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Global Medical Device Nomenclature User Guide

1. B Introduction This method has been devised to assist in the selection of one or more categories A product being classified shall be done so by selecting an appropriate compatible generic device group a preferred term This in turn shall be linked to at least one device category it can be linked to multiple categories when this is found appropriate EXAMPLE Code 13215 term Infusion pump general purpose categories 2 4 11 This device could theoretically function in an anaesthesiology setting a general purpose hospital institution setting or as an aid for a disabled person The product s intended purpose does of course totally depend upon the manufacturer s device type design E Method Generic device group terms should be assigned to the most specific category based on the intended use of the device The selection list below is the categories ordered from most specific top to least specific bottom By moving from the top and downwards of the arranged list of categories the product should be assigned to the first category in which it fits This process can be repeated should a product be potentially suitable for secondary or tertiary categories Device categories ordered by degree of specificity Code Term a 06 In vitro diagnostic devices IVD b 03 Dental devices C 08 Ophthalmic and optical devices d 02 Anaesthetic and respiratory devices e 12 Diagnostic and therapeutic radiation devices
2. Computer systems become a medical device when it is placed on the market with the intention that it be used with a medical device or itself to fulfil one or more purposes of a medical device as defined in the EU directives Software used on general purpose computer as well as general software used in a medical environment may function as a medical device depending on the intended use Software can be embedded an inherent component of the medical device or medical system or it can be stand alone software e g replacement software that changes the intended purpose of the parent device Terms covering software found in the GMDN are all defining dedicated software This means that a particular generic software term has a dedicated device or group of devices that it is intended to be used in Terms for software are located by searching on the qualifier software at the term name level E Systems Systems are best located by searching on the qualifier system in the term name See 6 3 Glossary of terms for the definition The word system is widely used and will often refer to methods mechanisms etc Therefore a search using system at the definition level will give a listing of terms that are not systems 45 GMDN User Guide version 2002 6 Appendices 6 1 Rules and Conventions for Nomenclature Development Based on the Global Medical Device Nomenclature Project I Basic Components Names for medical devices i e
3. Your local code for this new or improved or corrected term or this new synonym 74 GMDN User Guide version 2002 Form B GMDN Proposal Form continued page 4 of 4 Device documentation 7 In order to validate your proposal you are required to fill out the following information and submit relevant device documentation Make Fdo bd Dal Pat LI II al P Model LET Titi titi EL Trade name LLL IE LL II L A Attach product literature sales brochure technical documentation journal articles etc Date Signature When you have completed these 4 pages send to GMDN Maintenance Agency Att Mr Brock Hefflin 1350 Piccard Drive HFZ 530 Rockville MD 20850 USA E mail bjh cdrh fda gov 75 GMDN User Guide version 2002 6 8 Instructions for filling in the GMDN Proposal form 1 Term Name Please enter your proposal for a new term name generic device group If possible you should try to harmonize your proposal with similar products already named in the GMDN Don t be put off if this seems difficult as your input can provide valuable information for the evaluation process 2 Device category code You are required to tick at least one category box to indicate the category which applies to the term you are proposing Please note that a device may be applicable to more than one category in which case please tick all the boxes that
4. s sseasessesesnn 16 D Data relational 18 Defihilals Nee eo ee ven fd ree 15 Descriptor EP M 28 Device category 15 20 Device type ei ore eter 15 18 25 DiSClallTiGE oe GN dd A edes 8 E ECR EE 10 sb LY e aan EN 10 F A eR 15 File ed TEEN 31 G Generic device Oroup 15 20 Glossary of terms 61 ei lei S oti teeth oh tuU eiui tenet 11 I Installation se ob eR EE exe 30 Introduction ern 6 150 9999 xoc FE DREF HONN 10 J JFMDA No ere 10 L Beie EEN 24 M Maintenance Adencny 7 8 MAKE Eege 75 Manufacturer 12 17 ole e Lc NE Y eO I N 75 N Name erorten enner anana 16 Navigation See Synonym terms and or Template terms Navigational search 35 NEEN E 10 Nomenclature 11 16 Nomenclature structure 18 Notified Bodies 7 12 P Preferred term 16 21 Preferred term structure 27 Procedure packs 44 Punctuation eor cnn inae re 25 Q Qualif s ico ode tote a doe 27 R Relational structure 16 33 S KA 45 Standard EN ISO 15225 18 20 Standard EN ISO 15225 Annex C 23 EE EE 16 Synonym Terme 23 ej irri RR Em 45 T Template term 16 22 GMDN User Gu
5. terms has been introduced into the nomenclature It would be ideal if every synonym automatically leads directly to the preferred term it represents This would create a highly automated computerized nomenclature However because a synonym can sometimes lead the user to mentally visualize options and because human evaluation is required the system has been designed so that synonyms providing choices lead to the appropriate template term Here the user should be confronted with a narrowed down pick ist of terms from where he or she can select the appropriate preferred term The template term is constructed in the same manner as a preferred term but has a more general definition It is formed from the common base concept and always ends with the qualifier lt specify gt 22 GMDN User Guide version 2002 4 3 3 Synonym terms Synonym terms are navigational terms entry terms used in the nomenclature A synonym term is a common use or familiar name It is an alternative term for a preferred or template term that is linked to the preferred or template term to direct persons who use the synonym to the preferred or template term EXAMPLE Fluidized bed is a synonym term directly linked to the preferred term Bed air fluidized Term interactions Using the centrifuge as an example Centrifuge lt specify gt Centrifuge blood bank Centrifuge cell washing Centrifuge cytology Clinical centrifuge see Centrifuge lt sp
6. tips This section has been developed in order to provide some advisory hints and tips that should prove helpful The GMDN was basically designed to cover medical devices as defined in the EU directives e Active implantable Medical Devices Council Directive 90 385 EEC of 20 June 1990 e Medical Devices Council Directive 93 42 EEC of 14 June 1993 e In Vitro Diagnostica Directive 98 79 EEC of the European Parliament and Council of 27 October 1998 Therefore the GMDN caters for Medical devices Procedure packs Systems Accessories However it also includes technical aids for disabled persons and other hospital and home care products which may or may nor be medical devices 43 GMDN User Guide version 2002 E Accessories Accessories within the GMDN are defined as devices that are considered to be important enough for classification It does not attempt to incorporate parts Accessories are best located by searching on the qualifier accessory A wide search using accessory will produce a large listing of terms that may or may not be true accessories See the 6 3 Glossary of terms NOTE Other terms could be considered to be accessories E g Holder patient arm could be considered to be an accessory to an operation table or an examination table The user must therefore look at alternative classification possibilities before making a final decision E Multifunction A typical problem when classifying devic
7. Wound care kit Blood urea nitrogen kit X ray system Hyperthermia system Prostate specific antigen rapid test To aggregate devices under broad concepts the term definitions should be utilized The broad term could be included as a descriptor surgical instrument for example in all the definitions of appropriate device terms Terms for accessory component devices should describe the accessory component in the base concept and the parent device should be listed as a qualifier EXAMPLE Software thermography system NOT Thermography system software In all cases the device on which the term has principal focus should be included in the base concept B Qualifier Specificity Unambiguous qualifiers should be used to name medical devices words such as sundries others appliances miscellaneous various should not be used to form a generic device group term Conversely a generic term nomenclature should not contain terms that are developed to the most specific qualifier possible unless this is required to meet regulatory needs In general up to three or four qualifiers should be sufficient to develop most terms to an appropriate level of specificity Essentially qualifiers should be used to characterize device concepts so that they can be distinguished from one another 52 GMDN User Guide version 2002 The selection of qualifiers can be based on the functional aspect of devices clinical
8. in the GMDN will be useful Together with a possible specification or with defined attributes necessary data for the device itself is provided With electronic trading these advantages should be obvious for involved persons on both sides of the table The new GMDN will again provide a basic common platform which is necessary if electronic trading is to become a reality and not just local experiments Conclusion All parties involved with medical devices manufacturers regulators conformity assessment bodies traders owners or users will all have a common interest in an unambiguous classification i e definition and term for each device The obvious person to assign a device to its class is the manufacturer By using the GMDN all players will have at hand a globally recognized tool which provides better results for all 14 GMDN User Guide version 2002 3 Definitions This chapter defines specific words and concepts used by the GMDN character A member of a set of elements used for the organization control or representation of data ISO IEC 8859 1 1998 concept A unit of thought constituted through abstraction on the basis of properties common to a set of objects ISO 1087 1990 device category A term for the broadest grouping of devices having common areas of intended use or other common characteristics NOTE Twelve categories based upon European trade associations have been identified These are already being
9. linked to the preferred term Analyser coagulation Dinamap linked to the preferred term Sphygmomanometer electronic Heart starter linked to the template term Defibrillator lt specify gt Ambu bag linked to the preferred term Resuscitator pulmonary manual Each synonym term should be linked to only one preferred or template term In the case where a synonym could potentially be linked to more than one preferred term the link should be made to the template term to which the preferred terms are subordinate if applicable The grammatical rules that apply to preferred terms should also be applied to synonym terms Synonym terms should not be given definitions but are associated with a unique numerical code d Definitions The definitions for preferred terms and template terms should be concise and written in a manner that makes them comprehensible to all users If technical language is used then it should be explained in parentheses EXAMPLE The device determines hematocrit volume percent of red blood cells in a sample of blood 49 GMDN User Guide version 2002 The definitions for template terms should be general enough to incorporate all subordinate preferred terms while the definitions for preferred terms should be specific enough to allow clear differentiation between preferred terms As much as possible definitions should e express the intended uses of the device e express the target
10. manufacturer There are the authorities faced with the task of regulating manufacturers and their devices and there are people involved in trade with these devices e g suppliers before the devices themselves are finally brought into use And of course there are the users This means that we have a number of players with quite different responsibilities but all with the common interest of ensuring the availability of sound medical devices To assist this important process there is a need for a common method for describing and identifying the device in question in an unambiguous manner Prior to the GMDN many nomenclature systems existed that have been built upon different structures and that have been used locally or nationally for different purposes These different systems though often workable in their own right have had no impact on improving the overall situation of providing a common platform whereby medical devices can be correctly identified and related data safely exchanged The advent of the European directives have initiated a new era where national and indeed international bodies are given the opportunity to co operate and harmonize efforts to achieve something that they all need Furthermore the running and applying of different nomenclatures worldwide is extremely time consuming and expensive without improving the data quality to the level required by modern data communication 2 2 The users Potential users of the GMDN wil
