WHO Comparative Analysis of Nomenclature Systems: CND, GMDN, UMDNS, UNSPSC and SNOMED CT

WHO Comparative analysis of nomenclature systems: CND, GMDN, UMDNS, UNSPSC and SNOMED CT.

(originally December 2019, updated October 2020, for consultation for EB148/13, on standardization of medical devices nomenclature 1)

In document EB145/3, reference was made to a concept note produced in July 2018 in which the Secretariat had proposed the principles that would underpin an international classification, coding and nomenclature of medical devices, and invited input and collaboration2. Since then, WHO has been searching for a solution that complies with those principles, which are summarized below: (a) Governance (i) Organizational and review structures should be in place to ensure that all stakeholders from different regions are able to provide feedback according to global needs. (b) Classification, coding and nomenclature characteristics, the following are required: (i) a transparent methodology and processes; (ii) a transparent mechanism for regular updates (e.g. once per year); (iii) hierarchies grouped into categories and subcategories to meet stakeholder needs; (iv) medical devices used outside highly regulated countries; (v) mutually exclusive terms; (vi) availability of terms in other languages (c) Access to information Information should: (i) be capable of being referenced and used by regulators, procurers, managers and all users of medical devices (hospitals/health care workers and patients); (ii) be freely available and considered a global public good; (iii) support unique device identifier system ; (iv) be accessible through simple and intuitive search; (v) be available for use in all health-related data base systems.

1 https://apps.who.int/gb/ebwha/pdf_files/EB148/B148_13-en.pdf

2 Request for input and collaboration towards international classification, coding and nomenclature of medical devices. Concept note (https://www.who.int/medical_devices/priority/ConceptNoteNomenclaturemedicaldevicesv13forconsultation.pdf?ua=1, accessed 13 October 2020).

Organization Governance Classification, coding and nomenclature Access to information Remarks characteristics and convergence

ECRI Institute1 ECRI is a not-for-profit organization. (i) There is transparency in terms of public (i) Starting from 15th of Hierarchy, structure and Although the ECRI Institute has disclosure of approved codes; however, access to October 2019, ECRI relationships between terms are dedicated full- and part-time staff the mechanisms for establishment of these codes is announced that UMDNS not freely available. for maintenance and development only open to the ECRI and not to other stakeholders. free access will be subject Users need to purchase a of the UMDNS, it does not have a (ii) The periodicity of updates is dynamic and does to subscription and not free subscription in order to be able to transparent review and feedback not take place in a pre-set manner; however, any more. Many users may fully obtain, update and implement mechanism for defining updates are known to only the users of the UMDNS. also need to purchase other the UMDNS. nomenclature/codes. Some (iii) There is a polyhierarchical taxonomy, composed ECRI products to have full The nomenclature is a feedback is taken from users who of a main hierarchy and sets of attributes, which is utility of codes and access polyhierarchical taxonomy, flexible have paid for licenses to use other suitable for generating alternative views and to complete information. and suitable for various ECRI products. Regulators are not hierarchies. The hierarchy is rigid, with tags, flags, categorization and classification (ii) Code research, engaged in nomenclature review in attributes and cross-connections between terms. approaches. definitions and code list are any structured manner. (iv) There is non-discriminatory inclusion of medical available. devices across all categories available to licensed users. (iii) UMDNS is not currently required by any jurisdiction (v) The UMDNS is available in two United Nations to be assigned to the device languages (English and Spanish) and German, with identifier of UDI (UDI-DI) the cost of further such translation falling on the user community.

1 ECRI Institute comments on the WHO concept note and proposal for collaboration on international nomenclature, coding and classification of medical devices are available at https://www.who.int/medical_devices/priority/ECRI.pdf?ua=1 (accessed 13 October 2020).

Organization Governance Classification, coding and nomenclature Access of information Remarks characteristics and convergence

GMDN Agency1 The GMDN Agency is a not-for-profit (i) mechanisms for defining nomenclature and codes (i) Free for various GMDN nomenclature is not free organization with its own staff. It are privy only to GMDN and are not available to stakeholders, including for all stakeholders. does not have a transparent review other stakeholders. regulators, for defined Non-paying users can only search and feedback mechanism for (ii) The periodicity of updates is dynamic and does packages. and access individual codes on the defining nomenclature/codes. Some not take place in a pre-set manner GMDN website. The structure, (ii) Each package has feedback is taken from users with hierarchy and relationships are not (iii) The taxonomy is polyhierarchical, composed of distinct characteristics in licenses. It is free for regulatory freely available for consultation a main hierarchy and sets of attributes. terms of access to agencies and other users for a and download, so the public information. defined package. Regulators are not (iv) medical devices hierarchy across all categories is cannot take advantage of the engaged in nomenclature review in available to licensed users. (iii) Not free for GMDN hierarchy for analysis any structured manner. manufacturers and purposes. (v) Some terms are available in 23 languages, consultants. including four official United Nations languages. Implementation of GMDN (iv) Researchers and nomenclature requires academics cannot use subscription. multiple-user licenses

(v) GMDN is currently required by certain jurisdictions to be assigned to the device identifier of UDI (UDI-DI) and is made publicly available through the US Global UDI Database (GUDID).

