Know the Level of Protection Standards
The FDA recognizes the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.”
- Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit.
- Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab.
- Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an intravenous (IV) line, in the emergency room, or for trauma cases
- Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
AAMI LEVEL 4 HIGHEST FLUID AND MICROBIAL BARRIER protection against blood-borne pathogens in critical zones. Needed for long, fluid-intensive procedures. Also for operating on patients with potential blood-borne pathogen risk
AAMI LEVEL 3 MODERATE FLUID BARRIER PROTECTIOB used for the widest range of surgical procedures, where moderate fluid protection is indicated
AAMI LEVEL 2 MINIMAL TO LOW FLUID BARRIER PROTECTION for use only in low-fluid minimally invasive surgical procedures, lumps and bumbs
AAMI LEVEL 1 MINIMAL FLUID BARRIER PROTECTTION
- Disposable Isolation Gown
- Material is tested to the Level 1 AAMI Standard.
- AATCC 42 ≤ 4.5g
- AATCC 127 N/A
Material is tested to the Level 2 AAMI Standard. The seams have not been tested but have been submitted for testing and are awaiting results.
- AATCC 42 ≤ 1.0g
- AATCC 127 ≥ 20cm water column
- Material Tested to Level 3 AAMI
- Taped Seam
- PP+PE Material
- Used in moderate risk situations.
- Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2.
- Two tests are conducted to test barrier protection performance:
- Water impacting the surface of the gown material
- Pressurizing the material
- ASTM F1671
- ASTM F1670
- Tested to Level 3 Barrier Protection
- Tested to Level 4 Blood and Viral Penetration