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Why are Canada-made surgical masks so special?

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: 

  1. All masks should have an adequate bacterial filtration efficiency. This means that the bacterial filtration efficiency should be greater or equal to 95%. 
  2. All mask should have a sub-micron particulate filtration efficiency at 0.1 micron of at least greater than 95%
  3. The differential pressure for inhalation measured by mm H2O/cm2 should be at least less than 5 or 6. 
  4. 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. 
  5. 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: 

  1. 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. 
  2. 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. 
  3. 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. 
  4. 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. 
  5. 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. 

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