3M Health Care Academy What Is Happening Inside That
SM3M Health Care AcademyWhat is happening inside that magic box?Fundamentals of vaporized hydrogen peroxide sterilizationin health care facilitiesApril 28, 2017Chicago APIC
Disclosure Steven Zeplin, MSN, RN, CSPDT 3M Infection Prevention Division- Laboratory Email: sjzeplin@mmm.com 3M Sterilization Tech Line 1-800-441-1922, Option 23M Health Care AcademySM 3M 2016. All Rights Reserved2
Objectives1. Identify options for vaporized hydrogen peroxide sterilizationavailable to health care facilities2. Recognize significant variables that effect vaporizedhydrogen peroxide sterilization in health care facilities3. Describe quality assurance procedures for vaporizedhydrogen peroxide sterilizers in health care facilities 3M 2016. All Rights Reserved3
Sterilization processes in healthcareSteamOther 3M 2016. All Rights Reserved
Why we use steam so much ! FastEffectiveInexpensiveEasy to useReadily availableTechnology well understoodNo toxicity or hazardous residuesCompatible with many devicesRobust - capacity to remain unaffected by small variations in proceduralparametersmodified from USP 39 NF 34 General Information {1225} Validation of Compendial Procedures 3M 2016. All Rights Reserved
When steam is too extreme 3M 2016. All Rights Reserved
Low temperature sterilizationSterilization process usingchemical gases or vapors at lowertemperatures to process heat andmoisture sensitive instrumentsEthylene Oxide (EO)Hydrogen Peroxide (H2O2)Hydrogen Peroxide (H2O2) Ozone ml 3M 2016. All Rights Reserved
Vaporized hydrogen peroxide sterilizationAdvantages High efficacy Rapid activity Cost effectiveness Monitoring capabilityLimitations Materials compatibility Adaptability Penetrability Organic material resistance Toxic Technique Sensitive 3M 2016. All Rights Reserved
Steam sterilization kills with latentheatSteam condensation onsurfaces releases latent heat(energy) that damages anddestroys large biochemicalmolecules required for life Proteins denatured Nucleic acids damagedGAS2257 kJ/kglatent heatenergy !physical pounding !LIQUID 3M 2016. All Rights Reserved
Hydrogen peroxide kills by oxidationOxidation occurs when an atom LOSES electronsThe atom is the basic building block for moleculesELECTRONSCELL WALLDestroys membranelipids, DNA, otheressential cell moleculesATOMchemically ripped apart !BACTERIA 3M 2016. All Rights Reserved
Fun facts: hydrogen peroxide Discovered in 1818 - Thénard Naturally in milk, honey, ordinarytissues w/ normal cell function Wastewater applications 1970’s STERIS VHP process mid-1980’s ASP STERRAD 50 510(k) 19993M Health Care AcademySM 3M 2016. All Rights Reserved11
Which one is a hydrogen peroxidemolecule?Aperacetic acid molecule(liquid chemical sterilant- C 3M 2016. All Rights Reserved
SM3M Health Care AcademyVaporized hydrogen peroxide sterilizer optionsAdvanced Sterilization Products (ASP) STERRAD 100S Sterilization System U.S. 510(k) K991999 6/2000 (16 years ago) 1 cycle option today Standard Cycle55 min - most general surgical instruments STERRAD NX Sterilization System U.S. 510(k) K042116 4/2005 (11 years ago) 2 cycles options todaySTERRAD 100S STERRAD NX Standard Cycle28 min - most general surgical instruments Advanced Cycle38 min - smaller diameter and longer lumensASP is a trademark of the Division of Ethicon US, LLC, a Johnson & Johnson companyis aAcademytrademark of Advanced Sterilization Products.3MSTERRADHealth CareSM 3M 2016. All Rights Reserved13
SM3M Health Care AcademyVaporized hydrogen peroxide sterilizer optionsAdvanced Sterilization Products (ASP) STERRAD 100NX Sterilization System U.S. 510(k) K071385 11/2007 (9 years ago) 4 cycle options today STANDARD Cycle47 min - general surgical instruments DUO Cycle60 min - single-channel flexible endoscopes / light cords / cameras EXPRESS Cycle24 min - da Vinci 3-D endoscopes / other instrument without lumens FLEX Cycle42 min - two single-channel flexible endoscopesSTERRAD 100NXASP is a trademark of the Division of Ethicon US, LLC, a Johnson & Johnson companySTERRAD is a trademark of Advanced Sterilization Products.Vinci isCarea trademark3MdaHealthAcademyof Intuitive SurgicalSM 3M 2016. All Rights Reserved14
