Connectivity Summit - BD · 2020-03-10 · Executive Summary Conference Report 1 11th Invited Conference: Infusion Therapy and Information Technology—Taking IV Therapy to New Levels

Connectivity SummitInfusion Therapy and Information

Technology—Taking IV Therapy to

New Levels of Safety with IT Integration

Center for Safety and Clinical Excellence

Conference Report Published by the Center for Safety and Clinical Excellence

carefusion.com

Proceedings from the 11th Conference


June 2–3, 2011

National Conference on Infusion Therapy and Information Technology

The 11th invitational conference at the CareFusion Center for Safety and Clinical Excellence in San

Diego, held on June 2-3, 2011, brought together more than 40 experts and practitioners to share

information, offer perspectives and address issues on the topic of infusion therapy and information

technology. The day and a half of presentations and round-table discussions included individuals

representing academic institutions, large health care systems, professional associations and industry.

This conference report summarizes 17 presentations by nationally recognized experts.

Executive Summary Conference Report 1

11th Invited Conference: Infusion Therapy and Information Technology—Taking IV Therapy to New Levels of Safety with IT Integration

P3 Key Note Address: Medical Device Interoperability From 30,000 Feet

Tim Gee Medical Connectivity Consulting Beaverton, OR

P8 Infusing Patients Safely: Priority Issues from the 2010 AAMI/FDA Infusion Device Summit

Mary Logan AAMI Arlington, VA

P11 One or More Errors in 67% of the IV Infusions: Insights from a Study of IV Medication Administration

Marla Husch, RPh Central DuPage Hospital Winfield, IL

P13 CPOE and IV Infusions: Current Status and Future Opportunities David Bates, MD Brigham and Women’s Hospital Boston, MA

P17 How Well Does Bar Code Medication Administration Address the IV Process? Mark Neuenschwander The Neuenschwander Co. Bellevue, WA

P20 Have Smart Infusion Pumps Reached Their Full Potential? Tim Vanderveen, PharmD, MS CareFusion San Diego, CA

P23 Medication Administration from a Nurse’s Perspective: Prioritizing Making a Safety/Productivity Difference

Anne Pohlman, APN-CNS, CCRN, FCCM University of Chicago Chicago, IL

P25 Intravenous (IV) Medication Infusion Device Integration: Readiness Assessment

Mark Siska, BS Pharm, MBA/TM Mayo Clinic Rochester, MN

P28 CNIOs and IV Pump Interoperability: Is This a Must Have or a Nice to Have?

Judy Murphy, RN, FACMI, FHIMSS formerly with Aurora Health Care Milwaukee, WI

P31 Between Now and the “Big Bang”: Interim Technology Applications to Help Achieve IV-IT Interoperability

Nathaniel M. Sims, MD Massachusetts General Hospital Boston, MA

P36 Intravenous (IV) Infusion Pump Device Wireless Connectivity: Development, Current Status and Requirements for Success

Dan Pettus CareFusion San Diego, CA

P40 Medical Device Data Systems, IEC 80001 and Managing Networked Medical Technology

Todd Cooper 80001 Experts, LLC San Diego, CA

Content

http://www.80001Experts.com



P45 Considerations in Multi-Hospital Wireless Integration William A. Spooner Sharp HealthCare San Diego, CA

P48 What is IHE Doing About Pump Integration? Erin Sparnon, MEng ECRI Plymouth Meeting, PA

P51 The Role of Middleware in Interoperability Brian McAlpine Capsule Andover, MA

P55 Making Sure Critical Alarms are Heard: Promoting Critical Alarms from Bedside to Caregiver and Central Station

Ann Holmes, MS, RN Munson Medical Center Traverse City, MI

Content (continued)

The following presentations were pre-recorded and are available at: carefusion.com → Center for Safety and Clinical Excellence → Conferences

Auto-programming of Infusion IV Pumps: Idealized Work Flow Process

Kristen O’Shea, RN Wellspan, York, PA

Auto-programming of Infusion Pumps: Learnings from an Early Adopter

Tina Suess, RN, BSN Lancaster General Hospital Lancaster, PA

Episodic versus Continuous Wireless Connectivity: Are Medical Devices Ready for Real Time?

Jim Welch formerly with Masimo Irvine, CA

Medical Device Interoperability From 30,000 FeetTim Gee, Principal and Founder Medical Connectivity Consulting

Beaverton, OR

Key Points

• There are preexisting models of medical device interoperability that can provide models for point-of-care device interoperability

• Point-of-care device interoperability includes requirements that differ from past interoperability models

• Specific barriers to adoption exist and must be overcome to facilitate infusion pump interoperability

• Medical device interoperability has been divided into five levels of interoperability

Interoperability Experience

Point-of-caremedicaldeviceinteroperability

isdesirableasameanstoimprove

patientsafetyandstaffproductivityby

automatingerror-prone,time-consuming

andsometimescomplexmanualtasks.

Duetochronicpatientsafetyissueswith

infusionpumpmedicationadministration,

interoperabilitybetweenthepumpsand

theinformationsystemsusedtoorder

andmanagepatientmedicationshas

existedforsometime.Currentlyexisting

infusionpumpinteroperabilityisdonevia

purpose-builtinterfacesbetweenspecific

pumpsystemsandinformationsystems.

Theseexistingintegrationsaremorelike

prototypes—expensiveandnotparticularly

intuitiveoreasytouseorsupport—than

theyarereleasedproducts.

Theredoexistmedicaldeviceinteroperability

solutionsthathaveachievedsignificant

marketadoptionthatcanprovideuseful

modelsinconsideringinfusionpump

interoperability.Theseexamplesare

laboratoryinformationsystems(LIS)

andpicturearchivingcommunications

systems(PACS).

ThetypicalLISincludesproductsfrom

manydifferentvendors.Thediagnostic

instruments,interfaces,androboticsthat

handlethesamplesarefromdifferent

manufacturers.Therearecomplex

automatedworkflowsdrivenbyorders

thatgeneratediagnosticreportsdelivered

toclinicians.

Likewise,PACSincludediagnosticimaging

modalities,diagnosticworkstations

foranalysisandreportgeneration,

workflowengines,archives,andother

systemcomponents,allfromdifferent

manufacturers.Asintheclinicallaboratory,

nosinglemanufacturermakesallthe

componentsthatcouldbefoundinaPACS.

Theinteroperabilityofthesesystemsis

supportedbyasetofspecificcharacteristics.

