AORN’s Current Guideline for Sterilization

The Association of periOperative Registered Nurses (AORN) published their updated “Guideline for sterilization” last September. The guideline covers recommendations for sterilization reusable medical devices by steam, dry heat, as well as, low temperature methods including ethylene oxide, hydrogen peroxide gas plasma or vapor, ozone combined with hydrogen peroxide and peracetic acid.

In addition to addressing the diverse types of sterilization methods, this guideline covers:

  • How to load sterilizers
  • How to transport sterile items
  • Sterilization quality control
  • Installation and maintaining sterilization equipment. 

This guideline went under a strict evidence review process. Using the AORN Evidence Rating Model. The recommendations are rated based on the quality and quantity of similar published evidence and are given an appraisal score.  The evidence score is placed in brackets after each applicable reference.  For instance, Recommendation 1.a. “Items that enter sterile tissue, including the vascular system, should be sterile when used.” [: Strong Evidence]

Some of the new recommendations include:

Sterilize whenever possible.

The guideline discusses the need to update the Spaulding classification system due to newly identified pathogens resistant to high-level disinfection.  Some devices may no longer belong in the semi-critical category.  Several of devices (e.g., endoscopes) that have, in the past been, considered semi critical and processed by high-level disinfection have an increased risk of transmitting infections from one patient to another compared to those that were sterilized. AORN now recommends “Reusable semi critical items that are manufacturer-validated for sterilization should be sterilized if possible”. [3: Moderate Evidence] Fortunately, today there are new and updated low temperature sterilizers that are FDA cleared for processing items such as endoscopes.

Sterile Storage

Recommendation IV states “Sterile items should be stored in a controlled environment”.  We know that shelf life is reliant on many factors such as packaging material, storage conditions, transport, and handling. While this recommendation isn’t totally new, it now states “The shelf life should be event-related unless otherwise specified by the packaging system manufacturer’s labeled expiration date”. [4: Limited Evidence] 

Recommendation IV.b.2. states, “Sterile items outside a designated sterile storage room should be stored in closed cabinets or covered carts”. While there is limited evidence it makes sense because controlled conditions reduce the risk of contaminating sterile items. More information on this can be found in the AORN Guideline for Design and Maintenance of the Surgical Suite.

Phacoemulsification handpieces

A new recommendation is to ensure packages containing phacoemulsification hand pieces be positioned and held upright during the steam sterilization process. Current evidence shows that sterilization is more likely to be achieved when the channels of these handpieces are orientated vertically with no obstruction at the end of the channel so they can drain freely during steam sterilization.    

Immediate-use steam sterilization 

IUSS should only be performed by competent personnel using the right equipment in the right setting. For IUSS to be effective all appropriate conditions must be met including following the manufacturer’s instructions for use for:

  • Cleaning
  • Cycle type
  • Exposure times
  • Temperature settings
  • Drying (if recommended)

Containment devices must be validated by the FDA for IUSS cycles.  Steps should be taken to prevent contamination during transport.

Wet loads/packs

AORN recommends “Wet loads or wet packs in a terminal sterilization cycle should be inbestage4d and corrective measures taken”. [4: Limited Evidence]  After complete terminal sterilization cycle that include drying may indicate a problem with the steam supply, sterilizer function or load configuration.  The guideline describes practical approaches to investigating the causes of wet loads/packs.

Assess environmental effects

Recommendation XI. states “The health care organization may establish a strategy for shutting down idle steam sterilizers”  It goes on to discuss the need for environmental safety and responsibility for strategies for sterilization such as energy consumption, harmful emissions, toxicity, cost reduction etc. AORN encourages an interdisciplinary team to evaluate sterilization purchases and usage decisions. XI. a recommends “The health care organization may establish a strategy for shutting down idle steam sterilizers.” [3: Moderate Evidence]

Sterile Processing Leadership

A new recommendation is for health care facilities to assign responsibility and authority for leadership of the sterile processing team to qualified personnel.  A high degree of expertise is needed due to the complexity of sterilization processes together with ever-changing technologies and instrumentation.

This article covered only some of the newly updated recommendations based on current evidence.  I encourage you to review and follow the entire guideline in order to help reduce risks to patients and staff.    

References:

  • ‎Guideline for Sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2018.
  • Hauk, L. Guideline First Look.  AORN Journal. Aug. 2018, Vol. 108. No.2, pg. p10-p12.

Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT 
President/CEO Seavey Healthcare Consulting, LLC 

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3 Responses to “AORN’s Current Guideline for Sterilization”

  1. Charlie Webb CPP February 17, 2019 at 5:39 AM #

    Interesting update thank you for posting, wondering if there is more in the guideline regarding any changes in packaging requirements, ie packaging machines?

  2. Sue Blankenhorn February 27, 2019 at 2:00 PM #

    Thanks for the articles. I am printing them out and giving them to my Director. My Supervisor is old school. She got certified 20 years ago and still goes be those standards. I got certified 2 years ago and tried tell her some of the new things, but she don’t want to hear it. So by giving the articles to my Director I’m hoping something’s will change. I would appreciate it you could do an article on the proper way to wrap instruments. We are all way arguing over that. I’d appreciate any help you could give me. Thank you and keep the articles coming.

  3. Daphne Gilpin June 10, 2019 at 7:55 AM #

    Thanks for explaining that the shelf life of sterile items depends on a lot of factors, like packaging material and storage conditions. I’m interested in learning more about how products are kept sterile during the handling and packaging process. I’m glad I read your article because it was interesting to learn about the factors that affect a product’s shelf life.

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