All You Need CE ONLINE to Know About Rigid … · All You Need to Know About Rigid Sterilization Containers ... Infection prevention is a primary goal for all patients undergoing

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All You Need to Know About Rigid Sterilization Containers

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Welcome to

All You Need to Know About Rigid Sterilization Containers

(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 re-read 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.

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Pfiedler Enterprises, 2170 South Parker Road, Suite 125, Denver, CO 80231www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196

http://www.pfiedlerenterprises.com/

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OVERVIEW Preventing infection in the surgical patient is a primary goal for all members of the perioperative team. One key measure for reducing the risk for surgical site infection is to provide surgical instruments and devices that are sterile at the time of use; this requires appropriate packaging of the items for sterilization. This continuing education activity will provide an overview of the clinical considerations related to the use of reusable rigid sterilization containers as packaging for medical devices. It will provide a brief historical review of the evolution of reusable rigid sterilization containers. Current guidelines and professional recommendations related to packaging will be referenced and highlighted. Specifically clinical considerations for the proper use and care of rigid sterilization container systems, including examples of sterilization validation studies, will be discussed. The use of reusable rigid sterilization containers in green initiatives and other benefits will be described.

LEARNER OBJECTIVES After completing this continuing education activity, the participant should be able to:

1. Outline the historical development of reusable rigid sterilization containers. 2. Discuss the regulations, guidelines and recommended practices regarding the

use and care of reusable rigid sterilization containers. 3. Identify key clinical considerations regarding the proper use, care and handling of

reusable rigid sterilization containers. 4. Describe how the use of reusable rigid containers supports green initiatives.

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 current clinical considerations regarding the use of rigid sterilization containers.

CREDIT/CREDIT INFORMATION State Board Approval for Nurses 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.

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.

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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.

RELEASE AND ExPIRATION DATEThis 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.

DISCLAIMERPfiedler Enterprises does not endorse or promote any commercial product that may be discussed in this activity.

SUPPORTFunds to support this activity have been provided by Aesculap, Inc.

AUTHORS/ PLANNING COMMITTEE/REVIEWERJulia A. Kneedler, EdD, RN Denver, COProgram Manager/ReviewerPfiedler Enterprises

Rose Moss, MN, RN, CNOR Westcliffe, CONurse Consultant/Author/Planning CommitteeMoss Enterprises

Judith I. Pfister, MBA, RN Denver, COProgram Manager/Planning CommitteePfiedler Enterprises

Joan M. Spear, RN, MBA, CNOR Westminster, MDGroup Director Clinical Services/ReviewerAesculap, Inc.

Melinda T. Whalen, BSN, RN, CEN Denver, COProgram Manager/ReviewerPfiedler Enterprises

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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

http://pfiedlerenterprises.com/disclosure

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INTRODUCTIONInfection prevention is a primary goal for all patients undergoing surgery; one of the expected outcomes for every surgical patient is that he/she is free from signs and symptoms of infection.1 Today, surgical site infections (SSIs) have become common complications and as a result, represent one of the leading causes of postoperative morbidity and mortality; they are associated with enormous additional costs for hospitals and healthcare systems.2 Therefore, a major responsibility of the all members of the perioperative team is to minimize the patient’s risk for the development of a surgical site infection. One key measure in reducing the risk for SSI is to provide surgical items that are free of contamination at the time of use.3 In this regard, it is essential that packaging systems used for items to be sterilized provide an adequate barrier to microorganisms, particulates, and fluids; ensure the integrity of the sterilized contents until opened for use; and permit aseptic delivery of the contents to the sterile field.4

The selection and use of the most appropriate sterilization packaging in any healthcare facility today are challenging responsibilities for everyone involved, as they impact not only surgical instrumentation and medical devices, but also infection prevention practices, patient safety, and the facility’s bottom line. Sterilization packaging systems that are of high quality and performance facilitate achieving the goal of infection prevention in the surgical patient. One type of packaging is a reusable rigid sterilization container system. Sterilization container systems have been on the market for more than 30 years and vary in their design, mechanics and construction materials. Today, these container systems and accessories are packaging options designed to provide a more efficient organization and utilization of surgical instruments. While reusable rigid sterilization containers offer some distinct advantages over the other packing options (ie, wrap and peel pouches), they also require some special care and handling.

This presentation focuses on reusable rigid container systems designed to provide packaging for a variety of medical devices. An external wrap or covering is not required for this type of packing and a variety of organizers may be used within the device.

HISTORICAL REVIEW OF REUSABLE RIGID STERILIZATION CONTAINERSThe story on rigid containers begins with a review of their historical evolution. The first rigid container was produced in the 1890s. Dr. Curt Schimmelbusch was credited for the design of a system of boxes for use in sterilization. These boxes were constructed with lateral openings to allow the admission of steam (see Figure 1). The external diameter of the boxes was slightly smaller than the internal diameter of the sterilizing chamber; their height was also adjusted so that two of them would fill the sterilizer chamber to the top. These boxes consisted of a short metal cylinder, with solid bottom and a hinged metal cover; at that time, the cover was supplied with a hasp and padlock to prevent unauthorized entry into the container. The principal feature of the box was that it consisted of one or two lines of lateral perforations on the sides, which may be closed by sliding metal bands, which also had perforations that corresponded precisely in size and location with those in the box. These bands were arranged with a stop, so that by

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sliding the band to one side or the other, the openings in the two parts were matched or mismatched, as desired. When matched, the steam was freely admitted to the interior of the box; when mismatched, all openings were closed, which protected the condition of the box and its contents; if undisturbed, it could be kept in an aseptic condition for a considerable length of time. After sterilization, the boxes could be removed, closed and then stored or transported to the sterile field. For transportation, leather covers were provided so that there was no danger of contamination or infection while en route.5

Figure 1 – Dr. Curt Schimmelbusch’s Rigid Container Design: 1890s

INTRODUCTION Infection prevention is a primary goal for all patients undergoing surgery; one of the expected outcomes for every surgical patient is that he/she is free from signs and symptoms of infection.1 Today, surgical site infections (SSIs) have become common complications and as a result, represent one of the leading causes of postoperative morbidity and mortality; they are associated with enormous additional costs for hospitals and healthcare systems.2 Therefore, a major responsibility of the all members of the perioperative team is to minimize the patient’s risk for the development of a surgical site infection. One key measure in reducing the risk for SSI is to provide surgical items that are free of contamination at the time of use.3 In this regard, it is essential that packaging systems used for items to be sterilized provide an adequate barrier to microorganisms, particulates, and fluids; ensure the integrity of the sterilized contents until opened for use; and permit aseptic delivery of the contents to the sterile field.4 The selection and use of the most appropriate sterilization packaging in any healthcare facility today are challenging responsibilities for everyone involved, as they impact not only surgical instrumentation and medical devices, but also infection prevention practices, patient safety, and the facility’s bottom line. Sterilization packaging systems that are of high quality and performance facilitate achieving the goal of infection prevention in the surgical patient. One type of packaging is a reusable rigid sterilization container system. Sterilization container systems have been on the market for more than 30 years and vary in their design, mechanics and construction materials. Today, these container systems and accessories are packaging options designed to provide a more efficient organization and utilization of surgical instruments. While reusable rigid sterilization containers offer some distinct advantages over the other packing options (ie, wrap and peel pouches), they also require some special care and handling. The story on rigid containers begins with a review of their historical evolution. This presentation focuses on reusable rigid container systems designed to provide packaging for a variety of medical devices. An external wrap or covering is not required for this type of packing and a variety of organizers may be used within the device. HISTORICAL REVIEW OF REUSABLE RIGID STERILIZATION CONTAINERS The first rigid container was produced in the 1890s. Dr. Curt Schimmelbusch was credited for the design of a system of boxes for use in sterilization. These boxes were constructed with lateral openings to allow the admission of steam (see Figure 1). The external diameter of the boxes was slightly smaller than the internal diameter of the sterilizing chamber; their height was also adjusted so that two of them would fill the sterilizer chamber to the top. These boxes consisted of a short metal cylinder, with solid bottom and a hinged metal cover; at that time, the cover was supplied with a hasp and padlock to prevent unauthorized entry into the container. The principal feature of the box was that it consisted of one or two lines of lateral perforations on the sides, which may be closed by sliding metal bands, which also had perforations that corresponded precisely in size and location with those in the box. These bands were arranged with a stop, so that by sliding the band to one side or the other, the openings in the two parts were matched or mismatch, as desired. When matched, the steam was freely admitted to the interior of the box; when mismatched, all openings were closed, which protected the condition of the box and its contents; if undisturbed, it could be kept in an aseptic condition for a considerable length of time. After sterilization, the boxes could be removed, closed and then stored or transported to the sterile field. For transportation, leather covers were provided so that there was no danger of contamination or infection while en route.5 Figure 1 – Dr. Curt Schimmelbusch’s Rigid Container Design: 1890s

