Revital Healthcare EPZ Ltd. Achieves WHO Prequalification for Early-Activation Auto-Disable Syringe

A Milestone for African Manufacturing and Immunization Programming

Mombasa, Kenya – [26th September 2023] – Revital Healthcare EPZ Ltd., a leader in African medical device manufacturing, announces a historic milestone in African manufacturing excellence. The company is the first to be granted Pre-Qualification (PQ) status by the World Health Organization (WHO) on July 11, 2023 for their early activation auto-disable (AD) syringe in Africa. This marks Revital’s more than ten-year commitment to injection safety in immunization programming across Africa.

The early-activation feature is the gold standard for safety in immunization programs as preferred by UNICEF, and renders the syringe disabled at the start of administering and injection. Historically, the introduction of these devices have resulted in substantial reductions in rates of blood-borne infections such as HIV in immunization programs across Africa.

There are currently eight other manufacturers who have WHO PQ status for this product, however Revital’s is the first and only to be produced in Africa.

Roneek Vora, Director of Marketing and Sales for Revital Healthcare EPZ Ltd., comments, “Revital’s historic WHO pre-qualification for the early-activation AD syringe exemplifies the transformative power of African innovation and manufacturing excellence. Our commitment to the well-being of our fellow people, especially children receiving life-saving immunization, is our motivation to continue to progress.”

This work was made possible through a grant from the Bill and Melinda Gates Foundation. In addition to supporting the development of this product to increase supply security for Africa, this helped create more than 200 new local jobs in Kilifi County, 80% of which are staffed by women in support of a joint commitment to gender equality.

The WHO PQ listing for the 0.5mL early-activation AD syringe can be accessed through the WHO Vaccine Quality Catalogue.

Higlights

Key Takeaways: Revital Healthcare’s WHO Prequalified Syringe

Revital Healthcare EPZ Ltd. has achieved a significant milestone by becoming the first African medical device manufacturer to receive Pre-Qualification (PQ) status from the World Health Organization (WHO) for their early activation auto-disable (AD) syringe.

This groundbreaking achievement highlights Revital’s decade-long commitment to safety in Africa’s immunization programs. The early-activation feature, preferred by UNICEF, enhances safety by rendering the syringe disabled at the beginning of administration, contributing to a reduction in blood-borne infections like HIV. While eight other manufacturers worldwide hold WHO PQ status for this product, Revital’s is the first and only produced in Africa, exemplifying African innovation and manufacturing excellence.

Historic WHO PQ Status

Revital Healthcare achieves WHO Pre-Qualification for their early activation auto-disable syringe, a pioneering African milestone.

First African Manufacturer

Revital is the sole African producer to hold WHO PQ status for their early activation auto-disable (AD) syringe.

Enhanced Syringe Safety

The early-activation feature in Revital’s syringe sets a gold standard, reducing blood-borne infections in immunization programs.

Impact and Innovation

Revital’s achievement reflects African innovation and commitment to immunization safety and supply security