內窺鏡設備中殘留內毒素的檢測：高水平消毒的補充監測工具的實施.pdf

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1、Implementation of a Implementation of a complementary monitoring complementary monitoring tool for hightool for high-level level disinfection(HLD)of disinfection(HLD)of endoscopic endoscopic devicesdevicesTroy Ejsmentewicz1,Gerthy Rios-Rioseco2,Francisca Asis2,Karen Saldivia2,Celia Podesta-Medina3an

2、d Franz Villarroel-Espndola1.1Traslational Medicine unit,2Sterilization unit,3Endoscopy unit,Instituto Oncolgico Fundacin Arturo Lpez Prez.Santiago,Chile.E-mail:troy.ejsmentewiczfalp.orgTranslationalTranslational ResearchResearch at FALPat FALPTranslational Medicine Laboratory at FALP is a unit for

3、Researchand Innovation.MissionTo be the link between experimentation and clinicalapplicability to transfer benefits and opportunities to thepatient,theclinician and thescientific researcher.SinceSince 20192019,thethe directdirect pathpath betweenbetween a a discoverydiscovery andand itsits applicabi

4、lityapplicabilityIn aregularyear:125,000medicalconsultations21,000newpatients6,500surgeries19,100Chemotherapies37,000Therapeuticdoses1,200Radiotherapies40clinicaltrialsPrevention:900,000insured24,000mammographyFoundedbyArturoLopez Perezs widowin1954.FALPis anon-profitprivateCancerCentreThe The probl

5、emproblem size sizeUSA in 2019USA in 2019Total Total endoscopic procedures:22,162,641 endoscopic procedures:22,162,641 Colonoscopy:13,837,748Colonoscopy:13,837,748Upper endoscopy:Upper endoscopy:7,459,4197,459,419Others:865,474Others:865,474FALPFALP.AverageAverage perper monthmonth 20232023,486486 e

6、ndoscopicendoscopic proceduresprocedures512512 reprocessedreprocessed devicesdevices(Peery AF,et al.Gastroenterol,2021)Worldwide distribution of endoscopy-associated infection reported between 2011-2020.Deb,A.et al.,DigDisSci67,17181732(2022).endoscopicendoscopic retrograde retrograde cholangiopancr

7、eatographycholangiopancreatography(ERCP)(ERCP)nonnon-ERCP ERCP upperupper endoscopyendoscopylowerlower endoscopyendoscopyComposite infection Composite infection rate rate Non-ERCP upper endoscopy0.1230.123%(1083 out of 876,263 procedures)from 16 studiesLower endoscopy0.0730.073%(1081 out of 1,488,77

8、9 procedures)from 3 studies(Deb A,et al.,Dig Dis Sci,2022 systematic review-)HighHigh-levellevel disinfectiondisinfection(HLD(HLD)qualityquality controlcontrolAny HLD procedure for reused devices must generally comply with(FDA recommendation):Less than 1 colony-forming unit(CFU)for high-concern micr

9、oorganisms:such as Staphylococcus aureus,Enterococcus spp.,Streptococcussp.,Viridians group,Pseudomona auroginosa,Klebsiella spp.,Salmonella spp.,Shigella spp.,and other Gram-negative enteric bacilli.up to 10 CFU,for low-concern bacteria,such as coagulase-negative Staphylococcus,micrococci,Diptheroi

10、des,Bacillus spp.,and otherspherical Gram-positives.However,the absence of microbiological growth does NOT rule out the presence of biological remnants,such as lipid membrane,DNA,proteins,endotoxins and other molecules with a potential pro-inflammatory activity.Live cellsDead cellsVerification Verif

11、ication of a correct HLD procedureof a correct HLD procedureATP bioluminescence assay is frequently used as quality controlIs this assay the right control?Is this assay the right control?Can we evaluate the presence of a proCan we evaluate the presence of a pro-inflammatory molecule?inflammatory mol

12、ecule?Standard workflowforHLD at Fundacin Arturo Lpez Prez FALP-CancerCentre.B Biological sensors for iological sensors for in in vitro vitro assaysassaysFALP Translational Medicine Laboratory has the capacity to perform cell cultures of immune cells to perform in vitro assays.Gonzlez-Stegmaier,R.,e

13、t al.,Molecules2023,28(5),2394.Andreasen,A.S.,(2008).Currentmedicinal chemistry,15(17),1697-1705.InIn-househouse protocolprotocol to to evaluateevaluate HLDsHLDs performanceperformanceInternalInternal controlscontrols:Positive:1 mg/ml LPS(E.coliK12,InvivoGen)Negative:sterile&pyrogen-free waterSample

14、Sample:20%v/v endoscopes waterSamplingSampling designdesignSchematic representation of sampling collection.Wash water is collected from the working channel of each device atthree steps.ATP levels is tested by bioluminescence as an indicator of cleanliness.36 devices(IC 90%,5%error)wereevaluated befo

15、re and after manual washing,and after an automatic reprocessing machinestandardize standardize HLD protocolHLD protocolModified HDL Modified HDL protocol N1protocol N1RemarksRemarksImportance of bedside cleaningbedside cleaning.absence of detergent during aspiration at point of useRemarksRemarksImpo

16、rtance of brushingbrushingendoscope and using a reprocessing reprocessing machinemachineModified HDL Modified HDL protocol N2protocol N2Absence of brushing in the HDL roomCONCLUSIONS CONCLUSIONS We developed an in-house method based on the biological response of live cells to evaluate theefficiency

17、of high-level disinfection(HLD)protocols usedforreprocessingendoscopes.Based on our biological test,the standardized HLD protocol for devices used for colonoscopy orendoscopyatFALP is robustenough to eliminate anyinflammatorycomponent.Disruptions in the standardized HLD protocol,such as the lack of

18、detergentduring the aspiration stepat the point-of-use or the absence of brushing during the manual washing,significantly increases thepresence of residuaryinflammatorymolecules.ATP detection by bioluminescence is an indicator of cleanliness but it does not correlate withinflammatoryactivityandIL-1m

19、RNA levels.ACKNOWLEDGMENTACKNOWLEDGMENTTO ALLOURPARTICIPANTS,PATIENTSAND THEIRFAMILIESTranslational Medicine membersTranslational Medicine membersLab director.Dr.Franz VillarroelRoddyJorquera PhDRoxana Gonzlez PhD ConstanzaCrcamoPatricio RodriguezValeria ZentenoFALP collaboratorsFALP collaboratorsEn

20、doscopy UnitCarlos Barrientos MDCelia PodestBlood BankCarolina Selman MDAll members from the Sterilization UnitSterilization UnitFunding:Funding:Fundacin Arturo Lpez Prez Cancer CenterChilean National Agency for Research and Development National Fund for Scientific and Technological DevelopmentANID-FONDECYT grant N1221415