Mostofthemedicaldevicesandother

equipmentarepermanentlyinstalled,and

communicationsareaccomplishedvia

PROCEEDINGS

wiredEthernetnetworks.Asaresult,the

challengesofmobilityandportabilityare

avoided.Whilethesesystemsarelarge,they

arecontainedinlocalizeddepartments,

makingsystemdesignandmanagement

easier.Mostofthecomponents,including

themedicaldevices,includeindustry

standardstofacilitatecommunications

andinteroperability.Thematurityofthese

standardsandtheirimplementationmakes

thesesystemsvirtuallyplug-and-play,since

minimalconfigurationisrequired.Testand

certificationbodiessupportbothofthese

largeinteroperablesystems,resultingin

provenandreliablesystemconfigurations.

Point-of-Care Complexity

Takingthesametwoexamples,thePACS

andLIS,andextendingthemtothepoint

ofcarehighlightschallengessimilartothose

facedbyinteroperableinfusionpumps.

Byremovingmedicaldevicesfrom

establisheddepartmentssuchastheclinical

laboratoryanddiagnosticimaging,the

devicesareusedinnewenvironmentsin

waysthataredifferentfromconventional

department-baseddevices.

Mobileorportabledevicesareoften

wirelesslyenabled,whichprovidesthe

bestusabilityandconveniencefordevice

users.Besidesthenecessityofproperly

integratingawirelessradioandantenna

intothemedicaldevice,theenterprise

wirelesslocalareanetworkmustbe

designedtosupporttheapplicationof

wirelessmedicaldevicesinallthelocations

inwhichtheymaybeused.Thisoften



entailsasitesurveytoestablishabaseline

ofwirelessperformance,andaredesign

andmodificationoftheexistingnetwork.

Themorewidelythesemobiledevices

maybeusedintheenterprise,thegreater

thescopeofnetworkmodificationsand

validationtesting.

Whenconsideringmedicaldevice

interoperabilityorconnectivity,thefirst

thingmostpeoplethinkaboutisthe

connection.Whiletheabilityofmedical

devicestocommunicatetotheirrespective

computersystemsiscritical,itisthe

workflow—theseriesofstepsrequiredby

theusertosuccessfullycompleteatask

withthemobilemedicaldevice—that

isoftenmostdifficult.Theworkflowto

order,draw,testandreturnaresultfora

conventionallabtestiswellestablished,

asaresimilarworkflowsinradiology.The

workflowforpoint-of-caremedicaldevice

useisbeingcreatedwitheverynewpoint-

of-caretestingdeviceandsoftwarerelease

thatcomestomarket.Anditappearsthat

theindustryisstillquiteadistancefrom

establishingtheoptimalworkflows.

Oneadvantagethatclinicallaboratory

anddiagnosticimagingmodalitiesusedat

thepointofcarehaveoverconventional

point-of-caredevices(patientmonitors,

infusionpumps,ventilators,etc.)isthe

broadadoptionofindustrystandards

bymedicaldeviceandinformation

technology(IT)manufacturers.Standards

equivalenttoDICOMindiagnostic

imagingorASTMinthelabdonotexist

Point-of-Care Challenges

Portable or mobile – wireless

Increased area of use

New workflow

Insufficient standards

Crosses organizational silos

forinfusionpumpsandotherpoint-of-care

medicaldevices.

TheLISandPACSexistmostlywithintheir

diagnosticdepartments,providingan

organizationaladvantage.Evensupport

departmentslikeIToftenhavespecialized

resourceshousedinthelaboratoryand

radiologytosupporttheirinteroperable

systems.Mobileandportablemedical

devicesthatarebroadlydeployedinthe

enterprisecrossnumerousorganizational

silosinamoreovertway,complicating

themanagementandsupportofinfusion

pumpinteroperability.

Allofthesechallengesmustbeovercome

beforeinfusionpumpinteroperability

becomesawidelyadoptedcommercial

success.Besidesthesechallenges,there

areotherbarrierstoentryforboth

manufacturersandproviders.

Infusionpumpinteroperabilityisasystem

ofsystems.Thefirstsystemistheinfusion

pumpitself,referredtoasanembedded

systembyengineers.Nextisthesmart

pumpsystemthatincorporatesthe

infusionpumpsthemselvesandtherelated

network,serversandsoftwaretoprovide

thedrugerrorreductionsystem,clinical

documentationintoelectronicmedical

records(EMRs),andotheradvanced

infusiontherapymanagementfeatures.The

penultimatesystemprovidesinteroperability

betweenmedicationadministrationorders

inonesystem,thepharmacyinformation

system,medicationadministrationrecord

managementandthesmartpumpsystem

andinfusionpumpsthemselves.

ThisconfluenceofenterpriseIT—both

infrastructureandhospitalinformation

systems—andregulatedmedicaldevices

presentsasubstantialregulatorychallenge.

Existingregulationswerecraftedfor

conventionalstand-alonemedicaldevices.

Asmedicaldevicesystemssuchas

patientmonitoringnetworksandsmart

pumpshavecausedregulatorstomake

adjustmentsforsystems,anestablished

regulatoryframeworkforasystemof

systemsincorporatingregulatedmedical

deviceshasyettobedeveloped.

Likewise,theITandbiomedicalgovernance

inhospitalsdonotfullyaddressthis

confluenceofITandmedicaldevices.

Regardlessofwhetherthebiomedical

department(Biomed)reportstoITornot,

almostallhospitalsintheUSlacksufficient

rigorinriskmanagement,configuration

management,changecontrolandseveral

otherareastosupportinteroperabilityor

otherlife-criticalsystemsofsystems.

Thebestmodelforanoptimalhospital

governanceframeworkformedical

deviceinteroperabilityishowtheFood

andDrugAdministration(FDA)regulates

manufacturers.InIEC80001,arecently

promulgatedstandardtargetinghospitals

intendedtoaddressriskmanagement

ofnetworkedmedicaldevices,the

riskmanagementportionisbasedon

thestandardusedbymedicaldevice

manufacturestomanagerisk,ISO14971.

Asproviderorganizationsdeploytheir

ownlife-criticalsystemsofsystemsfor

whichtheyassumeprimaryresponsibility

forsupportandmanagement,providers

willneedabasicqualitysystemtoensure

ongoingsafeandeffectiveoperationof

interoperablemedicaldevicesystems.