11. medical device terms should be created at the level of the generic device group The generic device group is a set of devices having the same or similar intended use or common technology allowing general classification of the devices The names for medical devices should be organized as the following types of terms e Preferred terms e Template terms e Synonym terms a Preferred Terms The preferred term is the optimal name selected to represent a generic device group it consists of 1 A base concept which is the first and principal component of the term e g Catheter this may be followed by 2 Oneor more qualifiers if appropriate used to increase the degree of specificity of the term Qualifiers should be separated from base concepts and other qualifiers with a comma e g Catheter biliary manometric 3 An associated definition 4 A unique numerical code NOTE The base concept can be a single noun as in Catheter or a compound noun as in Catheter guide wire 46 GMDN User Guide version 2002 The base concept must represent a medical device object and not e pure procedure method e g Dialysis or Radioimmunoassay or e analyte e g Glucose The qualifiers moving from left to right should be ordered from broader less specific to narrower more specific The base concept and all qualifiers should be in a singular form e g Bottle not Bottles and the first letter of the base concept is the o
12. permanently in a hardware device as a Read only memory FIXED This means the device is physically fixed e g screwed bolted etc in a permanent position or location and cannot be moved unless dismantled FLEXIBLE Medical devices designed to be bent to a reasonably high degree without breaking Easily lead manageable with the intention of assisting positioning manoeuvrability GENERAL PURPOSE A medical device designed for general use It includes features common to the individuals of the Generic Device Group and is not for specialised purposes GENERIC DEVICE GROUP The generic device group is the level of the GMDN that contains sets of devices having similar intended uses or commonality of technology A generic device group is a so called preferred term by which a manufactured product may be classified A shortened version of this is Device group HAND HELD A device system or object that is designed to be held in the hand whilst it is being used HARDWARE For computers the physical mechanical and electronic components of a computer HOME USE A medical device specifically designed for use in the home and to be managed partly or wholly by the patient INFANT A child during the earliest period of its life up to 24 months of age this meaning also baby new born 63 GMDN User Guide version 2002 INSTRUMENT A tool implement or a measuring device This include
13. terms that is elaborated according to pre established naming rules ISO 1087 1990 preferred term Name recommended by that authoritative body to represent an entity Adapted from ISO 1087 1990 relational structure A structure of data arranged according to relationships made between data elements Adapted from ISO IEC 2382 17 1996 synonym term A common use or familiar name used to reference an entity Adapted from ISO IEC 2382 17 1996 template term A name created when the same base concept occurs in more than two generic device group terms preferred terms for the sole purpose of presenting these in a sub ordinated hierarchy EXAMPLE The function of the template term Audiometer specify Audiometer specify Audiometer auditory evoked response Audiometer automatic recording Audiometer computer controlled term Designation of a defined concept in a special language by a linguistic expression ISO 1087 1990 custom made device Any device specifically made in accordance with a duly qualified medical practitioner s written prescription that gives under his responsibility specific design characteristics and is intended for sole use of a particular patient NOTE See Council Directive 93 42 EEC concerning medical devices 16 GMDN User Guide version 2002 manufacturer The natural or legal person with responsibility for the design manufacture packing and labelling of a devic
14. the GMDN terms evoked response audiometry 1 electroretinogram The record made by an electroretinograph 2 electroretinograph a device for the registering the electrical potentials evoked in the retina and ocular fundus in response to a visual stimulus endoscopic subfascial dissection of the perforating veins 1 electron spin resonance 2 erythrocyte sedimentation rate electrosurgical unit extracorporeal shock wave lithotripsy not an official abbreviation It appears to be an accepted branch abbreviation for Ethelyne oxide exsufflation with negative pressure fast Fourier transform fluorescein isothiocyanate follicle stimulating hormone ABS fluorescent treponemal antibody absorption test Geiger Muller Global Medical Device Nomenclature 56 GMDN User Guide version 2002 Abbreviation HAV HCG HDL HEPA HGV HHRFS HIS HIS HIV HLA HMW hPLAP HPLC HTLV ICP ICU IM IMV IR ISE IUD KVO LAF LASER LDH Word or phrase hepatitis A virus human chorionic gonadotrophin high density lipoprotein high efficiency particulate air hepatitis G virus hand held radionuclide fluoroscopy system not an abbreviation It is a group of electrical fibres in the heart that are responsible for transmitting the electrical impulses that generate a normal cardiac contraction hospital information system human immunodeficiency virus human leukocyte anti
15. their descriptions are defined in the standard EN ISO 15225 Annex A See 6 8 Instructions for filling in the GMDN proposal form IMPORTANT One generic device group can be linked to more than one device category NOTE This process is described in 5 2 4 Category Selection method 4 3 Generic device group The generic device group is the nomenclature level and comprises three kinds of terms These are e Preferred terms e Template terms e Synonym terms 20 GMDN User Guide version 2002 4 3 1 EXAMPLE Adhesive lt specify gt template term Adhesive aerosol drape preferred term Drape adhesive aerosol synonym term Preferred terms Preferred terms are all the names available for the purpose of classification of medical devices It is a term representing a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics such as brand or trade names A generic device group represented by a preferred term comprises a set of devices which are identified by their device type and grouped together for the purpose of reporting or data retrieval IMPORTANT Only preferred terms can be used for GMDN classification EXAMPLE Term Bed air fluidised Definition A bed designed for the treatment of severely and extensively burned patients It may also be used in cases of decu
16. used to assist the implementation of the European vigilance system and must be adhered to device type A name the manufacturer s make and model designation given to a device or set of devices by the manufacturer for the purpose of identifying this these device s This name is used to identify related information such as the record holding the device type designation and its associated data such as its code and other attributes Device type has the smallest number of devices covered by each stored name NOTE A device type is the information the name or designation provided by the manufacturer that uniquely identifies a specifically produced type of medical device This unique qualifier is made up of the make and model file A named set of records stored or processed as a unit ISO IEC 2382 1 1993 generic device group A term representing a set of devices having the same or similar intended use or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics such as brand or trade names A generic device group comprises a set of devices identified by their device type that are grouped together for the purpose of reporting or data retrieval NOTE Product classification is to be performed using a preferred term only 15 GMDN User Guide version 2002 name Designation of an object by an linguistic expression ISO 1087 1990 nomenclature System of
17. which the products are marketed EXAMPLE Make Manufacturer Opel General Motors Ford Ford Motorverken GmbH Heraeus Heraeus Instruments GmbH E Model This is typically the manufacturer s identification of the product type often identified by alphanumeric letters and reproduced on the product s ID label Note When concatenated the contents of the data fields Make and Mode will be unique This will represent the device type data This is defined in ISO 15225 section 6 4 Device type data file 81 GMDN User Guide version 2002 E Trade Name This is typically the popular sales name of the product This is often shown on the front of the product and is referred to in brochures Not all devices have a trade name EXAMPLE make 3M model L300 trade name Maxi Driver II make B Braun Melsungen model 8715491 trade name Infusomat Fms make Alm model PRX 4001 SA trade name Prismalix make Olympus model UH1 2 trade name 82
18. GMDN User Guide version 2002 G M D N Global Medical Device Nomenclature User Guide Version 2002 GMDN 2002 All Rights Reserved This User Guide is approved by the GMDN MA Policy Group and is applicable to the GMDN versions e GMDN Beta 3 1 GMDN 2002 1 To e find out more about the information contained in this User Guide e access the constantly updated GMDN information service e Submit a query suggestion order or donation go to the GMDN website at www gmdn info GMDN User Guide version 2002 Contents 1 INTRODUCTION 5 ii i eee eine nee U ddd 6 Tels BACKGROUND 35 475 ect eos bene deet ed ec ipe cc Cd due NG EE 6 1 2 el 7 1 3 ACKNOWLEDGEMENTS eeeneh nennen nenne nume uru ara ka a RE raga agas agen rasan a a nnn 7 RE ESTRA dut E M 8 1 5 MeiimeeR E 8 1 6 4 COMMENTS 5 itd eeu nee e eee eS 9 2 THE GMDN PROJECT 2 2 nnn unuuanuuhu ERR Y YW ALW RR SR RR ENK ek 10 2 1 WHY THIS NOMENCLATURE eene LA RL iara RR a rag na rarae rana ra nnn 11 2 2 THE USERS EE De sdb Ores De seit ek ee Pee OON ier ved Leon 11 3s DEFINITIONS iie ui i ia eres rera seo see Eu Eo eddies ek 15 4 STRUCTURE 4 HN conrra dE ENN EE Rea NEUE 18 4 1 THE NOMENCLATURE STRUCTURE eenennemehem nenne hinein iare HERE REN arua rarae rana 18 4 1 1 The general data structure 1 Lore es isa e p aaa au
19. LE Terms Category Abrasive strip dental 03 Absorbent saliva 03 Adhesive denture 03 Bite registration device 03 etc d Word search Searching by a chosen word can have two targets This can be done by 1 searching either directly at the term name level hitting a targeted qualifier See 6 4 Search words by qualifier EXAMPLE By qualifier accessory custom made home use kit software etc A search on custom made gives Terms Category Cushion custom made 11 05 and 04 Dental veneer custom made 03 and 10 Fixation device internal custom made 07 Orthosis footwear orthopaedic shoe custom made 11 Prosthesis internal joint custom made 07 Root canal post custom made 03 etc 36 GMDN User Guide version 2002 OR 2 by searching on a descriptor a semantic link that has been purposely fitted into the definition EXAMPLE By descriptor blood disposable immunochemistry rigid surgical instrument etc A search on mmunochemistry gives Term Drug control Category 06 Definition Immunochemistry reagents controls standards calibrators immunochemistry control for therapeutic drug monitoring and or determination of drugs of abuse A control is a substance material or article intended by its manufacturer to be used to verify the performance characteristics of the device Term Monoethylglycinexylidide kit Category 06 Definition Immunochemistry reagents speci
20. TE Generic means characteristics of or relating to a class general not specific or special Having no brand name not protected by a registered trade mark The addition of more qualifiers to a term increases the degree of specificity and moving from left to right should be ordered from broader less specific to narrower more specific Qualifiers will also function in a word search facility for collective grouping of similar products across the entire nomenclature EXAMPLE Reusable Single use Software Accessory Custom made 29 GMDN User Guide version 2002 5 Application The GMDN is a nomenclature primarily designed for the purpose of classifying medical devices and related healthcare products see 1 Scope It covers medical devices and products as defined in the European directives which are devices systems procedure packs kits accessories and in vitro diagnostics IVD s This nomenclature is a very large data file that by the nature of its size and design will function best when imported into a suitable data programme application It has been designed so that a paper format can be produced should the user wish to do this e g print out a segment by category 5 1 Installation The GMDN electronic data file has been created according to the specification given in the standard EN ISO 15225 It will therefore function as intended e g automatic switch from a selected synonym term to the target t
21. a generic device group is a medical device or not this is entirely dependant on the regulating legislation In no circumstances will the GMDN MA be held liable for any direct indirect consequential or incidental damage including loss of profits business interruption loss of data incurred by the user through deficiencies the inability to use the GMDN or wrong information presented in the GMDN regardless of presentation medium It is the obligation of the user to ensure notification of dubious or incorrect classification presentation to the GMDN MA in the case of dissent between the user and the GMDN 1 6 Comments If you have any comments on this guide please complete FORM A at the back of the guide and send it to GMDN Maintenance Agency Attn Mr Brock Hefflin 1350 Pickard Drive HFZ 530 Rockville MD 20850 USA e mail bjh cdrh fda gov GMDN User Guide version 2002 2 The GMDN project The project brought together a team of experts from industry and regulatory bodies to create a single global medical device nomenclature This involved the implementing of the new European and International Standard EN SO 15225 Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange which defines the format and structure of terms for medical devices both for written communication and electronic databases To facilitate in the rapid production of the GMDN 6 chosen existing n
