Education & Training Packaging For Sterilization
Education & TrainingPackaging for SterilizationIT’S NOT JUST A BOX, A BAG OR GIFT WRAPPING!by Rose Seavey, RN, BS, MBA, CNOR, ACSPObjectives1.2.3.4,After completion of this self-study activity, the learner will be able to:Describe available options for sterilization packaging and containmentdevices.Discuss appropriate use for each type of sterilization packaging.Develop a Quality Control Program for evaluation, selection and use ofpackaging systems for items to be sterilized.Order the Association for the Advancement of Medical Instrumentation(AAMI) and Association of periOperative Registered Nurses (AORN)documents for your reference library.Test Questions1.True of False. Circle the correct answer.If major changes are made to packaging such as switching the type ofwrappers, peel pouches or containment devices used, or changing thepackage dimensions or weight of the set, facilities should conductproduct testing with biological indicators (BIs) and chemical indicators(CIs) as well as moisture content assessment.TrueFalse2.Both AAMI and AORN recommendations agree on a maximum weightlimit of 25 pounds for a containment device, the instruments, and anyaccessories or wrapper due to ergonomic and drying issues.TrueFalse3.Both solid and perforated bottom rigid containers can be sterilized bygravity or dynamic-air-removal steam sterilization cycles.TrueFalseMany thanks to the team at 3M Health Care for working withManaging Infection Control to provide the following accredited course.IAHCSMM has awarded one and one-half (1.5) contact points forcompletion of this continuing education lesson toward IAHCSMMrecertification. The CBSPD has preapproved this inservice for one andone-half (1.5) contact hours for a period of five (5) years from the dateof publication, and to be used only once in a recertification period. Thisinservice is 3M Health Care Provider approved by the California Boardof Registered Nurses, CEP 5770 for one (1) contact hour. This form isvalid up to five (5) years from the date of publication. Instructions forsubmitting results are on page 97.Managing Infection Control and 3M Health Care will be workingcollaboratively to provide continuing education courses in monthlyeditions of Managing Infection Control.82MANAGING INFECTION CONTROL4. Rigid sterilization container systems shouldbe cleaned after each use following themanufacturers written recommendations.TrueFalse5. Room temperature and relative humidityhas no effect on packaging materials and theability to achieve sterilization.TrueFalse6. Using the proper wrap size and grade isimportant and wrapping procedures shouldbe standardized.TrueFalse7. If packages are wrapped too loose, it couldcreate low spots that can collect condensate.TrueFalse8. If items are to be put in a double peel pouch,the inner pouch should fit inside the outerpouch without folding and the plastic side ofthe inner pouch should face the plastic sideof the outer pouch.TrueFalse9. Paper-plastic pouches should not be placedinside wrapped sets or containment devices.TrueFalse10. Instrument count sheets should be placed onthe inside of sterile packages.TrueFalseIntroductionThere are several types of sterilizationpackaging systems on the market today. Thesedevices help to maintain sterility, as well asprotect the contents of the package and supportaseptic presentation. Most healthcare facilitiesuse a variety of sterilization packaging systems.The available systems include woven andnonwoven wrappers, peel pouches of plastic,January 2008
Education & Trainingpaper and containment devices such as reusable rigidsterilization containers, organizing trays and instrument case/cassettes available in both plastic and metal. There are also awide variety of devices used to protect instruments orcomponents. These include insert cases or trays, reusableaccessories, paper-paper bags, foam and towels.Sterilization packaging is classified by the Food andDrug Administration (FDA) as a Class II medical device andis defined as:“A sterilization wrap (pack, sterilization wrapper,bag or accessories) is a device intended to be used toenclose another medical device that is to be sterilizedby a health care provider. It is intended to allow sterilization of the enclosed medical device and also tomaintain sterility of the enclosed device until used.”1WHICH PACKING TO USE?Deciding on the appropriate packaging system forsterilizing devices has become a challenging quest. The development of high tech, complicated surgical devices—especiallyfor minimally invasive surgical procedures—and an increasingvariety of sterilization processes require greater diligenceand critical thinking skills when choosing the type of packaging system to use for each device, or instrument set orsterilization process.Issues of cost, rapid turnover, ease of use, materialcompatibility and storage space need to be balanced withpatient safety and instrument protection concerns. Healthcareprofessionals should work closely with the instrument,sterilizer and packaging manufacturers to