CE ONLINE Rigid Containers for Immediate Use Steam Sterilization An Online Continuing Education Activity Sponsored By Funds Provided By
Welcome to Rigid Containers for Immediate Use Steam Sterilization (An Online Continuing Education Activity) CONTINUING EDUCATION INSTRUCTIONS This educational activity is being offered online and may be completed at any time. Steps for Successful Course Completion To earn continuing education credit, the participant must complete the following steps: 1. Read the overview and objectives to ensure consistency with your own learning needs and objectives. At the end of the activity, you will be assessed on the attainment of each objective. 2. Review the content of the activity, paying particular attention to those areas that reflect the objectives. 3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content. 4. For additional information on an issue or topic, consult the references. 5. To receive credit for this activity complete the evaluation and registration form. 6. A certificate of completion will be available for you to print at the conclusion. Pfiedler Enterprises will maintain a record of your continuing education credits and provide verification, if necessary, for 7 years. Requests for certificates must be submitted in writing by the learner. If you have any questions, please call: 720-748-6144. CONTACT INFORMATION: 2016 All rights reserved Pfiedler Enterprises, 2170 South Parker Road, Suite 125, Denver, CO 80231 www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196
Overview Preventing infection in the surgical patient is a primary goal for the perioperative nurse. Infection prevention has become an area of greater scrutiny today, as health care professionals are continually challenged by new pathogens and multi-drug resistant organisms, as well as the increased economic pressures to reduce health careassociated infections. One key measure in reducing the risk for surgical site infections is to provide surgical instruments and devices that are sterile at the time of use. Under certain clinical conditions, instruments may be subjected to an immediate use steam sterilization process utilizing rigid containers. While this is a practice in many operating rooms today, the when, where, and how are often misunderstood. This continuing education activity will provide an overview of the clinical considerations related to the use of immediate use steam sterilization using rigid containers. It will provide a brief overview of both the clinical and economic impact of surgical site infections today. The current guidelines and professional recommendations that outline the indications for immediate use steam sterilization and the use of rigid containers will be reviewed. Considerations for the proper use and care of rigid container systems for immediate use steam sterilization will be discussed. Learner Objectives Upon completion of this continuing education activity, the participant should be able to: 1. Discuss the clinical and economic impact of surgical site infections. 2. Define immediate use steam sterilization. 3. Identify the organizations involved in guidelines for immediate use steam sterilization. 4. Describe the proper use of rigid container systems for immediate use steam sterilization cycles. 5. Explain the trends in terminology change from flash to immediate use steam sterilization. Intended Audience This continuing education activity is intended for perioperative nurses, sterile processing personnel, and other health care professionals who are interested in learning more about the clinical considerations regarding the use of rigid containers with immediate use steam sterilization of surgical instrumentation. Accreditation Information State Board Approval Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP14944, for 2.0 contact hours. Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes. 3
The certificate of course completion issued at the conclusion of this course must be retained in the participant s records for at least four (4) years as proof of attendance. IAHCSMM The International Association of Healthcare Central Service Materiel Management has approved this educational offering for 2.0 contact hours to participants who successfully complete this program. CBSPD The Certification Board for Sterile Processing and Distribution (CBSPD) has approved this program for 2.0 contact hours. Expiration Date This continuing education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in August 2016 and can no longer be used after August 2018 without being updated; therefore, this continuing education activity expires August 2018. DISCLAIMER Accredited status as a provider refers only to continuing education activities and does not imply endorsement of any products. Support Funds to support this activity have been provided by Aesculap, Inc. AUTHORS/ PLANNING COMMITTEE/REVIEWER Julia A. Kneedler, EdD, RN Program Manager/Reviewer Pfiedler Enterprises Rose Moss, MN, RN, CNOR Nurse Consultant/Author/Planning Committee Moss Enterprises Judith I. Pfister, MBA, RN Program Manager/Planning Committee Pfiedler Enterprises Joan M. Spear, RN, MBA, CNOR Group Director Clinical Services/Reviewer Aesculap, Inc. Melinda T. Whalen, BSN, RN, CEN Program Manager/Reviewer Pfiedler Enterprises Denver, CO Westcliffe, CO Denver, CO Westminster, MD Denver, CO 4
