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How are surgical masks made and tested?

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How are surgical masks made and tested?

by BYO MCC on May 10 2021
Surgical masks were originally designed and made in order to keep operating rooms sterile. It was mandated in order to reduce the risk of surgical site infections on patients who undergo operations. Surgical masks prevent microorganisms from escaping the mouth and nose of a wearer which can pose a risk of contamination of a patient during surgery. However, during the pandemic such as the spanish flu and Coronavirus, surgical masks were utilized not only by healthcare workers but also by normal people in order to reduce the risk of transmission.  (Source: Pexels.com) Today, surgical masks are a necessity. You need to wear them not only to follow health protocols set by the government but to also protect yourself from the risk of being possibly infected with Coronavirus that is present in respiratory droplets floating in the air. Hence, surgical masks are indeed growing in popularity. Most, if not all, are wearing this protective equipment these days. However, even with such fame, many are still questioning the efficacy of surgical masks because they do not understand how these protective devices are made and tested. With that, in order to give light to that topic, here’s how surgical masks are made and tested.   How are Surgical Masks Made? Surgical face masks are produced using tissue formation techniques. With that, surgical masks can be classified into three types which include woven masks, unwoven masks, and knitted masks. Although these three techniques are utilized for the production of fabrics, today, most surgical face masks are produced through non-woven masks techniques with the goal of disposing them after one use. In addition to that, it is significantly cheaper to produce surgical face masks using the non-woven technique rather than utilizing the woven or knitted type.  Non-woven fabric is used for the production of surgical masks because they have better bacteria filtration and air permeability. Non-woven fabric is also more comfortable and less slippery compared to woven and knitted fabric. The material most commonly used to make non-woven fabric is polypropylene, either 20 or 25 grams per square meter (gsm) in density. Furthermore, surgical face masks can also be produced using polystyrene, polycarbonate, polyethylene, or polyester. Non-woven fabrics are usually made by combining small fibers together in the form of a sheet or web and then binding them either: (1) mechanically by interlocking them with serrated needles such that the inter-fiber friction results in a stronger fabric just like in felt; (2) with an adhesive; (3) thermally through the application of a binder in the form of paste, polymer melt, or powder and melting this binder onto the web through a very high temperature. It must be noted that most factories produce these surgical masks using Spunbond Meltblown Spunbound (SMS) technology As stated above, the GSM density layers of non-woven fabric for surgical masks vary. It can either be a 20 GSM density layer or a 25 GSM density layer. On one hand, the 20 GSM density layers are produced through the membrane process which includes a melted plastic extrude on a conveyor. The material is cultured in a net, where threads are bonded with each other while being cooled down.  On the other hand, the 25 GSM layers are made through a melting technology. This is a similar process where plastic is cultured through a mold with hundreds of small openings and blown in hot air into small fibers, and again these fibers are cooled by their extruding on a conveyor. These fibers are characterized by a diameter of less than one micron.  Once non-woven fabrics are made, surgical masks are assembled as a multi-layered structure, typically by covering a layer of textile with non-woven bonded fabric on both sides. Non-woven  layers are usually three to four layers. Furthermore, these disposable masks are usually designed with two filter layers effective at filtering out particles. It must be noted that the filtration capacity of a surgical mask depends on the fiber - the way the fiber was made, the fiber’s structure, and the fiber’s cross-sectional shape. Masks are made on a machine line that assembles the nonwovens from bobbins, ultrasonically welds the layers together, and stamps the masks with nose strips, ear loops, and other pieces. Once the masks are done, they are sterilized and then sent out of the factory. How are Surgical Masks Tested?  Once surgical masks are made, they should be tested in order to check for their quality and effectiveness.  (Source: Pexels.com) ASTM is the american society for testing and materials. ASTM International sets the preferred international standard in healthcare for best practices inclusive of testing and requirements for performance of materials.  There are currently five assessments that will be carried out by ASTM for surgical masks. These include:  Bacteria filtration efficiency in vitro (BFE)This test aims to address the capacity of the surgical masks to filter out bacteria. This method works by firing a staphylococcus aureus bacteria aerosol at a rate of 28.3 liters per minute. They will measure the data based on how many bacteria that the mask will contain vs the expected value it should have. Particle Filtration Efficiency (PFE)This test is also known as latex particle challenge. The PFE involves spraying the aerosol with polystyrene microspheres in order to make sure that the mask will absorb the size of the particle it is meant to process. Breathing resistanceOther than the filtration capacity, it is important that masks are comfortable for users to wear. With that, a breathing resistance test is performed in order to ensure that the mask maintains its form and provides adequate ventilation as the wearer breathes. Respiratory resistance is measured by aiming the air flow at it and then calculating the change in air pressure on both sides of the mask. Splash resistance This test is conducted to ensure that solvents such as blood, infectious droplets, and others cannot penetrate the mask. This test is done through splashing artificial blood using actual blood pressure-like pressure to the surgical masks. Flammability The flammability of surgical masks are checked because certain components in the operating room can potentially cause fire. This test is done through placing the surgical masks on fire in order to determine how slowly the substance is ignited and how long it takes to burn. It must be noted that ASTM levels 1, 2, and 3 are all necessary to be flame resistant to Class 1. Passing such tests, the ASTM will then give a certification for that surgical mask and where it is classified in, depending on the level of protection. These certifications include:  Limited protection face masks - These masks are manufactured for brief operations or tests not requiring gas, water, or aerosol. Level 1 surgical masks - These surgical masks are considered as low barrier protection. These surgical masks features a Bacterial filtration efficiency equal to or greater than 95%, Sub-micron particulates filtration efficient at 0.1 micron  equal to or greater than 95%, Differential pressure of less than 4 mm H2O/cm2, Resistance to penetration by synthetic blood (minimum pressure in mm Hg for pass) of 80 mm Hg, and a Class I flame spread. Level 2 surgical masks - This is considered as the moderate barrier protection surgical mask. These surgical masks features a Bacterial filtration efficiency equal to or greater than 98%, Sub-micron particulates filtration efficient at 0.1 micron  equal to or greater than 98%, Differential pressure of less than 5 mm H2O/cm2, Resistance to penetration by synthetic blood (minimum pressure in mm Hg for pass) of 120 mm Hg, and a Class I flame spread. Level 3 surgical masks –This is considered as the maximum barrier protection surgical mask. These surgical masks features a Bacterial filtration efficiency equal to or greater than 98%, Sub-micron particulates filtration efficient at 0.1 micron  equal to or greater than 98%, Differential pressure of less than 5 mm H2O/cm2, Resistance to penetration by synthetic blood (minimum pressure in mm Hg for pass) of 160 mm Hg, and a Class I flame spread.  Bottomline Now that the process of manufacturing and testing surgical masks were presented, we hope that you put more faith in the effectiveness of these facial coverings in reducing the risk of transmission of infectious pathogens such as the Coronavirus. These surgical masks undergo a tedious process just to make sure that the adequate protection level is reached. Hence, people can trust that these surgical masks are made and tested excellently.  References:  Ming Hui Chua, Weiren Cheng, Shermin Simin Goh, Junhua Kong, Bing Li, Jason Y. C. Lim, Lu Mao, Suxi Wang, Kun Xue, Le Yang, Enyi Ye, Kangyi Zhang, Wun Chet Davy Cheong, Beng Hoon Tan, Zibiao Li, Ban Hock Tan, Xian Jun Loh, "Face Masks in the New COVID-19 Normal: Materials, Testing, and Perspectives", Research, vol. 2020. Science Alert. 2020. How to Test Your Face Mask to Make Sure It Actually Works. Retrieved from: https://www.sciencealert.com/how-to-test-your-face-mask-to-make-sure-it-actually-works. Retrieved on 7 May 2021.  Thomas Publishing Company. 2020. How Surgical Masks are Made. Retrieved from: https://www.thomasnet.com/articles/other/how-surgical-masks-are-made/. Retrieved on 7 May 2021.  UL. 2020. Surgical, Nonsurgical and Nonmedical Face Mask Testing. Retrieved from: https://www.ul.com/services/surgical-nonsurgical-and-non-medical-face-mask-testing. Retrieved on 7 May 2021. 
