As COVID-19 pandemic has spread across the globe, Personal Protective Equipment (PPE) has become some of the highest demand items in the world. As many new suppliers emerged, many are faced with the challenges of identifying the appropriate levels of protection and standards of PPE that they need. What are the differences in the different AAMI levels available?
N Medical team with over 80 years of experience in the field of manufacturing and distribution of medical supplies intends to help answer some of the basic questions about the different stands for gowns that has AAMI ratings.
ANSI/AAMI PB70:2012 Level 1:
Minimal Fluid Barrier Protection – water impact test less than 4.5g. Tested by AATCC42 with water
Suitable for daily patient care with little to no risk of fluid exposure. Generally not suitable for use in the OR
ANSI/AAMI PB70:2012 Level 2:
Low level of fluid barrier protection – spray impact test less than 1.0g, hydrostatic pressure test greater than 20cm. Tested by AATCC42 and AATCC127 with water
Suitable for slight risk of fluid exposure and minimally invasive surgical procedures
ANSI/AAMI PB70:2012 Level 3:
Moderate level of fluid barrier protection – spray impact test less than 1.0g, hydrostatic pressure test greater than 50cm. Tested by AATCC42 and AATCC127 with water
Suitable for slight risk of fluid exposure and minimally invasive surgical procedures
Typically used as a surgical gown with EO sterilised package
ANSI/AAMI PB70:2012 Level 4:
High level of fluid barrier protection that provides protection against blood borne pathogens in critical zones. Tested by ASTM F1671 Viral Penetration Test (for surgical and isolation gowns) with Bacteriophage Phi-X174. Blood and viral penetration resistance (2 psi)
Suitable for high risk of fluid exposure and virus penetration for up to 1 hour
Typically used as a surgical gown with EO sterilised package
There are other isolations gowns that offer fluid protection but are not necessarily rated by AAMI due to construction features of the gowns, such as having an open back design and/or sewn seams.
Any isolation gown that carries an AAMI Level 3 or 4 are typically Class II medical devices are may require special registration in certain countries. For example, in the USA AAMI Level 3 or 4 gowns are considered Class II medical devices and would have to be registered with the US FDA along with premarket notification approval.
N Medical team has deep experience in the manufacturing of isolation gowns and surgical gowns. We designed the perfect balance between comfort and safety for medical professionals. We did not choose to use the thickest materials because it is unnecessarily thick and uncomfortable. We also did not choose shortcuts by using PE coating for all of our gowns. Instead, we picked the balance between the most protective materials and comfort that meets international standards. Here is our current line up for isolation gowns and surgical gowns.
N Medical offers a wide range of gowns that can be produced from AAMI Level 1-4. Please consult one of our experts to learn more about our product range. Learn more about our personal protective equipment PPE here:
Definitions of AATC42, AATC127, ASTM F1670-17, and ASTM F1671-13 tests:
AATCC 42-2017: Measures resistance of fabrics to the penetration of water by impact (AATCC, 2018)
AATCC 127-2017: Measures resistance of fabric to the penetration of water under hydrostatic pressure (AATCC, 2017)
ASTM F1670-17: Evaluate resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact (ASTM, 2017)
ASTM F1671-13: Measure penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact (ASTM, 2013)
Reference:
1. Pfiedler Enterprises 2016, AAMI Levels and Surgical Gowns: Know if You’re Protected, viewed 17 July 2018, <http://www.pfiedler.com/ce/1191/files/assets/common/downloads/AAMI%20Levels%20and%20Surgical%20Gowns.pdf>
2. AATCC TM42-2017, Water Resistance: Impact Penetration Test, American Association of Textile Chemists and Colorists, RTP, NC, USA, 2018, <https://www.aatcc.org/>
3. AATCC TM127-2017, Water Resistance: Hydrostatic Pressure Test, American Association of Textile Chemists and Colorists, RTP, NC, USA, 2017, <https://www.aatcc.org/>
4. ASTM F1670 / F1670M-17a, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood, ASTM International, West Conshohocken, PA, 2017, <https://www.astm.org>
5. ASTM F1671 / F1671M-13, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System, ASTM International, West Conshohocken, PA, 2013, https://www.astm.org
6. Sections 3.13 and 3.31 of the ANSI/AAMI PB 70:2012 (citing 21 CFR 878.4040).
7. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g4
8. Guidance document on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings
Disclaimer: The information on this website is intended for health care professionals only. Article information are for educational purposes only, please consult your local medical professionals for the most accurate and updated information. Product information is for educational purposes only, and not all products or indications are licensed in every country.