Figure 2 – Chrome-Plated Rigid Containers: 1900s.

In the early 1900’s, chrome-plated containers were manufactured (see Figure 2); these containers were primarily used by the military.

By the 1930’s, textile filters were added to rigid containers, followed by rubber seals and a change to the use of stainless steel in their manufacture (see figure 3).

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Figure 3 – Stainless Steel Rigid Container with Textiles and Rubber Seals: 1930s

Figure 2 – Chrome-Plated Rigid Containers: 1900s, the name “chrome-Plated Rigid containers should be repeated in the text following the picture or the text should appear beside the picture to assure clarity. In the early 1900’s, chrome-plated containers were manufactured (see Figure2); these containers were primarily used by the military.

Figure 3 – Stainless Steel Rigid Container with Textiles and Rubber Seals: 1930s By the 1930’s, textile filters were added to rigid containers, followed by rubber seals and a change to the use of stainless steel in their manufacture (see figure 3).

Since the 1960s, aluminum has been used in the manufacture of rigid containers; many of these containers use disposable filters (see Figure 4). Aluminum, a low weight but strong material, has several other characteristics that make it a good choice for construction of rigid sterilization container systems, such as:

Good drying properties; A long service life; Safe when combined with other metals; Impact-resistant; and Scratch-resistant.

Figure 4 – Aluminum Rigid Container with Disposable Filter


• Good drying properties;• A long service life;• Safe when combined with other metals;• Impact-resistant; and• Scratch-resistant.


Figure 2 – Chrome-Plated Rigid Containers: 1900s, the name “chrome-Plated Rigid containers should be repeated in the text following the picture or the text should appear beside the picture to assure clarity. In the early 1900’s, chrome-plated containers were manufactured (see Figure2); these containers were primarily used by the military.

Figure 3 – Stainless Steel Rigid Container with Textiles and Rubber Seals: 1930s By the 1930’s, textile filters were added to rigid containers, followed by rubber seals and a change to the use of stainless steel in their manufacture (see figure 3).


Good drying properties; A long service life; Safe when combined with other metals; Impact-resistant; and Scratch-resistant.


Around 1970, better hygienic standards prompted the development of a new method

of sterile supply – the set system, in which all instruments for one procedure were assembled and prepared as one set and in one sterile container. The first container set system (see Figure 5) was introduced in the U.S. at the 1980 Association of periOperative Registered Nurses’ (AORN’s) annual Congress.

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Figure 5 – First Container Set System Introduced in the US by Aesculap: 1980

Rigid reusable sterile container systems are used for the packaging, transportation, and storage of instruments prior to during, and after sterilization. These container systems consist of a broad line of products including lids and bottoms in various sizes, with assorted accessories such as baskets, filters, clamps, organization tools, containment devices, and tamper evident locks. Many medical devices may be sterilized using this packaging. Users must consult rigid reusable sterile container system manufacturer information and the device manufacturer information to determine devices to place in the container systems and the appropriate sterilization modality to be used.

REGULATIONS AND GUIDELINES FOR SELECTION, USE AND CARE OF RIGID STERILIZATION CONTAINER SYSTEMSUS FDAThe FDA has been regulating medical devices since 1976, at which time the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act established three regulatory classes for medical devices. These three classes are based on the degree of control necessary to assure that the various types of devices are safe and effective, as outlined below6:

• Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices; approximately 47% of medical devices fall in this category. Class I devices are subject to “general controls”, including labeling and current good manufacturing processes.

• Class II – 43% of medical devices are considered Class II devices. These devices are considered to pose potential risks requiring “special controls,” including 501(k)

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notification. That is, Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify the FDA of their intent to market a medical device; this is known as Premarket Notification (PMN) or 510(k). Under 510(k), before any manufacturer can market a medical device in the United States, it must demonstrate to FDA’s satisfaction that the device is substantially equivalent (ie, as safe and effective) to a device that is already on the market. If FDA rules the device is “substantially equivalent,” the manufacturer can then market the device.

• Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury and are the most highly regulated. Examples of Class III devices include implantable pacemakers and breast implants; 10% of medical devices fall under this category.

The U.S. FDA regulates all sterilization packaging systems (including wraps, pouches, trays, cassettes, and rigid containers) used by healthcare facilities to package and sterilize surgical instruments, medical devices, and equipment; since 1976, these must be cleared by the FDA for their intended use. Reusable rigid sterilization container systems are classified as Class II medical devices and require a Premarket Notification 510(k) Submission to the FDA for their intended use to be legally marketed. The submission must include a completed application, extensive data, documentation of testing and validation studies, special labeling, intended use, and instructions for use.

Both AORN (Association of PeriOperative Registered Nurses) and AAMI (Association for Advancement of Medical Instrumentation) provide guidance for users regarding selection and use of reusable rigid sterilization containers. These two standard setting groups work closely to assure recommendations are harmonized.

AORN Guideline for Selection and Use of Packaging Systems for Sterilization7

AORN Guideline for Selection and Use of Packaging Systems for Sterilization provides guidelines for the evaluation, selection, and use of packaging systems, including rigid sterilization containers, for items to be sterilized. Packaging systems should ensure the integrity of the sterilized contents until opened for use and should permit aseptic delivery of the contents to the sterile field. Recommendation I and VIII outlined below specifically address reusable rigid containers.

• “Recommendation I – Packaging systems and packaging materials should be considered before purchase and use.”

◦ Purchasers should verify that the containment device has been tested and validated for the sterilization method and cycles to be used. Purchasers should request, review, and be familiar with the manufacturer’s sterilization validation studies.

◦ Pre-purchase evaluation and biological testing of the containment device should be performed.

▪ Pre-purchase evaluation should determine:• Whether the facility can verify the manufacturer’s test

results;

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• If the container device has been cleared by the US FDA for use in a sterilization process;

• If the container device is compatible with the design of the sterilizer(s) in which it will be used;

• If the container device will allow complete air removal, adequate sterilant penetration, and drying; and

• The requirements for disassembly and cleaning. ▪ Pre-purchase biological testing should be performed according

to the AAMI standards. Each size container should be tested under the sterilization methods and cycles to be used.

▪ Sealed flash sterilization containers should be biologically tested during the pre-purchase evaluation and routinely thereafter. The container manufacturer should provide technical data regarding the best method for biologically testing the container.

• “Recommendation VIII – A rigid container should be used, cleaned, inspected, repaired and maintained according to the manfucatured written instructions for use (IFU).”

