The CSIR – in collaboration with a number of local partners – developed a ventilator that was rapidly rolled out nationwide to patients showing respiratory distress in the early phase of Covid-19 infection.

The development formed part of government’s National Ventilator Project (NVP) under the auspices of the Department of Trade, Industry and Competition (the dtic), and is supported by the Solidarity Fund. The first batch of ventilators was provided to state hospitals around the country that were experiencing pressure due to the unavailability of equipment to deal with the pandemic.

The CSIR solution is a Continuous Positive Airway Pressure (CPAP) device that uses an innovative design to provide a mild level of oxygenated air pressure to keep the airways open and, thus, assist with breathing.

The units are non-invasive and fill the need for readily available breathing apparatus, deployed and applied easily – even outside of hospitals if needs be – for intervention in cases where patients are at an early, not-intensive stage of respiratory distress caused by the Coronavirus. Therefore, the device can be used in both high-tech clinical environments, as well as temporary settings, such as field hospitals and quarantine facilities that were established across the country to handle rising Covid-19 cases. 

Under the project name, ‘CSIR L.I.F.E.’ (Lung Inspiratory Flow Enabler), the system uses standard, hospital-grade oxygen supply, and features easy-to-use, on-device flow gages to adjust the fraction of inspired oxygen in steps of 10% oxygenation.

Design and manufacture

The device was wholly designed and produced in South Africa by the CSIR and local manufacturing and industry partners such as Siemens, Simera, Akacia, Gabler, Umoya and the University of Cape Town (UCT).

The clinical requirement from the NVP was for the rapid development and distributed production of a non-invasive pre-intubation ventilation solution that could be used for most hospitalised Covid-19 patients as part of government’s response plan to the pandemic.

Despite short timeframes, a rigorous, documented product lifecycle methodology was followed that would ensure scalable manufacturing, as well as compliance and licensing under the South African Health Products Regulatory Authority (SAHPRA) and guidelines of the World Health Organization.

Siemens provided the necessary software support for the product lifecycle management, as well as software to facilitate rapid production scaling. This included components for systems engineering processes, computer-aided design tools, manufacturing execution tools, as well as quality management solutions that would ensure compliance with health product regulations for certification. Using a digital product lifecycle design methodology also ensured that the product could be manufactured in multiple factories in the industry and in large volumes.

By June 2020, the necessary R&D had been completed and the CPAP system was tested at UCT’s Medical Devices Laboratory, which houses specialised apparatus to evaluate such products. This led to regulatory approval and licensing obtained from the SAHPRA.   

By September 2020, in the order of 10 000 units were issued.

In another project, the CSIR is also working on a bi-level positive airway pressure ventilator with a local partner to develop a solution for patients with more severe symptoms. These units assist with both inhalation and exhalation, either in fixed pressure modes, or by sensing the oxygen supply required by a patient and adjusting the pressure accordingly.