CIS Lesson Plans provide members with ongoing education in the complex and ever-changing area of surgical instrument care and handling. These lessons are designed for CIS technicians, but can be of value to any CRCST technician who works with surgical instrumentation.
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After instruments have been cleaned, inspected and re-assembled, they must be packaged for sterilization. This is a critical processing step because packaging maintains the sterility of the sterilized items until the packaging is opened for use on the sterile field. Certified Instrument Specialist (CIS) technicians can use several types of packaging materials, including those that are disposable (pouches and nonwoven wrap) and reusable: woven textiles and rigid sterilization containers. They must know about these alternatives and use the correct packaging procedures to assure that sterilization is successful.
This first of a two-part series will explore the basics of rigid container systems. In this lesson, you will learn about objectives of the packaging process, receive an overview of rigid sterilization container systems, and explore some of the most important documentation requirements for their manufacturers.1 .
To be effective, a packaging material must allow the chosen sterilant to penetrate, and it must be compatible with all other requirements of the sterilization process in which it will be used. It must also maintain the sterility of package contents until opened and be accessible to the user without contaminating the contents so they remain sterile at the moment of use. Since they present a potential risk, sterilization packaging is classified as a Class II medical device by the U.S. Food and Drug Administration (FDA). Only materials specifically designed for sterilization packaging and cleared by the FDA can be used. The FDA also requires that rigid container systems have a 510k certification to verify they have a “substantial equivalence” to one or more legally marketed devices that can be used as a base of comparison with them.
Rigid containers, like all other packaging materials, must address the special concerns applicable to the sterilization method in which they will be used. Manufacturers of rigid containers must document that their containers will satisfactorily address these issues that include:
Rigid sterilization container systems are box-like structures with sealable and removable lids. They consist of an inner basket to hold the instruments to be sterilized and an outer container that provides a protective barrier. The inner basket and the outer container have handles that make them easy to carry. Containers are available in various sizes and designs and are constructed of anodized aluminum, stainless steel, high-temperature plastics, fiber glass, or combinations of these materials. Baskets often have instrument posts and dividers that help to organize the instruments.
Each container design incorporates a method for sterilant penetration and protection from after-sterilization contamination. Containers do not require outer wrappers since they operate using valves and filters. Some container designs provide perforations in the top lid and/or bottom surfaces. These perforations may be covered internally by sterilant-permeable, microbial barrier filters made of single-use (disposable) synthetic spunbond material held in place by a retention plate. Other designs use a bio-barrier comprised of ceramic filters or a valve system. Designs that include both filters and valves are also available. These allow sterilant permeability by expansion during the sterilization phase and positive closure during the drying phase of sterilization.
A container system provides containment of medical devices during preparation and sterilization, protection from contamination during storage and/or transport, aseptic presentation at the surgical field, and effective containment of some used devices during their return to the decontamination area. Note: most containers cannot retain fluids; therefore only dry instruments can be transported.
The design and material construction of a container system markedly affects its use for sterilization. For example, metal containers incorporating non-woven fabric filter systems are acceptable for steam and ethylene oxide (EtO) sterilization. As noted above, documentation from container manufacturers is critical. However, vacuum-closed valves can inhibit complete aeration of the contents after sterilization, so metal containers with valve closures are not recommended for use in EtO or plasma sterilization. Additionally, containers constructed of plastic have not been proven acceptable for repeated EtO sterilization cycles, and plastics are less efficient for drying than are metal materials. Another problem with plastic containers: build-up and retention of EtO residuals that unfavorably affect aeration of both the container and its contents.
Among the potential advantages to the use of rigid container systems is their ease of use, and they provide an excellent barrier to microorganisms. Price relative to alternative packaging systems is an important consideration, and a detailed cost benefit analysis is important to assure their cost effectiveness before purchase. Containers eliminate the possibility of torn wrappers that can delay a surgical case and the need for reprocessing that occurs. They also provide excellent protection for instruments during their processing, storage, and transport.
Safety concerns are always important, and the weight of loaded containers may be a disadvantage to rigid container systems. CIS technicians can be injured by lifting rigid containers because an empty large container (12” by 23” by 6”) weighs approximately eight to nine pounds. When baskets containing the medical devices to be sterilized are considered, the issue of total container weight becomes important. Heavy baskets of orthopedic instruments can pose an additional risk for staff members especially when baskets are removed from the container. Employees should be able to comfortably carry a container or instrument set at waist height, so a container’s total weight should normally be restricted to fewer than 25 pounds. Then, because the containers have handles, they will be relatively easy to remove from the sterilizer cart and to carry.
Latching mechanisms on containers are a potential source of problems. When latches and welds break, containers cannot be used, and sharp edges can cause employee injuries. Processing challenges occur if fewer containers are available while damaged containers are being repaired, and costs are incurred for container repair/replacement and/or a “stand-by” inventory.
As with all packaging methods, users of container systems must take special precautions when handling sharps, which should be placed in a separately designated part of the container. Techniques to handle sharp instruments after sterilization that consider the protection of CIS technicians are also important. If small instruments or parts must be packaged within the container, only packaging validated for use within the container can be used.
Additional cycle time may be needed to thoroughly dry the container, and sterilization efficiency is also reduced as a container’s weight increases because of excess condensate. In fact, some manufacturers of rigid container systems recommend that times for instrument sterilization, drying and aeration be extended. The “wet pack syndrome” has been discussed for many years, and it is difficult to generalize about solutions. However, it is known that heavier sets and those with greater metal mass are more likely to experience this problem, especially if they are not properly distributed throughout the container. Also, plastic containers may require longer drying times because they lack metal that produces heat by conduction to help drying.
Rigid container users sometimes report that filter retention plates become dislodged and contaminate instruments. Some manufacturers have addressed this potential problem by modifying or changing the design of the filter retention plate. More space may be necessary to store rigid containers than traditional wrapped containers, and additional labor may be needed to clean containers between uses. This may also affect washer loads if a mechanical washer is used.
Rigid container manufacturers must provide instructions that are a primary consideration for the evaluation, purchase, processing, and effective use of containers. They must provide documentation of tested performance qualifications and complete written instructions for use of their container system. This information must include:
Within-facility testing, including verification of the sterilization cycle for each method of sterilization and each sterilizer for which containerized product processing would be used, is needed. Biological and chemical indicators should consistently be used in accordance with recommendations for sterilization container testing, manufacturers’ directions, and quality controls to validate sterilization conditions within each sterilizer.
Rigid sterilization containers are integral components in the sterilization processes used by many healthcare facilities. As with any type of sterile packaging system, however, comprehensive policies and procedures for their use must be in place, and they must incorporate the recommendations of the containers’ manufacturers. As well, CIS technicians must be trained in proper usage protocols with additional periodic updates, as necessary.
Medical devices must be properly cleaned, prepared, assembled, and loaded for the sterilization process to be effective. Quality monitoring of the sterilization process is critical as is the need for applicable record keeping and control procedures. These are the topics of the second lesson in this two-part series.
1. This lesson is adapted from: Central Service Technical Manual. Seventh Edition. Chicago, Il. International Association of Healthcare Central Service Materiel Management. 2007, and Sterilization Principles for Medical Devices: Rigid Container Systems. Module 5 in EXX CELL 2000 Plus: Strategies for Success. Chicago, Il. International Association of Healthcare Central Service Materiel Management. 2000.
Susan Klacik, ACE, CHL, CRCST, FCS
St. Elizabeth Health Center
Carla McDermott, RN, ACE
Morton Plant Mease Healthcare
Jack D. Ninemeier, Ph.D.
Michigan State University
East Lansing, MI