Kenyans will have to wait a little longer before they can see a locally made ventilator put to use.
This is because the innovators identified to develop some of this critical equipment that helps many critically ill patients to breathe are now facing financial challenges and missing key parts needed to piece together functioning mechanical ventilators.
Touted as an essential machine in saving the lives of many patients who develop severe symptoms of Covid-19 like difficulty in breathing, the world was in a frenzy to get more ventilators to hospitals which were teeming with patients.
The mechanical device is coveted for its ability to push life-saving oxygen deep into damaged lungs. Yet it also is feared and reviled for the damage it inflicts — and for the slim odds of survival it affords.
Even so, the country continues to face a substantial gap in both intensive care unit beds and ventilators’ capacity needed to sustain the lives of Covid-19 patients who present with severe cases.
A study published in April in the medRXiv journal pointed out that Kenya faces substantial gaps in ICU beds and ventilator capacity. Only 22 out of the 47 counties have at least one ICU unit.
The study carried out by a team led by Kemri researchers led by Edwine Barasa notes that the country will need an additional 1,511 ICU beds and 1,609 ventilators (six months transmission curve) to 374 ICU beds and 472 ventilators (18 months transmission curve) to absorb caseloads due to Covid-19.
NO APPROVAL YET
Three months since the country reported its first Covid-19 case, the Ministry of Health now says that it is yet to approve any of the five ventilator prototypes it had received from local innovators as the latter are yet to implement the changes as advised by the ministry’s ad-hoc committee, Martin Owino, a biomedical engineer at the ministry who is leading the committee said during an interview with Nation.
“We received five prototypes from different institutions to review and have given them feedback on the corrections and adjustments they need to put in place before we can proceed,” explained Mr Owino.
To date, however, none of the innovations made by university students in the country has made it past the initial analysis stage, Mr Owino said.
Even worse, the technocrats (mostly anaesthesiologists), whose hands these devices will end up in, now say that the government has not involved them in reviewing any of the prototypes and some of the members who have had a chance to review some innovations in the counties have referred to them as contraptions of death.
“Before something is touted as a ventilator let it be properly tested and evaluated. One of our members was recently approached by a county to okay an already existing contraption that was being fronted as a mechanical ventilator,” explained Dr David Misango, a consultant anaesthesiologist and intensivist, and chairman of the Critical Care Society of Kenya (CCSK).
Dr Misango further likened the use of a faulty ventilator to throwing a rock to a drowning man.
“If someone is drowning and you throw them a floater they will either grab it or not. If they are heavy, they will drown. But if you throw a rock at them instead, you will not be saving them at all,” Dr Misango opined, adding that the critical care society has come up with a protocol of the critical things any ventilator must have.
AD HOC TEAM
But Mr Owino noted that the ad hoc committee comprises of a nurse, an anaesthesiologist, and a representative, each from the Kenya Bureau of Standards (Kebs) and Pharmacy and Poisons Board (PPB).
“In health, you cannot experiment on human life and, therefore, we have put together a competent team which can properly evaluate the quality of the products being made here,” he commented.
The five institutions whose prototypes were under review are Dedan Kimathi University of Technology, Kenyatta University, and Numerical Machining Complex.
The MoH team led by Mr Owino has also reviewed prototypes from two different freelance innovators. One of the freelance innovators lacked a prototype but brought designs which the review team approved and asked for a prototype to be built.
“As it is, the prototypes are big and cannot be used as they are. They are only used for demonstration of functionality and proof of concept,” Mr Owino further explained in a phone interview.
PROOF OF CONCEPT
The proof of concept, he added, entails checking whether the prototypes performed within some laid down parameter, and met the Kebs quality mark.
The team also reviewed the prototypes for safety.
According to Mr Owino, if things run smoothly, the innovators should by now be at the stage of fine-tuning their prototypes into equipment that are portable and aesthetically appealing which then can be taken for clinical evaluation within a hospital set-up.
But even though what the innovators have put together so far can at best only function as basic ventilator when actualised, many are still stuck with the bulky mock-ups which have not been fitted with the improvements the review team requested.
“Many of them are complaining of financial challenges and a lack of essential parts. Dedan Kimathi for example, had challenges acquiring some electronic components for the programmable parts of the machine which can only be sourced from China. For the team which we asked to build a prototype, they said they haven’t got the money they need to assemble the materials they need,” noted Mr Owino.
The proof of concept he added, entails checking whether the prototypes performed within some laid down parameter, and met the Kebs quality mark.
According to Mr Owino, so far, the ideas are good but there ought to be a framework to support these ideas into actualisation. The innovators will also have to ensure that their prototypes also meet some key parameters like tidal volume which is the volume of air moved into and out of the lungs during each ventilation cycle.
“As a ministry we cannot finance them. That is the mandate of the Ministry of Industrialisation and National Commission for Science, Technology and Innovation (Nacosti). Our work is to evaluate the final product,” he said.
ICU beds capacity across the country remains strained that the Critical Care Society of Kenya now warns that if the projections remain as they are, the country will still not be able to manage Covid-19 patients who will develop severe symptoms of the disease prompting the need for mechanical ventilators.
“Based on mathematical projection and disease progression, we estimated that based on 10,000 cases, a third will require mechanical ventilators. Now, if we are to consolidate all the ventilators available in this country and assume that there are no patients using them, they will still not be enough for the 300 or so severe patients,” explained Dr Misango.
As critically ill patients struggle to breathe, healthcare workers have deployed invasive ventilators that take on the job for them — and help protect those around them from infection.
Critically ill Covid-19 patients usually display symptoms of acute respiratory distress syndrome (ARDS) which makes it difficult for them to efficiently transfer oxygen from damaged lung tissue to their blood.
Typically, the first line of treatment for ARDS is a non-invasive form of assisted breathing where doctors try to raise oxygen levels by delivering it through a nasal tube, a face mask, or helmet.
HOSPITALS WITH VENTILATORS
So far, Dr Misango said, the CCSK only knew of three hospitals (Kenyatta University Teaching, Referral & Research Hospital (KUTRRH), Aga Khan, and Nairobi Hospital) that have managed some critically ill Covid-19 patients who needed mechanical ventilators.
“We have no idea about other Covid-19 designated hospitals. What I can say for sure is that if these ICU facilities and ventilators are not made or bought during this period, then they will never buy them,” he added.
But as more information becomes available about the success of mechanical ventilation in Covid-19 patients, some doctors are questioning whether intubation is the best way to keep these patients alive.
Health Cabinet Secretary Mutahi Kagwe Wednesday said that there are seven Covid-19 patients in critical condition, with four on ventilators while three are receiving oxygen supply.
Based on the latest comprehensive data, there are 245 functional ventilators across 110 public and private hospitals in the country.
However, 123 of these are currently being used on other patients.
With this realisation, local innovators decided to take up the mantle to come up with locally developed ventilators that can be used to boost the capacity for these machines that have become symbols of Covid-19 response globally.