Safety Science 129 (2020) 104830

Contents lists available at ScienceDirect

Safety Science
journal homepage: www.elsevier.com/locate/safety

Disposable masks: Disinfection and sterilization for reuse, and non-certified T

manufacturing, in the face of shortages during the COVID-19 pandemic
⁎
Juan Carlos Rubio-Romero , María del Carmen Pardo-Ferreira, Juan Antonio Torrecilla-García,
Santiago Calero-Castro
School of Industrial Engineering, Universidad de Málaga, C/Dr. Ortiz Ramos s/n (Teatinos), 29071 Málaga, Spain

A R T I C LE I N FO A B S T R A C T

Keywords: The COVID-19 pandemic is posing a huge global health threat. To deal with this problem, in addition to research
PPE and work in the medical field, the main health measures being taken in the workplace and at home involve the
SARS-COV-2 establishment of safety protocols, which include distance measures, hygiene and the use of personal protective
Coronavirus equipment, such as masks, etc. The WHO still does not recommend the use of masks for the general population.
Filtering facepiece respirators
However, their successful use in China, South Korea and the Czech Republic has encouraged their widespread
Decontamination
Reuse
use, and the shortage that already existed. This has caused that companies and individuals are looking at the best
way to reuse them, and to manufacture, homemade or not, of non-certified masks. This paper is based on two
objectives: to consult the scientific literature to identify the main strategies for disinfecting them, and to de-
termine the effectiveness of non-certified disposable masks. A rapid review has been conducted in which the
main publications and other information available online have been analyzed. Results showed that the most
promising methods are those that use hydrogen peroxide vapor, ultraviolet radiation, moist heat, dry heat and
ozone gas. Soapy water, alcohol, bleach immersion, ethylene oxide, ionizing radiation, microwave, high tem-
perature, autoclave or steam are not fully recommended. Regarding the effectiveness of surgical masks compared
to PPE, the former have been seen to be slightly less effective than PPE. As for other types of masks the effec-
tiveness of homemade or non-certified masks is very low.

1. Introduction to create detection tests, vaccines, antivirals and other treatments, the
main measures used in the health, work and domestic spheres have
The COVID-19 pandemic caused by the virus SARS-COV-2, which focused on social distancing and lockdown, as well as on the monitoring
first emerged in Wuhan, China, in the province of Huebei in December of safety protocols, the adoption of hygiene measures, and the use of
2019, is posing a huge global health threat. The total number of global personal protection equipment such as masks, gloves, etc. This has
deaths on the date of submitting this paper (24 April 2020) has risen to meant that terms that were previously used by occupational health and
191.263, with 2.717.004 infected (European Centre for Disease safety professionals alone, such as FFP2, FFP3, N95, KN95, etc., have
Prevention and Control, 2020c). The economic impact will be un- become part of the common language and have had a positive effect in
doubtedly colossal and we are still unaware of the real consequences the field of health and safety by popularizing and increasing the culture
this will have on each country's economy and on the labor market. It is of prevention of society as a whole.
not the first pandemic that we have suffered, but the dimensions of this However, we cannot forget the importance that the World Health
one are especially shocking and only comparable to the flu pandemic of Organization (WHO) has played in this context. It initially made dif-
1918, a little over a century ago. It is certainly a public health threat ferent recommendations for the groups including healthcare personnel,
that goes beyond occupational health and safety, and it transgresses the people in direct contact with the infected and people with symptoms
borders of business organizations, being of primary concern to virolo- (Holland et al., 2020, Jansson et al., 2020) on the one hand, and for the
gists and epidemiologists, but also to technicians, specialists and aca- rest of the people on the other. While recommending the use of masks
demics in the field of safety who can make a significant contribution to for the first three groups of people, it did not do the same for in-
its prevention. In addition to the past and present research carried out dividuals, where it focused on measures of social distancing, minimum

⁎
Corresponding author.
E-mail addresses: [email protected] (J.C. Rubio-Romero), [email protected] (M.d.C. Pardo-Ferreira), [email protected] (J.A. Torrecilla-García),
[email protected] (S. Calero-Castro).

https://doi.org/10.1016/j.ssci.2020.104830
Received 24 April 2020; Accepted 10 May 2020
Available online 13 May 2020
0925-7535/ © 2020 Elsevier Ltd. All rights reserved.
J.C. Rubio-Romero, et al. Safety Science 129 (2020) 104830

