oley update – 7/6/16 - c.ymcdn.com tubing misconnected to a nasal cannula used to deliver oxygen...
TRANSCRIPT
OleyUpdate–7/6/16
TopicsforDiscussion
! Background! Timing&Implementa@onLogis@cs! DoseAccuracy! BlenderizedTubeFeeding! Recommenda@ons! Repor@ngAdverseEvents! Ques@ons
MISSION
Promoteini@a@vessurroundingsafeandop@maldeliveryofenteralfeedingand
connec@vity
Unite.Connect.Deliver.
GEDSAMembers
AbboPA.HopfAlcorScien@ficAmsinoBardBaxterBBraunBostonScien@ficCairLglCedic/EntekCodanCookMedical
Corpak
DaleMedical
Degania
EnteralUK
FreseniusKabi
Halyard
Intervene
Medela
Medicina
Medline
Medtronic
Moog
NeoMed
Nestle
Nutricia
Qosina
Smith’sMedical
UComfor
VescoMedical
Vygon
VRMedical/Kentec
Xeridiem
Stayconnected.org
Suppor@ngOrganiza@ons
TubingMisconnec4onsAdverseEvents! IVtubingmisconnectedtoanasalcannulausedtodeliveroxygen—
thepa@entsurvivedaZerbeingtreatedforconges@veheartfailure
! Feedingtubetoatracheostomytube,deliveringmilkintoaninfant’slung,resul@ngindeath
! EpiduralinfusionsetconnectedtoaperipheralIV,deliveringepiduralmedica@ontobloodstream,resul@nginpa@entdeath
! Feedingtubeconnectedtoanin-lineven4latorsuc4oncatheter,deliveringfeedingcontentsintothepa@ent’slungs,resul@ngindeath
! Heparinlock(peripheralIVroute)connectedtoanautoma4cbloodpressurecuff,deliveringairtothebloodstream,causingdeath
! Feedingtubewascoupledwithaperipherallineofapregnantwoman,resul@nginenteralnutri@ondelivereddirectlyintothebloodstream;neitherthe35-week-oldfetusnorthewomansurvived
Stayconnected.org
ISODesignstandardsdevelopedforsystem-specificapplica4ons
80369Series-1Generalrequirements
Requirements:• Notconnectablewithothersinseries• Rigidorsemi-rigid• PassesMisconnec@on,RiskAnalysis,Usability/HumanFactorsTes@ng• NotconnectablewithLuerorneedlelessconnectorports
Stayconnected.org
Respiratory Enteral Urological LimbCuff Neuraxial Intravascular
-2 -3 -4 -5 -6 -7
SignificantTes4ngConductedtoVerify&ValidateEnteralStandardDesign
! ClinicalAssessment-20Physicians,Nurses&Pharmacists
! Usability/HumanFactors-53Clinicians(including15NICU)! Misconnec@onsAssessment! SyringeAccuracyReport! UserSurvey–35respondentsin3Europeanmarkets! AcceptabilityandSuitabilityStudy-48Cliniciansin6EuropeanMarkets
! LDTSyringe" PerformanceTes@ng" UsabilityTes@ng–140respondentsin8countries" Misconnec@onRiskAssessments
! Reverseorienta@onusage–UKreverseLuer" Millionsofpa@entsovernearly6yearswithoutareportedevent
Tes4ng&Assessments
®
IntroducingENFit,theproposednewISO80369-3designstandardconnector
CURRENT NEW
MaleSteppedor“ChristmasTree”ConnectorfromAdministra@onSet
FemaleFeedingTube
Port
FemaleENFitConnectorfrom
Administra@onSet
MaleENFitConnectorforFeedingTube
Stayconnected2015.orgStayconnected.org
GOAL:EliminatetheLongTermNeedforadapters
CheckwithyoursupplierregardingTransi@onConnectorsfromENLocktoENFit
TopicsforDiscussion
! Background! Timing&Implementa@onLogis@cs! DoseAccuracy! BlenderizedTubeFeeding! Recommenda@ons! Repor@ngAdverseEvents! Ques@ons
2016
2016
ENFitTransi@onTiming
! GEDSAMembershaveconfirmedtheircommitmenttoENFitandtheintroduc@onofsyringesandfeedingtubesin2016
2015
Varia@onsinEnteralFeedingPointofCarethatAffectAdop@on/Implementa@on
AcuteCare(AC)
LongTermCare(LTC)
DRAFT
HomeCare(HC)
17
OtherStates
OtherCountries
Complica@onsofSupplyChain! InventoryLevels
! Connec@vityBetweenSuppliers
! Addi@onalIssues" ChangingProductCodes" ExcessandObsolescence" Returns
DRAFT