Barriers to Adoption

Confluence of IT and regulated medical devices

Uncertainty how to regulate interoperable systems

Coordinating workflow across silos

Insufficient standards

Uncertain integration strategies: one-off or plug and play



Duetothebroaddeploymentofinfusion

pumps,hospitalswillhavetograpplewith

theorganizationalchallengesthatcome

withinitiativesoroperationsthatspan

organizationalsilos.Manyhospitalsare

experimentingwithmatrixorganizations,

committeesandcross-functionalworking

groupsinanefforttosuccessfullyresolve

theissuesthatimpactmultiplegroups.

Theresultingworkflows,which

crossorganizationsilos,arebothan

organizationalandoperationalchallenge.

Across-siloworkflowisnotasuccessuntil

itbenefits(oratleastdoesnotnegatively

impact)everyonethatusesthatworkflow.

Hospitalsandmanufacturershaveyetto

establishreliableandefficientmethods

fordocumentingexistingworkflows

andqualitativelycomparingthemto

automatedworkflows.Trialanderror

seemstobethedominatetechniquefor

optimizingworkflow.

Asnotedabove,thescarcityofworkable

standardsimplementedinpoint-of-care

devicesisamajorbarriertorealizingmedical

deviceinteroperability.Forpoint-of-care

medicaldevicemanufacturers,thelong-

standingproductstrategyisthecreation

ofproprietaryend-to-endsystems.The

advancementofworkflowautomation

atthepointofcare,necessitatinga

patient-ratherthandevice-centricfocus,

isperhapsthebiggestfactorpulling

manufacturersawayfromtheircherished

proprietaryend-to-endsolutions.

Thegoodnewsregardingstandardsfor

useatthepointofcareisthatthereare

manysuitablestandardsthatcouldbe

adopted;noreinventingthewheelis

required.Allmanufacturershavetodois

agreeonwhichstandardswillbeadopted

andthenadoptthem.Giventhelengthy

lifecycleofmedicaldevices,thisadoption

willtakesomeyears.Foraninterim

period,separateinterfacedeviceswill

beusedtoprovideanindustrystandard

interfacetolegacymedicaldevices,much

likeimageacquisitionmoduleswereused

intheearlydaysofDICOMandPACS.

Oncestandardsaredecideduponand

implementedinsomeway,amechanism

isrequiredtotestandcertifythat

implementationsareinconformance

withthestandardsandthatthedesired

workflowhasbeenenabled.Indiagnostic

imaging,thisfunctionisprovidedby

thetestandcertificationorganization

IntegratingtheHealthcareEnterprise

(IHE).TheIHEhasasimilarworkgroup

targetinginfusionpumpinteroperability.

Manyindustriesandmarketsegments

utilizetestandcertificationbodiesto

facilitatetheeffectivecreationofdevice

interoperabilityacrossmanufacturer’s

products.Itispossiblethatnewstandards

ortestandcertificationbodiesmayevolve

toaddressinfusionpumpinteroperability

and/orotherpoint-of-caredevices.

TheContinuaHealthAllianceisatest

andcertificationbodycreatedseveral

yearsagotoaddresstheambulatory

market,orwhatisoftencalled“mHealth”

(mobilehealth)or“healthcareunbound.”

Continuadoesnotaddresstheacutecare

market,thoughatsomepointproducts

withContinuacertificationmaybe

adoptedforuseinhospitals.

Medical Device Interoperability

Theterm“medicaldeviceinteroperability”

bringsmanythingstomind.Oneofthe

challengesofinteroperabilityisdefiningit

inasuccinctwaythathasclearmeaning.

Cleardefinitionsarealsoessentialforthe

regulationofmedicaldeviceinteroperability.

Basic Quality System

DMR – Device Master Record; DHR – Device History Record



SometimeagotheFDA,Continua,the

CenterforIntegrationofMedicineand

InnovativeTechnology(CIMIT)Medical

DevicePlug-and-PlayLab,andothers

convenedagroupforthepurposeof

developinganefficientandeffective

regulatoryframeworkforinteroperability.

Thisgroupiscurrentlyknownasthe

MedicalDeviceInteroperabilitySafety

WorkingGroup.Thisgrouphasdeveloped

anontologyofinteroperabilityanddefined

fivelevelsordegreesofinteroperability.

Akeyobjectiveofthisworkgroupisto

enablemedicaldevicesandsystemsto

operateinapatient-centricway.This

contrastswiththeLISandPACSthat

aremorespecimen-orexam-centric.

Aregulatorygoalistoavoidpair-wise

medicaldeviceregulation.TheFDA

typicallyregulatesmedicaldevicesystems

asonecompletesolution.Onlyone

manufacturercanbeclearedbytheFDA

tomarketthedevice/system,regardless

ofhowmanymanufacturers’products

areintegratedintothesystem.There

areexceptionstothis,forexample,

PACS.Earlyintheirinception,PACS

wereregulatedasasystem,butover

timetheFDAcametoregulateindividual

componentsofthesystemasseparate

medicaldevices.TheMedicalDevice

InteroperabilitySafetyWorkingGroupis

attemptingtofacilitatethesametransition

forinteroperablesystemstargetingthe

pointofcare.

Pair-wiseregulationmeansthatan

interoperableinfusionpumpsystem

wouldhavetogetclearedforintegration

withCernerandthengetclearedagain

forintegrationwithMcKesson,andfor

everyadditionalintegration.Thegoalisto

receiveclearanceonceandthenbeable

toconnectwithanyothersystemthathas

beencleared,too.Underthisframework,

aninfusionpumpmanufacturerwouldget

clearedonceforintegrationwithcleared

Level

1 Virtual device display

2Synthesis of derived notices or alarms

3 Virtual device control

4 Conditional device control

5 Programmable device control



patients,synthesismaynormalizealarms

acrossthesametypeofdevicefrom

differentmanufacturers.Forexample,

physiologicalparametersandalarms

canvaryconsiderablyacrossventilator

manufacturers.Inanenvironment

usingventilatorsfrommorethanone

manufacturer(acommonoccurrencein

hospitals),theresultingdissimilaralarms

canbeconfusing.Synthesiscannormalize

thesevariations,sotheuseronlyhas

toconsiderventilatorperformanceand

patientconditionframedbyonesetof

commonalarms.

Virtual device controlmeanstheremote

controlofthemedicaldevice.Many

medicaldevicesystemsallowcaregivers

tosilencealarmsortoadjustalarm

parametersfromacentrallocation,in

additiontothebedside.Virtualdevice

controlwouldprovideacommon

interface,sothatthiscentrallocation

couldmakethesekindsofchangesacross

devicesfromdifferentmanufacturers.