Disclosure of Relationships with Commercial Entities for Those in a Position to Control Content for this Activity Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for individuals who control content for an educational activity. Information below is provided to the learner, so that a determination can be made if identified external interests or influences pose potential bias in content, recommendations or conclusions. The intent is full disclosure of those in a position to control content, with a goal of objectivity, balance and scientific rigor in the activity. For additional information regarding Pfiedler Enterprises disclosure process, visit our website at: http://www. pfiedlerenterprises.com/disclosure. Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this continuing education activity. Relevant financial relationships are those in any amount, occurring within the past 12 months that create a conflict of interest. A commercial interest is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. Author/ Planning Committee/Reviewer: Julia A. Kneedler, EdD, RN No conflict of interest Rose Moss, MN, RN, CNOR No conflict of interest Judith I. Pfister, MBA, RN No conflict of interest Joan M. Spear, MBA, RN, CNOR Employee of commercial entity Melinda T. Whalen, BSN, RN, CEN No conflict of interest PRIVACY AND CONFIDENTIALITY POLICY Pfiedler Enterprises is committed to protecting your privacy and following industry best practices and regulations regarding continuing education. The information we collect is never shared for commercial purposes with any other organization. Our privacy and confidentiality policy is covered at our website, www.pfiedlerenterprises.com, and is effective on March 27, 2008. To directly access more information on our Privacy and Confidentiality Policy, type the following URL address into your browser: http://www.pfiedlerenterprises.com/privacy-policy In addition to this privacy statement, this Website is compliant with the guidelines for internet-based continuing education programs. The privacy policy of this website is strictly enforced. 5
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INTRODUCTION Infection prevention is a primary goal for all patients undergoing surgery: one of the expected outcomes for surgical intervention is that the patient is free from signs and symptoms of infection. 1 Therefore, a major responsibility of the perioperative nurse is to minimize the patient s risk for the development of a surgical site infection (SSI). 2 The creation and maintenance of a sterile environment has a direct influence on patient outcomes; one key component in providing an aseptic environment is the provision of surgical instruments that are free of contamination at the time of use. This is accomplished by subjecting the instruments to cleaning and decontamination, followed by a sterilization process. Sterilization provides the highest level of assurance that surgical instruments are free of viable microbes. The use of immediate use steam sterilization is one method used in most operating rooms (ORs) today to sterilize surgical instruments it is commonly used at facilities as a means of quickly turning around needed equipment under certain circumstances; but often, immediate use steam sterilization is misunderstood. In addition, the evolution of rigid containers for use in immediate use steam sterilization cycles offers perioperative personnel with new options for proper immediate use steam sterilization techniques. When performed correctly, immediate use steam sterilization is safe and effective for sterilizing medical devices. 3 Therefore, the effective use of immediate use steam sterilization requires knowledge of the what, when, and how in order to provide safe patient care. SURGICAL SITE INFECTIONS: THE DANGER IS REAL In order to appreciate the implications associated with immediate use steam sterilization in today s challenging surgical practice environment, the perioperative nurse must remain aware of both the clinical and economic impact of health care-associated infections (HAIs), specifically surgical site infections, for both patients and health care facilities. Health care-associated infections are infections acquired by patients during the course of receiving treatment for other conditions within a health care setting; they can be not only devastating, but deadly. 4 A new report from the Centers for Disease Control and Prevention (CDC) updates previous estimates of health care-associated infections. In the United States, an estimated 16 million operative procedures were performed in 2010. 5 In American hospitals alone, health care-associated infections account for an estimated 1.7 million infections and 99,000 associated deaths each year. 6 On an annual basis, estimates of the most frequent HAIs nationwide are 7 : SSIs 36.0% Clostridium difficile infection 30.3% Catheter-associated urinary tract infections (CAUTI) 17.4% Central line-associated bloodstream infections (CLABSI) 9.2% Ventilator-associated pneumonia (VAP) 7.1% 7
The CDC s National Nosocomial Infections Surveillance (NNIS) system has defined surgical site infections as those associated with surgical procedures that occur at or near the surgical incision within 30 days of an operative procedure, or within one year if an implant is left in place. 8 Furthermore, SSIs are common complications of surgery, occurring in 2% to 5% of patients after clean extra-abdominal operations and in up to 20% of patients undergoing intra-abdominal operations. 9 In addition to the clinical impact on the patient (eg, injury, mortality, suffering, and life-style changes), the economic burden of SSIs is also considerable. The estimated 300,000 SSIs that occur every year in the United States, prolong hospitalization by 7 to10 days, and are associated with an estimated annual incremental cost of $1 billion; in addition, the mortality rate associated with SSIs is 3%, with about 75% of deaths being directly attributable to the infection. 10 The economics of surgical site infections received greater attention from the Centers for Medicare and Medicaid Services (CMS) when, in July 2008, CMS announced new Medicare and Medicaid reimbursement and coverage policies. 11 The acute-care Inpatient Prospective Payment System (IPPS) final rule, which updated Medicare payments to hospitals for fiscal year 2009, included payment provisions to reduce preventable medical errors that occur in health care facilities in an effort to provide additional incentives for health care facilities to improve the quality of care provided to Medicare patients. The rule specifically states that, if a condition is not present upon admission, but is subsequently acquired during the course of the patient s hospital stay, Medicare no longer pays the additional costs of the hospitalization; moreover, the patient cannot be held responsible for the additional costs. Initially, hospitals were not reimbursed for infections associated with vascular catheters and coronary artery bypass graft surgery. However, as of October 1, 2008, hospitals were no longer reimbursed for surgical site infections after selected elective procedures, including certain orthopedic surgeries and bariatric surgery for obesity. The Joint Commission also recognizes the significance of preventing HAIs and SSIs. Goal 7 of the 2016 Joint Commission National Patient Safety Goals (NPSGs) is to reduce the risk of HAIs, including SSIs; this goal also recommends implementation of policies and practices that meet regulatory requirements and are aligned with evidence-based guidelines (eg, the CDC and/or professional organization guidelines) aimed at reducing the risk of surgical site infections. 