Surgical Mask vs Non-surgical Mask

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Surgical Mask vs Non-surgical Mask

by BYO MCC on Apr 30 2021
If you think that all masks are made equal, then you are definitely wrong! Not all masks provide the same level of protection that you need with today’s health crisis. While all masks offer some level of protection, understanding what separates medical masks from non-medical masks is a vital consideration, especially when you want to protect you and your family.  (Source: Pexels.com/photo/photo-of-man-and-woman-wearing-face-masks-4148971/) While both may be referred to as face masks, these two protective devices are actually utilized for different functions and different settings. Surgical masks and non-surgical masks are very different kinds of masks from the material used to the intended uses. Below is a breakdown of what separates surgical masks from non-surgical masks and the levels of protection that they provide.  What are Surgical and Non-Surgical Masks? (Source: Pexels.com/photo/blue-single-use-medical-face-masks-4197565/) Surgical masks are considered as medical masks. These masks are a form of disposable covers that are usually worn by medical professionals as personal protective equipment (PPE) during surgeries or other medical procedures. Furthermore, when indicated, surgical masks are typically worn in conjunction with other types of PPE in order to protect the wearer from exposure to the potentially infectious respiratory droplets of infected patients.  Surgical or medical masks are frequently made of a combination of paper and plastics, and are commonly manufactured to have a light blue color.  Studies have shown that surgical masks have the ability to protect wearers from large respiratory droplets but do not have as strong protection against smaller droplets. However, it must be noted that when worn correctly, medical masks can serve as a form of source control, protecting those around the wearer from potential exposure to their respiratory droplets, especially when the wearer is a carrier of a virus. Lastly, unlike non-surgical masks or cloth masks, medical masks cannot be washed or reused, hence it is intended to be worn only once before being discarded. (Source: Pexels.com/photo/business-people-wearing-face-masks-and-talking-4427957/) Non-medical masks are cloth masks or masks not certified as medical grade by Health Canada.  Just like surgical masks, a cloth face mask or non-medical masks fits against the face using either ear loops or ties around the head. Several layers of fabric creates a protection between your nose and mouth and the external environment, aiding in containing any respiratory droplets that you may breathe out. Hence, the sole purpose of wearing non-medical masks is for source control. With that, non-medical masks have the capacity to protect those around the wearer from possible exposure to the wearer’s respiratory droplets, especially when worn properly. However, it must be noted that non-medical masks are not considered as personal protective equipment and are not recommended to be used in scenarios where the use of PPE is indicated, such as when attending direct care to or within 2 meters of an individual suspected or confirmed to be infected with COVID-19.  What makes Surgical Mask different from Non-surgical mask? It is understood that surgical and non-surgical masks offer a degree of protection against respiratory droplets that may contain infectious viruses. Furthermore, it has been shown that both can actually work as a source of control, protecting others from the wearer’s potential infective muco-salivary secretions. However, it must be noted that surgical masks are far way better than non-surgical masks. The American Society for Testing and Materials  (ASTM) is an international standards organization that develops and publishes voluntary consensus technical standards for a wide array of materials, products, systems, and services, including those that are utilized in the healthcare field. Furthermore, the ASTM is responsible for setting the standards for surgical masks. Their ratings provide the criteria to which surgical masks should meet to have an adequate protection and performance. With that, ASTM F2100, the current standard, reviews 5 basic criteria. These include Bacterial Filtration Efficiency (BFE) or the ability to filter bacteria; the Particulate Filtration Efficiency (PFE) or the ability to filter sub-micron particles; Fluid Resistance or the ability to prevent fluid penetration through the mask to the wearer; Delta P (Pressure Differential) or the measurement of how light and breathable a mask feels; and Flame Spread or the ability to withstand exposure from flame. Unlike Cloth masks, surgical masks undergo the scrutiny of the ASTM. In addition to that, ISO (International Organization for Standardization) 10993-5 and ISO 10993-10 also provide certifications for  skin sensitivity and cytotoxic testing for surgical masks. This ensures optimal comfort and minimizes the risk of adverse reaction from surgical mask materials and surgical mask usage. (Source: Pexels.com/photo/photo-of-woman-wearing-protective-mask-4270078/) Cloth masks do not have ASTM ratings. Surgical masks, on the other hand, have ASTM ratings that span from Level 1 to Level 3, in which each level offers an increased level of protection across the range of criteria: ASTM Level 1 - these surgical masks are utilized for general procedures, minimally invasive surgery, ophthalmology, and respiratory etiquette. Surgical masks under ASTM Level 1 has a BFE at 3.0 micron of  ≥ 95%, PFE at 0.1 micron of  ≥ 95%, Delta P of < 5.0 mm H2O/cm2, Fluid Resistance to synthetic blood at 80 mm Hg, Flame Spread Class 1 per 16 CFR part 1610. ASTM Level 2 - these surgical masks are utilized for procedures such as general surgery and endoscopy while providing greater breathability than high barrier (Level 3) masks. These surgical masks were designed to resist a splash or spray at arterial pressure. Surgical masks under ASTM Level 2 has  BFE at 3.0 micron of  ≥ 98%, PFE at 0.1 micron of  ≥ 98%, Delta P of < 6.0 mm H2O/cm2, Fluid Resistance to synthetic blood at 120 mm Hg, and Flame Spread Class 1 per 16 CFR part 1610. ASTM Level 3 -  these surgical masks are utilized in order to have the highest fluid resistance. These surgical masks were designed to resist a splash or spray during tasks like orthopedic surgery or trauma. Surgical masks under ASTM Level 3 has BFE at 3.0 micron of ≥ 98%, PFE at 0.1 micron of  ≥ 98%, Delta P of < 6.0 mm H2O/cm2, Fluid Resistance to synthetic blood at 160 mm Hg, and Flame Spread Class 1 per 16 CFR part 1610. With that, surgical masks greatly differ from cloth masks because it has reached the standards and criteria set by the ASTM. It must be noted that if surgical masks are not available in a particular area, cloth masks can be utilized. However, particular guidance for wearing cloth masks was set by the Centers for Disease Control and Prevention (CDC). These include the following:  Wearers should ensure that the cloth masks cover the nose and mouth and are secured with ties or ear loops, fitting snugly but comfortably, without gaps. It is important that wearers do not touch their cloth masks while wearing it. If it has been touched, wearers should sanitize and wash hands immediately.  When removing cloth masks, one should not touch his or her face - especially the nose, eyes, and mouth - or the front of the mask. After removing the cloth mask, washing of hands should be done immediately Per manufacturer's instructions, cloth masks should be regularly cleaned in a washing machine. One should make or look for cloth masks that have more than one layer of fabric. To wear a gaiter as a mask, choose one with two layers, or fold it to make two layers. In order to aid in preventing fogging when wearing glasses with a face covering, choose a cloth mask with a nose wire or tight-fitting nose area. It is important to remember that while wearing a cloth mask is an important precaution, washing of hands frequently and following social distancing guidelines are still vital measures.  It is vital to remember that cloth face masks are not a substitute for required respiratory protection. Bottomline: Face masks are an important protection against viruses that may cause illness such as COVID-19. With that, it is vital that you should always choose the kind of masks that are scientifically proven and tested by a verified and certified body, so that you can make sure that you get the right protection that you need. At the end of the day, whether it may be a surgical mask or a non-surgical mask, the effectiveness of masks can be improved by ensuring that the masks are well fitted to the contours of your face to prevent leakage of air around the masks' edges. Make sure that your mask is snug over the nose, mouth and chin, with no gaps. Together with proper handwashing and social distancing, wearing your mask properly and at all times is an effective strategy in reducing the transmission of the deadly COVID-19 virus - hopefully ending this global health crisis.  References:  Canadian For Centre Occupational Health and Safety. Respirators, Surgical Masks, and Non-Medical Masks. 2020. Retrieved from: https://www.ccohs.ca/images/products/pandemiccovid19/pdf/masks.pdf. Retrieved on 29 March 2021.  Esposito S, Principi N, Leung CC, Migliori GB. Universal use of face masks for success against COVID-19: evidence and implications for prevention policies. Eur Respir J. 2020;55(6):2001260. Published 2020 Jun 18. doi:10.1183/13993003.01260-2020 MacIntyre CR, Chughtai AA. A rapid systematic review of the efficacy of face masks and respirators against coronaviruses and other respiratory transmissible viruses for the community, healthcare workers and sick patients. Int J Nurs Stud. 2020;108:103629. doi:10.1016/j.ijnurstu.2020.103629 Mayo Foundation for Medical Education and Research (MFMER). 2020. How well do face masks protect against coronavirus?. Retrieved from: https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-mask/art-20485449. Retrieved on 29 March 2021.  PRIMED Medical Products. 2020. Medical vs Non-Medical Masks: Considerations to Optimize Protection. Retrieved from: https://www.primed.ca/medical-vs-non-medical-masks/. Retrieved on 29 March 2021.  Public Health Ontario. 2020. COVID-19: Non-Medical Masks. Retrieved from: https://www.publichealthontario.ca/-/media/documents/ncov/factsheet/2020/11/covid-19-non-medical-masks-qa.pdf?la=en. Retrieved on 29 March 2021. 