determine the appropriate devices to wrap, package and contain sterilized items.Sterilization packaging is more complicated than youmight think. It is not just a box, bag or wrap! As a Class IImedical device, there are specific validated guidelines that mustbe followed with each type of system used. To ensure patientsafety, manufacturers’ written instructions must be followed.Not all packaging systems are compatible with all types ofsterilization processes.This article will cover the various types of sterilitypackaging and container systems, their intended use, and limitations. This educational offering will also discuss labeling,closures, tamper evidence, product evaluations and testing,weights and density of sets, compability issues, instrumentinventory list placement, options for internal containmentdevices, and maintenance of reusable containers.EVALUATING PACKAGING SYSTEMSBefore deciding on which packaging system(s) to purchaseand use, an evaluation should take place to investigate suitabilityfor items being sterilized, types and methods of sterilizationused. According to the Association of periOperative RegisteredNurses (AORN), sterilization packaging systems should: have a sufficient barrier to microbes, particulates and liquid; maintain sterility of contents until used; permit sterilant saturation and removal while allowingdirect contact with all surfaces of each item; have no toxic ingredients or nonfast dyes; allow aseptic presentation to the sterile field; close completely and securely; protect items from physical damage; provide a sufficient, reliable tamper-evident seal; be resistant to tears or punctures; have very little lint; allow for content identification; be of sufficient size to uniformly distribute the items; be easy to use when preparing and opening the packageor container; be cost effective and; have manufacturer’s written instructions for use.2Purpose of packagingThe intention of any sterilization packaging system is toallow sterilization of the package contents, maintain sterilityof contents until the package is opened, and permit delivery ofcontents without contamination.PACKAGING OPTIONSThe choice of packaging systems includes: woven fabrics, usually 100 percent cotton, cottonpolyester blends and synthetic blends, either treated oruntreated; nonwoven materials, made of plastic polymers,cellulose fibers or washed paper pulp bonded underpressure into sheets not woven on a loom. These areusually designed for single use; peel pouches of plastic and/or paper, made of a variety ofmaterials, including paper, cellophane, polyethyleneand various paper-plastic combinations; and rigid container systems which are specially designedmetal or plastic containers.84MANAGING INFECTION CONTROLImportant items to consider when evaluating a rigidcontainer system include: Ergonomics of container design for ease of carrying; Empty container weight; Ease of locking and closing the container; Ability to stack containers for storage and transportation; Design of filter retention and ease of use; Types of accessories for organization; Ability to stack baskets internally; Various sizes to accommodate a wide variety ofinstrument sets;January 2008
Education & Training Ability to clearly label sets; Ability to put container through an automatic washer; andPreventative maintenance and service.Practical Application Work closely with the instrument, sterilizerand packaging manufacturer to determine theappropriate packaging to use for each device andinstrument set. Evaluate packaging before purchasing.Product testingWhenever there are major changes made to packaging,e.g., switching the type of packaging material or containersused, and/or changes in the package dimensions or weight,product testing should always be performed. This test shouldinclude biological indicators (BIs) and chemical indicators(CIs) as well as moisture content (wet pack) assessment afterthe cycle is complete.3The BIs and CIs should be placed in the most challengingarea of the packages being tested and in multiple locations.More than likely, that will be the center of a wrapped pack orthe corners of containers, inside containment devices and oneach level of multilevel packs and next to the largest heatsink. The placement of the indicators should be identified forrecord keeping purposes. The packages should be labeled asproduct tests and run in a full load using the medical devicemanufacturer’s instructions. The packages are sacrificed andnot used so the CIs can be read and the BIs incubated.Test results should be documented and maintained with thesterilization log and the quality assurance records. The products with the changes should not be placed into routine useuntil the CIs reach their endpoint and the BIs are negative.2-4For specific instructions on facility product testing,healthcare providers should refer to the Association forthe Advancement of Medical Instrumentation’s (AAMI)Comprehensive guide to steam sterilization and sterilityassurance in health care facilities, ANSI/AAMI ST79:2006section 10 Quality Control, 10.9 