Image: Umoya | OxERA
South African medical invention dubbed a ‘game-changer’ for COVID-19 patients
The device was developed by a group of East London-based volunteers that includes doctors, engineers and entrepreneurs; and the South African Health Products Regulatory Authority (SAHPRA) has now approved the OxERA device for emergency COVID-19 use.
Image: Umoya | OxERA
As South African healthcare workers struggle to contain the second wave of COVID-19, it appears some hope is at hand with the formal licensing approval of what the developers say is a “simple, efficient, portable, and cost-effective device that delivers consistently high levels of oxygen to COVID-19 patients.”
The proudly South African invention, OxERA – Oxygen-Efficient Respiratory Aid – could be a “game-changer” where there are a large number of COVID-19 patients; a lack of skilled staff; ICU and high care facilities; and a shortage of bulk oxygen supplies.
Dr. Craig Parker, a medical officer, working in anaesthetics with a background in mechanical engineering, says 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.
It effectively bridges the gap between current standard oxygen therapy via face masks and ICU-based non-invasive or mechanical ventilation, while requiring no more oxygen flow than a standard face mask, Parker said.
“As oxygen supply can be adjusted to patient demand, less oxygen is usually required. In our oxygen resource-constrained environment, this is a game-changer. It allows even the most basic facilities, which are dependent on bottled oxygen or small oxygen concentrators, to provide a higher level of care than they are currently able to.”
The developers said they drew inspiration from sources as diverse as scuba diving equipment and 3D printing, and began work in March 2020, producing a working prototype within two weeks, and a 3D-printed final design within seven weeks.
Efficient oxygen use
The overwhelming need of COVID-19 pneumonia patients is oxygen, says Dr. Parker.
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 high oxygen level delivered by the device ensures that maximum oxygen content is available to diseased lungs. The valve on the device maintains slight pressure to prevent the lungs from collapsing when the patient breathes out and reduces the amount of work it takes to breathe.”
Dr Carolyn Mason, a specialist physician in internal medicine in East London in the state sector, has personally used over 40 devices, mainly selecting patients aged 40 to 70 years which, due to comorbidities, would not have been ICU candidates.
“Their baseline oxygen saturations were all horrific and terrifying, even to the point of 20%. What was so amazing to myself as a health care professional was to see the saturation improve to 90% and to eventually even successfully discharge these patients home was a blessing as they would not have survived.”
Africa distribution
The device has been used successfully in environments ranging from rural clinics to specialist hospitals, and by all levels of staff. These include the Volkswagen COVID-19 field hospital, Frere and Cecilia Makiwane Hospitals, and many of the academic hospitals in the country.
Hundreds of OxERAs have already been distributed to 25 hospitals from Cape Town to Pretoria, says Umoya Project Manager Trevor Rossouw, a civil engineer with a background in project and business management.
Many rural hospitals such as Zithulele on the Wild Coast and Madwaleni near Elliotdale have benefited from the devices.
“As oxygen supply can be adjusted to patient demand, less oxygen is usually required. In our oxygen resource-constrained environment, this is a game-changer. It allows even the most basic facilities, which are dependent on bottled oxygen or small oxygen concentrators, to provide a higher level of care than they are currently able to.”
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.
The device is SAHPRA-approved for use during the COVID-19 emergency period.
Medical personnel say they are impressed by its simplicity of use, oxygen efficiency and clinical effectiveness.
Dr. Warren Gregorowski, working in Internal Medicine at Frere Hospital in East London, said the device is very simple to assemble and user friendly.
“I have witnessed this device saving lives, and I think that it could be used to great effect in hospitals throughout South Africa.”
Reiner Gabler, MD of Gabler Medical who will manufacture and distribute the device, says industrialisation and licencing have been a lengthy process, but now that the company has obtained SAHPRA approval for the device they can focus on scaling up production.
“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.”
