Know Your Mask: How to Choose the Best Mask for Your Users and Spot a Counterfeit
Thanks to the COVID-19 pandemic, the demand for protective masks has exceeded global manufacturing capacity for months now–and for months, manufacturers around the world have been searching for creative solutions to meet this increased demand. At first glance, this may seem like a good thing, but the reality is more complicated. For example, factories in China have paused their normal operations to produce more masks–but unfortunately, some of these manufacturers do not meet the regulatory requirements to produce personal protective equipment (PPE) and sell it in other countries.
Even worse, some vendors are selling counterfeit masks that do not even attempt to meet regulatory standards. This has led to thousands of masks being discarded. Many hospitals have only discovered their mistake after the masks have already been used by healthcare professionals in high-risk situations.
To ensure their own safety and that of their patients, purchasers need to be aware of the different mask types and what quality standards they should expect from each of them.
Surgical masks will be familiar to anyone who has received surgery or witnessed it in a hospital setting. Although they do not provide full protection from coronavirus particles, these single-use masks are commonly used in surgery and are the standard in many healthcare settings. They fit loosely, cover the mouth and nose, and are designed to resist fluid transmission. At the present time, surgical masks are not recommended for everyday use outside of hospital settings, because they need to be conserved for use by healthcare professionals.
The FDA regulates the production of surgical masks, and they must meet certain standards for fluid protection effectiveness. In light of the mask shortage, the FDA has waived some of the premarket notification requirements for surgical masks. However, there are still methods customers can use to discern counterfeit masks that fail to meet basic quality standards. In particular, the inner layer of fabric in the mask should be melt-blown, not woven, and the masks should not be flammable.
For healthy members of the general public, face masks are recommended over other types. They are not guaranteed to protect wearers from either fluids or airborne particles, but they can protect those who are carrying the virus from infecting others. Because of this, countries around the world have recommended that everyone wear face masks in public to slow the spread of the disease. Cloth face masks are reusable, and often have filters that can be replaced.
Face masks for consumer use are also referred to as “non-medical, surgical masks”, are not as tightly regulated as masks used in healthcare settings, and they may not meet the same quality standards for protecting the wearer.
Respirator masks–also called filtering facepiece masks, or FFP, in the European Union–are the gold standard of personal protective equipment. In the US, the most well-known respirator mask is the N95, which is more stringently regulated and offers better protection than surgical masks. It protects against not only large droplets, but also 95% of small particle aerosols, making it a better choice for protection against the coronavirus. Unlike surgical masks, N95 masks are tight-fitting, and they must meet more stringent regulatory requirements than surgical masks. While the FDA regulates surgical mask testing and marketing, N95 respirators are evaluated and tested by NIOSH according to the standards laid out in 42 CFR Part 84.
In the United States, authentic N95 respirators will have an approval label on the packaging as well as the mask itself; approval labels are pictured here. Counterfeit respirators may not have these markings, or the markings may not match those on the website (watch out for misspellings). N95 respirators do not have decorative fabric or adornments, and they are held on with ear loops (not headbands). European Union purchasers can look for similar indicators: FFP masks should have CE markings and reference the UNE EN-149: 2001 standard .
No matter what type of mask they are considering, purchasers should watch out for counterfeits and low-quality products. This is especially true when purchasing FFP or N95 masks, which are in the highest demand and therefore the most counterfeited. However, if you are a member of the public and think you have a counterfeit mask, you need not throw it away–often, even masks that do not meet N95/FFP standards are still sufficient for use by healthy individuals who are not in high-risk situations. However, customers purchasing masks for use in healthcare or other high-risk contexts should consider switching to a new supplier immediately.