Devices

As voluntary medical male circumcision was scaled up as an additional HIV prevention intervention in high HIV prevalence settings, it became clear that conventional surgical circumcision methods posed challenges because they require surgical skills and infrastructure that are in short supply in priority countries.

Innovations in clinical methods of adult male circumcision, such as device-based methods, have the potential to make the procedure easier, faster, and safer to perform by non-physician providers as well as physicians 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, as well as health care providers. 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 limited and was not collected systematically, 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

In 2020, WHO updated its 2013 conditional recommendation on the use of devices as safe, efficacious methods of surgical male circumcision. The recommendation remains conditional because the use of devices was limited through 2018; however, device-based male circumcision may still help expand coverage, increase programme impact, and enhance safety. The WHO recommendation applies in settings where 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.

A current list of prequalified devices is available on the WHO website.

Resources

 
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Preventing HIV Through Safe Voluntary Medical Male Circumcision for Adolescent Boys and Men in Generalized Epidemics

Guidelines from the World Health Organization update earlier recommendations to maximize the HIV prevention impact of safe voluntary medical male circumcision services and to guide the transition to the sustained provision of interventions with a focus on the health and well-being of adolescent b

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Virtual Roundtable on ShangRing for VMMC: Country Perspectives

Project IQ held a virtual roundtable on 9 September 2019 to provide an orientation on the ShangRing device for voluntary medical male circumcision (VMMC) and the World Health Organization's recommended process for device introduction.

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Tetanus and Voluntary Medical Male Circumcision: Risk According to Circumcision Method and Risk Mitigation

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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Technical Advisory Group on Innovations in Male Circumcision: Meeting Reports

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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An Innovation in Public Health: Devices for Voluntary Medical Male Circumcision
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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WHO Prequalification of Male Circumcision Devices Public Report. Product: ShangRing™
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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Guideline on Use of Devices for Adult MC for HIV Prevention
Guideline on the Use of Devices for Adult Male Circumcision 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
Framework for the Clinical Evaluation of Devices for Male Circumcision

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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Beginning with the End in Mind: Planning Pilot Projects and Other Programmatic Research for Successful Scaling Up

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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