All About Surgical Masks: Level 1 vs Level 2 vs Level 3

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All About Surgical Masks: Level 1 vs Level 2 vs Level 3

by BYO MCC on Apr 30 2021
Today, safety should be your priority. With the ongoing health crisis, it is a must that you are equipped with the knowledge so that you can protect yourself and your family. There are many ways to prevent being sick these days - one of them is wearing surgical masks. These facial protection are scientifically proven to prevent transmission and control sources of infection. Image lifted from: https://www.pexels.com/photo/set-of-medical-protective-face-masks-4197564/ So What Are Surgical Masks?  The term surgical mask is utilized in order to refer to Food and Drug Administration (FDA)-cleared surgical, laser, isolation, dental, medical procedure or face masks with or without a face shield.  These single use, fluid-resistant, disposable and loose fitting protection devices create a physical barrier between the mouth and nose of the wearer and the immediate environment but may not achieve a close seal to the wearer's face. Before the pandemic, surgical masks are usually utilized by healthcare personnel in order to provide protection against respiratory droplets that may contain infectious matter. Today, with the health crisis that the world is facing, most, if not all, are using surgical masks to protect themselves from droplets that may come into contact to the nose and mouth. In addition to that, infection control guidance strongly recommends wearing surgical masks on everyone in order to limit the dissemination of infectious respiratory secretions from one person to others. There are definitely a lot of different surgical masks you can choose from in the market. All of them vary greatly by quality and levels of protection. With that, there are certainly variations on how surgical masks can protect you against respiratory droplets in the air that may contain infectious viruses, bacteria, and other microorganisms.  So if you want to know more about what surgical masks are and the differences between level 1, level 2, and level 3 masks, keep on reading this article. How Are Surgical Masks Produced? Before we go onto the different levels of surgical face masks. It is important to simply understand how they are produced, so that we can know how surgical masks are able to protect us from infectious materials.  Image lifted from: https://www.pexels.com/photo/man-people-woman-technology-4492074/ Surgical masks are made out of non-woven fabric.  This type of fabric has greater ability to  filter bacteria, viruses, and other microorganisms. Furthermore, compared to woven materials, it has better air permeability which makes it more suitable for surgical masks. Polypropylene, usually 20 to 25 grams per square meter (gsm) in diameter, is the material of choice that is widely utilized to produce surgical masks.  is polypropylene. However, other materials such as polystyrene, polycarbonate, polyethylene or polyester can also be used to produce surgical masks. On one hand, the 20 gsm mask material is produced through the spunbond operation. This procedure includes the extrusion of the molten plastic onto the conveyor. The content is extruded in a chain in which the strands bind with each other as they cool. On the other hand, the 25 gsm of cloth is produced through meltblown processing. This procedure is a common method in which plastic is extruded through a die with hundreds of small nozzles and blown by hot air to make tiny fibers, cooling and binding again to a conveyor.   A multiple layers are combined in order to produce surgical masks. These layers are usually achieved through covering the cloth sheet with a non-woven bonded fabric on both sides. Nonwovens are composed of three to four layers. They are easier to produce and safer because  they are lightweight in nature. Such disposable masks are also made of two filter layers. With that, they are effective in removing matter such as bacteria and viruses above 1 micron. However, it must be noted that the degree of filtration of the mask depends on many factors such as the type of fiber used, the process how it is made, the structure of the fiber network, and the cross-sectional shape of the fiber.  Surgical masks are made on a machine line that assembles nonwovens from bobbins, ultrasonic welds layers together, and stamps masks with nose strings, ear clips, and other bits. Once the surgical mask is done, both the masks and breathers are then sterilized before being shipped out of the facility. What is ASTM (American Society for Testing and Materials)? The American Society of Testing and Materials (ASTM) International is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. With that, it is the organization responsible for the global implementation of face mask standards. Since its establishment, there have been over 12,500 ASTM standards in use around the world in order to establish safety and quality reports and standards across a wide variety of industries and services. Healthcare organizations worldwide adopt ASTM recommendations in order to implement the best health practices.  Performance Metrics and Related Tests: ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. With that, the Standard Specification for Performance of Materials Used in Medical Face Masks or ASTM F2100-11 has indicated a comprehensive set of tests for procedure and surgical face masks. These tests are vital in order to make sure that the performance properties are validated to support claims and classify mask types. ASTM F2100 specifies the performance requirements for Surgical Face Masks with five basic criteria: BFE (Bacterial Filtration EfficiencyThe bacterial filtration efficiency measures how effective medical face masks are in filtering out bacteria when challenged with a bacteria-containing aerosol. ASTM utilizes a droplet size of 3.0 microns containing Staphylococcus aureus which has an average size of 0.6 to 0.8 microns. A minimum 95% filtration rate is required in order to be called a medical or surgical face mask. A bacterial filtration rate of equal to or greater than 98% is required for the moderate and high protection masks. In order to determine the BFE rating, the Modified Greene & Vesley method is utilized by some manufacturers. However, it must be noted that the Modified Greene & Vesley method is not recommended by ASTM for product comparison or evaluating consistency. PFE (Particulate Filtration Efficiency)The ASTM has set Particulate Filtration Efficiency in order to measure how well a face mask filters sub-micron particles with the expectation that viruses will be filtered in a similar manner. It must be noted that the higher the percentage, the better the mask filtration. ASTM F2100 specifies that a particle size of 0.1 micron be utilized, however testing is available using a particle size from 0.1 to 5.0 microns. A misleading PFE rating may occur when manufacturers use a larger particle size. Hence, it is important to note that when comparing test results, it is important to note the size of the test particles utilized for the test.  