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

theGpor@onofaG-Jtube.Isthatalegi@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