Covid-19: What is the evidence for cloth masks?

As the US Centers for Disease Control and Prevention has advised all Americans to wear cloth masks in public to prevent the spread of covid-19, The BMJ examines the evidence

What has the CDC recommended?

People should wear cloth face coverings in public places where social distancing measures are “difficult to maintain,” such as supermarkets and pharmacies, the CDC advises. It said the masks can be “fashioned from household items or made at home from common materials at low cost.” It also warned that surgical masks and N-95 respirators should not be used by the public, as these were “critical supplies that must continue to be reserved for healthcare workers and other medical first responders.”

How do you make a homemade cloth mask?

The CDC recommends using tightly woven cotton fabric, such as quilting fabric, cotton sheets, or T shirt fabric. It provided instructions on how to make masks with or without sewing, including using a bandana and coffee filter to create a face covering.1

But are they effective?

Very little good quality research exists on the use of cloth masks, especially in non-medical settings. One randomised controlled clinical trial of cloth masks, published in BMJ Open in 2015, compared their effectiveness with that of medical masks worn by hospital healthcare workers.2 The study, involving the industry partner 3M (which makes medical masks), reported that healthcare workers “should not use cloth masks as protection against respiratory infection. Cloth masks resulted in significantly higher rates of infection than medical masks, and also performed worse than the control arm.”

In an updated comment on the study (30 March),3 the authors said, “There have been a number of laboratory studies looking at the effectiveness of different types of cloth materials, single versus multiple layers and about the role that filters can play. However, none have been tested in a clinical trial for efficacy.”

They also advised healthcare workers who choose to wear cloth masks to “have at least two and cycle them, so that each one can be washed and dried after daily use. Sanitizer spray or UV disinfection boxes can be used to clean them during breaks in a single day. These are pragmatic, rather than evidence-based suggestions, given the situation.”

A preprint of a rapid systematic review has assessed the current evidence on respiratory illnesses and the use of face masks (mainly surgical paper masks) in community settings.4 The paper, yet to be peer reviewed, included 31 studies, of which 12 were randomised controlled trials. The researchers reported that “wearing facemasks can be very slightly protective against primary infection from casual community contact, and modestly protective against household infections when both infected and uninfected members wear facemasks.” However, they said that many of the studies “suffered from poor compliance and controls.”

They concluded, “The evidence is not sufficiently strong to support widespread use of facemasks as a protective measure against covid-19. However, there is enough evidence to support the use of facemasks for short periods of time by particularly vulnerable individuals when in transient higher risk situations.”

Commenting on these findings, Simon Clarke, associate professor in cellular microbiology at the University of Reading, said, “There is only very limited evidence of the benefits of wearing face masks by the general public, no evidence that wearing them in crowded places helps at all, and no evidence at all yet related to covid-19 . . . The authors also acknowledge that mass face mask wearing by the public would likely cause shortages among people who genuinely need protective equipment—healthcare workers on the front line in our hospitals.”

But Ian Jones, professor of virology at the University of Reading, said, “If an aerosol droplet hits the weave of the mask fabric rather than the hole it is clearly arrested. And lessening the aerosol dose chips away at the R0 [reproduction number] and helps to slow the epidemic . . . They are not a cure but they address the longer flatter epidemic curve everyone is trying to achieve.”

Have other countries recommended masks for the public?

Israel, Austria, the Czech Republic, Hong Kong, and Mongolia are among the countries that have implemented or recommended mask wearing in the community.

Could it have negative effects?

Experts have warned that recommending that members of the public wear masks can lead to shortages for those who are more in need: health and care workers and immunocompromised people, for example. It can also lead to complacency.

Susan Michie, director of University College London’s Centre for Behaviour Change and a fellow of the Academy of Medical Sciences, said, “There are several explanations as to why face masks have not generally been found to be effective if worn by the general population: they do not protect against the virus getting into the eyes (only close fitting goggles do this); people may not fit the masks properly or take them on and off; and people may have a false sense of reassurance and thus pay less attention to other behaviours key to reducing transmission, such as social distancing and handwashing.”

This was echoed by the infectious disease physician Ben Killingley. He said there were several reasons why masks were not seen as being as effective in the community. These included that people “find it difficult to be compliant with mask use all of the time and that people may start wearing the masks too late.” The other problem, he said, was that the public did not have the resources to ensure safe mask use: changing them often, frequent hand hygiene, and removing and disposing of them safely.

Killingley added, “Face masks are not an infinite resource and should be reserved for when they are most effective. It would not be good if we were not able to provide masks to healthcare workers because the public had consumed supplies.”

What does WHO say?

In guidance issued on 6 April,5 WHO said that medical masks should be reserved for health workers. Most spread of the covid-19 virus is from known cases and requires contact with droplets from a cough or sneeze or infected surfaces. It said that “there is currently no evidence that wearing a mask (whether medical or other types) by healthy persons in the wider community setting, including universal community masking, can prevent them from infection with respiratory viruses, including covid-19.” Wearing masks in the community can also give people a false sense of security, it said, and lead to them neglecting other measures, such as hand hygiene and physical distancing.

