Decontamination, Disinfection, And Sterilization

CLEANING,DISINFECTION, ANDSTERILIZATIONNovember 5, 2019

MARJORIE WALL,MLOS, CHL, CIS,CRCST, ASQ CSSBBDirector of Sterile Processing, Kaiser PermanenteIAHCSMM Board of Directors20 years of industry experienceContact Info:Email: mmawall@msn.comPhone: 714.316.4452Disclaimer:This presentation represents my own opinionand not any organization that I am affiliatedwith.

WHY SHOULD INFECTION CONTROLPARTNER WITH SPD?

OBJECTIVESAt the end of this lecture, participants will be able to:ENVIRONMENTALCONCERNSDiscuss environmental bestpractices for instrumentreprocessing.POINT OF USECLEANING ANDDECONTAMINATIONINSPECTION,ASSEMBLY, ANDSTERILIZATIONENDOSCOPE ANDHIGH LEVELDISINFECTIONDiscuss point of usecleaning anddecontamination bestpractices for surgicalinstrument reprocessing.Explain instrumentpreparation, sterilization andsterile storage bestpractices.Identify basic steps for highlevel disinfection of flexiblegastrointestinal endoscopes.

FOCUS 01STANDARDS/ENVIRONMENTAL CONCERNSDiscuss environmental best practices for instrument reprocessing.

STANDARDS

ASHRAE 170SPD FACILITY REQUIREMENTS*AAMI and AORN now defer to ASHRAE Standards. Organization is held to theASHRAE standard at the time of installation or last major 10Yes60-65F20%-60%Sterilizer Equipment 0%-60%Preparation and PackagingPositive10No68-73F20%-60%Textile Packaging RoomPositive10No68-73F20%-60%Clean/Sterile StoragePositive4No 75F 70%Functional AreaSterilizer Loading/Unloading

FACILITY DESIGNDirtyCleanSterile Clean and Dirty Areas must be physically separatedor 36” apart. People flow must move from clean to dirty. Equipment flow must move from dirty to clean.

ENVIRONMENTALCONSIDERATION Floors and horizontal work surfaces Clean and disinfect daily Floor should be seamless, not grout Walls and storage shelves should becleaned regularly on a scheduled basis. Ceilings and walls should be made ofnon-shedding and non-porousmaterials.

SURGICAL INSTRUMENTATION FLOW

FOCUS 02POINT OF USE CLEANING ANDDECONTAMINATIONDiscuss point of use cleaning and decontamination best practices for surgicalinstrument reprocessing.

IMPORTANCE OFPRECLEANING Effective Cleaning CANNOT TakePlace Without Effective Pre-cleaning Precleaning prevents formation ofBIOFILM. Biofilm is “a group of microorganismsthat form on a solid surface that comes incontact with water.” Biofilm can harbor resistantmicroorganisms reducing theeffectiveness of high level disinfection orsterilization.

CLEANING STARTS ON THEPROCEDURAL FIELDWipe instruments using a sterile, water moistened sponge.Instruments with lumens should be flushed with sterile water.Saline, bleach, or other solutions should NEVER be used.

POINT OF USECLEANING Pre-cleaning prevents damage ofinstrumentation and equipment. Dried blood is corrosive and causespitting, rusting, and metal fatigue. Damaged instruments and equipmentis unsafe to use on patients and canharbor microorganisms.

BIOHAZARDOUSTRANSPORTOSHA BLOODBORNEPATHOGENS 1910.103 Immediately or as soon as possibleafter use, contaminated reusablesharps shall be placed in appropriatecontainers until properlyreprocessed. These containers shall be: Puncture resistant Labeled or color-coded inaccordance with this standard Leak proof on the sides andbottom

DECONTAMINATION PPE

EnzymaticValidate dosing accuracyValidate NOT expiredValidate approved by OEMNo topping offDECONTAMINATIONCHEMICALS

MANUAL CLEANING Brushing of Instruments Nylon brushes are used to remove debris frominstruments. Brushing should occur as follows: Under water line to prevent aerosolization. Brush all serrations Brush all hinges. Brush all lumens

ULTRASONICCLEANING

AUTOMATEDCLEANING Place instruments in a position ensuringmaximum exposed surface area through theautomated wash process. Stringer should be placed so that hingedinstruments are held in the open position.

DECONTAMINATION QA TESTING

FOCUS 03INSPECTION, ASSEMBLY, AND STERILIZATIONExplain instrument preparation, sterilization and sterile storage best practices.

ASSEMBLYINSPECTION Check each instrument for the following: Corrosion Rust Pitting Cracks Burrs Sign of wear If any of the above are found, removethe instrument from service.

ASSEMBLY INSPECTION Check each instrument forfunctionality: Scopes Visual inspect lens for cracksor water penetration Verify optics not damaged Cameras Verify prisms not cracked orwet internally Check for damaged cords Light Sources Verify fiber optics notdamaged

ASSEMBLY STAINSStain ColorProbable CauseBrown/Orange StainsHigh pH - improper soaps, baked on blood, soaking in salineor using laundry soap (usually is not rust)Bluish-Black StainsExposure to saline, blood or potassium chloride Reverseplating if two types of metals are placed in ultrasonictogetherLight and Dark SpotsWater spots from allowing instrument to air dryDark Brown/Black StainsLow pH acid stain - detergents or dried bloodMulti-Color StainsExcessive heat - “hot spots” in autoclaveBluish-Gray StainsCold sterilization solution used outside manufacturerguidelines

ASSEMBLYCHEMICALINDICATORS

PEELPOUCHES Size of peel pouch: 1” aroundinstrument. Handle located by chevron. Chemical integrator included. Tip protector if appropriate. Double peel pack only ifvalidated. Do not overload with too manyinstruments. Do not use inside trays. Sterilize paper to plastic onside.

