Re-Usable Mouthpiece Sterilization Instructions

	A-M Systems Mouthpieces and Respiratory Connectors Recommended Cleaning and Sterilization Instructions  [Download PDF Version]

WARNING: A-M Systems thermoplastic, reusable, products are supplied non-sterile and should be sterilized before first use and after each patient use.

Recommended Cleaning Instructions:

1. Clean the products using one of the following validated processes:
   • Method 1:
     1. Thoroughly rinse products under tap water for a minimum of one minute to remove gross soil and debris.
     2. Prepare cleaning solution using Enzol®*, or equivalent, and lukewarm tap water. Prepare the solution according to the manufacturer’s recommendation.
     3. Using a soft bristled brush, dip the brush into the prepared detergent and scrub products for a minimum of one minute each, paying particular attention to crevices and other hard to reach areas.
     4. Once the products have been scrubbed, thoroughly rinse in reverse osmosis / deionized (RO/DI) water for a minimum of one minute to remove excess detergent.
     5. Immediately after rinsing, drain off excess water from products.
     6. Blow-dry the products using compressed air, especially in crevices and other hard to reach areas.
     7. Wipe and thoroughly dry products using a clean, lint-free, cloth.
     8. Visually inspect products to ensure all visible soil has been removed.
   • Method 2:
     1. Thoroughly rinse products under tap water for a minimum of one minute to remove gross soil and debris.
     2. Using a sonication unit, prepare a solution consisting of Renu-Klenz™**, or equivalent, and lukewarm tap water. Prepare the solution according to the manufacturer’s recommendation.
     3. Place products, fully immersed, in the detergent solution and allow to sonicate for ten minutes.
     4. Remove products from sonication unit and thoroughly rinse in reverse osmosis / deionized (RO/DI) water for a minimum of one minute to remove excess detergent.
     5. Immediately after rinsing, drain off excess water from products.
     6. Blow-dry the products using compressed air, especially in crevices and other hard to reach areas.
     7. Wipe and thoroughly dry products using a clean, lint-free, cloth.
     8. Visually inspect products to ensure all visible soil has been removed.

Recommended SterilizationInstructions:

1. Manually clean the products before sterilization according to attached cleaning instructions.
2. Sterilize the products using the following validated process:
   1. Individually pouch the products
   2. Use a Prevacuum (Steam under Pressure) Cycle of 4 Minutes at 132 °C with a minimum 20-minute Drying Time and 3 Preconditioning Pulses.
   3. After completion of the Prevacuum Cycle, immediately remove the products from the autoclave and store them in a dry/contamination free environment prior to use.

References:

1. "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance", Rockville, MD, FDA Center for Devices and Radiological Health, Office of Device Evaluation, April 1996
2. Association for the Advancement of Medical Instrumentation. "Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers". AAMI TIR No. 12-200
3. Arlington (Vir.): AAMI Technical Information Report.
4. Association for the Advancement of Medical Instrumentation. "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices". AAMI TIR No. 30-200
5. Arlington (Vir.): AAMI Technical Information Report.
6. Association for the Advancement of Medical Instrumentation. "Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings", ANSI/AAMI ST35-2003, Arlington (Vir.) AAMI, 2003 American National Standard.

* Enzol® is a trademark of Johnson & Johnson Medical Products, Inc.
** Renu-Klenz™ is a trademark of STERIS Corporation.