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SIU to probe six companies accused of supplying untested PPE

The SIU will probe six companies accused of flooding health facilities with untested masks during the early stages of the COVID-19 pandemic


Photo: Adobe Stock

The Special Investigating Unit (SIU) have six companies under the microscope after they were alleged to have supplied healthcare workers battling COVID-19 with non-compliant personal protective equipment (PPE), with a coalition of oversight authorities saying that “only a fraction” of the PPE that arrived in South Africa in the early stages of the pandemic was properly tested.

The Sunday Times reported that South African Health Products Regulatory Authority (Sahpra) confirmed the active probe into the businesses (whose names were not disclosed) and said that criminal charges will follow should clear evidence emerge that there the PPE was improperly primed for the front line.

In line with the findings, government has now committed to reinforce procurement methods and ensure that only quality products find their way into hospitals and clinics in the future.

SIU to probe undisclosed companies

Sahpra said that the Special Investigating Unit (SIU) is probing six charges against companies supplying non-compliant masks.

A coalition comprising various regulatory boards including the South African Bureau of Standards (SABS), Business for SA, and the National Regulator for Compulsory Specifications (NRCS) led a study alongside the University of Cape Town (UCT) in which the pressure placed on global supply chains appears to have enticed suppliers to flood the healthcare system with untested KN95 masks.

The research team found that nearly half of the 12 brands of masks sampled failed to pass the test for preventing “inward leakage”, and fell significantly short of the US N95 and  European FFP2 standard for filtration, which is considered both optimum and requisite. 

Professor Barry Schoub, a member of the ministerial advisory committee on vaccines, said that one aspect of the non-compliance involved the fact that KN95 masks “use ear-loops rather than head-straps.”

Business for SA health working group chair Stavros Nicolai told the Sunday Times that the UCT study revealed “a microcosm of what’s actually gone on out there”.

“From late February and most of March, global supply chains were highly constrained. As Chinese capacity recovered in May, a deluge of product began arriving in SA,” he said, adding that none of the suppliers whose masks were tested in the UCT study had been passed by Business for SA.

Untested PPE allegations levelled by Sahpra

Sahpra spokesperson Yuven Gounden told the newspaper that “where there is strong evidence that the non-compliance was approved by the company knowingly, criminal charges will be laid”.

“Sahpra has laid six charges against suppliers so far. These cases are under the jurisdiction of the SIU and therefore the names cannot be divulged.”

In response to the allegations, National Health Department spokesperson Popo Maja played down the findings of the study, saying that it had primarily considered masks from Western Cape facilities, and is therefore not necessarily an accurate representation of the national procurement effort.

“The researchers have now extended the opportunity to test masks in other areas, which we are working with them on,” he said.

“At this stage we are not aware of unsafe masks in other provinces. The Western Cape Department of Health had already withdrawn the poor-quality masks when the researchers shared the results with them.”

Government distances itself from procurement process  

Government played down its role in the procurement of the untested masks, placing the responsibility and subsequent blame at the door of provincial health departments “and in some cases directly by the health facility”. 

“Generally, KN95 must be evaluated and registered with Sahpra for medical use,” said Maja.