Unloading, Storage, Distribution, Transportation And .

Education & Trainingshould be careful to avoid burns because the tray and the itemswithin it will be very hot. The staff should wear sterile gloves whenremoving items from the sterilizer. (See Figure 2.) Sterile towelsmay be used as “potholders” when taking items from the sterilizer.Do not place the tray on a nonsterile surface.“Rationale: It is particularly important that the flash sterilizationmethod of steam sterilization processing be carried out in a clean environment and that devices processed by this method be transferred andhandled as little as possible, because the items are not protected bypackaging before or after the sterilization process.”1Flash cycles with single wrappers or other textile packaging(Section 8.8.4)All items that have been flash-sterilized should be usedimmediately and not stored for later use. There are some sterilizersthat will allow for flash cycles with a single wrapper or otherpackaging. These must be distinguishable from wrapped orpackaged devices processed in the conventional way. This cycleshould include a very brief drying time.“The wrapped/packaged tray should never be placed ona nonsterile surface. A sterile, impervious drape, placed ona surface separate from the sterile field, should be used so thatthe wrapped/ packaged tray can be placed there and then opened bythe circulator. The sterile items may then be removed from the trayby the scrub person and take to the sterile field.”1Flash cycles with sealed containment devices (Section 8.8.5)All items that have been flash-sterilized should be usedimmediately and not stored for later use. There are speciallydesigned sealed containment devices for flash cycles. These mustbe distinguishable from other sealed containment devices processedin the conventional way. As is typical of flash sterilization, condensatewill be present in the containment device; therefore, transferprocedures should be developed to minimize the chance of burns.The amount of condensation created will depend on the types andnumber of instruments being sterilized. Both the containmentdevice and the contents will be hot. As with open tray flash cycles,the staff should wear sterile gloves when removing items fromthe sterilizer, and sterile towels may be used as “potholders.”“The containerized items should never be placed on a nonsterilesurface. The sterile items may be removed from the containmentdevice by the scrub person and taken to the sterile field.”1Handling and inspection (Section 8.8.6)Procedures for minimizing the handling of all sterile itemsshould be developed and placed in writing. When packages areremoved from the sterilizer cart, they should be inspected visuallyfor any tears or wetness. Torn or wet packages should be consideredcontaminated. “If an item is dropped on the floor and the integrityof its packaging is compromised, it should be returned tothe decontamination area for reprocessing.”192MANAGING INFECTION CONTROLSterile storage (Section 8.9)Sterility maintenance covers (Section 8.9.1)Sterilized packages should be handled as little aspossible. If properly sterilized packages are thought to beexposed to environmental challenges or multiplehandlings before use, sterility maintenance covers (dustcovers) may be used to protect and extend the packageshelf life. The product used must be labeled exclusivelyas sterility maintenance covers. These covers aredesigned to provide protection against outside elementssuch as dust. These sterility maintenance covers should beapplied immediately after the items from the sterilizer arethoroughly cooled.Sterility maintenance covers must be sealed in orderto be an effective barrier. Some of the covers are designedto seal on to itself with a sticky strip (e.g., self seal).Others may need to be sealed with a specifically designedplastic-to-plastic heat sealer. Be sure the lot or loadcontrol number containing the expiration statement aswell as the description of the items can be seen though thedust cover. (See Figure 3.)Figure 3Storage facilities (Section 8.9.2)Sterile packages should be stored in a controlledenvironment to help reduce the potential for contamination.Generally speaking, the sterile storage area should beapproximately 24ºC (75ºF), have at least four airexchanges per hour, and have a relative humidity levelthat does not exceed 70%. Traffic needs to be limited topersonnel who know how to handle sterile items properly.“Adequate space is needed around sterile materialsto allow for air circulation in the room, to preventcontamination during cleaning of floors, and to preventcontact between sterile items and the condensation thatmight form on the interior surfaces of outside walls.”1January 2007

Education & TrainingFigure 4Sterile items should be stored at least: 8-10 inches above the floor, 18 inches below the ceiling or the level of thesprinkler heads, and 2 inches from the outside walls.Care should be taken to ensure the packaging isnot bent, crushed or punctured, or otherwisecompromised. Packages of sterile supplies, whichinclude items in rigid container systems, should notbe stored in any area that may cause them to beexposed to moisture. For ergonomic reasons, heavytrays should be placed on the middle shelves,without stacking. (See Figure 4.) Transport traysmay be used with larger trays to prevent tears in thewrappers during handling.Rigid sterilization container systems should bestored on shelves or racks designed to hold theweight and configuration of the containers. Ifcontainers must be stacked due to space constraints,94MANAGING INFECTION CONTROLJanuary 2007

