Occurrences in the year 2020 have made the protective characteristics of the medical masks and other PPEs most popular. They have put those that offer health care in a position of thinking about mitigating risks to their workforce and patients due to ‘big’ and unpredictable events, and other variables.

Procedures followed in hospitals, other ambulatory care centers, and community clinics today may differ significantly from those in today’s practices that were followed a few months ago. Masks are a part of public and HCFA infection control precautions; it is crucial to identify which masks provide the highest levels of protection for diverse cases. Let’s get started!

BRIEF DESCRIPTION OF MEDICAL AND NON-MEDICAL MASKS:

The concept of a medical mask and all other masks would be in a different category based on the purpose that the mask is designed for. This type can be used by members of the general population or in areas that are not related to health facilities. They should be used when the probability of getting exposed to the virus is low, in community settings and/or situations that require close contact.

However, medical masks are made more as personal protective equipment meant for use in medical practices. If you look further into the differences, there is also a combination of various designs and different types of material in the medical masks. Here are Many designs fall into one of two categories:

  • Surgical and procedural masks
  • Respirators

Although there is a traditional spotlight on N95 respirators in the current year 2020, surgical and procedural masks are easily the most popular mask types in present-day health care.

MEDICAL MASK RATINGS EXPLAINED:

Given the currently wide varieties of masks available, how does one choose the right single-use medical masks for his or her purpose?
The ASTM (American Society for Testing and Materials) rating offers information that enables comparisons of masks’ effectiveness and protection and performance characteristics with several kinds of crucial protection.

The ASTM is an international standards organization that produces, issues, and manages voluntary consensus technical standards for numerous materials, products, systems, and services, including healthcare settings. Their PPE ratings provide a glimpse of important factors to consider so that identifying the gap in the protective attributes of various models becomes easy.

ASTM F2100, the current standard, reviews 5 basic criteria:ASTM F2100, the current standard, reviews 5 basic criteria:

  1. BFE (Bacterial Filtration Efficiency): This might be the extent of how it is filtered to bacteria Also, this might be the measure it filters bacteria up to.
  2. PFE (Particulate Filtration Efficiency): It means it can filter very small particles that are sub-micron in size.
  3. Fluid Resistance: Flu and bacterial shield that is capable of preventing any fluid passage through the mask to the wearer.
  4. Delta P (Pressure Differential): Determines how light or as close to breathability as a mask could be.
  5. Flame Spread: Also what is referred to as flame resistance or fire resistance, the power of a material to resist burning or being ignited by flame.

These include skin sensitivity and cytotoxic testing ISO (International Organization for Standardization) 10993-5 and ISO 10993-10 also offer certifications on comfort and reduced chances of reaction from mask materials or usage of masks.

ASTM ratings range from Level 1 to Level 2 and finally to Level 3. All of them provide a higher level of protection against the mentioned criteria.

1. STM LEVEL 1 (LOW) RATED MEDICAL MASKS:

Light/minimum BFE & PFE protection worn for standard procedures, MIMS, ophthalmic surgery, and respiratory recognition.

  • BFE at 3. Retail poly-shroud 0 micron ASTM F2101 95%
  • PFE at 0. 1 micron ASTM F2299 95% and above
  • Delta P < 5. 0 mm H2O/cm2
  • The consistency in the case of resistance to synthetic blood to 2 at 80 mm Hg
  • Flame Spread Class 1 from 16 Code of Federal Regulations, part 161

2. ASTM LEVEL 2 IS MEDIUM PROTECTION-RATED MEDICAL MASKS:

High BFE & PFE protection along with moderate fluid resistance predominantly for general surgery and endoscopy with better breathability than high barrier (level 3) surgical masks. It is meant to stand up to a splash or spray traveling at arterial pressure.

  • BFE at 3. As for the comparison, it’s vital to specify that the material meets 0 micron ASTM F2101 at a rate of no less than 98%.
  • PFE at 0. The above table shows that the irritation index of the filtered solution is less than 1 micron, and the passing rate of the ASTM F2299 standard is greater than 98%.
  • Delta P < 6. 0 mm H2O/cm2
  • Fluid Resistance to Synthetic Blood at 120 mm Hg
  • Flame Spread Class 1 according to 16 Code of Federal Regulations part 1610

3. MEDICAL MASKS THAT HAVE RECEIVED AN ASTM LEVEL 3 (HIGH) RATING.:

The equipment offers a higher BFE & PFE protection with the greatest fluid resistance. Intended to keep out a splash or spray in activities such as orthopedic surgery or trauma.

  • BFE at 3. 0 micron ASTM F2101 passed the minimum of 98% of its requirement.
  • PFE at 0. 1 micron ASTM F2299 greater than or equal to 98%
  • Delta P < 6. 0 mm H2O/cm2
  • Coagulation of the Test Article and Synthetic Blood at 160 mm Hg
  • A Flame Spread Class 1 according to 16 CFR part 1610

WHAT COULD AFFECT THE RATINGS OF MASKS?

It becomes possible to speak about how a mask can meet such requirements with the needed rating when we have an understanding of mask rating standards. The majority of elements may be divided into two groups:

  • Design
  • Materials

DESIGN CONSIDERATIONS INCLUDE:

  • Overall Fit And Sizing: Adult, pediatric, and so on.
  • Total Face Coverage: Mouth only, face shields if available and optional, duck bills, and the like.
  • How The Masks Are Secured: Operation loops, procedure ear pieces, procedure headbands
  • The Number Of Pleats And/Or Plies In The Mask Design: Besides material selection, the level of protection will also be slightly affected; across a single material type, multiple plies/pleats will usually present better protection sometimes at the cost of heat and breathability.

Choices of material will also affect the kind of protection afforded by the masks and at the same time, the comfort of wearing them. Common materials include:

  • Polypropylene (most common)
  • Polystyrene
  • Polycarbonate
  • Polyethylene
  • Polyester
  • Cloth

It then turned out that the ability to encapsulate patients and health care workers from infectious disease or to contain contamination of a sensitive environment is not contained in a simple metric of the ASTM rating but in all the factors that have been earlier considered. As there may be differences in the mode of transmission of a disease, all the above-mentioned aspects are very significant when it comes to the function of medical masks in curbing the spread of the disease.

Nonetheless, if properly worn as recommended, a PRIMED mask certified by ASTM on level 1 will surpass the efficacy of any non-medical face mask that ASTM doesn’t rate. Any situation that implies the necessity of containing an infection or protecting the wearers from a broader range of potential threats merits using an ASTM Level 3-rated mask.

SUMMARY

The difference between medical and non-medical masks is pivotal in determining their suitability and protective efficacy. Medical masks, rigorously tested and certified under ASTM standards, are designed for healthcare environments to provide high levels of protection against pathogens and fluids. They undergo assessments such as BFE, PFE, fluid resistance, and breathability (Delta P), ensuring they meet stringent criteria for effectiveness.

In contrast, non-medical masks serve general purposes in community settings with lower exposure risks but lack standardized testing and certification. Choosing between them depends on the specific context and level of protection needed, emphasizing the importance of using ASTM-rated medical masks, especially Level 3 masks. In healthcare settings to ensure comprehensive infection control and safety for both wearers and patients.

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