By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS
The Association of periOperative Registered Nurses (AORN) anticipates a fall release for its revised Guideline for Sterilization for electronic subscribers; the print version will be available in 2025. This guideline provides recommendation for sterilizing reusable medical devices for use in perioperative and procedural settings.
The Guideline for Sterilization reminds 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 healthcare 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 important changes incorporated into the updated guideline:
Guideline 1.4.1 is a recommendation for the accessibility of written manufacturer’s instructions for use (IFU). It has been expanded to include a pre-purchase section, providing recommendations to obtain and review the manufacturer’s IFU during the pre-purchase evaluation of a new reusable medical device. Some key factors to considerations include whether sterilization methods described in the IFU are feasible, available at the facility, and compatible with existing sterilization equipment. Also essential is ensuring 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 issue by recommending healthcare stakeholders contact the manufacturers of the products being used to request clarification, preferably in writing. If the 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 recent 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 healthcare 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. Additionally, the guideline recommends that an interdisciplinary team of users and key decision-makers should be assembled to develop sterilization procedures for devices produced by additive manufacturing; the guideline provides a recommendation for whom should be included on the team.
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 healthcare 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. Another issue with additive manufacturing is the shelf life for a sterilized, patient-matched device. It is recommended that an event-related shelf life be established for the sterilized patient-matched devices produced by additive manufacturing. If the device or packaging system manufacturers have a labeled expiration date, however, that expiration date should be used.
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. Still, some surgery centers only have a one-room design, and the revised 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.
Further, 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.
Recommendations about how to perform short-cycle sterilization are also provided in the revised guideline, including ensuring the medical device, packaging system, and sterilizer manufacturer’s written IFU provide instructions for short-cycle sterilization or terminal sterilization. Further, if the drying time is shortened, the healthcare 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. To prevent confusion between a short cycle, terminal sterilization and IUSS, Table 1 in the updated guideline clearly identifies the differences between these sterilization methods.
A new recommendation has also been added to the guideline’s Low-Temperature Hydrogen Peroxide section to address load weight because it affects the sterilization process. Recommendation 6.2.3 states to follow the sterilizer manufacturer’s IFU for the maximum weight limit for each load and cycle type.
This article provided a broad overview of just some of the key changes in AORN’s revised Guideline for Sterilization. HSPA encourages all Sterile Processing departments and areas where device processing and sterilization occur to obtain the review the full document and make it readily available to staff members. More information about AORN’s guidelines, including the Guideline for Sterilization, can be found at www.aorn.org/guidelines-resources.
