WHO prequalification of immunization devices helps to ensure that national immunization programmes have access to reliable, high-quality products for the storage, transport and administration of prequalified vaccines. These products help maintain vaccines at the required temperatures, thereby safeguarding their potency in often challenging operating contexts, as well as expanding and extending their availability. WHO prequalification serves to protect the significant resource investments required to develop, procure and deliver life-saving vaccines globally. By optimizing the use of health resources, WHO prequalification contributes to increased access to essential medical products for those who urgently need them, and to improved health outcomes.
WHO prequalification of immunization devices plays an important role in the WHO Expanded Programme on Immunization (EPI). EPI seeks to ensure universal access to all relevant vaccines for all at risk, thereby supporting WHO’s disease elimination and eradication efforts, as well as countries' preparedness for health emergencies.
Key activities
WHO's activities to prequalify immunization devices include:
- identification of product end-user needs and the setting of standards of product performance, that are codified in product performance specifications and verification protocols. WHO IMD-PQS standards are minimum requirements; they are not restrictive
- verification of product compliance with WHO standards according to the criteria set out in IMD-PQS verification protocols, so that WHO Member States and UN procurement agencies are assured of their quality and suitability for use in immunization programmes
- publication of the IMD-PQS Catalogue of prequalified products for use by national immunization programmes and procurement agents
- gathering of equipment field performance and user-feedback from national immunization programmes and product manufacturers, to help improve product standards as well as stimulate innovation and the development of new technologies
- accreditation of testing laboratories through assessment of their facilities and competencies to test immunization products.
Key criteria for prequalifying immunization equipment and devices
WHO's approach to prequalifying immunization devices is based on three key criteria. The products evaluated must have:
- performance characteristics that meet the relevant product specification standards
- quality and reliability characteristics that are appropriate for the field conditions where they will be used
- cradle-to-grave safety characteristics that ensure that no harm is caused to users, patients, or to the environment, over the course of the product’s life cycle.
International standards as the basis
WHO IMD-PQS standards have been developed over many years, and go beyond and adapt International Standards Organisation (ISO) standards to address the specific and evolving needs of national immunization programmes. Standards are developed in collaboration with national immunization programmes and in consultation with product manufacturers, testing laboratories and a range of technical specialist organizations. Prequalification standards and protocols are regularly revised and updated based on:
- product field-testing
- ongoing user feedback on product performance in the operating environment
- Prequalification Holder's feedback on root causes of any product challenges as a part of the annual review.
IMD-PQS standards development is a three-step innovation, product development and improvement cycle supported by user feedback, whereby:
- product specifications and related verification protocols that adequately reflect programmatic and operational needs are developed for each product
- product’s in use in the operating environments are monitored for performance, quality and safety during their life cycle
- the suitability of each product in terms of programmatic and operational needs is monitored and all products are subject to a formal annual review process.