SM3M Health Care AcademyVaporized hydrogen peroxide sterilizer optionsSTERIS V-PRO maX Low Temperature Sterilization System U.S. 510(k) K102330 10/2011 (5 years ago) 3 cycle options today Non Lumen Cycle28 min - general surgical instruments Flexible Cycle35 min - single or dual channel flexible endoscopes Lumen Cycle55 min - single, dual and triple channeled rigid andsemi-rigid endoscopes V-PRO 1 Plus Low Temperature Sterilization System U.S. 510(k) K083097 8/2009 (7 years ago) 2 cycle options today Non Lumen Cycle28 min - general surgical instruments Lumen Cycle55 min - single, dual and triple channeled rigid andsemi-rigid endoscopes3MV-PROHealthisCareAcademyof STERIS Corporation STERIS is a trademark of STERISa trademarkV-PRO maXV-PRO 1 PlusVAPROX HCSterilantSM 3M 2016. All Rights Reserved15
SM3M Health Care AcademyVaporized hydrogen peroxide sterilizer optionsSTERIS V-PRO 1 Low Temperature Sterilization System U.S. 510(k) K062297 10/2007 (9 years ago) 1 cycle option today Standard Cycle55 min - general surgical instruments / single lumens V-PRO 60 Low Temperature Sterilization System U.S. 510(k) K140498 7/2014 (2 years ago) 3 cycle options today Non Lumen Cycle28 min - general surgical instruments Flexible Cycle38 min - single or dual channel flexible endoscopes Lumen Cycle60 min - single, dual and triple channeled rigid andsemi-rigid endoscopesV-PRO is a trademark of STERIS Corporation STERIS is a trademark of STERIS3M Health Care AcademyCorporationV-PRO 1V-PRO 60VAPROX HCSterilantSM 3M 2016. All Rights Reserved16
SM3M Health Care AcademyVaporized hydrogen peroxide sterilizer optionsGetinge STERIZONE VP4 Sterilizer (hydrogen peroxide ozone) U.S 510(k) K141163 12/2014 (2 years ago) 1 cycle option today Cycle 146 – 70 min - general surgical instrument /two double-channel and one single-channel orone multi-channel flexible endoscope.STERIZONE is a trademark of TS03 company3M Health Care Academy125-280 Solution (H2O2 50 wt%)8.4-24 g injected/phaseSTERIZONE VP4 SterilizerSM 3M 2016. All Rights Reserved17
Vaporized hydrogen peroxide cyclesDifferent technologies: different cyclesSome commonalities (adapted AAMI ST58)1. Evacuate2. Inject Sterilant (vaporized liquid H2O2)3. Sterilant Exposure (static, no make-ups)4. Vent (diffuse air into chamber & load)5. Evacuate6. Repeat H2O2 injections 2 - 4 times7. Aeration or plasma to removetoxic H2O2 residualsExample: STERIS V-PRO Lumen CycleSTERIS Technical Data Monograph3M Health Care AcademySMV-PRO is a trademark of STERIS Corporation STERIS is a trademark of STERIS 3M 2016. All Rights Reserved18
Vaporized hydrogen peroxide delivery methodsDifferent technologies:different H2O2 delivery methods1. Fixed Volume InjectionAll technologies have static sterilant exposure (dwell) phases Single-dose capsulesNo sterilant make-up in exposure like steam Multiple-use cup2. Dynamic Injection* Multiple use bottle* Total amount of H2O2 introduced into the sterilizationchamber and thus the duration of the injection variesdepending on the load’s size (e.g., surface area or weight),packaging and material composition, and temperature.3M Health Care AcademySM 3M 2016. All Rights Reserved19
Significant variables that may affectvaporized hydrogen peroxidesterilization in health care facilities3M Health Care AcademySM 3M 2016. All Rights Reserved20
Standard for effective use of vaporized hydrogenperoxideReference DocumentANSI/AAMI ST58:2013 - Chemicalsterilization and high-level disinfection inhealth care facilities3M Health Care AcademySM 3M 2016. All Rights Reserved21
