Four manufacturers receive approval to produce 20 000 CPAP devices
Four local manufacturing companies have received South African Health Products Regulatory Authority (SAHPRA) approval to produce 20 000 non-invasive Continuous Positive Airway Pressure (CPAP) devices, with funding secured for 10 000 units, the Department of Trade, Industry and Competition (DTIC) said in a July 17 release.
"Based on clinical experience in global epicentres like China, Italy, the UK and the US, senior critical care physicians advised that we should focus on the production of non-invasive CPAP devices while the health system focused on procuring more complex and invasive ventilators to supplement currently available devices.
"Out of the 95 proposals received, six were selected to continue to the prototyping phase," the department pointed out.
The Solidarity Fund had funded prototype development for the National Ventilator Project (NVP) to the value of R11.3-million.
"Given the enormous global shortage of ventilators, a few months ago we started the NVP, with the aim of rapidly facilitating local development and manufacturing of thousands of non-invasive ventilators," said Trade and Industry Minister Ebrahim Patel.
The Solidarity Fund has also approved funding for the Council for Scientific and Industrial Research (CSIR), which has started producing 10 000 ventilator units that will be delivered in stages over the next two months.
The CSIR anticipates that the first batch of 2 000 ventilators will be delivered within the next few weeks, with further units to be delivered by mid-August and the balance by the beginning of September.
Negotiations with other entities are also under way.
"Within the space of four months, we have gone from not producing any ventilators at all to having the first units in production. With prototypes approved, funding raised and component supply lines secured, manufacturing has begun," said Patel.
A thorough and open proposals request process from local innovators and industry resulted in 95 proposals, and the National Ventilator Project identified several companies/consortia with the capabilities to produce ventilators at the required specifications. The average unit cost is around R12 500, which is significantly lower than anything that can be found commercially, stated the DTIC.
"The NVP has also identified that we have the industrial capacity to scale up production for exporting ventilators to other African countries should the need arise," Patel noted.
"This development comes after an intense few months during which prototypes were designed, developed and tested, while adhering to very strict technical and safety specifications. In April, the South African Radio Astronomy Observatory, responsible for one of the world’s largest big-science initiatives, the Square Kilometre Array radio-astronomy project, put together an experienced team led by Professor Rob Adam to manage this process."
“The NVP is of huge importance during the Covid-19 crisis and we are pleased to be able to provide significant funding towards it. It is yet another example of how speedily we can achieve life-saving objectives when we come together and pool our expertise," said Solidarity Fund chairperson Gloria Serobe.
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