CompanyANutri@onBag/BoPle
CompanyBAdministra@onSet
CompanyCSyringe
CompanyDFeedingTube
18
Complexi@esinSupply
DRAFT19
ComponentManufacturing Shipping
FinishedGoodsManufacturing Manufacturer/Supplier
Distribu@onCenters
DistributorWarehouse
AC,LTCorHMEWarehouse
4-8Weeks 4-8Weeks 1Week 4-8Weeks
1Week
1Week
4-8Weeks2-4Weeks 1Week
2-4Weeks 4-12Weeks
4-8Weeks
14-34WeeksEst.InventoryinSupplyChain
6–12MonthsEst.Transi@onLeadTime
TopicsforDiscussion
! Background! Timing&Implementa@onLogis@cs! DoseAccuracy! BlenderizedTubeFeeding! Recommenda@ons! Repor@ngAdverseEvents! Ques@ons
DoseAccuracyConcerns
! Clinicians:" Clinicianshaveraisedconcernsondosingaccuracyofsmallvolume
ENFit®syringes,duetotheirreversegenderorienta@on" Cliniciansandpharmacistsindicateddosingaccuracyexpecta@onof
±10%atargetvolumeof0.2mL(whendeliveredusinga1mLsyringe)
! Industry:" Thereisnocurrentstandard(ISO,AAMI,ASTM,EN)dosingaccuracy
requirementorspecifica@onfororal/enteralsyringes" Dosingaccuracyisnotastandardtestperformedbysyringe
manufacturers,thereforenobaselinedataexistsforcomparison
ProposedENFit®LowDoseTipSyringe
! Designedtospecificallyaddressdoseaccuracyconcerns.
! StandardENFitfemalesyringe@pwithaninternal@plumen.
! Orienta@on/configura@onissimilartoLuerlocksyringes*
DoseAccuracyofENFit®LowDoseTipvs.CommonEnteral/OralTipSyringes
-3.96
-11.2
-7.37
-2.9
21.22
18.00
9.69
10.47
-15 -10 -5 0 5 10 15 20 25
ReverseF
ReverseE
E/OOverall
ENFitLDT
%DoseAccuracy(95%CI)
Note:Targetis±10%ofa0.2mLdosedeliveredina1mLsyringe.
LowDoseENFit®SyringeConclusionPerformanceTestResults(whenusedasinstructed):! DoseAccuracyrangeof-2.90%to+10.47%(95%CI)! Substan@allyequivalenttostandardorienta@on(male)enteral/oralsyringes! PerformsbePerthanReverseOrienta@on(female@p)syringes.! Useofanadaptor(suchasastraw)providesbePerperformancethanacupfill
Misconnec4onRiskAssessmentMi@gatesriskoftubingmisconnec@onsandprovidesaclinicalbenefitthatoutweighstheriskofitsuse.
Usability:Nosignificantdifferencevs.currentprac@cewhenfillingoradministeringdifferentviscosityfluidsorbetweenrespondents(Pharmacist,Nurses,orCaregivers)
FDAClearance:TheFDAhasthoroughlyreviewedandclearedtwo510(k)submissionsforENFitLowDoseTipSyringes
TopicsforDiscussion
! Background! Implementa@onLogis@cs! DoseAccuracy! BlenderizedTubeFeeding! Recommenda@ons! Repor@ngAdverseEvents! Ques@ons
Goal• EstablishimpactofENFit™Connectoronfeedingtubeperformanceandcharacterizecurrentuserprac@ceswithregardtoblenderizedtubefeedingBTF
MayoClinic(Rochester,MN)• RyanHurt,MD;ManpreetMundi,MD;LisaEpp,RD• Flowratecomparison(Legacyvs.ENFit)usingcommercialformulas
FDA• Suvajyo@Guha;JoshSilverstein• Flowratecomparison(Legacyvs.ENFit)confirma@onofMayotes@ngandcharacteriza@onofBTFuse• Forcetes@ngcomparison
GEDSAandOleysuppor@ngwithproductsandreviewofprotocolsonly
ThirdPartyFlowRateTes@ng
• Createavalidated,objec@vedatabasethatcanbeusedforpublica@on,inputintostandardsanddecisionmaking
• BuildsonMayo/Oleysurveytoiden@fyhometubefeedingprac@ces• SurveyfocusedonaxtudesaboutBTF,butexecu@oncreatedbiasinresults• Nothingonproductuse(cri@calGEDSAconcern)
• Summary• Demographicsofhometubefedpa@ents• Commercialvs.BTFuse• Basicques@onsonreimbursement• TubeCloggingconcerns• BTFprac@cessuchas–equipment,foodsused,mo@va@on,challengeswithcurrentdevices,howmade
BTFHomeUserQues@onnaire
• Defineaproblemifthereisone
• Recommenda@ons&BestPrac@ces
• NewIndica@onsforUse
• ModifiedConnectors?