Levelfourtakesremotecontrolastep

farther,toconditional device controlwhere

asystemcontrolsmultipledevicesbased

on“if/then”typesoflogic.Asystem

thatcansuspenddrugadministration

automatically,ifandwhenaspecific

parameteronapatientmonitorfallsbelow

avaluecontrolledbytheclinician,isusing

conditionaldevicecontrol.

Programmable device controlrepresents

themostcomplexandautomatedlevel

ofinteroperability.Hereanalgorithm

configuredbytheclinicianmakesdecisions

thataffectthecontrolofthevarious

devicesattachedtothepatient.Thework

groupisusingventilatorweeningasan

exampleofprogrammabledevicecontrol.

EMRinterfaces,ratherthanindividuallyfor

eachEMRvendor.Otherwise,iftherewere

fivepumpmanufacturersandfiveEMR

vendors,everycompanywouldhaveto

gainFDAclearancefivetimes.

Toachievethisregulatorygoal(andat

thesametimeprovideplug-and-play

interoperabilityratherthancustom

integrationsbetweenmanufacturers),

theworkgroupneededtodefinespecific

degreesofinteroperabilitybasedonriskand

howatechnologymightbeimplemented.

Thefirstlevelisvirtual display,whereby

datafrommedicaldevicesandsystems

areaggregatedanddisplayedina

clinicallysignificantway.Therearemany

differentapplicationsforthis,butthebest

descriptioncomesfromtheITindustry:

dashboards.Byextendingthedisplayof

datafromthedevicetoanotherlocation,

perhapscombiningitwithadditional

relateddatafromothersources,and

displayingthatdatachangingovertime,

youhaveadashboardofinformation.

Thesynthesis of derived notices or

alarmsappliescontrolandknowledge

toalarmsandeventsfrommultiple

devices.Whenthedevicesareattached

tothesamepatient,thissynthesismay

eliminateduplicatealarmswherethe

samephysiologicalchangegenerates

alarmsfrommultipledeviceswithout

addinganyadditionalclinicalinformation.

Whendevicesareattachedtodifferent

Summary

Perhaps the biggest challenge to interoperability is getting manufacturers to move past proprietary end-to-end solutions and work together to create a framework that will result in plug-and-play interoperability that is affordable, easy to deploy and maintain, and reasonable to get through regulators such as the FDA. There are many pressures driving manufacturers in this direction—customers, meaningful use requirements and the Office of the National Coordinator for Health Information Technology and others. How things will ultimately evolve remains a mystery.



Infusing Patients Safely: Priority Issues from the 2010 AAMI/FDA Infusion Device SummitMary Logan, JD, CAE President, Association for the Advancement of Medical Instrumentation (AAMI)

Arlington, VA

PROCEEDINGS

Key Points

• In 2010, the Food and Drug Association (FDA) made infusion system safety a high priority, because of 87 pump recalls, 56,000 adverse incidents and 710 deaths reported to the FDA in a five-year period.

• The Association for the Advancement of Medication Instrumentation (AAMI) and the FDA co-hosted a summit meeting of diverse experts from across healthcare to develop consensus on 13 priorities for infusion safety improvements. Some of the priorities need to be addressed by industry, others by healthcare systems; some with stronger device standards, others with standardized practices. The entire healthcare community’s engagement will be needed to turn the corner on significantly reducing adverse incidents.

• Ten volunteer working groups are addressing the 13 priorities from the AAMI-FDA Summit under the direction of an infusion steering committee in the AAMI Foundation’s new safety council.

• Five changes will be tested, assessed and validated that, if on target, could reduce IV medication errors by up to 90%.

OnOctober5-6,2010,aremarkable

groupofdiverseexpertsoninfusion

systemsafetycametogetheratthe

AAMI-FDAInfusionDeviceSummit,

determinedtochangetheworldof

infusionsafety.Theeventwassparked

bytheFDA’sannouncementthatmore

than56,000adverseincidentsand

710deathsassociatedwithinfusion

deviceswerereportedtotheFDAfrom

2005-2009,morethanwithanyother

healthcaretechnology.Therewere87

pumprecallsduringthatsameperiod.

TheFDA’sBillMaiselacknowledgedthat

“adverseeventsareamplifiedbecause

healthcarecommunity’sengagement

inthese13prioritieswillbeneededto

turnthecorneronsignificantlyreducing

adverseincidents.

13 Priority Issues and 5 Clarion Themes

TheAAMI-FDAInfusionDeviceSummit

wasframedbyexpertpresentations.

Thensummitparticipantsfromacrossthe

healthcarespectrumspentmostofthe

twodaysbuildingconsensusonalistof13

priorityissuesthattheybelievedwerethe

mostcriticalforimprovingpatientsafety.

AAMIthensynthesizedthese13priority

issuesinto5clarionthemes(Table1).

Theseissueswerenosurprisetoanyone.

Thetimewassimplyrightfortheissuesto

gaintraction,becausesummitparticipants

heardtheFDA’scalltoaction.Everyone

knewthatthetimehadcometochange

infusionsafetythroughoutthehealthcare

system.Summitparticipantsbelievedthe

healthcarecommunitywascapableofand

wouldprefertoaddresstheissuestogether,

ratherthanreacttoregulatoryaction.Nat

Sims,MD,saiditbest:“Thereisnowaythis

issuecansinkbackintoobscurity,because

theFDAhasmadeitapriority.”

Atthesummit,AAMIannouncedthe

formationofasafetycounciltospearhead

actiononthe13priorityissues.Ninety-one

summitattendeesvolunteeredtobeapart

ofthefollow-upwork.

ofthenumberandfrequencyofuse

ofinfusionpumps.Failurescanoccur

wheneverpumpsareused,withevery

typeofpump,withanymanufacturer.

Manyproblemsareduetodeficienciesin

designandengineering.Butit’snotjust

anissueofdevices;it’saboutusersand

userinterfaces.”

