Presentation on theme: "Cleaning, Packaging and Sterilization of Instruments"— Presentation transcript:
1Cleaning, Packaging and Sterilization of Instruments Provided by:McKesson CorporationMcKesson Medical-SurgicalRichmond, VA
2Continuing Education Program Following established protocols forinstrument processing is an importantaspect of modern health care as it helpsto minimize the patient’s risk forinfection of the surgical site.This program reviews the most currentrecommended practices for instrumentprocessing and is approved throughtwo national sterile processingorganizations.IAHCSMM and CBSPD offer certification programs for sterile processing personnel
3SPECIAL UPDATE The Centers for Medicare & Medicaid Services (CMS) has recently revised their Survey and Certificationdocument to include more stringent audits in the areasof infection control and sterilization.Areas of emphasis include:Compliance with nationally recognized standards documents.Formal training in areas of infection control and sterilization.Compliant cleaning, sterilization and monitoring procedures.Established criteria for flash sterilization.Reference:CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009
4SPECIAL UPDATE The Accreditation Association for Ambulatory Healthcare (AAAHC) added an infection control chapterto their standards handbook.Infection control highlights included:“Adhering to standards, guidelines, and manufacturer’sinstructions for cleaning, disinfection, and sterilizationof instruments, equipment, supplies, and implants.”Reference:OR Manager Magazine, Volume 26, Number 2, 2010.
5INSTRUMENT PROCESSING There are six (6) recommendedsteps for Instrument Processing:CleaningInspectionPackagingSterilizationStorage & Delivery6. Quality Assurance
6STEP 1 - CLEANING Cleaning of instruments should be performed in a designatedarea, immediately after thesurgical procedure.Quick cleaning removes bloodor debris much easier, and canminimize corrosion, pitting orinstrument staining.
7STEP 1 - CLEANING Whenever possible, it is best to mechanically clean instrumentswith an ultrasonic or washerusing a neutral pH detergent.Mechanical cleaning has beenproven to be up to 16 timesmore effective over manualcleaning.
8STEP 1 - CLEANING Ultrasonic cleaners use high frequency sound waves tocreate microscopic bubblesthat collapse.This “cavitation” process isvery effective in getting intothe serrations, box locks andcrevices of instruments.
9STEP 1 - CLEANING After cleaning, thoroughly rinse instruments with tapwater to ensure looseneddebris and detergents areremoved.If the tap water is of poorquality, consider usingtreated water as a final rinseto avoid instrument staining.
10STEP 2 - INSPECTION Each instrument must be critically inspected after each cleaning for residualdebris or damage.Replace instruments asneeded and never sterilizea “dirty” instrument.
11STEP 2 - INSPECTION In addition, check each instrument for proper function and lubricatethose that have “metalto metal” action.Instruments with stiffjoints could be a signof inadequate cleaning.
12STEP 3 - PACKAGING Instrument packaging should be done in a clean, low contamination area using onlyFDA approved materials,such as:Sterilization pouchesSterilization wrappersSterilization containers
13STEP 3 - PACKAGING Sterilization pouches are for packaging single instrumentsand small, light weight items.Paper/plastic pouches allowthe user to see the packagedinstruments and are availablein multiple sizes for use withSteam or EO gas sterilizationprocesses.
14STEP 3 - PACKAGING When packaging instruments, be sure to select an appropriatesize pouch and to place hingedinstruments in an open positionto allow sterilant contact.For quality control, be sure toinclude a chemical indicatorinside and a lot label outside.
15STEP 3 - PACKAGINGTo assist sterilization and aid drying, always place pouches facing each other and on edge using a pouch divider.Inexpensive pouch dividers are available for small and large sterilizers.
16STEP 3 - PACKAGING Sterilization wrap is used for packaging instrument cassettesand/or trays.To allow sterilant to reach theinstruments and to not trap airinside the package, cassettesand trays should be perforated.Wrap should be snug to prevent low spots that could collectcondensate, but not too tight to cause strike through.
