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

June 2013 - Reports, Guidelines, and Tools

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OGAC. U.S. Department of State: Diplomacy in Action (May 31, 2013).

The World Health Organization (WHO) has prequalified PrePex™, the first medical device for adult male circumcision. Prequalification ensures that medical devices and equipment for high-burden diseases meets safety and efficacy standards. The WHO conducted studies in Rwanda, Zimbabwe and Uganda as part of the prequalification process. The device has the potential to streamline the procedure and improve men’s experience of male circumcision. Given that the U.S. President’s Plan for Emergency AIDS Relief (PEPFAR) has supported implementation of voluntary medical male circumcision in 14 countries in eastern and southern Africa, OGAC’s Ambassador, Eric P. Goosby, voiced his support for countries that plan to implement PrePex™.  PEPFAR is supporting Ministries of Health and/or Defense in other African countries to conduct an initial assessment of the acceptability and safety of the device in various contexts, which is required before PEPFAR provides support for large-scale programs using the device.

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