Someoftheprioritiesemergingfromthe

Summitneedtobeaddressedbyindustry;

othersrequireattentionbyhealthcare

systems.Someoftheprioritiessuggest

theneedforstrongerdevicestandards;

othersarelikelytoleadtorecommended

standardizedpractices.Theentire



Working Group Projects and Progress to Date

Fastforwardtothesummerof2011,and

theAAMIFoundation’sInfusionSystems

SteeringCommitteeoverseestenworking

groupsandavisionof“Nopatientwill

beharmedbyadruginfusion.”Volunteer

workinggroupmembershavedeveloped

chartersandactionplansaroundthe13

priorityissues.Theirprogressinsixmonths

ofworkingtogetherisremarkable:

• Alarm Survey.Inordertobetterunderstandthenatureandfrequencyof

pumpalarms,theAlarmsManagement

workinggroupissurveyingfirstresponders.

ResultswillbesharedattheAAMI-

FDA-ECRI-ACCE-JointCommission

alarmssummitinOctober2011.

• Gaps in Connectivity.TheConnectivityWorkingGroupisstudyinggapsin

existingconnectivitystandards

andactivities.

• Failure Mode Study for Multiple Line Infusions.TheMultipleLineManagementWorkingGroupis

supportingastudybytheUniversity

HealthNetworkinTorontotoanalyze

failuremodesinadministering

multipleinfusions.

• Standardized Terminology.TheworkinggrouponStandardizedTerminologyis

developingatableoftermsanddefinitions

relatedtoinfusionsystemsandwillpropose

thesetermstoindustryandcliniciansfor

commentandultimatelyadoption.

• Library of Resources.TheInformationClearinghouseWorkingGroupisbuilding

alibraryofresources.

• Ideal Reporting System.TheIncidentReporting/ListeningSystemsWorking

Groupisdefininganddescribingtheideal

reportingsystemanditsrequirements.

• Drug Formulary. TheDrugLibraryWorkingGroupsare:(a)developinga

formularyofmedicationswithstandardized

dataelementsand(b)developingchecklists

onmaintainingandupdatingdrug

formulariesininfusionsystems.

• Matching Environments with Safety Features.TheWorkingGrouponEnvironmentofUseisdevelopingatool

thatwillhelpmatchuseenvironments

withspecificdevicesafetyfeatures,

inordertohelpreducetheriskof

prescribinginappropriateequipment.

• Training Gaps.TheTrainingWorkingGroupisdevelopingaplantocollect

informationfromvendors,manufacturers

andhealthcareprovidersoncurrenttraining

practices,inordertoaddressgaps.

Inseparatebutrelatedwork,AAMI’sInfusion

Devicestandardscommitteecontinues

towarditsgoaltoimprovetheANSI/AAMI

ID26:2004(R)(2009)standardforinfusion

devices.Ataskgroupisdevelopinganew

TechnicalInformationReport(TIR)onhow

todevelopasafetyassurancecasereportto

supporta510(k)application.



Table 1. Infusion Device Summit: 13 Priority Issues, 5 Clarion Themes

Standardize systems and processes for reporting, aggregating, and analyzing infusion device incidents

1. Poor (incomplete and inadequate) system for reporting data on adverse events.

2. Reported incidents do not convey the bigger picture in terms of the volume of incidents involving infusion devices (eg, close calls, near misses, and root causes).

3. Manufacturers often cannot determine root cause due to the difficulty of accessing and analyzing incident data from all sources.

4. No process for collaborative failure analysis (“safe space”).

5. Improve the integration of infusion devices with information systems and drug libraries

6. Incompatibility across devices and with systems (eg, consistent bar coding, wireless, power supply, HIT systems).

7. Lack of formulary and standards for drug libraries.

8. Uploading, managing, and maintaining drug libraries can be difficult.

Mitigate use errors with infusion devices

9. A high percentage of sentinel/adverse drug events are due to use errors. It is imperative to figure out how to develop design safety features that make it easy for the user to do the right thing.

10. Lack of standardization of terminology used in infusion systems.

11. Lack of knowledge/familiarity with infusion devices and lack of effective training.

Improve management of multiple infusions

12. Difficulty in infusion line management

Reconcile challenges and differences in the use environments of infusion devices

13. Alarm management is not effective

14. Injuries are caused by a lack of differentiation between the use of infusion devices in hospitals and in other environments.

How Will We Know We Have Been Successful?

Itisonethingtohaveaninspiringvision

thatnopatientwillbeharmedbyadrug

infusion.Itisquiteanotherthingtoanswer

thequestion,“Howwillweknowwehave

beensuccessful?”TheAAMIFoundation

infusionsystemssteeringcommittee

developedanearlylistofsuccessmeasures

tokeepfrontandcenter(Table2).

Lookingatthislistofsuccessmeasures,the

steeringcommitteeduringthespringof

2011starteddiscussingapossiblelistoffive

prioritychangesthat,ifimplemented,could

eliminateupto90%ofallIV-infusion-related

errors.FollowingtheInfusionTherapyand

InformationTechnologyconferencehosted

byCareFusiononJune2-3,2011,the

steeringcommitteedevelopedthedream

listof5items(Table3).

Thenextstepswillbetotest,assess

andvalidatethislistwithseveralelite

healthcareinstitutions.Whiletheentire

The Continuing Challenge

The challenge for all will be to keep the momentum going, to nurture the spark that gave the FDA, AAMI, the summit participants, and the working group volunteers the energy to get this far so fast. If the going gets tough, it will be important to reach out for that common bond shared by the entire healthcare community: improving patient safety.

Table 2. Infusing Patients Safely: Success Measures

• Improved design and manufacturing of devices

• Secure wireless networks

• Safety no longer depends on human accuracy

• No more “no fault found” errors

• Training, protocols, checklists and reporting are standardized

• Liability insurance premiums are reduced

• FDA, industry and hospitals are congratulated on their collective success of reducing infusion-related incidents

Table 3. Infusing Patients Safely: Priority Changes

The following changes, if implemented, could eliminate up to 90% of IV-infusion errors:

• Standardized drug nomenclature

• Auto documentation: closing the loop with computerized prescriber order entry (CPOE)

• Commitment to standardized critical drug hard stops across all care environments

• Standardized competencies: clinician training, checklists and competency assessments and audits

• All pumps on secure wireless networks

healthcarecommunityintheorywould

wanttoembracefivechanges,ifthey

knewthosefivechangescouldreduce

IV-drugrelatedincidentsby90%,thislist

nodoubtwillcreatesomeangst,ifnot

controversy.“Proof”thatthisistheright

listandhowmuchreductioninincidents

actuallycanbeachievedwillbecritical

tomakethelistcompelling.