Periodic product qualityassurance testing of routinely processed items.3Practical Application Perform product testing whenever there aremajor changes made to packaging, e.g., switchingthe type of packaging material or containers used,and/or changes in the package dimensions orweight on loaner instruments.86MANAGING INFECTION CONTROLWeight and density of setsAn ongoing issue is the instrument set weights.Instrument sets sometimes seem to take on a life of their own,growing at alarming rates. Some of the complete sets from theoriginal manufactures are almost too heavy to lift. Oftenadditional items get repeatedly added to sets creating a set witha metal mass that is not equally distributed. From time to time,due to lack of storage space or for staff convenience, we mergemultiple sets into one. With all of these issues there is agrowing concern with the weight of instrument sets.Due to ergonomic, sterilization and drying issues, bothAAMI and AORN recommendations agree on a maximumweight limit of 25 pounds. AORN states:“The total weight of instrument containmentdevices should not exceed 25 pounds, including thecontents and containment method (eg., wrappers,rigid container systems, cassettes, organizing trays).Excessively heavy instrument sets may compromisesterilization and drying. The focus should be on the setconfiguration (i.e., how the instruments are distributedin the set) and the overall weight of the set. Lifting andmoving heavy instrument sets may cause health careworker injury.”2The AAMI Containment devices for reusable medicaldevice sterilization, ANSI/AAMI ST77 and ANSI/AAMIST79:2006 section 4 Requirements, 4.3.5 recommends amaximum combined weight limit of 25 pound. This weightlimit includes the containment device, the instruments, andany accessories or wrappers.5If you are using a containment device, the manufacturershould be consulted on the recommendations for weightsand density of instrument sets. However, it is the facility’sresponsibility to verify that the instrument set can be effectively sterilized and dried in their sterilizers by doing producttesting and following the medical device manufacture’sinstructions for use.3Four years ago, The Children’s Hospital of Denver(TCH) chose to institute a maximum weight limit of 20pounds for any sterilized package. This was instituted tocomply with the container manufacturers recommendationsof a 16-20 pound limit as well as ergonomic issues for staff.The implementation of this weight limit was establishednot only for the rigid containers but for any packageincluding wrapped trays and loaner instrumentation trays.This program has proven very successful in many ways. Thecomplaints of back, neck, shoulder and wrist pain fromemployees have been significantly reduced as well as almostvirtually eliminating any wet loads while decreasing some ofthe dry times. Here are steps for an instrument set weightreduction strategy:January 2008
Education & Training Establish the maximum acceptable weight limitsfor your healthcare facility instrument sets withinput from surgical services. Add the established weight limit to your policyand be sure to get the approval of surgical services,infection control and risk management; alsoinform the facility and loaner instrument vendors. Obtain written reprocessing and sterilizationguidelines from all medical device manufacturers including rigid containers. Redesign the instrument sets to even out themetal mass. Perform product testing using biological andchemical indicators inside representative sets inthe areas determined to be the most challengingand following the medical device manufacturers’ sterilization parameters. Place the sets into use. Routinely monitor sets to ensure the weight isnot “inching” up.4Figure 1. Wrapped pan being weighedSTEAMSteam sterilization is affected by such things as the amount ofavailable humidity, the altitude, the type of packaging material, itscontents, the size and configuration of the load, the size, weight anddensity of the pack or container, and the parameters of the sterilizationcycle. It is important to follow the manufacturers’ written instructionsfor each type of packaging system used in the steam sterilizer.2ETHYLENE OXIDE (EO)When using EO sterilization, the packaging systems must be EO,moisture and air permeable, allow aeration of the gas, be constructed ofa material recommended by the sterilizer and sterilant manufacturer,and be compatible with the process of EO sterilization. Peel-packs,wrappers, both woven and nonwoven and some rigid container systemsare permeable to EO.2HYDROGEN PEROXIDE GAS PLASMASterilization packaging systems used for packages undergoinghydrogen peroxide gas plasma sterilization must allow vapor phasehydrogen peroxide to penetrate packaging materials, be compatiblewith the process, and be recommended by the manufacturer. Boththe packaging and sterilizer manufacturer’s written instructions shouldbe followed. Because cellulose products are not compatible withhydrogen peroxide gas plasma, peel packs used in these sterilizers mustbe made of