A home-grown, portable and easy-to-use oxygen device that can be used by less skilled healthcare workers at clinic level is set to be a game-changer in the use of oxygen on Covid-19 patients.
The OxERA (oxygen-efficient respiratory aid), produced by Cape Town-based company Gabler Medical, is the brainchild of a group of SA doctors, engineers and designers who wanted a cost-effective oxygen device that would bridge the gap between the standard high-flow oxygen therapy and mechanical ventilation. Due to rising numbers of Covid-19 cases during the second wave, ventilators and oxygen machines are under immense pressure. It is hoped the new device will help thousands of Covid-19 patients who ordinarily would not have had access to the standard treatment.
The device was recently approved by the SA Health Products Regulatory Authority (SAHPRA). It uses an anaesthetic mask and an adjustable mechanical valve, known as a positive end respiratory pressure (peep) valve. Oxygen supply is transported via a hose and accumulator bag, connected to any available oxygen source.
Its developers are convinced it could be a game-changer, especially for areas where there are few skilled staff, insufficient bulk oxygen supplies and a large number of Covid-19 patients.
The device was developed by a group of East London-based volunteers who include doctors, engineers and entrepreneurs.
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 SA would face patient loads similar to those seen in Europe during the Covid-19 pandemic, but would have limited high-care capacity and fewer resources to respond.
They set up a social enterprise in March 2020, trading as Umoya (“air” in isiXhosa). 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.
“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 lungs from collapsing when the patient breathes out and reduces the amount of work it takes to breathe,” explained Parker.
“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.”
Umoya project manager Trevor Rossouw, a civil engineer with a background in project and business management, said the device had 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. These include the Volkswagen Covid-19 field hospital, Frere and Cecilia Makiwane hospitals and many of the academic hospitals in the country.”
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, the DRC and the Central African Republic.
Medical personnel who have seen and tested the device have been impressed by its simplicity of use, oxygen efficiency and clinical effectiveness.
Dr Carolyn Mason, a specialist physician in internal medicine in East London, who works in the public sector, has personally used more than 40 devices, mainly selecting patients aged 40 to 70 who, due to comorbidities, would not have been ICU candidates.
“Their baseline oxygen saturations were all horrific and terrifying even to a point of 20%. What was so amazing as a healthcare 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.”
Reiner Gabler, MD of Gabler Medical, said its manufacturing and licensing processes had been lengthy, but after approval by SAHPRA the production of the device is to be scaled up.
“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.”
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