PROCEEDINGS



One or More Errors in 67% of the IV Infusions: Insights from a Study of IV Medication AdministrationMarla Husch, RPh Central DuPage Hospital

Winfield, IL

In2002amultidisciplinarygroup

comprisingpharmacists,nursesand

biomedicalengineersatNorthwestern

MemorialHospitalinChicagoundertook

thechallengeofperformingafailure

modesandeffectsanalysis(FMEA)around

theuseofbedsideintravenous(IV)infusion

devicestoinfuseIVmedicationstopatients

atacontrolledrate.Thismethodologyis

usedtoanalyzepotentialfailuremodes

withinaprocessforpotentialseverity,

misprogrammingleadingtoseverelife-

threateningoverdosesofhigh-alert

medicationssuchasheparinandinsulin

thataremorelikelytocausepatientharm

ifadministeredincorrectly.Tovalidatethis

suspectedrootcauseandgainabetter

understandingoftheactualnatureand

rootcauseofsucherrors,anobservational,

prospectiveinvestigationwasperformed

usingapointprevalenceapproach.1The

objectivesweretodeterminethetype,

frequency,andseverityoferrorsassociated

withIVinfusionpumps,andtoevaluate

thelikelihoodthatstand-alonesmart

pumpswithoutaninterfacetoother

systemscouldhavepreventedtheerrors.

InJanuary2003fourteams,each

comprisingonepharmacistandone

nurse,observedIVinfusionsatthe

bedsideandcomparedtheinfusing

medication,doseandprogrammedrate

ontheinfusiondevicetotheordered

medication,doseandrateinthepaper

medicalchart.Anerrorwasdefinedas

“anypreventableeventthatmaycause

orleadtoinappropriateIVmedication

useviaanIVpumportopatientharm

whilethemedicationisinthecontrolof

thehealthcareprofessional,patient,or

consumer.Sucheventsmayberelatedto

professionalpractice,healthcareproducts,

proceduresandsystems,including

ordercommunication,productlabeling,

compounding,dispensing,administration,

education,monitoringanduse.”This

definition,althoughslightlymodified

Key Points

• An observational, prospective investigation evaluated the type, frequency, and severity of IV infusion pump-related errors and whether these errors could have been prevented by stand-alone smart pumps not interfaced to other systems.

• Four teams, each with a pharmacist and a nurse, observed IV infusions and compared the infusing medication, dose and programmed rate on the infusion device to the ordered medication, dose and rate in the paper medical chart.

• In one nine-hour shift a total of 426 IV medication infusions were observed; of these 285 (66.9%) infusions had one or more errors associated with their administration, and three of these were judged to be due to a programming mistake.

• Further analysis showed that only one of these errors would have been prevented by a stand-alone smart infusion device.

• To provide maximum protection against all errors associated with IV infusion device use, seamless bi-directional communication is necessary among smart pumps and other devices (electronic medical record, computerized physician order entry [CPOE] system, barcode medication administration system, and pharmacy system), so that all nodes of the medication use process communicate with one another electronically in real time.

frequencyofoccurrenceandeffectsof

thefailureontheoverallprocessoutput.

Infusiondeviceswerechosentobe

subjectedtotheFMEAmethodology

duetotheincreasingevidencebothin

theliteratureandattheorganization

thatinfusiondeviceusewasresultingin

unintendedharmtopatients.

TheFEMAidentifiedthesuspected

rootcauseofpatientharmasdevice



forthemethodologyofthisstudy,was

establishedin1995bytheNational

CoordinatingCouncilforMedicationError

ReportingandPrevention(NCCMERP).It

includesdeviationsintheadministration

ofadrugfromthephysician’sprescription

orfromthehospital’spolicies.NCCMERP

errordefinitions(Table 12)wereusedto

determinethespecifictypeofeacherror

documentedbytheteams.Foreach“rate

deviation”error,theteamalsoestimated

thelikelihoodthatstand-alonesmartpump

technologycouldhavepreventedtheerror.

Results

Atotalof426medicationsinfusingviaan

IVinfusiondevicewereobservedbythe

teamsinonenine-hourshift(0800–1700).

Ofthe426medicationsobserved,285

(66.9%)hadoneormoreerrorsassociated

withtheiradministration,foratotalof389

errorsoverall.Ofthese,only37weredeemed

“programmingerrors,”andonlythreeofthese

werejudgedtobeduetoaprogramming

mistake.Furtheranalysisshowedthatonly

oneofthedocumentedprogramming

errorswouldhavebeenpreventedbya

non-integratedsmartinfusiondevice.

Table 1. Error Types: Definitions2

• Rate deviation: a different rate is displayed on the pump from that prescribed in the medical record. Also refers to weight-based doses calculated incorrectly, including using a wrong weight.

• Incorrect medication: a different fluid/medication as documented on the IV bag label is being infused compared with the order in the medical record.

• Delay of rate or medication/fluid change: an order to change medication or rate not carried out within 4 hours of the written order per institution policy.

• No rate documented on label: applies both to items sent from the pharmacy and floor stocked items per institution policy.

• Incorrect rate on label: rate documented on the medication label is different from that programmed into the pump. Applies both to items sent from the pharmacy and floor stocked items.

• Patient identification (ID) error: patient either has no ID band on wrist or information on the ID band is incorrect.

• Unauthorized medication: fluids/medications are being administered but no order is present in medical record. This includes failure to document a verbal order.

Study Conclusion

The use of stand-alone smart infusion devices will prevent a small number of programming errors that have the potential to harm patients; however, in order to achieve meaningful improvements in patient safety, more advanced technology is required. Such technology would provide seamless bi-directional communication among smart pumps and (a) an electronic medical record (EMR); (b) a computerized physician order entry (CPOE) system with sophisticated rules and alerts and solid human factors engineering; (c) a barcode medication administration (BCMA) system that assures correct patient/drug/medication/dose/route/schedule per the original order; and (d) a pharmacy system that allows pharmacists to verify orders, dispense accurately, monitor infusion rates and volumes, and better anticipate patients’ needs. To provide maximum protection against all errors associated with IV infusion device use, all nodes of the medication use process from prescribing through administration and monitoring should be able to communicate electronically with one another in real time.

Theothertypesofadministration

errorswerenottheresultofdevice

misprogramming,whichtheFEMAteam

haddeterminedwasthemajorroot

causeofIVinfusiondevice-relatederrors.

