Slow start to national ventilator project as infection surge looms

SA is in a race against time to build more than 15,000 ventilators in a matter of weeks to meet a predicted surge in Covid-19 cases.

Yet the national ventilator project, launched amid fanfare by the department of trade & industry (DTI) almost two months ago, has yet to kick into top gear.

The government acknowledged this week it was still deciding which of the six shortlisted companies it would give contracts to.

At the same time, the health department released new projections that 20,000-35,000 ICU beds would be needed between June and November.

An ICU bed generally requires a ventilator, a machine that helps a patient to breathe. The coronavirus can cause severe respiratory problems.

SA currently has 3,300 ICU beds in the private and public sectors. A donation of 1,000 ventilators arrived from the US last week and 300 are on order from Israel and are due to arrive in July.

This will bring the tally to just under 5,000 ventilators, leaving a shortfall of at least 15,000 that will need to be made locally within a matter of weeks.

Irshad Kathrada, an adviser to the DTI, said although mass production would only start in about two weeks, this target was achievable.

Dr Anban Pillay, acting director-general of the department of health, said that in some cases the government would require every ICU bed to have a ventilator, but in other cases one machine could be shared by two beds.

An industry source closely involved in the ventilator project said the production target was unrealistic.

"You can't just fly into production and produce hundreds of units at a time. Supply chains need to be reinforced and teething problems smoothed out," the source said.

"When we thought the peak would hit in September, we had time, but we are coming close to the wire."

Iain Ambler, co-owner of Clifford Machines & Technology, said the government's target was "near impossible".

"Production would have had to have been started months ago," said Ambler, whose company has built a prototype ventilator. It is not on the shortlist for the ventilator project, although it did apply to join.

Graham Raynor, Ambler's partner in the company, said certification of the prototype by the South African Health Products Regulatory Authority (Sahpra) would be laborious. The authority's requirements often took months to meet and had not been relaxed.

"The department should be going to Sahpra and the ventilator project to do something to get the ventilators through the system," Raynor said. "There's no sense in getting certification when all this is over."

Now the company is seeking certification for its device from the US federal drug administration, with a view to exporting it.

Raynor's comments were echoed by the head of another consortium that submitted a bid for the ventilator project. This executive, who requested anonymity, slammed the "broken promises" that requirements for medical approvals would be relaxed.

"It just imposes a number of extra barriers and, quite frankly, it's not something that we would entertain. We are a commercial operation and I can't afford to waste time and money on spurious projects."

Yuven Gounden, spokesperson for the Sahpra, said processes had been streamlined but all ventilators needed to comply with World Health Organisation standards.

"The process has not hampered any local manufacturing," he said.

DTI spokesperson Sidwell Medupi said shortlisted prototypes would be tested next week, after which 20,000 systems would be ordered from three of the bidders, to be available by the beginning of July. The prototypes were chosen on April 22.

The ventilator project, launched by trade & industry minister Ebrahim Patel on April 3, was driven by the need to produce non-invasive ventilators in SA amid a global surge in demand and resulting shortages.

Patel said this week the project's success was "critical in saving lives and [it] is benefiting from the time that was bought with the lockdown".

Conventional ventilators require patients to be sedated and have a tube placed down their throats, with breathing controlled by the machine.

Non-invasive ventilators, by way of either a mask or a hood, push oxygen into a patient's face under pressure to aid breathing. Often patients can be conscious, and they don't require as much attention and monitoring from medical staff.

Dr Kerrin Begg, public health specialist at Stellenbosch University, said global data showed that Covid-19 patients did not fare well on traditional ventilators and that the non-invasive machines produced promising results.

She said ventilators were often a key component of intensive care. "If you get to the stage where you need a ventilator and don't have one, you basically have nothing else."

Medupi said the national ventilator project had been expedited in light of the crisis, but that safety was as much of a concern as haste. Rigorous testing was necessary to ensure the finished product was fit for purpose.

"The prototypes are at an advanced stage of development and will be completed in the next week, after which manufacturing contract negotiation will commence if the qualification tests pass scrutiny."

Professor Mosa Moshabela, a primary health-care specialist at the University of KwaZulu-Natal, said it was inevitable that ICU facilities would be overwhelmed by demand.

"In the general course of things, you have a ventilator or ventilatory support for each ICU bed, but in practice it doesn't always happen. It's not necessarily a direct correlation," he said.