Fluid Resistance: The ability of the surgical mask to minimize the amount of fluid that could transfer from the outer layers through to the inner layer as the result of a splash or spray is reflected by its fluid resistance. In order to qualify for low, medium, or high fluid resistance, ASTM specifies testing with synthetic blood at pressures of 80, 120, or 160 mm Hg, respectively. These pressures correlate to blood pressure such that 80 mm Hg is equivalent to venous pressure (Level 1); 120 mm Hg is equivalent to arterial pressure (Level 2); and 160 mm Hg (Level 3) is linked to possible high pressures that may happen during trauma, or surgeries that uses high pressure irrigation including those that are done in orthopedics. Delta P (Pressure Differential)The objective measure of how breathable a face mask is done through testing the pressure differential. Furthermore, the Delta P measures the air flow resistance of the surgical mask. The Delta P is measured in units of mm H2O/cm2. It must be noted that the lower this value, the more breathable the mask feels. According to the ASTM standard, a moderate and a high barrier mask should have a Delta P of less than 6.0, whereas low barrier masks should have a Delta P of less than 5.0. Flame SpreadThe ASTM standards require testing for flame resistance as hospitals contain sources of oxygen, heat, and fuel. The ASTM standard testing dictates that all hospital masks must withstand exposure to a burning flame, within a specified distance, for three seconds.  In addition to the above tests, all surgical face masks must be ISO Certified. With that, surgical masks are tested to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests. These tests are conducted in order to make sure that no materials are harmful to the wearer. Tests are conducted on materials utilized in construction of the mask which come in contact with the user's skin. Levels of Surgical Masks Image lifted from: https://www.pexels.com/photo/face-mask-on-blue-background-3786126/ Now that the standards of the ASTM certification were introduced, there basically are four levels in which surgical masks are identified. These levels are based on the level of defense they provide to the individual wearing them. These include:  Limited Protection face masks - These masks are manufactured for brief operations or tests not requiring gas, water, or aerosol. Level 1 surgical masks - These surgical masks are considered as low barrier protection. These surgical masks also come with ear ties and are the general standard. This is considered as the low barrier protection surgical mask. The level 1 surgical mask is intended for general use. The general purpose of these surgical masks is for medical procedures where the wearer is not at risk of blood or body fluid splash or to protect staff and/or the patient from droplet exposure to microorganisms. These surgical masks features a Bacterial filtration efficiency equal to or greater than 95%, Sub-micron particulates filtration efficient at 0.1 micron  equal to or greater than 95%, Differential pressure of less than 4 mm H2O/cm2, Resistance to penetration by synthetic blood (minimum pressure in mm Hg for pass) of 80 mm Hg, and a Class I flame spread. Level 2 surgical masks - This is considered as the moderate barrier protection surgical mask. The level 2 surgical mask is intended for use in areas with low to moderate levels of aerosols, spray and/or fluids. The general purpose of these surgical masks is for use in emergency departments, dentistry, changing dressings on small wounds or healing wounds where minimal blood droplet exposure may possibly occur. These surgical masks features a Bacterial filtration efficiency equal to or greater than 98%, Sub-micron particulates filtration efficient at 0.1 micron  equal to or greater than 98%, Differential pressure of less than 5 mm H2O/cm2, Resistance to penetration by synthetic blood (minimum pressure in mm Hg for pass) of 120 mm Hg, and a Class I flame spread. Level 3 surgical masks - are for heavy and maximum possible exposure to aerosol, fluid and spray, with 160 mmHG fluid resistance. This is considered as the maximum barrier protection surgical mask. The level 3 surgical mask is intended for use in areas with high risk of fluid, spray or aerosol exposure. The general purpose of these surgical masks is for all surgical procedures, major trauma first aid or in any area where the health care worker is at risk of blood or body fluid splash. These surgical masks features a Bacterial filtration efficiency equal to or greater than 98%, Sub-micron particulates filtration efficient at 0.1 micron  equal to or greater than 98%, Differential pressure of less than 5 mm H2O/cm2, Resistance to penetration by synthetic blood (minimum pressure in mm Hg for pass) of 160 mm Hg, and a Class I flame spread.  References: Chua, M. H., Cheng, W., Goh, S. S., Kong, J., Li, B., Lim, J. Y. C., Mao, L., Wang, S., Xue, K., Yang, L., Ye, E., Zhang, K., Cheong, W. C. D., Tan, B. H., Li, Z., Tan, B. H., & Loh, X. J. (2020). Face Masks in the New COVID-19 Normal: Materials, Testing, and Perspectives. Research, 2020, 1–40.  Interim infection prevention and control guidelines for the management of COVID-19 in healthcare settings – Version 1.14. 2020. Retrieved from: https://www.health.qld.gov.au/__data/assets/pdf_file/0042/969297/properties-of-PPE-for-use-in-healthcare.pdf. Retrieved on 2 April 2021.   Matuschek, C., Moll, F., Fangerau, H., Fischer, J. C., Zänker, K., van Griensven, M., Schneider, M., Kindgen-Milles, D., Knoefel, W. T., Lichtenberg, A., Tamaskovics, B., Djiepmo-Njanang, F. J., Budach, W., Corradini, S., Häussinger, D., Feldt, T., Jensen, B., Pelka, R., Orth, K., . . . Haussmann, J. (2020). Face masks: benefits and risks during the COVID-19 crisis. European Journal of Medical Research, 25(1), 1. https://doi.org/10.1186/s40001-020-00430-5
What Makes 3 Ply Face Masks So Special?

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What Makes 3 Ply Face Masks So Special?

