Devices

Modelling studies suggest that voluntary medical male circumcision (VMMC) for HIV prevention will have the greatest public health impact in 14 priority countries in eastern and southern Africa if scaled up rapidly, averting up to 3.4 million HIV infections through 2025 at a cost savings of USD 16.5 billion. Conventional surgical circumcision methods pose challenges because they require surgical skills and infrastructure that are in short supply in priority countries.

Innovations in adult male circumcision, such as devices, have the potential to make the procedure easier, faster, and safer to perform in a wider variety of settings. Alternatives to conventional surgery may also influence the acceptability of the procedure among men, their partners, and the parents of uncircumcised youth and infant boys. A number of different types of devices for adult male circumcision are available in the market, but until recently evidence on their clinical safety and efficacy was lacking, particularly in African settings.

WHO prequalification of devices 

The World Health Organization (WHO) established a Prequalification Programme for Devices for Male Circumcision for HIV Prevention to promote and facilitate equitable access to safe, appropriate, and affordable male circumcision devices. Prequalification indicates that a device meets international standards for three components: 1) the regulatory dossier, 2) the inspection of the quality management system under which the product is manufactured, and 3) clinical studies on efficacy and safety in settings of intended use. WHO prequalification does not replace countries’ own regulatory processes but paves the way for procurement of the devices by United Nations agencies, WHO member states, donors, and other interested purchasers. Current information on the status of the applications for prequalification is available on the WHO website.​

Framework for evaluation

WHO, through its Technical Advisory Group on Innovations in Male Circumcision, developed the Framework for the Clinical Evaluation of Devices for Male Circumcision, which stipulates a pathway of clinical studies to provide the data for WHO to evaluate the clinical safety and efficacy of a device for use in VMMC programmes in resource-limited settings. The framework also provides suggestions for a phased introduction of male circumcision devices within national programmes.

Guideline on use

WHO published the Guideline on the Use of Devices for Adult Male Circumcision for HIV Prevention in October 2013, offering an evidence-based recommendation on the use of such devices in public health programmes in resource-limited settings with high HIV prevalence. The recommendation states that “WHO prequalified male circumcision devices are efficacious, safe and acceptable as additional methods of male circumcision for HIV prevention among healthy men 18 years of age and older in high HIV prevalence, low resource settings.” It applies in settings where the devices are used by health-care providers, including physicians and mid-level providers, who are appropriately trained and competent in the use of the specific device and where the necessary surgical backup facilities and skills are available.

By June 2015, two devices had been prequalified by WHO: the PrePex™ device and the ShangRing.™ A current list of prequalified devices is available on the WHO website.

In September 2016, WHO published updated recommendations on preventing tetanus, a rare but serious complication, following VMMC. The new recommendations call for different risk mitigation measures by circumcision method.

 

Resources

 
An Innovation in Public Health: Devices for Voluntary Medical Male Circumcision

A collection of 17 articles, published in the Journal of Acquired Immune Deficiency Syndromes, examines research on the introduction of two devices for performing voluntary medical male circumcision on adults and adolescents.

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After reviewing the evidence on 12 cases of tetanus following VMMC, the World Health Organization’s (WHO’s) Technical Advisory Group on Innovations in Male Circumcision updated its 2015 recommendations for preventing this rare but serious complication.

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PrePex™ Field Safety Notice - March 2016

Issued by the manufacturer of PrePex, this notice informs users that use of the device for performing adult medical male circumcision has been extended to adolescents ages 13 to 17. The notice lists the updates to indications for use of PrePex and its labelling.

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In 2010, the World Health Organization (WHO) established a Technical Advisory Group (TAG) on Innovations in Male Circumcision in 2010 to advise WHO on the safety, acceptability, and public health need for male circumcision.

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WHO MC TAG report

The deliberations and recommendations of the September-October 2014 meeting of the WHO Technical Advisory Group on Innovations in Male Circumcision are summarised in this report. 

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WHO Prequalification of Male Circumcision Devices Public Report. Product: ShangRing™

A public report from the World Health Organization on the 3 June 2015 prequalification of the ShangRing™ device for performing male circumcision summarises the review of the product and provides labeling information and instructions on use.

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Meeting on Use of Devices for Medical Male Circumcision for HIV Prevention in East and Southern Africa, November 2013, Entebbe, Uganda

WHO convened a meeting in Uganda in November 2013 to inform key stakeholders about the details of a new guideline on the use of devices for performing male circumcision on adult men.

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Frequently Asked Questions on Non-Surgical Devices for VMMC

Developed by AVAC, these questions and answers provide basic information on non-surgical devices for performing adult male circumcision, with a focus on the implications of WHO prequalification.

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WHO Technical Advisory Group on Innovations - Evaluation of Two Devices

The WHO Technical Advisory Group on Innovations in Male Circumcision met in January 2013 to review the clinical performance of two male circumcision devices, PrePex and the ShangRing.

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Guideline on Use of Devices for Adult MC for HIV Prevention

Published by the WHO, this guideline offers an evidence-based recommendation on the use of devices for performing adult male circumcision for HIV prevention in resource-limited settings.

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Framework for Clinical Evaluation of Devices for MC

Developed by WHO through a technical advisory group, this framework describes the steps and studies for evaluating the clinical performance, safety, and acceptability of a device for male circumcision.

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This guide contains 12 recommendations on how to design pilot projects with scaling up in mind and a checklist for assessing the feasibility of scaling up a project.

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Information update on the PrePex device

In this update WHO announces the prequalification of the PrePex device and it conclusions about the requirements for safe and effective use of the device to perform adult male circumcision.

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