The 75th World Health Assembly (WHA 75) discussed a report by the Director General concerning the standardization of the medical device nomenclature system, a topic that has been on the agenda of several World Health Assembly and Executive Board sessions. In the lead up to the WHA 75, the World Health Organization (WHO) carried out several mapping and converging exercises of the existing nomenclature system to create a standardized nomenclature system that will meet all countries’ needs.
Medical devices are health products needed for the protection, prevention, diagnosis, and treatment of illnesses, and include X-rays, hip implants, thermometers, and oxygen concentrators. These devices are very important in the healthcare delivery system, because they equip health providers with the necessary tools to perform effectively.
The COVID-19 pandemic exposed the shortfall in the supply of critical and basic medical devices. During the pandemic, medical personnel around the world lacked access to gloves and personal protective equipment, laboratory testing supplies and equipment, ventilators, and oxygen tanks. A lack of medical devices is detrimental to patients, especially in the midst of a pandemic, when the shortage hampered service delivery and care that resulted in avoidable deaths.
Equally so, improper regulations may lead to a disportionately high healthcare delivery cost. Medical devices are often not fully covered by insurance plans, producing costly out of pocket expenses for patients.
Fragmentation leads to access and safety concerns
The nomenclature of medical devices is a coding and naming system used for the classification and identification of such devices. Medical devices are classified according to a risk-based approach and assigned a regulatory class based on the level of control needed to assure safety and the effective use of the device (see table 1 for an overview). However, existing systems of nomenclature are fragmented.
|Class I||Class IIa||Class IIb||Class III|
|Risk level||Non-evasive, low risk||Low-medium risk||Medium – high risk||High risk devices|
|Examples||stethoscopes, bandages, latex gloves, surgical mask||Hearing aid, blood transfusion tube, catheter||Infusion pump, Ventilators, Intensive Care monitoring equipments, surgical lasers||balloon catheters, prosthetic heart valves, pacemaker|
Table 1: Classification of medical devices
Currently, countries around the world use multiple nomenclature systems, making coordination and communication between users of technologies difficult. The current multiplicity of nomenclature systems has a huge regulatory impact. This hinders large-scale production of generic medical devices and obstructs access to essential medical devices. It is more difficult to develop cheaper, generic products if there are no standardized specifications. This way, in combination with Intellectual Property (IP) privileges, the lack of a standardized nomenclature allows for a monopoly, as is the case in some medical devices.
In many cases, the fact that there is no defined global standard also leads to uncertainties about compatibility of products classified according to different nomenclature systems. This means that in some countries, health providers are reluctant to purchase cheaper medical products because of the fear they might not be compatible with other devices already used in the health system, and instead purchase more expensive equipment.
|Nomenclature system||Number of countries|
|Universal Medical Device Nomenclature System (UMDNS)||16|
|European Medical Device Nomenclature (EMDN)||27|
|Global Medical Device Nomenclature (GMDN)||15|
|No Nomenclature System||75|
|Use of one or more nomenclature system||15|
|National developed nomenclature system||32|
Table 2: Overview of the nomenclature systems used by countries
A standardized, independently developed nomenclature system would serve as a common language between countries for the recording and reporting of medical devices across the whole health system. It would support patient safety, assessment of access, defining, naming, classification as well as the streamlining of medical devices. This would also remove the barriers to procurement, supply and trade which hampers affordability, timely access, and safety especially in resource-poor areas.
For this reason, the WHO is working together with nations, UN agencies, biomedical and clinical engineers, biomedical and chemical industry and civil society organizations and the four most widely used medical devices nomenclature systems towards a global standard system which is transparent and accessible to all. The industry and some countries have opposed this because it would affect monopoly and profits.
A global public good
In contrast to rich countries, many low and middle income countries (LMICs) around the world have expressed need and broad support for the standardization of nomenclature. Many African countries and other LMICs requested that the WHO provide support for the implementation of their nomenclature system. The COVID-19 pandemic highlighted the need for an international classification, coding, and nomenclature for medical devices, which will facilitate rapid access to medical devices and timely emergency response.
Although many nations have expressed support for an inclusive and transparent procedure, there is still no clear pathway forward.
The WHO had initially proposed the potential uptake of the EMDN as the standardized nomenclature system, but concerns were raised by countries that the EMDN is not synchronized with the GMDN widely used by countries such as the UK, Japan, the US, and Canada. Canada, the US, Brazil and the Russian federation echoed that the GMDN is the most widely used system, and duplicating the system might have a negative impact.
During the World Health Assembly, the WHO assured countries that they heard the concerns expressed. Nonetheless, it is worth keeping in mind that the comments against the uptake of EMDN should not be read exclusively as a critique of this nomenclature system, but as an opposition to the idea of introducing a unified system. Despite resistance and arguments, there is a need for standardization as it is important to meet public health needs, especially when implemented by a multilateral agency such as the WHO.
Current nomenclature systems have been developed with differing needs in mind. The EMDN, for one thing, was developed for the context of Europe, which is not the same throughout the world.
The fairest outcome of the WHO discussion would be developing an independent nomenclature system through multilateral negotiations, similar to what has been achieved in the field of medicines with the international nonproprietary name (INN) system.
The process towards a standardized nomenclature system should continue, and WHO should provide timely updates about the mapping exercises. The WHO should use its constitutional mandate to maintain control over international standardization, prioritization, and regulation of medical devices, and establish an essential devices list through a process which involves all its members and is based on everyone’s needs. Progress towards a universal medical device nomenclature needs to encourage open innovation for appropriate technologies. Anything that comes out of the process should also support the development of local production and technology and facilitate access to IP-protected technologies.
There is a need for proper regulation in the field of medical devices: we need a unified standard global regulation that is carried out by impartial and member state processes like those at the WHO. After the WHA 75, there is still no clear path ahead: hopefully, standard setting and scientific work will be prioritized and completed in the WHO process, independently of industry interference or interest.
The WHO-Watch team members are Abhishek Royal, Alan Rossi Silva, Aletha Wallace, Anton Sundberg, Ben Verboom, Dian Maria Blandina, Jasper Thys, Maria Alejandra Rojas, Marta Caminiti, Sarai Keestra, Sopo Japaridze, Lauren Paremoer, Jyotsna Singh, and Gargeya Telakapalli.
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