by BYO MCC on Apr 30 2021
In December 2019, a novel coronavirus was detected in China. Since its discovery, it has swiftly spread throughout the world. This novel coronavirus was then named as SARS-CoV-2, and the illness that it causes is termed as COVID-19. Older adults and those with underlying health conditions are most at risk for serious illness which include symptoms such as fever, difficulty breathing, pneumonia, and even respiratory failure.  Through small respiratory droplets, SARS-CoV-2 can be transmitted from person to person. These small respiratory droplets are made when an infected person exhales, talks, coughs, or sneezes. With that, you can contract the virus if you breathe in these droplets. Moreover, studies have shown that respiratory droplets containing the virus can land on objects or surfaces. Hence, there is a possibility that you could get infected with SARS-CoV-2 if you touch these surfaces and then touch your eyes and nose after.  However, it must be noted that this is not the primary way that the virus is transmitted from person to person. Because SARS-CoV-2 is easily transmitted, there have been rising cases of COVID-19. With that, scientists and health experts have come together to come up with a prevention strategy Image lifted from: https://www.pexels.com/photo/cold-landscape-man-people-4909474/ Face mask is a scientifically proven effective material you can utilize in order to protect yourself from having COVID-19. Studies have shown that properly wearing face masks, which means covering your nose and mouth, can have approximately 95% protection against SARS-CoV-2.  So when you hear about face masks, there are typically three types. These include homemade cloth face masks, N95 respirators, and surgical masks. One of the most common and most effective types of face masks out there is the 3 ply surgical face mask. But the question is: what really makes this face mask special? So if you are curious about the answer, then keep on reading! What is a 3 Ply Face Mask? Image lifted from: https://www.pexels.com/photo/woman-in-white-face-mask-3873193/ A 3 ply face mask is disposable, loose-fitting face mask that covers your nose, mouth, and chin. If worn properly, surgical masks can aid in blocking out most, if not all, large-particle droplets, splashes, sprays, or splatter that may contain viruses and bacteria, keeping them from entering the wearer's nose and mouth and conversely are also effective barriers for retaining large droplets released from the wearer's the mouth and nose. With that, the 3-ply surgical mask is usually used in the COVID-19 pandemic. As the name implies, the 3-ply surgical mask is manufactured through the combination of 3 various layers of nonwoven fabric with each layer having a vital function. Here are the parts of a 3 ply face mask:  The outermost layer is the waterproof layer which aids in keeping out fluids such as mucosalivary and respiratory droplets.  The middle layer is the filter. This layer blocks particles or pathogens above a specific size from penetrating in both directions.  The innermost layer is made of absorbent materials to confine mucosalivary droplets from the user. This also improves comfort through absorbing the moisture from exhaled air.  When combined together, these 3 layers effectively protect both the user and the surrounding people by reducing the penetration of particles and pathogens in either direction.  In addition to that, 3 ply masks are made of nonwoven fabric. As its name suggests, nonwoven fabric is not composed of intertwining strands, rather it is produced through bonding a mass of fibres together by heat, chemical, or mechanical procedure. Moreover, nonwoven fabric is cheap and fast to manufacture. With that, nonwoven fabric is the ideal material for surgical masks. The two most common methods of making nonwoven fabric for surgical masks are spunbond and melt-blown. Both of these technologies can process a great variety of thermoplastic such as polypropylene, polyester, polyethylene, polyamide, and polyurethane. Polypropylene is the most common material utilized for a 3-ply surgical mask. What makes 3 Ply Mask Special? There are a number of different types of face masks and respirators offering different levels of protection to users. These masks can either be reusable or disposable. Industrial-use half or full facepiece respirators with cartridge filters attached and homemade or commercial cloth masks are considered as the reusable ones, while surgical masks, N95 respirators, and KN95 respirators are considered as the disposable ones. It must be noted that all these face masks serve the general purpose of providing some form of protection against contaminants in the air.  The level of protection against pollutants and pathogens is greatly dependent on the filtering capacity which highly depends on the materials used and the engineering design. SARS-CoV-2 has a size of approximately 60 to 140 nm. This size is smaller than bacteria, dust, and pollen. Hence, masks made of materials with larger pore sizes, such as those made from cotton and synthetic fabric, will not be able to effectively filter these viruses or tiny virus-laden droplets, as compared with those made of materials with smaller pore sizes. Moreover, masks made of or coated with water-resistant materials are significantly more effective in repelling large virus-laden respiratory droplets and fluid spills.  Image lifted from: https://www.pexels.com/photo/woman-wearing-face-mask-3902732/ In this case, a 3-ply face mask is the most effective and standard product to prevent the entry of SARS-CoV-2. The 3-ply face mask has passed the requirements set by international and national standards organizations such as the American Society for Testing and Materials (ASTM). The ASTM is responsible for setting the masks as certified protective devices. In order to be classed as a medical mask, manufacturers have met required standards from raw materials to finished product. The performance requirements classify the product as Level 1, 2, or 3. There are basically five criteria to reach standard in order to qualify as an ASTM Medical Mask. It must be noted that the higher the performance rating of the mask, the greater the protection. Here are the following criteria: Fluid Resistance –This means that the mask is resistant to penetration by synthetic blood under pressure (mmHg). The higher resistance, the higher protection. PFE Particle Filtration Efficiency – This is the percentage of particles filtered out at a pore size of about 0.1 – 1.0 microns (µ). BFE Bacteria Filtration Efficiency – This is the percentage of particles filtered out at a pore size of 1.0 – 5.0 microns (µ). Delta P Differential Pressure – This is the pressure drop across mask, or resistance to air flow in mmH2O/cm2 . The greater resistance, the better protection (however there is also less breathability). Flame Spread –  this measures the flame spread of the mask material. A 3-ply face mask has passed this criteria set by the ASTM. In addition to these criteria, 3-ply face masks must also be tested to an ISO certification that makes sures that no materials have been utilized in making the mask that are harmful to the wearer as it comes in contact with their skin. Furthermore, a 3-ply medical mask can be level 1, 2, or 3. A Level 1 Disposable Medical Mask is ideal for scenarios where low amounts of fluid, spray and aerosol are produced. Level 2 are for procedures where moderate amounts are produced and Level 3 is for surgery. It must be noted that ASTM Level 1 requirements include Fluid Resistance of greater than 80mmHg, PFE of greater than 95%, and BFE of greater than 95%. Unlike disposable 3 ply protective face masks, there are also other disposable medical face masks that are common in the market right now and are usually manufactured in China. With that, it must be noted that the Chinese National Standards for disposable masks are not required to meet the standards of ASTM Level 1 Mask. For example, for disposable protective face masks made in China, fluid resistance, PFE, or BFE may not be required. With that, it may not bring the level of protection against SARS-CoV-2 compared to those 3-ply face masks that are manufactured in Canada and tested under the ASTM.  Bottomline Face mask, when worn properly, is an effective protection against SARS-CoV-2. The 3-ply face mask that is certified by the ASTM is the best one you can get in the market. Now that we have outlined the details on why the 3-ply face mask is special, we hope that you always wear them, especially when going out, so that we can protect ourselves and others from COVID-19. References:  ASTM. F2100-19e1, Standard Specification for Performance of Materials Used in Medical Face Masks. West Conshohocken, PA, USA: ASTM International; 2019. Chua, M. H., Cheng, W., Goh, S. S., Kong, J., Li, B., Lim, J., Mao, L., Wang, S., Xue, K., Yang, L., Ye, E., Zhang, K., Cheong, W., Tan, B. H., Li, Z., Tan, B. H., & Loh, X. J. 2020. Face Masks in the New COVID-19 Normal: Materials, Testing, and Perspectives. Research (Washington, D.C.), 2020, 7286735. https://doi.org/10.34133/2020/7286735  Phend, C. MedPage Today. 2020. Not All Cloth Masks Are Equally Protective — Droplet study shows which are better. Retrieved from: https://www.medpagetoday.com/infectiousdisease/covid19/87716. Retrieved on 26 March 2021.  Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Chu DK, Akl EA, Duda S, Solo K, Yaacoub S, Schünemann HJ, COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Production Automation Corporation. 2020. Why 3 Ply Face Masks and Surgical Masks are Meaningful N95 Mask Alternatives. Retrieved from: https://blog.gotopac.com/2020/05/07/why-3-ply-face-masks-and-surgical-masks-are-meaningful-n95-mask-alternatives/. Retrieved on 26 March 2021.  Pung R, Chiew CJ, Young BE, Chin S, Chen MI, Clapham HE, Cook AR, Maurer-Stroh S, Toh MPHS, Poh C, Low M, Lum J, Koh VTJ, Mak TM, Cui L, Lin RVTP, Heng D, Leo YS, Lye DC, Lee VJM, Singapore 2019 Novel Coronavirus Outbreak Research Team. Lancet. 2020 Jun 27; 395(10242):1973-1987. Seladi-Schulman, J. Healthline. 2020. Can Face Masks Protect You from the 2019 Coronavirus? What Types, When and How to Use. Retrieved from: https://www.healthline.com/health/coronavirus-mask. Retrieved on 26 March 2021.