◦ The recommended sterilization method and cycle exposure times for each rigid container system should be provided in the manufacturers’ data and instructions. Construction materials and container design may affect compatibility with the sterilization process (eg, penetration of sterilant [gas plasma], release of moisture or sterilant [EO]). Recommendations related to the type of sterilization method vary by the container manufacturer. Prevacuum sterilizers may be preferred because air removal is difficult in gravity displacement sterilizers.

◦ Rigid containers with single-use or reusable filters and valve systems should be secured and in proper working order before sterilization.

▪ Filter plates should be examined for integrity both before installation and after the sterilization process. If the filter is damp; dislodged; or has holes, tears, or punctures, the contents should be considered unsterile.

▪ Only components of the rigid container system specified by the manufacturer and compatible with the system should be used.

▪ The integrity of the rigid container should be inspected and damaged items repaired or replaced after each use. Inspection should ensure that:

• Sealing and mating surfaces and edges of the container and lid are free of dents or chips;

• Filter retention mechanisms and fasteners (eg, screws, rivets) are secure and not distorted or burred;

• Securing mechanisms are functioning;• Integrity of the filter media is not compromised;

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• Gaskets are pliable, securely fastened, and without breaks or cuts; and

• Valves work freely. Loosened rivets, improperly maintained valves, worn gaskets, dents, or other

damage compromises the integrity of the container and will compromise the sterilization process.

◦ Rigid container systems should be cleaned after each use. All components (eg, filter retention plates) should be disassembled for proper cleaning.

◦ The manufacturer’s written instructions for cleaning, inspection, repair, and preventive maintenance should be followed.

◦ The manufacturer’s written instructions for loading rigid containers should be followed. Instructions should include instrument set configuration requirements.

◦ The manufacturer’s instructions for recommended filter material, security locks, and external chemical indicators should be followed.

◦ Additional materials placed inside rigid containers (eg, silicone mats, surgical towels) should not be used unless the container manufacturer has provided validation for their use.

◦ The manufacturer’s technical data for types of devices validated for use inside the container, such as power equipment or items with lumens, should be obtained and special instructions for sterilization followed.

AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities8

This guide provides direction for Sterile Processing of reusable medical devices in healthcare facilities on all aspects of practice and includes guidance for using reusable rigid sterilization container systems. Guidance is provided for; receiving; handling, collection, and transport of contaminated items, cleaning and other decontamination processes, packaging, preparation, and sterilization, quality control, and quality process improvement are all sections that provide guidance on the use of reusable rigid sterilization container systems. In addition, Annex I focuses on the evaluation and selection of reusable rigid sterilization container systems.

Section 5 Receiving9

Sterility assurance begins at the loading dock and all rigid container systems should be thoroughly inspected for the following at the time of acceptance by the user:

• All gaskets should be free of breaks, cracks, or cuts. Each gasket should be properly secured and should mate evenly at joining surfaces.

• All filter material should completely cover the perforated area, and the device holding the filter in place should provide a tight, uniform seal that keeps the filter from dislodging.

• The latching mechanism should secure the lid so that it cannot move when locked.

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• A method of demonstrating that the latching mechanism has not been opened after sterilization and before use is preferred.

• Mechanical valves should function properly; they should move freely with no sign of damage.

• Rivets and screws should be secure and show no evidence of damage or corrosion.

Section 8 Packaging, Preparation, and Sterilization10

• Reusable rigid container systems are a form of packaging. Requirements for effective packaging material for steam sterilization should:

◦ Allow adequate air removal from and steam penetration of the package contents;

◦ Provide a barrier to microorganisms or their vehicles; ◦ Resist tearing or puncture; ◦ Allow a method of sealing that results in a complete seal that is tamper-

evident and provides seal integrity; ◦ Allow for ease of aseptic presentation; ◦ Be free of toxic ingredients and nonfast dyes; ◦ Be non-linting; and ◦ Be shown by value analysis to be cost-effective.

• Before use, packaging materials should be held at room temperature (68-73°F) and at a relative humidity ranging from 30% to 60% for a minimum of 2 hours. (Temperature and humidity equilibration of packaging material and product is needed to permit adequate steam penetration and to avoid superheating during sterilization.)

• Package labels (eg, process indicators, labels for product identification and lot number, expiration statement labels) should be capable of remaining securely affixed to packages throughout the course of their handling from sterilization to use.

• The latching mechanism on rigid sterilization container systems should secure the lid so that it cannot move when locked.

• The weight of an instrument set should be based on whether personnel can use proper body mechanics in carrying the set, on the design and density of the individual instruments comprising the set, on the recommendations of the medical device and sterilizer manufacturers, and on the distribution of mass (the density) in the set and sterilizer load. Instrument sets should be prepared in trays large enough to equally distribute the mass; set configuration should be evaluated to help ensure dry sets.

• Drying should be evaluated by controlled, random sampling and opening selected sets at the completion of the drying/cooling time.

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• Instrument placement. ◦ Instruments to be sterilized should be arranged according to the

following guidelines; ▪ If a rigid sterilization container system is used, the basket(s)

placed in the container should be large enough to allow the metal mass of instruments and devices to be distributed equally in the basket(s) (the use of nonabsorbent tray liners can cause condensate to pool).

▪ Instruments should be positioned to allow the sterilant to come into contact with all surfaces.

▪ Small, basket-type accessory containers with covers or lids, protective organizing baskets, trays or cases should be placed into rigid sterilization container systems only if the container systems have been specifically designed and tested for this purpose. Collaborative testing should be performed by the device manufacturer, the manufacturer of the protective organizing case, and the container system manufacturer. The user has the responsibility to test and evaluate the effectiveness of sterilization and drying of protective organizing cases during the specific sterilizer cycles to be used for sterilization processing. Before preparation and sterilization of multipart sets or complex instruments, processing personnel should review the specific written instructions that apply.

▪ When rigid sterilization container systems are used, all items should be contained in the basket or tray within the container system.

◦ Use of tray liners or containment devices. ◦ The judicious use of tray liners or other absorbent material can alleviate

drying problems. Absorbent inner wraps can also assist in the aseptic presentation of instruments. Containment devices such as organizing trays can help keep items in place but should ensure adequate sterilant contact. The recommendations of the packaging manufacturer concerning the use of containment devices or inner absorbent material should be consulted, and the user should evaluate the effectiveness of the sterilization and drying process when such devices or materials are used.

• Rigid container systems can be sterilized safely and economically in the same load as other supplies that require a common exposure cycle. Container systems should be placed on shelves below absorbent items, as should other metal items. Before stacking container systems for sterilization, the user should consult the manufacturer’s recommendations and documentation. The user should also conduct verification testing in the sterilizer to be used.

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• Sterilization parameters for wrapped or containerized items. ◦ Tables in ST79 describe the most common temperature and time

parameters for various types of loads. ◦ Any differences between the programmed cycle parameters and the

cycle parameters recommended by the medical device manufacturer should be investigated and resolved before the items are sterilized.

• Storage facilities. ◦ Sterile items should be stored in a manner that reduces the potential for

contamination. In general, the temperature in storage areas should be approximately 75°F. There should be at least 4 air exchanges per hour, and relative humidity should be controlled so that it does not exceed 70%. Traffic should be controlled to limit access to sterile items to those individuals who know how to handle them properly. Sterile items should be stored far enough away from the floor, the ceiling, and outside walls to allow for adequate air circulation, ease of cleaning, and compliance with local fire codes. Sterile items should be stored at least 8-10 inches above the floor, at least 18 inches below the ceiling or the level of the sprinkler heads, and at least 2 inches from outside walls. Medical and surgical items, including those packaged in rigid sterilization container systems, should not be stored next to or under sinks, under exposed water or sewer pipes, or in any location where they could become wet.

◦ When stacking container systems, the user should take care to ensure that they are firmly seated one upon another and that they can be removed easily.