interpersonal distance, and personal hygiene, more specifically the as Personal Protection Equipment (PPE) or medical use. Likewise, other
adequate washing of hands, since airborne propagation was ruled out types of masks have been included in the classification in order to ob-
under normal conditions (WHO, 2020a). To date, although the WHO tain a complete overview of those that are currently being used due to
acknowledges that “wearing a medical mask is one of the prevention the situation caused by COVID-19 such as cloth, hygienic, homemade or
measures that can limit the spread of certain respiratory viral diseases, non-medical masks. This classification has been developed based on the
including COVID-19” (WHO, 2020c) it also says that “however, the use definitions proposed by the European Center for Disease Prevention and
of a mask alone is insufficient to provide an adequate level of protec- Control (European Centre for Disease Prevention and Control, 2020a),
tion, and other measures should also be adopted”. Therefore, on 20 although it has been adapted to include new types of masks such as
April 2020, it still recommends that “If you are healthy, you only need hygienic masks according to Specification UNE 0064:2020 and UNE
to wear a mask if you are taking care of a person with COVID-19” 0065:2020 recently developed by the Spanish Association for Standar-
(WHO, 2020b). Nevertheles, it advises that each country apply a risk- dization (UNE, 2020a, 2020b, 2020d). These masks are intended for
based approach, that is, considering the benefits (possibility of reducing people or children without symptoms who are not susceptible to using
the potential risk of exposure during the presymptomatic period) as surgical, medical or PPE/filter masks to protect them against particles,
well as the potential risks (self-contamination, false sense of security, in accordance with the restrictions established by the Government of
impact on mask shortages), when deciding whether to recommend the Spain, which currently recommends these latest types of masks for
use of masks by the general population (WHO, 2020c). healthcare workers and people infected or with symptoms of COVID-19.
In this sense, the success of policies followed by countries such as Therefore, Table 1 focus on disposable mask such as PPE, medical mask
South Korea, China and the Czech Republic regarding the use of masks and others that can be single use (non-reusable hygienic mask) or some
from the very beginning, in addition to other measures, have demon- uses (barrier mask, reusable hygienic mask, cloth mask…). Reusable
strated their benefits (World Economic Forum, 2020). News of this has face mask respirators, such as reusable half mask or full face mask, that
spread through social networks and the media, and has meant that the allow long-term use by changing their filters are not included in this
use of masks has become widespread in countries such as Italy, Spain classification (see Fig. 3).
and others hit hard by the pandemic, despite the fact that to date the Disposable filtering facepiece particulate respirators, including
WHO still does not explicitly recommend it. reusable and disposable ones, are Personal Protective Equipment
This has led to the European Center for Disease Prevention and (hereinafter PPE) in European working environments, and are regulated
Control (European Centre for Disease Prevention and Control, 2020a) to by Regulation (EU) 2016/425 of the European Parliament and of the
recognize that the use of masks by the population could reduce the Council of March 9, 2016, on personal protective equipment and re-
spread of the infection, but it remembers that this should be a com- pealing Council Directive 89/686/EEC (European Parliament and the
plementary measure to preventive hygiene measures. Likewise, the Council of the European Union, 2016) which obliges the manufacturer
Centers for Disease Control and Prevention (2020b) recommends the to apply the CE marking and to follow the procedure for evaluating and
use of cloth face coverings to help slow the spread of COVID-19 and the complying with the requirements for that marking specifically estab-
Government of Spain recommends the use of hygienic masks by the lished in that directive (see Figs. 1–3). For this purpose, the manu-
population (Ministry of Health of Spain, 2020b). facturer will have a set of standards, the main one being EN
These circumstances together with the mass use of masks by health 149:2001 + A1:2009, entitled “Respiratory Protective Devices. Fil-
workers, essential service companies, cleaners, supermarkets and other tering half mask to protect against particles. Requirements, testing,
people in food supply, security, transport, etc., have caused a shortage, marking” (AENOR, 2010). Additionally, the manufacturer should abide
leading the authorities in different countries to confiscate PPE and by a series of standards, among which the following should be high-
medical masks, among other means, that are used to fight the disease. lighted: EN 132: 1999. “Respiratory protective devices - Definitions of
Furthermore, this situation is expected to persist for some time, since terms and pictograms” (AENOR, 1999); EN 134: 1998. “Respiratory
the WHO itself estimates that approximately 89 million medical masks protective devices - Nomenclature of components” (AENOR, 1998),
are needed each month to respond to COVID-19 (WHO, 2020d). EN143:2001. “Respiratory protective devices. Particle filters. Require-
This is why governments, hospitals, companies and even in- ments, testing, marking.” (AENOR, 2001), and EN 13274-7: 2008.
dividuals, have also begun to look for solutions of all kinds, including “Respiratory protective devices – Test methods - Part 7: Determination”
the reuse, cleaning and disinfection of certified disposable masks, either (AENOR, 2008). This summary of standards will facilitate the presumed
Personal Protection Equipment or medical, and the manufacture of compliance of the manufacturer, and will usually lead to the certifica-
homemade or non-certified ones (European Centre for Disease tion of the mask according to the standard. There are also other
Prevention and Control, 2020a). In addition, at the time of submission countries outside Europe with their own similar certification or
of this paper, a lockdown is in place in many countries around the homologation systems, such as the United States (42 CFR 84), China
world, but once it is lifted, a greater number of masks will be required (GB2626-2006), South Korea (KMOEL-2017-64), Australia/New
to meet increasing needs. Zealand (AS/NZA 1716:2012), Japan (JMHLW-2000), etc. (see
Consequently, prevention professionals, companies and individuals, Table 3). For example, Fig. 4 shows a disposable N95 face mask ac-
from all over the world need to know how to disinfect and sterilize cording to 42 CFR 84 used in the United States.
masks that, in principle, were designed, manufactured and certified for Additionally, European healthcare systems use disposable medical
short-term use and subsequent disposal, and also to be aware of the or surgical masks, which are not PPE but “surgical/medical apparatus
effectiveness of homemade or non-certified ones. Thus, in this pub- and devices”, which are standardized by EN 14683:2019 + AC:2019
lication we conducted a rapid review of scientific publications, pre- “Medical face masks - Requirements and test methods” (UNE, 2019)
prints, protocols, guides and other information available online with (see Fig. 5). As in the case of PPE, there are also different certifications
two objectives. On the one hand, to identify in the scientific literature in other countries such as ASTM F2100-11 in the United States or YY
the effectiveness of disposable or non-certified masks. On the other 0469 in China.
hand, to identify the main strategies for their disinfection and/or ster- Due to the public health threat caused by SARS-COV-2, there has
ilization, as well as their advantages and disadvantages. been a lack of disposable masks certified to meet European technical
standards. In this situation, the European Commission published the
2. Types of masks Commission Recommendation (EU) 2020/403 of March 13, 2020 on
conformity assessment and market surveillance procedures within the
Table 1 presents a classification of the different types of disposable context of the COVID-19 threat to allow, as long as the shortage lasts,
masks available according to the use for which they are intended, such the commercialization of PPE or medical devices that comply with non-

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J.C. Rubio-Romero, et al. Safety Science 129 (2020) 104830

Table 1
Classification of disposable face masks for particle filtration. (Adapted from: European Centre for Disease Prevention and Control, 2020a).
Types Description