ANSI/AAMI ST58:2013Effective use vaporized hydrogen peroxide (Annex H.3)a) Device & sterilizer manufacturers’ written IFUsb) No cellulose-based products (towels, gauze, or paper)c) Lumen sizes cleared by the FDA (based on model cycle)d) Devices should be thoroughly cleaned and driede) Hinged instruments should be openedf) Tyvek -Mylar pouches, polypropylene wrap, or reusable rigid containersg) Trays and mats per IFU and cleared by the FDAh) Ensure adequate sterilant contact, follow all loading recommendationsi) CI’s and Geobacillus stearothermophilis BIs cleared by FDA to monitor3M Health Care AcademySM 3M 2016. All Rights Reserved22
Observed variations in practice affectingperformance Adherence to sterilizer chamber loading recommendations–Limits on weight and device types per models and cycles is complex!–Always refer to the sterilizer manufacturer’s instructions for use Failure to follow rigid container weights Placement of pouched biological indicator Adequacy of drying of load items Materials compatibility (packaging and devices) Use of non-validated containers3M Health Care AcademySM 3M 2016. All Rights Reserved23
Chamber loading practicesTo ensure adequate sterilant contact, personnel shouldload the sterilizer as recommended in the sterilizermanufacturer’s written IFU (AAMI ST58)Example STERRAD 100S* allow 1 inch fromtop of load and the electrode STERRAD 100S* allow 1 inchbetween packages in the load STERRAD 100S* place packagesflat on shelves in a single layer STERRAD 100S* do not stack trays3M Health Care AcademySM*STERRAD 100S Instrument Processing Guidelines AD-51825-01 US CSTERRAD is a trademark of Advanced Sterilization Products 3M 2016. All Rights Reserved24
Chamber loading practicesExampleSTERRAD 100NX Express cycleEmpty top shelf*STERRAD 100NX System Cycle Selection AD-090152-0-CT CSTERRAD is a trademark of Advanced Sterilization Products3M Health Care AcademyBottom shelf onlySM 3M 2016. All Rights Reserved25
Sterilizer chamber loading weightsModelCycleWeight(lb)STERRAD 100SStandard (default) 1Not definedSTANDARD 210.7STERRAD NXAdvancedSterilizationProducts (ASP) -ADVANCED 2Notes1 flexible scope ONLY noadditional load10.7STERRAD 100NXSTANDARD 321.4FLEX 321.42 flex scopes, no additional loadEXPRESS 310.7Bottom shelf only!DUO 313.22 flexible scopes & access.Example STERRAD 100S does not have a defined weight limit, but rigid containersdo Always refer to the sterilizer manufacturer’s instructions for use.ASP is a trademark of the Division of Ethicon US, LLC, a Johnson & Johnson companySTERRAD is a trademark of Advanced Sterilization Products.3M Health Care Academy1.2.3.FDA 510(k) K111377 SummaryFDA 510(k) K160818 SummaryFDA 510(k) K160903 Summarywww.accessdata.fda.govSM 3M 2016. All Rights Reserved26
Sterilizer chamber loading weightsModelCycleWeight (lb)NotesNon Lumen 450.0Mixed load ref IFU-2 flex scopes, no additional load24.01 flex scope and additionalnon-lumened instrumentsLumen 419.6Mixed load ref IFUCycle 1 575.0Mixed loads allowed ref IFULimitson weightV-PRO and devicetypesper models and cycles is complex!STERIS maXFlexible 4GETINGEVP4 Always refer to the sterilizer manufacturer’s instructions for use.4.5.V-PRO is a trademark of STERIS CorporationSTERIS is a trademark of STERIS CorporationSTERIZONE is a trademark of TS03 company3M Health Care AcademyFDA 510(k) K160433SummarySTERIZONE VP4 LowTemperature SterilizerBrochurewww.accessdata.fda.govSM 3M 2016. All Rights Reserved27
Container manufacturers’ recommended D 100SWeight (lb)Carefusion RigidV.Mueller GenesisContainers4.03.4*B.Braun Aesculap SterilContainerS SystemCarefusion V.Mueller GenesisContainerscontainerweight5.04.4* limits vary!6.05.2*4.57.05.57.06.07.0B.Braun Aesculap SterilContainerS SystemVerify limits per container manufacturer IFU,6.031.95**containersize, sterilizer model, and sterilizer cycle !4.0Case MedicalSteriTite 8.0* Excluding the container weight**Do not use nylon coated brackets or silicone mat.V. Mueller and Genesis are trademarks of CareFusion CorporationAesculap and SterilContainer is a trademark of the B.Braun Corp.3MHealthAcademyof Case MedicalSteriTiteis Carea trademarksCase MedicalSteriTite SM 3M 2016. All Rights Reserved28