22. a single unit for use in combination to achieve the intended use of the device 6 XLM FILE An XML file is a broader type of file that can be used to represent a multitude of data not only restricted to database tables It features a system for tagging the contents of a file with their correct semantic meanings These tags can have attributes and can contain other tags making it easy to represent a hierarchical structure In addition the XML format includes a Document Type Definition DTD which is used to set strict rules for the ordering of the tags and their contents This enables the file to be self explanatory and enables parsers programs that read the file e g Microsoft Access to perform checks to see if the XML file contains any errors deviations from the DTD lt xml version 1 0 encoding ISO 8859 1 gmdn version 2002 1 gt group lt GMDNCode value 38956 gt lt termName _ value 1 nitroso 2 naphthol fluorometric free tyrosine gt lt synonymCode value 31358 gt lt templateSpecifier value 0 gt lt definition value gt categories category value 6 gt lt categories gt lt group gt group lt GMDNCode value 30367 gt lt termName value 17 hydroxyketosterone kit gt lt synonymCode value 0 gt lt templateSpecifier value 0 gt lt definition value Immunochemistry reagents fertility pregnancy hormones proteins 17 hydroxy ketoste
23. ameter indexed safety system connector digital mammography system deoxyribonucleic acid digital subtraction angiography Digital spot imaging Epstein Barr virus 1 electrocardiogram The record made by an electrocardiograph Also called cardiogram 2 electrocardiograph a device for recording the waveforms of voltages developed in the chest and lower parts of the human body in synchronism with action of the heart electronic data interchange 1 electroencephalogram The record made by an electroencephalograph 2 electroencephalograph a device for recording the waveforms of voltages developed in the brain using electrodes applied to the scalp electrical impedance scanner 55 GMDN User Guide version 2002 Abbreviation ELISA EMG ENA ENG ENT ERA ERG ESDP ESR ESU ESWL ETO EWNP FFT FITC FSH FTA GM GMDN Word or phrase enzyme linked immunoabsorbent assay 1 electromyogram The record made by an electromyograph 2 electromyography a device for measuring and recording voltages generated by muscles in the body extractable nuclear antigen 1 electronystagmogram The record made by an electronystagmograph 2 electronystagmograph a device for the detection of the involuntary movement of the eye It is especially used for the examination of the balance organs equilibrium in the inner ear ear nose and throat This is displayed as ear nose throat in
24. and this level and its purpose The device type information is the concern of the product manufacturer and is the level considered specific enough to provide unigue product identification for the purpose of declaration of conformity product registration and product traceability EXAMPLE Make Model Heraeus Sepatech 3635 Heraeus Sepatech 5003490 Kubota 8100 Kubota KS 5200C Sigma 203 Sigma 3E 1 Sigma 4K10 When concatenated joined or linked together the contents of the data fields make and model shall be unique This will represent the device type data EXAMPLE Heraeus Sepatech 3635 Kubota 8100 Sigma 203 NOTE This is defined in ISO 15225 section 6 4 Device type data file All of these device types produced by three different manufacturers have sufficient characteristics in common allowing them to be grouped under one common generic device group using the preferred term 25 GMDN User Guide version 2002 EXAMPLE Centrifuge general purpose laboratory GMDN code 36465 A device that is a general purpose laboratory centrifuge used to separate the components of suspensions by the application of centrifugal force It typically consists of an electrically powered drive unit with a vertical shaft and horizontal rotor attached to the upper end This device is intended to centrifuge patient samples e g body fluid either alone or after addition of reagents or other additives before measu
25. apply EXAMPLE GMDN term Infusion pump syringe GMDN code 13217 Categories 2 4 11 This means that this particular device can be used for e anaesthesia category 2 e general hospital institution use category 4 e asatechnical aid category 11 76 GMDN User Guide version 2002 The GMDN Device Categories as defined in EN ISO 15225 are Code 01 Term Active Implantable Devices This category includes devices relying on a source of power other than that directly generated by the human body or by gravity and intended to be totally or partially introduced surgically or medically into the human body or by medical intervention into a natural orifice and which is intended to remain there after the procedure Note Examples of devices in this category are pacemakers implantable infusion pumps cochlear implants and their accessories Note See Active implantable medical device directive Code 02 Term Anaesthetic and Respiratory Devices This category includes devices and accessories for supplying conditioning monitoring dispensing and delivering respiratory medical and anaesthetic gases and vapours for providing and or controlling respiration and or anaesthesia Note Examples of devices in this category are anaesthetic work stations respiratory circuits ventilators and their accessories Code 03 Term Dental Devices This category includes devices for use in dia
26. area of intended use e describe how the device is used through technical principal or working method e describe materials and or components involved e describe the form shape physical state of the device These points are demonstrated in the following definition of the preferred term Catheter angioplasty balloon dilatation coronary perfusing EXAMPLE A thin flexible plastic tube that is inserted into a narrowed artery of the heart to dilate the vessel by controlled inflation of a balloon attached to the tube The tube contains holes on both sides of the balloon that permit blood to flow around and beyond the balloon when it is distended so that the coronary arteries will continue to receive blood during the procedure e Abbreviations The use of abbreviations in preferred and template terms should be avoided Even well known abbreviations e g HIV should be spelled out when used in preferred or template terms Abbreviated names for medical devices can be used as synonym terms In addition abbreviations can be used in the definitions of preferred and template terms if they are accompanied by explanations as in the following example EXAMPLE TUMT Trans Urethral Micro wave Thermo therapy CPAP Continuous Positive Airway Pressure ENDOCAM ENDOscopy CAMera f Field Length Generic device group terms should be constructed so that they are explicit the attempt should be made to limit their field length t
27. aries may be compiled by the user according to their own requirements accessory adult aerosol airway audio automatic balloon blood By body part hand foot etc bone calibrator carbon dioxide cardiac circuit component contrast control control unit custom made dental diagnostic dialysis ear nose throat electrical electronic emergency endodontic endoscope external fibreoptic fixed flexible gas general purpose gynaecologic hand held hand piece home use hydraulic implantable infant inflatable infusion internal intrauterine invasive kit laboratory long term manual mechanical medicine mercury mobile module monitor motorized mount MRI multifunction multiple nitrogen dioxide noninvasive non motorized non sterile obstetrical operating operation ophthalmic orthopaedic oxygen pacemaker partial perfusion peritoneal pneumatic portable powered programmable pulmonary radiation radio frequency radioactive reusable rigid set short term single single use software solution stand stationary stereotactic sterile strip surgical system temporary therapeutic total transcutaneous transport transportable ultrasonic ultrasound unit urine vacuum video whole body wire x ray 68 GMDN User Guide version 2002 6 5 Bibliography CEN Report CR 14230 Global Medical Device Nomenclature GMDN 1 Nov 2001 ISO TS 20225 Council of European Communiti
28. arrest and or technical failures of critical care medical devices e g ventilators Other examples of alarms include those devices designed to alert one to a patient falling out of bed Devices designed to alert one to sudden loss of power or unexpected shutdown AMBULATORY Of or adapted for walking Medical devices designed to be carried upon the patient s person usually because the device is actively functioning in an ongoing treatment 61 GMDN User Guide version 2002 ANALYSER Devices designed primarily to separate or break any whole e g sample into its parts for the purposes of determining their nature proportion function or relationship NOTE Analysers are typically used for in vitro analysis in the clinical laboratory setting and or at the point of care Other types are used in direct physiologic or technical parameter analysis APPARATUS The equipment needed for a particular purpose or function NOTE This word is not used in any preferred terms and is purposely avoided used in the GMDN though in some instances it is utilised APPLIANCE A device or piece of equipment used for a specific task CALIBRATOR A calibrator is any substance material or article intended by its manufacturer to be used to establish the measurement relationships of a device CATEGORY The individual broad usage definitions that represent disparate devices having common areas of intende
29. ase use this form to e suggest a new term e improve an existing term e correct an existing term NOTE Use only one form for each proposal Proposer s name Title Country Company Name City Postal Code House number and street P O Box Telephone Fax E mail GMDN User Guide version 2002 Form B GMDN Proposal Form continued page 2 of 4 PROPOSAL FOR REQUIRED GMDN ACTION IN RESPECT OF 1 new term 2 improvement to an existing term 3 correction to an existing term New term 1 Term name maximum 120 characters 2 Device category code 1W20U30405060708090 100 11 12 3 Definition maximum 700 characters intended use has target has context of use is based on has constituent is presented as has specification Reason for your submission 73 GMDN User Guide version 2002 Form B GMDN Proposal Form continued page 3 of 4 Improvement or Correction to Existing Term tick one box only 4 Suggestion for improvement of a GMDN term correction of a GMDN term term name term code your suggestion New synonym 5a New synonym name s maximum 120 characters 5b This new synonym is to be linked to GMDN term GMDN code 6 If you use a Loca Coding System then please provide the following information
30. bitus ulcers of where the patient has little remaining body fat and the displacement of the body weight is vital for treatment It employs the circulation of filtered and temperature regulated air being forced through large quantities of ceramic spherules small round ceramic beads which become almost liquid fluidized in this state providing the patient with complete uplift over the whole body surface The combined effect of this process provides other extremely beneficial results Code 35921 Category 04 21 GMDN User Guide version 2002 4 3 2 Template terms Template terms are broad names that are used to collectively group similar preferred terms a kind of heading NOTE This is a navigational tool only and must NOT be used for classification purposes It is a term used when the same base concept occurs on more than two preferred generic device group terms for the sole purpose of presenting these in a sub ordinated hierarchy RULE Where there is more than two preferred terms having the same base concept a template term shall be introduced EXAMPLE Bed lt specify gt Bed aids treatment electric field generation Bed air fluidized Bed birthing Bed circle Bed hospital This idea behind the introduction of a template term is to assist the user by presenting the narrowest list of choices In order to create a user friendly nomenclature a liberal use of synonyms entry
31. crobial sensitivity systems and their accessories Code 07 Term Non active implantable devices This category includes devices other than active implantable devices which are implanted for longer than thirty days Note Examples of devices in this category are interuterine devices heart valves bone prosthesis and their accessories 78 GMDN User Guide version 2002 Code 08 Term Opthalmic and optical devices This category includes devices for use in diagnosis prevention monitoring treatment correction or alleviation of eye diseases and optical malfunctions Note Examples of devices in this category are tonometers intraocular lenses slit lamps and their accessories Code 09 Term Reusable instruments This category includes devices which are used in surgery or elsewhere and are intended to be cleaned and sterilized for reuse Note Examples of devices in this category are retractors haemostats drills saws and their accessories Code 10 Term Single use devices This category includes devices which are intended to be used only once Note Examples of devices in this category are intravenous infusion sets condoms and laparotomy sponges Code 11 Term Technical aids for disabled persons This category includes devices specially produced or generally available which compensate for relieve prevent or neutralize an impairment disability or handicap Note Exa
32. d use or common technology The GMDN is divided at its broadest level into 12 categories CHILD A young human being below the age of puberty NOTE Paediatric shall be used in the GMDN when referring to sick children COMPONENT A part of a device that is composed of two or more parts CONSOLE A panel or unit accommodating a set of switches controls etc Any operating control mounted together to form an array of controls where the operator can stand and steer control the parent device to some degree CONTROL A control is a substance material or article intended by its manufacturer to be used to verify the performance characteristics of the device CONTROL UNIT All steering devices with connections to the parent device and which can steer direct or change its operational parameters This can be done by automatic semi automatic or manually operated commands 62 GMDN User Guide version 2002 DEVICE GROUP A shortened version of Generic device group typically used in the term definitions to save allocated space DEVICE TYPE This is the level of the GMDN structure containing types of medical devices A device type is recognised by information provided by the manufacturer this being the Make and Model information EQUIPMENT The necessary article for the purpose A general word with no special application FIRMWARE For computers computer programs contained
