At first, there was a supply problem. The national rush for face masks amidst the COVID-19 pandemic ran through the stock of all known distributors. Then, as the market reacted, acquisition departments were met with a new challenge. When shopping online, who could they trust? In just one month, the federal government intercepted 3 million dollars’ worth of counterfeit masks. Furthermore, the FDA gave KN95 masks emergency use authorization, only to later retract it due to several Chinese manufacturers failing to meet minimum standards. As if that weren’t enough, delays and price gauging wreaked further havoc on institutions bound by the new PPE regulations.
So, what are end users supposed to do?
COVID-19, the age of disinformation, and new regulations combined to create a demand not just for safe masks, but for knowledgeable consumers and transparent suppliers. This blog functions as the third prong of MRI’s mission to help overcome the current sanitation crisis: supplying masks, providing laboratory testing results for all their products, and informing customers about the latest research on masks and their supply.
The WHO divides masks into two main categories: medical masks and fabric masks. We will also briefly consider disposable masks below.
These masks can also go by the name of “surgical, laser, isolation, dental or medical procedure masks.[i]” For the scope of this blog, we will not consider the N95 respirators currently reserved exclusively for healthcare workers.
Surgical masks have been around for more than a century. Their main purpose, as opposed to respirators, is to keep infected workers from transmitting diseases through their saliva and respiration as they move around their workplaces. However, they also provide the wearer with protection. “If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching [the users’] mouth and nose.[ii]”
“The decision whether or not workers need to use either respirators or surgical masks [or both] must be based upon a hazard analysis of the worker’s specific work environment and the protective properties of each type of personal protective equipment.
Respirators are designed to help reduce the wearer’s respiratory exposure to airborne contaminants such as particles, gases, or vapors. Respirators and filters must be selected based on the hazards present. They come in various sizes and styles and should be individually selected to fit the wearer’s face and to provide a tight seal. A proper seal between the user’s face and the respirator forces inhaled air to be pulled through the respirator’s filter material, thereby providing protection.
Surgical masks […] are designed to help prevent contamination of the work environment or a sterile field from large particles generated by the wearer/worker (e.g., to prevent the spread of the wearer’s spit or mucous). Surgical masks may also be used to help reduce the risk of splashes or sprays of blood, body fluids, secretions, and excretions from reaching the wearer’s mouth and nose. Surgical masks may also be worn by patients to help limit the spread of infections.[iii]”
The WHO recommends medical masks for[i]:
- All health workers in clinical settings.
- Anyone who is feeling unwell, including people with mild symptoms, such as muscle aches, slight cough, sore throat, or fatigue.
- People caring for suspected or confirmed cases of COVID-19 outside of health facilities.
When they cannot guarantee a distance of at least 1 meter from others, medical masks are also recommended for the following groups, as they are at a higher risk of becoming seriously ill with COVID-19 and dying:
- People aged 60 or over.
- People of any age with underlying health conditions, including chronic respiratory disease, cardiovascular disease, cancer, obesity, immunocompromised patients, and diabetes mellitus.
- Material and Design of Medical Masks
Unlike fabric masks, surgical mask manufacturers are regulated by the FDA. “For a surgical mask to be added to the Surgical Mask EUA Appendix A, test reports must be submitted to the FDA demonstrating that the surgical mask meets the performance criteria for liquid barrier protection.[ii]”
Like the best fabric masks, modern surgical masks have three layers, each one with a different function. “The outermost layer (typically blue) is waterproof and helps to repel fluids such as mucosalivary droplets. The middle piece is the filter, which prevents particles or pathogens above a certain size from penetrating in either direction. The innermost layer is made of absorbent materials to trap mucosalivary droplets from the user. This layer also absorbs the moisture from exhaled air, thus improving comfort. Together, these 3 layers effectively protect both the user and the surrounding people by limiting the penetration of particles and pathogens in both directions.[iii]”
For the best bacterial filtration, medical masks are made with non-woven materials, such as polypropylene. Manufacturers use spun bond and melt-blown processes to create the material. Further details on the manufacturing process can be found here.
After manufacturing, the masks are tested for 5 different conditions[iv]:
- Bacteria filtration efficiency in vitro (BFE). This test works by shooting an aerosol with staphylococcus aureus bacteria at the mask at 28.3 liters per minute. This ensures the mask can catch the percentage of bacteria it is supposed to.
- Particle filtration efficiency. Also known as the latex particle challenge, this test involves spraying an aerosol of polystyrene microspheres to ensure the mask can filter the size of the particle it is supposed to.