Instead,theothererrorsweretheresult

oflackofsystemintegrationorlackof

sufficientknowledgeofthepatientthat

couldhavebeenmitigatedbyappropriate

integrationwithotherclinicalsystems.For

example,halfofthemedicationlabelswere

erroneouslymissingmedicationdoseand

rateinformation;pumpsintegratedwitha

pharmacyinformationsystemwouldhave

interceptedthistypeoferror.Additionally,

stand-alonesmartinfusiondevicescouldnot

warnaclinicianthatapatientwasallergicto

amedicationabouttobeinfusedorthata

medicationwasabouttobeadministeredto

thewrongpatient.

Reference:

1 M Husch, C Sullivan, D Rooney, et al. Insights from the sharp end of intravenous medication errors: implications for infusion pump technology. Qual Saf Health Care. 2005;14:80-6.

2 National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP).

PROCEEDINGS



Computerized Physician Order Entry and IV Infusions: Current Status and Future OpportunitiesDavid W. Bates, MD Medical Director of Clinical and Quality Analysis, Partners Healthcare; Chief Quality Officer, and Chief, Division of General Medicine

Brigham and Women’s Hospital

Onekeyreasonforestablishing

interconnectivityamongvariousmedical

devicesistoimprovemedicationsafety,

asthishasthepotentialtoreducethe

incidenceofadversedrugevents(ADEs)

andrelatedpatientharm.Twoofthe

mostimportanttechnologiestolinkare

computerizedprescriberorderentry

(CPOE)andcomputerizedintravenous

(IV)infusionpumps(smartpumps).

Thisarticleincludesbriefreviewsofthe

recentevidenceonCPOEandmedication

safety,includingdataonepidemiology

andpreventionofADEsespeciallyin

communityhospitals;abriefoverview

ofthe“meaningfuluse”requirements;

asummaryoftherisksofCPOE;new

evidenceaboutclinicaldecisionsupport

andhumanfactors;andthecurrentstatus

andfutureopportunitieswithrespectto

CPOEandIVinfusionsinparticular.

Frequency of ADEs

MostofthedataonthefrequencyofADEs

havecomefromstudiesconductedat

large,academicmedicalcenters.Arecent

study1soughttodeterminethebaseline

rateofADEsinsixcommunityhospitalsin

thegreaterBostonarea,comparetheADE

ratesamongthehospitalsandestimatethe

potentialbenefitandsavingsassociated

withADEratereduction.

TheaverageADErateinthesixcommunity

hospitalswas15per100admissions

(range,11to19.5),1abouttwicewhat

itwasinacademiccenters.2Onaverage

75%(range,68%to85%)oftheseADEs

werepreventable,1whichismuchhigher

thaninacademiccenters,where28%

ofADEswerepreventable.2Moreover,

ADEsareverycostly,withtheestimated

costtotheU.S.healthcaresystem$3.8

billionin2008forinpatientADEsalone.3

Asreimbursementchanges,hospitalswill

likelynolongerbeabletochargeforthe

treatmentofpreventableADEs,soitwill

beintheirfinancialinteresttoinvestin

solutionstopreventthem.

Impact of CPOE on Medication Safety

Astudydonein20034foundfivetrialsof

theimpactofCPOEimplementationon

medicationsafety.Twoshowedalarge

decreaseintheseriousmedicationerror

rate;oneshowedimprovementintheuse

ofcorollaryorders(forexample,ifyouorder

anaminoglycocide,thesystemsuggests

Key Points

• In six community hospitals, the average rate of adverse drug events (ADEs) and the percent of ADEs that were preventable were much higher than what had been found in prior studies in academic medical centers.

• The drug-safety benefits of implementing computerized prescriber order entry (CPOE) represent only a small portion of the potential financial benefit.

• In another study, user acceptance of interruptive safety alerts positively correlated with frequency of the alert, quality of display and level of the alert level, making it abundantly clear that institutions should be tiering alerts.10

• In a simulation study CPOE systems detected only 53% of orders that would have been fatal and 10% to 82% of orders that would have caused serious ADEs, with no relationship between CPOE vendor and error detection.11

• Key opportunities to improve IV medication safety include standardizing IV orders across institutions and systems, including dose ranges and titration orders; sending orders directly to smart pumps, eliminating the need for re-entry and linking smart pumps with monitoring devices such as end-tidal CO2, patient movement and respiratory data.



Visualalertsshouldbeprioritized,and

colorshouldbeusedtohelpcuetheuser

totheimportanceofaspecificalert.In

manysystems,thelife-threateningalerts

lookexactlythesameasonesthatarenot

atallimportant,makingiteasytomissthe

criticalones.Thenumberofcolorsused

shouldbekepttoaminimum.Tomake

visualalertsmoredistinct,itisimportant

tominimizethenumberofsharedvisual

features,sotheydonotlookalike.Text-

basedinformationshouldbesuccinct.

Human Factors Principles and Alert Acceptance

Toexaminehowalertsaffectbehavior,

anotherstudy9lookedatalmost51,000

drug-druginteraction(DDI)alerts,both

inpatientandoutpatient.Providers

acceptedonly1.4%ofnon-interruptive

alerts.Forinterruptivealerts,user

acceptancepositivelycorrelatedwith

frequencyofthealert(OR1.30),quality

ofdisplay(OR4.75),andalertlevel(OR

1.74).Alertacceptancewashigherin

inpatients(OR2.63)andfordrugswith

dose-dependenttoxicity(OR1.13).The

textualinformationinfluencedthemode

ofreaction,andprovidersweremore

likelytomodifytheprescriptionifthe

messagecontaineddetailedadviceon

howtomanagetheDDI.

Impact of Tiering on Inpatient DDI Alerts

Anotherstudybyourgrouplookedat

theimpactoftiering(differentiatingDDI

alertsinCPOEbylevelofseverity)attwo

academicmedicalcentersinBostonthat

wereusingthesameknowledgebase.10

SiteAdisplayedalertsusingthreetiers,

includinghardstopsforthemostsevere

alerts(Level1),andSiteBhadallthe

alertsasinterruptive(orLevel2),andLevel

3wasnon-interruptive—informational

only.Theinformationsystemsgroupat

youcheckrenalfunction).Onestudy

showedimprovementinfiveprescribing

behaviors,andoneshowedimprovement

innephrotoxicdrugdoseandfrequency.

Asubsequentmeta-analysisfounda

66%reductioninprescribingerrors

onaverage.5Yetanothermeta-analysis

evaluated10studiesofCPOEandADEs:

fivefounddecreasesintheADErate,four

showednon-significanttrends,andone

showednoeffect.6Mostindividualstudies

todatehavenothadsufficientstatistical

powertolookatthefrequencyofADEs,

whicharerelativelyrare.