Filtering facepiece (FFP) respirators (also known as respirator) It is classified as personal protective equipment (PPE) designed to protect the wearer from exposure to
airborne contaminants. Filtering facepiece respirators comply in Europe with requirements defined in
Regulation (EU) 2016/425 through European Standard EN 149:2001 + A1:2009. In other countries
with similar standards such as NIOSH-42CFR84 in the United States or GB2626-2006 in China.
Medical face mask (also known as surgical mask or procedure mask) It is classified as a medical device that covers the mouth, nose and chin ensuring a barrier that limits
the transition of an infective agent between the hospital staff and the patient. Medical masks comply
with requirements defined in Directive 93/42 CE or Regulations UE/2017/745 through European
Standard EN 14683:2019 + AC:2019 or with similar standards in other countries such as ASTM
F2100- 11 in the United States or YY 0469 in China.
Other face masks (also commonly known as non-medical, home made, This type of mask includes various forms of self-made or commercial masks or face covers made of
cloth, fabric, ‘community’, hygienic or barrier masks) cloth, other textiles or other materials such as paper. Within this group most are not standardized
except those that are manufactured according to AFNOR SPEC S76-001 or Specifications UNE 0064-
1:2020, UNE 0064-2:2020 and UNE 0065:2020. In any case, these masks are not intended for use in
healthcare settings, or by healthcare professionals nor for workers. The European Centre for Disease
Prevention and Control (2020a) calls these masks non-medical face masks or “community” masks and
the Centers for Disease Control and Prevention (2020b) call them cloth face coverings. Masks
manufactured according to the AFNOR Specification (2020) are called barrier masks and those
manufactured according to the UNE Specifications (UNE, 2020c, 2020e) are called hygienic masks.

Fig. 3. Non-Disposable Face Mask FFP3. Source: Marcapl (2020).

Fig. 1. Disposable Face Mask FFP2. Source: Bimedica, 2020a.

Fig. 4. Disposable Face Mask N95.

Fig. 2. Disposable Face Mask FFP3. Source: Bimedica, 2020b. Source: Battelle (2016).

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J.C. Rubio-Romero, et al. Safety Science 129 (2020) 104830

Spanish Association for Standardization (UNE) published some key

specifications to facilitate the manufacture of hygienic masks that, if
made under this specification, would offer people protection against the
COVID-19 pandemic (UNE, 2020c, 2020e). In that way, on April 2020,
the Specification UNE 0064 for non-reusable hygienic masks and the
Specification UNE 0065 for reusable hygienic masks were published.
The first is made up of two parts: Specification UNE 0064-1. Non-reusable
hygienic masks. Materials, design, manufacturing, marking and usage re-
quirements. Part 1: For adult use and Specification UNE 0064-2. Non-
reusable hygienic masks. Materials, design, manufacturing, marking and
usage requirements. Part 2: For children use and establishes specifications
for manufacture and use. The second is made up of a single part: Spe-
cification UNE 0065. Reusable hygienic masks for adults and children.
Materials, design, manufacturing, marking and use requirements (UNE,
2020d). The interesting fact is that these Specifications allow con-
formity assessment to be certified by a laboratory based on technical
specifications UNE-EN 14683:2019 + AC: 2019, or another equivalent,
which offers greater guarantees to wearers.
Fig. 5. Medical or surgical mask. Source: own elaboration.
The advantage of hygienic masks compared to barrier masks is that
the former have been tested following some of the procedures of EN
European standards even if they do not have the CE marking. WHO 14683:2019 + AC:2019, achieving good results in the acceptance cri-
recommendations may be followed for their selection, but an adequate teria for the effectiveness of bacterial filtration and breathability, as
level of protection must be guaranteed and the corresponding notifying explained in the next section.
authority immediately informed (European Commission, 2020). Simi- The development of this Specification is positive due to the effect it
larly and subsequently, on March 28, 2020 and April 3, 2020 (Food and may have on the availability of masks for the general population, or
Drug Administration, 2020a, 2020b), the United States government rather people that are healthy or asymptomatic, since many countries
published authorizations to import Non-NIOSH-Approved filtering fa- have begun to announce that they will require the use of masks despite
cepiece respirators from other countries (see Table 3). the current shortage. However, it still takes time for hygienic masks to
This situation of widespread shortages has led the civil society in reach the population. As it mentioned above, on April 8, 2020, the
different countries to dedicate itself to making all kinds of improvised European Centre for Disease Prevention and Control recommended the
facemasks without any guarantee of certification or homologation (see use of masks by the population as a complementary preventive measure
Fig. 6). Initially, individuals began to do this and the idea spread across (European Centre for Disease Prevention and Control, 2020a) and there
social networks, which resulted in misunderstandings and sometimes are countries, such as Spain, that recommend their use beginning April
including intentional fakes or hoaxes by trolls. Thus, individuals and 13, 2020, without sufficient stock to cover the entire population. This is
even organizations began to prepare masks from different types of why “improvised” or “community” masks have become crucial and
materials that allow users to cover their mouth and nose. Subsequently, must be used with caution, since their effectiveness has not been
the authorities or institutions themselves have released their own proven.
documents to maximize the effectiveness of masks and minimize the
negative impact of not being manufactured in accordance with the 3. Effectiveness of the masks
quality standards established by international standardization and
certification bodies. The effectiveness of disposable masks is different depending on the
Faced with this situation, some standardization organizations began type and certification standard. In particular, the EN 149:2001-A1:2010
to develop reference documents. In this regard, it should be noted that, standard (AENOR, 2010), establishes 3 levels of protection depending
at the end of March, the French Association for Standardization pub- on the leakage of all particles into the interior, either through the ad-
lished AFNOR SPEC S76-001 Barrier masks. Guide to minimum require- justment of the mask to the face, by the exhalation valve if any, or
ments, test methods, manufacture and use for mass manufactured and penetration through the filter, always measured according to the ar-
homemade masks (AFNOR, 2020). However, this document contains ithmetic measurement of the laboratory tests carried out by carriers.
recommendations for design and use but does not allow conformity These are:
assessment by notified bodies or laboratories. On the other hand, the
• 22% for FFP1.
• 8% for FFP2.
• 2% for FFP3.
In the case of the North American standard 42 CFR Part 84 devel-
oped by NIOSH (NIOSH, 1995), nine types of filters are established,
composed of three levels of minimum filtration efficiency and three
categories of resistance to the degrading effects of the oil at the work-
station. These resistance categories are: “N” Non-oil resistant, “R” Oil
resistant and “P” Oil-proof. The levels of efficiency of filtration against
aerosols have been determined considering a 0.3 µm aerodynamic mass
median diameter and these are:

• 95% for N95, R95, P95.

