Quality Control Challenges of Imported Respiratory and Surgical Face Masks Meant To Fight Covid-19

As the second wave of covid-19 descends on the country, it brings with it memories which takes us as far back as March 2020 when the first case of the virus was reported in South Africa. At that time, the world was scurrying for the limited quantities of personal protective clothing, more specifically respirator and surgical face masks. The increased demand stimulated an increase in the supply of these masks as opportunists took advantage of this demand to also supply inferior quality masks. The quality of masks from established companies also started deteriorating as they traded quality for quantity; as nations imported in bulk and trusted manufacturers whom they had never heard of or whose quality systems were unknown to them.
It later came as no surprise when several countries started recalling some of the respirators. During May 2020, Health Canada issued a recall of KN95 respirators manufactured by dozens of Chinese companies because they posed a health and safety risk to end-users. During the same month, The Food and Drug Administration (FDA) prohibited 65 of the 80 authorised Chinese manufacturers from selling masks for medical use in the United States of America (USA).


While the recalls and re-accreditation of suppliers took place in developed nations, developing countries found themselves faced with limited or no mask testing capacity. The lack of testing capacity has continued to expose these nations to the spread of the virus due through inferior quality masks. In South Africa, the most recent empirical evidence from a study by the University of Cape Town (UCT), published during December 2020, revealed that, based on a sample of 12 KN95 masks brands which failed the safety thresholds associated with the protection of healthcare workers against airborne pathogens such as SARS-CoV-2, some of the KN95 filtering facepiece respirators which have been and are currently in use in South Africa do not meet safety testing protocols.


The fundamental question to ask at this moment is, how easy is it to monitor and control the quality of respirator and surgical face masks that are manufactured in other countries? While several countries implement similar quality standards, the two differences in the quality of masks mainly arise as a result of the extent of oversight by regulatory and compliance bodies in these countries. This is evident when you consider the fact that the requirements of the Chinese standard GB2626:2006 are broadly the same as the European standard BSEN149:2001+A1:2009 for FFP2 facemasks, but most of the KN95 respirator face masks which must comply with the Chinese standard have been found not to comply with this standard or those of other countries. The affixing of the certification symbol on the products at times does not mean that the product conforms to a particular standard as some of these companies rely on once-off testing for certification due to lack of internal capacity. It is difficult for consumers to establish the quality of face masks and nearly impossible for importers to ascertain the quality of these products before there are fully paid for and delivered unless they have sufficient resources to visit the international manufacturers and test these masks, something which is difficult in light of restricted international in the quest of mitigating the spread of covid-19 by countries.


Many countries have allowed the utilisation of imported products without subjecting them to any kind of tests. No one even bothers to check whether the purchased mask is certified by the accreditation body whose symbol or name is affixed to it. Face masks recall of about 5 masks by the European Union in its week 19/2020 report found that either the particle/filter retention of the material of the masks were insufficient or the mask had a CE marking without being certified as protective equipment by the relevant body. Many other recalls by the EU were based on the same or similar reasons.


While the imported quantities are such that it becomes an expensive exercise to undertake numerous tests on respirator and surgical face masks from multiple suppliers used by multiple importers, it is also difficult to attempt to have oversight of the production environment of international companies. It is much easier and less expensive to provide oversight of locally manufactured masks than those which are internationally manufactured. A focus on domestic production has the potential to not only ignite the domestic manufacturing sector and address the unemployment problems faced by the country, but the ease of oversight of local manufacturers may result in the production of masks which meet the required specifications.


While many companies rely on once-off external testing, which is mainly meant for product certification as part of accessing markets, companies such as LNG Scientific (Pty) Ltd have in-house laboratories which ensure consistent and rigorous testing of its N95 respirator and 3 ply surgical face masks. In a country where laboratories struggle with capacity, including laboratories of institutions such as the South African Bureau of Standards (SABS) which are supposed to safeguard the nation, it’s now requiring individual companies to invest in in-house laboratories if the danger posed by inferior quality masks is to be averted. This must be complemented by increased surveillance by the regulatory body, namely the South African Health Products Regulatory Authority (SAHPRA).


As the second wave gains, momentum and the access to the vaccine remains in the distant future for countries like South Africa due to developed nations being in the front of the covid-19 vaccine queues in most pharmaceutical companies, the country must be inward-looking when sourcing respiratory and surgical face masks. The survival of the nation and its frontline workers is heavily anchored on the supply of quality respiratory and surgical face masks.

Published in the City Press Newspaper on the 8th January 2020, Article available here: https://www.news24.com/citypress/voices/to-ensure-quality-ppe-supply-sa-should-manufacture-its-own-20210108

Bornapart Sibanda

Bornapart Sibanda is the Head of Strategy and Planning at LNG Scientific (Pty) Ltd, a BBBEE level 1 accredited and SAPHRA licensed manufacturer of SANAS approved N95 respiratory and 3 Ply surgical masks. The company is located at the Gateway Industrial Park in Centurion.

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