Healthcare Luminaires Providing Continuous Visible Light Disinfection Indigo-Clean ®www.kenall.com | P: 800-4-Kenall | F: 262-891-9701 | 10200 55th Street Kenosha, Wisconsin 53144 This product complies with the Buy American Act: manufactured in the United States with more than 50% of the component cost of US origin. It may be covered by patents found at www.kenall.com/patents. Content of specification sheets is subject to change; please consult www.kenall.com for current product details. Table of Contents Why Indigo-Clean? 3 How Does Indigo-Clean Work? 4 What Does Indigo-Clean Kill? 5 Clinical Effectiveness 6 Surgical Site Fixtures 10 Treatment Area Fixtures 12 IC100 Control System 14 Testimonials 16 Warranties, Listings 18 2 Indigo-Clean ®3 Indigo-Clean ® www.kenall.com | P: 800-4-Kenall | F: 262-891-9701 | 10200 55th Street Kenosha, Wisconsin 53144 This product complies with the Buy American Act: manufactured in the United States with more than 50% of the component cost of US origin. It may be covered by patents found at www.kenall.com/patents. Content of specification sheets is subject to change; please consult www.kenall.com for current product details. Why Indigo-Clean? The problem: Current environmental disinfection methods are short-lived, and harmful bacteria begin re-populating the space as soon as cleaning is complete. The solution: Indigo-Clean is a patented, continuous environmental disinfection technology that uses visible light to safely, automatically and continuously kill harmful bacteria, 24/7 , in the air, and on hard and soft surfaces. It also prevents bacteria from repopulating the space, consequently bolstering current infection prevention efforts. What makes Indigo-Clean Unique: • Indigo-Clean is an environmental disinfection device that is integrated into your lighting • Indigo-Clean kills bacteria in the air, and on hard and soft surfaces, that can be missed during routine cleaning • Indigo-Clean requires no special training, additional staff or consumables to operate • Indigo-Clean is NOT UV light... it uses safe 405nm visible light M4SEDIC Series MEIC Series M4DLIC6 Series 4 Indigo-Clean ® www.kenall.com | P: 800-4-Kenall | F: 262-891-9701 | 10200 55th Street Kenosha, Wisconsin 53144 This product complies with the Buy American Act: manufactured in the United States with more than 50% of the component cost of US origin. It may be covered by patents found at www.kenall.com/patents. Content of specification sheets is subject to change; please consult www.kenall.com for current product details. Visible light spectrum showing the active element in Indigo-Clean Indigo-Clean requires no line of sight to disinfect, but instead reflects off surfaces, disinfecting everywhere the light reaches. How It Works * : • The 405nm emitted from Indigo-Clean luminaires reflects off of walls and surfaces, penetrating harmful micro-organisms • The 405nm light targets and excites naturally occurring molecules within the bacteria called porphyrins, to produce intra-cellular Reactive Oxygen Species (ROS). • Similar to bleach, these ROS create an oxidative environment within the organism, inactivating it and preventing it from re-populating the space. 405nm Creates ROS Peroxide Hydrogen PeroxideHydroxyl ionHydroxyl radical OxygenSuperoxide anion O 2 O 2 - O 2 2 - H OH - O 2 H 2 H HH OH . Inactivation of bacteria via visible light absorption Porphyrin Bacteria Cell Inactivated Bacteria Cell How Does Indigo-Clean Work? * Indigo-Clean products and technology covered by U.S. Patent No. US 9,039,966 and US 8,398,264. May also be covered by patents found at www.kenall.com/patents. Other patents pending. ULTRAVIOLET WAVELENGTH (nm) Typical UV-C germicidal wavelength Indigo-Clean germicidal wavelength (405nm) HARMFULSAFE5 Indigo-Clean ® www.kenall.com | P: 800-4-Kenall | F: 262-891-9701 | 10200 55th Street Kenosha, Wisconsin 53144 This product complies with the Buy American Act: manufactured in the United States with more than 50% of the component cost of US origin. It may be covered by patents found at www.kenall.com/patents. Content of specification sheets is subject to change; please consult www.kenall.com for current product details. ESKAPE Pathogens: E nterococcus faecalis S taphylococcal Aureus (incl. MRSA) 1 K lebsiella pneumoniae A cinetobacter baumannii P seudomonas aeruginosa E nterobacter species As well as a range of other organisms: • C. diff 1 • VRE • Aspergillus niger • E.coli • Salmonella enteritidis Clinical testing has shown Indigo-Clean can achieve a continuous 70% + reduction of harmful bacteria 2 in the environment. At the same time, recently published studies show that improved cleaning can reduce HAI rates for certain organisms. 3 These results, combined with the additional cost per patient due to HAI, suggest that preventing even a single infection would create a positive ROI and drive down costs for healthcare providers. Continuously Reduce Harmful Bacteria by 70%+ with Indigo-Clean What Does Indigo-Clean Kill? 1: Antimicrobial Activity of a Continuous Visable Light Disinfection System by Rutala, et. al, ID Week 2016 2: Maclean M., S.J. MacGregor, J.G. Anderson, G.A. Woolsey, J.E. Coia, K. Hamilton, I. Taggart, S.B. Watson, B. Thakker & G. Gettinby (2010). Environmental Decontamination of a Hospital Isolation Room using High‐Intensity Narrow‐Spectrum Light. Journal of Hospital Infection, 76(3); 247‐251. DOI: 10.1016/j.jhin.2010.07.010 3: Alfa MJ et. al. “Use of a daily disinfectant cleaner instead of a daily cleaner reduced hospital-acquired infection rates”, Am J Infect Control 2015;43:141-146 Non-Exposed Exposed to Indigo-Clean ™ High Low Elapsed Time Episodic Disinfection Continuous Disinfection Bacteria in Room Continuous Vs. Episodic Disinfection Represents a 70%+ Bacterial Reduction6 Indigo-Clean ® www.kenall.com | P: 800-4-Kenall | F: 262-891-9701 | 10200 55th Street Kenosha, Wisconsin 53144 This product complies with the Buy American Act: manufactured in the United States with more than 50% of the component cost of US origin. It may be covered by patents found at www.kenall.com/patents. Content of specification sheets is subject to change; please consult www.kenall.com for current product details. withaPvalue<.20insimplelinearregressionwassubsequentlycon- sideredforcontinuedinclusioninmultipleregressionanalysis. Inadditiontototalculturecountresultsforeachsamplingdate, individualsamplingsitecountswereanalyzedatthe15CFUperplate threshold.Previousresearchhassuggestedthatcounts≥15CFUmay representaninfectiousthresholdforcontamination.15,22-23Therefore, theindividualplatecountfromeachsamplingsiteoneachsampling date,withthosesiteshaving2facetssampled,averagedfor1count (eg,topandbottomofdoorhandleaveragedfora“doorhandle” count)andwereanalyzedtodeterminewhatpercentageofsamples fellabovethe15CFUthresholdduringeachperiod.Fischerexacttest wasusedtodeterminewhetherthedifferenceinpercentages betweenperiodsweresigni fi cant. FortheSSIdata,summarystatisticswerecalculatedforallvaria- bles,aswellasANOVAandposthocttestsperformedforcontinuous independentvariables(totaloperationtime,elapsedroomtime).The Fisherexacttestandthex2test(whenpossible)wereperformedfor bothindependentanddependentcategoricalvariables(procedure severity,SSI).Fischerexacttestresultsarereportedinallcases becauseofsmallcellfrequencies.Logisticregressionanalysiswas thenperformedtodeterminewhatfactorswerepredictiveofculture countsusingaforwardstepwiseprocedurewithasigni fi cancelevel ofP<.20ascriteriatoenterthemodelandP≥.20toberemovedfrom themodel. RESULTS