• 99% for N99, R99, P99.
Fig. 6. Homemade or non-certified disposable Face mask. Source: El País
(2020).
• 99.97% for N100, R100 and P100.
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J.C. Rubio-Romero, et al. Safety Science 129 (2020) 104830

Table 2
Filtering Face Piece (FFP) respirators that could be used as PPE against COVID-19. ().
Adapted from Food and Drug Administration, 2020a, 2020b
Country Performance Standard Acceptable Product Classification Standards/Guidance Documents Protection Factor ≥ 10

Australia AS/NZS 1716:2012 P3, P2 AS / NZS 1715: 2009 YES

Brazil ABNT/NBR 13698:2011 PFF3, PFF2 Fundacentro CDU 614.894 YES
China GB 2626-2006, KN100 KP100 KN95 KP95 GB / T 18664-2002 YES
GB 2626-2019
Europe EN 149-2001 FFP3 FFP2 EN 529: 2005 YES
Japan JMHLW-2000 DS/DL3 DS/DL2 JIS T8150: 2006 YES
Korea KMOEL-2017-64 Especial Primero GUÍA KOSHA H-82-2015 YES
Mexico NOM-116-2009 N100, P100, R100 N99, P99, R99 N95, P95, R95 NOM-116 YES
USA NIOSH 42 CFR 84 N100, P100, R100 OSHA 29CFR1910.134 YES
N99, P99, R99
N95, P95, R95

Logically, other regulations also establish their particular level of reduction factor in exposure of 100 while a surgical mask would pro-
effectiveness. Table 2 below summarizes the FFP respirators that are vide a mean reduction factor of 6. On the other hand, Lee et al (2008)
recommended as PPE against COVID-19, according to the standards of have undertaken the task of comparing the N95 respirators and surgical
different countries (Food and Drug Administration, 2020a, 2020b). It masks against particles representing bacterial and viral size ranges. As a
should therefore be noted that masks with an exhalation valve, re- result, their study found that around 29% of N95 respirators and 100%
gardless of their level of effectiveness, are not recommended as PPE of surgical masks had a protection factor < 10 (protection factor set by
against SARS-COV-2, since exhaled air is released directly into the en- OSHA for that type of mask). So, they concluded that the N95s may not
vironment without any type of filtration and would favor the spreading offer the expected protection level against bacteria and viruses. How-
of the coronavirus (European Centre for Disease Prevention and ever, in 2016 we found the work of Smith et al. (2016) in which they
Control, 2020a, Ministry of Health of Spain, 2020a). compared the effectiveness of N95 respirators versus surgical masks in
Regarding the effectiveness of surgical or medical masks, the EN protecting healthcare workers from acute respiratory infection. Their
14683:2019 + AC:2019 (UNE, 2019) standard establishes two types study did not find sufficient evidence to uniquely determine that N95
depending on their bacterial filtration efficiency and breathability. In respirators are superior to surgical masks as protection for healthcare
addition, within Type II there are two categories depending on whether workers against acute respiratory infections in clinical settings. How-
they are splash resistant or not, as shown in Table 3. Type I masks are ever, they pointed out that in the laboratory setting, the N95 respirators
only recommended for patients and other people including healthcare seemed to offer greater protection than the surgical masks. A similar
professionals to reduce the risk of spreading infection. study was carried out by Radonovich et al (2019) to compare the effect
The effectiveness of homemade or cloth masks is unknown a priori, of N95 respirators vs. surgical masks to protect healthcare workers
as they are not manufactured according to a standard. However, in the against influenza and other viral respiratory infections. They found no
case of hygienic masks abiding by the Specifications UNE 0064 and significant difference between the two masks in the incidence of in-
UNE 0065 (UNE, 2020a, 2020b, 2020d), tests have been carried out and fluenza in the laboratory setting.
some of the operating requirements established in EN Regarding the comparison with non-certified or homemade masks,
14683:2019 + AC:2019 (UNE, 2019) have been analyzed. The results Rengasamy et al (2010) carried out an evaluation of the filtration ef-
are presented in Table 4. ficiency of this type of mask against particles. To do this, they tested
Although the effectiveness of the masks depends substantially on these masks for 20–1000 nm size particles, specifically, polydisperse
their correct use, and they can often be overestimated (Garrigou et al, and monodisperse aerosols, at two speeds. Since there are a wide
2020), it is especially interesting to know the comparative effectiveness variety of homemade masks with various characteristics, they used the
of different types of masks, assuming their correct use, to determine the five main types made of sweatshirts, T-shirts, towels, scarves, and cloth
level of protection in each case. In particular, the bibliography re- in the test. Furthermore, they compared the results with the penetration
garding the comparative effectiveness of PPE-certified, surgical and levels presented by N95 respirators. Their results indicated that these
other masks has been reviewed below. masks had 40–90% instantaneous penetration levels at a low speed and
Thus, in a HSE study, Gawn et al. (2008) compared in a laboratory between 9 and 98% at a higher speed. Subsequently, MacIntyre et al.
the protection for airborne particles of surgical masks against FFP re- (2015) compared the effectiveness of cloth mask vs. medical mask in a
spirators and found the lowest level of respiratory protection in surgical hospital. In this study, 1607 healthcare workers participated, who wore
masks against FFP respirators. Specifically, they calculated a reduction the masks for 4 weeks during their shifts in the hospital and performed
factor for exposure to live aerosolized influenza virus as the ratio of the procedures where aerosols are usually generated, such as suctioning of
particle concentration inside and outside for each mask. Their results airways, sputum induction, endotracheal intubation and bronchoscopy.
indicated that a properly adjusted FFP respirator can provide a mean Their results indicate that the penetration of the medical mask by the
particles was 44% while the penetration for the cloth mask was almost
97%.
Table 3
In addition to the above, some organizations indicate that these
Performance requirements for surgical masks according to EN
improvised masks should be the last solution and for low-risk cases, but
14683:2019 + AC:2019.
that they can even increase the risk of infection due to humidity, liquid
Test Type I a Type II Type IIR diffusion and virus retention (European Centre for Disease Prevention
and Control, 2020b).
Bacterial Filtration Efficiency (BFE), ≥ 95 ≥ 98 ≥ 98
(%)
Differential pressure (Pa/cm2) < 40 < 40 < 60 4. Reuse, disinfection and sterilization of disposable masks
Splash resistance pressure (kPa) Not Not required Not required 16
required Not required 3 16.0
Microbial cleaning (ufc/g) ≤ 30 ≤ 30 ≤ 30 To analyze reuse, disinfection and sterilization, we must differ-
entiate between the different types of marks presented in Table 1.

