Att E Salient Characteristics - AAMI Level 3 Chemotherapy Gown.pdf

Salient Characteristics – AAMI Chemotherapy Rated Gowns

• Gowns must comply with The United States Pharmacopeial Convention (USP 800) o Gowns are disposable or single-use only o Gowns must be made of polyethylene-coated polypropylene (also called SMS) material or other laminate, lint-free, and low permeability fabric. [NIOSH 2004;

ASHP 2006]

SMS = (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 a solid front with long sleeves.

No seams or closures are present on the front of the gown that could permit drugs to pass through.

o Must have tight/closed knit cuffs o Must be a full coverage gown including a full back for max protection o Must have tie backs or way to secure gown closure o Should be Universal size /fits most or Sizes Large and Extra Large

• Must have an AAMI rating (AAMI PB70 guidelines) – can be level 2,3, or 4 o Level 3 or higher is preferred

• Must be Chemotherapy rated and labeled as such. Either of the below standards is acceptable.

o Should have

ASTM F739-12e1 ‘Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact’

• All gown manufacturers should provide results for certification and validation purposes o Or:

ASTM D6978-05(2019) ‘Standard Practice for Assessment of Resistance of

Medical Gloves to Permeation by Chemotherapy Drugs’

• Some manufacturers follow the testing standards for chemo gloves as an alternate (Manufacturers may just list as ASTM F739 and ASTM D6978) o If international manufacturer not normally selling in the US, the International Equivalent for Chemotherapy (Antineoplastic Therapy) gowns = ISO 6529:2013 ISO 6529:2013 ‘Protective Clothing – Determination of Resistance of

Protective Clothing Materials to Permeation by Liquids and Gases.’

• Should still state gown was tested ‘for Chemotherapy use’ or ‘for use with antineoplastic drugs’

• May have ASTM F1670 ‘Standard Test Method for Resistance of Materials Used in

Protective Clothing to Penetration by Synthetic Blood’

Reference Products

• Compounding requires sterile chemo gown

ISO-MED ISOSCG800W-L ISO STERILE CHEMO

GOWN USP 800

COMPLIANT, LEVEL-3

IMPERVIOUS, WHITE -

LARGE, 50 PER/CS

CASE

ISO-MED ISOSCG800W-XXL ISO STERILE CHEMO

GOWN USP 800

COMPLIANT, LEVEL-3

IMPERVIOUS, WHITE -

XX-LARGE, 50 PER/CS

CASE

• Chemo administration gown can use non-sterile chemo gown

CONTEC HCGA0800 CONTEC, INC.

CRITIGEAR

DISPOSABLE CHEMO

GOWN , ASTM D6978-

05,KNIT CUFF, FULL

BACK

CASE