12 SURGICAL SITE INFECTIONS: PROCEDURE-RELATED RISK FACTORS Microbial contamination of the surgical site is a prerequisite for an SSI; further, the risk of an SSI increases with the dose of bacterial contamination and the virulence of the bacteria. 13 Microbial contamination of the surgical site may be from either the endogenous microorganisms (ie, the bacteria from the patient s own skin, mucous membranes, or hollow viscera) or exogenous microorganisms (ie, the microorganisms from health care personnel, the environment, surgical instruments and other materials). 8
Most SSIs are caused by the patient s endogenous bacterial flora; when introduced into body tissues by surgery or through surgical instruments, the pathogenic potential of endogenous microorganisms increases. 14 The top five pathogens that are most often associated with cases of SSIs include (in rank order) 15 : Staphylococcus aureus, Coagulase-negative staphylococci (CoNS), Enterococcus species (E. faecalis; E. faecium; not otherwise specified), Escherichia coli, and Pseudomonas aeruginosa. There are both patient-related and procedural-related factors that contribute to the development of SSIs. While perioperative personnel cannot control the patient-related factors (eg, the patient s status in regard to age, overall health, nutrition, and history of drug and/or tobacco use), proper instrument processing and sterilization is a significant risk factor that is under the control of the hospital; furthermore, it is one which has the potential for a significant impact on the prevention of surgical site infections (see Table 1). 16 Failure to properly sterilize equipment carries not only the risk associated with breach of host barriers, but also the risk for person-to-person transmission as well as transmission of environmental pathogens. 17 Therefore, thorough cleaning of the item is required prior to a sterilization process because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of this process. Table 1 Procedure-Related Factors That May Influence the Risk of Surgical Site Infection Development Procedure-Related Factors Related to SSI Risk Duration of surgical scrub Skin antisepsis Preoperative shaving Preoperative skin prep Duration of operation Antimicrobial prophylaxis Operating room ventilation Inadequate sterilization of instruments Foreign material in the surgical site Surgical drains Surgical technique Poor hemostasis Failure to obliterate dead space Tissue trauma IMMEDIATE USE STEAM STERILIZATION Flash Sterilization, a practice used in the operating room suites, is an antiquated term that has been replaced with the descriptor Immediate Use steam sterilization. The practice of flashing was reserved for the practice of quick sterilization of an 9
instrument that was needed for immediate use, and not for storage. Now, standards and practices associations such as the Association for the Advancement of Medical Instrumentation (AAMI), the Association of perioperative Registered Nurses (AORN), and the Centers for Disease Control and Prevention-Health care Infection Control Practices Advisory Committee (CDC-HICPAC) use the new terminology of immediate use steam sterilization. 18 Educational and certification agencies such as the Certification Board for Sterile Processing and Distribution (CBSPD) and the International Association of Health care Central Service Materiel Management (IAHCSMM), use this term as well. IMMEDIATE USE STEAM STERILIZATION: GUIDELINES AND RECOMMENDATIONS Today, perioperative professionals face two conflicting challenges on a daily basis: on one hand, regulatory agencies including CMS as previously discussed, are now holding health care facilities more accountable for the costs associated with surgical site infections; on the other hand, surgical services departments are accountable to increase productivity and efficiency by accommodating surgical case volume and reducing turnover time. In many practice settings, immediate use steam sterilization using rigid containers is used when there is a need. Sterilization is defined as a validated process used to render a product free from viable microorganism. 19 In any sterilization process, the nature of microbiological inactivation is described by an exponential function, known as the sterility assurance level (SAL) or the probability of a single viable microorganism occurring on an item after sterilization. Therefore, the presence of a viable microorganism on any individual item can be expressed in terms of probability. This probability can be reduced to a very low number, but it can never be reduced to zero. SAL is normally expressed as 10-6 for items intended to come into contact with compromised tissue (ie, tissue that has lost the integrity of natural barriers). An SAL of 10-6 means that there is less than or equal to one chance in a million that a single viable microorganism is present on a sterilized item. Saturated steam under pressure is the preferred sterilization method for heat-and moisture stable instruments and devices, unless otherwise indicated by the device manufacturer. 20 Steam is an effective, inexpensive, and relatively rapid sterilization method for most porous and nonporous materials. Immediate use steam sterilization is defined as a process designed for the steam sterilization of patient care items for immediate use. And, as noted above, when performed correctly, immediate use steam sterilization is a safe and effective process for sterilizing surgical instruments and medical devices. However, performing immediate use steam sterilization requires control of many variables. One of the major concerns with immediate use steam sterilization is maintaining the sterility of the items from the sterilizer to the OR. Rigid containers address one concern by protecting the sterilized items from contamination during transport from the sterilizer to the point-of-use. 21 Several professional organizations have developed and regularly update guidelines and recommendations that provide guidance for perioperative nurses regarding the 10
