ASTM International Standards in review

As I researched this article on ASTM, we were informed and surprised at some of the data we uncovered from various credible sources. Among them and most prominent is that this fundamental testing institution is relatively unknown, with nearly 50% of health care professionals. With this said, we have taken it upon ourselves to spread the word on how ASTM works and why you should care about the life-saving standard they recommend HCW comply within ER and ICU settings.

Crown Mutual Medical Group is proud to offer our ASTM International Level 1, Level 2 and Level 3 surgical masks Made in Canada and available to hospitals and clinics across North America.

Our ASTM criteria includes BF 32/32, DP 2.54, PFE 99.9%, BFE 99.9%

But what does the ASTM International standard really mean? Let’s break it down.

  • ASTM International is the global authority for testing and defines more than 12,500 international standards across a wide variety of industries and services
  • Healthcare organizations globally adopt ASTM recommendations to implement best practices.
  • In 2001, ASTM created protocol F2100 to define three standardized mask levels.

Three Standardized Mask Levels

  • Level 1: Low Barrier Protection – General use for short procedures and exams that don’t involve aerosols, spray or fluids
  • Level 2: Moderate barrier protection – For low to moderate levels of aerosols, spray and or fluids
  • Level 3: maximum barrier protection – for heavy levels of aerosols, spray and or fluids.

ASTM Testing Criteria

BFE – Bacterial Filtration Efficiency, % ASTM F2101-19
PFE – Submicron Particulate Filtration Efficiency at 0.1 microns, % 0.1 Micron Silica Spheres tested at 5cmsec or greater
DP – Differential Pressure, mm H2O/cm2 EN 14683:2019, Annex C or equivalent
BF – Blood Spatter Filtration Splash Resistance/Synthetic Blood Resistance mmHg
ASTM F1862
FS -Flame Spread Flame Spread 16 CFR Part 1610

Why is choosing the right mask essential?

As health workers are at risk of infection, guidance for appropriate protection must be available. ASTM standards require medical staff to wear the proper PPE based on the patient care they are providing.

ASTM Level 1 Procedure Masks – General use for HCW
ASTM Level 2 Medical Mask – Moderate Medical Procedures
ASTM Level 3 Surgical Masks – Surgeon and OR Professions

Is your team informed on the ASTM Standards for PPE?

• 75% use the incorrect PPE for the procedure or setting

• May lead not only to staff and patient health risk but also regulatory citations and fines

• 48% of OR staff unaware of ASTM standard and different levels of protection

• 57% of face mask units sold in 2016 did not have or claim an ASTM rating

What are some of the specific differences?

Procedure masks
• Three or four layers of construction
• Two ear loops secure the mask to the face.
• Not suitable for OR
• Used on hospital floors, isolation,
• Sterile core and processing, labour and delivery, ER and ICUSurgical mask
• Three or four layers of construction
• Two straps secure the mask to the face.
• Primarily used by OR staff.
• Intended for a high risk of fluid exposure

Crown Mutual Group ASTM Level 3 Masks

The following demonstrates the multilayered design of the Level 3 mask and the protection and comfort it provides.

Referenced information:
https://www.astm.org/
https://www.sgs.com/en/campaigns/protective-face-masks
https://www.cardinalhealth.com/en/product-solutions/medical/infection-control/facial-protection/surgical-and-procedural-masks/procedural-masks.html
https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1862/F1862M17
Choosing the right mask – Becker’s ASC Review. https://www.beckersasc.com/webinars/cardinalhealth_webinar_june.pdf

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