• Shelf life. ◦ The shelf life of a packaged sterile item is event-related and depends

on the quality of the packaging material, the storage conditions, the conditions during transport, and the amount of handling. Shelf life is not simply a matter of sterility maintenance but is also a function of device degradation and inventory control.

• Handling and inspection. ◦ Care should be taken to avoid dragging, sliding, crushing, bending,

compressing, or puncturing the packaging or otherwise compromising the sterility of the contents.

• Opening sterile packages. ◦ Before it is opened, the package should be inspected for the appropriate

appearance of the external CI(s) and the physical integrity of the packaging. If the packaging is a rigid sterilization container system, the external latch filters, valves, and tamper-evident devices should be inspected for integrity.

◦ Rigid sterilization container systems should be opened by disengaging the tamper-evident device in accordance with the manufacturer’s written

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instructions. The external lid latches should be positioned as far away from the container system rim (seal) as possible. The manufacturer’s recommendations for lid removal should be followed, and care should be taken to ensure that there is no contact between the lid and the inner rim, the sterile contents, or any part of the inside of the container system. The lid should be inspected for the integrity of the filter or valve and the gasket.

◦ For all packaging, the internal CI should be checked to confirm the appropriate endpoint response.

• Removing items from sterile packaging and transferring them to the sterile field. ◦ Before removing the sterile contents, the surgically attired scrub person

should check the internal CI for the appropriate endpoint response. ◦ Avoiding all contact with the table or external surfaces of the packaging,

the scrub person should remove the contents of the package. If the packaging is a rigid sterilization container system, the scrub person should grasp the inner basket handles with both hands and lift the basket well above the container bottom, avoiding all contact with the upper rim of the container. (If multiple instrument baskets are stacked inside a container system, they should be removed individually to the sterile field).

◦ Before the package contents are placed on the sterile field, the bottom of the wrapper or container system should be inspected visually for integrity and moisture.

◦ For container systems, the circulator should inspect the integrity and proper alignment of the plate and filter or valve in accordance with the manufacturer’s written instructions.

Section 10 Quality Control11

• Lot control numbers. ◦ Each item or package intended for use as a sterile product should

be labeled with a lot control identifier. The lot control identifier should designate the sterilizer identification number or code, the date of sterilization, and the cycle number (cycle run of the sterilizer).

• Internal chemical indicators. ◦ An internal CI should be used within each package, tray, or rigid

sterilization container system to be sterilizes. ◦ The CI should be placed in the area of the package, tray, or containment

device (rigid sterilization container system, instrument case, cassette, or organizing tray) considered least accessible to steam penetration; for a containment device, the manufacturer’s written instructions for placement of the CI should be consulted. This location might or might not be the center of the package, tray, or containment device.

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◦ If the interpretation of the CI suggests inadequate steam processing, the contents of the package should not be used.

• Periodic product quality assurance testing of routinely processed items. ◦ Quality assurance testing or routinely processed items representing a

product family should be performed on an ongoing basis. A program should be established to periodically test routinely sterilized products. Before newly purchased or loaner sets are placed into routine use, they should be evaluated to determine if the existing product testing is applicable to these sets. If the existing product testing is applicable, then the sterilization cycle used for the applicable product family should be used for the new or loaner set. If the existing product testing is not applicable to these sets, then product testing should be performed before they are placed into routine use. Whenever changes are made in a product family’s composition, designated master product, or written sterilization instructions, then product testing should be repeated. Product testing should always be performed when major changes are made in packaging, wraps, or load configuration, such as dimensional changes, weight changes, or changes in the type of material of packaging or wrapper. The test program should include both BI and CI testing and an evaluation of post-sterilization moisture content (ie, the occurrence of “wet packs”).

▪ Note-the following product characteristics should be considered when evaluating new or loaner sets to determine whether they belong to an existing product family: design configuration, number of components, materials of construction, size and/or surface area, need for disassembly, surface finish or texture, the presence of cannulations, lumens or mated surfaces, and the written reprocessing instructions provided by the manufacturer. If the new or loaner set does not fit within an existing product family, then a new product family should be established, with the new or loaner set becoming the master product for that family. Medical device manufacturers can assist in the identification of the product family and master product.

◦ Biological indicators should be placed within the product test samples. ▪ For an instrument set, the BI’s and CI’s should be placed at

each end of the tray and among the instruments that are placed on stringers.

▪ For containment devices, the BIs and CIs should be placed in the areas recommended by the containment device manufacturer.

▪ For multilayered instrument sets in containment devices, the BIs and CIs should be placed in the locations determined by the product manufacturer to create the greatest challenge to the sterilization process. It might be necessary to use BIs

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contained in glassine envelopes rather than BIs in ampules if test areas cannot accommodate BI ampules (eg, inside multilayered trays with sliding lids).

• Periodic product quality assurance testing of rigid sterilization container systems. ◦ Rigid sterilization container systems vary widely in design, mechanics,

and materials of construction. Work practices, sterilizer performance characteristics, and the function of the healthcare facility utilities supplying the sterilizer can also affect the dynamics of the sterilization process. These factors can markedly affect the specific performance characteristics of rigid sterilization container systems and their suitability for particular sterilization methods and cycles.

◦ Sterilization. ▪ Documentation of the manufacturer’s test methodology and

results should include information verifying that the sterilization efficacy of the rigid sterilization container system has been qualified in standard hospital sterilization cycles. At least the following information should be made available to the user: The types of cycles;

• The types, sizes, and placement of filters or valve assemblies in the container system;

• The types, placement, and rationale for the use of any inner wrapping or absorbent materials included in the contents that could affect sterilization and if applicable, drying;

• The types, number, placement sites, and performance characteristics of the BIs and, if applicable, CIs used for validation of cycle processing;

• The sterilizer load configuration, including the recommended container stacking pattern if stacking has been validated; and

• Rationale for the recommended sterilization exposure time.

◦ Drying. ▪ Documentation of the test methodology and results should

include at least the following information:• The time of the drying phase;• The factors that can influence the drying time of

the container system and its contents, such as the following;

◦ The materials of construction of the container system;

◦ The size and contents of the container system; ◦ The number of container systems in the load;

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◦ The temperature of the container system and contents at the beginning of each test;

◦ Whether the load was preheated and to what temperature;

◦ The environmental conditions (temperature, relative humidity, air exchange rate) of the cool-down area; and

◦ The use of any inner wrapping or absorbent materials within the contents.

◦ Sterility maintenance. ▪ Maintenance of sterility is event-related, and the probability

of occurrence of a contaminating event increases over time and with handling, whether woven or nonwoven materials, pouches, or rigid sterilization container systems are used as the packaging method. Manufacturers of rigid sterilization container systems should provide test data that support the ability of the correctly assembled system to inhibit microbial migration.

◦ User responsibilities. ▪ Healthcare personnel bear the ultimate responsibility for

ensuring that any packaging method or material, including a rigid sterilization container system, is suitable for use in sterilization processing and sterility maintenance. Before purchasing any packaging system, the user should gather information and perform testing to ensure that items to be packaged can be sterilized by the specific sterilizers and/ or sterilization methods to be used within the facility. The interaction of container system, medical device, and sterilizer technologies is complex. A container system to be used for steam sterilization needs to allow complete air removal, adequate steam penetration, and drying.

▪ The specific design of the rigid sterilization container system needs to be compatible with the design and performance characteristics of the sterilizer(s) in which it is used. Prepurchase evaluation assures that the particular container system being considered will be acceptable to all prospective users in the facility and that it will perform properly in the healthcare facility’s sterilizing equipment.

◦ Prepurchase evaluation. ▪ Users should conduct a prepurchase product evaluation of any

rigid sterilization container system being considered for use in sterilization processing. Before a rigid sterilization container system is purchased, users should determine whether the healthcare facility can verify the manufacturer’s test results.