use of immediate use steam sterilization and rigid container systems. In addition, The Joint Commission recently updated its position on immediate use steam sterilization. The applicable guidelines and recommendations issued by the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of perioperative Registered Nurses (AORN), as well as The Joint Commission s updated position on immediate use steam sterilization, are used in practice settings. For example, for IUSS of both nonporous and porous items in a rigid container using either a gravity-displacement or dynamic airremoval steam sterilizer, perioperative personnel should refer to the device and container manufacturer instructions for use for the appropriate exposure times. 22 AORN Guidelines for Perioperative Practice As noted, the creation and maintenance of an aseptic environment and the provision of surgical items that are free from contamination at the time of use are key factors in minimizing the patient s risk for SSI and thereby promoting positive patient outcomes. AORN publishes two recommended practices related to the use of rigid container systems and IUSS sterilization; selected recommendations from these documents are outlined below. AORN Guideline for Selection and Use of Packaging Systems for Sterilization 23 The AORN Guideline for Selection and Use of Packaging Systems for Sterilization was updated in 2016. These evidence-based recommendations provide guidance for perioperative personnel on the evaluation, selection, and use of packaging systems for items to be sterilized and the used in patient care. The recommendations related to the use of rigid sterilization containers are outlined below. Please refer to the recommended practices document for the complete list of recommendations, interpretive statements, and references, including the evidence rating. Recommendation I. Packaging systems and packaging materials should be evaluated prior to purchase and use. When packaging systems are compatible with the sterilization method and equipment, there is an increased probability that sterility can be achieved and maintained until the packaged items are used. Packaging materials and systems should: Be cleared by the US Food and Drug Administration (FDA) for performance claims for intended use; Be suitable for the items to be sterilized; Include the manufacturer s instructions for use (IFU); Be free of toxic ingredients; Be odor free; Be low linting; Be large enough to allow equal distribution of the contents; Be easy to use for the health care workers who prepare, transport, and/or open the package; provide for secure and complete closure of items; Provide sealing that is tamper-evident; Allow identification of the contents prior to opening; Permit adequate air removal; Allow the sterilant to penetrate and come into direct contact with the item(s) and surfaces; 11
Permit removal of the sterilant; Be resistant to tears and punctures; Protect the package contents from physical damage; Maintain the sterility of the package contents until it is opened; Allow aseptic delivery of the contents to the sterile field (eg, easy removal of lids from rigid sterilization containers); Have a positive cost-benefit ratio; and Be free of restrictive regulatory requirements in regards to waste disposal. Prior to selecting a packaging system, personnel should evaluate and verify the performance of the materials and packaging system in the environment where they will be used in order to determine if the conditions for sterilization, shelf life, transport, storage, and handling can be met. The characteristics that should be determined during a prepurchase evaluation include: Clearance by the FDA for the performance claims for the intended use; The ability to verify the manufacturer s IFU by facility testing; Barrier effectiveness; Compatibility with the sterilization methods and cycles used in the practice setting; Biocompatibility; Availability of an external chemical indicator (CI); Durability; The useful product life of all components; Requirements and methods for tracking use; Labeling method; The ability of the seal to maintain the integrity of the package; The requirements for disassembly and cleaning; Storage and maintenance requirements; Ease of use, transport, and aseptic presentation; Weight; The available sizes; The environmental impact; and Cost-effectiveness. The manufacturers IFU should also be evaluated to verify that the packaging system and packaging material are intended for use with the method(s) of sterilization and the specific equipment to be used in the practice setting. The manufacturer s validation information should be reviewed and evaluated prior to purchasing. The validation information may include sterilant penetration, resistance to tears and punctures, barrier performance, use with extended steam sterilization cycles, sterility maintenance, as well as shelf life. Prior to purchase, product testing should be performed if the packaging system is a major change in the type of packaging currently in use (eg, a change 12