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Table 4
Acceptance criteria for hygienic masks according to the Specifications UNE 0064:2020 and UNE 0065:2020.
Test Acceptance criteria for non-reusable hygienic masks Acceptance criteria for reusable hygienic masks

Bacterial Filtration Efficiency (BFE), (%) ≥ 95 ≥ 90

Differential pressure (Pa/cm2) < 60 < 60

We must remember that either PPE (-FFP respirators) or medical Like all respiratory equipment used for protection against particles,
face masks manufactured according to technical standards, require that filtering FFP2 respirators are thermally tested for their marking and
they be discarded after use, since they are heat sensitive and are not certification, which entails subjecting the equipment to 70 °C for 24 h,
designed to undergo a process as severe as sterilization (Rowan and followed by another 24 h at 30 °C (Ministry of Labor and Social
Laffey, 2020). This is why manufacturers like 3M initially advised Economy, 2020). It therefore appears that this method is of singular
against the sterilization process (3M, 2020a). However, due to the importance. Therefore, Song et al. (2020) carried out a study on FFP
shortage of these masks caused by the COVID-19 crisis, manufacturers, respirators, but with the flu virus, and used an oven for 30 min at 56 °C
including 3M, governments and related agencies and institutions began as well as hot air from a hair dryer for 30 min. These researchers ob-
to analyze the reuse, disinfection or sterilization of PPE (– FFP re- tained total inactivation in the case of the dryer and partial inactivation
spirators). of the virus in the case of the oven, without affecting filtering capacity.
As far as reuse of PPE is concerned, the first thing to know is how Based on this, both the Spanish Ministry of Labor and Social Economy
long the SARS-COV-2 remains on surfaces. Kampf et al. (2020) analyzed (2020) and the International Medical Center of Beijing (2020) indicate
22 studies focused on this question and studied different human cor- that FFP respirators maintain their filtration efficiency after being dis-
onaviruses, such as Severe Acute Respiratory Syndrome (SARS) cor- infected at 70 °C for 30 min, although no effects on the fit or de-
onavirus, Middle East Respiratory Syndrome (MERS) coronavirus or formation are mentioned. According to N95DECON (2020d), it could be
endemic human coronaviruses (HCoV). They concluded that human pointed out as an advantage that under these conditions, heat in-
coronaviruses remain on inanimate surfaces such as metal, wood, activates related coronavirus, although the disadvantage is that there
paper, glass or plastic for up to 9 days, but they can be efficiently in- are no data confirming that SARS-COV-2 is inactivated with dry heat
activated through disinfection with 62–71% ethanol, 0.5% hydrogen and several decontamination cycles could lead to the degradation of the
peroxide or 0.1% sodium hypochlorite within 1 min of exposure. effectiveness of the filtration or the fit. In this way, Spanish Society of
However, it is important to note that none of the studies analyzed by Preventive Medicine, Public Health and Hygiene (2020) recommends,
Kampf et al. (2020) focused specifically on SARS-COV-2 and that only as a method of decontamination for FFP respirators, dry heat < 70 °C
one of them showed 9-day persistence of the coronavirus, all the others for 30 min in a convection oven to guarantee constant and uniform
indicated 5 days at most. In another recent study, tests were conducted temperature maintenance. Likewise, Price and Chu (2020) recommend
with the SARS-CoV-2 and SARS-CoV-1 in aerosols and on various sur- disinfection under those same conditions and they add that it could be
faces. Their results indicate that SARS-CoV-2 remains on plastic, done for 20 cycles.
stainless steel, copper and cardboard surfaces for up to 72 h (Van Regarding decontamination of FFP respirators by ozone, Zhang
Doremalen et al., 2020). et al. (2004) studied the inactivation of the SARS-CoV-1 by applying
Based on this study and given the need to reuse FFP respirators, the different concentrations of ozone solution disinfectant. They found that
US government has recommended that each healthcare worker receives this virus could be inactivated using a high concentration of 27.73 mg/
five FFP respirators and uses one per day in a specific order. At the end L for 4 min. Dennis et al. (2020) conducted another study where they
of the workday, the FFP respirator must be kept in a breathable paper analyzed the scientific literature available in this regard and concluded
bag and stored by order of use. If the worker stores and uses their FFP that the existing findings in other studies seem to support that ozone
respirators in order each day, a minimum of five days between the use inactivates viruses by attacking capsid proteins. They proposed a de-
of each FFP respirator elapses (Centers for Disease Control and contamination method using ozone to inactivate SARS-CoV-2. Thus,
Prevention, 2020a). However, these recommendations should be they performed different experiments in two ozone decontamination
treated with caution, since FFP respirators are designed for single-use boxes. Based on this, they proposed practical recommendations to im-
and could be damaged, lose some of their properties and become in- plement a simple disinfection box system using inexpensive and readily
effective as a barrier against contagion. Furthermore, due to the available components that could be used for FFP respirators. The ozone
aforementioned shortage, five FFP respirators may not be available per concentrations required are 10–20 ppm with an exposure for at least
healthcare worker. Therefore, it is necessary to study disinfection or 10 min. They noted that it is an improvised solution for situations of
sterilization methods. need such as the COVID-19 pandemic, but not an optimal long-term
In this regard, it should be noted that any method used for the solution. Among the advantages of ozone gas, they indicated that its
disinfection of FFP respirators must guarantee effectiveness against virucidal action is faster than the degradation effect of the FFP re-
COVID-19, that the mask is not damaged in terms of the adjustment to spirator, which is effective for disinfecting fibrous materials, as it is a
the face or its filtration capacity, and that it is not harmful to the person dry virucidal, and that it reaches shadows and crevices in the process
wearing the respirator (3M, 2020b). Therefore, governments, manu- disinfection, unlike ultraviolet radiation as will be seen later.
facturers, scientists or experts in the field are working towards finding Other methods that seem promising are Vaporized Hydrogen
the most effective method for disinfecting FFP respirators against Peroxide, Low Temperature Moist Heat and ultraviolet C radiation (3M,
COVID-19. 2020b, Centers for Disease Control and Prevention, 2020a, N95DECON,
Under these premises, multiple potential methods for disinfection 2020a). Firstly, regarding the use of ultraviolet (UV) radiation,
and sterilization have begun to be studied. Some based on chemical Jinadatha et al. (2015) studied disinfecting PPE prior to doffing by
methods, such as the use of H2O2 hydrogen peroxide, chlorine dioxide, applying pulsed xenon ultraviolet (PX-UV) on glass carriers and PPE
bleach, alcohol, soap solutions, ethylene oxide, ozone decontamination, material contaminated with an Ebola surrogate virus. As a result, the
etc., and physical methods, such as the use of heat with steam or with viral load on both glass carriers and PPE materials decreased after ex-
dry air, UV rays, gamma irradiation, microwave, etc. (Mohapatra, posure to PX-UV. Numerous studies are therefore currently being car-
2017), although strict follow-up of procedures is undoubtedly of vital ried out to determine its effectiveness for decontamination against the
importance, and this is not always the case (Bessesen et al., 2015). coronavirus. O'Hearn et al. (2020), have developed a systematic review

