosein*Eric GendreauMike JuskaMarie-Claude DufresneLiette ChampagneNathalie VoyerFrancis ChanAlberta Health ServicesBaxter CorporationBoston ScientificCentre Hospitalier Universitaire de Montreal (CHUM)Centre Hospitalier Universitaire de Québec (CHUQ)Consolidated Health Information ServicesLogidGS1 CanadaMcKesson Provider TechnologiesMedXLMerck FrosstNovartis Consumer Health Canada Inc.PfizerSandozSchering-PloughSchering-Plough* Co-chairHealthcare AIDC: Product Identification4
2 EXECUTIVE S UMMARYThe Healthcare Automatic Identification and Data Capture (AIDC): Product Identification– Canadian Implementation Guidelines and Leading Practices is the result of internationalrecommendations and Work Group results that have been reviewed by members of theCanadian industry. GS1 Healthcare established a global AIDC Application Standards WorkGroup, as well as a Symbol Placement Team, to review the existing GS1 System of standardsfor symbol placement on packaging in order to identify gaps and propose recommendations tothe Application Standards Development Team. The results are for inclusion into the initial GS1Application Standard for Healthcare.3 INTRODUCTIONThe GS1 Canada Healthcare Product Identification Task Group was assembled to reviewcurrent and ongoing global recommendations and reports related to the identification ofpharmaceutical and medical-surgical devices using AIDC techniques. This document is theresult of those discussions and is meant as an aid to the manufacturers, distributors and endusers to implement a capability for encoding and decoding this data in their systems.These recommendations are for manufacturers and resellers who are marketing their productsin multiple jurisdictions with the goal of reducing the number of localised package designsand/or AIDC markings applied there-on. All users of this guide are encouraged to familiarizethemselves with the regulations and trade agreements set forth by the governments and tradeassociations in the regions where these items are traded to ensure conformity to thoserequirements.3.1 Scope of WorkFor pharmaceuticals (e.g. vaccines, nutritionals) and medical devices, the team was to: Collect, define and evaluate both business and technical needs specific to theCanadian healthcare sector; Determine how current and/or emerging healthcare regulations impact data capturingrequirements; Examine the current AIDC standards and determine the possible use of thesestandards as the basis for future published healthcare standards; and Identify and document gaps between local Canadian market needs and globalstandards, dialogue with GS1 Healthcare to develop recommendations to close thegaps.3.2 Out of ScopeOut of scope items that this document will not include are: Modifications to the Marking Grids Introduction of Radio Frequency Identification (RFID)3.3 Product Marking GridsThe product marking grids were prepared to aid the development of the application standardand to provide an illustration to readers of the AIDC data that will be carried by healthcareproducts at different packaging levels for different product applications.Healthcare AIDC: Product Identification5
4 B ASICS OF PRODUCT IDENTIFICATIONProper product identification should be able to respond to each of the following requirements: The symbology must work in the environment it is intended for.The symbology must contain the required data.The symbology must fit into the space available.4.1 Static vs. Dynamic DataAs the name implies, static data remains constant throughout the manufacturing of products andis directly linked to the Global Trade Item Number (GTIN). Static data includes the GTIN, size, orstrength.Dynamic data changes in the production process and requires identification at a shipment or itemlevel. Dynamic data includes the lot, or expiration/ manufacturer dates.Exact dynamic data fields will be based on legislated requirements, trade partner agreements,and affiliated association recommendations.Note s:Standards are written to meet virtually all government requirements. If there is a differencebetween the global standards and a particular country’s requirements. dialogue must beestablished to determine why there is a difference and how to close that gap.At no point should these requirements limit any government-required information.5 MARKING L EVEL HIERARCHYThe marking levels for symbol placement in this study are: Direct Part Mark Primary Package Secondary Package Case/Shipper Pallet5.1 Direct Part Mark (DPM)As the title implies, this level includes items without any form of packaging is directly marked. Inthis document this level of marking is reserved for medical devices classified in the highest levelof AIDC marking. Includes many (or all) complex medical devices that are subject toTrack/Trace requirements. The suggested markings are therefore likely to be scanned andutilized by downstream trading partners.Examples include complex medical devices, re-usable medical devices, and implants requiringspecial medical training and/or additional special processes to ensure proper use andadministration (e.g. implants, surgical equipment, re-processed instruments, software-controlleddevices, pacemakers, assets – i.e. infusion pumps, ventilators, monitors).Healthcare AIDC: Product Identification6