Placement of biological indicators - STERRAD ASP STERRAD Cyclesure 24 most challengingarea for the sterilantto reachASP is a trademark of theDivision of Ethicon US, LLC, aJohnson & Johnson companySTERRAD is a trademark ofAdvanced Sterilization Products. typically shelf close tothe rear of thesterilizerActivate immediatelyFinal result in 24 hours white Tyvek sideshould be facing up*How to Use the STERRAD CYCLESURE 24 BiologicalIndicator AD-51868-01-US F3M Health Care AcademySM 3M 2016. All Rights Reserved29
Placement of biological indicators - STERRAD STERIS Verify V24 SCBIIf not immediate,activate within 72hours if stored atroom temperatureReference Document # M3997EN.2015.03 Rev. B 2015 STERIS CorporationV-PRO is a trademark of STERIS Corporation STERIS is a trademark of STERISCorporation3M Health Care AcademyFinal result in 24 hoursSM 3M 2016. All Rights Reserved30
Placement of biological indicators – V-PRO STERIS Verify V24 SCBIIf not immediate, activate within 72hours if stored at room temperatureReference Document # M3997EN.2015.03 Rev. B 2015 STERIS CorporationSTERIS VERIFY V24 Self-Contained Biological Indicator IFUV-PRO is a trademark of STERIS Corporation STERIS is a trademark of STERISCorporation3M Health Care AcademyFinal result in 24 hoursSM 3M 2016. All Rights Reserved31
Placement of biological indicators - STERRAD and V-PRO 3M Attest Rapid Readout Biological Indicator 1295Activate within 1 hour of thecompletion of the cycleFinal result in 4 hours3M Health Care AcademySMASP is a trademark of the Division of Ethicon US, LLC, a Johnson & Johnson companySTERRAD is a trademark of Advanced Sterilization Products.V-PRO is a trademark of STERIS Corporation STERIS is a trademark of STERIS 3M 2016. All Rights Reserved32
Interpreting VH2O2 biological indicators resultsASP Sterrad Cyclesure 24 and / orexhibitsturbidity Steris Verify V24 SCBI3M Attest Rapid Readout BI 1295?Automatic clear distinct / -3M Health Care AcademySM 3M 2016. All Rights Reserved33
Adequacyof drying“Devices should be thoroughly cleanedand dried before sterilization becauseexcessive moisture can cause cyclecancellation” (AAMI ST58)“If the load is not properly dried,effective sterilization may not beachieved because of localized coldspots.condensing vaporized H2O2”HPN Self-Study Using HPG sterilization forheat-sensitive devices, Jan 2015, Nancy A.Robinson, Ph.D. and Randal W. Eveland, Ph.D.3M Health Care AcademySM 3M 2016. All Rights Reserved34
Atmospheric Pressure1000Adequacyof dryingVacuum orEvacuation StageVacuum MeetsTargetCycle ProceedsPressure (Torr)100Target VacuumLevelWater VaporCycleCancelation1010.13M Health Care AcademySMlocalized cold spotVacuum Time (minutes) 3M 2016. All Rights Reserved35
Materials compatibilityNo cellulose-based productsAbsorptive of H2O2Can result in cycle cancellationsCellulose-based productsPrecedent set for U.S. FDAcleared hydrogen peroxideindicator products to containinsignificant amounts cellulose(AAMI ST58) towels gauzeSTERRAD SEALSURE Chemical Indicator Tape paper muslin3M Health Care AcademySM3M Attest RapidReadout BiologicalIndicator 1295STERRAD and SEALSURE are a trademarks of Advanced Sterilization Products 3M 2016. All Rights Reserved36
Materials compatibility“The medical device and sterilizermanufacturers’ written IFU should beconsulted to determine the compatibilityof the device with hydrogen peroxidegas sterilization” (AAMI ST58)July 24, 2014 - Compatibility of Olympus Small Diameter Flexible Endoscopes, Camera Heads and Accessories withthe STERRAD NX Sterilizer: Technical Information for Olympus and Gyrus ACMI Customers in the United States3M Health Care AcademySMOlympus is a trademark of the Olympus companySTERRAD is a trademark of Advanced Sterilization Products. 3M 2016. All Rights Reserved37
Materials compatibility – observed variation“ Tyvek -Mylar pouches, polypropylenewrap, or reusable rigid sterilizationcontainer systems cleared by the FDA ”(AAMI ST58)3M Health Care AcademyOver time surface damage/wearand tear of trays and rigid metalcontainers can affect compatibilityin vaporized hydrogen peroxideSM 3M 2016. All Rights Reserved38