Impactofavisible-lightCEDsystemonbacteriallevelsintheOR Theresults,asshowninTable1,indicatethatavisible-lightCEDsys- temwaseffectiveinreducingtotalsurfacebacterialcountsinbothOR1 andOR2.InOR2alone,therewasan81%meanreductioninCFUcounts (P=.017)and85%medianbacterialreduction(P=.002)betweenperi- ods1and2.ThereductioninmeantotalBPAplatecountwas185.2 CFU.Therewasadditionallyastatisticallysigni fi cant49%meanand medianreductioninbacterialcountsintheneighboringOR1thatdid nothaveavisible-lightCEDsystem(P=.015;P=.006),likelyattribut- abletothecontiguouslocationandsharedairsupplywithOR2.The reductioninmeantotalBPAplatecountinOR1was124.8CFU. Analysisoftheother2variablescollectedinthebacterialreduc- tionstudy — numberofcases(numberofproceduresperformedsince thepriordatacollectiondate)andtotalcaseduration(totalduration inminutesofallsurgicalcasesperformedsincethepriordatacollec- tiondate)—revealedthatOR2hadastatisticallysigni fi cantdifference intotalcasedurationcomparedtoOR1.OR2hadahighermean totalcaseduration(P=.039)withadifferenceinmeanduration of382.7minutesduringperiod1and237.7minutesduringperiod 2.Itiswidelyacknowledgedthatthereisadirectcorrelationbetween SSIriskanddurationofsurgery,withSSIratesincreasingwithlonger durationofsurgery.24Thelongerthecase,thegreater theopportunityformicrobialsheddinganddisbursementintheOR. stOR2lightinstallation) Period2MeanbacterialreductionMedianbacterialreduction 8≥49%≥49% 24-216 130.5ttestMWWtest 127.8(57.8)P=.015*P=.006* 8≥81%≥85% 13-79 34ttestMWWtest Mean(SD)226.6(106.6)41.4(24.4)P=.017*P=.002* CFUs,colony-formingunits;MWW,Mann-WhitneyUWilcoxon;OR,operatingroom;SD,standarddeviation. *P<.05. L.J.Murrelletal./AmericanJournalofInfectionControl00(2018)1−73 Oct-2015 to Oct-2016 Oct-2016 to Oct-2017 Room # of Cases # of SSI # of Cases # of SSI SSI Change Bacterial Reduction OR-2 (with IC) 778118503>=−73%>=-85% OR-3 (Distant Control) 75168097<=+17%Not Measured Clinical Effectiveness AJIC Peer Reviewed Study Results from Maury Regional Medical Center Goal To reduce the number of surgical site infections (SSIs) with the addition of the Indigo-Clean Visible Light Disinfection (VLD) system. Methods Indigo-Clean was installed into one orthopedic OR and its effect on bacteria levels throughout the room was measured using Baird Parker Agar (BPA) contact media for a period of 30 days. During this time, each room was cleaned using the facility’s standard work process. Infection rates were compared one year before and after the VLD system implementation. Results The results from the test room show a continuous, average bacterial reduction of between 56%–88% from the sampled surfaces as compared to those in the two weeks before and after the VLD system installation. Infections were tracked for 12 months and showed a 73% reduction in the test room as compared to the baseline period. Asitisintegratedintotheoverheadlighting,itrequiresadditional considerationsrelatedtothecenterwavelength(perphotonefficacy), irradiance(disinfectingpoweratapointinspace),andnumberoffix- turesandlayout(disinfectingpowerthroughouttheroom)toensure theproperendresult.ThisimpliesthatjustaswithUVsystems,no2 productsinthiscategorywillbeidenticalhighlightingtheimpor- tanceofclinicalevidenceinevaluatingtheirtruebene fi tsbasedon themanufacturer ’ srecommendedusage.Theserecommendations shouldincludethetotalaveragedosetotheroom,thequantityof fi x- turesneeded,therequiredoperationtime,andclinicalevidencedem- onstratingtheperformanceusingtheserecommendations. Themanufacturerprovidedtechnicalassistancebeforeandduring installationtoensurethatproperilluminationanddisinfectingdose wasachievedacrosstheentireOR.Eachunitisaceiling-mounted lightingsystemmeasuring2ft £ 4ft.Eightunitswereinstalledinthe ceilingofOR2,whichmeasured450squareft2with9-footceilings. Theantimicrobiallightintheunitisgeneratedfromamatrixoflight- emittingdiodes,whichemitlow-irradianceviolet-bluelightwitha narrowspectralprofilecenteredwithin405nm-410nm(indigo). Thislightconformstointernationalsafetyguidelinesforclinicaluse inoccupiedrooms. 