By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS
The Association of periOperative Registered Nurses (AORN) has revised its Guideline for Sterilization, and the print version will be available in 2025.
The guideline provides recommendation for sterilizing reusable medical devices for use in perioperative and procedural settings.
The updated document reminds readers that sterility can be achieved with a variety of physical or chemical processes. The selection of the sterilization method depends on a number of factors, including device design, material, packaging, sterilant compatibility, load limitations, safety requirements, and organization-specific considerations. The most common sterilization methods used in health care in the U.S. are addressed in the guideline. Note: The document provides guidance only for sterilization processes commonly used in health care and currently cleared by the FDA.
The following are key changes incorporated into the revised guideline:
Guideline 1.4.1 – a recommendation for the accessibility of written manufacturer’s instructions for use (IFU) – has been expanded to include a pre-purchase section with recommendations about obtaining and reviewing the manufacturer’s IFU during the pre-purchase evaluation of a new reusable medical device. Key factors to consider include whether sterilization methods described in the IFU are feasible, available at the facility and compatible with existing sterilization equipment. It is also vital to ensure that personnel education needs are met.
Occasionally, a conflict can exist between the IFU from manufacturers of sterilization equipment, packaging and medical devices. 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. If IFU conflicts cannot be reconciled, the recommendation is to follow the manufacturer’s IFU for the device being sterilized.
Medical device technologies continuously evolve, and the revised Guideline for Sterilization provides recommendations on how to respond to these changes. Among the most notable new technologies are devices produced by additive manufacturing such as 3D printing. Like other medical devices, the devices should be sterilized according to the manufacturers’ IFU for the specific device, packaging and sterilization equipment. These devices are often provided to the health care facility unsterile for preoperative planning. The manufacturer should provide cleaning and sterilization instructions, even if the device is intended for single use. The manufacturer is also expected to use a validated process to remove residual manufacturing matter, such as excess material, support structures, or lubricant, before providing the final finished device to the end user.
Recommendations are also provided for experimental devices manufactured onsite at the facility that lack FDA-cleared, validated sterilization instructions in accordance with regulatory requirements. Cleaning and sterilization validation studies require numerous resources and expertise not available to health care facilities; therefore, a facility should establish a process for sterilizing experimental devices that are manufactured onsite at the facility and do not have FDA-cleared, validated sterilization instructions.
The guideline’s section for sterilization processes describes methods for ensuring decontamination and clean work areas remain separated. Recommendation 2.3.1 specifies a two-room sterile processing configuration with physical separation between the decontamination room and a clean workroom. Some surgery centers, however, only have a one-room design, and the guideline provides a conditional recommendation to safely process medical devices in such an environment. A one-room design has a decontamination and clean work area that uses a small or table-top sterilizer. Separation of the areas can be achieved with four feet between the instrument-washing sink (from the edge of the sink or separating wall or screen that extends four feet above the sink rim) and the clean preparation area. This revision aligns with the AORN Guideline for Design and Maintenance.
Additionally, a new sterilization practice, called “short-cycle sterilization,” is addressed in the updated guideline. The abbreviated sterilization cycle relates to packaged items with a reduced dry-cycle time [this is a common practice in ophthalmology centers and is recognized by the Centers for Medicare and Medicaid Services (CMS)]. In a memorandum, CMS clarified its position that they do not consider short-cycle sterilization to be equivalent to immediate use steam sterilization (IUSS). Note: The CMS definition of short-cycle sterilization only includes packaged items that are suitable for storage; items that are not packaged for storage would fall under their definition of IUSS.
Further, the guideline includes recommendations about how to perform short-cycle sterilization. This includes ensuring that the medical device, packaging system and sterilizer manufacturer’s written IFU provide instructions for short-cycle sterilization or terminal sterilization. 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.
A new recommendation has also been added to the guideline’s Low-Temperature Hydrogen Peroxide section to address load weight due to its effect on the sterilization process. Recommendation 6.2.3 states that the sterilizer manufacturer’s IFU should be followed for the maximum weight limit for each load and cycle type.
HSPA encourages all sterile processing departments and areas where device processing and sterilization occur to obtain the review the full Guideline for Sterilization and make it readily available to staff members.
For more information, visit aorn.org/guidelines-resources.
