Presentation on theme: "Cleaning, Packaging & Sterilization of Surgical Instruments"— Presentation transcript:
1Cleaning, Packaging & Sterilization of Surgical Instruments
2Presented by SPSmedical Largest sterilizer testing Lab in North America with over 50 sterilizersDevelop and market sterility assurance products that offer advanced technologiesProvide full day sterilization Seminars and Facility audits for compliance with standards and recommended practicesCorporate member: CSA and AAMI, serving on numerous sterilization committees
3Continuing Education Program Following established protocols forinstrument processing is animportant aspect of modern healthcare as it helps to minimize thepatient’s risk for infection of thesurgical site.This program is intended to providean “overview” of currentrecommended practices and isaccredited by both national sterileprocessing organizations.Approved for 1.5 contact hours through IAHCSMM and 1.0 contact hour through CBSPD
4Meets in Washington, DC throughout each year and Association for the Advancement of Medical InstrumentationMeets in Washington, DC throughout each year andestablishes best practices for sterilization whichbecome the American national standards.Membership includes:Health care facilitiesHealth care organizationsGovernment agenciesMedical device manufacturersTesting labs and Consultants
5Association of periOperative Registered Nurses Recommended Practices are developed by the AORNRecommended Practices Committee and approved bythe AORN Board of Directors.The Joint Commission inspectsfacilities for compliance withbest practices.
6INSTRUMENT PROCESSING There are six (6) recommended steps for Instrument Processing:DecontaminationInspectionPackagingSterilizationStorage & Delivery6. Quality Assurance
7DECONTAMINATION Soiled instruments should be cleaned and disinfected in a designated area, immediately after the surgical procedure. Quick cleaning removes blood or debris much easier and can minimize staining, corrosion or pitting of instruments.If there is a delay in cleaning, keep the blood from drying by placing a wet towel over the instruments or soak with an enzymatic solution.
8DECONTAMINATION Mechanical cleaning is a safer practice for staff and a more effective process over manual cleaning.Therefore, whenever possible,mechanically clean instruments,using warm water and a neutralpH detergent.
9DECONTAMINATION After cleaning, thoroughly rinse instruments with tap water to ensure looseneddebris and detergents areremoved.If the tap water is of poorquality, consider usingtreated water as a final rinseto avoid instrument staining.
10INSPECTION All instruments should be critically inspected after each cleaning for residualdebris or damage.Replace instruments asneeded and never sterilizea “dirty” instrument.
11INSPECTION In addition, check each instrument for proper function and lubricatethose that have “metalto metal” action.Instruments with stiffjoints may be a sign ofinadequate cleaning.
12PACKAGING Instrument packaging should be done in a clean and low contamination area, usingFDA approved products:Sterilization pouchesSterilization wrappersSterilization containers
13PACKAGINGSterilization pouches are recommended for packaging single instruments and small, light weight items.Paper/plastic pouches allowyou to see the contents and areavailable in heat seal and self sealdesign and a wide selection ofsizes.
14PACKAGING When pouching instruments, select an appropriate and be sure to remove any excess air before sealing.For quality assurance, includea multi-variable indicator or an integrator, inside to verify the sterilization parameters were met.IndicatorIntegrator
15PACKAGINGTo assist sterilization and aid drying, place pouches facing each other and on edge using a pouch divider.Double pouching instruments is okay if desired, but be sure to select the correct size pouches.
16PACKAGING Sterilization wrap is recommended to be used for packaging instrumenttrays or cassettes.For an effective barrier and tomaintain sterility until point ofuse, be sure to double wrap perthe wrap mfg’s Instructions ForUse (IFU) and FDA clearance.
17PACKAGING Wrap in a way that allows sterile presentation of the processed tray or cassette.Select the appropriate sizewrap and be careful not towrap too tight or too loose asthis can compromise sterilityby creating air pockets orallowing strike through.
18PACKAGING Wrapped instruments should be sealed with a color change indicator tape. Latex/Lead free indicator tape is now available.For quality assurance, includea multi-variable indicator oran integrator inside, to verifysterilization parameters weremet.Indicator Integrator
19PACKAGING Wrapped trays (being heavier) should be placed on the lower shelf 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 should be visibly dry before removing from the sterilizer
20PACKAGINGSterilization containers are also available to package instrument trays. Made of rigid metal or plastic, filters allow the sterilant to enter the case and sterilize the items.Posts or instrument stringersshould be used to separate andkeep hinged instruments in theiropen position.For quality assurance, be sure to includea chemical indicator or integratorinside every case prior to processing
21PACKAGING Packaging systems (pouches, wrapped sets or rigid containers)can be mixed in the same loadproviding they are approved foruse with the sterilization process.Rigid containers offer excellentprotection during storage and canbe stacked without compromisingsterility.