33. d its use in their recommendations Although the nomenclature was initially created to provide a method for classification of medical devices their accessories systems and procedure packs it also includes many technical aids hospital and home care products which may or may not be medical devices It has been anticipated that the GMDN will because of its status in Europe and potential impact at a global level be used by many professions within the healthcare services Therefore products which are border line to true medical devices are also included The GMDN is a data file that by nature of its content requires continual updating and revision To achieve this the GMDN Maintenance Agency GMDN MA has been established in accordance with the rules of procedure that have been approved by CEN 1 3 Acknowledgements To attain global acceptance the planners of the GMDN had to take account of a number of considerations Through the co operation of ISO full participation of major stakeholders outside of Europe who played a vital role in the GMDN development was brought about These were the Food and Drug Administration FDA of the USA the Japanese Federation of Medical Device Associations JFMDA Japanese manufacturers and the ECRI organization Also recognising that the ECRI UMDNS nomenclature had a prominent position in many organizations dealing with nomenclature it was evident that it would be highly beneficial should this nomenc
34. e before it is placed on the market under its own name regardless of whether these operations are carried out by that person himself or on his behalf by a third party NOTE See Council Directive 93 42 EEC concerning medical devices 17 GMDN User Guide version 2002 4 Structure 4 1 The nomenclature structure 4 1 1 The general data structure Figure 1 General structure for the nomenclature Nomenclature Level Manufacturer s naming level ID The general structure of the GMDN is regulated by the requirements provided in the standard ISO 15225 or EN ISO 15225 and the Proposed Draft Amendment to EN ISO 15225 document Draft amendment ISO 15225 2000 DAM 1 Figure 1 shows the basic three level data structure which is the backbone of the system Each level carries independent information that divides medical devices into more refined groups The three levels are data relational e g a Generic Device Group can be linked to one or many Device Categories Likewise one Generic Device Group can be linked to zero or many Device Types The GMDN stops at the device type level which is the level considered specific enough to identify the model and provide the grounds for the EC declaration of conformity The identification of types of devices device type level e g by make and model is outside the scope of the GMDN nomenclature 18 GMDN User Guide version 2002 4 1 2 Attributes The concept of the GMDN also i
35. ecify gt Cytocentrifuge see Centrifuge cytology Lab equipment centrifuge cyto see Centrifuge cytology The broad synonym term C inica centrifuge directs the user to the template term Centrifuge lt specify gt where several choices are listed and a human evaluation is required as to which of the three subordinated preferred terms Centrifuge blood bank Centrifuge cell washing Centrifuge cytology is applicable for classification The synonym terms Cytocentrifuge and Lab equipment centrifuge cyto are direct hits to the preferred term Centrifuge cytology EXAMPLE of real time data relationships Code Term name Synonym code 10778 Centrifuge lt specify gt 15115 Centrifuge blood bank 35901 Centrifuge cell washing 35881 Centrifuge cytology 30869 Clinical centrifuge 10778 32933 Cytocentrifuge 35881 37214 Lab equipment centrifuge cyto 35881 NOTE See also EN ISO 15225 Annex C 23 GMDN User Guide version 2002 4 3 4 Example of style In the standard EN ISO 15225 under Annex B and section 5 2 Generic Device Group there are requirements and examples for the method used to create terms During the GMDN project phase certain guidelines evolved and these were adopted to enhance the overall nomenclature layout These amendments are given in the Proposed Draft Amendment to EN ISO 15225 document Draft amendment ISO 15225 2000 DAM 1 See also 6 1 Rules and Conventions for Nomenclature D
36. erm either a preferred term or a template term when installed into a data application configured to this standard This standard defines the minimum requirements for the data fields that are needed to hold the nomenclature and the relationships between the data levels and code links NOTE During the GMDN project phase it was anticipated that the field length requirement of alphanumeric 60 characters for the generic device group data file given in the standard would be insufficient IMPORTANT This field length has been increased to be 120 characters and this adjustment must be catered for when setting up a database or importing the GMDN electronic file The governing CEN and ISO technical committees have approved this change to the standard See document Draft amendment ISO 15225 2000 DAM 1 The GMDN electronic file can be imported into existing software applications e g spreadsheets 30 GMDN User Guide version 2002 5 1 1 File format The GMDN will be released as an electronic data file as version 2002 1 The data is presented as ASCII files as specified in ISO IEC 8859 1 1998 These being a tilde delimited file and an XML file The data string will contain the information as presented in the standard EN ISO 15225 section 6 Data file dictionary and exemplified in Annex C These data elements are 1 CODE A unique five digit number used to identify each term These codes are unintelligent that is they p
37. es Council of European Communities Council of European Communities Draft amendment ISO 15225 2000 DAM 1 ENV 12611 ECRI UMDNS EDMA EN ISO 15225 FDA CNMD ISO 1087 1990 ISO 9999 ISO IEC 2382 1 1993 Council Directive concerning medical devices 93 42 EEC Council Directive on the approximation of the laws of the Member States relating to active implantable medical devices 90 385 EEC Directive 98 79 EEC of the European Parliament and of the Council on in vitro diagnostic medical devices Proposed text for amendment 1 to EN ISO 15225 2000 Medical informatics Categorial structure of systems of concepts Medical devices Universal Medical Device Nomenclature System Product Categories Thesaurus 1197 and 1998 Product Classification for in vitro Diagnostic Products Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange ISO 15225 2000 Classification Names for Medical Devices and In Vitro Diagnostic Products Terminology Vocabulary Technical aids for disabled persons Classification Information technology Vocabulary Part 1 Fundamental terms 69 GMDN User Guide version 2002 Bibliography continued ISO IEC 2382 17 1996 ISO IEC 8859 1 1998 HHS Publ FDA 91 4246 MHW 1995 NKKN Information technology Vocabulary Part 17 Databases Information processing 8 bit si
38. es that have more than one function is knowing how to approach this Many devices especially those taking measurements or delivering treatment to or from the patient are able to do several tasks simultaneously The search word mu tifunction is currently not widely utilized in the GMDN and will therefore not provide a usable listing of all such devices Multifunction is also synonymous with other qualifiers such as multichannel and general purpose It will be best to search on the base concept of the device intended use EXAMPLE Infusion pump multichannel Patient monitor specify Pulmonary function analyser specify This will especially apply to devices that have been manufactured for one main intended purpose but which include other s ge eatures Let us say that a device has been designed with its main function being an electronically driven sphygmomanometer that can also measure pulse oximetry and calculate and display heart rate This device although being able to display more than one measurement is not constructed with a true multifunctional role and should be classified according to the main intended function EXAMPLE Sphygmomanometer electronic automatic Sphygmomanometer electronic manual E Procedure packs Procedure packs are represented by terms including the qualifier or word Kit or Set See 6 3 Glossary of terms for the definition 44 GMDN User Guide version 2002 E Software
39. eter lt specify gt 7 Catheter preferred terms Catheter angioplasty lt specify gt 3 Catheter angioplasty preferred terms Catheter angioplasty atherectomy Catheter angioplasty atherectomy ablative Catheter angioplasty balloon dilatation Catheter cardiac lt specify gt 4 Catheter cardiac preferred terms Catheter cardiac ablation Catheter cardiac balloon lt specify gt 3 Catheter cardiac balloon preferred terms Catheter cardiac balloon intra aortic Catheter cardiac balloon oxygenation monitoring Catheter cardiac balloon pacing electrode The grammatical rules that apply to preferred terms should also be applied to template terms Each template term should have an associated definition that is broad enough to encompass all of the terms for devices that fall under its hierarchical domain Template terms are also associated with a unique numerical code c Synonym Terms The synonym term is a common use or familiar name used in the nomenclature It is an alternative term for a preferred term or a template term that is linked to the preferred or template term to direct persons who use the synonym term to the preferred or template term Synonym terms commonly include hospital jargon terms for medical devices 48 GMDN User Guide version 2002 The following are examples of linked synonyms EXAMPLE Anesthesia arm linked to the template term Facility boom lt specify gt ACT meter
40. evelopment In order for the user to fully understand the GMDN those sections relating to the presentation style of the terms are given below E Uppercase lowercase The first letter of a device category term or a generic device group term is in upper case capital letters Thereafter all letters are reproduced in lower case small letters Capitalized first letter of the base concept EXAMPLE Defibrillator Capitalized first letter of the base concept followed by a qualifier in small letters EXAMPLE Microscope general purpose Capital letters may be used in the generic device group term when appropriate EXAMPLE Inventor s name Von Frey hairs Chemical substances Anti B2 glycoseprotein I antibody calibrator Device name X ray tube support C arm 24 GMDN User Guide version 2002 B Punctuation The following punctuation has been adopted for use in the GMDN as legal character elements used in generic device group names or in the definitions Comma used as a delineator or comma Hyphen used to create compound words Forward slash means and alternatively or or both Apostrophe used in some chemistry names or as an apostrophe Plus character used in some chemistry names 4 4 Device Type The device type level is not part of the GMDN nomenclature It is however an essential part of the GMDN general data structure and it is important for the GMDN user to underst
41. f 11 Technical aids for disabled persons g Oi Active implantable devices h 07 Non active implantable devices i 04 Electromechanical medical devices j 10 Single use devices k 09 Reusable instruments H 05 Hospital hardware 42 GMDN User Guide version 2002 5 2 5 No GMDN term available If you can not find an appropriate compatible generic device group preferred term for the classification of your product you will need to notify the GMDN Maintenance Agency You are requested to fill in the GMDN proposal Form Form B in this manual and together with informative product documentation submit this to the address given at the bottom of the form Your proposal will be evaluated by the expert panel for that particular product As soon as a result has been concluded you will receive notification on the outcome which will also inform you of the classification The term Unclassified code 38442 has been made available in the GMDN to use when no existing GMDN term is found to be appropriate for classification by the user This term may be used by Notified Bodies or manufacturers as a temporary measure during the process of certification of the product prior to release on the market When applying this term the manufacturer is obligated to contact the GMDN MA with the intention of finding an applicable preferred term The manufacturer is obligated to supply the necessary information as described above 5 2 6 Classification hints amp
42. fic organ function assays liver function Immunochemistry kit for MEGX A kit is one or more items provided as a single unit for use in combination to achieve the intended use of the device 37 GMDN User Guide version 2002 Depending upon the set up of the data application into which the GMDN is installed a search using either a qualifier or a descriptor can produce a listing where the search word can be found both in the term name and or the definition EXAMPLE A search on blood gives Term Category Analyser blood gas transcutaneous 06 and 02 Flowmeter b ood magnetic resonance 04 and 12 Sphygmomanometer electronic automatic 04 Stethoscope ultrasonic 04 etc Term Analyser blood gas transcutaneous Definition An automatic or semi automatic instrument used to measure the partial pressure of oxygen po2 or carbon dioxide pCo2 in blood Category 06 and 02 Term Flowmeter blood magnetic resonance Definition A device that provides a quantitative method for determining the adequacy of blood Category 04 and 12 Term Sphygmomanometer electronic automatic Definition An electronically steered device used for the indirect noninvasive measurement of the blood Category 04 Term Stethoscope ultrasonic Definition A device used with a hand held ultrasound scanner for audible detection of blood Category 04 These methods will create listing of terms that do not necessari
