New Face Mask Standards - Are You Compliant?
Please Note: Due to global demand, we are unable to provide Eagle branded masks to our distributors at this time. We have sampled a variety of alternatives and have concerns over quality, source of origin, standards/accreditation claims and price of these alternatives. We'll advise when we are able to source from our regular manufacturer again.
Are you using the correct level of Face Masks in your practice? The Australian Standard for single-use Face Masks for use within New Zealand healthcare environments has changed to AS 4381:2015, which now supersedes AS 4381: 2002.
WHAT ARE THE NEW CHANGES?
Single-use face masks are now measured on three performance metrics: Bacterial filtration (BFE), Fluid Resistance and breathability. They are rated on their fluid exposure performance levels and must withstand a pressure of 80 - 160 millimeters of mercury.
Level 1 - 80 mm Hg - low
Level 1 barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the minimum velocity specified in Table 2, bacterial filtration efficiency and differential pressure.
Applications: For general purpose medical procedures, where the wearer is not at risk of blood or bodily fluid splash or to protect staff and/or the patient from droplet exposure to microorganisms (e.g. patient with upper respiratory tract infection visits GP)
Level 2 - 120mm Hg - moderate
Level 2 barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the middle velocity specified in Table 2, bacterial filtration efficiency and differential pressure.
Applications: For use in emergency departments, dentistry, changing dressings on small or healing wounds where minimal blood droplet exposure may possibly occur (e.g. endoscopy procedures)
Level 3 - 160 mm Hg - high
Level 3 barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the maximum velocity specified in Table 2, bacterial filtration efficiency and differential pressure.
Applications: For all surgical procedures, major trauma first aid or in any area where the healthcare worker is at risk of blood or bodily fluid splash (e.g. orthopaedic, cardiovascular procedures)
| Characteristics | Level 1 | Level 2 | Level 3 | Test Method |
| Bacterial Filtration Efficiency (BFE) % | ≥ 95% | ≥ 98% | ≥ 98% | ASTM F2101-14 or EN 14683:2014 |
| Particulate Filtration Efficiency (PFE) % (0.1 μm) | Not Required | Not Required | Not Required | N/A |
| Differential Pressure (Delta P) mm H2O/cm2 | < 4.0 | < 5.0 | < 5.0 | EN 14683:2014 |
| Resistance to penetration by synthetic blood (fluid resistance) min pressure in mm Hg for pass result |
80mm Hg | 120mm Hg | 160mm Hg | ASTM F1862 / F1862M-13 or ISO 22609 |
WHAT MASK SHOULD YOU HAVE?
Finding the right mask doesn’t have to be complicated if you consider the characteristics below:
- Fit: The mask needs to be contoured to the individual's chin; nose and upper neck. The mask should not be gaping as this defeats the purpose of the mask if fitted poorly and increases the risk of infection due to exposure of the mouth and nose area (where microorganisms are prone to entering).
- Convenience: Easy to put on and take off. This will be a choice between ear loops or tie-ons. Masks should be packed such that each mask can be removed without becoming entangled in another.
- High ply: The thickness of the mask for the absorption of fluids.
- Bacterial filtration (BFE): Able to capture micro-organisms and prevent them from entering the mouth/nose area. > 98%
- Differential Pressure i.e Breathability: <5. The mask may have anti-fog properties or consist of breathable material. This will assist in any fogginess in eyewear.
- Flammability: Class 1
- Resistance against synthetic blood (fluid resistance): 120mmHg is the standard. Fluid resistance is essential as this prevents fluids from being exposed to the mouth and nose area
Source: Morgan, David R. Mission the Point: A Review of Needlestick Injury and Occupational Risks From BloodBorne Viruses. Journal of American Biological Safety Association. 2001
HOW CAN YOU IDENTIFY THE LEVEL OF MASK YOU ARE CURRENTLY USING?
|
Face mask packaging should state whether they meet the AS 4381:2015 standard and what level rating they adhere to. If there is no statement on your box of masks, ask your supplier. Our updated Face Masks are now called Fluid Resistant Face Masks; look out for the updated artwork in your next order! These are 3 ply, non-sterile masks and now meet the AS 4381:2015 specification changes below:
|
 |
