About MEDEVIS

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

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:

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.”

More information on the process of selection of priority medical devices and related publications are described in the WHO website: Prioritizing medical devices.

Acknowledgments

The project was developed under the overall coordination of Adriana Velazquez Berumen, Team Lead, Medical Devices and In Vitro Diagnostics, Health Product Policy and Standards Department, Access to Medicines and Health Products Division, WHO Headquarters, Geneva, Switzerland.

WHO is very thankful to the experts members of the Strategic and Technical Advisory Group of Medical Devices (STAG MEDEV) for their continuous input to improve this clearinghouse.

Technical support was provided by the following WHO staff and consultants (listed in alphabetical order) with relevant expertise in the field of medical devices:

  • Nicolò Binello (technical officer, Italy – 2022-2023): definitions and classifications of healthcare units, service delivery platforms, naming of medical devices, revision of clinical domains, linkage to the Universal Health Coverage Compendium database.
  • Mário Forjaz Secca (consultant, Mozambique – 2020-2022): structure of the database, medical devices for cancer management, naming of medical devices.
  • Olga Pineda Velasquez (consultant, El Salvador – 2022-2023): structure of the database, medical devices for the management of cardiovascular diseases and diabetes.
  • Francesco Ribolzi, (consultant, Italy – 2020-present): medical devices for COVID-19 response, technical specifications, naming of medical devices.

Furthermore, the following external contributors produced and developed the images of medical devices that are currently included as part of the MeDevIS online platform: Stefano Bergamasco (project coordinator) on behalf of MedTech Projects SRL; Paolo Lago and Beatrice Boarin on behalf of the Fondazione IRCCS Policlinico San Matteo di Pavia, Italy; Martina De Luca and Giuseppe Fasano on behalf of the IRCCS Centro di Riferimento Oncologico di Aviano, Italy.

The web platform was designed and developed by Evidence Prime, under the coordination of Artur Nowak, with the assistance of Helen Dietl and Kuba Kulesza.