1 GMDN Agency comments on the WHO concept note and collaboration proposal for international nomenclature, coding and classification of medical devices are available at https://www.who.int/medical_devices/priority/GMDN_Agency.pdf?ua=1 (accessed 13 October 2020).

Organization Governance Classification, coding and nomenclature Access of information Remarks characteristics and convergence

GS11 International, not-for-profit (i) Nomenclature is developed for the trading sector (i) Free to a limited extent. GPC nomenclature is managed by organization that develops and and includes all possible goods and services – not GS1 with no fully open and (ii) Does not include many maintains standards for business specific to medical devices. transparent review process and categories of medical communication. GS1 is a business criteria. GPC is a general (ii) Rigid codes are additive and include the full devices and the list it covers process developer which uses an nomenclature for trading, not hierarchy path. is restrictive depending identification method common to all specifically developed for the upon the trade needs. goods/products (iii) The creation of codes is only in the purview of health sector. GS1 and the process is not known or shared with (iii) Unique product The structure and hierarchy are stakeholders. identification is possible but rigid, and this structure does not not specific to medical meet the need for flexibility devices. required by the health sector.

(iv) Access is subscription based

(v) GPC is not currently

required by any jurisdiction to be assigned to the device identifier of UDI (UDI-DI)

1 GS1 comments on the WHO concept note and collaboration proposal for international nomenclature, coding and classification of medical devices are available at https://www.who.int/medical_devices/priority/GS1.pdf?ua=1 (accessed 13 October 2020).

Organization Governance Classification, coding and nomenclature Access of information Remarks characteristics and convergence

SNOMED A not-for-profit entity founded by (i) Development and update criteria are not fully (i) Free access only allows for SNOMED CT was International1 the governments of Australia, published. downloading of the current code developed for health Canada, Denmark, Lithuania, set, not the framework. records and is not the (ii) Ontology and terms are unique, and hierarchy is Sweden, the Netherlands, New optimal solution for generated by a set of relationships. (ii) Free for institutions from Zealand, the United Kingdom and regulatory, management territories that have become paid the United States. Members of (iii) Intended for use in electronic health and procurement purposes members of the consortium. SNOMED International can be an records/clinical records and focuses primarily on related to medical devices. agency of a national government, or health care interventions with the purpose of (iii) The list of codes is available, but another body (such as a corporation capturing information in clinical records. As part of the methodology for code or regional government agency) this process, terminologies for health products are generation/modification is not endorsed by an appropriate national also captured. available. government authority within the territory it represents. Members play (iv) Available in five languages (iv) Requires members to develop a critical governance role through extension pathways for the approval of the organization's nomenclatures, as per their needs. budget and strategy. (v) Participation is limited by subscription/membership.

(vi) SNOMED is mapped to a subset of GMDN terms and through that connection is currently mapped in certain jurisdictions to the device identifier of UDI (UDI-DI)

1 SNOMED International comments on the WHO concept note and collaboration proposal for international nomenclature, coding and classification of medical devices are available at https://www.who.int/medical_devices/priority/SNOMED.pdf?ua=1 (accessed 13 October 2020).

Organization Governance Classification, coding and nomenclature Access of information Remarks characteristics and convergence

CND1 Developed by the Italian Ministry of (i) Nomenclature developed and managed (i) Freely available on the website in (i) The European Health, and adopted by the specifically for medical devices by Italian Ministry of Italian and in English. Commission has informed

European Commission to help fulfil Health. WHO that it will be (ii) Although it is not based on an (Responsible the regulatory requirement in the adopting the CND. (ii) methodology of coding, classification and interactive platform, it is organization: new European Union regulations updating is done through a structured process which downloadable. Italian involves stakeholders. (iii) other countries which adopted Ministry of (iii) transparent methodology, processes for the CND (Greece and Portugal) carried Health) classification, coding and establishment of out the translations (iv) Non- nomenclature terms. subscription/ license based.

(iv) Codes are additive and include the full hierarchy (v) CND will be used as the basis for path. developing the EMDN. EMDN is required by the European Commission to be assigned to the device identifier of UDI (UDI-DI) as will be available as part of the publicly available European Union UDI Database (Eudamed)

1 More information on the CND from the Italian Ministry of Health (in Italian) is available at http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=328&area=dispositivi-medici&menu=classificazione (accessed 13 October 2020).