Note:Implants are not required to be direct part marked with AIDC technology to ensurebiocompatibility, infection control, and comfort. The brand owner should determine if direct partmarking DPM is appropriate.5.2 Primary PackagePrimary or first level of packaging symbology would be placed either on the packaging or on alabel affixed to the packaging. It may consist of one single item or a group of items for a singletherapy, such as a kit.The marking grid should be used to determine what information is required at what level basedon government regulations. Please note that to standardize the information required on theitems, it may be necessary to increase the level of identification.Note:At the time this document was created, the GS1 General Specifications requires that a GTIN-12be used to identify the lowest level of product. The Indicator Digit Work Group is reviewing thepossibility of allowing the marking of items out of hierarchical order. Please review the GS1General Specifications before attributing any GTIN other than a GTIN12 to this level ofpackaging to ensure conformity to the standards.Examples of Primary PackagingPill BottleVialPre-FilledSyringe5.2.1 Perforated Blister CellsIt is recommended that at the immediate package level for pharmaceutical products packagedwith perforated blister cells, the symbol shall be placed on each blister cell (see image below).Healthcare AIDC: Product Identification7
5.2.2 Non-Perforated Blister CellsIt is recommended that at the immediate package level for pharmaceutical products packagedwith non-perforated blister cells, the symbol shall be placed once on the blister card and may beplaced anywhere on the blister card.If random printing is used the symbol may be placed multiple times to ensure that the symbolremains scannable until the last blister has been used (see image below).Examples of Blister Cell MarkingPerforated Blister CellsNon-Perforated Blister Cells5.2.3 Pharmacy Labelled Bottles Placed in BoxesIt is recommended that retail and hospital pharmacies include or expand the symbol placementfor labels on bottles placed in boxes.The GTIN Allocation Rules should be referred to when taking any product marking decisions toensure supply chain accuracy.5.3 Secondary PackageSecondary or next level of packaging, containing one or more single items in their immediatepackaging include a box containing blister packs, a bottle, or other like items.The marking grid should be used to determine what information is required at what level basedon government regulations. Please note that to standardize the information required on theitems, it may be necessary to increase the level of identification.Healthcare AIDC: Product Identification8
Examples of Secondary Packaging5.3.1 All Packaged Transactional Item LevelsAs indicated in the marking grids, all levels of packaging should be identified with the minimumrequired information.Each packaging hierarchy should be identified with a symbology containing the GTIN and anycorresponding Application Identifiers (AIs) defined at that level.Items bundled for ease of manipulation in clear plastic need not be identified with a bar code asan item grouping so long as the item code(s) can be read through substrate. If this level is adefined trade item, all Marking Grid recommendations should be applied to the informationencoded.If an item is not destined for the retail market, all levels of marking should include all the dataelements as outlined by regulation and/or trade agreements.Note:Where possible, both the GTIN and the additional information should be encoded on each levelof packaging to increase the accuracy and ease of capture as the product moves throughout thesupply chain.5.4 Non-Retail Case/Shippers/PalletsIt is recommended that only one bar code should be scanned to capture all the requireddata(i.e. GTIN, lot and serial number).Current GS1 standards include the GS1-128symbology, which can incorporate all required dataelements to meet regulatory requirements for product identification.6 HUMAN READABLE INTERPRETATION (HRI)It is common sense to have Human Readable Interpretation (HRI) of the AIs and theirassociated data near the GS1 Symbol in which they are encoded. Typical conventions place theprimary information, such as the GTIN, in the human readable data underneath the bar code.The characters must be clearly legible and must be obviously associated with the symbol.Healthcare AIDC: Product Identification9
AIs should be clearly recognizable within the HRI to facilitate key entry in the event that thesymbol cannot be scanned – achieved by putting the AI between parentheses.Note s:The parentheses are not part of the data and are not encoded in the symbol.This is in clear contrast to the use of the Function 1 (FNC1) character that must be encoded inthe symbol when used as a start or separate character. This does not appear in the HRI.The following examples illustrate the encoded data in the GS1 DataMatrix bar code symbol andhow the HRI could appear:Example 1: FNC101034531200000111709112510ABCD1234Example 2: FNC10195011010209171708050810ABCD1234 FNC14109501101020917Example 3: FNC101034531200000111709112510ABCD1234The HRI may also use legible text rather than employing AI digits using standardized data titles.Healthcare AIDC: Product Identification10
