choosing the best needle free connector in 2017 · 2017-12-12 · choosing the best needle free...
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ChoosingTheBestNeedleFreeConnector
in2017
11THPICCDay‘TheComplications’
GAVeCeLT
December2017
NancyTrickRN,CRNI
Disclosure • Employee
ManagerWWClinicalMarketingEvidence&EducationInfusionDisposablesBectonDickinsonVernonHills,IL
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Nooff-labeluseofproductwillbediscussedduringthispresentation
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Objectives • Considerthecriteriaofa‘bestneedlefreeconnector’
• Discusstheimpactofneedlefreeconnectordesignondocumentedriskofcontamination&complications
• DescribeaUSA-based,FDAmandatetoaddressthethreatofBSIsspecifictoneedlefreeconnectordesign
• Outlineresolution&product-specificimplicationsastheresultoftheFDAmandate
INS SOP #34 The Primary Purpose Needleless Connectors
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‘To protect health care personnel by eliminating needles and subsequent needlestick injuries when attaching
administration sets and/or syringes to the VAD hub or injection site for intermittent infusion’
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Needle Free Connectors What is ‘Best’?
LeastAmountPatientRisk
ReliablePerformance
SustainablePerformance
RepeatablePerformance
Substantial3rdPartyClinicalEvidence
ReduceNeedleStickInjuriestoHCP
BSI Occlusion
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Evolution “unfolding,change,progression,metamorphosis.”Dictionary.com
TheEvolutionofLight....
Allprovideasourceoflight
• Allhavevaryingdegreeofriskassociatedwithuse
Designsevolvedtoimprove:Safety~Effectiveness~Efficiencies
Evolution of Needle Free Technology: USA
1980’s 1991 2000 2001 2005 2008
Bloodbornepathogenexposurerisksgaingreaterattention
OccupationalSafety&HealthAdministration(OSHA)recommendshealthcarefacilitiesuse“engineeringcontrols”tohelpprotectHealthCareWorkersfromthesepathogens
NeedlestickSafetyandPreventionAct(Pub.L106-430)signedintolaw
Engineeredcontrols,includingNeedlelessConnector(NC)systemsmandatoryunderNeedlestickSafetyandPreventionAct
FDArecognizesmicrobialriskwithNC’sTestingshoulddemonstratedisinfectionproceduresusedareeffectiveforremovingmicroorganismsfromthedevice
FDArevisesGuidanceTestingshoulddemonstratedisinfectionproceduresareeffective
HealthcareWorkerProtection PatientProtection
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Generations of Needle Free Technology
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• Allprovideanaccesspoint
Allhavevaryingdegreesofriskandbenefitsassociatedwithprotocolsforuseinvariousclinicalsettings
TermsNegative/PositivePressureMechanicalValves
wereintroduced
TermNeutralwas
introduced
TermAnti-Reflux
Introduced
Designsevolvedtoimprove:Safety~Effectiveness~Efficiencies
NFC Design & Fluid Dynamics
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Negative Displacement NC. Allows blood reflux into vascular access device (VAD) lumen upon disconnection due to movement of valve mechanism or removal of syringe/set Positive Displacement NC. Allows a small amount of fluid to be held in the device; upon set or syringe disconnection, this fluid is pushed through the catheter lumen to clear any blood that refluxed into the lumen Neutral NC. Contains an internal mechanism designed to prevent blood reflux into the catheter lumen upon connection or disconnection Anti-Reflux NC. Contains a pressure-sensitive internal mechanism designed to prevent blood reflux into the catheter lumen when the flow of infusion solution has stopped
Clinical Practice Highly Influences Effective Flushing & Locking Technique
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NFC Features that Increase Risk Infection Difficultycleaningaccesssurface
HCW’smaynotadequatelycleantheintricatesurfacedetails,leadingtofluidpathcontamination.
Gaparoundplungerharborsbacteria
GapcannotbeaccessedfordisinfectionandcanleadtofluidpathcontaminationespeciallywithrepeatedaccesssuchasSASorSASHmethod.
Opaquehousinghidesincompleteflushingofmediabasedfluids
Duringthecourseofnormalmanipulationofthecathetersmallamountsofmedialikefluidcontaminatethevalve.Iftheseorganismsproliferate,thentheycanbeinfusedwithsubsequentmanipulations.
Internalmechanismsobscurefluidpath
Impossibletovisuallyconfirmcompleteflushing.
1.WilliamJarvis,MD–PresentedatCHICA(CommunityandHospitalInfectionControlAssociation)February24,2009,APICandAVA2006,SHEA2005,2006.
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• FDA concerned about the safety of positive pressure needle free connectors after receiving three reports of death associated with bloodstream infections and positive displacement needleless connectors
• The FDA cited multiple clinical reports showing an association between multi-branded, positive displacement needless connectors and bloodstream infections and a subsequent reduction in bloodstream infections when facilities switched to another type of needleless connector
2010FDAPostMarketingSurveillanceMandate
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2010 FDA 522 Mandate 9 Manufacturers Post-marketing surveillance required 1)Whatistherateofbloodstreaminfectionsforsubjectsreceivingyourpositivedisplacementconnectorforcentrallineaccessandisitstatisticallynon-inferiortotheratesseeninsubjectsreceivingotherneedlelessconnectors(e.g.negative,neutral,orsplit-septumconnectors)forcentrallineaccess,givencomparablepatientpopulations?2)Aretherepatientdemographics,comorbidities/severityofillness,ordevicecleaningpracticesforwhichplacementofyourpositivedisplacementconnectorforcentrallineaccessincreasessubjects’riskofbloodstreaminfectionscomparedwithotherneedlelessconnectors?