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Annex I in the latest version of the AAMI guideline states that the decision to evaluate the use of reusable rigid sterilization container systems should be followed by the development of a specific protocol or plan by the healthcare facility. Answering the Annex I lists the following questions to assist the facility in the development of an evaluation protocol12:

• What are the reasons for considering reusable rigid sterilization container systems? Can these reasons be quantified?

• How much time will be necessary to evaluate each container system?• Who will be involved in the evaluation process? Infection prevention and control,

operating room, central processing, other user departments, purchasing? (Generally, it will be appropriate to include all departments that would be handling or using the product.)

• What are the comparative costs of all the packaging methods under consideration (disposable wrapping material, reusable wrapping material, container systems)? How does the current cost-benefit ratio compare with the projected cost-benefit ratio of a new system?

• If one type of container system currently is in use, what will be the impact of a second type of container system (ie, one of different manufacture)?

• What key points will be critical in the evaluation?• How many of each type of container system will be needed for the evaluation?• What information will be needed from whom to prepare the assessment?

The evaluation protocol should include specific questionnaires concerning product needs or problems in each use and handling area. In addition, a detailed plan in regards to the actual evaluation process in each area of use or handling should be included. AAMI outlines the following questions and statements that personnel might use as guidelines when developing a healthcare facility’s prepurchase evaluation protocol for reusable rigid sterilization container systems.

• General Considerations. ◦ Has the container system been FDA-cleared for use in a sterilization

process? ◦ Have the scientific data to support label claims (eg, specific sterilization

methods and cycle parameters) been provided by the container system manufacturer?

◦ Was the testing performed with biological spore strips or inoculated devices?

◦ Does the documentation address sufficiently all performance elements in sterilization (via steam or EO, including aeration), drying, and sterility maintenance?

◦ Was the testing representative of the types of items that will be sterilized routinely?

◦ Is the container system suitable for use in the steam sterilizers available in the healthcare facility (gravity-displacement, prevacuum, steam-flush pressure-pulse)?

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◦ Have complete written instructions been provided? Are they illustrated and easy to follow?

◦ Will knowledgeable and qualified assistance (technical support) be readily available during the evaluation process; for employee education; during implementation; and for follow-up, troubleshooting, and problem solving? What is the scope of service after the sale?

◦ Are container systems available in appropriate sizes for the items to be sterilized? Is it important that one container system meet everyone’s needs? (Be certain that the container systems are acceptable to all users.)

◦ What is the estimated or expected life of the container system and its parts? What kinds of warranties, preventive maintenance assistance, replacement parts, and refurbishment services are available from the manufacturer?

◦ Is the total system cost-effective for the healthcare facility?

• Instruments and Devices to be Containerized. ◦ Will all surgical instruments and equipment be containerized or only

delicate instruments (eg, microsurgical or plastic instruments) or certain specialty items (eg, powered instruments, orthopedic instruments, cardiac instruments, neurosurgical instruments)?

◦ Will holders, clips, or other retaining or protective devices be needed to customize trays for specialty instruments?

◦ Will all the instruments being used in one room be prepared in container systems?

◦ Will emergency room, obstetrical, ambulatory surgery, respiratory therapy, or radiology instrumentation be containerized?

◦ What is the maximum number of instrument sets arriving from the operating room or other user departments within 30 minutes?

◦ Will container systems be used as procedural trays (eg, for cut-down, lumbar puncture, chest tube insertion, or cardiac catheter procedures)? That is, can the inner container be used as a sterile field?

◦ Will instruments be organized into standard sets that travel through the system as complete units with their assigned containers?

• Cleaning and Decontamination Considerations. ◦ Can the container system be disassembled easily for cleaning? Will any

parts interfere with adequate cleaning? ◦ Can the container system, interior baskets, and accessories be

processed manually or in a cart washer, washer-decontaminator, or washer-sterilizer?

◦ Will the design of the container system, baskets, or accessories create a barrier to effective cleaning by any of these methods when the generic recommendations for cycle times are used?

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◦ Will it be necessary to change the detergents or disinfectants that are used currently in order to avoid harming the container system? Is special handling necessary?

◦ Is there adequate workspace in decontamination areas to break down and queue container systems for processing?

◦ Will the addition of container systems have an impact on the decontamination workload? Are there sufficient processing equipment, utilization time, and personnel available to accommodate an additional workload using manual or mechanical cleaning or decontamination methods?

◦ Is the processing equipment adequate to handle the container systems? ◦ Will special holders for container systems be required? Is there

adequate equipment cycle time for processing the container systems? ◦ Can the container system be used to confine and transport

contaminated items?

• Preparation and Assembly Considerations. ◦ Is the container system easy to assemble? Are the lid and bottom

interchangeable or easily identifiable? Are the top and bottom filter-retaining plates interchangeable or easily identifiable for proper placement? Are parts interchangeable among the various sizes of container systems?

◦ Can damage to parts such as gaskets, sealing edges, filter-retention plates, filter-holding rings, valves, and locking mechanisms be recognized easily?

◦ Are accessories available to organize and secure instruments in the proper position for sterilization and for the protection of the instruments? Has testing been performed to assure that these accessories will not impede contact with the sterilant?

◦ Is there a maximum weight recommended by the manufacturer, with supporting documentation, for the amount of instrumentation that can be placed into a container system for sterilization and drying or aeration? Does the recommended weight refer only to the instruments or to the combined weight of the instruments and the container system? Does the recommended weight relate to sterilization and drying, personnel safety when lifting, or both?

◦ Are there any special instructions regarding the distribution of dense masses of metal (eg, orthopedic instruments) when assembling the instrument set in the basket?

◦ Can instrument trays or baskets other than those designed for the container system be used if they fit the container system? What is the impact on sterilization and drying?

◦ Can specialty instrument organizing or protecting trays (eg, orthopedic implant sets) be used with the container system if they fit? What is the impact on sterilization and drying?

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◦ What is the manufacturer’s advice concerning the use of absorbent material (eg, surgical towels) within the set to facilitate drying? If the use of absorbent material is recommended, where should it be placed (eg, in the basket, in the tray, in the bottom of the container system)?

◦ Are there any special recommendations regarding the placement of internal CIs and BIs?

◦ Can the container system be easily closed, secured, and labeled? ◦ Do the external label and CI meet the requirements established within

the healthcare facility?

• Matching the Rigid Sterilization Container System and Sterilization Cycle. ◦ What sterilization processes are compatible with the container system?

Are there any special considerations for each process? ◦ Has the compatibility of the container system been tested with BIs in

each type of sterilizer in the facility and in each appropriate sterilization cycle?

• Loading the Sterilizer. ◦ Can the container systems be positioned flat on sterilizer loading

shelves without touching chamber walls? ◦ Does the size of the container system optimize the available shelf space

on the sterilizer loading cart? ◦ Will the placement allow personnel to use good body mechanics when

loading and unloading the container systems from the cart? ◦ Are there any special considerations related to dedicated loads, mixed

loads, the positioning of container systems on shelves, or other aspects of sterilizer loading? For example, will a mixed load tend to produce wet packs or other drying difficulties?

◦ In general, are there a maximum number of container systems per usable sterilizer volume or load? Is there a maximum weight per load?

◦ Does the manufacturer recommend the use of absorbent sterilizer shelf covers to facilitate drying? Are there liner materials that are contraindicated?

◦ Can the container systems be stacked? If so, in which type of sterilization process (gravity-displacement steam sterilization, dynamic-air-removal steam sterilization)? In what configuration (“one over one” or “offset, straddling two”)? How many can be stacked? Can two different types of container systems be stacked?

◦ Has product testing demonstrated effective sterilization and drying or aeration when container systems are stacked? Were the items used in the testing representative of the items that will be processed in the container system?

