The Guideline for Sterilization was approved by the AORN Guidelines Advisory Board and became effective as of October 17, 2024. Information about the systematic review supporting this guideline, including the PROSPERO registration number, systematic review questions, description of the search strategy and evidence review, PRISMA 2020 flow diagram, evidence rating model, and evidence summary table is available at https://www.aorn.org/evidencetables/.
This document provides guidance for sterilizing reusable medical devices to be used in perioperative and procedural settings. Items that enter sterile tissue, including the vascular system, are categorized as critical according to the Spaulding classification and should be sterile when used.1-3 An important factor in preventing surgical site infections (SSIs) is the use of only sterile instruments and medical devices for operative and other invasive procedures. Surgical site infections are among the most common health care–associated infections, comprising 20% of all health care–associated infections.4 The Centers for Disease Control and Prevention (CDC) health care–associated infection prevalence survey found there were an estimated 110,800 SSIs associated with inpatient surgeries in 2015.4
Surgical site infections can cause serious injury or death at enormous cost to patients, their families, and the health care organization. They are associated with a 2- to 11-fold increase in mortality, with 75% of deaths directly attributable to the SSI.4 In the United States, SSIs are estimated to cost $3.3 billion annually and extend hospital length of stay by 9.7 days, which increases the cost of hospitalization by more than $20,000 per admission.4 A systematic review of the literature on SSI from 1998 to 2014 found the estimated average cost of an SSI ranged between $10,433 (2005 dollars) and $25,546 (2002 dollars),5 which equates to approximately $16,758 to $44,550 in 2024 dollars. Costs can exceed $90,000 per infection when the SSI involves a prosthetic joint implant or an antimicrobial-resistant organism.5
Sterility is accomplished through a multistep process. This process begins immediately after instrument use with the removal of gross soil, application of a point-of-use treatment product, decontamination, inspection, packaging, and finally sterilization. Each step is critical in producing sterile items and maintaining sterility until the item is opened and delivered to the sterile field for use. Effective sterilization cannot take place without effective cleaning, decontamination, and packaging. Substances such as bioburden, biofilm, plaques, soils, and oils inhibit sterilization. The degree to which sterilization is inhibited correlates to the amount, number, type, and inherent resistance of these substances. Any of these substances can shield microorganisms on items from contact with the sterilant or combine with and inactivate the sterilant. Sterile barrier packaging increases the probability that sterility will be maintained until the package is opened at the point of use.
Sterility can be achieved by a variety of physical or chemical processes. The selection of the sterilization method is dependent on a number of factors including device design, material, packaging, compatibility with the sterilant, load limitations, safety requirements, and organization-specific considerations. The most common sterilization methods used in health care in the United States are addressed in this guideline. New sterilization technologies are being developed and may become commercially available in the future but are not yet cleared by the US Food and Drug Administration (FDA) for use in the United States. This document provides guidance only for sterilization processes commonly used in health care and currently cleared by the FDA.
The guideline addresses
saturated steam under pressure;
ethylene oxide (EO);
low-temperature hydrogen peroxide gas plasma;
low-temperature hydrogen peroxide vapor;
ozone combined with hydrogen peroxide;
dry heat;
liquid chemical sterilization using peracetic acid;
loading the sterilizer and load configuration;
transport of sterile items;
quality control measures; and
installation, care, and maintenance of sterilization equipment.
Guidance for the following topics is outside the scope of this document:
specific guidance for reprocessing medical devices labeled as single use, identifying single-use items for reprocessing, and evaluating the services of a third-party reprocessor;
cleaning and decontamination of surgical instruments;
high-level disinfection;
packaging;
loaned instruments (See the AORN Guideline for Care and Cleaning of Surgical Instruments6 );
facility design;
sterilization processes not cleared by the FDA for use in health care facilities (eg, gamma or electron beam radiation, chlorine dioxide, nitrogen dioxide, formaldehyde);
industrial EO sterilization;
processing of medical devices that have been or potentially have been exposed to prions; and
cost comparison and analysis of various methodologies.
Refer to the AORN Guideline for Care and Cleaning of Surgical Instruments,6 Guideline for Manual High-Level Disinfection,7 Guideline for Processing Flexible Endoscopes,8 Guideline for Sterilization Packaging Systems,9 and Guideline for Design and Maintenance of the Surgical Suite10 for guidance on these important topics related to the sterilization process.
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