Nomenclature of medical devices

What are medical devices?

Medical devices include all the health technologies (except for vaccines and medicines) required for prevention, diagnosis, treatment, monitoring, rehabilitation and palliation. They are indispensable for universal health coverage, monitoring wellbeing and addressing outbreaks or emergencies. Some types of medical devices include:

• single use devices (i.e. syringes, catheters)
• implantable (i.e. hip prothesis, pacemakers)
• imaging (i.e. ultrasound and CT scanners)
• medical equipment (i.e. anesthesia machines, patient monitors, hemodialysis machines)
• software (i.e. computer aided diagnostics)
• in vitro diagnostics (i.e. glucometer, HIV tests) 
• personal protective equipment (i.e. mask, gowns, gloves)
• surgical and laboratory instruments
  

What is nomenclature for medical devices?

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 between 5,000 to 24,000 different types of medical devices. They range from the very simple to complex, inexpensive to costly.  The number and types of devices are increasing exponentially

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

The multiple nomenclatures 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. Some important information negatively impacted by an absence of a standardized nomenclature include:

• patient safety
• intended use of medical devices
• regulatory status
• technical information
• adverse events
• availability
• others

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 also 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

Member States requests

In resolution WHA60.29 (2007), WHO was requested  to work with interested Member States and WHO collaborating centres on the development of guidelines and tools relating to health technologies (in particular medical devices). Such guidelines and tools were to include norms, standards and a standardized glossary of definitions. All stakeholders were to use a transparent and evidence-based process.

A standardized international classification coding and nomenclature of medical devices could link to WHO’s other international classification systems, such as the International Statistical Classification of Diseases and Related Health Problems, the International Classification of Functioning, Disability and Health and for health products, the International Non-proprietary Name for medicines, in order to support organized and standardized information for policy-makers and managers. In March 2011 WHO convened representatives from the nomenclature agencies to search for convergence in Nomenclature of Medical Devices which has not been achieved to date.

WHO consultations on nomenclature for medical devices

Since 2010, WHO has conducted several consultations on issues related to medical devices, including discussions during WHO’s  past Global Fora on medical devices (in 2010, 2013, 2017 and  2018), and country surveys to determine country needs. WHO has also developed guidance documents on: how to formulate policies on medical devices; how to select, assess, manage and procure relevant devices; and effective donation of medical devices.  In all the above-mentioned Fora, documents or consultations, the topic of lack of standardized nomenclature was noted.

WHO request for collaboration on nomenclature for medical devices

In 2018,  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. WHO received 43 comments from Member States and other organizations. Since then, WHO has been searching for a solution that complies with those principles, which are summarized below.

Governance

1. 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

The following are required:

1.  a transparent methodology and processes;
2.  a transparent mechanism for regular updates (e.g. once per year);
3.  hierarchies grouped into categories and subcategories to meet stakeholder needs;
4.  medical devices used outside highly regulated countries;
5.  mutually exclusive terms;
6.  availability of terms in other languages

Access to information

Information should:

1.  be capable of being referenced and used by regulators, procurers, managers and all users of medical devices (hospitals/health care workers and patients);
2.  be freely available and considered a global public good;
3.  support unique device identifier system;
4.  be accessible through simple and intuitive search;
5.  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 that adhere to WHO principles. The lack of such a system is impeding progress toward access to medical devices, which has a negative impact on efforts to facilitate emergency interventions and, more broadly, achieve universal health coverage.

2019-2021 WHO Executive Board sessions related to a standardized nomenclature for medical devices