South African team launches non-invasive breathing system for early-stage intervention

12th August 2020

By: Marleny Arnoldi

Deputy Editor Online

     

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In response to the Covid-19 public health emergency and an impending ventilator shortage in South Africa and other parts of the world, a team of experts has designed the first-ever Non-Invasive Breathing System (NiBS) in South Africa.

The makers of the NiBS comprise a team of engineers, an anaesthetist, intensive care physicians, a robotics engineer, a manufacturer and respiratory surgeons and pulmonologists.

The ventilator was a collaborative effort between the Aerospace, Maritime and Defence Industries Association of South Africa, surgical equipment repair company Maqcare, Kiara MedTech and the South African Military Health Service (SAHMS).

SAHMS will provide training support for the introduction of NiBS across the country and equip all healthcare workers to use the technology.

Industrial group Ritam Holdings COO and NiBS CEO Laurence Savage confirm that NiBS is reliable, safe and simple to use.  

The South African Health Products Regulatory Authority has licensed the sale of NiBS, with the system adhering to accepted levels of patient safety, quality and performance.

During a press conference on August 12, Savage explained that the NiBS ventilator does not use an invasive artificial airway and has three strands of work, including bi-level positive airway pressure (BiPAP) with continuous positive airway pressure and air pressure release ventilation functionality. 

NiBS has already secured an exclusive distribution agreement with Kiara MedTech, which is owned by Imperial Health, for distribution in Africa, Bangladesh and Sri Lanka.

“The product had specific parameters [it needed to adhere to], including dealing with the virus’ symptoms effectively and having a high level of local content, since it is a struggle to bring in components from Europe and China at the moment.

"It was also necessary to develop a solution quickly and simple enough for medical personnel to use at any hospital.

“We formed a grouping of a dozen experts, working on a traditional engineering methodology, speaking to various parties in the medical field to understand what was required to assist patients that got this virus,” Savage notes.

The NiBS team built six prototypes and its chief engineer contributed to developing a final product that comprises 87% local content.

NiBS can produce 10 000 of these units a month.

“Today, we can produce the product in sizeable volumes [that] meet patient needs and can be used for treating patients with other lung diseases as well, which are prominent in South Africa aside from the pandemic,” notes Savage.  

He further explains that the device is turbine-based, so it does not require a blender and humidifier. It also uses less oxygen than the traditional high-flow nasal cannula system, which is an obvious benefit when oxygen is in short supply.  

“We have incorporated inhalation and exhalation virus filters to protect staff and other patients against the spread of Covid-19, while the use of the device has been simplified so that medical personnel can learn how to use it in 30 minutes.”

Savage adds that the BiPAP functionality offers clinicians the ability to increase inhalation volumes while the patient has a reprieve on exhaling against a lower controlled pressure.

The system is delivered with a sterile single-use patient kit, comprising a mask, inlet and outlet filters, necessary tubing and oxygen lines. A pulse oximeter measuring oxygen saturation is also included in each patient consumable pack presenting immediate diagnosing and treatment of low patient oxygen levels.

The system is non-invasive and, therefore, does not require patients to be sedated or intubated.

The simplicity of the system compared with conventional invasive ventilators reduces the demand for highly skilled and specialised nursing and, in turn, the training requirement is reduced. User certification and the related medical liability implications are also reduced.

NiBS can be safely used in earlier stages of the infection, reducing the patient demand for intubation and more invasive treatments. This early-stage intervention slows the deterioration of the patient and thus reduces the burden on health systems, especially in relation to ventilation and critical care interventions.

The NiBS team is in the process of developing an interactive human machine interface monitoring function, which is modelled on smartphone technology for ease of use.

This is being developed for remote monitoring and location of the device, and will be released later this year.

“We have recognised that African countries that are severely affected by the pandemic have been trying to procure lung ventilation equipment with limited access to suppliers and with limited financial capacity to treat their populations that are infected with Covid-19 and through our work a large number of patients will have access to a clinical treatment at a functional level and affordable cost,” concludes Savage.

Edited by Chanel de Bruyn
Creamer Media Senior Deputy Editor Online

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