Summary of mask types and compliance with standards
The COVID-19 pandemic has led to a substantial increase in demand of personal protection equipment(PPE), including face masks and respirators. A shortage in supplies has particularly affected health workers who are at most risk of infection (Soucheray, 2020). The short fall has led to a rapid increase in the production of face masks motivated by the need for public and health care authorities to acquire hitherto unprecedented numbers of masks, from varying sources, to meet the acute demand. However,operational restrictions placed upon the supply chain have meant that many of these face masks are without certification.
Authorities can be left with vast quantities that have to be either used as uncertified (putting health workers at risk) or put through a lengthy certification process, thereby delaying the deployment of the masks and incurring additional certification expenses. In the worst cases, masks may need to be returned (and potentially not refunded) or destroyed, thus incurring costs and without addressing the shortage.
type:
Face mask:
Loose fitting, to cover the nose & mouth, to capture fluid leaving from the nose & mouth of the wearer. No respiratory protection for the wearer. No protection against liquid or bodily fluids for wearer.
standard:FDA 21 CFR 878.4040 (2019) (USA)
Medical face mask:
Loose fitting, to cover the nose & mouth, to capture fluid leaving from the nose & mouth of the wearer. Offers a specified level of bacterial filtration efficiency. No protection against liquid or bodily fluids for wearer.
standard:EN 14683:2019 (2019) (CEN - European Union)
Fluid resistant surgical face mask:
Loose fitting, to cover the nose & mouth, to capture fluid leaving from the nose & mouth of the wearer. Offers a specified level of bacterial filtration efficiency. Offers a specified level of splash resistance against liquid or bodily fluids for wearer.
standard:EN 14683:2019 (2019) (CEN - European Union)
Respirator:
Tight fitting masks, creating a facial seal. Filters airflow in both directions with a specified level of efficiency.
standard:EN 149:2001+A1:2009 (2009) (CEN - European Union)
Fluid resistant surgical respirator:
Tight fitting masks, creating a facial seal. Filters airflow in both directions with a specified level of efficiency. Offers a specified level of bacterial filtration efficiency. Offers a specified level of splash resistance against liquid or bodily fluids for wearer.
Standard:EN 149:2001+A1:2009 (2009)+ EN 14683:2019 (2019) (CEN - European Union);NIOSH – 42C FR 84 (2014)+ ASTM – F1862 (2017) (USA)
Several National and International certification protocols exist for masks and respirators (see Table 1).
The processes involved in certification and approval can be lengthy and costly (CDC, 2018) either for the manufacturer,importer, institution or authority looking to distribute the devices. During a public health emergency, such as the current pandemic, limited available resources makes it increasingly difficult to carry out these procedures effectively. In such a scenario, access to appropriate, expedient and reliable scientific test data is an essential part of the process that leads to an informed decision; whether to send the devices for certification or to employ them in suitable settings that do not require certification or are considered of lower risk.