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The Guideline for Sterilization Packaging Systems was approved by the AORN Guidelines Advisory Board and became effective as of October 1, 2019. The recommendations in the guideline are intended to be achievable and represent what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the guideline can be implemented. AORN recognizes the many diverse settings in which perioperative nurses practice; therefore, this guideline is adaptable to all areas where operative or other invasive procedures may be performed.

Purpose

This document provides guidance to perioperative personnel for evaluating, selecting, and using sterilization packaging systems and for packaging the items to be sterilized and subsequently used in operative and other invasive procedures. Packaging systems are designed to permit sterilization of the contents within the package, protect the integrity of the sterilized contents, prevent contamination of the contents until the package is opened for use, and permit the aseptic delivery of the contents to the sterile field. Packaging systems include woven fabrics, single-use nonwoven materials, paper-plastic pouches, polyethylene material-plastic pouches, plastic-plastic pouches, and rigid containment devices (eg, sterilization containers, instrument cases, cassettes, organizing trays) composed of a variety of materials.

This guideline does not include recommendations for high-level disinfection, liquid chemical sterilization, processing flexible endoscopes, cleaning contaminated instruments, inspecting instruments, loading a sterilizer, sterilization, or aseptic presentation at the point of use. Refer to the AORN Guideline for Cleaning and Care of Surgical Instruments,1  Guideline for High-Level Disinfection,2  Guideline for Processing Flexible Endoscopes,3  Guideline for Sterilization,4  Guideline for Sterile Technique,5  and the packaging system manufacturer’s instructions for use (IFU) for more information.

Evidence Review

A medical librarian with a perioperative background conducted a systematic search of the databases Ovid MEDLINE®, Ovid Embase®, EBSCO CINAHL®, and the Cochrane Database of Systematic Reviews. The search was limited to literature published in English from January 2013 through October 2018. At the time of the initial search, weekly alerts were created on the topics included in that search. Results from these alerts were provided to the lead author until December 2018. The lead author requested additional articles that either did not fit the original search criteria or were discovered during the evidence appraisal process. The lead author and the medical librarian also identified relevant guidelines from government agencies, professional organizations, and standards-setting bodies.

Search terms included barrier integrity, barrier properties, basket, biological indicators, central service department, central sterile processing, central supply (hospital), chemical indicators, clinical competence, colony count (microbial), condensation, cross infection, dental instruments, device packaging, disposable equipment, equipment and supplies, equipment contamination, equipment failure, equipment reuse, event-dependent, event-related, fabrics, flash sterilization, heat sealer, hospital central supply, hospital purchasing, humidity, immediate use steam sterilization, immediate use sterilization, indicators and reagents, infection control, instrument case, instrument cassette, instrument set, instrument tray, Kraft, loaner instruments, materials testing, medical packaging, microbial colony count, monitoring, Mylar, olefin, one tray, organizing tray, outdating, package integrity, packaging device, packaging material, packaging system, paper count sheets, peel pack, peel pouch, plastics, polypropene, polypropylene, pouch, product labeling, product packaging, purchasing department, quality control, reusable pack, rigid container, safety management, sequential wrapping, single use, steam, sterile instruments, sterile package, sterile packaging, sterile processing, sterile storage, sterile supplies, sterility maintenance cover, sterilization, sterilization and disinfection, sterilization container, sterilization wrap, surgical equipment, surgical equipment and supplies, surgical instruments, textiles, time-dependent, time-related, and Tyvek.

Included were research and non-research literature in English, complete publications, and publications with dates within the time restriction when available. Excluded were non-peer-reviewed publications and older evidence within the time restriction when more recent evidence was available. Editorials, news items, and other brief items were excluded. Low-quality evidence was excluded when higher-quality evidence was available, and literature outside the time restriction was excluded when literature within the time restriction was available (Figure 1).

Articles identified in the search were provided to the project team for evaluation. The team consisted of the lead author and one evidence appraiser. The lead author and the evidence appraiser reviewed and critically appraised each article using the AORN Research or Non-Research Evidence Appraisal Tools as appropriate. A second appraiser was consulted if there was a disagreement between the lead author and the primary evidence appraiser. The literature was independently evaluated and appraised according to the strength and quality of the evidence. Each article was then assigned an appraisal score. The appraisal score is noted in brackets after each reference as applicable.

Figure 1
Flow Diagram of Literature Search Results

Flow Diagram of Literature Search Results

Adapted from Moher D, Liberati A, Tetzlaff J, Atman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(6):e1000097.

Each recommendation rating is based on a synthesis of the collective evidence, a benefit-harm assessment, and consideration of resource use. The strength of the recommendation was determined using the AORN Evidence Rating Model and the quality and consistency of the evidence supporting a recommendation. The recommendation strength rating is noted in brackets after each recommendation.

Note: The evidence summary table is available at http://www.aorn.org/evidencetables/.

Editor’s note: MEDLINE is a registered trademark of the US National Library of Medicine’s Medical Literature Analysis and Retrieval System, Bethesda, MD. Embase is a registered trademark of Elsevier B.V., Amsterdam, The Netherlands. CINAHL, Cumulative Index to Nursing and Allied Health Literature, is a registered trademark of EBSCO Industries, Birmingham, AL. Mylar is a registered trademark of DuPont Tejin Films, Chester, VA. Tyvek is a registered trademark of DuPont, Wilmington, DE.

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