43. gen high molecular weight human placental alkaline phosphatase high performance liquid chromatography human T cell lymphocytotropic virus human T cell lymphoma leukemia virus intracranial pressure intensive care unit 1 internal medicine 2 intramuscularly intermittent mandatory ventilation infrared ion selective electrode intrauterine device keep vein open laminar air flow light amplification by stimulated emission of radiation lactate dehydrogenase 57 GMDN User Guide version 2002 Abbreviation LDL LED LMW lox LSD LV MA MCA MEMS MR MRI NIST OB GYN OR OTC PAP PCA PDU PEF PET PMMA ppm PTCA PTFE PUVA Word or phrase low density lipoprotein light emitting diode low molecular weight liquid oxygen lysergic acid diethylamide left ventricular Maintenance Agency The responsible organization for the running of the GMDN mucin like carcinoma associated antigen 1 medical equipment management system 2 medication event monitoring system magnetic resonance magnetic resonance imaging non interchangeable screw threaded connector obstetrical and gynaecologigical operating room operational research over the counter non prescription drug Papanicolaou test 1 passive cutaneous anaphylaxis 2 patient controlled analgesia Power Distribution Unit peak expiratory flow positron emission tomography polymethylmethacrylate parts per million percutaneou
44. gnosis prevention monitoring treatment or alleviation of oral maxillo facial and dental disease Note Examples of devices in this category are dental hand instruments impression materials dental amalgam dental tools and their accessories 77 GMDN User Guide version 2002 Code 04 Term Electro mechanical medical devices This category includes devices where the operation depends upon a source of electrical energy electromedical or source of energy other than that directly generated by the patient s body or gravity and which uses this energy to produce its effect or action mechanical Note Examples of devices in this category are EEG infusion pumps monitors for haemodialysis monitors for ECG spring driven and elastomeric pumps Code 05 Term Hospital hardware This category includes devices which are not directly used in diagnosis or examination nor have direct influence on the clinical evaluation of the patient s condition test results or further treatment Note Examples of devices in this category are sterilizers patient transfer equipment as well as disinfectants Code 06 Term In vitro diagnostic devices This category includes devices which are used for in vitro examination of samples from the human body for the purpose of determining physiological or pathological conditions Note Examples of devices in this category are blood glucose monitors bilirubinometers mi
45. have been imported from existing source nomenclatures or have been created as brand new terms EXAMPLE Original EDMA term code GMDN term code cr Albumin CC 11 02 01 01 00 Albumin kit 30155 Original FDA term code GMDN term code Alarm blood pressure CVDSJ Alarm blood pressure 31691 Brand new term GMDN term code Ambulance terrain Ambulance terrain 41475 The GMDN code being the unique identifier of the classification and all related information should be ideally be applied to the product and or packing of the product in question 4 6 Preferred term structure The preferred term is the only term that can be used for classification of products It is recognizable by the 3 elements it is made up of These being the 5 digit unique code the term name and the unique definition NOTE The template term which must NOT be used for classification also consists of these 3 elements It is however easily recognizable by the last qualifier in the term name shown as specify EXAMPLE Restraint specify Resuscitator pulmonary specify IMPORTANT Any term ending with specify must not be used for classification 27 GMDN User Guide version 2002 4 6 1 The preferred and template terms are structured in a flat hierarchical layout comprising a base concept the first level of the term name and when appropriate one or more qualifiers The base concept represents the broadest co
46. hen the term is a preferred term 5 DEFINITION A brief generic description of the scope of the term The definition usually includes the intended use of the device and may include cross references Only preferred and template terms are defined 6 CATEGORY A number that represents a general medical device family to which the term has been assigned All terms have a primary category some also have secondary and tertiary categories The numbers correspond to the category code 31 GMDN User Guide version 2002 EXAMPLE TILDE DELIMITED FILE Each separate data element is delimited by using the ISO character number 126 name tilde character Reference Latin alphabet No 1 as specified in ISO IEC 8859 1 1998 Each line of the file contains eight tilde characters and is ended by CrLf Carriage return Line feed this represents one row from the database table Code Term Synonym code Template specifier Definition Category Category Category 38956 1 nitroso 2 naphthol fluorometric free tyrosine 31358 0 6 30367 17 hydroxyketosterone kit O 0 Immunochemistry reagents fertility pregnancy hormones proteins 17 hydroxy ketosterone kit A kit is one or more items provided as a single unit for use in combination to achieve the intended use of the device 6 30324 17 hydroxyprogesterone kit O 0 Immunochemistry reagents fertility function hormones proteins 17 OH progesterone kit A kit is one or more items provided as
47. ide version 2002 RT D 16 Term selecltlOllu a Y GaL Fei 39 Term specificity 29 ele REES 75 U DONS a 10 DIDPCICASE EG 24 Ee 11 W Word search iiie 36 Word search facility 28 GMDN User Guide version 2002 1 Introduction Recent work by the standards organizations CEN and ISO have resulted in a standard for building a nomenclature for medical devices This standard is published as EN ISO 15225 Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange Following this a project was set up by CEN with financial support from the European Commission The aim of the project being to create a comprehensive nomenclature for all medical devices suitable for use by all interested parties globally On the 1 of November 2001 the Global Medical Device Nomenclature GMDN was published as CEN Report CR 14230 and as ISO TS 20225 The nomenclature is officially named by its governing technical committee to be GMDN Global Medical Device Nomenclature 1 1 Background Many nomenclatures for medical devices and healthcare products exist on a worldwide basis having been created with different approaches structures and for different purposes In spite of this little has been achieved regarding the possibility of unambiguously classifying medical devices These different nomenclatures though often workable in their ow
48. indication application of devices general technology of devices general design of devices There are special circumstance qualifiers REFERENCES 1 The qualifiers single use and reusable are applicable to many devices These qualifiers should only be used in terms for devices that come in both single use and reusable forms If single use is incorporated as a qualifier in the term of such a device then a term incorporating reusable as a qualifier should be created or the reverse If a device is ONLY single use or ONLY reusable then the qualifier should not be used in the device name but it can be used in the term definition custom made should only be used if it is necessary from a post market vigilance perspective prENV 12611 Medical Informatics categorical structure of systems of concepts medical devices 2 ISO FDIS 15225 International standard for nomenclature specification for a medical device nomenclature system for the purpose of regulatory exchange 3 EN ISO 15225 European standard for nomenclature specification for a medical device nomenclature system for the purpose of regulatory data exchange ISO 15225 2000 53 GMDN User Guide version 2002 6 2 Abbreviations Abbreviation ACE ACT ADC AEP AIDS ANA APC APGAR APL ASK AST ATP BIS BPH BSER BTA CAD CAM CAPD CAR CCD CD CD ROM CF Word or phrase angiotensin converting enzyme activated clott
49. ing time analogue to digital converter auditory evoked potentials acquired immune deficiency syndrome antinuclear antibody activated protein C name of inventor Virginia Apgar who devised the Apgar score often transpired as Appearance colour Pulse heartbeat Grimace reflex Activity muscle tone and Respiration breathing Medical students memorize these signs by using the mnemonic of Apgar s name Appearance Pulse Grimace Activity Respiration adjustable pressure limiting valve antistreptokinase aspartate aminotransferase adenosine triphosphate bispectral Index benign prostatic hypertrophy brain stem evoked response bladder tissue antigen computer aided design computer aided manufacturing continuous ambulatory peritoneal dialysis Cancer Associated Retinopathy charge coupled device compact disc compact disc read only memory complement fixation 54 GMDN User Guide version 2002 Abbreviation CMV CPM CPR CPU CRT CSF CTG DAT DCM DEXA DHEA DISS DMS DNA DSA DSI EBV ECG EDI EEG EIS Word or phrase 1 controlled mechanical ventilation 2 cytomegalovirus continuous passive motility cardiopulmonary resuscitation central processing unit cathode ray tube 1 colony stimulating factor 2 cerebrospinal fluid cardiotocograph digital audio tape dehydrated culture media dual energy x ray absorptiometry dehydroepiandrosterone di
50. iscipline would recognize as a sensible term ordered in a nomenclature hierarchy will facilitate communication There will then be little dispute about what the manufacturer claims he has produced For those involved in the assessment process access to reference literature and to standards would be improved and certificates issued will be less ambiguous This process is in contrast to the methods applied previous to the GMDN where the user hospitals or the authorities were individually making qualified classification attempts of the products they were selectively interested in 12 GMDN User Guide version 2002 This of course resulted in the proliferation of mass ambiguity A classification done at the start of the process will be the only accepted device data E Hospitals institutions A standardized classification system will be beneficial to many of the professions engaged with medical devices These professions include logistics maintenance quality control planning and clinical e g doctors nurses and pharmacists E Clinical Engineering Departments CED Some of the many tasks performed by the CED include the upkeep of an inventory for medical devices proposing replacement requirements and maintaining the hospital s equipment To summarize the needs of the Clinical Engineering Department their tasks are to be able to e identify type make and model fit the local identification number keep a record of guarantee period
51. keep a record of compulsory voluntary recheckings and recalibrations keep a record of training receive incidents accidents and take the necessary measures keep a record of technical state of medical device ad hoc prompt services collaborate with the departments of the Institution keep a record of the accessories and materials necessary to operate the medical device e identify certifying Notified Body e co operate with CED of other institutions E Purchasing Department Administration Logistics The Purchasing Department normally controls the procurement of medical devices to the hospital This applies both to the consumables such as single use sterile products and to capital goods like Computer Tomographs A common classification system will simplify the process of tender both nationally and throughout the Common Market alleviating the mechanisms for free flow of products To summarize the needs of the Administration their tasks are e Administrative management of medical devices e Planning purchases e Keeping and maintaining the inventory of medical devices e Providing information for top management on available stock nominal value of the stock real value of the stock Connection to manufacturers and dealers of medical devices e Purchase of necessary medical devices 13 GMDN User Guide version 2002 E Suppliers and Trade For trading purposes and in particular with tendering procedures the generic definition given
52. l be e Regulatory Competent authorities for registration and vigilance Notified Bodies and Conformity Assessment entities Accredited test houses Manufacturers Health authorities Purchasers of the Buyers Departments in Hospital BDH Suppliers Trading E commerce Clinical engineers Technicians Clinical personnel Researchers 11 GMDN User Guide version 2002 The way in which some of these organisations and individuals will use the nomenclature will be E Regulatory Competent authorities The Competent Authority will in most countries simply be identical with the Health Authorities Their job will be to 1 establish a surveillance system for incidents accidents related to medical devices and 2 ensure that remedial or corrective actions are carried out in accordance with the governing directives legislation These are complex and important tasks and success will be totally dependent upon a smooth running data exchange system With a comprehensive nomenclature authorities receiving the pre marketing registration of devices will have a much greater opportunity to build up a database useable for their coming tasks In order to make registration an activity useful for the future and not simply another useless burden a proper generic description of the device together with its make and model is essential The nomenclature must be comprehensive and cover all the devices put on the market or considered a device at a global level and