from the use of nonwoven packaging materials to using rigid sterilization containers). This testing verifies that adherence to the manufacturer s IFUs for sterilization is achievable within the practice setting. Prepurchase product testing should include: Evaluation of sterilization efficacy through placement of biological indicators (BIs) and CIs inside various sets and packages (eg, instrument and basin sets) to be processed; Placement of both BIs and CIs within a package in the areas that are most challenging in regards to contact with the sterilant (consult the medical device and/or packaging manufacturer if assistance is needed in identifying the challenging areas); Moisture assessment; Documentation of all product testing activities; and Reprocessing of the product prior to use. Recommendation II. Packaging systems should be compatible with the specific method of sterilization for which they will be used. Because the interaction between medical devices, packaging systems, and sterilizer technologies is complex, not all packaging systems are appropriate for all methods of sterilization. Packaging systems used for steam sterilization should allow steam penetration. Attention to steam penetration reduces the possibility that the efficacy of steam sterilization will be adversely affected by factors such as humidity; elevation; package contents; packaging material; load; position of items within the sterilizer; size, weight, and density of the pack or rigid sterilization container; and other parameters of the sterilization cycle. Recommendation IV. Items to be sterilized should be packaged in a manner that facilitates sterilization and also allows for aseptic presentation of the package contents. Packaging should be used according to both the packaging and sterilizer manufacturers written IFU. Incorrect packaging can prevent sterilization from occurring. Inappropriate handling can result in the loss of package integrity. Aseptic delivery of the contents to the sterile field may be difficult or impossible if the items are incorrectly packaged. All packaging materials, including filters for rigid sterilization container systems, should be inspected for defects and/or extraneous matter prior to use. Packaging materials with any type of defect should not be used. The total weight of instrument containment devices, including the contents, should not exceed 25 pounds. Instrument sets that weigh over 25 pounds pose a greater risk of ergonomic injury to health care workers. Instruments that are composed of more than one part, which can be disassembled, should be disassembled unless the manufacturer s written IFU specifies that disassembly is not required during sterilization. 13
Recommendation V. Chemical indicators that are specific to the sterilization method selected should be used with each package. Chemical indicators are used to verify that one or more of the conditions required for sterilization have been achieved within each package; external and internal CIs do not verify the sterility of the package contents. A CI should be placed on the outside and inside of every package to be processed unless the internal indicator is visible and readable through the package material. External CIs are used to verify that a package has been exposed to a sterilization process. External indicators are intended to distinguish processed packages from unprocessed packages. Internal CIs are used to verify that the sterilant has reached the contents of the package and also that the critical variables of the sterilization process have been met. The number of critical process variables that can be monitored with an internal indicator depends upon the specific type of internal indicator that is used. More than one CI may be needed for multilayered trays; they should be placed according to the tray manufacturer s IFU. Recommendation VIII. A rigid sterilization container should be used, cleaned, inspected, repaired, and maintained as specified in the manufacturer s written IFU. Both the design and materials of rigid sterilization container may affect compatibility with a sterilization process (eg, penetration of the sterilant, release of the sterilant, and moisture). The directions regarding the method of sterilization may vary by manufacturer. The recommended sterilization method and cycle exposure times for each rigid sterilization container system should be provided by and also obtained from the container manufacturer. The manufacturers of rigid sterilization containers which are FDA cleared have validated that their containers will allow sterilization using specific sterilization methods and cycle exposure times. The efficacy of sterilization of rigid sterilization containers should be evaluated prior to initial use and also periodically, as outlined in the manufacturer s written IFU. Because rigid sterilization container systems vary widely in their design, mechanics, and construction, these variables affect the performance of the containers as well as their compatibility with sterilization methods. Health care workers are responsible to ensure that rigid sterilization container systems are appropriate for the proposed sterilization uses and are also compatible with the existing sterilizers in the facility. Before cassettes or organizing trays are placed within a rigid sterilization container, the users should refer to the containment device or organizing tray manufacturer s IFU in order to determine if this practice is acceptable and/or consult with the rigid sterilization container manufacturer and the 14
device manufacturer to determine if this practice is acceptable. Some device manufacturers provide specifications that should be met in order to ensure sterilization efficacy when cassettes or organizing trays are used within rigid sterilization containers. The integrity of a rigid container should be inspected after every use. These inspections should include that the: Edges and mating surfaces of both the container and lid are free of dents and chips; Container and lid fit together properly and securely; Filter retention mechanisms and fasteners are secure and not burred or distorted; Latching mechanisms are functional as they should be; Handles are in proper working order; Integrity of the filter media has not been compromised; Gaskets are pliable, securely fastened, and free from breaks or cuts; and Valves are in proper working order. Improperly maintained valves, worn gaskets, dents, or other damage may compromise the integrity of the container as well as the container s ability to maintain sterility. Reusable or single-use filters and valve systems should be secured and in proper working order before sterilization. Filter plates should be examined before and after the sterilization process for integrity; only filters that are intact should be used. If the filter is dislodged, damp, or has holes, tears, or punctures, the contents in the container should be considered unsterile. All items that are damaged should be removed from service and repaired or replaced. After each use, rigid sterilization containers should be cleaned. For proper cleaning, all components (eg, filter retention plates) should be disassembled according to the manufacturer s IFUs, unless otherwise specified. Any debris that is retained on container surfaces and components can inhibit sterilant contact. Additional materials, such as silicone mats or towels, should not be placed within a rigid sterilization container unless the container manufacturer has provided directions for their use. Adding materials to the container in a manner that is not in accordance with the manufacturer s IFU may inhibit both sterilization as well as the container s performance. Personnel should consult the manufacturer s IFU in order to determine limitations related to density of materials, weight, and distribution of contents before devices are placed within a rigid sterilization container. Following the manufacturer s requirements for density of materials, weight, and distribution 15
