The awarding of a tender by National Treasury for a circumcision device has been challenged in the Gauteng High Court (Pretoria), with accusations that it is unsafe and untested, particularly for boys aged 10-14.
However, writes Tania Broughton for GroundUp, the state has defended its decision, saying that bidders did not have to present scientific data to support the device’s use on adolescent boys.
The device is to be used at provincial health centres and the military in South Africa, but the award of the tender to CircumQ is being challenged by Unicirc, which also bid for the tender, and which says the device is untested and unsafe, especially for youngsters.
Unicirc is seeking an order which, if granted, will mean the tender process will have to start afresh.
In an answering affidavit, Treasury’s chief procurement officer Mendoe Ntswahlana defended the tender award.
But Unicirc co-director Dr Cyril Parker said Ntswalhlana – who is not an expert in any field of healthcare, research, delivery or policy – failed to deal with “uncontested evidence” that there was no scientific data supporting the use of the CircumQ device.
Ntswalhlana had merely stated that the tender did not include requirements that bidders must present scientific data, and CircumQ’s application had satisfied all relevant requirements of the tender.
In response, Parker said: “It beggars belief that (Ntswalhlana) is of the view that it is appropriate to use a medical device on young boys in circumstances where there is no evidence to suggest that this can be done safely.”
Parker, an expert in circumcision and HIV prevention strategy, has worked in the field for 30 years. He and his wife, Elizabeth Pillgrab-Parker, are co-directors of Unicirc, which has the licence to distribute and sell a single-use circumcision device for safe and cost effective circumcision.
They say their device, which is used in public and private healthcare facilities, is tried and tested. It allows for a complete circumcision in one visit, performed by a single healthcare provider, using a local anaesthetic and without any sutures. The whole procedure is completed in about 10 to 12 minutes and with proper training, and it can also be performed by nurses.
They say when the World Health Organisation (WHO) published its device guidelines in 2020, only the Unicirc device came close to meeting the requirements.
The manufacturer has started the process of securing WHO pre-qualification, which requires devices to meet strict standards of quality, safety and efficacy.
The device had also been tested in medical trials and proven to be safe in the target group of age 10 to 14.
In contrast, Parker said, very little was known publicly about the CircumQ device, which required suturing, itself risky, and which could not be done at outreach and mobile sites.
“I am not aware of any peer-reviewed publications that consider its use. It has not been reviewed in any of the WHO literature I have perused or in any systematic review of circumcision devices that I have read. This is in contrast to the Unicirc device as well as other products,” Parker said.
“While I have come across two studies, I have not been able to find out anything about this research and I have not seen any evidence to suggest that it is close to being pre-qualified or even evaluated by the WHO.
“I am deeply concerned about the harm that is likely to result should the award of the tender to CircumQ not be reviewed and set aside.”
Although the CircumQ device was submitted for WHO pre-qualification a few years ago, it is not clear how far along in the process the application has progressed.
Yet Ntswalhlana had contended that a mere submission of an application for WHO pre-qualification was sufficient in terms of the tender.
Parker said WHO’s Technical Advisory Group had flagged deficiencies in CircumQ’s evidence base, noting concerns with the “quality of data, particularly on adverse events”.
“The mere submission of an application for approval tells us nothing about the chances of approval being actually granted,” he said, noting that four years later, CircumQ’s application remained unapproved and that the device had only been tested on adult men.
This should have raised alarm bells, he said.
“We have provided uncontested evidence that makes it abundantly clear that should the CircumQ device be used to perform circumcisions on boys aged 10 to 14, there is a very real risk of irreparable harm, both to the boys themselves, and the circumcision programme as a whole.
“It is clearly in the public interest to ensure that the risk of such harm is removed,” he said.
CircumQ, while cited as a party, has not filed any papers.
The tender was awarded in August 2023, but has not been implemented. In March 2025, National Treasury cited delays in training and advised healthcare professionals to continue using a conventional dorsal slit surgical method.
The parties will now have to file heads of argument before the matter is set down to be heard by a judge.
See more from MedicalBrief archives:
Court battle over ‘unsafe’ circumcision device
Anaesthetists group urges caution after circumcision death