7 HRI D ECISION T REEGiven the space requirements for government legislated information, the following decision treehas been developed to aid the manufacturer/distributor in the attribution of required HRI.Please Note:According to the GS1 General Specifications, medical devices(instruments and implants) require only the carrier. HRI not isrequired.NoIs there sufficient space to apply the carrierand HRI at, or above the minimum size andquality?Is the item to be identified used in a homecare environment?YesConforming to the GS1 GeneralSpecifications, apply the carrierand the HRI.HRI takes precedenceover the AIDC.NoBy removing the HRI elements, is there sufficient spaceto apply the carrier at or above the minimum size andquality standard?YesYesReview the carrier selection for theproduct to be encoded or address theartwork constraints limiting the spaceavailable.NoNoNoIs it possible to maintain the minimum sizeand quality standard, but include some of theHRI elements?Are the HRI elements identified for removal availabl eelsewhere on the item as a regulatory or marketrequirement?YesYesAre the HRI elements identified for removal availableelsewhere on the item as a regulatory or marketrequirement?NoRemove HRI associated with thecarrier and ensure the carrierconformstoGS1GeneralSpecifications for size and quality.YesRemove the HRI associated to the dataavailable elsewhere on the item. Ensure thecarrier and remaining data elementsconform to GS1 standards .Healthcare AIDC: Product IdentificationReview carrier selection for the product to beencoded or address artwork constraints. Should noalternative exist, remove the HRI and encode thedata elements in the chosen carrier conforming tothe GS1 General Specifications.11
8APPLICATION IDENTIFIERS (AIS)Current AIs include:00011017217003800380048008NEWSerialized Shipping Container Code (SSCC)GTINBatch or Lot NumberExpiration Date (YYMMDD)Serial NumberExpiration Date Time (YYMMDD HHMM)Global Returnable Asset Identifier (GRAI)Global Individual Asset Identifier (GIAI)Date and Time of Production (YYMMDD HHMMSS)*Canadian Change Request (CR) in process to have this AI added for the purposesof nuclear medicine.PotencyThe above mentioned list contains the approved healthcare standard AIs.For a full list of GS1 AIs, please see the GS1 General Specifications.9S YMBOLOGYMost discussions centered on symbology applications during the development of theseguidelines, as well as the flexibility to support the information required through local regulations.A data carrier is a means of representing data in machine readable form. The GS1 Systemspecifies the data carrier used to represent any given element string. Section 2.0 of the GS1General Specifications covers rules indicating which data carrier should be used to representwhich element strings in particular applications.The GS1 System uses the data carriers in the following sections.9.1 EAN/UPCEAN/UPC bar code symbols (UPC-A, UPC-E, EAN-13, EAN-8; two- and five-digit add-onsymbols) can be read omnidirectionally. These symbols must be used for all items that arescanned at the Point-of-Sale (POS) and may be used on other trade items. Please refer to theGS1 General Specifications for size and quality requirements.EAN-13 UPC-A Symbol Type: LinearApplication Type: PrintedHealthcare AIDC: Product Identification12
Note:This symbology type is limited in the amount of information it can contain. Given the largesurface area required for the accurate readability of this symbol, it was determined to beinadequate for applications where space constraints and additio
The Healthcare Automatic Identification and Data Capture (AIDC): Product Identification – Canadian Implementation Guidelines and Leading Practices is the result of international recommendations andWork Group results that have been reviewed by members of the Canadian industry. GS1 Healthcare established a global AIDC Application Standards Work
healthcare industry through local support initiatives like GS1 Healthcare US in the United States. About GS1 Healthcare US GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to help improve patient safety and supply chain efficiency.
industry through local support initiatives like GS1 Healthcare US in the United States. ABOUT GS1 HEALTHCARE US GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency.
Foodstuffs GS1 NPC Supplier Guidelines Version 2.2 Page 4 of 28 GS1 PRODUCTFLOW / NPC PROCESSES As a supplier to Foodstuffs you will need to: Register for GS1 ProductFlow and work with GS1 to achieve GS1 Product Flow Certified status. Foodstuffs will then "activate" your company in the Foodstuffs eXchange to be a ProductFlow user.
GS1 , under its IP Policy, seeks to avoid uncertainty regarding intellectual property claims by requiring the participants in the Work Group that developed this GS1 AIDC Fresh Foods Sold at Point -of-Sale Implementation Guideline to agree to grant to GS1 members a royalty-free licence or a RAND licence to Necessary Claims, as that term is defined in the GS1
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John Terwilliger Abbott John Pearce Axicon Auto ID Ltd John Ryu GS1 Global Office Jonas Buskenfried GS1 Sweden Kai Hachmann Edeka Zentrale AG & Co. KG Karen Arkesteyn GS1 Belgium & Luxembourg . Work request 18-260 Logistic Label placement: Work request 18-270 2D without 1D for Healthcare
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