plastic. Only compatible container systems which have beenvalidated for this application should be used.2OZONEPackages used for sterilization with Ozone must allow Ozone topenetrate the package material, be compatible with the process, and berecommended by the manufacturer. Both the packaging and sterilizermanufacturer’s written instructions for use should be followed. Ozonecompatible packaging includes uncoated nonwoven materials, plasticpouches and commercially available anodized aluminum containersusing noncellulose disposable filters.2Practical Application Establish a maximum weight limit of 25pounds for a containment device, theinstruments, and any accessories orwrapper to protect your employees’health and to decrease drying times.Packaging systems compatibilityNot all packaging systems are compatible withall types of sterilization processes. As a Class IImedical device, packaging systems must be clearedby the FDA for their intended purposes as well as themethod of sterilization used.January 2008Practical Application Choose a packaging system that is cleared by the FDA forthe purpose and sterilization method you are using.Types of packaging systems availableRIGID STERILIZATION CONTAINER SYSTEMSReusable rigid container systems are used for the packaging,transportation and storage of surgical instruments prior to, during andafter sterilization. These self-contained closed sterilization containersuse filters or valves as a barrier system to permit air removal and thesterilant to enter and exit the container. The reusable box-like structuresact as a microbial barrier and must have a tamper proof seal.Rigid container systems have internal baskets, come in many sizes,and may have solid or perforated bottoms. The container manufacturer’sMANAGING INFECTION CONTROL87
Education & Trainingwritten recommendations for sterilization cycleparameters should be followed. In general, thesolid bottom containers are to be used in steamsterilizers using dynamic-air-removal cycles only.Perforated bottoms can be sterilized by gravity ordynamic-air-removal steam sterilization. Somecontainers have been validated for use in EthyleneOxide, Hydrogen Peroxide Gas Plasma, Ozoneand flash sterilization. Solid bottoms can also beused to transport contaminated moist instruments.Figure 2. Solid bottom rigid containerPre-assemblyBefore placing items in the tray, both the boxand the lid of the container system should beinspected to ensure the entire container, top andbottom is free from dents or cracks. The gasketsshould be pliable and securely fastened withoutbreaks or cuts. The locking mechanism shouldfunction properly.All of the container’s components (top,bottom, valve or filter mechanisms, securing orlatching mechanisms) must function effectively asa unit. It is vital to the maintenance of sterility, thatthese components work together to allow airremoval, to facilitate sterilant penetration andremoval, and to inhibit contamination.Filter retention mechanisms, valves andfasteners such as screws and rivets should be secureand not loose. If the filter or valve is found loose,the sterility of the contents should be questioned. Ifany part of the container is not satisfactory or free offunctional defects, the container should be repairedor replaced.AssemblyTo assure all instruments are exposed to thesterilization agents, the basket(s) placed in the88MANAGING INFECTION CONTROLcontainer should be large enough to allow the metal mass of instrumentsto be distributed evenly.Only filter materials that have been tested and documented tobe efficacious in the specific container system should be used. Ifdisposable filters are used, a new filter should be used each time thecontainer is sterilized. If mechanical filters are used, their functionalitymay need to be checked daily or before each use. Follow the manufacturers’ instructions.Internal stackingSome container manufacturers have validated internal stacking of twoor more layers within a containment device. According to ANSI/AAMIST77:2006 4.3.4.1, Internal stacking:“If organizing trays are to be stacked within a containmentdevice, the following factors shall be addressed for eachsterilization method for which stacking is recommended:a) ease of removal of stacked items within a containment device;b) the maximum density of contents within the containmentdevice to allow for proper sterilization and drying;c) adequate perforations to allow for sterilant penetration,sterilant evacuating, drying, and, if applicable, aeration;d) the stability of the stacked items during transport and handling;e) a dry outcome (see 4.4.2.1);f) achievement of sterilization throughout the layers of stackedorganizing trays and the recommended accessories (e.g.,mats, holders)
Education & Training Objectives After completion of this self-study activity, the learner will be able to: 1. Describe available options for sterilization packaging and containment . “A sterilization wrap (pack, sterilization wrapper, bag or accessories) is a device intended to be used t
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