Covid-19: important potential side effects of wearing face masks that we should bear in mind

Dear Editor

In their editorial to the BMJ,[1] Greenhalgh et al. advise that surgical masks should be worn in public to prevent some transmission of covid-19, adding that we should sometimes act without definitive evidence, just in case, according to the precautionary principle. The Authors quote a definition of the precautionary principle found on Wikipedia, “a strategy for approaching issues of potential harm when extensive scientific knowledge on the matter is lacking.”

However, while no single formulation of that principle has been universally adopted,[2] the precautionary principle aims at preventing researchers and policy makers from neglecting potentially-harmful side effects of interventions. Before implementing clinical and public health interventions, one must actively hypothesise and describe potential side effects and only then decide whether they are worth being quantified on not.

Most scientific articles and guidelines in the context of the covid-19 pandemic highlight two potential side effects of wearing surgical face masks in the public, but we believe that there are other ones that are worth considering before any global public health policy is implemented involving billions of people.

The two potential side effects that have already been acknowledged are:

(1) Wearing a face mask may give a false sense of security and make people adopt a reduction in compliance with other infection control measures, including social distancing and hands washing.[3]

(2) Inappropriate use of face mask: people must not touch their masks, must change their single-use masks frequently or wash them regularly, dispose them correctly and adopt other management measures, otherwise their risks and those of others may increase.[3,4]

Other potential side effects that we must consider are:

(3) The quality and the volume of speech between two people wearing masks is considerably compromised and they may unconsciously come closer. While one may be trained to counteract side effect n.1, this side effect may be more difficult to tackle.

(4) Wearing a face mask makes the exhaled air go into the eyes. This generates an uncomfortable feeling and an impulse to touch your eyes. If your hands are contaminated, you are infecting yourself.

(5) Face masks make breathing more difficult. For people with COPD, face masks are in fact intolerable to wear as they worsen their breathlessness.[5] Moreover, a fraction of carbon dioxide previously exhaled is inhaled at each respiratory cycle. Those two phenomena increase breathing frequency and deepness, and hence they increase the amount of inhaled and exhaled air. This may worsen the burden of covid-19 if infected people wearing masks spread more contaminated air. This may also worsen the clinical condition of infected people if the enhanced breathing pushes the viral load down into their lungs.

(5B) The effects described at point 5 are amplified if face masks are heavily contaminated (see point 2)

(6) While impeding person-to-person transmission is key to limiting the outbreak, so far little importance has been given to the events taking place after a transmission has happened, when innate immunity plays a crucial role. The main purpose of the innate immune response is to immediately prevent the spread and movement of foreign pathogens throughout the body.[6] The innate immunity’s efficacy is highly dependent on the viral load. If face masks determine a humid habitat where the SARS-CoV-2 can remain active due to the water vapour continuously provided by breathing and captured by the mask fabric, they determine an increase in viral load and therefore they can cause a defeat of the innate immunity and an increase in infections. This phenomenon may also interact with and enhance previous points.

In conclusion, as opposed to Greenhalgh et al., we believe that the context of the current covid-19 pandemic is very different from that of the “parachutes for jumping out of aeroplanes”,[7] in which the dynamics of harm and prevention are easy to define and even to quantify without the need of research studies. It is necessary to quantify the complex interactions that may well be operating between positive and negative effects of wearing surgical masks at population level. It is not time to act without evidence.

Respirators and Surgical Masks: A Comparison

Conclusion

In conclusion, surgical/procedure masks are intended to help put a barrier between the wearer and the work environment or sterile field. They may help keep spit and mucous generated by the wearer from reaching a patient or medical equipment. They can also be used as a fluid barrier to help keep blood splatter from reaching the wearer’s mouth and nose. However, surgical/procedure masks cannot provide certified respiratory protection unless they are also designed, tested, and government-certified as a respirator. If a wearer wants to reduce inhalation of smaller, inhalable particles (those smaller than 100 microns), they need to obtain and properly use a government-certified respirator, such as a NIOSH-certified N95 filtering facepiece particulate respirator. If the wearer needs a combination surgical/procedure mask and a particulate respirator, they should use a product that is both cleared by FDA as a surgical/procedure mask and tested and certified by NIOSH as a particulate respirator. Such products are sometimes called a "medical respirator," "health care respirator," or "surgical N95.

Background

Since certain disposable filtering facepiece particulate respirators are similar in appearance to many surgical/procedure masks, their differences are not always well understood. However, respirators and surgical/procedure masks are very different in intended use, fit against the face, wear time, testing and approval. The purpose of this document is to highlight some of these differences, particularly for healthcare workers. Surgical/procedure masks may be provided to patients to help protect healthcare workers and other patients from particles being introduced into the room as a patient talks, sneezes or coughs.

