The following information has been received from the Provincial Departments of Health:
PROVINCES | (a) number of the specified KN95 masks were imported for use and/or supply to SA healthcare workers | (b) total amount paid to the suppliers of these masks during the first wave of the COVID-19 pandemic |
Eastern Cape | 900,000 | R38,270,000.00 |
Free State | 450,000 | R20,501,000.00 |
Gauteng | 12,165,760 | R114,863,550.03 |
KwaZulu-Natal | The only KN95 masks received were all donated stock. | R0.00 |
Limpopo | 600,002 | R16,500,025.00 |
Mpumalanga | 450,000 | R20,501,000.00 |
Northern Cape | 280,000 | R11,028,800.00 |
North West | 165,000 | R2,863,500.00 |
Western Cape | 600,000 | R28,715,000.00 |
(2) During the outset of the Covid-19 pandemic the only supplier contracted as part of the transversal contract was for Respirators that complied with the N95 (United States NIOSH-42CFR84) standard. The USA government during this period placed an embargo on the exportation of N95 respirators due to the demand for these in the USA. This situation impacted on the availability of N95 respirators in South Africa.
To manage the procurement of PPE, in this case respirators within the context of a global shortage, Treasury Notes 3 and 5 of 2020/21 made special provisions for the procurement of PPE in an emergency. National Treasury issued Treasury Note 3 of 2020/21 to allow for a central procurement mechanism which would have assisted provinces. However due to objections raised by stakeholders this note was repealed and replaced by Treasury Note 5 of 2020/21. Treasury Note 5 of 2020/218 then enabled local procurement of PPE within the framework of emergency procurement under the Public Finance Management Act (PFMA), as amended, and up to a value of R30 million on a decentralised basis by provinces.
(3) The Infection Prevention and Control guidelines developed in response to the Covid-19 pandemic recommends the use of respirators in environments where aerosol generating procedures are performed.
These respirators or filtering facepiece respirators (FFR), are subject to various regulatory standards around the world. These standards specify certain required physical properties and performance characteristics for respirators to claim compliance with the particular standard.
Noting that all of the above standards are comparable as per the below table.
The National Department of Health Respiratory Protective Equipment (RPE) policy includes Class B devices as registered by SAHPRA and specifically references half face particulate respirators as Class B: “N95”, “KN95”, “FFP2”, and “FFP3” single use disposable filtering facepiece respirators categorised as Class B medical devices by SAHPRA.
All respirators either procured or donated were submitted to the Protechnik Laboratory to assess their compliance with the equivalent South Africa standard: SANS1866-2:2018, SANS50149:2003, SANS50143:2003. Respirators that did not comply with the specified standard were repurposed to be used as surgical masks in low risk infectious areas or in instances where these were purchased the supplier claimed to meet these standards the respirators were returned to the supplier for possible replacement or refund. Any of the respirators that were inadvertently distributed to a setting where it was recommended that a respirator was required these were recalled and replaced with respirators that were compliant with the specified standard. Noting that the laboratory test results were used to assess the compliance of respirators that claimed compliance of the KN95 (China GB2626-2006) specified standard and not all KN95 were found to be non-compliant.
(4) The National Department of Health: Policy for the Regulation of Quality Respiratory Protective Equipment (RPE) Supply in Healthcare, August 2020 makes the following provision, in accordance with SAHPRA requirements, for all licensed establishments to conduct post marketing surveillance.
“Prior to use of respirators purchased, a minimum of 10 respirators per 1000 (or part thereof) and at least 100 units of 10000 should be randomly picked by the purchaser from the boxes in their possession and sent at a minimum for a Particulate Filter Penetration test at a published accredited South African test laboratory (to sodium chloride) which test must indicate that the respirator has passed the minimum specification. This cost is borne by the seller (incorporated into cost of sale) and selection of respirators for testing is conducted by the purchaser to maintain integrity of random selection, testing and reporting to the purchaser.
END.