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• Choosing the Appropriate Exposure and Drying Times. ◦ Can routine sterilization cycles recommended for wrapped packs by the

sterilizer manufacturer be used? ◦ Does the container system manufacturer provide a method of testing the

efficacy of the sterilizer in which the container systems will be processed? ◦ According to the container system manufacturer’s studies, is it necessary

to extend exposure or drying time to accomplish sterilization and drying? Is documentation available of the testing done to determine appropriate parameters? Has the documentation been reviewed?

◦ To produce a dry set at the end of the cycle, is it recommended or necessary that the load be preheated before the cycle is initiated? Is it recommended or necessary that the load be dried by leaving the container systems in the sterilizer chamber for a specified period of time before they are unloaded? Are test data available?

◦ Does the manufacturer provide a method of determining and verifying the effectiveness of the drying process?

◦ Has the compatibility of the container system with the chosen sterilization process and cycle been verified by testing at the healthcare facility?

• Unloading the Sterilizer and Cooling the Load. ◦ Are there any special instructions regarding how soon container systems

can be touched once the cycle has been completed or the loading cart has been removed from the sterilizer? How should the container systems be handled?

◦ What are the manufacturer’s recommendations for cool-down? Do the recommendations pertain to personnel safety (ie, the avoidance of thermal burns from touching metal that is too hot), condensation, or both? Are there recommendations regarding the environment in which a container system should be cooled?

• Sterility Maintenance. ◦ Can the manufacturer produce test data that support the effectiveness

of the container system as a microbial barrier? Do the test results demonstrate satisfactorily the container system’s ability to prevent contamination during normal handling and storage? Do the test methods used by the manufacturer simulate the environment and activities within the healthcare facility?

◦ What are the potential causes of barrier failure (eg, slipped filter, failure of the gasket to seal, failure of the locking mechanism, loosened screws or rivets)? Has the manufacturer provided inspection criteria to ensure that the container system is functioning effectively?

◦ Is moisture within the container system after sterilization considered a potential source of contamination? Or is the set to be considered sterile? Are data and documentation available to support the claim?

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• Sterile Storage. ◦ Are there any special requirements for the storage area? ◦ Are special storage systems necessary? Are special carts or racks

available for storage of sterilized container systems? Will they minimize handling?

◦ Will existing storage shelving and space in all areas of use or handling accommodate the container systems?

◦ Will the added weight of the container systems require reinforcement of the existing storage system?

◦ Can personnel easily place the container systems into storage units and remove them using good body mechanics and infection prevention and control practices? Can the container systems be stacked? Are there any limitations?

◦ Will the container systems fit into case carts?

• Transportation. ◦ Are there any special recommendations or requirements for handling

transportation? ◦ Are special transportation carts or other vehicles necessary for on-site

or off-site delivery? ◦ Would the vehicles differ from those used for packaged items?

• Aseptic Presentation. ◦ Is the container system easy for personnel to handle? ◦ Are the container system locks and handles easy to remove or open? ◦ Is the labeling and external indicator located in a place that is

convenient for the user to check? ◦ Can the lid be removed easily without contaminating the contents or the

scrub person’s hands? ◦ Can the instrument baskets be removed easily without contaminating

the contents or the scrub person’s hands? ◦ Can filters, retaining mechanisms, and valves be easily identified and

inspected for security? ◦ If an internal wrap is used, can it be opened easily without contaminating

the contents or the scrub person?

The Bottom LineAfter reviewing the applicable regulations and guidelines regarding the selection and use of packaging materials, especially rigid containers, the bottom line is that every facility has to make a choice that will satisfy its patient care needs. If questions arise regarding sterilization of a specific item or device in a reusable rigid containers, facilities should check the device validation/instructions for use information; if that states the item may not be sterilized in a reusable rigid sterilization container, the effort stops there.

If the device manufacturer information states that it has been validated in a specific reusable rigid sterilization container with product numbers, then follow the information

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provided. If the device manufacturer information is silent on instructions, the facility should form a multidisciplinary group with representation from infection control, risk management, OR, medical staff, and sterile processing, to review all information available for the device and reusable rigid sterilization container in order to make a decision on policy/practice for the facility to follow.

CLINICAL CONSIDERATIONS RELATED TO REUSABLE RIGID STERILIZATION CONTAINER SYSTEMSOverviewArmed with the applicable regulations and guidelines, there are key clinical considerations regarding the selection and implementation and use of reusable rigid sterilization containers. Today, reusable rigid sterilization container systems are popular choices for sterilization packaging, since they can be sterilized, stacked, and stored; they also offer a simple, effective packaging method and are available in a variety of sizes to meet virtually all packaging needs.13 The story continues with additional clinical considerations related to the daily use of reusable rigid containers.

In this regard, because of the rigid container material, these systems protect the instruments because they cannot be punctured, abraded, or easily contaminated by environmental microbes14; therefore, they help eliminate the risk for compromise of package integrity through package compression, tears or holes that are associated with other types of packaging systems (eg, wraps and peel pouches). And, as will be discussed, when properly initiated, rigid container systems are also a cost-effective packaging method.

Design Considerations: Anatomy of a ContainerIn order to maximize the clinical benefits of any reusable rigid container system, the following design considerations should also be reviewed prior to purchase:

• Handle – Ideally, the handle is one-piece, easily grasped for ergonomically correct lifting and moving. (see Figure 6).

Figure 6 – Handle Design

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• Latch – Securing the container lid to the bottom should be simple to use, and foolproof in design. The latching mechanism must sustain long length of service based on usage. Ideally the latch should one-piece, centrally located with no protruding parts, latch security easy to determine (see Figure 7).

Figure 7 – Latch Design

• Retention Plate and Gasket – A filter or valve system in the lid (and/or the base) of the container permits air to be removed and the sterilant (eg, steam, ethylene oxide) to enter the container; if this system in intact and functioning properly, it prevents pathogens from entering the container. Filters are either disposable (ie, use once and discard) or reusable for multiple cycles. The retention plate holds the filter firmly in place; it should also be designed for quick and easy assembly to minimize error during handling (see Figure 8).

Figure 8 – Retention Plate and Gasket

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• Container Lid – The lid should be constructed to maintain security and to allow stacking (see Figure 9).

Figure 9 – Container Lid


Container Bottom – The bottom of the container should not have feet; be able to adequately support the weight of the contents; and elevate the basket to maximize sterilant contact. (see Figure 10). Container bottoms are either solid, ie, no filter; or perforated, with a filter in the bottom.

Figure 10 – Container Bottom

Accessories – Other accessories for rigid containers include mats, baskets, various types of identification labels, eg, tags, and tamper-proof locks (see Figure 11).

Figure 11 – Container Accessories

Cleaning, Care and Handling of Rigid Containers Proper cleaning, care, and handling of rigid containers are also key clinical considerations. Water quality as well as cleaning agent(s) is critical to maintaining the surface of rigid container. Rigid sterilization container systems should be cleaned carefully before sterilization, even if they are to be returned to use immediately.15 Before obtaining container systems, the facility should confirm that the manufacturer’s validated cleaning method complies with the facility’s procedures. Container systems can be cleaned by either manual or mechanical methods; however, the container system manufacturer’s instructions for cleaning and rinsing should always be followed. General care and handling guidelines are outlined below.

Preparation for cleaning. o Remove the lid, basket, any instruments, and the retention plates. o Discard all disposable filters, locks and indicators. o Preventive maintenance – includes checking lids, including the gaskets and filters; handles; and the

container itself including the body as well as the filter retainer mechanism.

• Container Bottom – The bottom of the container should not have feet; be able to adequately support the weight of the contents; and elevate the basket to maximize sterilant contact (see Figure 10). Container bottoms are either solid, ie, no filter; or perforated, with a filter in the bottom.