Effectiveness of Face Masks: Surgical Masks vs Home-made Masks

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Effectiveness of Face Masks: Surgical Masks vs Home-made Masks

by BYO MCC on Apr 30 2021
The Covid-19 has halted the world. Other than causing deaths of millions and draining the economy, the pandemic also changed the way our daily life activities go. From being able to enjoy the outside and see the world, we had to stop and stay in our spaces inside our homes.  After more than a year since the Covid-19 health crisis started, we are now accustomed to the fact that we have to wear face masks in order to be protected against the infectious pathogen. However, even after all this time, there are still debates on what face mask one should wear in order to be provided with adequate protection and comfort both at the same time. While one would argue that it should be surgical masks, another would disagree because he thinks it should be home-made or cloth masks.  So to put an end to this debate, here is the difference on the effectiveness of surgical masks and home-made or cloth face masks.    (Source: Pexels.com)   A surgical mask is a loose-fitting, disposable device that produces a physical barrier between the mouth and nose of the wearer and possible pathogens in the direct environment. Surgical masks are heavily regulated by organizations such as the American Society for Testing and Materials  (ASTM). If worn properly, surgical masks can help in blocking almost all large-particle droplets, splashes, sprays, or splatter that may contain contaminants, keeping them from entering the wearer's nose and mouth. Also, surgical masks are effective barriers for retaining large droplets released from the wearer's mouth and nose.   Surgical masks are produced using a variety of materials with different thicknesses and different abilities in protecting you against contact with respiratory droplets. Most surgical masks are manufactured through the combination of three various layers of nonwoven fabric with each layer having a vital function. The outermost layer is the waterproof layer which helps in keeping out fluids including mucosalivary and respiratory droplets. The middle layer is the filter. The middle layer has the ability to block particles or pathogens above a specific size from penetrating in both directions. The innermost layer is the absorbent layer. Absorbent materials are utilized in order to confine mucosalivary droplets from the user. The innermost layer also improves comfort through absorbing the moisture from exhaled air. When combined together, these three layers effectively protect both the user and the surrounding people by reducing the penetration of particles and pathogens in either direction. The comfort, breathability, and filtering capacity of surgical masks are greatly dependent on the properties of these materials that were utilized in manufacturing the mask. It must be noted that due to the materials used, surgical masks are not intended to be reused and should only be utilized once. With that, if your surgical mask is soiled or damaged, or if breathing through the surgical mask becomes hard, you should remove the face mask, discard it safely, and replace it with a new one. Unlike Home-made or cloth masks, surgical masks undergo the scrutiny and testing of the ASTM. The ASTM is responsible for setting the standards for surgical masks. The ASTM F2100, the current standard for surgical masks, reviews 5 basic criteria. These include: Bacterial Filtration Efficiency (BFE) - the ability to filter bacteria; Particulate Filtration Efficiency (PFE) - the ability to filter sub-micron particles Fluid Resistance - the ability of the surgical mask to prevent fluid penetration from the mask to the wearer; Delta P (Pressure Differential) - the measurement of how comfortable, light, and breathable a mask feels; Flame Spread - the ability to withstand exposure from flame. In addition to these criteria set by the ASTM, skin sensitivity and cytotoxic testing for surgical masks should also be done by the ISO (International Organization for Standardization). This is important for it makes sure optimal comfort is achieved and the risk of adverse reaction from surgical mask materials and surgical mask usage is greatly minimized. If the surgical masks passed these quality checks, certification will be provided by the ISO. The filtering capacity, which depends significantly on the materials and engineering design utilized for making the mask, dictates the level of protection that the surgical mask can offer against pollutants and pathogens. With that, surgical masks are greatly effective in filtering out viruses such as SARS-CoV-2 that has a size of approximately 60 to 140 nm. Unlike those masks made of materials with larger pore sizes such as those made from cotton and synthetic fabric, surgical masks are tested and proven to have filtering capacity for matter smaller than that of viruses and other microorganisms. The effectiveness of surgical masks can be categorized as ASTM level 1, 2, or 3. Level 1 Surgical masks are ideal for scenarios where low amounts of fluid, spray and aerosol are produced. Level 2 Surgical masks are for procedures where moderate amounts are produced and Level 3 Surgical masks are ideal for surgery. Home-Made or Cloth Masks (Source: Pexels.com) Unlike surgical masks that undergo standard checks to provide maximum protection against airborne pathogens, home-made masks do not undergo the scrutiny of internationally recognized quality assurance bodies. Hence, cloth masks are the most permeable and offer the least protection. A home-made mask acts as a reusable barrier to protect the wearer from inhaling droplets released by others. It is intended to trap respiratory droplets that are released when the wearer talks, coughs or sneezes. Cloth masks are commonly retained long term and reused a number of times, with a variety of cleaning methods and widely different intervals of cleaning. There are many materials to utilize in order to make home-made masks. These include cotton and silk, among others. The most effective home-made masks are those that have multiple layers of tightly woven fabric like cotton. A home-made mask with several layers is better in preventing the respiratory droplets from getting through your mask or escaping from it. Other people also make cloth masks that have filter slots so that it can have an additional protective layer. Furthermore, home-made masks are made of flexible material. Hence, they can tightly cling on to your face which removes gaps, such as those in the side of your face, which reduces the risk of pathogens possibly entering these spaces. Cloth masks are frequently utilized in resource-poor settings because of the reduced cost of a reusable option. Several types of cloth masks, including those made of cotton, gauze and other fibres, have been tested in many in vitro studies in the past. Findings show lower filtration capacity compared with disposable surgical masks. However, it must be noted that studies also showed that the protection offered by home-made or cloth masks increases with the fineness of the cloth and the number of layers, indicating potential to develop a more effective cloth mask, for example, with finer weave, more layers and a better fit. The Verdict Findings of studies showed that all types of masks reduced aerosol exposure, relatively stable over time, unaffected by duration of wear or type of activity. Many studies conclude that any type of general mask, whether surgical or home-made cloth masks, is likely to decrease viral exposure and infection risk on a population level, despite imperfect fit and imperfect adherence. This is because it is always better to have some form of protection than have nothing at all. However, multiple evidence show that the filtration, effectiveness, fit, and performance of home-made masks are significantly inferior to those of surgical masks and respirators. With that, the scientific body does not recommend home-made or cloth masks for use in healthcare settings, whose workers should as a priority be given proper respiratory protection through surgical masks or N95 respirators. Therefore, cloth mask use in the community is only advisable in certain situations such as when surgical masks are unavailable. If the supply of surgical masks are low, one can improve the protection provided by home-made masks through selecting appropriate material, adding a number of layers, and utilizing those with a design that offers better filtration and fit. References: Howard, J. (2021, January 26). An evidence review of face masks against COVID-19. PNAS. https://www.pnas.org/content/118/4/e2014564118 Chughtai AA, Seale H, Macintyre CR. Effectiveness of Cloth Masks for Protection Against Severe Acute Respiratory Syndrome Coronavirus 2. Emerg Infect Dis. 2020;26(10):e200948. doi:10.3201/eid2610.200948 Seongman Bae, Min-Chul Kim, Ji Yeun Kim, et al. Effectiveness of Surgical and Cotton Masks in Blocking SARS-CoV 2: A Controlled Comparison in 4 Patients. 2020. Ann Intern Med. 173; W22-W23. Doi: 10.7325/M20-1342. U.S. Food And Drug Administration. 2021. N95 Respirators, Surgical Masks, and Face Masks. Retrieved from: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks. Retrieved on 26 April 2021. Popular Mechanics. 2021. Cloth Masks, Surgical Masks, or Double Masks: Which Are Safest?. Retrieved from: https://www.popularmechanics.com/science/health/a35290705/which-face-mask-is-best-for-covid-protection/. Retrieved on 26 April 2021. Johns Hopkins Medicine. 2021. Coronavirus Face Masks & Protection FAQs. Retrieved from: https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-face-masks-what-you-need-to-know. Retrieved on 26 April 2021.
