Att F Salient Characteristics - AAMI Level 3 or 4 disposable Sterile Surgical Gowns.pdf

Salient Characteristics – AAMI Level 3 & 4 Disposable Sterile Surgical Gowns o Registered with the FDA o All Companies selling class 2 medical devices (surgical gowns and gloves included) should be registered with the FDA to sell the type of product.

FDA registration process ensures sterilization methods are proper and produce a sterile end product.

• Look up companies registered with FDA to sell medical devices

• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm o Characteristics o Must be made of SMS fabric (tri laminate non-woven fabric, top layer of spunbond polypropylene, a middle layer of meltblown polypropylene and a bottom layer of spunbond polypropylene) o Must have Knit Cuff o Must have tie back closure (closed back gowns only) o Must be full length for max coverage o Testing o NIOSH and FDA require that all surgical gowns must meet (American National Standards

Institute (ANSI) and the Association of the Advancement of Medical Instrumentation) ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

o Must be labeled as AAMI Level 3 or Level 4 Level 3 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

Level 4 Used in HIGH risk situations -the only garments considered impermeable to viral penetration and blood penetration through fabrics.

o AAMI also requires level 3 surgical gowns meet AATCC 42 and AATCC 127 Must provide certification of passing these two tests that are conducted to test barrier protection performance.

AATCC 42 testing data is Water Resistance: Impact Penetration Test

• result should be ≤ 1 g for level 2 & 3 gowns AATCC 127 testing data is Water Resistance: Hydrostatic Pressure Test

• result should be ≥ 20cm for level 2 gowns

• result should be ≥ 50cm for level 3 gowns o AAMI also requires level 4 surgical gowns meet ASTM F1671 ASTM 1671 = Viral Penetration Test for surgical and isolation gowns.

Must provide certification of passing this test Results should be a PASS following a blood and viral penetration resistance test of 2 psi o All gowns should have an Acceptance Quality Level (AQL) of 4% and a Rejectable Quality

Level (RQL) of 20% https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm o Sterilization o Sterility Information for Surgical Gowns must be provided in documentation

Product must be labeled ‘sterile’ and a description of sterilization method provided in documentation

FDA Approved sterilization methods:

• Autoclave (Steam or moist heat)

• Dry heat

• Irradiation with either gamma-ray or electron beam

• Ethylene Oxide (EO) with devices in a fixed, rigid chamber o If EO was used, provide the maximum level of sterilant residuals.

AAMI/ANSI/ISO 10993-7 Biological Evaluation of

Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals

If available, the sterility assurance level (SAL) for the device (SAL of 10-6 is required for surgical drapes and surgical gowns which are to be used during surgical procedures).

o Alternate international standards o EN 13795 not equivalent to ANSI/AAMI PB70

Because the test methods and performance requirements cannot be compared directly o Alternate international standard: ISO 16603 equivalent to ASTM F1670 result should be ≥3.5 kPa o ISO equivalent standards to ANSI/AAMI PB70 (see Pages 7-8 for chart) https://www.aami.org/docs/default-source/products_store/standards/pb70_1206.pdf?sfvrsn=9d7b9544_2 o Testing components of ANSI/AAMI PB70:2012 that might appear o These may or may not be tests stated on the documentation. They are all just the individual components of AAMI PB70 to be considered level 2, 3 or 4 Complies with ASTM F2407 standard recognized by the FDA:

Tensile Strength: Complies with ASTM D5034, ASTM D1682 Tear resistance: Complies with ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424

Seam Strength: Complies with ASTM D751 (stretch woven or knit) Lint Generation: Complies with (ISO 9073 Part 10) Water vapor transmission (breathability): Complies with ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75 o For comparisons, Pre- Approved Known products that meet the above requirements:

Manufacturer Part Number Size Qty per CS Cardinal Health 9511 9511NB Large 20 Cardinal Health 9541 9541NA X-large 18

References:

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g2 https://www.halyardhealth.com/media/538845/Guide-to-Gown-Guidelines.pdf https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/cardinal-health-surgical-gowns-aami-level-3-educational-brochure.pdf https://www.cdc.gov/niosh/npptl/ppecase/pdfs/PPE-CASE-P2018-0104-508.pdf https://www.cdc.gov/niosh/npptl/ppecase/PPE-CASE-P2018-0104.html https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4 https://www.aami.org/docs/default-source/products_store/standards/pb70_1206.pdf?sfvrsn=9d7b9544_2 https://www.aami.org/docs/default-source/products_store/standards/pb70_1206.pdf?sfvrsn=9d7b9544_2 https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns#g2 https://www.halyardhealth.com/media/538845/Guide-to-Gown-Guidelines.pdf https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/cardinal-health-surgical-gowns-aami-level-3-educational-brochure.pdf https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/cardinal-health-surgical-gowns-aami-level-3-educational-brochure.pdf https://www.cdc.gov/niosh/npptl/ppecase/pdfs/PPE-CASE-P2018-0104-508.pdf https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4