• Accessories – Other accessories for rigid containers include mats, baskets, various types of identification labels, eg, tags, and tamper-proof locks (see Figure 11).

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Cleaning, Care and Handling of Rigid ContainersProper cleaning, care, and handling of rigid containers are also key clinical considerations. Water quality as well as cleaning agent(s) are critical to maintaining the surface of rigid container. Rigid sterilization container systems should be cleaned carefully before sterilization, even if they are to be returned to use immediately.15 Before obtaining container systems, the facility should confirm that the manufacturer’s validated cleaning method complies with the facility’s procedures. Container systems can be cleaned by either manual or mechanical methods; however, the container system manufacturer’s instructions for cleaning and rinsing should always be followed. General care and handling guidelines are outlined below.

• Preparation for cleaning. ◦ Remove the lid, basket, any instruments, and the retention plates. ◦ Discard all disposable filters, locks and indicators. ◦ Preventive maintenance – includes checking lids, including the gaskets

and filters; handles; and the container itself including the body as well as the filter retainer mechanism.

• Manual cleaning. ◦ Use a soft sponge and a mild detergent (ie, neutral pH 7) as specified by

the manufacturer and clean under water. ◦ Rinse thoroughly under running water to remove all residual detergent. ◦ Remove all adhesives and tape residue with non-abrasive cleaner and

rinse thoroughly. ◦ Thoroughly dry all components before re-assembly.

• Automated cleaning. ◦ Place the container bottom in the washer with the inside surface facing

down. ◦ Fold lid handles in. ◦ Place the lid with the inside surface facing down or at an angle with

inside leaning downward. ◦ Place retention plates away from direct force of pressurized water (use

basket to hold plates). ◦ Thoroughly dry all components before re-assembly.

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• Assembly. ◦ Place one sheet of disposable or reusable filter paper over each

perforated area; assure the integrity of the filter. ◦ Secure the filter with the retention plate; assure proper fit. ◦ Examine the gasket; ensure there are no dents, cracks, or damage. ◦ Place internal basket with contents in reusable rigid sterilization

container. ◦ Secure latches. ◦ Place tamper evident locks, if applicable, on reusable rigid sterilization

container. ◦ Place external and internal chemical indicators (CIs) appropriately.16

External CIs may be on tamper evident locks or labels. Internal CIs must be placed in basket, or on each level if multi-level baskets.

Some CIs, such as Class 1 and Class 3 chemical indicators, are sensitive only to certain variables (eg, temperature); others, such as Class 5 integrating indicators and Class 6 emulating indicators, integrate multiple critical variables. Healthcare personnel should select CIs that are suitable for use in the specific sterilization cycle.

Shelf LifeShelf life is an important consideration related to all sterilization packaging systems. The shelf life of any packaged sterile item should be considered event related. Otherwise stated, the loss of sterility of a packaged item is event related; that is, an event must occur to compromise package content sterility. Events that may compromise the sterility of a package include, but are not limited to17:

• Multiple handling that leads to seal breakage or loss of package integrity;• Compression during storage;• Moisture penetration;• Exposure to airborne contaminants and other environmental contaminants;• Storage conditions, eg, type of shelving, cleanliness, temperature, humidity, traffic

control;• Type and configuration of packaging materials used;• Use of sterility maintenance covers and methods of sealing; and• Storage. Reusable sterilization containers should be, stored in a restricted area

with at least 4 air exchanges per hour, temperature approximately 75°F, and a controlled humidity not exceeding 70%. Sterile storage should be 8-10 inches above the floor, 18 inches from the ceiling or sprinkler heads, and 2 inches from an outside wall. Shelving or racks should be designed for the weight and configuration of the items to be stored.

They should not be stored near: ◦ Sinks, water or sewer pipes where they can become wet; ◦ Counters; sterilized items should be stored in a manner that permits

adequate air circulation and under environmentally controlled conditions,

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in an area that limits exposure to moisture, dust, excessive light or handling, and temperature and humidity extremes.18 These conditions cannot be assured if sterilized containers are stored on countertops; and

◦ Soiled carts, equipment, instruments, etc.

• Aseptic presentation. It is important to remember that the outer container is not sterile; the steps for aseptic presentation are:

◦ Place the container on a non-sterile flat surface; ◦ Examine tamper evident lock to assure integrity; ◦ Release the locks; ◦ Remove the lid; Check the chemical indicator if in view; ◦ Check the lid filters for integrity; ◦ Surgically attired scrub person must remove contents carefully (contents

touching unsterile outside of container are not considered sterile); ◦ Surgically attired scrub person examines internal CI to determine sterility

assurance prior to placing on sterile field; ◦ If solid bottom, check for moisture; and ◦ Circulator must check bottom filters for integrity if present.

• Set weight and configuration. Manufacturers of packaging systems should be consulted for configuration; further, the total weight of an instrument set should not exceed 25 pounds, as instrument sets weighing more than 25 pounds are known to be difficult to dry without lengthy drying times and also present an increased risk of ergonomic injury.19

◦ Replace basket with instruments and indicator in container bottom; ◦ Replace container lid and close the latches securely; and ◦ Insert sterile indicator card and secure the latches with tamper evident

locks.

Validations Studies – What Are They and Why Are They Important?A sample manufacturer’s sterilization validation study is outlined below.

SAMPLE STERILIZATION VALIDATION STUDY RESULTS FOR REUSABLE RIGID CONTAINERSObjective – To evaluate the effects of a stacking sterilization container system with lids for a 270°F (132°C) four-minute prevacuum cycle with a fully loaded weight of 35 pounds.

Test Samples – Three full sized and six half sized six inch solid bottom containers were stacked to a full height of 18 inches. The full sized containers were filled with 35 pound of medical items with simulated medical devices, including those with lumens.

Test Process – Each of the sold bottom containers was paired with an appropriate lid. The containers were cleaned and dried according to the manufacturer’s

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recommendations. Each full sized container was loaded with medical instruments and simulated instruments to attain a total combined load of 35 pounds and seeded with seven biological pore strips. Three 3mm interior diameter (ID) x 400 mm lumens were each inoculated with a spore wire and one of the lumens was placed in each full sized container; three 3 mm ID x 200 mm lumens were each inoculated with a spore wire and placed in each half sized container. Each container was also seeded with two steam integrators. Three of the full sized containers were placed in the sterilizer in a stacked position; the three half sized containers were also stacked in similar positions. The containers were processed at the half cycle parameters of 270°F (132°C) for two minutes exposure time and 15 minutes of dry time to conform to AAMI guidelines for Rigid Container Validation. All samples and controls were incubated at 55-60°C for seven days and monitored for daily growth.

Test Results – All test spore strips and wires for the full sized containers showed no growth of the target organism after seven days incubation. The positive controls were positive for growth; the negative and environmental controls were negative for growth.

Conclusions – These results validate the recommended steam sterilization cycle in a stacked configuration when using a maximum of three rigid container systems. Performance testing has shown that the recommended cycle parameters are safe and effective for use when processing these stacked rigid containers and lids in the following prevacuum steam sterilization cycle:

Temperature: 270°CExposure Time: 4 minutes

As noted above, before purchasing reusable rigid containers, personnel should request and review the sterilization validation studies from the manufacturer to verify that the containment device has been tested and validated for the sterilization method and cycles to be used.

How to Use Validation Testing Results in the Clinical SettingForm a group to look at product information and how the product/s will be used in your facility. It is important to follow manufacturer’s instructions for use. This group should include, but is not limited to the following:

• Sterile processing;• Operating room;• Infection control practitioners; and• Risk management.

