• Friday, July 19, 2024
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WHO unveils open access to medical device data

The 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 2,301 types of medical devices used for broad-ranging health issues, including reproductive, maternal, newborn and child health, noncommunicable diseases such as cancer, cardiovascular diseases, and diabetes as well as infectious diseases such as COVID-19.

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“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,” 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 the protection, prevention, diagnostics, treatment or rehabilitation of health issues globally.

Medical technologies of all complexities are included, from basic tools like pulse oximeters and digital thermometers to single-use syringes and medical masks. The spectrum expands to encompass a wide range of diagnostic laboratory tests and more advanced equipment like electrocardiograms, endoscopes, and all imaging radiology technologies.

Finally, it includes treatment-oriented technologies such as hemodialysis units, defibrillators, implantable prostheses, 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 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 50th 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.