May 8, 2020
Consistent use of personal protective equipment (PPE) is an important part of the strategy to protect healthcare professionals from inhaling infectious particles, preventing the spread of respiratory infection between healthcare professionals and patients. Two types of devices are most commonly used in the healthcare setting: N95 filtering facepiece respirators (FFRs) and surgical masks (commonly called facemasks). In consideration of the shortage of N95 respirators during this global outbreak of coronavirus disease 2019 (COVID-19), which is thought to be predominantly transmitted by respiratory droplets, it is important to understand the difference between N95 respirators and surgical masks to ensure proper protection and accurate information when possible.
When worn properly, FFRs are designed to protect the wearer (e.g., healthcare worker) by removing at least 95% of particles from inhaled air. The National Institute for Occupational Safety and Health (NIOSH) regulates FFRs by using stringent test conditions to evaluate these devices, approving those that meet a minimum filtration efficiency requirement for occupational use. However, to provide this expected level of protection, an FFR must seal to the wearer’s face, without allowing air leaks to pass through gaps between the respirator and the wearer’s skin. FFRs also provide a physical barrier to protect the wearer’s mouth and nose from being touched by contaminated hands or gloves.
Surgical masks, on the other hand, are not specifically designed to protect the wearer from airborne hazards. These devices limit the spread of infectious particles expelled by the wearer. They are used to help protect a sterile field, such as the area surrounding the site of a surgical incision, from contamination by particles expelled by the wearer, such as those generated by coughs or sneezes. Surgical masks also help provide a physical barrier to protect the wearer from splashes, sprays, or contact with contaminated hands. The Food and Drug Administration (FDA) regulates surgical masks. The FDA regulations do not require surgical masks to form a seal against the user’s face or to have a level of filtration that provides the user protection from aerosol exposures.
Recently, there has been discussion whether N95 FFRs or surgical masks should be the recommended minimum level protection for use in healthcare facilities during outbreaks of infectious diseases. Since the results of studies comparing effectiveness of N95 FFRs and surgical masks are inconsistent, it could not be determined if surgical masks provided comparable protection to healthcare professionals as N95 FFRs.1-4 It should be noted that respirators are designed to reduce the wearer’s exposure to airborne particles. Respirators do not make claims regarding disease prevention. To determine the effectiveness of respirators in the workplace, it is important to verify the performance of the respirator and ensure the wearer is protected.5 Laboratory studies have demonstrated that FFRs provide greater protection against aerosols compared with surgical masks6,7; however, the results of clinical studies have been inconclusive.1-4, 8
During times of shortage, it is important to prioritize N95 respirators for aerosol-generating procedures. When the supply chain is restored, facilities with a respiratory protection program should follow established OSHA and CDC guidelines to protect healthcare workers in cases of airborne transmissible diseases, as described in the Hospital Respiratory Protection Program Toolkit.
The Journal of the American Medical Association’s article, “N95 Respirators versus Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial (ResPECT),” has sparked additional discussion on the topic of the comparative ability of respirators versus surgical masks to protect healthcare professionals against airborne pathogens, such as influenza virus. Its authors reported that, “among outpatient health care personnel, N95 respirators versus medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza.” 8 The study design and setting were described as “a cluster randomized pragmatic effectiveness study conducted at 137 outpatient study sites at 7 U.S. medical centers between September 2011 and May 2015, with final follow-up in June 2016.” Pragmatic studies, such as this one, seek to measure the effectiveness of an intervention under routine clinical conditions.9
The authors identified six limitations to their study.8 One limitation worth highlighting is in response to current discussions and questions about the minimum level of protection to be recommended for healthcare professionals during outbreaks of infectious disease. The authors stated that, “…only two N95 respirator and medical mask models were studied, limiting the ability to generalize about the protectiveness of other models.” Currently, over 500 N95 FFR models are NIOSH-approved for use and approximately 200 surgical mask models are cleared for use by the FDA.
Given the performance standards that regulate respirators, consistency is expected regarding filtration and fit, if used within a program that includes fit testing. However, with no performance requirements for surgical masks regarding the filtration of environmental aerosols and with no fit testing required, there is no expectation of consistency with filtration or fit based upon a sample of less than 1% of the surgical masks cleared by the FDA in the US at the time of publication.
This continued discussion about the use of respirators versus surgical masks by healthcare professionals highlights a more prominent point, on which no debate is necessary – PPE, respiratory protection included, cannot effectively protect the users if it is not properly and consistently worn.
Inconsistent use of personal protective equipment is commonly reported among healthcare professionals and substantially reduces protection.12 Unfortunately, observational studies have shown that healthcare professionals frequently do not put on or remove respirators correctly, take their respirators off when they should be wearing them, or do not wear them at all.13,14
For example, the ResPECT study authors also noted that approximately 35% of healthcare professionals reported using respirators or surgical masks only “sometimes” or “never.” According to the authors, incomplete adherence to using respirators or surgical masks “could have contributed to more unprotected exposures, increasing the probability of finding no difference between interventions even if a difference existed.”
Although the ResPECT study cannot definitively determine whether there is any practical difference in the protection provided by N95 respirators versus surgical masks, it emphasizes an important opportunity for prevention—improving adherence to infection control recommendations by enhancing safety culture.
Improving safety culture begins with understanding and addressing the many reasons for non-compliance. For example, compliance with proper PPE use improves depending on the level of health risk the worker perceives, such as influenza exposure verses tuberculosis (TB) or the Ebola virus.12 Therefore, establishing a safety culture that emphasizes training and worker safety every day is imperative for consistent compliance. These behaviors can be bolstered with training, observation, metrics, and by reinforcing safety culture.
NIOSH elaborates on this understanding that routine compliance increases preparedness during a public health emergency in the Hospital Respiratory Protection Program Toolkit. Additional resources are available below. Healthcare personnel should be mindful of best practices when implementing respiratory protection program policies as they balance their own safety with other factors associated with patient care in the context of a comprehensive infection control program.
CDC respirator use guidance for healthcare professionals for COVID-19: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html