53. lature be given a default preference when creating the GMDN This meant that whenever a new term made for the GMDN was derived from an original UMDNS term 1997 and 1998 editions the UMDNS code was retained to become the new GMDN code Likewise for the FDA all of their existing terms were entered into the GMDN and linked in most cases as synonym terms to a new GMDN preferred term This is GMDN User Guide version 2002 intended to help the FDA customers to identify the original FDA terms and trace them to the new GMDN terms The submission of the European Diagnostic Manufacturers Association EDMA product classification of 1996 also played an invaluable role in merging this knowledge into the GMDN The quality of the GMDN product and the inherent future development capability has to be accredited to the excellent product knowledge and expertise provided by the participating experts Not forgetting that behind all great achievements there is the ground crew the management the secretaries and the data people all of who made it possible Great credit must be given to the organizations and the participating individuals for their resilience in providing resources technical input and high level technical knowledge 1 4 Copyright Copyright for CEN by authorization of the GMDN Maintenance Agency GMDN MA No part of this publication may be reproduced or transmitted in any form or by any means electronic mechanical ph
54. ly for ophthalmic use only etc EXAMPLE Four manufacturers e g Erbe Martin Mira and Olympus produce Electrosurgical units Two of the products are similar whilst those of Mira and Olympus have differing intended purposes GMDN classification would be E Erbe 10122 041 and Martin ME 400 category code 04 generic device group code 30005 generic device group name Electrosurgical unit general purpose device definition use GMDN definition and if required submit suggestion for improvement See section 6 7 Form B E Mira MD1000 category code 08 and 04 generic device group code 41645 generic device group name Electrosurgical unit ophthalmic device definition use GMDN definition and if required submit suggestion for improvement See section 6 7 Form B E Olympus PSD 20 category code 04 generic device group code 33602 generic device group name Electrosurgical unit endotherapy device definition use GMDN definition and if required submit suggestion for improvement See section 6 7 Form B 40 GMDN User Guide version 2002 The last example demonstrates the difference reflected by intended purpose The Erbe and the Martin devices are clearly for general purpose use whilst the Mira device is a dedicated design for use in ophthalmic surgery only and could not be used for general purpose surgery The Olympus device could however be used for general purpose su
55. ly of course there is the myriad of users who when the devices initially arrive struggle with the quite hopeless task of trying to correctly classify the devices This means that there are a number of players all of whom have quite different responsibilities but all with the common interest of ensuring the availability of sound medical devices To assist this important process GMDN User Guide version 2002 there is a need for a common method for describing and identifying these medical devices in an unambiguous manner Consequently as medical devices are manufactured distributed and brought into use worldwide it has been necessary to develop the GMDN as the new global nomenclature for medical devices 1 2 Scope The GMDN is a nomenclature the purpose of which is to enable Competent Authorities CA Notified Bodies NB and manufacturers to meet the requirements of Council Directives on medical devices The GMDN is also intended to assist in the implementation of community sectorial legislation and to facilitate co operation and exchange of information within the European Community and at an international level Through international participation of ISO the GMDN is vested to become a comprehensive nomenclature for all medical devices suitable for use by all interested parties globally The Global Harmonization Task Force GHTF has been continually updated on the GMDN activities the intention being that they will endorse the GMDN an
56. ly have any similarity other than that of containing the word searched for They can easily come from different device categories 38 GMDN User Guide version 2002 e Term selection When selecting an appropriate preferred term whether this is done by a direct hit or through a selection list automatically presented or generated by word search it is important to make sure that you select the term that is most specific to the intended use of the product being classified EXAMPLE The device to be classified is an Electrosurgical unit which in some parts of the world are popularly known as a Diathermy These are devices used to cut tissue by using applied electric current In the alphabetical listing these will be found under the template term Electrosurgical unit lt specify gt Here we can also find generic device group terms under the template term Diathermy unit lt specify gt If one reads the definition defined as Diathermy unit lt specify gt A therapeutic device that applies to specific areas of the body energy e g electromagnetic or high frequency microwave energy which is intended to generate heat within body tissues for the treatment of selected medical conditions e g relief of pain muscle spasms or joint contractures but is not for the treatment of malignancies The tissues are warmed but not damaged as in surgical diathermy therefore this is not an electrosurgical unit ESU See also Interferen
57. ly or in combination with an instrument to achieve its intended purpose It may be a self testing or a point of care device e g colorimetric glucose test strip glucose biosensor strip urine dipstick TRANSPORTABLE A device specially designed for constant transportation easily movable Can have been designed to be carried by hand whether or not it has to be partly dismantled for this purpose e g A portable x ray apparatus or transported as a fixture in a vehicle This device will typically be designed to withstand constant transportation e g a more robust protective construction See a so Portable UNIT An individual thing or group regarded as single or complete A device with a specified function forming part of a complex mechanism UNIVERSAL Being able to do all the general applications for that particular field of medical devices or clinical speciality USER The user A person who uses a particular commodity or service 67 GMDN User Guide version 2002 6 4 Search words by qualifiers This list of search words will target on terms that have one of these This list of search words will target on terms that have one of these words as a qualifier comprising the term name In many cases they may also target a word in the definition This list has been compiled to illustrate to the user the potential of word search in the GMDN but it is by no means comprehensive Search words diction
58. mosis yttrium aluminium garnet NOTE Abbreviations marked with an asterisk have not been corroborated and the presentation of the word or phrase may be incorrect 60 GMDN User Guide version 2002 6 3 Glossary of terms Introduction This chapter provides a glossary of terms which within the context of the GMDN are defined as the specific meaning provided with the term or abbreviation Term Definition ACCESSORY A device will be considered as an accessory when it can only fulfil a purpose when functioning together with a parent medical device or the parent device can not fulfil all its potential functions as intended by the manufacturer without the accessory An accessory when applied will typically enhance the function of the parent device NOTE Accessory is the chosen form when used as part of the term construction ADAPTOR A device for making equipment compatible NOTE This spelling of adaptor shall be used in the GMDN when referring to these devices ADOLESCENT A person above the age of puberty that has not yet attained full growth usually about 13 24 years of age ADULT A mature grown up human ALARM A device designed to produce audible visible and or tactile signals when certain events occur or prefixed limits of a variable parameter are exceeded NOTE Alarms are typically used to alert one to sudden changes in patient status e g respiratory or cardiac
59. mples of devices in this category are crutches artificial limbs hearing aids wheelchairs and their accessories Code 12 Term Diagnostic and therapeutic radiation devices This category includes devices which are diagnostic and or therapeutic and use such modalities as x rays magnetic resonance imaging ultrasound imaging computed tomography scanners and their accessories Note Examples of devices in this category are x ray equipment computed tomography scanners and their accessories 79 GMDN User Guide version 2002 3 Definition device descriptors In order to provide uniform definitions for all the GMDN terms the following format for constructing a definition has been adopted It is important that you attempt to provide information for each of the seven levels provided An explanation for each of these seven device descriptors is given below 1 performs must express the intended purpose of the device 2 target must express the target area of intended use but may indicate possible alternative usage if this is considered to be enlightening information 3 context of elaborates upon the medical speciality where use the device is used and in what context vis a vis the patient 4 is based on gives the technology technical principle or working method 5 has describes materials and or components constituent involved 6 is presented gives the form shape phy
60. n aa naar EE EE au aaa uas 18 4 2 ue th EE 19 4 2 DEVICE CATEGORY EEN 19 4 23 DEVICE CATEGORY 2 12 22 euro co deuce Devi ce kw E c cecclicri zefcro s ere rk ol gr ak 20 4 3 GENERIC DEVICE GROUP 20 4 3 1 Preferred COMING EE 21 43 2 Template COMING 15 Ea EF inaani SERE RERRREXERRERIARRRREPRRMER TE R anaana RR 22 4 3 3 Synonym LOLINS HF FFFFFFFFEFNDR FF ERR IKE ERERRRRNERREAR FE EUAREDATRR NES RES E SE DEEKENRREA E 23 4 3 Ee E 24 4 4 DEVICE TYPE RI Maroc erii ec cR _ e c 25 45 Gesch C REN 26 4 6 PREFERRED TERM STRUCTURE eeeenenen nemen nenne nini RE nne e kia ra gna arae ran n 27 4 6 1 Base concept construction us soo isis o oor esae aan aaa noua aaa NEE EE aaa uaa 28 4 6 2 TERMSpECIEICTT nemine nunnerusiie ria ra na a agi LEE A ER RR ra na 29 5 APPLICATION HEH HM dE SEKR dE SEHR 30 Dl INSTALEATION EE 30 5 1 1 FHefonmat i eis rra eye a ER ees ei eas 31 5 2 CLASSIFICATION 2 nens ER KKK ENK EK ER KEREN ENK uu uu 33 5 2 CLASSIFICATION 2 25 a zoe EENS EES EN RSNNKehERE NEEN iwn 34 5 2 1 WHO SHOULD CLASSIFY a a HN RL innen heme ara ARR ER rana ara nnn 34 5 2 2 HOW mrexeP cafe M M Rm 34 5 2 3 Classification of deViCes ooo RE au EEN aaa aaa KEREN RERR RR RR Een 41 5 2 4 Category selection method 41 ooo s o
61. n right have had no impact on improving the overall situation of providing a common platform whereby medical devices can be unambiguously identified and related data safely exchanged For the manufacturer having to deal with the different national and international requirements regarding classification can be a nightmare scenario Many of the larger manufacturers simply use their own in house product identification scheme and whilst this approach may work extremely well for them it is likely to be incompatible with and unusable for others The medium and small size manufacturers experience even greater difficulties but simply try to carry on as best they can The running and application of different nomenclatures worldwide is extremely time consuming and expensive this without improving the data quality to the level required by modern data communication With the advent of the European Union EU Directives for Medical Devices a new era was initiated where both national and international bodies are given the opportunity to co operate and harmonise efforts to achieve something that they all need Within all regulations concerned with medical devices there are a number of obligations placed on the manufacturer In addition the authorities are faced with the task of regulating manufacturers and their devices and there are people involved in trade with these devices e g suppliers before the devices themselves are finally brought into use Final
62. ncept level The addition of each qualifier adds greater specificity to the term EXAMPLE Base concept Resuscitator Base concept qualifier Resuscitator pulmonary Base concept qualifier qualifier qualifier Resuscitator pulmonary manual single use NOTE A comma and one space delimit each qualifier each level of specificity Base concept construction Base concepts are created whenever generic device group terms share the same or similar intended use or commonality of technology EXAMPLE Alarm Laser Base concepts should be constructed so that they incorporate only a homogenous group of medical devices EXAMPLE Applicator Clamp Retractor Scissors etc Very broad concepts that incorporate heterogeneous medical devices e g surgical instrument are not appropriate for use as base concepts To aggregate devices under broad concepts the term definitions should be utilized In such cases a common descriptor e g surgical instrument shall be provided in the first sentence of the definition for each appropriate term providing a common word search facility See document Section 6 1 Rules and Conventions for Medical Device Nomenclature Development 28 GMDN User Guide version 2002 4 6 2 Term specificity The GMDN is a generic nomenclature and is not developed to the most specific qualifier possible unless this is required to meet regulatory needs NO