Education & Trainingit is imperative that they are firmly seated, one upon the other, andcan be easily removed. Facilities should create and enforce policiesand procedures for the storage, handling, rotating and labeling ofcontainer systems.Seldom-used supplies should be stored in closed or coveredcabinets. When items are stored in closed cabinets, dust is limited,handling is discouraged, and inadvertent contact with sterile itemsis minimized. If open shelving is used, it requires special attentionto traffic control, housekeeping and environmental ventilation.Sterile storage shelves should be maintained in a clean and drycondition. The bottom shelf of an open-wire cart requires a physicalbarrier between the shelf and housekeeping activities. “Shippingcontainers serve as generators of and reservoirs for dust; hence,shipping containers should never be allowed in the sterile storagearea.” 1in such a way that would prevent them from beingcrushed, damaged or contaminated.Unintentional contact with staff and other sourcesof contamination along the transportation route can beavoided if covered or enclosed carts are used for transportation of clean and sterile items. If reusable coversfor carts or other transport vehicles are used, they shouldhave a reclosable opening and should be cleaned aftereach use. “Carts should be decontaminated and driedbefore they are reused for transporting sterile supplies.For automated cart distribution systems and pneumaticsystems, the manufacturer’s instructions on distributionand decontamination procedures should be followed.”1Shelf life (Section 8.9.3)The period of time during which a sterile package is considered safe to use is called the shelf life. “The shelf life of a packagedsterile item is event-related and depends on the quality of packaging material, the storage conditions, the conditions duringtransport, and the amount of handling. Shelf life is not simply amatter of sterility maintenance but is also a function of devicedegradation and inventory control.”1 The probability of an itembecoming contaminated grows over time and with increasedhandling. Each facility should establish specific written policiesthat state how shelf life is determined. Specific policies and procedures should be established describing how to assess the shelf lifein the event that a sterility maintenance cover is removed but thepackaged items are not immediately used. In most cases, stock rotation should be according to t he “first in, first out” (FIFO) principle.Tables and carts (open or closed) (Section 8.11.2)Packages should be placed securely in a flat position and should not extend beyond the edge of the cartshelf or table surface.Distribution (general) (Section 8.1)Handling and inspection (Section 8.10.1)Sterile supplies should always be carefully handled. Personnelshould avoid compromising the sterility of the item by not dragging,crushing, bending, compressing or puncturing the package.Appropriate care and handling of sterile packages will help to preventcontamination of the items inside. All items should be inspected forintegrity before being dispensed.It is the responsibility of the end user to carefully inspect thepackage visually for integrity and labeling immediately beforeopening and using a sterile item.Transport of sterile packaged items(Section 8.11.2)Hand Transport (Section 8.11.3)When transporting sterile packages containinginstruments, the package should be kept parallel withthe floor in order to avoid shifting of the instruments.Good body mechanics should be used when transportingany items.Dedicated lifts (Section 8.11.4)If a dedicated lift is used to transport clean or sterileitems from the processing area to the user area, the liftshould be located in a designated “clean area.” (SeeFigure 5.) The clean or sterile items should be containedin a closed bin, a closed case cart or a plastic bag whenbeing transported via a dedicated lift.Figure 5Distribution containers (Section 8.10.2)A covered or enclosed cart with a solid bottom shelf should beused to transport all clean or sterile items. “A solid bottom shelf onthe cart prevents contamination via the so-called “rooster- t a i leffect,” in which the wheels pick up contaminants from the floor andspin them upwards.”1 If plastic or paper bags or boxes are used tocontain and transport items, they should be placed in the container96MANAGING INFECTION CONTROLJanuary 2007

