By Elisa Morin, Consultant, IB Consultancy
Of all the coronavirus-induce subjects, masks, their types, their use, their certifications might me the blurriest. Ever since the beginning of the COVID-19 crisis, the mask shortage has led to an explosion of the masks market while the use of masks is the new norm in most countries. However, as the French Minister of Health stated that wearing masks was not necessary for healthy people, the US Center for Disease Control and Prevention (CDC) recommended the generalized wearing of masks, making it increasingly difficult to know who is right and who is wrong. In the meantime, the number of different masks available on the market has never been that significant, increasing confusion. Although this short article does not pretend to bring all the answers to the table, this overview should help our reader to make the mask craziness a little bit clearer.
What RPE for COVID19?
When speaking about masks, we refer to a certain type of Respiratory Protection Equipment: the disposable air-purifying particulate respirators. These latter use filters to remove contaminants from the air. They are only effective at protecting the wearer against particles (not gases or vapors) and are discarded when becoming unsuitable for further use.
Although every disposable air-purifying particulate respirator seems to be the same item – an apparatus worn over the mouth and nose – and have the same purpose – prevent the inhalation of dust, smoke or other noxious substances – the COVID-19 crisis has proven that the amount of different masks on the market and the lack of clarity surrounding each is blatant and dangerous.
What efficiency for single, double, triple layered, cloth masks, surgical masks?
The main misunderstanding concerns the single- double- triple-layered, cloth masks, face coverings and surgical (or medical) masks. First of all, these types of masks are not considered or certified as RPE because they do not protect the wearer from inhaling airborne materials and are not tight-fitting, i.e. not designed to prevent leakage around the edge.
With that being said, just because a mask is not considered RPE does not mean it is not efficient. Indeed, these masks are designed to protect people from the wearer and in that sense are effective barriers for retaining large droplets which can be released from the wearer through talking, coughing or sneezing. Thus, if you do wear this type of masks, it does not prevent you from inhaling airborne particles potentially infected with COVID-19, but it dramatically reduces the number of virus particles emitted from your mouth.
In terms of certifications, in the USA, the only devices that can be called surgical masks are fluid-resistant three-layered masks with a particulate filtration efficiency of at least 80%. Single or double layered paper masks are not medical devices and cannot be called “surgical”.
As for Europe, a Standard exists for this type of masks (EN14683:2005) and is based on three characteristics: the Bacterial Filtration Efficiency in vitro – used to determine the amount of bacteria released through the mask into the air – the Breathing Resistance and the Splash Resistance – to determine the resistance penetration of potentially contaminated fluid splashes.
From these three assessments originate four EU Standard Classes: I, IR, II, IIR. The IIR masks have a bacterial filtration efficiency of 98% and are fluid resistant, which makes them the most protective. Even then however, they are not considered RPE because they do not protect the wearer enough.
This first explanation already highlighted the fact that most of the confusion around masks derives from the misconception of the two functions they have: protecting the wearer from the outside world or vice versa.
To recapitulate, single- double- triple-layered, cloth masks, face covering, and surgical masks are efficient when worn to protect the others, as a mean of source control. However, for populations at high-risk for severe illness of COVID-19, it is recommended to wear N95, FFP2 or KN95 masks.
N95, FHP2, KN95: what difference?
Everybody has heard of N95, FFP2 and KN95. They are the most wanted masks on the market currently but for many, the difference between these three types of masks remain unclear.
To begin with, N95 is part of the US National Institute for Occupational Safety and Health’s (NIOSH) nine types of particulate respirator filters. The N stands for “Not resistant to oil” and 95 for the percentage of particles collected by the filter. Thus, a N95 respirator refers to a filtering facepiece respirator (FFR) that seals to the face and uses a filter to remove at least 95% of airborne particles from the user’s breathing air but is not resistant to oil.
