The Council for Scientific and Industrial Research (CSIR), an entity of the Department of Science and Innovation (DSI) – in collaboration with a number of local partners – has completed work on a local ventilator to be rolled out nationwide to patients showing respiratory distress in the early phase of COVID-19 infection.
The development forms 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 will be provided to state hospitals around the country that are currently 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 have been 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 Fraction of Inspired Oxygen in steps of 10% oxygenation.
Design and Manufacture
The device is 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), with others soon to join.
According to Martin Sanne, Executive Manager of CSIR Future Production: Manufacturing, 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.
“While ensuring that we achieve this in a short period of time, we had to ensure that we follow a rigorous, documented product lifecycle methodology 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,” he says.
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 ensures that the product can be manufactured in multiple factories in the industry and in large volumes.
“This way, we remain true to the role of the CSIR – which is to perform research and development (R&D) that is cutting edge, involves local industry in their niche areas, and ensures that together we address issues that are of national importance,” Sanne explains.
By June, 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.
There are ongoing discussions with the Department of Health and the dtic to produce additional devices before the end of August as data on the spread of the virus becomes available.
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.
This article was first published on 10 July by DSI.