MeDevIS By WHO

Blog Credit: Trupti Thakur

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MeDevIS By WHO

World Health Organization (WHO) has introduced an online platform called MeDevIS (Medical Devices Information System), the first global open access clearing house for information on medical devices. It is designed to support governments, regulators and users in their decision-making on selection, procurement and use of medical devices for diagnostics, testing and treatment of diseases and health conditions.

The MeDevIS platform includes 2301 types of medical devices used for a broad-ranging health issues, including reproductive, maternal, newborn and child health, noncommunicable diseases such as cancer, cardiovascular diseases, diabetes as well as infectious diseases such as COVID-19.

“The number of medical technologies used in health care is growing, as is their complexity, which can make it challenging for health care practitioners and patients to navigate,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “We aim to provide a one stop shop of international information, which can be invaluable for those making decisions on life-saving medical technologies, especially in resource-limited settings, and to improve access”.

There are over 10 000 different medical devices that are being used for protection, prevention, diagnostics, treatment or rehabilitation of health issues globally. These include multiple simple and complex medical technologies ranging from pulse oximeters, digital thermometers, single-use syringes and medical masks to various diagnostic laboratory tests and other medical equipment including electrocardiograms, endoscopes, all imaging radiology technologies, and technologies used for treatments such as hemodialysis units and defibrillators, implantable prothesis, cardiac stents and complex radiotherapy equipment.

However, currently there are multiple, separate sources of information produced by major international organizations, regulatory bodies, and donor agencies, making it difficult for users to discern and utilize the most reliable data. In MeDevIS, users can check devices they require, including type, level of health care systems to support the device (such as community or specialized hospitals), scope of the device, and infrastructure required, among other categories.

MeDevIS replaces paper-based literature search across multiple publications with non-standard device names which can add to the complexity. Along with providing a single platform, MedevIS also aims to help make the naming of the medical devices simpler.

MeDevIS references two international naming systems for medical devices – the European Medical Device Nomenclature (EMDN), mostly used in European countries for registration in the European database, and the Global Medical Device Nomenclature (GMDN) used in regulatory agencies in Australia, Canada, the United Kingdom and the USA and other Member States. The naming systems include coding and definitions and can be used in every country to facilitate registration for regulatory approval, procurement and supply, inventories in health facilities, tracking and pricing.

“The MeDevIS platform can be useful for national policy-makers to develop or update their own national lists for procurement of health technologies and devices and can contribute to the progress towards universal health coverage,” said Dr Deus Mubangizi, WHO Director for Health Products Policy and Standards in the Access to Medicines and Health Products Division. “It can also help agencies in health insurance and reimbursement policies for patients.”

This is the first time WHO has developed such a global repository on medical devices, based on its experience with the WHO Priority Medical Devices List (MDL), which itself was based on the experience of creating the WHO Essential Medicines List (EML). Approaching its 50^th anniversary in 2025, EML is regarded as a pillar of public health in countries across the world, supporting health progress and touching billions of lives.

WHO will be continually improving the MeDevIS platform, engaging multiple stakeholders and partners and expanding it with additional technologies and devices used in various health areas, including in pandemic and emergency settings.

About MeDevIS:

MeDevIS (Priority Medical Devices Information System) is an open access WHO electronic database of Medical Devices.

In the 2007 World Health Assembly, resolution WHA60.29 called for the World Health Organization (WHO) to “establish and update an evidence web-based health technologies database to serve as a clearinghouse which will provide guidance on appropriate medical devices according to the levels of care, setting and intended health intervention, which can be tailored to the specific needs of country or region.”

The WHO therefore convened the Priority Medical Devices (PMD) project to emphasize the need for a global agenda to improve access to medical devices worldwide, based on four critical components – availability, accessibility, appropriateness, and affordability. The project developed a health-based, stepwise approach to medical devices, which was published in Medical Devices: managing the mismatch in 2010. The first step was to identify and prioritize diseases with high global burden and/or risk factor estimates. Evidence-based clinical guidelines were subsequently used to define the priority interventions for disease prevention, screening, diagnosis, treatment, monitoring, rehabilitation, and palliation. Finally, lists of selected medical devices were developed through a multidisciplinary approach to address the management of the identified high-burden diseases across different levels of care in different healthcare settings.

As a result of this project, Member States, governmental institutions, public health bodies and funding agencies have access to the WHO priority medical devices lists and may use them as a reference to develop or update their national lists for procurement, reimbursement, and facility planning needs to address their benefit packages for universal health care coverage, respond to outbreaks and emergencies, and ensure the wellbeing of their populations.

To this purpose, three publications were initially conceptualized and developed to define the medical devices required for essential interventions for reproductive, maternal, newborn and child health, management of cancer, and management of cardiovascular diseases and diabetes. Following the onset of the SARS-CoV-2 pandemic in 2020, a technical publication on the priority devices for COVID-19 response was also rapidly finalized. As a result, the MeDevIS database was created to consolidate the following WHO publications:

• Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health (2015)
• WHO list of priority medical devices for cancer management (2017)
• WHO List of medical devices list for the COVID-19 response and associated technical specifications (2020)
• WHO List of Priority Medical Devices for management of cardiovascular diseases diabetes (2021)

More recently, additional priority medical devices for the management of other diseases have been identified and selected based on relevant WHO materials and publications and incorporated as part of the database. The WHO Package of eye care interventions (2022) was used as a reference to identify, select and include in MeDevIS the medical devices required for a set of evidenced-based priority eye care interventions. Moreover, MeDevIS currently contains the medical devices that are part of the Trauma and Emergency Surgery Kit (2019), a standardized, pre-packed kit, designed to meet the resource needs for 50 patients requiring surgical care in emergency settings.

As an online electronic database, MeDevIS serves as the companion to the WHO publications by facilitating searches for and access to priority medical devices, providing thorough and in-depth technical information, and guaranteeing continuous updating and inclusion of newly selected priority medical devices based on recent evidence-based WHO guidelines and recommendations.

Furthermore, the 2022 World Health Assembly re-affirmed the WHO’s role in the development of a standardized glossary of definitions relating to medical devices and urged WHO to use MeDevIS as the clearinghouse to terms, codes and definitions of medical devices. Specifically, the WHA75(25) resolution requested WHO “to integrate available information related to medical devices, including terms, codes and definitions, in the web-based database and clearinghouse established in line with resolution WHA60.29 (2007) and now available as the Medical Devices Information System (MeDevIS)); and to link this to other WHO platforms, such as the International Classification of Diseases  (ICD-11), to serve as a reference to stakeholders and Member States.”

 

 

 

Blog By: Trupti Thakur