of the container contents will facilitate sterilization and optimize the container s performance. Recommendation IX. Packages that will be sterilized should be labeled. Accurate labeling provides identification of the package contents and also information that enables the sterilizer, sterilization cycle, personnel involved in the sterilization process, and the patient for whom the items were used to be tracked. Recommendation X. Perioperative team members who are responsible for the selection and/or use of packaging systems should receive initial and ongoing education and competency verification on their understanding of the selection and use of packaging systems. The health care organization is responsible for providing initial and ongoing education and to verify the competency of perioperative team members. Both initial and ongoing education of perioperative personnel regarding the selection and use of packaging systems facilitates the development of knowledge, skills, and attitudes that impact safe patient care. Periodic education programs provide opportunities to reinforce the principles of packaging and packaging systems evaluation and may also be used to introduce relevant new equipment and practices. Competency verification assesses individual performance, provides a mechanism for documentation, and may verify that perioperative personnel have an understanding of the principles and processes regarding the selection and use of packaging systems. Members of the perioperative should receive education and complete competency verification activities that address the specific knowledge and skills regarding the selection and use of packaging systems. The ongoing development of knowledge and skills and documentation of personnel participation are regulatory and accreditation requirements for hospitals as well as ambulatory care settings. Educational activities related to the selection and use of packaging systems should cover the following aspects: Complying with the manufacturers IFU; The safe use of packaging systems; The risks and potential hazards regarding packaging and measures to minimize the risks; Product testing; Corrective measures to use in the event of a failure of the packaging system; and New information about changes in packaging technology and its compatibility with sterilization equipment and processes. 16
In regard to the selection and use of packaging systems, the perioperative registered nurse (RN) should: Participate in ongoing education; Identify his/her personal learning needs; Pursue experiences to acquire, maintain, and augment personal knowledge and skills proficiency; Share his/her knowledge and skills with other team members; Communicate relevant information to other perioperative team members; Promote a healthy work environment by using appropriate and courteous verbal and nonverbal communication techniques; and Develop and implement conflict resolution skills in order to manage difficult behavior, promote positive working relationships, and serve as an advocate for patient safety. Education, collegiality, and collaboration are standards of perioperative nursing; they are primary responsibilities the RN in the perioperative practice setting. Recommendation XI. Policies and procedures for the selection and use of packaging systems should be developed, periodically reviewed, revised as necessary, and readily available in the practice setting where they are used. Policies and procedures assist in the development of patient safety, quality assessment, and performance activities; serve as operational guidelines used to reduce patient risk for injury or complications, standardize practice, direct perioperative personnel, and establish continuous performance improvement programs; and also establish authority, responsibility, and accountability within the practice setting. Policies and procedures regarding the selection and use of packaging systems should be developed. The development of policies and procedures that guide and support patient care, treatment, and services are a regulatory and accrediting agency requirement for hospitals as well as ambulatory care settings. Policies and procedures related to the selection and use of packaging systems should include, but are not limited to, the following parameters: Prepurchase evaluation; Assembly of items within packaging systems; Weight limitations; Product testing; Labeling; Positioning and placement of packages within the sterilizer; Storage requirements before and after sterilization; Shelf life; Use of internal and external sterilization monitors; and Wrapping technique and requirements. 17