History of Face Masks

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History of Face Masks

by BYO MCC on Apr 30 2021
In times such as when an infectious agent that is transmitted by air causes a pandemic, common sense dictates that we must protect ourselves by all available means. Being under the global health crisis like today, one of the methods tested and approved to bring protection to our lives is through wearing a face mask. (Source: Elements.envato.com) Currently, there are many debates in the modern community about the effectiveness of wearing face masks in order to avoid the exposure to infectious agents like SARS-CoV-2 which causes the infection known as Covid-19 or Influenza virus that causes flu. However, no matter what the community stands for, the truth still remains - face masks have been utilized for a long time for medical and health purposes in order to prevent infections transmitted by air. So while many people fight over on how really effective wearing a face mask during this Covid-19 Pandemic, history has already taught us that face masks have been providing the protection that we need to stop the transmission of deadly pathogens. From the Plague to Covid-19, face masks have evolved over time to do its job in keeping us safe. With that, if you are interested in how the face mask came to be, let us run through its history. Ancient Days There is archaeological evidence that objects similar to face masks were utilized in the 6th century BC. There were some images and paintings in the walls of Persian tombs of Royals that also indicate the use of such objects. In those images, there are people wearing cloth over their mouths. However, their function might not be the same as what we know today as face masks, but it is one of the first few evidence that ancient people wore facial coverings that function very closely to face masks.  In Asia, specifically in China during the Yuan Dynasty in the 13th century, a kind of scarf woven with silk and gold threads is thought to be the earliest item in the land that is indistinguishable to present day’s face mask. Also during the same era, according to historians, there are written accounts that servants who served the Emperor during meals needed to wear silk scarves to cover their mouths and noses. It was believed that servants had to wear these silk scarves in order to prevent their breath from impacting the smell and taste of the food the Emperor. Middle Ages to Renaissance Period In the early modern age, it is a well-documented fact that medical professionals during time wore beak-like masks in order to treat patients suffering from the bubonic plague. These medical professionals were termed as “beak-doctors” because the masks they wore were that similar to a beak of bird supposedly filled with herbs such as clove or cinnamon as well as medicinal liquids. During this time period, the beak-doctors were dressed in black cloaks and dark hats and thus, became the symbol of the deathly epidemic of the Middle Ages. People during the middle ages believed that the miasma caused the plague. They  termed it as “blight.” It was proclaimed that spoiled air from the East had caused the transmission of this miasma. With that, medical professionals wore masks this time in order to protect themselves from the blight. In present times, there are two masks displayed in German museums that are suspected to be forgeries from a younger date. These typical masks have glass openings for the eyes and a curved beak shaped like a bird's beak with straps that held the beak in front of the doctor's nose. Nevertheless, there are still some debates whether these beak-doctors were really medical professionals back in the day or were people who did not really possess the knowledge in medicine. 19th century Joseph Lister, Louis Pasteur, and Ignaz Semmelweis were the people who in the 19th century revolutionized our understanding of microorganisms and infectious diseases. Their research into bacteriology, infection in wounds, prevention of disease, raised operative techniques to a new plane where their observations, deductions and practices changed clinical medicine and surgery throughout the world. Their discoveries in the 19th century placed the trend-setting discourse about wound infections and their prohibition and containment. As the years go by, many more scientists used the concepts of Lister, Pasteur, and Semmelweis to develop studies that further expand the human knowledge on infectious disease. One of them is the hygienist Carl Friedrich Flügge. In 1897, he published his works on the development of droplet infections as part of his research on the genesis of tuberculosis. During this year, the respiratory system as a transmitter of germs came into focus of research and already mandated instructions to keep distance. In the same year, Flügge, Theodor Billroth, and Johannes von Mikulicz published a paper in which they highly recommended using a “mouth badge” when performing surgical operations. In this paper, they described a one-layered mask made out of gauze. At this time, Mikulicz is already well-known for he was responsible for the introduction of sterile gloves made from cloth. He noted in their paper the applicability of surgical mask for it offers protection while also allowing use to breath through it easily. The following years, Hübner, Mikulicz’ assistant, resumed the topic of using masks, however described a two-layered mouth protection made of gauze that can prevent driblet spread that may contain infectious agents. Following this study, more research findings regarding the germ content in the operating room air emerged. Not until 1910, the use of mouth and face covers was uncommon in surgery and in hospitals in general. Nevertheless, during almost the end of the 19th century, British surgeon B.G.A. Moynihan utilized and taught the use of a multilayer face mask made of gauze when performing surgical operations. Modern Days The surgical mask was used first in the operating rooms of Germany and the USA in the 1920s. During this time, Martin Kirschner in his multi-volume operational theory elaborately described the need to wear a facemask in order to fight off infections. In the United States, following the First World War, more and more research addressed facemasks with varying degrees. However, even with a number of already rising evidence on the use of face masks, they were still not generally accepted as of this time. According to written accounts, interns and nurses were already wearing facemasks made of cloth or gauze but head physicians rejected them in all phases of an operation for they were considered irritating by them. The research on the role of facemasks developed in Germany and the USA in the middle of the 1930s. However, washable and sterilizable masks with varying numbers of gauze layers only gained approval for use internationally for surgical procedures in the 1940s. In the first decades of the 20th century, medical professionals have already agreed on the function of masks. However, many still attempted to determine the most effective and efficient type of masks. There were many patents on various designs that were put in place. Meanwhile, masks continued to be developed in medicine. During the early decades in the 20th century, masks were commonly manufactured from a number of layers of cotton gauze, sometimes with an additional layer of impervious material, held by a metal frame. (Source: Elements.envato.com) In the 1960s, medical masks became increasingly made out of synthetic materials for single use. During this time, non-woven synthetic materials were used in filtering masks and were greatly advertised. Compared to most traditional medical masks, these cup-shaped respirator masks were much more comfortable because they fitted snugly on the face and were designed to filter both incoming and outgoing air in order to prevent the spread of droplets like traditional masks. Furthermore, because their synthetic fabric would deteriorate during sterilisation, these filtering masks were all disposable. In 1969, a “total disposable system” which included syringes, needles, trays, and surgical instruments, led to the substitution of reusable masks. One of the reasons for establishing this system is because there is reduction in the risk of contamination when medical materials are disposable. Another reason is to reduce labour costs, control the management of supplies, and to respond to the increased demand for disposables that aggressive marketing campaigns had created among health-care workers. In the present 21st century, with several outbreaks of infectious diseases and flu, and the rise of smog from modern industry, the materials in masks have continued to evolve to better filter viruses and pollution. Today, with the ongoing public health crisis, disposable masks and respirators remain an essential part not only of medical personal protective equipment for health workers but also of day-to-day protective barriers for all people. With the evolution of face masks from mere facial coverings to possessing specific filtration qualities designed for health-care situations and for daily-use, face masks surely have come a long way. We know that face masks will still be developed in the future in order to provide even greater protection for users but for now, we hope that we get to see the day soon where we do not have to wear them outside our homes again. References: Global Times. 2012. The evolution of face masks. Retrieved from: https://www.globaltimes.cn/content/1179358.shtml. Retrieved on 23 April 2021. Isaacs, D. 2021. Mask wearing: A historical, cultural and ethical perspective. J Paediatr Child Health, 57: 176-177. https://doi.org/10.1111/jpc.15162 Matuschek, C., Moll, F., Fangerau, H. et al. The history and value of face masks. Eur J Med Res 25, 23 (2020). https://doi.org/10.1186/s40001-020-00423-4 Strasser, Bruno J et al. 2020. A history of the medical mask and the rise of throwaway culture. The Lancet, Volume 396, Issue 10243, 19-20
Why are Canada-made surgical masks so special?

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Why are Canada-made surgical masks so special?