Materials compatibility - real world scenarioBackgroundProblem STERRAD 100S Sterilizer Intermittent automatic cycle cancelations Tens of thousands of cyclesMessage: Low Pressure In Injection Preventative maintenance current Intermittent positive biological indicators Vaporizer plate changed routinely Intermittent incomplete chemicalindicators3M Health Care AcademySMASP is a trademark of the Division of Ethicon US, LLC, a Johnson & Johnson companySTERRAD is a trademark of Advanced Sterilization Products. 3M 2016. All Rights Reserved39
Materials compatibility - real world scenarioRoot Cause Investigation Low Pressure In Injection Corresponds to the vaporizedH2O2 in the chamber Automatic cycle cancel 6torrfor a Injection pressure Further review of cycles revealmany cycles with InjectionStages close to failure 6–7torr3M Health Care AcademySM 3M 2016. All Rights Reserved40
Materials compatibility - real world scenarioRoot Cause Investigation Review of load and cycle recordsindicated a trend in a load Load: 2 plastic trays 2 cameras and 2 light cords Wrapped disposable blue wrap Operator’s manual troubleshooting tipfor this fault: “Load may contain cellulose,linen, paper pouch, or other absorbentmaterials. Check load, repackage, and restartthe sterilizer”3M Health Care AcademySM 3M 2016. All Rights Reserved41
Materials Compatibility - Real World ScenarioRoot Cause Investigation Cont. Bottom & lid of plastic tray were fromdifferent manufacturers Lid compatible w/ STERRAD 100S Could not confirm compatibility bottomof tray Switched to APTIMAX traysDoubled load size (4 cameras) !Cycle cancellations stopped !Negative biological indicators !Complete color change CI’s !3M Health Care AcademySMSTERRAD is a trademark of Advanced Sterilization Products. 3M 2016. All RightsReservedAPTIMAX is a trademark of Advanced SterilizationProducts42
Discuss standards and guidelinesfor monitoring vaporized hydrogenperoxide sterilizers3M Health Care AcademySM 3M 2016. All Rights Reserved43
Fun facts: microbiology and disease“I wouldn’t touch him with a 10 ft-foot pole” Great Plagues 17th Century (primary bubonic plague) Clothes of victims destroyed by fire Physicians wore protective clothing Bodies skewered with at least a 10 foot pole3M Health Care AcademySM 3M 2016. All Rights Reserved
Standards and guidelines for monitoring vaporizedhydrogen peroxideReference Documents ANSI/AAMI ST58:2013 – “Chemical sterilizationand high-level disinfection in health carefacilities” AORN – “Guidelines for Perioperative Practice”– 2016 Edition– Guideline for Sterilization (2016)3M Health Care AcademySM 3M 2016. All Rights Reserved45
AAMI ST58:2013 Section 9 Quality Control9.5 monitoring gaseous chemical sterilization processes Physical MonitorsChemical IndicatorsBiological Indicators3M Health Care AcademySM 3M 2016. All Rights Reserved46
AAMI ST58:2013 Section 9 Quality Control9.5 monitoring gaseous chemical sterilization processesPhysical Monitorstime, temperature,pressure physicalmonitoring andother recorders;indicators of sterilizer performancedisplays;printouts; aandgaugesfor careful adherence toshouldneverdigitalbe consideredsubstitute prescribedprintout shouldbe verifiedpackagingand loading procedures . (AAMI ST58) cycle identification number end of the cycle examine and interpret verify cycle parameters met and initial3M Health Care AcademySMSTERRAD is a trademark of Advanced Sterilization Products. 3M 2016. All Rights Reserved47
AAMI ST58:2013 Section 9 Quality ControlRecommended Chemical Indicator (CI) Usage Exposure Control:external CI on every package“Using chemical indicators .A CI should be used on the outside ofeach package unless the internal indicatoris visible ”– AAMI ST58:2013, Section 9.5.3.23M Health Care AcademySM 3M 2016. All Rights Reserved48