How Reusable Containers Support Green Initiatives and Reduce CostsToday, an increasing number of healthcare facilities are exploring sustainability or “green” opportunities to reduce their environmental impact, with the added benefits of improved patient outcomes, better staff health, and economic gains. These initiatives logically focus on the departments associated with the highest costs and that generate the largest volumes of waste. The OR produces between 20% to 30% of a hospital’s total waste volume,20 despite its rather small spatial footprint.

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A best practice in going green initiatives is switching to reusable rigid sterilization containers for surgical instrumentation.21 Disposable sterilization wrap, a polypropylene plastic, that is used for packaging and then sterilizing various instrument sets is thrown away after the set is opened, thereby creating approximately 19% of the waste generated in surgical services. The use of reusable rigid sterilization containers effectively reduces the waste stream generated by the OR and sterile processing departments; this can result in significant cost savings for the facility by reducing waste disposal costs.

Questions to Ask22

Reusable rigid sterilization containers can provide many benefits relative to quality, sterilization, storage, protection, and associated cost reductions. While the procurement of sterilization containers can be somewhat costly initially, it should be considered an investment that will offer long range benefits, as well as a long useable life. The key points to consider in the evaluation and selection of rigid sterilization containers are summarized as follows:

• What is the intended use of containers, ie, the method of sterilization?• Does the container have FDA clearance for use in the sterilant of choice,

including immediate use sterilization?• Are contents completely dry after sterilization without the need to extend drying

time or use towels or disposable tray liners for wicking?• Is the container FDA cleared?• Are locking devices tamper-evident?• Are contents easy to lift and remove from container aseptically?• Can the containers be easily cleaned manually and/or through automated

washers?• What is the estimated product life?

SUMMARYOne of the expected outcomes for every surgical patient is that he/she is free from the signs and symptoms of infection. One key strategy to reduce the patient’s risk for infection is to provide surgical instruments and devices that are sterile at the time of use; this requires appropriate packaging of the items for sterilization. The story on reusable rigid container systems concludes that they are packaging options which provide efficient, cost effective, organization and utilization of surgical instruments in addition to providing a high-level support of infection prevention goals.

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GLOSSARYContainer Filter A device secured to the rigid sterilization

container system lid and/or bottom that serves to allow passage of air and sterilants, yet provides a microbial barrier. (Note: the filter media could be reusable, disposable, or permanently affixed to the container system.)

Container Filter Retention System A mechanism that secures disposable filters in place. (Note: the filter retention system could be a retention plate or a retaining ring. It is disengaged to release used filters for disposal and reengaged to secure new filters.

Container Gasket A pliable strip that serves as a seal between the lid and the base of a reusable rigid sterilization container to prevent entry of microorganisms.

Container A mechanical device that opens during sterilization to allow air evacuation and sterilant penetration; it closes after sterilization to prevent contamination.

Infectious Agent A parasite (eg, bacterium, fungus, virus) that is capable of producing an infection.

Package Integrity Unimpaired physical condition of a final package.

Prevacuum Steam Sterilizer A steam sterilization cycle in which air is removed from the chamber and load via a series of pressure and vacuum excursions.

Rigid Sterilization Container Specifically designed heat-resistant, metal, System plastic, or anodized aluminum receptacles used to package items, usually surgical instruments, for sterilization. The lids and/or bottom surfaces contain steam- or gas-permeable, high-efficiency microbial filters.

Shelf Life The period of time during which a sterilized medical device is considered safe to use.

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Sterile The state of being free from all living microorganisms. In practice, usually described as a probability function, eg, as the probability of a microorganism surviving sterilization being 1 in 1,000,000.

Sterilization A validated process that removes or destroys all viable microorganisms, including bacterial spores, to an acceptable sterility assurance level, usually 1 in 1,000,000. In a sterilization process, the presence of microorganisms on any individual item can be expressed in terms of probability. Although this probability can be reduced to this very low number, it can never be reduced to zero.

Sterilization Validation Studies Tests performed by the device manufacturer that demonstrate that a sterilization process will consistently yield sterile container contents under defined parameters.

Validation Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.

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REFERENCES1. Petersen C. Perioperative Nursing Data Set: The Perioperative Nursing Vocabulary,

3rd ed. Denver, CO: AORN, Inc.; 2011:254. 2. Graf K, Ott E, Vonberg RP, Kuehn C, Schilling T, Haverich A, Chaberny IF. Surgical

site infections: economic consequences for the healthcare system. Langenbeck’s Archives of Surgery. 2011;396(4):453-459.

3. AORN. Guideline for sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN; 2016: 823-850.

4. AORN. Guideline for selection and use of packaging systems for sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN; 2016:809-822.

5. Bosvrorth DB. The mechanics of surgery comprising detailed descriptions, illustrations and lists of the instruments, appliances and furniture necessary in modern surgical art. http://www.archive.org/stream/mechanicsofsurge00truaiala/mechanicsofsurge00truaila_djvu.txt. Accessed August 11, 2016.

6. U.S. Department of Health and Human Services. FDA. Medical Devices. http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm. Accessed August 11, 2016.

7. AORN. Guideline for selection and use of packaging systems for sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.; 2016:809-822.

8. AAMI. ANSI/AAMI ST79:2010 & A4:2013 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Arlington, VA.: AAMI; 2013.

9. AAMI. Receiving. In: ANSI/AAMI ST79:2010 & A4:2013 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Arlington, VA.: AAMI; 2013:43-44.

10. AAMI. Packaging, preparation, and sterilization. In: ANSI/AAMI ST79:2010 & A4:2013 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Arlington, VA.: AAMI; 2013:67-90.

11. AAMI. Quality control. In: ANSI/AAMI ST79:2010 & A4:2013 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Arlington, VA: AAMI; 2010:97-136.

12. AAMI. Annex I: Development of a prepurchase evaluation protocol for rigid sterilization container systems. In: ANSI/AAMI ST79:2010 & A4:2013 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Arlington, VA.: AAMI; 2013:207-211.

13. Spry, C. Infection prevention and control. In: JC Rothrock, Ed Alexander’s Care of the Patient in Surgery, 15th ed; St. Louis, MO.: Mosby; 2015:69-123.

14. AORN. Guideline for selection and use of packaging systems for sterilization. In: Guidelines for Perioperative Practice. Denver, CO.: AORN; 2011:809-822.

http://www.archive.org/stream/mechanicsofsurge00truaiala/mechanicsofsurge00truaila_djvu.txt

http://www.archive.org/stream/mechanicsofsurge00truaiala/mechanicsofsurge00truaila_djvu.txt

http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm

http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm

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15. Spry. Infection prevention and control. In: JC Rothrock, Ed. Alexander’s Care of the Patient in Surgery, 15th ed.; St. Louis, MO.: Mosby;2015:69-123.

16. AAMI. ANSI/AAMI ST79: 2010 & A4:2013 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Arlington, VA: AAMI; 2010:102-103.

17. AORN. Guideline for selection and use of packaging systems for sterilization. In: Guidelines for Perioperative Practice. Denver, CO: AORN; 2016: 809-822.



20. Esaki RK, Marcario A. Wastage of supplies and drugs in the operating room. http://www.medscape.com/viewarticle/710513. Accessed August 11, 2016.

21. Practice Greenhealth. The business case for greening the OR™. https://practicegreenhealth.org/sites/default/files/upload-files/caseforgor_r5_web_0.pdf. Accessed August 11, 2016.

22. IAHCSMM discussion forum. Instrument containers. http://iahcsmm.org/forum/archive/index.php/t-746.html. Accessed June 27, 2011.

http://www.medscape.com/viewarticle/710513

http://www.medscape.com/viewarticle/710513

https://practicegreenhealth.org/sites/default/files/upload-files/caseforgor_r5_web_0.pdf

https://practicegreenhealth.org/sites/default/files/upload-files/caseforgor_r5_web_0.pdf

http://iahcsmm.org/forum/

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