POLYPROPYLENE WRAP

RIGIDCONTAINERS

IUSSSTERILIZATION Rapid sterilization process for emergency useInstruments must be validated by OEMImplants should not be IUSS’dTransport in a closed containerCan be wetTray cannot be stored for another patient

PREVAC STEAMSTERILIZATION AAMI removed parameters, followinstrument manufacturer’sinstructions for use/validatedsterilization parameters. Must not be wet. Load Configuration: Linen Peel pouches Wrapped items Rigid containers

PREVAC STEAMSTERILIZATION QA Required Testing: Bowie Dick Test 1st load daily Biological for weakest cycle weekly Biological in every implant load Sterilizer Qualification Testing 3 consecutive Biological Tests 3 consecutive Bowie Dick Tests Document lot number and expirationdate Start a new control daily or when lotnumber changes

LOW TEMPERATURESTERILIZATION H202 based technology Plasma or Vaporized Used for heat sensitive items Only items validated for cycle can be ran Weight restrictions on loads No porous or absorbent materials Only use validated chemical integratorsand tape.

STERILE INTEGRITY Items should be stored as not to crush,compress, puncture or compromise sterility ofcontents. Whenever there is a question as to whetherthe package is sterile or not, it is consideredunsterile.

STERILESTORAGE Configure so wrapped Trays arenot stacked Items are stored ergonomicallycorrect

STERILETRANSPORT Sterile trays should be covered duringtransport to protect from contamination. Trays should be handled minimally to preventdamage to packaging.

ROBOTIC INSTCONSIDERATIONS Davinci Robotic Instrumentsrequire special processes to cleanand sterilize. Routine direct observationcompetencies FDA now requires 510K forvalidating automated processes. Currently no validatedmanufacture on the market inUSA

TASSCONSIDERATIONSMultiple outbreaksRCA completedEnzymatic detergentsEye Instruments MUST go througha full rinse, preferably withdeionized water. Lumens must be flushed with waterprofusely prior to sterilization

CJD CONSIDERATIONS CJD Risk for any proceduresinvolving dura matter, spinal fluid,back of eye If unknown, treat as CJD. Process required for surgery tocommunicate to SPD Internal risk assessment for how tohandle trays Single Use Instruments? CJD Cycle: 134C for 18 minutes

FOCUS 04ENDOSCOPE AND HIGH LEVEL DISINFECTIONIdentify basic steps for high-level disinfection of flexible gastrointestinalendoscopes.

FLEXIBLE SCOPES s/flexible-endoscope-reprocessing.html

FLEXIBLE SCOPESPROCESSING STEPS Follow the OEM IFU. Pre-Clean scope Leak Test scope Manual clean Follow directions exactly,may include Brushing Flushing Suctioning Rinse after cleaning Visual inspection High level disinfection Rinse after HLD Dry (alcohol if required by OEM) Storage

Three Bay Sink Sink 1 Leak Test Sink 2 Soak/Brush/Flush Sink 3 Rinse Dirty to clean flow 36” or physical barrierbetween dirty and clean Same PPE and chemicalrequirements as SPDFLEXIBLE SCOPEDECONTAMINATION

MANUAL HIGHLEVELDISINFECTION Ensure chemical is validatedby Scope OEM Manual solutions requirespecific time, temperature,and length of use followingmanufacturer IFU.

Chemical may requireactivation. Date chemical opened anddate expired after opening. Chemical strip opening andtesting. After expiration, chemicalmay need to be neutralizedprior to disposal. PPE should always be wornwhen handling chemicals. Never top off. Have a spill kit and eyewash.MANUAL HIGH LEVELDISINFECTION

MANUAL HIGH LEVEL DISINFECTION Scope must stay fully submergedfor OEM required time Temperature must meet OEMrequirement Rinse must be completed withsterile or filtered water accordingto OEM

AUTOMATEDENDOSCOPEREPROCESSOR HLD Ensure your scope is validatedfor your machine. Ensure you have all requiredattachments Scope washers do not replacemanual cleaning

Machine should be selfdisinfecting No residual water shouldremain in hoses andreservoirs Cycles for alcoholflushing and forced airdrying are desirable Self contained or externalwater filtration system Follow scope OEM andAER OEM instructionsexactlyAUTOMATED ENDOSCOPEREPROCESSOR HLD

GI Scope Processing must betraceable between patients Time between stepsdocumentation is monitored bysome OEMs If too much time elapses,extended processing isrequired. Leak Testing pass or fail mustbe documented If failed, scope must besent out for repair Chemical strip test should becompleted and documenteddaily and on each cycle. Temperature of chemicalsolution Exposure time of chemicalsolutionHIGH LEVEL DISINFECTIONDOCUMENTATION

FLEXIBLE SCOPESSTORAGE Storage cabinets should be made of a materialthat can be disinfected. In conventional storage (no drying options)scopes are hung vertically to facilitate drying. When using drying cabinets, follow OEM IFU forhow to position scopes.

FLEXIBLE SCOPESSTORAGE Removable buttons and valves shouldbe reprocessed and stored with thescope as a unique set for trackingpatient to patient. Hung scopes should not come incontact with each other, and glovesshould always be worn to preventcross contamination. Do a Risk Assessment for Hang Time

QUESTIONS?

STERILIZATION Explain instrument preparation, sterilization and sterile storage best practices. ENDOSCOPE AND HIGH LEVEL DISINFECTION . Saline, bleach, or other solutions should NEVER be used. POINT OF USE CLEANING Pre-cleaning prevents damage of instrument