Statement by the Office of the U.S. Global AIDS Coordinator (OGAC) on World Health Organization Prequalification of First Medical Device for Adult Voluntary Medical Male Circumcision


May 31, 2013

 

Today, PrePex™ became the first medical device for adult male circumcision to receive World Health Organization (WHO) prequalification as an alternative to the conventional surgical circumcision methods already recognized by WHO.  Medical devices like PrePex™ may change the landscape of voluntary medical male circumcision (VMMC) scale-up by potentially simplifying the procedure and improving men’s experiences.

VMMC is a one-time, low cost intervention shown to reduce men’s risk of HIV infection by approximately 60 percent. The WHO recommends VMMC as part of a comprehensive package of HIV prevention services. The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) supports the implementation of VMMC programs in 14 East and Southern African countries including Botswana, Lesotho, Ethiopia, Kenya, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe, and has supported more than two million voluntary surgical procedures as of September 30, 2012.

U.S. Global AIDS Coordinator, Ambassador Eric P. Goosby said, “The WHO prequalification of PrePex™ represents an unprecedented opportunity to further the safe and rapid scale up of voluntary medical male circumcision programs. PEPFAR is ready to support countries that wish to introduce PrePex™ right away. This announcement will truly help save lives. ”

WHO prequalification is a process intended to verify the quality, safety, and efficacy of clinical devices and medicinal products. Studies of PrePex™ in Rwanda, Zimbabwe, and Uganda were considered as part of the WHO prequalification of PrePex™. WHO guidelines will further summarize available information on a class of products and provide recommendations and considerations on their use in public health programs.

In light of WHO prequalification, PEPFAR is supporting Ministries of Health and/or Defense in other African countries, including Botswana, Lesotho, Malawi, South Africa, Swaziland, and Tanzania, to assess the acceptability and safety of PrePex™ in their local public health contexts – a requirement before PEPFAR can fund broader program implementation with the device. PEPFAR is optimistic that at least one additional medical circumcision device may receive prequalification for use in adult men in the near term, further widening the spectrum of available options for safe and acceptable VMMC.

PEPFAR-supported programs will continue to offer conventional surgical VMMC services. Forthcoming WHO guidelines will further inform PEPFAR’s support for introducing device-based adult VMMC into existing programs.

For more information about WHO prequalification of adult male circumcision devices, please visit: http://www.who.int/diagnostics_laboratory/evaluations/PQMCdevices_list/en/index.html

For the detailed public report on WHO prequalification of PrePex™, please visit: http://www.who.int/entity/diagnostics_laboratory/male_circumcision/130530_pqmc_public_report_final_v1.pdf

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