Why test the medical ventilator prototypes?
“The main objective was to assess whether the ventilator’s mechanical function is per expectation in terms of ‘Breathe-in-and-out’ ratios, air pressure, and tidal volume. The prototype performed excellently well on all parameters, behaving like any standard ventilator on the market,” Nawangwe said.
Two weeks ago, Makerere University, Resilient Africa Network, Kiira Motors, and the Ministry of Science and Technology innovations set out to develop a low cost ventilator to fill the critical gap in the event Covid-19 cases in the country swell. This week, Nawangwe said a team of Kiira Motors engineers and veterinarians will start the validation process by testing the ventilator on animals before proceeding to clinical trials.
“This is an ethical requirement before any new treatment intervention is conducted on human beings. Animal tests will be led by a team from the College of Veterinary Medicine, Animal Resources and Biosecurity at Makerere,” the vice chancellor said.
After a successful validation process, the team will seek approval from the National Drug Authority (NDA) for testing to begin on human beings.
According to Prof. Nawangwe, in two weeks’ time, the team will start Randomized Clinical Trials (RCT) on human subjects, led by Anaesthesiologists and Epidemiologists from the College of Health Sciences, Makerere.
The studies will commence with patients who are moderately ill, then scale up to patients who are severely ill. These assessments will be conducted at the Uganda Heart Institute. The engineering team will receive continuous feed-back to optimise the design.
Thereafter, the team will seek pre-launch approval of the product from NDA and relevant quality certifications from UNBS, after which 40 ready-to-use units will be initially manufactured. The whole process is estimated to take 8-12 weeks.
“This ventilator will not only be handy for Covid-19 but will transform the country and the region’s capacity to provide decentralized critical care for patients with other serious conditions,” the vice chancellor said.
The chief engineer of the project and director product development, Kiira Motors Corporation, Richard Madanda said the ventilators are a major milestone for the country. Once approved, he said, they will be used in hospital Intensive Care Units (ICUs) across the country to fight the COVID-19 pandemic.
“We undertook open technology assessment and adaptation. We have done tests about the functionality and verification of the ventilator with clinicians and now we are proceeding to do validation in clinical settings before we license the product and we produce at least 40 units for medical use across the country,” Madanda explained.
msserwanga@gmail.com