17STEP 3 - PACKAGING Instrument trays should be double wrapped to maintainsterility per the wrap mfg’sinstructions for use.wrapped in a way that allowsfor sterile presentation of theprocessed items.
18STEP 3 - PACKAGING Wrapped packs should be sealed with 1”, 3/4” or ½” sterilizationindicator tape.For quality control, be sure toinclude a chemical indicatorinside and a lot label outside.Class 5Class 4
19STEP 3 - PACKAGING Wrapped packs (being heavier) should be placed on the lowershelf of the sterilizer.Loading heavier items on thebottom shelf and lighter itemson the top, enables condensateto drain out without wettingother items in the load.To maintain sterility, packages need to be visibly dry before transporting to a sterile storage area
20STEP 3 - PACKAGING Sterilization containers can be used to process instruments orsets. Containers offer excellentprotection during storage andtransport to the sterile field.As with wrapped trays, loadingcontainers on the bottom shelfand lighter items on the top,enables condensate to drainaway from lighter packages.Some rigid containers can be stacked during sterilization; however, all can be stacked during storage to save space
21STEP 4 - STERILIZATION Steam sterilization is CDC recommended as the processof choice whenever possible.Steam under pressure isconsidered safe, fast and themost cost effective sterilizationmethod for health carefacilities.Gravity displacement and pre-vacuum are the two common types of steam sterilizers
22STEP 4 - STERILIZATION Steam sterilizers are Class II medical devices subject to FDAapproval per a 510(k) clearanceletter.They are available in a widevariety of shapes and sizes forsterilization of heat-stableinstruments.
23STEP 4 - STERILIZATION Always process according to the sterilizer or instrumentmanufacturer’s validatedInstructions For Use (IFU).Some common steam cycleparameters are:250°F/121°C for 30 minutes270°F/132°C for 10 minutes273°F/135°C for 4 minutes
24STEP 4 - STERILIZATION Not all instruments can be processed at these common steam cycles.Therefore, it is critical that you haveeach device mfg’s IFU that detailsthe cycle parameters (exposure timeand temperature), along with themode (gravity, prevacuum, steamflush pressure-pulse).
25STEP 5 – Storage & Delivery Sterile items should be stored in amanner that reduces the potentialfor contamination.The shelf-life of sterile packagesis event related and depends onthe quality of the packagingmaterial, storage conditions andamount of handling.
26STEP 5 – Storage & Delivery Sterile packages should always behandled with care. Avoid dragging,crushing, bending, compressing orpuncturing, as this will compromisethe sterility of the contents.Be sure to inspect sterile packagesbefore distributing. Do not use anypackage that is damaged, wet oropened.
27STEP 5 – Storage & Delivery Sterility maintenance bags(dust covers) may be usedto protect items that couldbe subjected toenvironmental challengesor multiple handlingbefore use.Should be 2-3 mils thick and applied ASAP after sterilization and after the item has cooled.
28STEP 6 – Quality Assurance Chemical indicators should be locatedon the outside/inside of each packageto visibly show they have beenprocessed.Biological indicators should be runat least weekly to verify sterilizationand recorded as part of your formalInfection Control – QA program.
29STEP 6 – Quality Assurance Chemical Indicators are availablein tape, card and strip formats foruse with all processes.These devices change color asindicated, for the process theyare monitoring.
30STEP 6 – Quality Assurance Most large steam sterilizersare prevacuum and requirean air removal check beforeusing. This daily test is donewith a Bowie-Dick test pack.Most table top sterilizers aregravity displacement and donot require this special test;however, prevacuum table topsterilizers are now available.
31STEP 6 – Quality Assurance Test Procedure:Place a Bowie-Dick test pack onthe lowest shelf, over the drain inan empty chamber at 273°F for3.5 or 4 minutes.After processing, the indicatorsheet inside the test pack mustshow a uniform color change topass.A shortened cycle omitting dry time should be run first to properly heat up the sterilizer.