• NewDevices?
• OthersSolu@ons
BTFTes@ngWillLeadto…
…wewillkeepthecurrentdesignproductonthemarketforanindefiniteperiodof@metoensureasmoothtransi@onforallusers.
ManufacturersMaintainingLegacyDevices
CookMedicalRepresenta@ve…”Wehavenotsetadatetodiscon@nuelegacydevices
ands@llofferthesedevicesasanenteralop@on”
TopicsforDiscussion
! Background! Timing&Implementa@onLogis@cs! DoseAccuracy! BlenderizedTubeFeeding! Recommenda@ons! Repor@ngAdverseEvents! Ques@ons
Recommenda@ons! WorkwithyourHomeHealth/InfusionSuppliers:
" Prepared?○ No,reachouttoGEDSAandstayconnected.org○ Yes,understandspecificENFitTransi@onTimingforalltubesandsyringes
" Makesuretheyhavetherightcomponentsyouneed
! Syringes:" 5mLandbelowshouldconsideraLowDoseTip" 6mLandaboveshouldnotrequireaLowDoseTip" Verifyadequatesupplytomeetyourneeds
! Stayconnected.org" SignupforournewslePertostayontopofanyupdates,changes,news
Brochures,Presenta@ons,FAQs&Checklistsallatwww.stayconnected.org
New global design standards for medical device tubing connectors
Enhancing Patient Safety
TopicsforDiscussion
! Background! Timing&Implementa@onLogis@cs! DoseAccuracy! BlenderizedTubeFeeding! Recommenda@ons! Repor@ngAdverseEvents! Ques@ons
Repor@nganAdverseEvent! Reachouttothemanufacturercustomerserviceviaphoneoremail.! Eachmanufacturermayhaveadifferentprocedureforhandlingthe
complaintbuthavethesameobliga@ontokeeptrackofandinves@gateacomplaint
! Contactinforma@oncanbefoundonthecompanywebsite! Commoninforma@onyouwillneedwhenyoucontactthecompany:
" Pa@entage,gender,andmedicalcondi@on" Clearanddetaileddescrip@onofevent" Listofalldevicesrelevanttotheevent" Productiden@fierslikebrandname,modelandlotnumber
Repor@nganAdverseEventtotheFDA! SendreporttoFDAviaon-linereportform(&instruc@ons)
accessibleat:hPp://www.fda.gov/Safety/MedWatch/HowToReport/default.htm" Form3500A(mandatoryreport)" Form3500(voluntaryreportforprac@@oners/physicians)" Form3500B(voluntaryreportforconsumers/pa@ents)
! PhoneFDAat:1-800-FDA-1088;or
! Downloadtheformandmailtotheaddressontheform
! Facili@esthataresubjecttoFDA’suserfacilityrepor@ngrequirementsshouldfollowtherepor@ngproceduresestablishedbytheirfacili@es.
Ven@ngQues4ons:! HowwillpeopleventwithanENFitconnector?! Peopleareconcernedthattheywillnotbeabletoventthrough
[email protected]@mateconcern?Answers:! DevicespecificperformanceIssue.! MostcommonG-Jtubesinnerdiameterswillnotchangeand
thereforeperformancewillnotbenega@velyimpacted
CleaningQues4on:HowwillconsumerskeepENFitconnectorsclean?Answers:! AreversesystemwithaverysimilardesignhasbeeninplaceintheUnited
Kingdomresolvedbypropertubemaintenanceandflushing.! Whenflushingwithasyringe,keepfinal0.5inch(cen@meter)ofthetubingor
syringefreeofformula.! TherearealreadyproductsbeingpromotedforthecleaningoftheENFit
connectors.! ASPENwillbeissuingguidanceonpropercleaningtechniquesincludingthe
useofhouseholdswabs(ie.Q-Tips)
CloggingQues4on:! Cloggingisalwaysabigproblemwithfeedingtubes.Doyouan@cipatemore
cloggingwithasmaller-boreconnector?! ManyareconcernedthattheirtubeswillneedtobereplacedmoreoZen,
eitherbecauseaclogortubegetsdislodged(pulledout)accidentally.Answers:! CloggingwouldbeadevicespecificperformanceaPribute.! ISORequirementsspecifyaforcingfunc@onandpreferalockingfeature! Theriskinadvertentdisconnec@ons,acommoncomplaintfromtubefed
pa@entsandcaregivers,willbelowerwiththeENFitsystemduetotheinterlockingdesign.
BDNotsuppor@ngENFit