Respirator masks weren’t designed to fit most people — it’s time to change that

The COVID-19 pandemic has revealed sex and gender differences across every aspect of our lives including in the availability and design of personal protective equipment (PPE) for health care professionals, essential workers and the general public.  

Because the omicron variant is the most transmissible variant in this pandemic, the Centers for Disease Control and Prevention updated mask guidelines to recommend that the public consider wearing N95 respirators, leading to a nationwide effort to distribute over 400 million free N95 respirators from the National Stockpile. It is the largest deployment in U.S. history. Particulate respirators, such as N95 masks, have a non-woven fibrous filter media that captures particles. N95 respirators have been shown to filter 99.8 percent of particles as small as SARS-Cov-2, the virus associated with COVID-19. 

It’s worth noting that CDC states on its website that “It is most important to wear a well-fitted mask or respirator correctly that is comfortable for you and that provides good protection.”   

And here lies the challenge.  

N95 respirators only successfully fit 85 percent of women (and just 60 percent of Asian women) in contrast to the higher 95 percent rate in men. This poses health risks given facial anthropometric (body proportion and shape) differences between males and females. Clearly, it’s more than the size of the respirator that counts. These devices were designed to fit the ‘Reference Man’ who is an average size, clean-shaven, adult Western European man. The Reference Man was established in 1975 to estimate radiation doses that could be tolerated without side effects. The pattern of using the male model has been the norm in medicine and engineering for centuries. 

Some of the first modern respirators were developed to protect troops from chemical warfare during World War I, which was followed by respirators designed for male-dominated professions such as construction workers, coal miners and firefighters. Basically, respirators were designed for male bodies in occupational settings and on battlefields. The designs did not take into account women’s bodies. 

The U.S. Department of Labor reports the following criteria must be assessed to help determine the adequacy of respirator fit, namely, proper placement over the chin adequate strap tension, fit across the nose bridge, a proper size to space the distance from the nose to the chin, the tendency of the respirator to slip and self-observation in a mirror to evaluate fit and position. It is doubtful that this is being assessed when N95 respirators are now being distributed across the country.  

Ill-fitting N95 respirators lead to skin abrasions and, most importantly, poor seals. If there is a leak, unfiltered air will be drawn inside the mask. The public who does not look like the Reference Man may now have a false sense of security that they have increased protection from the SARS-CoV-2 virus. when they wear these respirators.  

My female colleagues in healthcare and I have faced this problem for years when trying to wear N95 respirators while practicing medicine. During this pandemic, the consequences have been dangerous — over 70 percent of healthcare professionals who have gotten infected are women. We struggle to find face coverings that will protect us at work and at home. Factors such as sex, age and race must be incorporated in the design and fit of masks, respirators, and all PPE to ensure an effective defense against COVID-19, which can enhance safety in the workplace, schools and in all our communities.  

And here lies another challenge. However, this time, it’s for the government to host a “challenge competition” to engage the public to address and finally solve these design issues. Everyone needs to be protected on the front line and the home front and not just the outdated Reference Man. 

Saralyn Mark, MD is the founder of SolaMed Solutions, LLC and iGIANT (Impact of Gender/Sex on Innovation and Novel Technologies.) She is the American Medical Women’s Association’s COVID-19 lead and a former Senior Medical and Policy advisor to the White House, the Department of Health and Human Services and NASA.