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J.C. Rubio-Romero, et al. Safety Science 129 (2020) 104830

on the efficacy and safety of FFP respirators(N95) after decontamina- respirator, shadows may appear giving rise to parts of the FFP re-
tion with ultraviolet germicidal irradiation (UVGI). They have analyzed spirator that have not been decontaminated, straps may not be com-
13 papers and have concluded that the filtering effectiveness of FFP pletely decontaminated, the strap and facepiece may be damaged after
respirator is maintained after a UVGI cycle and they propose the use of UV-C and at high UV-C doses (≥120 J/cm) the N95 can be damaged.
a cumulative UV-C dose of 40,000 J/m2 in future research to validate On the other hand, the use of Hydrogen Peroxide or H2O2 has also
this promising method. Likewise, they have indicated that it will be been recently evaluated, although there were already previous studies
necessary to carry out fit tests. Moreover, Card et al (2020) analyzed the such as that carried out by Battelle, an FDA Contractor, which analyzed
possibility of using biosafety cabinets for the decontamination of FFP the decontamination and reuse of FFP respirators (N95) using
respirators (N95) by ultraviolet germicidal irradiation (UVGI). For this Hydrogen Peroxide Vapor (HPV) and the Bioquell Clarus C system. In
purpose, they tested the UV-C radiation in two randomly chosen idle this study, only the efficacy of disinfection for the inactivation of G.
biosafety cabinets in which they measured the minimum intensity and stearothermophilus spores was verified. They specifically demonstrated
obtained a factor of 1:71 and 1:98 less than the maximums of each that they had achieved a 6-log reduction in organism and that in-
biosafety cabinet, respectively. Based on the maximum observed ratio activation continued to occur in up to 50 decontamination cycles.
(1:98), they estimated the sterilization time for FFP respirators (N95) in Regarding mechanical integrity and performance in up to 50 cycles, the
a biosafety cabinet. Finally, they developed a protocol to disinfect an filtration capacity was maintained, but the adjustability was affected
FFP respirator after irradiating it for 15–20 min per side with a fluence because the strap became degraded after 10–20 cycles and broke after
of 100 µWcm−2 (per manufacturer’s records). 30 cycles. The recommended wash cycle was 480 min. In this way, they
Recently, another report also focusing on the use of ultraviolet demonstrated that this process was feasible to decontaminate large
germicidal irradiation (UVGI) on FFP respirators (N95) has been pub- amounts of FFP respirators simultaneously (up to 50 cycles) with
lished online by Nebrasca Medicine (Lowe et al., 2020). They demon- Hydrogen Peroxide Vapor, since the filtration requirements of FFP re-
strated that UVGI is effective in inactivating a large number of human spirators were maintained, although they recommended studying al-
pathogens, including coronaviruses, and that if UVGI is applied on FFP ternative materials for the straps or studying other models of FFP re-
respirators (N95), these pathogens are inactivated. Likewise, the ne- spirators (Battelle, 2016).
cessary levels of UVGI do not affect the fit and filtering effectiveness of Actually, based on this study, Schwartz et al. (2020) have performed
the FFP respirators and can be safely administered after providing validation tests on Hydrogen Peroxide Vapor (HPV) to decontaminate
adequate safeguards. According to them, Hamzavi et al. (2020) re- FFP respirators (N95) using the Bioquell 61 Clarus™ C system with a
commend its use for the inactivation of SARS-CoV-2 due to the shortage 35% hydrogen peroxide solution for the time recommended by Battelle
of FFP respirators, highlighting that UVGI does not degrade the poly- (2016). They have validated the method and point out that FFP re-
mers. Thus, there are already other organizations that recommend this spirators retain their filtering effectiveness after 50 cycles in the la-
protocol proposed by Nebrasca Medicine as a decontamination method boratory. In addition, they performed fit tests and the results indicate
(N95DECON, 2020e). Similarly, Spanish Society of Preventive that no loss of fit occurred. Therefore, they say that they are going to
Medicine, Public Health and Hygiene (2020) includes among the re- start using this decontamination process, which has been internally