There is a slight difference between standard N95 respirators and Surgical N95 respirators. While Standard N95 respirators reduce particles inhaled by the wearer, the Surgical N95 respirators help reduce particles both inhaled and expelled by the wearer and is fluid resistant which make them usable in situations when expelled particulates must be contained or fluid resistance is required. The Surgical N95 is both certificated by NIOSH as an N95 respirator and also cleared by the US Food and Drug Administration (FDA) as a surgical mask.
Regarding FFP2, they are usually referred to as the European equivalence for N95 because it is the European standard with the closest features to the N95. FFP stands for Filtering Facepiece Particles, and the three types (1, 2, 3) refer to the quantity of filtered particles as well as the maximum percentage of internal leak. A FPP1 mask filters at least 80% of particles and has an internal leak rate below 22%, while FFP2 filters 94% and have an internal leak rate below 8% and FFP3 filters 99% with an internal leak rate below 2%.
Finally, KN95 are masks that meet the requirements of China GB2626 standards. They are equivalent to the European and US standards they have a filter efficiency of above 95% for non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses).
Valved or non-valved?
Many masks have an exhalation valve, whether certified N95, N99, FFP2, FFP3… A breathing valve is beneficial to let air out more easily, which allows to avoid building moist and improve your exhaling capability. There is a debate regarding the efficiency of valved respirators. According to some experts, the valve is only a comfort device and does not affect or contribute towards the level of protection that the mask offers. However, according to the European Centre for Disease Prevention and Control, valved respirators are not recommended to be used for coronavirus prevention because they do not prevent the release of exhaled respiratory particles from the wearer into the environment and are not splash-proof.
Certifications: a rapid evolution in policies
On March 13, the European Commission issued a recommendation stating that in the context of the COVID-19 outbreak, non-CE marked PPE were authorized in the European market for a limited period of time as long as they are evaluated by relevant market surveillance authorities and meet the health and safety requirements laid down by the relevant regulation. In Italy, this recommendation was quickly implemented and the National Institute for Insurance against Accident at Work (INAIL) issued a list of non-CE marked masks meeting the essential requirements for the placing on the market. Accordingly, the marketing of non-CE marked PPE is temporarily permitted by the Dutch Minister of Health (HWS), under the conditions listed by the European Commission.
As for the USA, on April 3, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH approved N95 respirators from China, which made KN95 respirators eligible for authorization if certain criteria were met. This second EUA was issued almost two weeks after the first one authorizing non-NIOSH-approved masks from Australia, Brazil, Europe, Japan, Korea and Mexico.
The flexibility shown regarding the certifications of masks mainly comes from the fact that RPE are currently in short supply. This observation leads to different mask policies throughout the world.
What are the countries recommendations about wearing a mask?
As many countries are getting ready to reopen their schools and borders thus putting an end to the lockdown, a question remains: should masks become mandatory in public place? For Asian countries such as Taiwan, Japan, Hong Kong, where the use of masks was relatively common before the coronavirus pandemic, the answer seems easily found and the population easily convinced. However, elsewhere, there are many arguments against the mandatory use of face masks, including the prioritization of health workers in a context of short supply, the lack of direct evidence that non-medical masks are effective, the creation of a false feeling of security that would lead to a relaxing of physical distancing, etc.
In Europe, there is still a few countries that consider face masks and other face covers as a mean of source control. This category includes the Czech Republic (the first country to have made masks mandatory in supermarkets and public transport on March 18), Slovakia, Bosnia and Herzegovina, Austria, Poland and Germany. As for the USA, on April 3, the CDC updated its guidelines to recommend the wearing of “cloth coverings” in public places where social distancing measures are difficult to maintain.
Although the main goal of this article was to make the world of masks clearer than what the future holds in this current situation, it was also the opportunity to highlight the unregulated nature of the mask market. In that respect, we strongly recommend buyers to be careful about the quality and efficiency of the masks they are provided with.
About the Author
Elisa graduated from the University of Bordeaux with a “Global Security and Analysis” Political Science master’s degree in 2019. After working as a research and analyst trainee for a risk and strategic consulting firm in Paris, she joined the IBC team in November 2019.
