Standardization of medical devices nomenclature:

By Srinivasa Reddy

Director QARA & Govt.Affairs

SSI Innovations Pvt. Ltd

The nomenclature of medical devices is a coding and naming system used to generically classify and identify all medical devices and related health products. According to different classification and nomenclature systems, there are more than 5000 types of medical devices. They range from very simple to complex, inexpensive too costly.  The number and types of devices are increasing exponentially very year due to new innovations in the market.

Medical devices include all the health technologies (except for vaccines and medicines) required for prevention, diagnosis, treatment, monitoring, rehabilitation and palliation.

Why is there a need for a standardized nomenclature system for medical devices?

The multiple nomenclature systems in existence makes it difficult to communicate important information between individuals and organizations, which can result in health, economic and social impact. It complicates procurement, supply and trade, and tracking of medical devices. A standardized classification and nomenclature of medical devices will serve as a common language for recording and reporting medical devices across the whole health system, at all levels of health care, and for a whole range of uses. Therefore, WHO is working towards a globally accessible, transparent and harmonized  nomenclature system.

Standardization of nomenclature is essential for:
grouping and evaluating innovative technologies
classifying for regulatory approval (registration)
streamlining procurement
supporting device descriptions for universal health coverage benefits packages
ordering and grouping of devices in electronic health records and other health information systems

Global Status quo
WHO baseline country survey in 2017 and 2021 reported information about whether countries had nomenclature systems in place and if so, which type of system was used, in 2017 total 174 countries and in 2021 total 178 countries responded.

Nomenclature use comparison in 2013-2017 versus 2021 data
Decrease of the countries that do not have an official one (from 49% to 46%).
Increase in the % of countries (10% to 11%) that based their nomenclature in one of the two systems either UMDNS or GMDN
Increase in the % of countries (3% to 8%) that use more than one system (either nationally developed; UMDNS, GMDN, or other)
Appearance of the CND/EMDN nomenclature that EU (27 countries) have agreed to use it.

More than 50% of the low-to-middle-income countries do not have an official nomenclature system (71 from 126 low-and middle-income countries). In contrast, 74% of high -income countries have an official nomenclature system (36 from 49 high-income countries)

The use of Nomenclature in most regions, is used for procurement and regulatory processes. However, in the African region (AFR), where regulatory processes of medical devices are very limited, the nomenclature systems mainly used for procurement when available. The countries of the South East Asia Region (SEAR) did not specify any specific uses for the nomenclature system.

Nomenclature is used in all stages of medical devices life cycle to ensure improved access of safe and quality;
Research &Development
* Industry production to comply with regulatory bodies and procurement systems
Regulations
* Regulatory clearance: premarket registration
Assessment (HTA)
* Selection of medical devices list for procurement or reimbursement (Essential or priority national lists).
Management;
* Procurement and supply (trade, customs)
* Inventory systems in Health facilities
* Patient safety
* Post market surveillance
* Decommissioning

The key outcomes of 2019 and 2021 WHO Executive Board sessions with member states, related to a standardization of nomenclature system are:
Member states suggested not to support the development of other new nomenclature system which will cause complexities and confusion. Proposed that WHO uses existing systems.
WHO will not be creating a new nomenclature to be added to the existing ones, but will select from the available ones which one can be hosted, made available to all Member States.
WHO to consider the existing nomenclature systems analyse options to ensure the selected nomenclature becomes a Global Good with governance system based in WHO, transparent process and availability of data to all stakeholders in all MS, sustainable.

WHO standardized nomenclature system for medical devices

The international Nomenclature (INMD) system, classification and coding should be used for manufacturers, regulators, policy makers, procurement systems, supply systems, in health care facilities and by final users.

A standardized international classification coding and nomenclature of medical devices could link to WHO’s other international classification systems, in order to support organized and standardized information for policy-makers and managers.

WHO published a  Request for input and collaboration towards international classification, coding and nomenclature of medical devices, that included the principles of governance, classification and access of information.

The Characteristics of an international nomenclature, classification and coding for medical devices include:

Governance
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.

Classification, coding and nomenclature characteristics, required:
* a transparent methodology and processes;
* a transparent mechanism for regular updates;
* hierarchies grouped into categories and subcategories to
meet stakeholder needs;
* Include medical devices used outside highly regulated
countries;
* mutually exclusive terms; (vi) availability of terms in other
languages

Access to Information should:
* be capable of being referenced and used by regulators,
procurers, managers and all users of medical devices
(hospitals/health care workers and patients);
* be freely available and considered a global public good;
* support unique device identifier system;
* be accessible through simple and intuitive search;
* be available for use in all health-related data base systems.

Countries and other stakeholders need a globally accessible, transparent and harmonized nomenclature system for medical devices. The lack of such a system is impeding progress towards access to medical devices, which has negative impact on efforts to facilitate emergency interventions and, more broadly, achieve universal health coverage.

“WHO will not be creating a new nomenclature, but will work with existing nomenclatures and with countries to select from the available ones which ones are best to work towards convergence”. Further consultation maybe considered by WHO.

In India Medical Devices regulated by Central Drugs Standard Control Organization (CDSCO), and has discussed on the implementation of Nomenclature in the road map, if so, India will be the first member state of WHO in SEARN countries to adopt the nomenclature in regulatory approvals.