Recommendation XII. Perioperative personnel should participate in a variety of quality assurance and performance improvement activities, which are consistent with the health care organization s plan, to improve their understanding of and compliance with the principles and processes related to the selection and use of packaging systems. Quality assurance and performance improvement activities assist in evaluating and improving the quality of packaging items to be sterilized for use in an operative and other invasive procedure. Quality assurance programs provide information that is used to determine whether packaging practices are in compliance with recognized standards and also to identify areas that may require corrective action. The health care organization should establish quality assurance and performance improvement programs to monitor the workplace environment and practices related to the selection and use of packaging systems. Monitoring of the packaging processes provides a mechanism to compare results against a predetermined level of quality. Reviewing the findings provides information for identifying any problems and/or trends that can be used to improve practice. Performance improvement activities related to the selection and use of packaging systems should include monitoring health care workers understanding of the principles and processes of selection and use of packaging systems. Collecting data to monitor and improve patient care, treatment, and services is a regulatory and accrediting agency requirement for both hospitals and ambulatory care settings. Process monitoring for activities related to the selection and use of packaging systems should include monitoring compliance with policies and procedures for the following parameters: Using packaging systems and their IFU appropriately; Verifying the compatibility of packaging systems with sterilization processes used in the facility; Storing packaging materials; Assembling, handling, packaging, and labeling of wrapped, pouched, and containerized items for sterilization; Determining event-related sterility; Product testing; and Investigating wet packs. The quality assurance and performance improvement program for selection and use of packaging systems should include the following parameters: Reviewing and evaluating activities periodically to verify compliance or to identify areas needing improvement; Identifying the corrective actions needed and directed toward priorities in improvement; and Taking additional corrective actions when improvement is either not achieved or sustained. 18
Reviewing and evaluating quality assurance and performance improvement activities assists in identifying failure points that contribute to errors in the use of packaging systems and also helps to define the actions needed for improvement and increased competency. Taking corrective actions may improve patient safety by enhancing personnel understanding of the principles of and compliance with the processes for selecting and using packaging systems. Quality assurance testing of packaging systems and related equipment (eg, heat sealers) should be performed prior to initial use and also periodically, according to the manufacturers written IFU. Because packaging systems and related equipment vary in design, mechanics, and construction, these variables can affect the performance and compatibility of packaging systems with sterilization methods. Perioperative personnel should consult the packaging system manufacturer to determine the areas within the package that present the greatest challenge. Testing and monitoring of heat seal equipment should also be performed according to the manufacturer s IFU. During periodic product quality assurance testing of packaging systems, sterilization efficacy and drying effectiveness should also be evaluated for each sterilizer and cycle used. Health care organizations are responsible for obtaining and maintaining manufacturers documentation of the methodology and performance testing for packaging systems; health care personnel are responsible for ensuring that packaging systems are suitable for the proposed sterilization uses and compatible with the sterilizers existing within the facility. Product testing should be performed whenever there is a major change in packaging systems, eg, a change from using wrapping materials to the use of rigid sterilization containers, or when there are changes to materials, tray configuration, or content density. There are two types of tests that should be performed: biological indicators and CIs/integrators/emulating indicators should be placed inside a set, tray, or pack being tested. After the set is run in a full load, the indicators should be evaluated for pass or fail results. After steam sterilization, the package should be inspected for any moisture on the outside and/or on its contents (ie, a wet pack). Product testing verifies the ability to achieve a sterile, dry package and contents within the health care facility. Any occurrence of a wet pack should be investigated and resolved. Internal or external moisture has the potential to compromise both the integrity of the barrier material as well as the sterility of the contents. Moisture that is present inside a package after steam sterilization is indicative of problems either with the packaging or the sterilization process. 19
Measures to resolve wet packs should include an evaluation of the following parameters: The weight, density, and configuration of the package; The packaging methods and materials used; Load configuration and contents; Placement of the package on the sterilizer cart; Compliance with the manufacturer s recommendations for the use of containers, instruments, and wrappers; Process of removing the load from the sterilizer after sterilization; Conditions (eg, temperature, humidity) and location of airconditioning vents in the cool down area; and Water and steam quality. Evaluation by engineering personnel or the sterilizer manufacturer representative may be needed in the event of sterilizer performance, utility supply, and steam quality issues. Perioperative RNs should participate in ongoing quality assurance and performance improvement activities regarding the selection and use of packaging systems through the following activities: Identification of processes that are important for quality monitoring (eg, weight of containment devices not exceeding 25 pounds); Development of strategies for compliance; Establishment of benchmarks to evaluate quality indicators, Collection of data related to levels of performance and quality indicators; Evaluation of practice based on the cumulative data collected, Implementation of measures and appropriate action to improve compliance; and Assessment of the effectiveness of the actions taken. Participating in ongoing quality assurance and performance improvement activities is a standard of perioperative nursing; it is also a primary responsibility of the RN in the perioperative practice setting. AORN Guideline for Sterilization 24 The AORN Guideline for Sterilization was updated in 2016. These evidence-based recommendations provide guidance for perioperative personnel on sterilizing items to be used in perioperative patient care. The recommendations related to IUSS are outlined below. Please refer to the guideline document for the complete list of recommendations, interpretive statements, and references, including the evidence rating. Recommendation VII. Immediate use steam sterilization (IUSS) should be kept to a minimum; it should only be used only in selected clinical situations and in a controlled manner. Immediate use steam sterilization should only be used when there is insufficient time to process items by the preferred wrapped or container method intended 20