20-21 Toprovideoptimalilluminationforsurgery, eachunitoperatesina “ whitemode ” thatcombinesindigolightand whitelightwhentheroomisoccupied.Whentheroomisunoccu- pied,theunitsswitchto “ Indigomode, ” whichprovidesindigolight only,atapproximately4-timesthedoseofthewhitemode — and therefore,agreaterdegreeofdisinfection.Anoccupancysensor switchesbetweenmodesautomaticallybutcanbeoverriddenwith anemergencyswitch,ifneeded. BacterialbioburdenintheOR Theeffectofthevisible-lightCEDsystemonbacteriallevelsona varietyofsurfacesthroughoutOR1andOR2wasstudiedpriorto (period1,October4-14,2016)andafter(period2,October19to November4,2016)installationofthevisible-lightCEDsystemin OR2.Toestablishabaseline,surfacesampleswerecollectedon5sep- arateoccasionsduringperiod1inbothORs(schedulingoflight installationlimitedsamplingtimesduringperiod1),andthesame surfacesinbothORswerethensampledon8differentoccasionsdur- ingperiod2.The50surfacessampledwerethesameinbothORs, andinbothperiods,andincludedthetopsandbottomsofthedoor handleontheinsideofthemaindoortotheOR,thedoorhandleto theblanketstoragecabinet,thecomputermouseandkeyboard,the insideofthephonehandle,thedoorhandletotheglovestoragecabi- net,theboomlightcontrol,therightandleftarmsoftheanesthesia chair,andtherightandleftedgesoftheanesthesiacart.Additionally, surfacesweresampledaboveandbelowthetopoftheintravenous warmer,thelowerrightandleftfrontcornersoftheanesthesia machine,thehandleofthefluidcollectionmachineandontheleft andrightsidesofthelaundrybinlid,thetopoftheORchair,thecom- puterkeyboardandtopofthecomputer,thefrontoftheanesthesia screen,thetopofthesyringebin,thefrontoftheboviemachine,the topofthe fl uidcollectionmachine,theanesthesiamonitor,andthe bloodpressurebutton. Thedirectorofinfectionpreventionandcontrolcollectedallsam- plesinbothORsandperiodsbetween5AMand6AM,priortothe firstroomentryandaftertheroomhadbeenterminallycleanedthe previousevening.Sampleswerecollectedusing15mm£65mm Baird-Parkeragar(BPA)witheggyolktelluritecontactplates(Hardy Diagnostics,SantaMaria,CA).Nonflatsurfacesweresampledusing therollplatetechniqueand fl atsurfacesweresampledbydirectly pressingplatesagainstthesurface.Eachsamplewastakendirectlyto thelaboratoryfora48-hourincubationperiodat35°C.Following incubation,enumerationoftotalcolony-formingunits(CFU)from eachplatewasmadebyablindedmicrobiologytechnicianandresults weretalliedtocreateatotalCFUcountforeachORonthedateof collection. L.J.Murrelletal./AmericanJournalofInfectionControl00(2018)1−7 Read the AJIC peer-reviewed article at www.indigo-clean.com MajorArticle In fl uenceofavisible-lightcontinuousenvironmentaldisinfectionsystem onmicrobialcontaminationandsurgicalsiteinfectionsinanorthopedic operatingroom D1XX LynnelleJ.Murrell D2XX BSN,RN,CICa, D3XX ErinKinzelHamilton D4XX PhDb, D5XX HelenBoehmJohnson D6XX MDc,*, D7XX MaureenSpencer D8XX BSN,RN,MEd,CIC,FAPICd aDepartmentofInfectionPreventionandControl,MauryRegionalHealthCenter,Columbia,TN bKinzel-Hamilton,Louisville,KY cSeaHawkBiomedical,VeroBeach,FL dInfectionPreventionConsultant,Weymouth,MA Background:Agrowingbodyofresearchhasdemonstratedthatmanualcleaninganddisinfectionofthe operatingroom(OR)issuboptimal.Residualenvironmentalcontaminationmayposeaninfectionrisktothe surgicalwound.Thisstudyevaluatestheimpactofavisible-lightcontinuousenvironmentaldisinfection (CED)systemonmicrobialsurfacecontaminationandsurgicalsiteinfections(SSI)inanOR. Methods:Samplesfrom25surfaceswithin2contiguousORssharinganairsupplywereobtainedafterman- ualcleaningonmultipledaysbeforeandafteravisible-lightCEDsysteminstallationin1oftheORs.Samples