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
3INSTRUMENT PROCESSING There are six (6) recommendedsteps for Instrument Processing:CleaningInspectionPackagingSterilizationStorage & Delivery6. Quality Assurance
4STEP 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.
5STEP 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.
6STEP 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.
7STEP 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.
8STEP 2 - INSPECTION Each instrument must be critically inspected after each cleaning for residualdebris or damage.Replace instruments asneeded and never sterilizea “dirty” instrument.
9STEP 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.
10STEP 3 - PACKAGING Instrument packaging should be done in a clean, low contamination area using onlyFDA approved materials,such as:Sterilization pouchesSterilization wrappersSterilization containers
11STEP 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 heat-seal & self-seal designfor use with all sterilizationprocesses.
12STEP 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.
13STEP 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.
14STEP 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.
15STEP 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.
16STEP 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
17STEP 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
18STEP 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
19STEP 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
20STEP 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.
21STEP 4 - STERILIZATION Always process according to the sterilizer or instrumentmanufacturer’s validatedInstructions For Use.Some common sterilizer cyclerecommendations are:250°F/121°C for 30 minutes270°F/132°C for 10 minutes273°F/135°C for 4 minutes
22STEP 4 - STERILIZATION Not all instruments can be processed at common or “normal” cycle times.For example, SYNTHES Generalgraphic cases:Gravity sterilizer:°C for 22 minutesPre-vacuum sterilizer:°C for 8 minutes
23STEP 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.
24STEP 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.
25STEP 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.
26STEP 6 – Quality Assurance Chemical indicators should be placedon 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.
27STEP 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.
28STEP 6 – Quality Assurance Most large steam sterilizersare pre-vacuum 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.
29STEP 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.
30STEP 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.
31STEP 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:
32STEP 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
33McKesson thanks you for taking the time to review… The six (6) recommended stepsfor Instrument processing:CleaningInspectionPackagingSterilizationStorage & Delivery6. Quality Assurance
34CE 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.
35SPSmedical Supply Corp. The largest sterilizer testing Labin North America with over 48sterilizers, SPSmedical serves on10 AAMI sterilization standardscommittees & provides seminarSpeakers to health careorganizations.For technical questions andCE Certificates, please call:or
36ReferencesANSI/AAMI ST35:2003ANSI/AAMI ST33: 1996Safe handling and biological decontamination of reusable medical devices in health care facilities and in nonclinical settingsGuidelines for the selection and use of reusable rigid container systems for EO & Steam sterilization in HC facilities, 2ed
37References Steam sterilization and sterility assurance ANSI/AAMI ST46: 2002ANSI/AAMI ST37: 1996Steam sterilizationand sterility assurancein health care facilitiesFlash sterilization – Steam sterilization of patient care items for immediate care use
38ReferencesANSI/AAMI ST 60: 1996ANSI/AAMI ST 66: 1999Sterilization of health care products-Chemical indicators- Part 1: General requirementsSterilization of health care products-Chemical indicators- Part 2: Class 2 indicators for air removal test sheets and packs
40McKesson Brand Sterility Assurance Products To assist users in meeting their sterility assurance needs, contactyour local McKesson Representative and ask for the followingMcKesson brand quality products:PACKAGING MONITORINGSelf-Seal & Heat-Seal Pouches • Chemical IndicatorsDisposable Sterilization Wrap • Biological IndicatorsSterilization Indicator Tape • B-D and BI Test PacksRecord Keeping System • 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”Heat-Seal Pouches73-HSP250 4” x 8”73-HSP ” x 10”73-HSP ” x 15”73-HSP256 6” x 10”73-HSP ” x 13”
42McKesson Brand Sterile Packaging Products Sterilization Wrap73-HDW ” x 15”73-HDW ” x 18”73-HDW ” x 20”73-HDW ” x 24”73-HDW ” x 30”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-PCS025 Peracetic Acid Culture Set (for STERIS System 1)73-NDB °C Dry Block Incubator, 16 mm73-NDB °C Dry Block Incubator, 11 mm73-PP012 Mail-In System (12 bx)73-PP052 Mail-In System (52 bx)