22STERILIZATION Steam sterilization is CDC recommended as the process of 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 most common types of steam sterilizers
23STERILIZATION 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.
24STERILIZATIONAlways process instruments according to the sterilizer or instrument manufacturer’s validated cycle parameters.Some common sterilizer cycle exposure times are:250°F/121°C for 30 minutes270°F/132°C for 10 minutes273°F/135°C for 4 minutesDry times are additional and can be from 20 to 40 minutes, depending on load type.
25Storage & Delivery Sterile items should be stored in a manner 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.
26Storage & Delivery Sterile packages should always be handled with care. Avoid dragging,crushing, bending, compressing orpuncturing, as this can compromisesterility.Be sure to inspect sterile packagesbefore distributing. Do not use anypackage that is damaged, wet oropened.
27Storage & Delivery Sterility maintenance bags (dust covers) may be usedto provide additional protectionto wrapped instruments thatcould be subjected to adverseenvironmental conditions ormultiple handling before use.Dust covers should be 2-3 mils thick and applied ASAP after sterilization, once the package has cooled.
28Quality AssuranceSterility assurance of processed instruments should be routinelyverified using three (3) types of indicators:1) Physical2) Chemical3) Biological
29Quality Assurance 1) Physical indicators are the time, temperature and pressure gaugesbuilt into sterilizers.These readings should be recordedfor every cycle and verified prior tounloading the sterilizer.Hospital sterilizers are required tohave a chart or printout, whereas this is optional for sterilizerslocated in private offices or clinics.
30Quality Assurance 2) Chemical indicators change color or show movement during processing, toverify sterilization parameters were met.Chemical indicators should be used withevery package on the outside and inside.
31Quality AssuranceIf your facility has a large steam sterilizer, it is typically apre-vacuum type sterilizer that requires an air removal check before using.This daily check is done with aBowie-Dick test pack, usuallybefore the first load of the day.Most table top sterilizers aregravity displacement and donot require this special test;however, recently table topprevacuum sterilizers (Class B) have been introduced.
32Quality Assurance Test Procedure: Place a Bowie-Dick test pack on the lowest shelf, over the drain inan empty chamber at 273°F for 3.5or 4 minutes exposure time.After processing, the color changeindicator inside the test pack shouldshow a uniform color to pass.Retain the indicator as part ofyour Infection Control records.PASS FAIL
33Quality Assurance 3) Biological indicators provide users the highest level of sterility assuranceand contain bacterial spores availablein plastic vial or paper strip format.Steam sterilizers should be biologicaltested at least weekly, preferably dailyand every load that contains an implant.
34Quality Assurance A BI inside a Test Pack should be used to monitor large sterilizers whenprocessing packaged instruments.Steam - place on the bottom shelf,directly above the drain with a load.The SPSmedical Steam BI test packincludes a BI, along with a Class 5 integrator for immediaterelease of load, and is FDA cleared for use with standard orextended sterilization cycles.
35Quality Assurance Flash sterilizers are different in that the BI is not placed inside a test packor with a load, but rather in an emptytray over the drain.If a rigid container is used, then aBI should be run inside the container without a load. AORN standards now recommends using a sealed container when flashing, that is FDA cleared for use with flash sterilization.
36Quality Assurance Biological Indicators can also be sent to an outside Lab for 3rdparty verification.This system is most popular with private offices and uses paper BI strips and pre-paid mailer. After processing, the BIs are mailed to the Lab for incubation and a Test Report is returned.If a failure is recorded, SPSmedical calls the user with recommendations and instructions to retest
37Quality Assurance While sterilizers can and do mechanically fail, humanerror is the leading cause ofsterilizer failure, e.g.Cold startWrong cycleOverloadingImproper packagingAccording to the CDC, sterilizers that fail the routine BI test should not be used until a passed test is recorded.
38SPSmedical thanks you for taking the time to review… The six (6) recommended steps for Instrument Processing:DecontaminationInspectionPackagingSterilizationStorage & DeliveryQuality Assurance
39Monthly Audio Seminars Continuing EducationAdditional Self-Study CD-ROMS available:Hazard CommunicationDecontamination, You & BiofilmsPersonal Protective EquipmentCleaning Surgical InstrumentsSelection & Use of Packaging SystemsSteam Sterilization: Process of ChoiceFlash Sterilization in the ORSafe & Effective Use of ETOSterilization Quality AssuranceEliminating Sterile OutdatesCJD: A Sentinel EventMonthly Audio Seminars
40Purchasing AAMI Standards If your organization is not a member of AAMI, you may want to purchase the Standards directly from SPSmedical at our member discount. We can save you 40-50% depending on the document.For example:ORDER CODE: AAMI ST:79List Price: $240Member Price: $120