AAMI ST58:2013 Section 9 Quality ControlRecommended Chemical Indicator (CI) Usage Pack Control: internal CI inside everypackage, tray, containment device,cassette, instrument tray“Using chemical indicators . The CI should be placed in that area of thepackage, tray, or containment device that createsthe greatest challenge to sterilant penetration.”- AAMI ST58:2013, Section 9.5.3.23M Health Care AcademySMUnprocessedProcessed 3M 2016. All Rights Reserved49
AAMI ST58:2013 Section 9 Quality ControlBiological Indicators9.5.4.1 General considerations“ Biological indicators are intended todemonstrate whether the conditions wereadequate to achieve sterilization.”9.5.4.3 Frequency of use “A PCD with the appropriate BI should also beused at least daily, but preferably in everysterilization cycle (see 9.5.4.5)”Each load containing implantable.”- AAMI ST58:2013, Section 9.5.4.33M Health Care AcademySM 3M 2016. All Rights Reserved50
AORN Guideline for Sterilization (2016)Low-temperature hydrogen peroxide gasplasma sterilizers and hydrogen peroxidevapor sterilizer Geobacillus stearothermophilus biological indicators routine load release routine sterilizer efficacy monitoring sterilizer qualification testing, period product quality assurance testing2016 AORN Guideline for Sterilization, Recommendation XX.h.4AORN: routine BI testing at least daily on each cycle type, preferably with each load3M Health Care AcademySM 3M 2016. All Rights Reserved51
Routine sterilizer efficacy monitoringvaporized hydrogen peroxide sterilizersModalityAAMIAORNHydrogen Peroxide(H2O2) Gas PlasmaSterilizerPCDwith BI daily butpreferably every cycleAt least daily on each cycletype, preferably with eachload (XX.h.4)Hydrogen Peroxide(H2O2) vaporsterilizerPCDwith BI daily butpreferably every cycleAt least daily on each cycletype, preferably with eachload (XX.h.5)AAMI– Association of Advancement Medical Instrumentation AAMI/ST58:2013AORN - 2016 Edition Guidelines for Perioperative Practice. Guideline for Sterilization.3M Health Care AcademySM 3M 2016. All Rights Reserved52
AAMI ST58:2013 Section 9 Quality ControlSection 9 Quality Control Daily Control BIAcceptance criteria:– Negative result from test BI– Positive result from control BI– Appropriate readings from physical monitors– CI with acceptable end-points control- AAMI ST58:2013, Section 9.5.4.5.33M Health Care AcademySM 3M 2016. All Rights Reserved53
AAMI ST58:2013 Section 9 Quality Control9.5.4.6 Positive biological indicator results“b) Because a sterilization failure hasoccurred, items processed in thatsterilizer since the sterilization cyclehaving the last negative BI should beconsidered nonsterile.They should be retrieved, if possible, andreprocessed.The sterilizer in question should be takenout of service.”- AAMI ST58:2013, Section 9.5.4.5.6 b)3M Health Care AcademySM 3M 2016. All Rights Reserved54
SEM pictures of spores exposed, can you guess how?Dead – Exposed to EODead – Exposed to SteamDead – Exposed to H2O2Happy Viable SporesADead – Exposed to H2O23M Health Care AcademyBDead – Exposed to EOCDead – Exposed to SteamSM 3M 2016. All Rights Reserved
SM3M Health Care AcademySummary1. Sterilization with steam is different than chemical sterilization. Themode of action for vaporized hydrogen peroxide sterilization isthrough the chemical process of oxidation.2. Health care facilities have many options for vaporized hydrogenperoxide sterilization, they all have advantages and limitations.Manufacturers’ IFU should always be followed to ensure the highestlevel of patient safety.3. The AAMI document ST58 covers chemical sterilization and high-leveldisinfection in health care facilities. AORN also provides sterilizationmonitoring recommendations for hydrogen peroxide sterilizers inhealth care facilities.3M Health Care AcademySM 3M 2016. All Rights Reserved56
Thank you3M Health Care AcademySM 3M 2016. All Rights Reserved
ReferencesAssociation of Perioperative Registered Nurses (AORN)Guidelines for Perioperative Practice (2016) Guideline for Sterilization Guideline for Selection and Use of Packaging Systemsfor Sterilization3M Health Care AcademySM 3M 2016. All Rights Reserved