commended decontamination methods for FFP respirators the UVGI validated and approved by the Duke Institutional Biosafety Review
with double lamp (up and down) 36 W and exposure time of 148 s. Committee (IBRC).
They indicate an effectiveness of bacterial disinfection with 7log re- It is important to note that, on March 29, 2020, the FDA issued an
duction and harmlessness on respirators. Emergency Use Authorization (USA) for the emergency use of the
However, it must be considered that the effectiveness of UV depends Battelle CCDS Critical Care Decontamination System™ at the Battelle
on the dose or fluence and shading, since it only inactivates by irra- Memorial Institute for decontaminating N95 FFP respirators or the
diating surfaces. The FFP respirators must thus be irradiated from both equivalent for reuse by health personnel during the COVID-19 pan-
sides (Rowan and Laffey, 2020). The International Medical Center of demic for a maximum of 20 FFP respirators decontamination cycles
Beijing (2020) indicates that UV disinfection does not affect the filtra- (Food and Drug Administration, 2020d). Subsequently, on April 2020,
tion levels of the FFP respirators, although it does not recommend its the FDA also authorized the use of STERIS V-PRO 1 Plus, maX, and
use because the inactivation effect it produces on FFP respirator fibers is maX2 Low Temperature Sterilization Systems and STERRAD 100S, NX,
unknown. and 100NX Sterilization Systems for the same purpose and for a max-
This has given rise to uncertainty about the actual decontamination imum of 10 and 2 decontamination cycles per FFP respirator, respec-
capacity in the inner layers of the FFP respirators. Thus, the (Centers for tively (Food and Drug Administration, 2020e, 2020f). All these systems
Disease Control and Prevention, 2020a) warns that “UVGI is unlikely to use Vaporized Hydrogen Peroxide (VHP), which is the only FDA-au-
kill all the viruses and bacteria on an filtering facepiece respirator due thorized decontamination method to date. Likewise, Spanish Society of
to shadow effects produced by the multiple layers of the filtering fa- Preventive Medicine, Public Health and Hygiene (2020) recommends
cepiece respiratoŕs construction”. Therefore, it would be necessary to the use of low-pressure vaporized hydrogen peroxide for the deconta-
develop methods or procedures that can eliminate this uncertainty. In mination of FFP respirators, except those containing cellulose, and may
this regard, Fisher and Shaffer (2011) established a method to evaluate only be reprocessed a maximum of 2 times.
decontamination of inner layers of FFP respirators (N95) using ultra- Similar conclusions regarding Hydrogen Peroxide Vapor have been
violet-C. Therefore, based on this study, a standard procedure could be established by the Dutch National Institute of Public Health and the
established to evaluate the effectiveness of UVGI in the inner layers and Environment (RIVM) through a pilot study carried out with MATAC-
confirm or rule out its possible use for the inactivation of the cor- HANA Hydrogen Peroxide sterilizers. This study has confirmed that
onavirus in FFP respirators. hydrogen peroxide sterilization is a valid reprocessing method for FFP
The use of ultraviolet radiation is currently being evaluated by 3M respirators (FFP2) in order to inactive coronavirus. To reach this con-
with a 254 mm UV Lamp for its possible use as an FFP respirator de- clusion, unused FFP respirators were reprocessed by applying different
contamination method during the COVID-19 pandemic. However, the types of processes such as cleaning and drying with and without de-
evaluations have not yet been completed nor has its use been author- tergent or chemical disinfection, vaporized hydrogen peroxide low
ized by the FDA (3M, 2020b). According to N95DECON (2020c), the pressure gas sterilization applied at different times and steam ster-
advantages of this could be that ≥1 J/cm of UV-C inactivates viruses ilization. Subsequently, FFP respirators were subjected to a fit test to
similar to SARS-CoV-2 on N95s and the N95 maintains fit and filter verify that they fit properly and that the filter material continued to be
performance after 10–20 cycles of 1–1.2 J/cm UV-C; and the dis- a good barrier against particles. The fit test results for an untreated FFP
advantages are that UV-C may not reach the inner layer of the FFP respirator showed an average value of 162. Therefore, a reprocessed