Wear Time

Respirators must be properly selected and carefully donned (put on) and doffed (taken off) in a clean area, and worn the entire time in the contaminated area to have a significant effect on reducing exposure. Having the respirator off even 10% of the time in a contaminated area significantly reduces the protective effect of the respirator. Surgical/procedure masks are typically donned (put on) for a specific procedure. For infection control purposes, masks are typically disposed of after each procedure/patient activity.

Use and Reuse of Respiratory Protective Devices for Influenza Control

… Manufacturers told the committee that currently marketed disposable medical masks are made of materials that are likely to deteriorate with standard levels of disinfection (e.g., chemicals, heat, radiation). Because medical masks are intended for disposal, and are submitted to FDA with that labeling, manufacturers have no reason or incentive to develop methods for decontamination. However, they noted that it is physically possible for a device to be used repeatedly by the same wearer until it becomes damaged, interferes with breathing, or is visibly soiled (Jensen, 2006; D. Parks, letter to the Institute of Medicine, February 27, 2006). In addition, manufacturers expressed concern that they would incur increased liability if devices designed and intended for disposal were recommended for reuse.

In the context of SARS, the National Institute for Occupational Safety and Health (NIOSH) recommends that workers wear any NIOSH-approved particulate respirator for protection if it has been properly fit-tested and maintained. The agency warns that once worn in the presence of a SARS patient, the respirator should be considered potentially contaminated with infectious material and touching the outside of the device should be avoided. Upon leaving the patient’s room, the disposable respirator should be removed and discarded, followed by hand hygiene.

If a sufficient supply of respirators is not available, NIOSH and CDC recommend that healthcare facilities may consider reuse as long as the device has not been obviously soiled or damaged (e.g., creased or torn). Reuse may increase the potential for contamination; however, this risk must be balanced against the need to provide full respiratory protection to healthcare personnel. The agency recommends that if disposable N95 respirators are reused for contact with SARS patients, institutions should implement a procedure for safer reuse to prevent contamination through contact with infectious droplets on the outside of the respirator (see Box 3-1). Data on reuse of respirators for SARS are not available.

Also in the context of SARS, WHO recommends that disposable equipment should be used wherever possible in the treatment and care of patients with SARS (WHO, 2003). When the situation dictates the use of nondisposable equipment, the equipment should be sterilized in accordance with the manufacturer’s instructions. Surfaces should be cleaned with broad-spectrum (bactericidal, fungicidal, and virucidal) disinfectants of proven efficacy.

Respiratory and facial protection: a critical review of recent literature

Conclusion

The lack of clear superiority of respirators over facemasks in the studies of Loeb et al. and MacIntyre et al. may result from poor respirator face seals, poor compliance due to discomfort, lack of recognition of infectious patients and consequent inappropriate non-use of respirators, infection arising from infectious co-workers, trans-ocular infection despite appropriate respirator use but no eye protection, or infection from sources outside the healthcare setting.

Regardless of the reason for failure, the high rate of infection in both of the groups in the Loeb study is impressive and reinforces the need to consider how protection can be strengthened. In relation to aerosol-generating pro- cedures the results of a recent review concluded that, although there are a number of these procedures listed under this heading, few have sufficient evidence to confirm they actually do produce - therefore further research in this area is warranted. The view that cross-infection may be reduced by placing masks on potentially infectious patients, supported by bench and clinical studies, opens up an additional approach to protection. The demonstration of trans-ocular infection by aerosols needs further investigation and suggests that eye protection may be required as a component of respiratory and facial protection, not only to mitigate risks associated with direct splash or splatter contamination, but also to prevent aerosol exposure. Finally, as pointed out by Srinivasan and Perl, and also by a recent Department of Health scientific review, the use of masks and respirators should be considered as the last line of defence in the hierarchy of infection prevention measures. These include vaccination (when available), hand hygiene (always), environmental mea- sures including sufficient ambient ventilation, the provision of single occupancy rooms, and administrative practices that emphasize early recognition of infectious patients and their removal from others.

Microbial Contamination on Used Surgical Masks among Hospital Personnel and Microbial Air Quality in their Working Wards: A Hospital in Bangkok

… Evidences showed that the surgical mask might not be enough to protect the person from air-borne pathogens and might also be the source of air-borne or droplet infection. This study aimed to investigate the microbial contamination on used disposable surgical masks among hospital personnel and microbial air quality in their working wards and its relationship. These are useful in developing prevention and control programs among HCWs.

…Generally, the surgical mask is designed to prevent microorganisms from the nose and mouth of the wearer from spreading to others. It is not efficient to filter particles of some infectious agents, especially M. tuberculosis and some viral particles.15 The present study found that both bacterial and fungal contamination on outside areas of the used masks were significantly higher than the inside areas  

Conclusion

This present study revealed that the high bacterial contamination on the outside area of the used surgical masks had significantly positive correlation with bacterial and fungal counts found in air samples that were collected from the working wards. To reduce the load of bacterial contamination on the used masks, the hospital environments, especially microbial air quality in the working wards should be improved.