Education & TrainingOff-site transportation (Section 8.11.5)When sterile packages are transported between healthcarefacilities, the vehicle used to transport these items must beable to completely separate clean and sterile items fromcontaminated items. In this situation, all external shippingcartons (corrugated or otherwise) are to be consideredcontaminated, even if they contain wrapped sterile items.“Transport vehicles must be completely enclosed andshould be checked periodically, at least annually and morefrequently as needed, to ensure that they do not leak. Cartscontaining sterile packages should be secured withinthe vehicle to prevent damage or contamination. Transportvehicles and handling practices should allow for ease ofloading and unloading.”1“When motor vehicles are used, environmental conditionsshould be assessed while the vehicle is in motion and when itis not in motion.” In areas of the country that frequently havehigh humidity, specific tests should be done to determinewhether potential sterile items have the potential to becomecontaminated through absorption. Evaluations should be doneJanuary 2007to determine if there is potential for the contents of sterilepackages to become wet through condensation. Condensatecan occur on plastic or metal surfaces that are moved from airconditioned environments to non-air-conditioned environmentsand then back to air-conditioned environments.All transport vehicles (motorized or manual) should beconstructed of materials that allow for proper decontaminationprocesses. This is even more important if the vehiclewill transport alternating sterile and soiled items. Loadedtransport vehicles should never be left unattended or in anunsecured location.Aseptic presentation (Section 8.12)Opening sterile packages (Section 8.12.1)Sterile items should be opened aseptically followingspecific guidelines.1. Position package at the level of the sterile field on dryflat surface.2. Inspect the physical integrity of the packages or rigidcontainers as well as the external chemical indicator (CI).MANAGING INFECTION CONTROL97

Education & Training3.4.5.6.Break the seal of the exterior tape and unfold the wrap, layerby layer.Peel packs should be opened by folding the top down half way,and then presenting the contents.For rigid containers, the manufacturer’s recommendations for lidremoval should be followed, making sure there is no contactbetween the lid and the inner rim or any part inside of the container.The internal CI should be checked on all packages to confirmappropriate end point response.The 2006 Association of PeriOperative Registered Nurses(AORN) Recommended Practices for Maintaining a Sterile Field(RP III) states: “Items used within the sterile field should besterile. To ensure that only sterile items are presented to the sterilefield, all items should be inspected immediately before presentationto the field for proper packaging, processing, seal, package containerintegrity, and inclusion of a sterilization indicator. The indicatorshould be inspected immediately to verify the appropriate colorchange for the sterilization process selected.”2The 2006 AORN Recommended Practices for Maintaining aSterile Field (RP IV) states: “All items introduced to a sterile fieldshould be opened, dispensed, and transferred by methods thatmaintain item sterility and integrity. Sterile items should bepresented to the scrubbed person or placed securely on the sterilefield. Items tossed onto a sterile field may roll off the edge, create ahole in the sterile drape, or cause other items to be displaced, leadingto contamination of the sterile field.”2 (See Figure 6.)1.2.3.4.The internal CI should be checked for properendpoint response by the surgically attired scrubperson before removing the sterile contents.The scrub person should avoid all contact with thewrap or peel pack. When removing the inner basketof a rigid container, both handles should be used inorder to lift the basket straight up to clear thecontainer. (See Figure 7.) Care should be taken toavoid the inner rims. If a container has more thanone basket, they should be moved to the sterile fieldone at a time.Visually inspect the bottom of the wrapper orcontainer system for integrity and moisture beforeplacing contents on the sterile field.The circulator should inspect container system forproper alignment and the integrity of the filtersystem per the manufacturer’s recommendations.While discussing the aseptic practice of maintaininga sterile field, we should also address the need to quarantine any implants that are flashed until the results ofthe biological indicator (BI) are known.Figure 7Figure 6Removing items from sterile packaging and transferring them tothe sterile field (ANSI/AAMI, Section 8.12.2)When removing the contents from a sterile package andtransferring the contents to the sterile field specific guidelinesshould be followed.98MANAGING INFECTION CONTROLThe 2006 Association of PeriOperative RegisteredNurses (AORN) Recommended Practices forSterilization in Perioperative Practice Settings states:“Flash sterilization should not be used forimplantable devices. Implants are foreign bodies,and they increase the risk of surgical site infections.Careful planning, appropriate packaging, and inventorymanagement in cooperation with suppliers canminimize the need to flash sterilize implantable medicaldevices. When an implantable device is sterilized ata health care facility, a biological indicator should beJanuary 2007