- Breathing resistance. To ensure the mask will hold its shape and have proper ventilation while the wearer breathes, breathing resistance is tested by shooting a flow of air at it, then measuring the difference in air pressure on both sides of the mask.
- Splash resistance. In splash resistance tests, surgical masks are splashed with simulated blood using forces similar to human blood pressure to ensure the liquid cannot penetrate and contaminate the wearer.
- Flammability. Since several elements of an operating room can easily cause fire, surgical masks are tested for flammability by being set on fire to measure how slowly it catches and how long the material takes to burn. ASTM levels 1, 2, and 3 are all required to be Class 1 flame resistant.
- Efficiency of Medical Masks
As stated previously, the main purpose of medical masks is to create a physical barrier that prevents particles from the user from spreading around a room or space. If enough people wear masks, there will be less harmful airborne particles floating around, causing significant safety improvements.
However, medical masks have also been shown to protect users in contaminated environments. A commonly cited number is 60% filtration (for example here and here). In some studies, they have been as effective as N95 masks at preventing user contagion[i]. “In a survey of 5 hospitals in Hong Kong during SARS, hospital staff were asked about the protective measures they took, and this information was correlated with whether they were infected by SARS. It was found that wearing masks was the single most important protective measure in reducing the chance of getting infected (p = 0.0001), and the people who wore either surgical masks or N95 masks were not among the 11 infected staff.[ii]”
Mask efficiency depends on proper use, covering both nose and mouth, and works best when combined with other safety measures such as frequent handwashing and social distancing.
One type of mask closely related to medical masks are disposable face masks. Although surgical masks are also disposable, “disposable face masks” per say refer to masks that have not been approved by the FDA.
These masks often share characteristics with surgical masks, including three-layer design and materials. In some cases, they can have 99% bacterial filtration. Also, like surgical masks, disposable face masks are designed to protect others from the wearer’s respiratory emissions. The mask covers a user’s mouth, nose, and jaw providing a physical barrier.
However, disposable face masks are not intended for medical use. They are not surgical masks, do not provide liquid barrier protection, and should not be used in a clinical setting where the infection risk level through inhalation exposure is high. It is always recommended to include masks with other protective measures such as handwashing with non-antimicrobial soap and water, and an alcohol-based hand rub if soap and water are not available.
Disposable face masks can come sterilized and individually wrapped or in cardboard packing and are made at one of three filtration levels.
Along with protective gowns and nitrile gloves, protective face masks can help prevent the spread of the Coronavirus.
These masks can also go by the name of “cloth” and “non-medical” face masks. The WHO advises that these masks be worn by “the general public when physical distancing cannot be maintained, as part of a comprehensive ‘Do it all!’ approach […].[iii]”
- Material and Design of Fabric Masks
Not all fabric masks are created equal. The efficiency of the masks depends on several factors, such as material, design, fit, thickness, and thread count.
As the CDC reports, “further research is needed to expand the evidence base for the protective effect of cloth masks and in particular to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal.[iv]”
With much research in its infancy, several points have already been identified. For example, we know that the more layers, the better. Single layer masks perform worse than double layer masks, and triple layer masks are the gold standard.
The inner most layer should be absorbent and made of a hydrophilic material, like cotton.
The middle layer is a filter (many companies now provide interchangeable filters for best results) and should be made from a polypropylene fabric. Research is being conducted into electrostatic filters which augment the mechanical filters provided by materials such as cotton.
The outer layer should repel water and moisture and be made of a material such as polyester.
After assuring that your mask has three layers, you can look at some other factors to choose the best mask.
The CDC has concluded that masks with higher thread counts work better. The Hartford Healthcare Center further specified that “the best cloth masks were made of heavyweight quilter’s cotton with a thread count of 180 or more. Masks with even thicker thread, tightly woven like a batik, and double-layer masks with a basic cotton outer and flannel inner also proved effective. ”
Efficiency of Fabric Masks
The trend in the research heads in one direction: in places of contagion, fabric masks reduce the risk of COVID-19 transmission. As such, the WHO recommends the use of masks by the general public in geographic areas where COVID-19 contagion persists. However, further research is needed to consolidate the findings and differentiate between different types of fabric masks. Until then, consumers can take matters into their own hands by adhering to the best practices in mask use.