63. ncludes the inclusion of attributes This means that other areas of information can be linked to the general data structure to fulfil the particular requirements of that user Such attributes can be e g e commerce information providing the necessary granulation of product detail links to standard references expanded generic device group definitions etc code Device Category Generic Device Group GMDN future 1 p Code 19 GMDN User Guide version 2002 4 2 Device category The device category is the broadest breakdown of the medical device product market The device category currently contains 12 product areas based upon clinical speciality use technology or common characteristics These categories are fully implemented in the EU and EEA and are used by governments for the accumulation of statistical information The established device categories are Code Term 01 Active implantable devices 02 Anaesthetic and respiratory devices 03 Dental devices 04 Electro mechanical medical devices 05 Hospital hardware 06 In vitro diagnostic devices IVD 07 Non active implantable devices 08 Ophthalmic and optical devices 09 Reusable instruments 10 Single use devices 11 Technical aids for disabled persons 12 Diagnostic and therapeutic radiation devices It is anticipated that through technology development it will be necessary to add new categories of devices to this list The device categories and
64. ngle byte coded graphic character sets Classification Names for Medical Devices and In Vitro Diagnostic Products Nomenclature and Classification for Medical Devices ISBN4 8408 0383 8 C3407 P5500E Nomenclature for Medical Devices version 3 00 1996 ISBN 82 91328 04 08 including English translation 70 GMDN User Guide version 2002 6 6 FORM A Reader s Comment Form Reader s Comment Form GMDN User Guide Issue 1 We would greatly appreciate your comments about this manual Your feedback will be taken into account for the next issue Please print out and complete this page with your comments Did you find the information you wanted Tick one box only LI Yes everything I wanted L Only some of the information I wanted L No Additional comments What are your thoughts about the way in which the information is presented Your general comments Tf there is not enough space please send additional pages How would you classify your own experience with nomenclature Please tick one box only L First time user Some experience Experienced user Programme Please send this completed form to GMDN Maintenance Agency Attention Mr Brock Hefflin 1350 Pickard Drive HFZ 530 Rockville MD 20850 USA E mail bjh cdrh fda gov Your name Your address Your e mail 71 GMDN User Guide version 2002 6 7 FORM B GMDN Proposal Form Page 1 of 4 GMDN Proposal Form Ple
65. nly letter of a term that should be capitalized except for proper names and other appropriate capitalization Where appropriate the preferred term should be structured so that the nomenclature acquires a functional architecture EXAMPLE Catheter angioplasty atherectomy Catheter angioplasty atherectomy ablative Catheter angioplasty balloon dilatation Catheter angioplasty balloon dilatation coronary perfusing Trade names inventor names and transitory terms shall not be used as preferred terms NOTE Qualifiers giving specifics like size volume capacity or colour will normally not be accepted as these can make the Generic Device Group to narrow and they could easily become discriminating by sometimes accepting only a few or only one type Make amp Model b Template Terms The template term is a name used to group similar preferred terms and to develop a hierarchy in the nomenclature The template term should be created and added to the nomenclature when the same base concept occurs in three or more preferred terms The template term should be formed from the common base concept followed by a comma and then the qualifier lt specify gt Depending on its hierarchical level a template term may have additional qualifiers between the base concept and the lt specify gt 47 GMDN User Guide version 2002 Use of the template term is demonstrated in the following example EXAMPLE Cath
66. o a maximum of 120 alphanumeric characters Likewise concisely written definitions shall not exceed a maximum field length of 700 alphanumeric characters 50 GMDN User Guide version 2002 II Term Specificity It is important to set parameters for how broad and how narrow generic device group names should be constructed An established level of specificity will provide stability for the nomenclature Normally all devices having the same intended purpose i e suitable for the same job based on the same technology and operated in more or less the same manner should fall within the same Generic Device Group a Base Concept Specificity Base concepts should be constructed so that they incorporate only a homogenous group of medical devices EXAMPLE Catheter Bed Prosthesis Table Very broad concepts that incorporate a heterogenous set of medical devices are not appropriate for use as base concepts Examples of inappropriate base concepts include Accessory Agent Anesthesia equipment Kit Laboratory equipment Material Ophthalmic instrument Oxygen therapy equipment Patient transport equipment Surgical instrument System Test It would be appropriate to construct base concepts using some of these broad terms in compound nouns to increase the specificity of the concept as shown in the following example 51 GMDN User Guide version 2002 EXAMPLE Corneal smoothing agent Anesthesia kit
67. omenclatures were adopted These covered a wide range of terms defining medical devices and healthcare products and constituted approximately 13 500 terms The 6 chosen nomenclatures were e CNMD Classification Names for Medical Devices and in Vitro Diagnostic Products Developed by Food and Drug Administration FDA Is the USA official nomenclature e EDMA European Diagnostic Manufacturers Association in vitro diagnostic product classification Used in Europe e ISO 9999 Technical Aids for Disabled Persons Classification International use e JFMDA Japanese Medical Device Nomenclature Used in Japan and south East Asia e NKKN Norsk Klassifisering Koding amp Nomenklatur Norwegian Nomenclature Used in Norway and some use in Europe e UMDNS Universal Medical Device Nomenclature System Developed by ECRI Is in use in the USA some countries in Europe and some countries worldwide During the project phase trace ability between the new and old nomenclature terms was maintained providing a link for users changing to the new nomenclature This link allowed users to use and interpret data collected over time without having to establish a new set of records This mapping data is the property of the organization responsible for the respective nomenclatures 10 GMDN User Guide version 2002 2 1 Why this Nomenclature Within all regulations concerned with medical devices there are first of all a number of obligations placed on the
68. onfined area SYSTEM A system is a number of items connected together and placed on market or put into use by one manufacturer or responsible person for a specific intended purpose If all the items and their connections have the CE marking affixed and are used as intended their mutual compatibility having been verified the system does not bear a CE marking If some of the items or connections do not bear a CE marking or are not intended for the specified purpose the complete system is treated as a medical device In either case the system will require a Generic Device Group name using the base concept system with appropriate descriptive semantic linking such as performs has target has constituent s etc TEST INSTRUMENT A device primarily designed to measure register and display readings whereby a calibration of the technical parameters of the device being tested may be adjusted NOTE Test instruments are typically used for the periodical and post repair evaluation and or calibration of the electric mechanical and other physical parameters of medical devices They may simulate a physiologic characteristic e g phantoms or organ tissue function e g bioelectric signals Test instruments are also used to determine the safety of a particular medical device 66 GMDN User Guide version 2002 TEST STRIP A test strip is a strip intended by the manufacturer to be used either manual
69. otocopying recording or otherwise or stored in any retrieval system of any nature without the written permission of the copyright holder and the publisher The product described in this guide is not intended for use as a critical component in life support devices or any system in which failure could be expected to result in personal injury The product described in this guide is subject to continuous development and improvement All information of a technical nature and particulars of the product and its use including the information and particulars in this guide are given by the GMDN MAPG in good faith However the GMDN MAPG cannot accept any liability for any loss or damage arising from the use of any information or particulars in this guide 1 5 Disclaimer The GMDN Maintenance Agency GMDN MA is at all times working to create a best possible nomenclature that defines medical devices related healthcare products at a generic level for the purpose of product classification This will provide a globally acceptable method so that related information can be utilized for a number of purposes It is the responsibility of the GMDN user to ensure that the correct applicable term is used when classifying products nor does the inclusion of a device definition in the GMDN exempt the responsible person from any product approval requirements called for by legislation Nor does the GMDN attempt to predefine GMDN User Guide version 2002 when
70. pas a aaa n aaa au aan aaa u auno u uu 42 5 2 5 No GMDN term available 4 4 asas aaa uana ENKER ENEE KEREN EE Een 43 5 2 6 Classification hints amp tips iis iiri ee aera arae n aaa aun aan tau RYN NND aaa EDR 43 6 APPENDICES 1 YL HN 46 6 1 RULES AND CONVENTIONS FOR NOMENCLATURE DEVELOPMENT nmn 46 GMDN User Guide version 2002 6 2 ABBREVIATIONS sain Re TER anctavermenasanauuachetsetaasawbeune Ehe AER 54 6 3 GLOSSARY OF TERMS EE 61 6 4 SEARCH WORDS BY QUALIFIERS sacs issansswaaesintnasacaac EAM YDA NOG AO DAEAR DRO DAU 68 6 5 BIBIIOGRAPHY EE 69 6 5 FORM A READER S COMMENT FORM cigecescewsestecitsa Ges nd den Con ML Yn OE REG 71 6 7 FORM B GMDN PROPOSAL FORM 11eeec eene eene ene nh emen ENEE ER ERKENNEN 71 6 7 FORM B GMDN PROPOSAL FORM 5 2 nausea dre nna mnn nux ua dax ak ENEE 72 6 8 INSTRUCTIONS FOR FILLING IN THE GMDN PROPOSAL FORM eeenn menn 76 GMDN User Guide version 2002 Index A Abbreviations eee 54 ACCOSSOLIBS ergeet gei ee 44 Alphabetical search 35 Application crei no edet 30 B Base concept construction 28 C Category selection search 36 Chatactep i ei ne 15 ClaSSiMCAU ON cs i ie ee ener 21 43 CNM bI NN WU 10 COCING LIMES 26 Belle 9 Competent Authorities 7 12 CONGO D 15 Conventions for Nomenclature Development 46 eine EE 8 Custom made device
71. play ongoing physiologic data for the critically ill patient i e vital signs and or technical data from devices PORTABLE Easily movable convenient for carrying This also includes devices that can be easily dismantled transported to another location and easily reassembled See a so Transportable PROCEDURE PACK See KIT or SET RECORDER A device designed to produce and store a representation of information usually in the form of time varying signals NOTE Recorders typically store information in a chart tape magnetic optical disc or electronic media REFERENCE DEVICE MATERIAL A reference is a material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus the assessment of a measurement procedure or for assigning values to materials 65 GMDN User Guide version 2002 RIGID Not flexible cannot be bent SELF TESTING DEVICE A self testing device is any device intended by the manufacturer to be able to be used by lay persons in a home environment SEMI RIGID Partly to some degree bendable SET See KIT SOFTWARE For computers the programs and other operating information used by a computer STATIONARY A device designed to be located in one place for extended periods It may have wheels but these are only for the convenience of movability within a c
72. provide a definition suitable for a correct classification of the device in question E Notified Bodies and Conformity Assessment Bodies The new situation brought about by the EU its expansion to include Eastern Europe as well as MRAs Mutual Recognition Agreements with other trading partners introduces free movement of medical devices across borders A conformity assessment carried out according to rules in one place will provide the proof that the product complies with all necessary and relevant standards Notified Bodies and other Conformity Assessment entities will monitor and assist these proceedings Their tasks are e Identification of types Keeping records of certification and refused types Keeping records of audited certified manufacturers Supervision of QA system of audited manufacturers Certification of types regular rechecking of safety and performance E Manufacturers Whatever regulations exist the manufacturer will have to go through some kind of procedure before the device is allowed on the market This will normally be a conformity assessment according to agreed criteria for high risk devices by a third party or as an approval in more traditional regulations In most cases this will lead up to a registration of the device with some authorities It is obvious that a standardized well formulated generic description of the device together with an appropriate term name e what people involved in that particular d
73. rgery but it has been specially designed for use together with endoscopic equipment It may e g have a built in light source special attachments for connecting dedicated endoscopes and is therefore classified to this degree of product specificity 5 2 3 Classification of devices The method for classifications used in the GMDN includes the following steps 1 Select most specific applicable preferred term 2 Check that the definition is adequate If not submit a suggestion for improvement see Form B 3 Check that the device category or at least one of the categories already indicated and linked to the selected preferred term is applicable If not submit a proposal for an additional category see Form B 4 Register the product with the following details Category code s 2 digits Generic device group code 5 digits NOTE A product may have an intended use that is applicable to more than one category and must be classified to show the categories it can belong to NOTE The codes for the category and the generic device group are the information carriers Anyone receiving these codes and having access to the GMDN will be able to retrieve the full information string e g the selected category name s and definition s the generic device group name the selected preferred term and its definition generic device group definition 41 GMDN User Guide version 2002 5 2 4 Category selection method