Education & Trainingrun with the load and the implant should be quarantineduntil the results of the biological indicator are known. If anemergency situation makes flash sterilization unavoidable, arapid-action biological monitoring device should be usedalong with a class V chemical integrator. The implantshould not be released until the rapid-action indicatorprovides a negative result. After the rapid-action negativeresult is obtained, the implant can be released for use in theimmediate situation.” 2Because of this stringent standard, I wanted clarificationon how to quarantine a flashed implant and maintain thesterility, while waiting for the BI results. I questioned RamonaConnor, RN, MSN, CNOR, who currently represents AORNon the AAMI Sterilization Standards Committee. She stated,“The sterilized implant can be placed on a corner of the backtable and segregated from the rest of the sterile field untilthe rapid-readout BI is ready to read. When the BI resultis negative, then the implant can be placed in the patient.If the BI is positive, the implant hasn’t been used; and the restJanuary 2007of the sterile field hasn’t been contaminated.” Remember,the recommendation to not flash sterilize is because of the riskof surgical site infection.SummaryThe AAMI Comprehensive guide to steam sterilizationand sterility assurance in health care facilities (ANSI/AAMIST79:2006) is the principal resource for steam sterilization andshould be part of every healthcare facility’s library. The keyrecommended practices in Sections 8.8-8.12 are: When unloading large chamber sterilizers, all itemsincluding rigid sterilization container systems shouldremain on the sterilizer cart until cooled. The minimum cooling time recommended for a sterilizedload is 30 minutes; however, adequate cooling couldrequire 2 hours or more. All items (except implants) that have been flashsterilized should be used immediately and not storedfor later use.MANAGING INFECTION CONTROL99

Education & TrainingSterile Process and Distribution CEU InformationCEU Applicant NameAddressCity State Zip CodeThe CBSPD (Certification Board for Sterile Processing and Distribution) haspre-approved this inservice for 1 contact hour for a period of five years from the dateof publication and to be used once in a re-certification period. Successful completionof the lesson and post test must be documented by facility management and thoserecords maintained by the individuals until re-certification is required. DO NOT SENDLESSON OR TEST TO CBSPD.For additional information regarding Certification contact: CBSPD, 2 IndustrialPark Road, Suite 3, Alpha, NJ 08865 or call 908.454.9555 or visit Web site atwww.sterileprocessing.org.IAHCSMM has awarded 1 contact point for completion of this continuing educationlesson toward IAHCSMM recertification.Nursing CE Application Form3M Health Care provider approved by the California Board of Registered Nurses, CEP5770 for 1 contact hour. This form is valid up to five years from the date of publication.1. Make a photocopy of this form.2. Print your name, address and daytime phone number and position/title.3. Add your social security number or your nursing license number.4. Date the application and sign.5. Answer the CE questions.6. Submit this form and the answer sheet to:Workhorse PublishingManaging Infection ControlPO Box 25310, Scottsdale, AZ 85255-99987. Participants who score at least 70% will receive a certificate of completion within30 days of Managing Infection Control’s receipt of the application.ApplicationPlease print or type. Sterilized packages should be handledas little as possible. Sterilized packages should be stored ina controlled environment to help reducethe potential for contamination. A covered enclosed cart with a solidbottom shelf should be used to transport all clean or sterile items. All transport vehicles (motorizedor manual) should be constructed ofmaterials that allow for proper decontamination processes, this is even moreimportant if the vehicle will transportalternating sterile and soiled items. All items introduced to a sterile fieldshould be opened, dispensed and transferred by methods that maintain itemsterility and integrity. The internal chemical indicator shouldbe checked for proper endpoint responseby the surgically attired scrub personbefore removing the sterile contents.In addition, the 2006 Association ofPeriOperative Registered Nurses (AORN)Recommended Practices for Sterilization inPerioperative Practice Settings states:Flash sterilization should not be usedfor implantable devices.If flash sterilization is used, implantsshould not be released until the rapid-actionbiological monitor devices provides a negative result.NameMailing AddressCity, State, Country, ZipDaytime phone ()Position/TitleSocial Security or Nursing License NumberDate application submittedOrdering InformationAAMIANSI/AAMI ST79:2

8.When transporting sterile packages containing instruments, the package should be kept vertical to the floor. 9.AORN recommends opening sterile packages and tossing items onto the sterile field. 10.When an implantable device is sterilized at a healthcare facil