1) As reported by the Australian government, “The effectiveness of face masks depends on consistent and correct use, including covering the nose and mouth adequately. ”
2) Furthermore, masks should be washed after every use. The reason is that fabric masks are “increasingly less effective as they become increasingly damp. These issues may have contributed to results of a clinical comparison of cloth versus medical masks or no mask. ” In other words, some research shows, although inconclusively, that improper use of fabric masks may do more harm than good. Fortunately, with washable masks and interchangeable filters, these products are becoming increasingly sophisticated and consumer friendly.
3) Although fabric masks are not meant to completely seal off the face, “gaps (as caused by an improper fit of the mask) can result in over a 60% decrease in the filtration efficiency. ” Finding a snug design that feels comfortable and doesn’t slide around the face not only makes for a more efficient mask, but also means that you are more likely to actually use the mask consistently in social situations. Lastly, users with well-fitting masks are less likely to touch their faces, as they don’t have to constantly readjust it.
But just how efficient are these fabric masks, really?
They are better than nothing, and when properly worn, they may even be better than surgical masks, filtering more than 80% of harmful airborne particles. “Although the filtration efficiencies for various fabrics when a single layer was used ranged from 5 to 80% and 5 to 95% for particle sizes of <300 nm and >300 nm respectively,” by following the information given in this section, end users can get as close to that 95% efficiency as possible.
Spotting Frauds and Counterfeits
In the Midwest, 59,000 unapproved masks were seized in 2020. Boston Authorities confiscated 163,000 dollars’ worth of counterfeits. In California, Kaiser Permanente was tricked into believing it was about to buy from a stockpile of 39 million non-existent masks. The list goes on and on.
With shady brokers, middlemen, and suppliers multiplying as fast as the virus itself, acquisition offices have found themselves on shaky ground. The logo and registration numbers may all look right, but the product ultimately does not provide the same protection as original products. As Shelly Arnold, at Trusted Business Insights reports, masks are being branded with trusted names such as M3, but that the “counterfeit masks are usually made in unsterile sweatshops that were previously used to manufacture designer jeans or fake handbags.” How can consumers navigate all the uncertainty?
Much of the attention for identifying counterfeits has been geared towards catching falsified N95 respirators and KN95 respirators, yet surgical masks can also be sub-par if bought from the wrong source. Burning test and other simple to set-up experiments with lasers and cameras may detect anomalous operations in masks. Yet, businesses and medical facilities hardly have time for that, and in any case the results may be inconclusive without more sophisticated equipment.
Institutions can head over to a webpage that the CDC has set up with several links and tips about identifying fakes, for starters. But ultimately, finding a trustworthy supplier takes time and research.
MRI, for our part, has taken a hands-on approach. Spending months finding the best manufacturers around the world and through numerous visits, MRI builds personal relationships with the owners. Each manufacturer is given a compliance audit to evaluate factors like their manufacturer certification, delivery times, and our own evaluation of the final product. In addition, MRI reviews for fair wages, reasonable hours, and environment. The goal? A score of 90 or above for every factory we work with.
Then, MRI cuts out the middleman to ensure direct, safe delivery to end users.
Masks work, and it seems that mandates and regulations are here to stay. As masks become more sophisticated and research gives us more clarity about how to make masks, it becomes more important for consumers to be knowledgeable about masks. Materials, proper use, and design can all make a difference for whether masks work effectively. Informed consumers not only stay safe but are less likely to be duped by shady companies.
If you would like us to do the legwork for you, head over to mri-care.com to see product selection, with pertinent lab results, and guaranteed quality and delivery.
MRI provides wholesale, bulk delivery of:
• Personal Protection Equipment
• Disposable face masks
• Isolation gowns
• Single-use gowns
• Level 1 masks
• Level 2 masks
• Latex-free masks
• Sterilized individually wrapped masks
• More PPE
MRI is not only open about the stringent testing their PPE is subjected to, prior to coming to their warehouse, but they are also proud to be born from philanthropy… with one mission only: to help. To date, over 1 million masks have been donated, and MRI’s desire to make PPE available to underserved communities is still at the heart of all they do. Therefore, MRI sells deeply discounted, bulk quality PPE to the public.
Also, MRI makes it easy for you or your business to donate FDA-approved, thoroughly tested disposable masks and PPE to worthwhile charities and organizations. Check out MRI’s “Send the gift of PPE” donation page!
If you are interested in placing large quantity orders at discounted pricing or would like to speak with our sales team before placing an online order, please email email@example.com or contact us by phone: (224) 268-6428.