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Table 5 studies, the European Center for Disease Prevention and Control (2020)
Comparison of different sterilization systems and their effect on mask de- indicated that coronaviruses are inactivated with a gamma radiation
formation and the fit test outcome. (Dutch National Institute for Public Health dose of 20 kGy (2MRad). However, possible deformations appear with a
and the Environment, 2020). dose of 24 kGy on the FFP respirator and therefore, the inner filtering
Process Face mask Fit test layer and the fit are compromised (Feldmann et al., 2019).
deformation outcome As for steam sterilization, like the Dutch National Institute for
yes/no +/− Public Health and the Environment (2020) of the Dutch Ministry of
Control N/A + (1 6 2)
Health, Welfare and Sport, the International Medical Center of Beijing
1. 60°Celsius cleaning without No − (60) (2020) indicates on its website that there is a reduction in the efficiency
detergent and disinfectants of FFP respirators to below 95% and serious deformation when sub-
2. 90 °C cleaning without detergent Yes N/A* jected to the steamer damp heat method with high pressure and high
3. 90 °C cleaning with detergent Yes N/A*
temperature. Nevertheless, a study by Stafondford Medicine (Price and
4. Hydrogen peroxide sterilization 1x No + (151)
Hydrogen peroxide sterilization 2x No + (103) Chu, 2020) indicates that hot water steam could be used for 3 treatment
Hydrogen peroxide sterilization 3x No − (28) cycles or less while maintaining a filtration efficiency of > 95%, but for
Hydrogen peroxide sterilization 4x Yes N/A* a greater number of cycles they found that the filtration efficiency was
5. Steam sterilization 134 °C Yes N/A*
affected. Based on this, Spanish Society of Preventive Medicine, Public
Health and Hygiene (2020) indicates that water vapor could be used to
* Fit test was not performed because FFP respirators were deformed and they
were no longer usable. cycle at 65 °C for 30 min for decontamination of FFP respirator.
There are even those who need an alternative disinfection method
FFP respirator must have a minimum average value of 100 to pass the and propose a two-step process to maximize the effectiveness. Thus,
fit test. The results are presented in Table 5. Based on these, it was Derraik et al. (2020) propose to store the FFP respirators for 4 or more
preliminarily concluded that “double sterilization using a short process days and then subject them to a disinfection process using ultraviolet
with hydrogen peroxide gives an acceptable result” (Dutch National light (UVC), dry heat treatment or chemical disinfection, although the
Institute for Public Health and the Environment, 2020). efficiency of these has not been proven.
The use of ethylene oxide, which is widespread in hospitals, is less Summarizing, there seems to be a more or less generalized con-
safe than hydrogen peroxide vaporization and less environmentally sensus on some methods that are not recommended for disinfection or
friendly. Research seems to confirm that the coronavirus is highly af- sterilization such as cleaning with soapy water, alcohol, bleach im-
fected by vaporization of hydrogen peroxide, which is lethal with a mersion, ethylene oxide, ionizing radiation, microwave, high tem-
concentration of 0.5% in less than one minute (Rowan and Laffey, perature, autoclave or steam because they can significantly degrade the
2020). According to N95DECON (2020b) the advantages of Hydrogen filter, either because they alter the electrostatic properties of the filter
Peroxide Vapor (VHP) are that it inactivates the coronavirus and that fibers, affect particle penetration levels, or deform the FFP respirator
after 20 cycles it does not degrade the effectiveness of the filter, fit or leading to FFP respirator degradation (3M, 2020b, Centers for Disease
straps. Control and Prevention, 2020a; N95DECON, 2020a, Viscusi et al.,
Other study was also found that analyzed the use of hydrogen 2007, Viscusi et al., 2009).
peroxide as plasma gas (HPGP) for disinfection. The results showed that Masks that are not PPE, medical or surgical, such as the Spanish
out of the six models of FFP respirators analyzed, four of them de- reutilizable hygienic mask or the French barrier mask. there are de-
monstrated mean penetration levels of less than 5%. However, this has tailed instructions for machine washing. In the first case, Specification
not been tested for the specific case of SARS-COV-2 (Bergman et al. UNE 0065:2020 (UNE, 2020d) recommends washing the hygienic mask
2010). According to N95DECON (2020b) a low dose HPGP for 2 cycles in the washing machine through a complete cycle of washing at 60 °C
does not degrade fit for 3M 8822 N95s and a high dose reduces FFP with the usual detergent and afterwards it must be completely dried for
respirator filtration. 2 h. after washing. Next, the hygienic mask must be visually checked
Also, moist heat has been proposed as a decontamination method. (minor adjustment, deformation, wear) and if its degradation is de-
This is a process based on applying heat and humidity to the FFP re- tected it must be discarded. In the second case, AFNOR SPEC S76-001
spirators. There are different studies that address this method for the (AFNOR, 2020) recommends that, before washing the barrier mask, the
disinfection of FFP respirators (3M, 2020b, Bergman et al., 2010, empty washing machine should be cleaned using a cold rinse with
Bergman et al., 2011, Heimbuch et al., 2011, Lore et al., 2012, Viscusi bleach or by turning it to 60 or 95 °C without spinning. The washing
et al., 2011). Among them, the study carried out by 3M is the only one cycle must be equal to or longer than 30 min at 60 °C. The use of regular
that specifically focuses on the inactivation of SARS-COV-2. They used detergents is recommended. As for drying, it is recommended to use the
an environment chamber and introduced each FFP respirator in a high dryer for two hours and then clean its filters. Once the barrier mask is
temperature self-seal pouch. A temperature of 65 ± 5 °C and 50–80% completely dry, the fit should be checked.
relative humidity were used for 30 min. They tested up to 10 re- In the case of the Spanish non-reusable hygienic mask, according to
processing cycles and both the filtration efficiency and the fit were Specification UNE 0064 (UNE, 2020a, 2020b) a maximum use of 4 h is
maintained. Although 3M indicates that they are still working to obtain recommended, unless the mask becomes previously degraded or humid.
from the U.S. Food and Drug Administration issue an Emergency Use Therefore, washing or disinfecting are not recommended.
Authorization for decontamination of FFP respirators of SARS-CoV-2 In relation to homemade masks, cloth face coverings or non-certi-
(3M, 2020b). fied masks, the Centers for Disease Control and Prevention (2020b)
In relation to other disinfection or decontamination methods that indicate that these can be washed in the washing machine, although no
could be used for SARS-VOC-2, the use of powdered alcohol, another specific washing instructions are provided.
traditional disinfectant, does not seem to be recommended, since it Finally, it must be considered that many of these studies and tests
eliminates the electrostatic retention of the mask fibers, reducing fil- presented are carried out with a specific type and/or model of mask.
tration capacity by 95% (International Medical Center of Beijing, 2020, Therefore, it is necessary to be cautious since they can have different
Ministry of Labor and Social Economy, 2020). Additionally, washing effects on other models or types of masks and reduce their effectiveness
with soapy water can also affect the electrostatic properties of the fibers or affect the properties of the mask or even the straps.
or even deform the mask (Ministry of Labor and Social Economy, 2020).
Regarding the use of gamma radiation and based on previous

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J.C. Rubio-Romero, et al. Safety Science 129 (2020) 104830

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