by BYO MCC on Apr 30 2021
Today, with the public health crisis that we are currently facing, to leave the home without our masks is definitely considered irresponsible; it does not only increase your risk of becoming infected but it also puts the health of others at risk.  The Covid-19 pandemic has created an unprecedented surge in demand for personal protective equipment (PPE), with emphasis on medical grade face masks. This increase in demand has resulted in a resultant spike in prices of face masks due to worldwide shortage of raw materials and finished products.  Image lifted from: https://medicalxpress.com/news/2021-02-covid-deaths-uk.html During the peak of the coronavirus lockdown in 2020, The Canadian Government developed a  multi-pronged strategy in order to ensure that Canadians have the equipment they need, including medical grade face masks. The government strategy included an international agreement with credible suppliers abroad to source raw material and products of face masks. In addition, the government also developed a permanent and significant domestic production capacity so that Canadians can be assured of availability from Canadian suppliers. Furthermore, the National Research Council of Canada (NRC) promoted alternative solutions for the industrial production of effective filtration material completely obtained and made in Canada as a supplemental element of the extensive strategy of the Canadian government. These alternative solutions were utilized for manufacturing of medical grade face masks and N95 respirators, increasing the security supply of Canadians. With all these efforts by the Canadian government, there was a significant increase of medical grade face masks in Canada. However, even with the fast production of these surgical masks, its quality is still one of the best in the world. So the question now is: Why are canada-made surgical masks so special?  During precovid times, surgical masks were primarily used by surgeons to keep the surgical field sterile. Hence, before the pandemic, surgical masks were not utilized as personal protective equipment.  The surgical mask that we use today consists of 3 plies: (1) A fluid-resistant material makes up the outer ply; (2) a filtration medium, usually a polypropylene sheet, makes up the middle; and (3) moisture-absorbing sheet makes up the inner layer of the surgical mask.  Image lifted from: https://schildline.com/product/disposable-face-masks/ In Canada, there are 4 classification for medical devices. The lowest risk is represented as Class I, while the highest risk is classified as Class IV. Manufacturers are encouraged to refer to the classification rules for medical devices in the Medical Devices Regulations in order to determine the appropriate classification for their device. Here are the examples of COVID-19 medical equipment that fall within each class: Class I includes masks, respirators, gowns, and face shields; Class II includes infrared thermometers, gloves, personal protective equipment, decontamination devices, and syringes; Class III includes mechanical ventilators; and Class IV includes SARS-CoV-2 testing devices such PCR testing devices. With that, using this classification by Health Canada, surgical masks are classified as a Class 1 medical device. One of the reasons why Canada-made masks are special because all surgical masks sold in the market undergo the scrutiny and evaluation of the International Association for Testing Materials (ASTM). ASTM International tests products to improve quality and safety. It defines more than 12,500 international standards across a wide variety of services and industries, including barrier protection standards for surgical masks. According to the ASTM, five criteria must be met by all surgical masks sold to the public:  All masks should have an adequate bacterial filtration efficiency. This means that the bacterial filtration efficiency should be greater or equal to 95%.  All mask should have a sub-micron particulate filtration efficiency at 0.1 micron of at least greater than 95% The differential pressure for inhalation measured by mm H2O/cm2 should be at least less than 5 or 6.  There should be a resistance to penetration by synthetic blood. The minimum pressure in mmHG for pass result is at least 80, 120, or 160.  There should be flame resistance.  In addition to that, the ASTM sets three levels for the surgical face masks. These include three levels that are classified according to the following:   Test Standard Specification for Performance of Materials Used in Medical Face Masks Level 1 Level 2 Level 3 Bacterial Filtration Efficiency, % ≥95  ≥98 ≥98 Submicron particulate filtration, % ≥95  ≥98 ≥98 Differential Pressure, mm H2O/cm2  <5  <6 <6 Resistance to synthetic blood 80  120 160 Flame spread Class 1  Class 1 Class 1   With that, surgical face masks made in Canada are required to meet at least the level requirements of ASTM so that it can be allowed to be sold in the market. To explain further, the Level 1 surgical mask is considered as a low barrier protection. This type of mask is used for general use for low-risk, nonsurgical procedures and exams that do not involve aerosols, sprays, and fluids. It must be noted that an ear loop mask is a level 1 mask. ASTM level 1 masks are the general standard for both surgical and procedural use. The ASTM level 2 mask is considered as a moderate barrier protection. Hence, it is used as a protective mask against low-to-moderate levels of aerosols, sprays and fluids. Lastly, the ASTM level 3 surgical mask is considered as a maximum barrier protection. Thus, it is utilized for any scenario that has the risk for exposure to heavy levels of aerosols, sprays and fluids. ASTM recommends this level as a best practice for supporting operating room safety initiatives. Image lifted from: https://www.defend.com/new-defend-level-1-2-3-face-masks/ These standards that are set by the ASTM for the general public use makes Canada-made surgical masks so special. Because the ASTM covers very specific requirements for barrier face coverings such as design and general construction criteria, particle filtration efficiency levels, sizing and fit testing criteria, labeling instructions, and guidance on cleaning and the likes, it makes sure that wearers have means of source control by reducing the extent to which droplets and aerosols from the wearer’s nose and mouth are released into the surrounding air; and it makes sure that there is a potential limit to the inhalation by the wearer of the expelled droplets and aerosols of others around them by particulate filtration. Furthermore, design criteria set by ASTM include minimum coverage areas over the wearer’s nose and mouth, a means of keeping the covering in place over the nose and mouth, the prohibition of open vents or valves, the assessment of leakage of exhaled air, and a representation of product sizing. There is also a performance and testing criteria that define minimum performance properties for filtration efficiency, including sub-micron particles filtration efficiency, and airflow resistance, as well as the effect of repeated sanitizing, cleaning, or laundering on the efficacy of reusable coverings. ASTM also has set labeling requirements which specify the minimum amount of information that should be given on labels on the covering, its immediate packaging, and point-of-sale packaging. Lastly, user instruction requirements by the ASTM includes selection and sizing, proper positioning and adjustment, and replacement and disposal. Bottomline:  Today, surgical masks are a daily need for us to be protected against COVID-19. Surgical masks made in Canada are one of the best face masks that one can procure in the market these days. The standard set by the Canadian government and the International Association for Testing Materials have made sure that these surgical masks are of greatest quality.  At the end of the day, you should only wear a mask that is proven to be effective - one that has gone through the scrutiny and evaluation of a verified and credible body. That being said, Canada-made surgical masks have surely fit the criteria of being comfortable, safe, and effective - and this is why Canada-made masks are special.  Reference:  Beckers Hospital Review. 2018. The '4 Fs' of medical mask selection. Retrieved from: https://www.beckershospitalreview.com/quality/the-4-fs-of-medical-mask-selection.html. Retrieved on 24 March 2021.  CMAJ Group. 2020. RE: Surgical Masks And Covid-19 In Canada. Retrieved from: https://www.cmaj.ca/content/re-surgical-masks-and-covid-19-canada. Retrieved on 24 March 2021.  Government of Canada. 2020. COVID-19 Challenge: Made in Canada filtration material for the manufacture of N95 respirators and surgical masks. Retrieved from: https://www.ic.gc.ca/eic/site/101.nsf/eng/00102.html. Retrieved on 24 March 2021.  Government of Canada. 2021. Authorized medical devices for uses related to COVID-19: List of authorized medical devices other than testing devices. Retrieved from: https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized/other.html. Retrieved on 24 March 2021.  JD Supra. 2021. ASTM Publishes Its First Standard Specification for Face Masks. Retrieved from: https://www.jdsupra.com/legalnews/astm-publishes-its-first-standard-4894481/. Retrieved on 24 March 2021.