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The Association of Perioperative Registered Nurses (AORN) has recently updated its Guideline for Sterilization, with the print version scheduled for release in 2025.

This guideline provides recommendations for sterilizing reusable medical devices in perioperative and procedural settings. The updates address evolving sterilization methods, new technologies, and best practices to ensure patient safety and compliance with FDA-cleared processes.

In this edition of the Sky is the Limit, we want to share insights from OR Today’s article written by Susan Klacik, BS, CRCST, CIS, CHL, ACE, and FCS that provide very useful information related to AORN guidelines.

Skytron recognizes the importance of these updates and offers Sterile Processing Solutions designed to enhance efficiency, ensure compliance, and improve patient outcomes. Below, we review the key updates to AORN’s guidelines and how Skytron’s innovative solutions align with these changes.
 

Key Updates in the AORN Sterilization Guidelines

1. Pre-Purchase Evaluation of Medical Devices

 
The guideline now recommends obtaining and reviewing the manufacturer’s instructions for use (IFU) during the pre-purchase evaluation of new, reusable medical devices. This ensures that the required sterilization methods are feasible, available, and compatible with existing equipment. Personnel education needs should also be considered before purchasing.

2. Resolving IFU Conflicts

Conflicts may arise between IFUs from sterilization equipment, packaging, and medical device manufacturers. AORN recommends reaching out to manufacturers for clarification and, if conflicts remain unresolved, following the IFU of the device being sterilized.

Guideline 1.4.4 addresses this concern by recommending health care stakeholders contact the manufacturers of the products being used to request clarification, preferably in writing.

3. Sterilization of 3D-Printed Medical Devices

 
With the increasing use of additive manufacturing (3D printing) for medical devices, AORN advises that these devices be sterilized according to the manufacturer’s IFU. Manufacturers should provide validated cleaning and sterilization processes to remove residual manufacturing materials before delivery.
 

4. Sterilization of Experimental Onsite-Manufactured Devices

 
Hospitals may produce experimental devices onsite that lack FDA-cleared sterilization instructions. AORN recommends developing facility-specific sterilization protocols for such devices.
 

5. Separation of Decontamination and Clean Work Areas

 
AORN’s revised guideline 2.3.1 emphasizes a two-room sterile processing configuration to separate decontamination and clean work areas. A minimum four-foot separation between the instrument-washing sink and clean preparation area is recommended where only one room is available.
 

6. Short-Cycle Sterilization

 
AORN has included guidance on short-cycle sterilization, commonly used in ophthalmology centers. The Centers for Medicare and Medicaid Services (CMS) clarifies that short-cycle sterilization is not equivalent to immediate-use steam sterilization (IUSS). Facilities must verify that shortened dry times still result in properly dried packages.

If the drying time is shortened, the health care organization should perform verification testing to demonstrate that the abbreviated time can produce dry packages as described in ANSI/AAMI ST8:2013/(R)2018 Hospital steam sterilizers. Note: It is essential to recognize that if a shortened dry time is not specified in the manufacturer’s IFU, the organization is responsible for verifying that a shortened dry time can produce a dry package.

7. Load Weight in Low-Temperature Hydrogen Peroxide Sterilization

 
The new guideline 6.2.3 recommends following the sterilizer manufacturer’s IFU for maximum load weight in low-temperature hydrogen peroxide sterilization.
 

How Skytron Supports Compliance with AORN Guidelines

 
Skytron’s Sterile Processing solutions are designed with compliance, efficiency, and cost reduction in mind. Some of our key innovations include:

• Integrity Sterilizers – Featuring integrated water conservation systems that reduce water consumption by 35% to 65%, processing more in a smaller footprint.
• Flex Ultrasonic Washer Disinfector – Can handle mixed loads of cannulated, non-cannulated, and robotic instruments.
• Efficient Department Layouts – Our design experts can help you address needs via assessments and expert planning, whether you are remodeling or building a new sterile processing department. To reference additional details, visit our newsletter archives on Key Design Insights

By integrating Skytron’s solutions into your facility, you can confidently meet updated AORN guidelines, ensuring the highest standards of patient care and operational efficiency.

Overall, it is recommended that all sterile processing departments and areas where device processing and sterilization occur obtain the full Guidelines for Sterilization and make them readily available to staff members.

For more information on how Skytron can support your facility, contact our team today!

Resources
1. Association of Perioperative Registered Nurses (AORN) Guidelines
2. Centers for Medicare & Medicaid Services (CMS)
3. ANSI/AAMI ST8:2013/(R)2018 Hospital Steam Sterilizers
4. Skytron Sterile Processing Solutions
5. Key Article Insights