wereincubatedandenumeratedastotalcolony-formingunits.SSIsinbothORs,andadistantOR,were trackedfor1yearpriortoand1yearafterthevisible-lightCEDsysteminstallation. Results:Therewasan81%(P=.017)and49%(P=.015)reductionintotalcolony-formingunitsafterthevisi- ble-lightCEDsysteminstallationintheORinwhichthesystemwasinstalled,andinthecontiguousOR, respectively.IntheORwiththevisible-lightCEDsystem,SSIsdecreasedfrom1.4%intheyearpriortoinstal- lationto0.4%followinginstallation(P=.029). Conclusions:Avisible-lightCEDsystem,usedinconjunctionwithmanualcleaning,resultedinsignificant reductionsinbothmicrobialsurfacecontaminationandSSIsintheOR. ©2018AssociationforProfessionalsinInfectionControlandEpidemiology,Inc.PublishedbyElsevierInc. ThisisanopenaccessarticleundertheCCBY-NC-NDlicense. (http://creativecommons.org/licenses/by-nc-nd/4.0/) KeyWords: Environmentaldisinfection Visiblelightcontinuousenvironmental disinfection Surgicalsiteinfections Automateddisinfection Visiblelightdecontamination Surgicalsiteinfections(SSI)continuetoplaceasubstantialburdenon theUShealthcaresystem.1Theyareamongthemostcommonhealth care−associatedinfections,accountingforamajorsourceofperiopera- tivemorbidity,prolongedhospitalizations,andhealthcareexpendi- tures.1-3ThisisparticularlytrueforSSIsinvolvinganimplant,suchas periprostheticjointinfections(PJI),whichhavebeenassociatedwitha costof$389,307-$474,004perinfection,amortalityrateof2%-7%,anda 5-yearsurvivalrate—thatisworsethanmanycancers.4-6 Traditionalstrati fi cationofSSIriskbeginswiththepatient ’ s ownmicrobiome,followedbyperioperativepracticevariables includingsurgicaltechnique,attireandinstrumentsterility,and operatingroom(OR)environment.7Thelatter,however,is increasinglyrecognizedasapotentiallysigni fi cantreservoirfor pathogens.Multiplestudieshavedemonstratedthepresenceof organismscommonlyassociatedwithSSIsintheairandonsurfa- ceswithintheOR,despiteregularmanualcleaning,8-11underscor- ingtheideathatmanytraditionalmanualdisinfectionand decontaminationprotocolsaresuboptimalinachievingatruly “clean”ORenvironment. 11-15 Residualcontaminationcanposean infectionriskviathecomplexinterplayofsurfaceandairdynamics inanoccupiedOR.Staffandequipmentmovementcandisturb residualorganismsandparticulatesonsurfacesleadingtotheir aerosolizationandpotentialsettlingontohigh-touchsurfaces, sterileequipment,andintothesurgicalwound.15-19 Thepresentstudywasa2-prongedinvestigationtoassesstheeffi- cacyofavisible-lightcontinuousenvironmentaldisinfection(CED)sys- temin(1)reducingbacterialcontaminationonsurfaceswithinan orthopedicOR,and(2)impactingSSIratesforproceduresperformed *AddresscorrespondencetoHelenBoehmJohnson,MD,SeaHawkBiomedical,1321 SeaHawkLn,VeroBeach,FL32963. E-mailaddress:HBoehm705@aol.com(H.B.Johnson). Conflictsofinterest:Nonetoreport. https://doi.org/10.1016/j.ajic.2018.12.002 0196-6553/©2018AssociationforProfessionalsinInfectionControlandEpidemiology,Inc.PublishedbyElsevierInc.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense. (http://creativecommons.org/licenses/by-nc-nd/4.0/) AmericanJournalofInfectionControl000(2018)1−7 ContentslistsavailableatScienceDirect AmericanJournalofInfectionControl journalhomepage:www.ajicjournal.org Project: Maury Regional Medical Center Location: Columbia, Tennessee 7 Indigo-Clean ® “We believed that Indigo-Clean would give us a substantial improvement in our disinfection given the prior research with environmental reduction in bacteria, but we were thrilled when we experienced a 73% reduction in SSIs.” – Lynnelle Murrell, Director of Infection Prevention Maury Regional Medical Center, Columbia, TN 8 Indigo-Clean® Continuous Visible Light Disinfection for Critical Care Treatment Areas Project: Spring Valley Hospital Location: Las Vegas, Nevada9 Indigo-Clean ®