Over the last few months, we’ve seen a great discussion regarding face masks and their effectiveness in the fight against COVID-19. The Centers for Disease Control and Prevention has alone changed its face masks recommendations several times.
The CDC advised at first that masks should be worn by only those who have symptoms, and then they stated that everyone should wear a face mask outside of their home. This has stirred up the world and created a high demand for face masks.
People started selling and buying masks everywhere, without really knowing whether they are certified, approved by the WHO and FDA, or whether they’re efficient.
Soon, the rumors about surgical masks being highly effective spread, and the demand for these masks was at its all-time-high.
However, there was a problem, and is there even today; there’s wasn’t and isn’t enough surgical masks for everyone, and the priority always shifts to healthcare workers and first responders.
Even today, the CDC urges people to not wear surgical masks, for logical reasons; doctors, nurses, and other healthcare workers need those masks the most. But if you do come across a surgical mask and decide to wear it, here’s what you should know!
But, before we start, make sure to check out Dr. Richard Davis conducting two demonstrations about how wearing a mask can block respiratory particles. In the first demonstration, he talked, sang, coughed and sneezed without a mask, and in the other, he used a mask. The result surely speak for themselves;
What does a mask do? Blocks respiratory droplets coming from your mouth and throat.
Two simple demos:
First, I sneezed, sang, talked & coughed toward an agar culture plate with or without a mask. Bacteria colonies show where droplets landed. A mask blocks virtually all of them. pic.twitter.com/ETUD9DFmgU
— Rich Davis, PhD, D(ABMM), MLS 🦠🔬🧫 (@richdavisphd) June 26, 2020
Remember that wearing a mask, regardless of what kind, can lower your risk of getting infected or infecting someone else. Wearing a mask, alongside other safety measures can save lives!
Surgical Mask FAQs
1. What Are Surgical Masks?
Surgical masks are loose-fitting, disposable devices that are designed and created to prevent potential contaminants from entering your mouth and nose.
These masks are regulated under 21 CFR 878.4040, as stated by the FDA. These masks are created to have a one-time use and are not to be shared.
Often referred to as face masks, surgical masks can also be labeled as isolation, dental, and medical procedure masks.
2. Are Surgical Masks Tested And Approved?
Surgical masks are FDA-regulated masks, approved for medical purposes and use. These masks are designed to be fluid resistant and ensure the proper protection against hazardous bodily fluids (droplets, splashes, sprays – coughing, sneezing).
However, surgical masks are not certified as respirator masks, and shouldn’t be confused with respirator masks.
In the Europe Economic Area (EEA), surgical masks have to be certified through the CE marking process, before commercialization (a product needs to conform with health, safety, and environmental protection before sold within EEA). This means that the masks need to be made with respect to Medical Device Regulations, or directives for medical devices.
Surgical masks, both in the USA and EEA need to conform to the ASTM F2100 and EN 14683 standards. In both standards, there needs to be Bacterial Filtration Efficiency (BFE) higher than 95% with particles of size higher than 3.0 μm.
3. What Is The Purpose Of A Surgical Mask?
Surgical masks are intended to protect the wearer from any form of hazardous bodily fluid if worn properly. The masks are also intended to create a barrier between the wearer of the mask and the particles like bacteria, viruses, or fluid that may contain bacteria or viruses.
Surgical masks may reduce the risk of exposure to contaminants, saliva, and respiratory secretions of others, or may lower the risk of you exposing other people to the same contaminants and bodily fluids.
4. How Are Surgical Masks Made?
Surgical masks are made of nonwoven fabric, created using a melt blowing process. These masks are made in different thickness levels, so they have different protective efficiency.
That is why it is important to bear in mind that not every surgical mask is made equally the same, nor do they have the same protective efficiency.
Surgical masks are often three-ply (have three layers). The three-ply material is made from melt-blown polymer, placed between the nonwoven fabric. The masks can often expand in such a way to cover the area from the nose to the chin, and they are secured to the head with either head ties, elastic straps or ear loops.
5. Who Should Wear A Surgical Mask?
The CDC and the WHO recommend surgical masks only to be worn by health care staff during the evaluation of and care for suspected or confirmed COVID-19 patients, as stated by Health Departments across the US.