74. ring analytes It is typically a low speed up to 6000 rpm or medium speed up to 12000 rpm machine 4 5 Coding All terms in the GMDN are assigned a unique code This code is an incremental sequential cardinal number comprising five digits starting from 10000 The codes can be deemed nonsensical because they do not feature any inherent hierarchical structure Whilst through the lifetime of the GMDN the term name and definition may be subject to revision because of technological changes the code will always remain the same and therefore act as the unique identifier E codes in the range of 1 9999 are not represented in the GMDN since these are exclusively reserved for assignment by the end user and may be used as desired in the user s local application E codes in the range of 10000 30000 are represented in the GMDN and have been reserved to represent the original code given to an ECRI UMDNS term that has been adopted for use in the GMDN This will provide the GMDN user with automatic mapping from the ECRI UMDNS terms that could be adopted to the GMDN to assist in transition EXAMPLE Original ECRI term code GMDN term code Adhesives 10034 Adhesive specify 10034 Adhesives aerosol 10035 Adhesive aerosol general purpose 10035 Adhesives liquid 10036 Adhesive liquid 10036 26 GMDN User Guide version 2002 E codes in the range of gt 30000 represent all other terms used in the GMDN whether these terms
75. rone kit A kit is one or more items provided as a single unit for use in combination to achieve the intended use of the device gt lt categories gt lt category value 6 gt lt categories gt lt group gt 32 GMDN User Guide version 2002 Figure 2 Relational structure of the data model Device Categor K P Abstract General knowledge Concrete Occurences in the real world Manufacturer Relations One and only one to zero or many e Zero or many to one ore many Optional entity 33 GMDN User Guide version 2002 5 2 Classification 5 2 1 Who should classify It is not an easy task to assign a medical device or related health care product its correct classification i e its predefined definition and linked term Even among people trained by the same instructor there will be different views and hence a different classification The only secure way to have a device classified is by or through its manufacturer who will know its intended purpose and the way it is intended to operate and perform as well as the technology involved This operation will make certain everybody later involved be it in assessment registration trade purchase or incident reporting knows its proper classification the code term and definition IMPORTANT The job of claiming the class for a product is the responsibility of the product s manufacturer since by using the nomenclatures defini
76. rovide no information on term meaning or nomenclature structure 2 TERM A chosen name representing a defined concept typically a medical device In the GMDN there are of three kind of terms e Preferred Term an established name used to classify a medical device group e Synonym Term common use or familiar name used to reference a device e Template Term a name used to group similar preferred terms into a simple hierarchy Identified by the qualifier specify at the end of the term Template terms exist only where three or more preferred terms begin with the same description base concept 3 SYNONYM CODE A number that indicates the status of a term as a synonym term If the number is O then the term is not a synonym term If the number is a five digit code then the term is a synonym term and the number is the code of the preferred or template term to which it is linked 4 TEMPLATE SPECIFIER A number that indicates the status of a term as a template term If the number is O then the term is not a template term If the number is other than O then the term is a template term and the numerical figure represents the number of characters in the term that should be used to reference subordinate preferred terms e g if the number is 10 then the first 10 characters of the template term are identical to the first 10 characters if its subordinate preferred terms If both the synonym code and the template specifier are 0 t
77. s surgical tools both mechanical and electrical and devices providing measurements readings e g Test instrument for measuring testing electrical or mechanical KIT A kit is one or more items provided as a single unit for use in combination to achieve the intended use of the device A procedure pack is a number of items packaged together and placed on the market or put into use by one manufacturer or responsible person to be used in a specified medical procedure or procedures If all items in the pack have the CE marking affixed and are used as intended the procedure pack does not bear a CE marking If some of the items do not bear a CE marking or are not being used for their intended purpose the whole pack is treated as a medical device In either case the pack will require a Generic Device Group name including the qualifier kit or set with appropriate descriptive semantic linking to include Aas constituens and has specification lt sterility type gt LONG TERM An event occurring in or relating to a long period of time MOBILE Designed to be easily moved from one place to another usually on wheels May have a powered drive to the wheels NOTE See also Portable Transportable Ambulatory MODULE A standardized unit made to readily fit into a parent device It will typically have a plug in design for easy exchange between compatible devices It will usually have one or more functions tha
78. s transluminal coronary angioplasty polytetrafluoroethylene Psoralen UVA Oral administration of psoralen and subsequent exposure to ultraviolet light of A wavelength uv a 58 GMDN User Guide version 2002 Abbreviation QA QST RCF RF RIS RNP RPD rpm RQ RTTPS sa node SAD SGOT SIDS SIMV SM SPECT TBG TCI TDM TEM TENS TLD UHMWPE UPS UV Word or phrase Quality Assurance quantitative sensory testing relative centrifugal force radio frequency radiology information system ribonucleoprotein removable partial denture revolution per minute respiratory quotient Radiation therapy treatment planning system sinoatrial node seasonal affective disorder serum glutamic oxaloacetic transaminase aspartate aminotransferase sudden infant death syndrome 1 synchronised intermittent mandatory ventilation 2 spontaneous intermittent mandatory ventilation smooth muscle single photon emission computed tomography thyroid binding globulin target controlled infusion therapeutic drug monitoring 1 transanal endoscopic microsurgery 2 transmission electron microscopy transcutaneous electrical nerve stimulation thermoluminescent dosimetry ultra high molecular weight polyethylene uninterruptable power supply ultraviolet 59 GMDN User Guide version 2002 Abbreviation VDU VER WRO YAG Word or phrase visual display unit visual evoked response water reversed os
79. sical state in which as the device may be presented 7 specification describes some of the device s distinctive properties and characteristics 4 Improvements or Corrections This is where you can enter your suggestion for improving or correcting any already existing GMDN term It is in the interests of all users worldwide that the GMDN is maintained to the highest possible standards of accuracy and quality The GMDN maintenance agency recognizes as essential the need for input from users and appreciates any suggestions you submit relating to improvements or corrections It is extremely important that you fill in the GMDN code and term name so that a correct reference can be upheld 80 GMDN User Guide version 2002 5 New Synonyms In this section you are invited to provide your suggestions for adding new useful synonym terms to the GMDN These can be synonyms for an already existing GMDN term or a synonym for your newly proposed term Please be sure to tick the appropriate box 6 Local Codes In this section you are asked to provide your local code for the new improved or corrected term or new synonym You may of course not use a local coding system in which case please leave this section blank 7 Device Documentation In this section you are requested to submit factual device documentation verified by the Make Model and Trade name E Make This is the collective company name under
80. t interface with the parent device the patient or other devices MONITOR A device primarily designed for the display of information data signals etc from other devices that have made the registration This can be e g regarding physiologic morphologic or technical data MULTIFUNCTION Having or fulfilling several functions 64 GMDN User Guide version 2002 NEONATE An infant during the first four weeks of postnatal life This period is usually accepted to be the first 28 days of life OPERATOR A person operating a device or a person acting in a specified way The operator is the person who has been provided with qualified instructions as how to use a specific medical device NOTE This person can be a professional worker e g doctors nurses engineers or the patient him herself PAEDIATRIC Relating to the care and medical treatment of children belonging to or concerned with paediatrics PARENT DEVICE A medical device acting as the parent being the device and where other devices connected to it are its children PATIENT Person receiving or registered to receive medical treatment PATIENT MONITOR A device which performs the measurement registration signal and data processing and display of patient related data It typically includes measuring instruments electronic data processors recording and display features Monitors are typically used to dis
81. t until the term or similar groups of terms are found EXAMPLE Terms 1 nitroso 2 naphthol fluorometric free tyrosine 17 hydroxyketosterone kit al acid glycoprotein Abacus B lymphocyte marker kit Baby care kit b Navigational search The GMDN is supported by many synonym terms that may direct the user directly to the term being sought or to a group of similar terms subordinated under a template term EXAMPLE Using Clinical centrifuge as a search word Centrifuge lt specify gt Centrifuge blood bank Centrifuge cell washing Centrifuge cytology Clinical centrifuge see Centrifuge lt specify gt Cytocentrifuge see Centrifuge cytology Lab equipment centrifuge cyto see Centrifuge cytology The broad synonym term Clinical centrifuge directs the user to the template term Centrifuge specify where several choices are listed and a human evaluation is required as to which of the three subordinated preferred terms Centrifuge blood bank Centrifuge cell washing Centrifuge cytology is most appropriate for classification 35 GMDN User Guide version 2002 c Category selection search By knowing what the intended purpose of the product is one should have knowledge of what category the product belongs to A product made e g for dental use will be found in Category 3 By selecting terms in Category 3 only the listing of terms will be considerably narrowed EXAMP
82. tial treatment unit Code 41540 One can see that this relates to a device other than an electrosurgical unit So this is not the term to use Should one choose to do a word search on Diathermy the following list will show up EXAMPLE Diathermy unit analyzer shortwave Diathermy unit lt specify gt Diathermy unit microwave Diathermy unit shortwave Diathermy unit surgical Gel electrode Phantom therapeutic hyperthermia test object 39 GMDN User Guide version 2002 The synonym term see 4 3 3 Synonym terms Diathermy unit surgical eads directly to the preferred term Electrosurgical unit general purpose We are lead back to the listing of preferred terms under the template term Electrosurgical unit lt specify gt This list includes the different generic device groups preferred terms EXAMPLE Electrosurgical unit lt specify gt Electrosurgical unit argon enhanced Electrosurgical unit cautery line powered Electrosurgical unit endotherapy Electrosurgical unit gas delivery argon Electrosurgical unit general purpose Electrosurgical unit mechanical vibration Electrosurgical unit ophthalmic For classification of the product you are required to select the most specific preferred term appropriate for your device Is the device an Electrosurgical unit Is it used for general purpose surgery or does it have a more dedicated intended purpose e g for endotherapy use on
83. tion the manufacturer appoints the claim of intended purpose and mode of action However it will probably be the case that the manufacturer will require assistance to find the correct applicable term 5 2 2 How to classify The classification of a medical device or related health care products is a process of human judgement This process will be best achieved by using the electronic version of the GMDN in an appropriate data programme e g having a good word search facility The intended use of the device shall be used to select the term that provides the most specific classification IMPORTANT Only preferred terms can be used for GMDN classification Only one preferred term is to be used for each product device type to be classified It is then necessary to locate the appropriate preferred term and assure that this term and the definition is compatible to the product in question Because the category code is also a classification requirement it will be necessary to check that at least one of the linked categories made available are applicable A product can be classified to one or more categories See section 5 2 4 Category selection method The GMDN is set up so that there are a number of ways in which listing of terms can be viewed in order to locate and select a compatible term 34 GMDN User Guide version 2002 a Alphabetical search The terms are listed alphabetically and users can scroll up and down the lis

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