IN THE NAME OF GOD (G.M.D.N (. Global Medical Device Nomenclature

The Global Medical Device Nomenclature (GMDN) is a comprehensive system of internationally recognized coded descriptors in the format of preferred terms with definitions used to generically identify medical devices and related health care products.

Ownership The copyright for the GMDN is owned exclusively by CEN: European Committee for Standardization. This also includes the Intellectual Property (IP) of the nomenclature concept and the content.

1991 – First international workshop on harmonization of Medical Devices Nomenclature between EU, EFTA, Canada, and USA.  1997/2001 – The GMDN Project was undertaken based on the structural standard (EN ISO 15225:2000, Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange). It defined the general structure of the nomenclature and provided the required understanding of field lengths, data relationships, etc. 2001 – The release of the GMDN Nomenclature as the CEN Technical Report CR 14230, which is identical to ISO Technical Specification ISO TS 20225.

To facilitate in the rapid production of the GMDN 6 chosen existing nomenclatures were adopted. These covered a wide range of terms defining medical devices and healthcare products and constituted approximately 13,500 terms.

6 chosen nomenclatures • CNMD Classification Names for Medical Devices and in Vitro Diagnostic Products. Developed by Food and Drug Administration (FDA) Is the USA official nomenclature. • EDMA European Diagnostic Manufacturers Association in vitro diagnostic product classification. Used in Europe. • ISO 9999 Technical Aids for Disabled Persons Classification. International use. • JFMDA Japanese Medical Device Nomenclature. Used in Japan and south East Asia. • NKKN Norsk Klassifisering Koding & Nomenklatur, Norwegian Nomenclature. Used in Norway and some use in Europe. • UMDNS Universal Medical Device Nomenclature System. Developed by ECRI. Is in use in the USA, some countries in Europe and some countries worldwide.

Alternative nomenclatures- Are there any that can be used? No! Not for the purpose of registering Medical Devices at a National and/or International Regulatory level. The main reasons for this are: 1. In order to achieve the necessary capability for data exchange required by the regulatory bodies the nomenclature must be conform to the established standard EN ISO 15225, otherwise data from one system cannot be exported and imported to another. 2. No other nomenclature is comprehensive enough in its coverage of the entire Medical Device market to encompass all the devices covered by the European Directives.

Runs and Updates the GMDN All nomenclature systems must be kept updated in order to reflect the current technologies being applied. This will be done by the GMDN Maintenance Agency (GMDN MA), which has been set up according to predetermined CEN rules and is the legal entity under CEN charged with this task.

The master copy of the GMDN will always be available in an English version, (UK English). It is anticipated that a number of countries will require a translation of this for National use. The GMDN MA will appoint licenses to entities that apply for this task, and they will then be recognized as the official translator for the language of that country.

The GMDN is currently in use in 23 countries and the data dictionary has been translated in twelve languages with further translations in progress. Australia ,Austria ,Belgium, Brazil ,Czech Republic Denmark, Estonia, Finland, Germany ,Ireland, Japan, Mexico ,New Zealand ,Norway ,Portugal, Singapore, Spain ,Switzerland,Sweden,Thailand, Turkey, UK ,USA .

A new revision of the GMDN It is anticipated that a new revision of the GMDN will be released once a year. The revisions will be numbered with a version number that corresponds to the year of production, e.g. Version 2002.1 It is possible that, because of the inclusion of a large amount of data in a particular year, that an intermediate version will be released. This would be seen by the increment of the decimal numeral on the version number, e.g. Version 2002.2

THE USERS and applications The primary users and applications for the GMDN are expected to include the following: Medical device manufacturers ! Product registration with public authorities. ! Tracking complaints and liaison with regulatory bodies. ! Responding to tenders from healthcare agencies. Regulatory and conformity assessment bodies ! Product registration required by regulations. ! Post-market surveillance data collection and analysis. ! Information relating to death/serious injury incidents exchanged between countries and trade blocs. ! Conformity assessment certification awarded to manufacturers. ! Safety and performance warnings and advice issued to medical device users and patients.

continued Healthcare agencies ! Specification of devices for purchasing. ! Medical device stock control systems. ! Asset registers (a regulatory requirement in some countries). ! Service and maintenance registers. Suppliers of data management systems ! Standard up to date listing of all medical devices for integration into commercial systems supplied to manufacturers and healthcare agencies.

Structure The GMDN is a system, as defined in the ISO 15225 standard, having a general structure of three levels. Each level differs in the breadth of the sets of devices represented by the terms defined within that level. The levels have a relational structure in the following order: Device Category Generic Device Group Device Type

Figure 1 shows the basic three level data structure, which is the backbone of the GMDN 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 one or many Device Types.