However, if someone does have a surgical mask, they can wear it. But, it is better if they choose alternative masks, especially if they’re asymptomatic.
6. Are Surgical Masks Efficient?
Surgical masks are effective when it comes to blocking splashes and large-particle droplets.
However, they do not provide complete protection from germs, bacteria, viruses, and other contaminants, because these masks are loose-fitting.
There’s always space between the mask and the face, which doesn’t make surgical masks 100% efficient. Surgical masks DO NOT filter or block very small airborne particles that can be transmitted by sneezing, coughing, or during medical procedures.
However, with respect to some infections, like influenza, surgical masks appear just as effective as N95, KN95 respiratory face masks, and FFP masks.
Collection efficiency of surgical masks can range from 10% to 90%, depending on the mask manufacturer and the test parameters used during the NIOSH certification.
Studies show that most of the surgical masks fail the OSHA-accepted qualitative fit tests, and there is usually a 12% to 25% of leakage with these masks.
7. Are Surgical Masks Effective Against COVID-19 (Coronavirus)?
Three randomized studies have shown that surgical masks can be just as effective as N95 or KN95 respiratory face masks against COVID-19, only if worn properly and if the loose-fit is fixed as much as possible.
These masks, just like the respiratory face masks can reduce hand-to-face contact, as well as lower the risk of getting infected or infecting someone else.
8. How Is The Performance Of A Surgical Mask Evaluated?
The performance of a surgical mask is evaluated using the parameters of filtrations, exposure, mask airflow resistance, liquid penetration resistance, air and water vapor permeability, and water repellency.
9. Are Surgical Masks Disposable?
Surgical masks are made for one-time use and aren’t intended to be used more than once. They are also made to be disposable.
If you notice that a mask is damaged, or if the breathing through the mask becomes difficult, you should remove the mask and dispose of it safely.
Make sure to dispose of the mask using a plastic bag, which you will throw in the trash. It is essential you wash your hands with soap or alcohol-based sanitizer (at least 60% alcohol) after handling a used surgical, or any kind of mask.
10. How To Recognize A Certified Surgical Mask?
Certified surgical masks are supposed to come with labeling that accurately describes the product as a surgical mask. There should also be a list of the body contacting materials, as well as the uses for antimicrobial and antiviral protection, infection prevention, protection during a surgical procedure, or any other related uses.
However, it is important to know that the FDA does NOT issue any kind of certification to demonstrate a manufacturer is in compliance with the FDA requirements.
The FDA also does NOT have a list of all counterfeit or fraudulent products.
They also do NOT have a list of mask suppliers.
11. What Are The Limitations Of Surgical Masks?
- Limited supply due to high demand.
- Have to be safely handled; these masks shouldn’t be touched, and if touched, the person wearing/touching the mask needs to wash their hands thoroughly.
- Surgical masks cannot be washed.
- Surgical masks cannot be reused, even if the FDA and CDC advise possible extended use or reuse as a part of the protective measure strategy.
- Surgical masks need to be discarded immediately if there are signs of damage or deformity if the mask is wet, dirty, if breathing becomes difficult, if the mask is contaminated by blood, saliva, respiratory secretion, or any other bodily fluid.
12. Are Surgical Masks Harmful?
A study shows that heart rate, microclimate (temperature and humidity), and general bodily functions are significantly affected when wearing a surgical mask.
High breathing resistance makes it difficult for individuals to breathe and take in sufficient amounts of oxygen.
A shortage of oxygen is proven to affect the nervous system and heart rate, which can further cause stress and reduce work tolerance. There is further evidence of surgical masks causing skin irritation, thermal stress, itchiness, fatigue, and overall discomfort while wearing the mask.
13. What Are The Best Alternatives For Surgical Masks?
Some tests have shown that DIY masks can filter a percentage of virus-sized particles.
Sure, these are not as effective as respiratory face masks, but they can still provide protection and reduce hand-to-face contact.
You can also purchase N95 or KN95 respiratory face masks, which are currently the best-performing masks when it comes to virus filtration and protection.
Either way, regardless of which other masks you choose, you will do a good job and enable surgical masks to be more available for health care staff.