for terminal sterilization; IUSS should not be used as a substitute for sufficient inventory of instruments. Items to be steam sterilized for immediate use should receive the same decontamination processes as outlined in AORN s Guideline for Cleaning and Care of Surgical Instruments. 25 Items should be decontaminated in an area intended, designed, and equipped for decontamination activities. Proper decontamination is essential for removing bioburden and preparing an item for IUSS, as with terminal sterilization. Failures in proper instrument cleaning have led to the transmission of infectious agents. Immediate use steam sterilization should only be performed if all of the following conditions are met: The device manufacturer s written instructions include directions for IUSS. The device manufacturer s written instructions for cleaning, cycle type, temperature settings, exposure times, temperature settings, and drying times (if recommended) are readily available and followed. A containment device that has been validated for IUSS and cleared by the FDA for this purpose is used. Items are placed in a containment device in a manner that permits steam to contact all surfaces of the item. The written instructions for use provided by the containment device manufacturer are followed. Appropriate actions are taken to prevent contamination during transfer to the sterile field. Items that have been subjected to IUSS are used immediately, not stored for later use, and not held from one procedure to another. Packaging and wrapping materials (eg, textiles, paper-plastic pouches, nonwoven wrappers) should not be used in an IUSS cycle, unless both the sterilizer and packaging are specifically intended and labeled for this use. Cycle parameters differ according to sterilizer design. The sterilizer manufacturers written instructions should be followed and reconciled with the packaging and device manufacturers written instructions for sterilization. Every sterilization cycle should be monitored to verify that the parameters required for sterilization have been met. The sterilizer operator should use physical monitors (eg, digital readings, printouts, graphs, gauges) to verify cycle parameters for each load. Physical monitors record cycle parameters (eg, time, temperature) for each cycle and can indicate immediate sterilizer failure. Biological and chemical indicators should be used to monitor the efficacy of the sterilizer and also to assess whether conditions of sterilization have been achieved. While products used to monitor sterilizer efficacy and also achievement of the required parameters vary according to type of cycle or type of sterilizer, monitoring requirements are the same for all types of 21
steam sterilization. (Refer to Recommendation XX in the Guidelines for Perioperative Practice for more detailed recommendations regarding a quality monitoring program and application of monitors.) A class 5 chemical integrating indicator or a class 6 indicator should be used within each tray or sterilization container used for IUSS. Because class 6 indicators are cycle-specific, they should only be used in the specific cycles for which they are labeled. Rigid sterilization containers that are designed and intended for IUSS cycles should be used. Rigid IUSS containers protect items so that the risk of contamination during transport of items to the point of use is reduced; they also facilitate ease of aseptic presentation to the sterile field. After every use, rigid IUSS containers should be cleaned, inspected (eg, checked for wear of gaskets and other critical components), and maintained as specified in the manufacturer s written instructions. Sterilization containers for IUSS should be opened and the contents used immediately. Items processed in IUSS containers should not be stored for later use or held from one procedure to the next. Items processed by IUSS should be distinguished from items that are processed using terminal sterilization. Immediate use steam sterilization should not be used for implantable devices, except in cases of a defined emergency, when no other sterilization option is available. Implantable devices are foreign bodies and thus increase the risk for SSI. Perioperative personnel can minimize the need for IUSS of implantable devices through careful planning, appropriate packaging, and inventory management in collaboration with suppliers. When IUSS of an implantable device is necessary, the cycle selected should be determined by the manufacturer s written instructions for use. A biological indicator and a class 5 chemical integrating indicator should be included and run with the load. If an implant is used before the biological indicator results are known and the biological indicator is later determined to have a positive result, both the surgeon and infection preventionist should be notified as soon as the results are obtained. If the implant is not used, it should not be saved as a sterile item for later use. If, after inspection, the implant is determined to be suitable for future use, resterilization is required. Every implant should be completely traceable to the patient in whom it was implanted. Documentation of IUSS cycle information as well as monitoring results should be maintained in a log (ie, electronic or manual). This documentation serves as a means for tracking items that are processed using IUSS to individual patients and also for quality monitoring. 22