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A group of East London-based volunteers, including doctors, engineers and entrepreneurs, have developed a portable, the cost-effective device said to deliver high levels of oxygen to Covid19 patients and helps keep their lungs from collapsing.
According to a statement on Monday, the Oxygen-Efficient Respiratory Aid, OxERA, has been approved by the South African Health Products Regulatory Authority and will be produced and distributed by Cape Town specialist medical device manufacturer, Gabler Medical.
Dr Craig Parker, a medical officer working in anaesthetics with a background in mechanical engineering, said the group was determined to find a solution when they realised that South Africa would face similar patient loads seen in Europe during the COVID-19 pandemic, but would have limited high care capacity and fewer resources to respond.
A "social enterprise" was established in March 2020 and "drawing inspiration from sources as diverse as scuba diving equipment and 3D printing,", they built a working prototype within two weeks, and a 3D-printed final design within seven weeks.
Dr Parker said the overwhelming need of COVID-19 pneumonia patients is oxygen.
"OxERA's key components are an anaesthetic mask and an adjustable mechanical valve, known as a positive end respiratory pressure (PEEP) valve. Oxygen supply is via a hose and accumulator bag, with the hose connected to any available oxygen source."
"A viral filter removes viral particles from expired air, which is a safety benefit for health practitioners using the device."
The device has been used successfully in environments ranging from rural clinics to specialist hospitals, and by all levels of staff. Hundreds of OxERAs have already been distributed to 25 hospitals from Cape Town to Pretoria, said Umoya Project Manager and civil engineer, Trevor Rossouw.
"Many rural hospitals such as Zithulele on the Wild Coast and Madwaleni near Elliotdale have benefited from the devices. They have also been used by GPs for home and clinic treatment. Devices have also been distributed as far as Zimbabwe, DRC and the Central African Republic," he added.
A consortium was established between Umoya and Gabler Medical, which holds ISO13485 certification and specialises in the manufacture of oxygen therapy equipment.
"We can produce over 15 000 units a week, so capacity is not an issue. This will definitely create jobs during the pandemic and, if the product achieves general acceptance, also after the pandemic. The device holds export potential too," said MD, Renier Gabler.
He said now that the company has obtained SAHPRA approval for the device they can focus on scaling up production.