32STEP 6 – Quality Assurance Biological Indicators are processed alongwith a load for sterilizer verification. Forsteam sterilizers, users purchase a 55-60°Cincubator and biological indicator vials.Sterilizer failure is noted if the BI growsduring incubation. Growth is observed bya color change in the media from purpleto yellow.
33STEP 6 – Quality Assurance Biological Indicators can also besent to an outside Lab for 3rd partydocumentation.Mail-in systems use BI strips andpre-paid mailer envelopes. Userssimply run the BI strip and thenmail. A Lab Report is returned andplaced on a “password protected”website:
34STEP 6 – Quality Assurance While sterilizers can and domechanically fail, human erroris the leading cause of sterilizerfailure.Cold startWrong cycleOverloadingImproper packagingAfter processing, the BI strip is mailed to an outside Laboratory for incubation. After hrs, a formal Lab Report is returned to verify steam sterilization
35McKesson thanks you for taking the time to review… The six (6) recommended stepsfor Instrument processing:CleaningInspectionPackagingSterilizationStorage & Delivery6. Quality Assurance
36CE Certificate Available This continuing education programwas developed and produced bySPSmedical Supply Corp. for theMcKesson Corporation.Customers who view this programmay request a complimentary CECertificate from SPSmedical.
37SPSmedical Supply Corp. The largest sterilizer testinglaboratory in North America withover 60 sterilizers SPSmedicalserves on multiple AAMIsterilization standards committeesand provides Seminar speakers tohealth care organizations.For technical questions and CE Certificates, please call:or
38References & Resources Association for the Advancement of Medical Instrumentation1110 North Glebe Road, Suite 220, Arlington, VAFax:Association of periOperative Registered Nurses2170 South Parker Road, Suite 300 Denver, COCertification Board for Sterile Processing & Distribution2 Industrial Park, Suite 3 Alpha, NJ 08865International Assoc. of Healthcare Central Service Materiel Management213 W. Institute Place, Suite Chicago, IL 60610Fax:
40McKesson Brand Sterility Assurance Products To assist users in meeting their sterility assurance needs, contactyour local McKesson Representative for the following McKessonbrand quality products:PACKAGING MONITORINGSelf-Seal Sterilization Pouches • Chemical IndicatorsSterilization Indicator Tape • Biological IndicatorsRecord Keeping Systems • Bowie Dick Test Packs• Incubators/Record Books
41McKesson Brand Sterile Packaging Products Self-Seal Pouches73-SSP ” x 9”73-SSP ” x 10”73-SSP ” x 13”73-SSP387 8” x 16”73-SSP391 12” x 18”
42McKesson Brand Sterile Packaging Products Sterilization Tape73-ST048 3/4” x 60 yds73-ST036 1” x 60 yds73-BT048 3/4” x 60 yds73-BT036 1” x 60 yds73-GT036 1” x 60 ydsLabel Applicator 73-MDG001 Load Record Label 73-URL012 Load Record Card 73-DLC250 Records Envelope 73-LEB100
43McKesson Brand Sterilization Monitoring Products Chemical Indicators73-SIS ” Steam Strip73-SIL ” Steam Strip73-GIL ” EO Strip73-DMS ” Dual StripChemical Integrators73-SSI100 Steam (100 pk)73-SSI1000 Steam (1,000 pk)73-STP025 Steam Test PackDaily Air Removal Test73-SBD030 Bowie-Dick Test Pack
44McKesson Brand Sterilization Monitoring Products Biological Indicators73-SCS025 Steam vial (25 bx)73-SCS100 Steam vial (100 bx)73-SBT025 Steam Test Pack w/25 controls73-SBT255 Steam Test Pack w/5 controls73-NDB °C Dry Block Incubator, 11 mm73-PP012 Mail-In System (12 bx)73-PP052 Mail-In System (52 bx)