Device Category The Standard allocates codes for a possible 20 categories. 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 Code Term 11 Technical aids for disabled persons 12 Diagnostic and therapeutic radiation devices 13 Complimentary therapy devices 14 Biologically-derived devices 15 Vacant 16 Vacant 17 Vacant 18 Vacant 19 Vacant 20 Vacant

Generic Device Group The generic device group is the generic naming level of the GMDN nomenclature and comprises three kinds of terms. These are: preferred terms template terms synonym terms

Preferred terms with their associated 5 digit codes are the only terms available for the purpose of product identification of medical devices. It is a term representing a group of devices having the same or similar intended uses or commonality of technology allowing them to be grouped in a generic manner not reflecting specific characteristics such as brand or trade names. Each preferred term is supplied with a definition that defines the most prominent characteristics of the types of medical devices it encompasses.

  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 decubitus 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  

Template terms are terms that are used to collectively group all the preferred terms that have an identical character string to that of the template term up to the lastqualifier “<specify>”. They function as a kind of heading and are added to the nomenclature when the same character string occurs in more than two preferred terms for the sole purpose of presenting these in a subordinated hierarchy. Each template term is also supplied with a definition that defines the broader characteristics of the preferred terms that are subordinated under it.

Synonym terms are purely navigational terms providing many differing points of entry into the nomenclature. Synonym terms do not need, nor do they have a definition. They are usually based upon an alternative term name or concept, or are commonly used and known within the healthcare environment.Or, in many cases within the GMDN the synonym function has been set up to retain original source nomenclature term names, as is the case for many FDA terms, or to retain the original source nomenclature code, as is the case for the ECRI terms.

EXAMPLE Fluidized bed is a synonym term directly linked to the preferred term: Bed, air fluidized Heartstarter is a synonym term that directs the user to the template term Defibrillator, <specify>.

More term interactions using the group of centrifuge terms as the example Centrifuge, <specify> Centrifuge, blood bank Centrifuge, cell washing Centrifuge, cytology Centrifuge, general-purpose laboratory Centrifuge, haematocrit Centrifuge, ultra- Cytocentrifuge -see Centrifuge, cytology Laboratory equipment, centrifuge cyto -see Centrifuge, cytology Tabletop centrifuge -see Centrifuge,

  EXAMPLE of real time data relationships ------- Code Term name Synonym code 10778 Centrifuge, <specify> 15115 Centrifuge, blood bank 35901 Centrifuge, cell washing 35881 Centrifuge, cytology 30869 Clinical centrifuge 10778 32933 Cytocentrifuge 35881 37214 Lab-equipment, centrifuge cyto 35881  

The Device Type The device type level is not part of the GMDN nomenclature. It is, however, an essential part of the GMDN general structure and it is important for the GMDN user to understand 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 unique product identification for the purpose of declaration of conformity, product type registration and traceability. This is the level where the manufacturer assigns the product its actual name. This is the place for the make and model and any other accompanying information, e.g., serial number, trade name, etc.

Coding All terms in the GMDN are assigned a unique code 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. 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, being the unique identifier.

Codes in the range of 1-9999 Codes in the range of 1-9999 are not represented in the GMDN. These, as stated in the standard are exclusively reserved for assignment by the end user and may be used as desired in any user’s local application. NOTE: It is important for users to understand that this range of codes should not be used for any kind of official purpose, e.g. as temporary codes, as national translated synonyms, where the data is exchanged between users outside of the local application. This would probably lead to ambiguity.

Codes in the range of 10000-30000 Codes in the range of 10000-30000 are represented in the GMDN and have been reserved to represent the original code used by the ECRI for their UMDNS terms that has been adopted for use in the GMDN. This will provide the GMDN user with automatic mapping from the ECRI code representing the UMDNS term to the identical GMDN code now used to represent the GMDN term. This has been done to assist in the transition for users who had previously used the ECRI UMDNS.

Codes in the range of > 30000 Codes in the range of >30000 represent all other terms used in the GMDN whether these terms have been imported from existing source nomenclatures or have been created as brand new terms.

Search -1Alphabetical search The terms are listed alphabetically and one can scroll up and down the list until the term or similar groups of terms are found. -2Navigational 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.

Continued -3Category 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, for example, for dental use will be found in Category 3. By selecting terms in Category 3 only, the listing of terms will be considerably narrowed. -4Word search Searching by a chosen word can have two targets. This can be done by either making a direct search at the term name level, hitting a targeted qualifier, or by searching on a descriptor (a semantic link) that has been purposely fitted into the definition.

Product Identification/Registration (1) Select most specific applicable preferred term. (2) Check that the definition is adequate. If not, submit a suggestion for improvement/correction. (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. (4) Register the product with the following details: Category code(s) (2 digits). Generic device group code (5 digits).

No GMDN term available If you cannot find an appropriate compatible generic device group (preferred term) for the identification/registration of your product you will need to notify the GMDN Maintenance Agency. The term Unclassified code 38442 has been made available in the GMDN to use as a temporary measure when no existing GMDN term is found to be appropriate.

www.gmdnagency.com For more information about the Global Medical Device Nomenclature visit: www.gmdn.org or www.gmdnagency.com

THANKS