- A Durban-based non-profit has received regulatory approval for a locally produced non-invasive ventilator for Covid-19 patients.
- The approval comes after months of work and preparation.
- The design is based on a 40-year-old machine made by UK-based company, Penlon.
A group of Durban-based businessmen, who started a non-profit organisation to locally produce ventilators to meet the need of Covid-19 patients, has received regulatory approval for their locally made product.
The South African Ventilator Emergency Project (SAVE-P), in a press statement issued recently, confirmed it had received approval from the South African Health Products Regulatory Authority (SAHPRA) after months of painstaking work.
SAVE-P is led by businessman Justin Corbett and Dr Greg Ash, who also run a non-profit named Nurturing Orphans of Aids for Humanity.
According to Corbett, the project stands ready to start manufacturing.
On Monday, President Cyril Ramaphosa announced that 1 700 new ventilators had been procured. He did not specify whether this included a donation of more than 1 000 ventilators from the United States.
According to the statement, Corbett and Ash "called upon local manufacturers they were familiar with the reliability and conformance of" to join the SAVE-P project.
News24 previously reported that the SAVE-P project was attempting to reverse engineer a Penlon Nuffield 200, a small compact ventilator unit that did not contain any complicated electronics that would take months to reproduce and develop.
"As a team, they evaluated designs that would be best suited to meet the requirements of respiratory therapy to treat Covid-19 patients, as well as ease-of-use for medical staff operating under highly stressful conditions with minimal training prior to using the device," the SAVE-P statement read.
More than 90 volunteers worked on the project, according to SAVE-P.
"SAVE-P has also been working alongside the National Ventilator Project team, led by (South African Radio Astronomy Observatory) SARAO, for the development and performance testing of the device. The results of those tests and usability trials have proven the device to be highly effective and reliable," the statement said.
"The design itself and method of manufacture have rendered it to be a truly affordable solution which can be produced quickly. SAVE-P recently became the first home grown non-invasive ventilator producer to receive a SAHPRA license to manufacture the devices."
News24 understands that SAVE-P was granted license by SAHPRA in late June.
The unit is what is known as a Continuous Positive Airway Pressure (CPAP) device – a type of ventilator that does not require patients to be intubated - and will be locally manufactured.
In June, 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 – announced that it had completed work on a local ventilator to be rolled out nationwide to "patients showing respiratory distress in the early phase of Covid-19 infection" – also a CPAP unit.