How to Purchase AORN Standards forYour Reference LibraryAORN standards can be purchased through AORN usingthe following options: Internet: https://www.aornbookstore.org/ Call: 1-800-755-2676 x 1 or 303-755-6304 x 1(Monday-Friday, 8AM To 4:30PM MST) Fax: 303-750-3212 By mail: AORN, Inc., Customer Service/Book Orders,2170 South Parker Road, Suite 400, Denver, CO 80231, USA3M Health Care AcademySM 3M 2016. All Rights Reserved
ReferencesAssociation for the Advancement of MedicalInstrumentation (AAMI) ANSI/AAMI ST58:2013 - Chemicalsterilization and high-level disinfection inhealth care facilities3M Health Care AcademySM 3M 2016. All Rights Reserved
How to Purchase AAMI Standards forYour Reference LibraryAAMI documents can be purchased through AAMI by credit card using the following fouroptions: ProductDetail.aspx?ItemNumber 1383 Call: 1-877-249-8226 Fax: 301-206-9789 Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD 20701-02113M Health Care AcademySM 3M 2016. All Rights Reserved
Additional References USP 39 NF 34 General Information {1225} Validation of Compendial Procedures Schneider, M.S. New Technologies for Disinfection and Sterilization. Published in Disinfection,Sterilization and Antisepsis from: Principles, Practices, Challenges, and New Research, edited byWilliam Rutala. Published by the Association for Professionals in Infection Control and Epidemiology,Inc, Washington, DC, 2003. www.apic.org Russel, Hugo, and Ayliffes. Sterilization. Principles and Practice of Disinfection, Preservation andSterilization, 4th ed, 2004, Chapter 12, p. 413-414, Blackwell Publishing, MA. User’s Guide STERRAD NX Sterilization System Ref 99920 (STERRAD is a trademark of Advanced Sterilization Products) www.accessdata.fda.gov FDA 510(k) summaries, U.S. 510(k) K991999, U.S. 510(k) K042116, U.S.510(k) K071385, U.S. 510(k) K102330, U.S. 510(k) K083097, U.S. 510(k) K062297, U.S. 510(k)K140498, U.S 510(k) K141163 STERIS AMSCO V-PRO 1 AND AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATIONSYSTEM Technical Data Monograph (V-PRO is a trademark of STERIS Corporation STERIS is a trademark of STERIS Corporation)3M Health Care AcademySM 3M 2016. All Rights Reserved
Additional References STERIZONE VP4 Low Temperature Sterilizer Product Specification (STERIZONE is a trademark of TS03 company) STERRAD 100S Instrument Processing Guidelines AD-51825-01 US C(STERRAD is a trademark of AdvancedSterilization Products) STERRAD 100NX System Cycle Selection AD-090152-0-CT CSTERRAD is a trademark of Advanced SterilizationProducts) www.accessdata.fda.gov FDA 510(k) summaries FDA 510(k) K111377 Summary, FDA 510(k)K160818 Summary, FDA 510(k) K160903 Summary, FDA 510(k) K160433 Summary STERIZONE VP4 Low Temperature Sterilizer Brochure Carefusion V.Mueller Genesis Containers Instructions for Use B.Braun Aesculap SterilContainerS System Instructions for Use Case Medical SteriTite Instructions for Use How to Use the STERRAD CYCLESURE 24 Biological Indicator AD-51868-01-US F Reference Document # M3997EN.2015.03 Rev. B 2015 STERIS Corporation3M Health Care AcademySM 3M 2016. All Rights Reserved
Additional References HPN Self-Study Using HPG sterilization for heat-sensitive devices, Jan 2015, Nancy A. Robinson,Ph.D. and Randal W. Eveland, Ph.D. July 24, 2014 – Olympus Alerts and Statements - Compatibility of Olympus Small DiameterFlexible Endoscopes, Camera Heads and Accessories with the STERRAD NX Sterilizer:Technical Information for Olympus and Gyrus ACMI Customers in the United States3M Health Care AcademySM 3M 2016. All Rights Reserved
V.Mueller Genesis Containers Half-Size Containers Depth (inch) STERRAD 100S Weight (lb) Carefusion V.Mueller Genesis Containers 4.0 3.4* 5.0 4.4* 6.0 5.2* B.Braun Aesculap SterilContainerS System 4.5 7.0 5.5 7.0 6.0 7.0 Case Medical SteriTite 4.0 6.0 31.95** 8.0 B.Braun Aesculap
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