Framework for clinical evaluation of devices for male circumcision
Male circumcision devices have the potential to accelerate delivery of male circumcision programmes in resource-limited settings by reducing the time to perform the operation, by simplifying the procedure so that providers can perform it more easily and in some circumstances by making the procedure more acceptable to clients than a surgical approach. Devices are widely used for circumcision in infants and young boys, but experience in post-pubertal boys and adults is limited, particularly in the countries in the African region where rapid expansion of male circumcision programmes for HIV prevention is most urgent.
Regulations governing approval of medical devices require clinical evaluation but may only require limited clinical trials for devices that are used as aids to surgery or remain external to the body. This includes male circumcision devices. As male circumcision programmes for HIV prevention are a public health intervention and involve large numbers of healthy men, a more rigorous assessment of the clinical safety, efficacy, acceptability and cost-effectiveness of male circumcision devices is required.
The Framework for clinical evaluation of devices for male circumcision focuses mainly on clinical requirements for assessing the suitability of a device for male circumcision within public health HIV prevention programmes in resource-limited settings and, secondarily, on regulatory and manufacturing considerations. A series of steps and clinical studies is described to evaluate the clinical performance, safety and acceptability of a new male circumcision device, as are the minimum sizes of these different studies.