As COVID-19 cases hit record highs as a result of the highly contagious Omicron variant, people are re-evaluating what masks they should be wearing.
Though the CDC didn’t update its guidance to the general public to advise wearing only KN95 or N95 masks, the agency did offer more details on Friday on which types of masks provide the best protection, and said shortages of higher-quality masks are no longer a concern. For people looking to upgrade their masks, there are concerns about paying more for products in a crowded market where counterfeits have emerged.
“All masks are not created equal,” Anthony Santella, DrPH, director of the Doctor of Health Sciences program at the University of New Haven in Connecticut, told MedPage Today.
Disposable surgical masks — traditionally seen in clinical settings and in countries that have previously worn masks during respiratory illness seasons — are pretty low cost. “Is it the best [mask]? No. Does it work? Yes,” Santella said, though “it depends on the setting you’re in.”
KN95s are more fitted than surgical masks, and are not extremely uncomfortable for most people, he noted. In the case of airborne viruses, “the more fitted the better,” especially in a densely populated area, he said. However, KN95s are generally not being handed out for free, as is sometimes the case with surgical masks.
N95 masks — which are approved by the National Institute for Occupational Safety & Health (NIOSH) — are not comfortable to wear for a long time, and really should be reserved for those in high-intensity settings with a lot of virus exposure, Santella said.
“What we’re telling our community [is to wear] a surgical mask with a cloth mask on top of it or a KN95,” he added.
When it comes to purchasing higher-quality masks, there’s often a plethora of possibilities to sort through, or an inclination to scoop up what’s readily available. But in doling out more dollars for higher-quality options, people want to be sure they’re getting real protection.
The CDC has warned that some 60% of KN95s in the U.S. are fake. On its website, the agency states that common warning signs include documents being altered so models appear to comply with a particular standard when they do not, counterfeit certification marks, or fake manufacturers’ names, logos, and model numbers.
The CDC also said that NIOSH is conducting modified filtration efficiency assessments of respirators not certified by NIOSH, and that test results can be checked for products that have been evaluated. It also advises not purchasing any model that achieved results of less than 95% efficiency. Evaluation of additional factors is needed before purchasing models from another country that achieved results greater than or equal to 95% efficiency.
The CDC did not respond to a request for comment on how best to evaluate masks for purchase, in terms of their ability to filter large and small respiratory particles, by press time.
Santella noted that there are common-sense measures that consumers can take in evaluating KN95s. Just like for counterfeit designer clothes and handbags, watch out for misspelled names, he said. Be aware of any packages that appear to be tampered with, and be wary if it is difficult to determine where a product comes from.
However, even a KN95 derived from a questionable source may be better than none at all, he conceded. “We’re not living in an ideal world right now.”
Masks for Healthcare Professionals
For healthcare personnel, the FDA regulates the use of personal protective equipment (PPE).
“NIOSH-approved N95s remain authorized for use by health care personnel under the FDA’s emergency use authorizations [EUAs] and are the gold standard for respiratory protection for healthcare personnel,” a spokesperson for the FDA told MedPage Today in an email.
In July 2021, “the FDA revoked the EUAs for non-NIOSH-approved disposable filtering facepiece respirators, including KN95s, for use in health care settings by health care personnel,” the spokesperson continued. “The agency has recommended health care facilities no longer employ crisis capacity strategies for respirators and no longer purchase non-NIOSH-approved N95s, which reflects CDC recommendations for disposable respirators for health care facilities.”
“The FDA will continue to provide health care personnel recommendations and updates regarding PPE as the pandemic continues to evolve,” the spokesperson added.
To identify whether an N95 mask may be counterfeit, the CDC has said that signs include having no markings at all on the filtering facepiece respirator, no approval number on the filtering facepiece respirator or headband, no NIOSH markings, or having NIOSH spelled incorrectly, in addition to the presence of decorative fabric or add-ons like sequins, claims of approval for children, or ear loops instead of headbands.
The CDC has also posted images of some of the most recently identified fakes on its website.
Consistency Over Quality
Overall, what may be most important, even amid the Omicron surge, is “ensuring that people are correctly and consistently using masks,” Santella said. “That message sometimes gets forgotten.”
In many instances, decisions on masks may come down to access and affordability, he noted. For people outside of high-intensity settings, KN95s can be reused multiple times.
“It’s balancing what’s practical and realistic for the user,” Santella said.
Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.