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CaseReportsNarrative/Expertopinion/Nodesign
CaseControlStudiesRetrospective/Lookingforriskfactors
Animal&LaboratoryStudiesNohumans
CohortStudiesProspective/Measuringexposedrisk
RCTProspective/testingRx
Meta-AnalysisSystematicReviews
ClinicalPracticeGuidelinesStrengthofE
vide
nce
AvailabilityofStrongEvidenceBasedonabilitytocontrolforbiasandtodemonstratecause&effectinhumans
PyramidofEvidence
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In-Vitro Study Completed
StudyPurpose:Identifyanydifferencesbetweentheratesofmicrobialingressintodifferentdevicesfollowingcontamination.
• Tested5secondand15seconddisinfectionprotocols• 7-dayclinicalsimulation=repeatedmicrobialcontaminationofaccesssurfaceanddisinfectionfollowedbysalineflushes
• Plusbloodaspirationthroughthedevices,mimickingblooddiscardandsampling,commonlycarriedoutinclinicalpractice
AnnaCasey,PhD,BSc,TarjaKarpanen,PhD,BSc,RGN’PeterNightingale,PhD,BSc,TomElliott,PhD,DSc,MRCP,BM,BS,BMedSci,FRCPath“AnInVitroComparisonofMicrobialIngressInto8DifferentNeedlelessIVAccessDevices”JournalofInfusionNursing,Volume38,Number1,January/February2015
JournalofInfusionNursingJanuary2015(AnnaCaseyetal)
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Interesting Conclusions • TheMaxPluswasassociatedwithingressofsignificantly
fewermicroorganismscomparedwiththeotherdevicestested
• SignificantlyfewerCFUwererecoveredfromneedlelessIVaccessdeviceswithrelativelylargeprimingvolumes,suchasMaxPlus,thanthosewithsmallprimingvolumes
• TheMaxPluswasassociatedwithsignificantlyfewercontaminatedadministrationsetmaleluersthantheotherdevicestested,whichsupportstheconjecturethattheinjectionsitedesignmayprotectthemaleluersterility
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AnalysisofstudiesreportingCLABSIsinpatientswhenusingapositivedisplacementneedlefreeconnector(studyNFC)comparedwith
negativeorneutraldisplacementneedlefreeconnectors
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Meta-Analysis Literature
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Thisarticlehasbeenretracted:pleaseseeElsevierPolicyonArticleWithdrawal(http://www.elsevier.com/locate/withdrawalpolicy).ThisarticlehasbeenretractedattherequestoftheEditor-in-Chief.AninvestigationintoanallegedfailuretodiscloseCOIwasconductedbyaninterdisciplinaryscientificreviewcommitteeconvenedbyseniorleadershipatGeorgiaRegentsUniversity(GRU).Thecommitteereachedthefindingsofafailuretoproperlydisclosetherelationship.Duringthecourseofthatinvestigation,questionswereraisedaboutthemethodsanddatapresentedinthisarticle.Thequestionsfocusedinparticularontheconsistencyofthestatisticsovervariousstudyperiodsaswellasthemethodsbywhichstudysiteswerechosen.Theinvestigationconcludedthatthesciencewasflawed
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“USAHospitalCompareAnalysis”
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The advantages of using publicly reported outcome data such as used in this study include:
• There was no sampling bias, because all eligible hospitals were included
• There was no potential conflict of interest compared to data collected by manufacturers themselves
• It was the most current with minimal time lag • The comparison was concurrent, which eliminated potential bias
inherent to pre-post period study designs
In order to satisfy an FDA post-market surveillance request (known as a ‘522’), CareFusion undertook the largest analysis known to-date for needleless connectors. Used 2013 Center for Medicare and Medicaid Services Hospital Compare data • 3,074 hospitals • Nearly 11,000 recorded events • Nearly 10 million catheter days • Merged with Manufacturer’s client database
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‘Hospital Compare Results’
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Source: Tabak et al Poster 897 IDWEEK 2014
* Hospitals with > 1 CLD
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MaxPlus is a registered trademark of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners.
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FDA Post Market Surveillance
This is the future for medical devices
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35 © 2015-001 CareFusion Corporation or one of its subsidiaries. All rights reserved.
Final Thoughts Preferred Design & Extended Usage
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Featurestoimprovedisinfecting&flushingtechniques:
• Solidaccesssurface• Sealedbetweenaccesssurfaceandhousing
• Completelyfluidfilleddesignwithaonepieceinternalmechanism
(nointernalcannulaorcomplicateddesign)
JarvisWR.NeedlelessConnectorsandimprovementofPatientandHealthcareProfessionalSafety.InfectionControlToday.December2013
