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When COVID-19 created an unprecedented demand for personal protective equipment (PPE), many countries were caught off guard and did not have sufficient inventory of medical face masks and respirators to help keep frontline workers protected.
As demand began to surpass available supply from experienced manufacturers, a variety of companies with no medical device manufacturing experience decided to produce face masks to make a quick profit.
Unfortunately, producing medical grade face masks that provide medical professionals with reliable respiratory protection requires extensive knowledge and experience with raw materials, manufacturing techniques and quality controls to meet the stringent regulatory standards that are in place to keep healthcare professionals safe.
That’s why it is critical to purchase respiratory protection only from a reputable mask supplier with the required knowledge, experience and equipment.
Why who made your mask matters
Given the critical importance of reliable respiratory protection, two international standard-setting bodies, the American Society of Testing and Materials (ASTM) and the International Organization for Standardization (ISO), established stringent quality standards for all face masks intended for use in healthcare settings.
What are ASTM standards for medical face masks?
ASTM F2100-19 (2019) is the international standard for medical face masks. It classifies medical masks as providing Level 1, Level 2 or Level 3 barrier protection, with Level 3 providing the highest level of protection, based on the following criteria:
Criteria
- BFE (Bacterial Filtration Efficiency):
- PFE (Particulate Filtration Efficiency):
- Fluid Resistance:
- Delta P (Pressure Differential):
- Flame Spread:
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- BFE measures how well a mask filters out bacteria when challenged with a bacteria-containing aerosol. ASTM specifies testing with a droplet size of 3.0 microns containing Staphylococcus aureus (average size 0.6-0.8 microns). To qualify as a medical mask, a minimum 95% filtration rate is required. Moderate and high-level protection masks must have bacterial filtration rates greater than 98%.
- PFE measures how well a mask filters out sub-micron particles (similar to viruses). The higher the percentage, the better the mask filtration. ASTM F2100-19 specifies that a particle size of 0.1 micron be used for testing.
- Fluid resistance measures a mask’s ability to minimize the amount of fluid that penetrates the mask as the result of a splash or spray. ASTM F2100-19 specifies testing with synthetic blood at pressures of 80, 120 or 160 mm Hg to qualify for low, medium, or high fluid resistance. These pressures correlate to blood pressure:
• 80 mm Hg = Level 1
• 120 mm Hg = Level 2
• 160 mm Hg = Level 3 - Delta P measures a mask’s air flow resistance and provides an objective measure of its breathability. The Delta P is measured in units of mm H2O/cm2. The lower the value, the more breathable the mask. ASTM Delta P requirements:
• Level 1 masks: less than 5.0
• Level 2 and 3 masks: less than 6.0 - Because oxygen, heat and fuel sources are found in most hospital settings, ASTM F2100-19 standards require that masks be tested for flame resistance. All hospital masks must withstand exposure to a burning flame within a specified distance for 3.5 seconds.
Criteria
• 80 mm Hg = Level 1
• 120 mm Hg = Level 2
• 160 mm Hg = Level 3
• Level 1 masks: less than 5.0
• Level 2 and 3 masks: less than 6.0
What are the 3 ASTM protection levels?
ASTM-rated masks are classified according to the level of barrier protection they provide, based on the five criteria listed above, with Level 1 masks providing the lowest level of protection and Level 3 masks providing the highest:
|
|
|
|
|---|---|---|---|
| Bacterial filtration efficiency (BFE) | ≥ 95% | ≥ 98% | ≥ 98% |
| Sub-micron particulate filtration efficiency at 0.1 μm (PFE) | ≥ 95% | ≥ 98% | ≥ 98% |
| Resistant to penetration by synthetic blood | @80 mm Hg | @120 mm Hg | @160 mm Hg |
| Differential pressure (ΔP) | < 5.0 mm H2O/cm2 | < 6.0 mm H2O/cm2 | < 6.0 mm H2O/cm2 |
| Flame spread | Class 1 | Class 1 | Class 1 |
What level of mask protection do you need?
It is recommended that you choose your mask’s barrier protection level based on its intended use:
ASTM Level
- Level 1
- Level 2
- Level 3
Procedure Type
- For procedures and examinations with a low risk of fluid exposure. Level 1 masks resist splashes and sprays at venous pressure.
- For procedures with a low to moderate risk of fluid exposure. Level 2 masks resist splashes and sprays at arterial pressure.
- For procedures with a high risk of fluid exposure.
ASTM Level
Procedure Type
ISO Standards
In addition to meeting ASTM performance criteria, all medical face masks must comply with the International Organization for Standardization (ISO). ISO 10993-5 and ISO 10993-10 are the international standards for cytotoxic and skin sensitivity testing. This testing aims to ensure that no part of the mask that comes into contact with the wearer’s skin contains potentially harmful materials.
When you wear a mask all day, comfort matters
While newcomers to medical mask manufacturing have been eager to produce the simplest, lowest-cost options, dedicated and experienced procedure mask makers have a vested interest in maintaining their reputation for providing safe and reliable respiratory protection that is also comfortable to wear.
Mask experts like Medicom, a Canadian company that has been manufacturing personal PPE for over 30 years, know how to produce reliable respiratory protection. They also understand that as healthcare professionals are required to wear masks for longer periods of the day, mask breathability and comfort are more important than ever.
That’s why Medicom has developed specialized medical mask expertise by collaborating with healthcare professionals, investing in ongoing research and development, and sourcing premium materials and state-of-the art machinery, to produce masks that meet the needs and preferences of those who wear them.
The Medicom SafeMask® Premier™ line includes Premier Plus™, as well as Premier Elite™, made in Augusta, Georgia, and the Premier Elite™ ProShield™ with an integrated visor for added protection.
For those who find it hard to breathe or feel claustrophobic in ordinary masks, Medicom developed the SafeMask® FreeFlow™ with Air Space™ technology. This mask has innovative contoured pleats create a unique pocket between the face and the mask to allow air to flow freely.
Breathability is not the only key to comfort. Wearing a mask all day can be irritating to the skin on the face and ears and this is especially true for those with sensitive skin. That’s why Medicom developed the SafeMask SofSkin® Earloop Mask to provide reliable barrier protection without irritating sensitive faces. SafeMask SofSkin® has a unique lightweight, breathable cellulose-blend inner layer that is designed to soften with wear and keep face dry and cool, making it ideal for even the most delicate skin.
While respiratory protection is serious business the experts at Medicom have not lost their sense of fun. Many of their most popular mask lines are available in a variety of colours, ranging from traditional to vibrant. You can view the complete portfolio of masks made by the medical mask experts at Medicom on their website at Medicom.com or in this convenient downloadable Mask Quick Reference Guide.
Recent example of the dangers of masks from unknown sourcesIn March 2021, a worker in Quebec, Canada, reported experiencing strange symptoms after wearing a type of mask that had been provided to thousands of workers in the province. After conducting a preliminary scientific assessment, Health Canada identified a potential for early lung toxicity in rats from inhaled graphene, the substance coating the masks. The masks in question were promptly recalled, as was a second model of mask coated with nanoform graphene.Masks manufactured and distributed by Medicom do not contain nanoform graphene, or any type of graphene. |
Whatever mask you choose, be sure you’re wearing it properly
A medical mask can only protect effectively if it is worn correctly. That means there should be no gaps along the sides of the mask between the mask and the face and that the mask should extend from the bridge of the nose to the chin. It is critical that the mask covers not only the mouth, but also the nose. To ensure adequate coverage of the nose, masks should not be worn below or at the tip of the nose.
For simple step-by-step instructions, watch this short video.