Takentogether,though,itappearsthat

CPOEclearlyreducesthefrequencyof

medicationerrors,andprobablyalso

decreasesthefrequencyofpreventable

ADEs;theresultsforthelatteraremore

mixed.However,thedrug-safetybenefits

ofimplementingCPOErepresentonly

asmallportionofthefinancialbenefit.

Inaddition,gettingfullvaluefrom

CPOErequiresbuildingingooddecision

support,ensuringthatyouhavetheability

tomodifythesystemandtheniteratively

improvingit.Itisimportanttoidentify

andtrackproblems,andaddressthem

oneatatime.

Meaningful Use and Medication-Safety-Related Decision Support in Hospitals

In2011,financialincentivesforproviders

withregardtomeaningfuluseofan

electronichealthrecord(EHR)were

introduced.Themedication-related

targetsfocusedonthefollowing:

1. haveanactivemedicationlistand

anallergylist

2. formorethan30%ofpatients,have

atleastonedrugorderedusingCPOE

3. havedrug-druginteractionand

drug-allergychecks.

Byfarthemostcontroversialofthese

provisionswasincludingCPOEonthe

list,asalargeproportionofthepublic

commentsabouttheregulationsfocused

onthisarea.

The2013recommendationsareunder

consideration,althoughitappearslikely

theywillbereleasedsoon.Thelatest

iterationdirectshospitalstouseCPOE

forallordertypes.ThetargetforCPOE

usehasbeenincreasedto60%of

patients.Otherrequirementsaretouse

evidence-basedordersets,domedication

reconciliationat80%ofkeytransitions

andimplementelectronicmedication

administrationrecord(eMAR).7

CPOE Risks

Anynewtechnologycanintroduce

newerrors,andCPOEisnoexception.

TheuseofCPOEcanmakeitpossible

towriteordersthatareunclearorthat

haveinternalconflicts.Almostallnew

implementationshavesomeissues,

whichtypicallyaremoreprofoundfor

IVmedicationsthanforothertypesof

orders.Theissuesneedtobeidentified,

trackedandeliminatedonebyone.

Human Factors and Alarms

Arecentstudyofhumanfactorsandalarms

inrelationtomedicationsafetymadea

numberofrecommendationsbasedon

theevidenceinthisarea.8Uniformalerting

mechanismsandstandardizedalarm

responsesareneeded.Aninstitution’s

alarmphilosophyshouldbeestablished,

andonekeyistominimizethenumber

offalsepositivealerts.Extensiveevidence

showsthatiftherearetoomanyalerts,

peoplestarttoignoreeventheimportant

ones.Otherfactorsthatemergedinclude

thatvisibilityiscritical—placementofthe

alertssubstantiallyimpactsthelikelihood

thatuserswillseethem.Thefontsize

shouldbelargeenoughtobereadilylegible.



SiteBdidnotwanttostructurethings

inthisway,buttechnicalissuesmadeit

impossibletoimplementtiering,sowe

tookadvantageofthisnaturalexperiment.

Thefindingswerestriking.AtSiteA,100%

ofthemostseverewarningswereaccepted,

becausetheywerebasicallyhardstops,

versusonly34%atnon-tieredSiteB.In

essence,people“ranstopsigns”66%of

thetime.Overallalertacceptancewashigher

atthetieredsite(29%vs10%,p<.001).

Thesedatamakeitabundantlyclearthat

institutionsshouldbetieringalerts.10

Safety Results of CPOE Decision Support Among Hospitals

Anotherimportantissueishowhospitals

atlargearedoingwithrespectto

implementingalerts.Inastudydone

jointlywiththeLeapfrogGroupwhich

wasledbyMetzger,weevaluatedthe

alertshospitalshadimplemented,using

aCPOE“flightsimulator.”Overall,62

hospitalsaroundthecountryvoluntarily

participated.11Thehospitalsweregiven

afewsimulatedpatients,andthen

ordersthathadeitheractuallykilledor

seriouslyinjuredsomeonetoenterinto

theirCPOEsystems,sotheycouldcheck

whetherornotwarningswoulddisplay.

Allresultswereenteredintoawebsite,

andthehospitalsreceivedtheirscores.

Theresultswerealarming:theCPOE

systemsdetectedonly53%ofordersthat

wouldhavebeenfatal,andonly10%to

82%ofordersthatwouldhavecaused

seriousADEs.Furthermore,therewas

almostnorelationshipbetweenCPOE

vendoranderrordetection.11Eventhough

somepeoplethinkthatpickingthe

rightvendorwillsolvetheirmedication

safetyproblems,thisfindingshowsthat

beliefisnotcorrect.Howasystemis

implemented,especiallythedecision

supportputinplace,isprobablymuch

moreimportant—allthevendorshad

hospitalswhichscoredwell,butalsoall

hadhospitalswhichscoredpoorly.This

underscorestheneedforsuchtestingon

anon-goingbasis,sothathospitalscan

assesswheretheyarewithrespectto

decisionsupportimplementation.

CPOE and IV Infusions: Current Status

CurrentlylinkagesbetweenCPOEand

smartinfusiondevicesarerare.IVinfusion

ordersvarywidelyandpumpstypically

areprogrammedmanually,creatingmany

opportunitiesforerrorstooccurbetween

placinganorderandprogrammingitintoa

pump.Enormousvariabilityinpracticealso

increasesopportunitiesforerrors.Smart

pumpshavedocumentedmanyerrorsthat

previouslywereunknown.Asnotedabove,

theratesofIVmedicationerrorsaremuch

higherthanmanysuspected.

Analysesofsmartpumpdatahave

identifiedshockingbehaviorssuchasa

nurseoverridingafataloverdosealert

sixtimesortoxicmedicationsbeing

infusedwithoutanorderinplace.A

100-hospitalstudy12foundhugevariation

inpractice,withanaverageacross

hospitalsof8.5namesperdrug,three

differentdosingunitsperdrug,and15

differentcontinuousdosingunitsper

hospital(range8to24),notincluding

bolusdosing.12Thus,thereissubstantial

potentialtoimproveIVmedicationsafety.

CPOE and IV Infusions: Key Opportunities

Keyopportunitiestoimprovemedication

safetyincludestandardizingIVorders

acrossinstitutionsandsystems,including

doserangesandtitrationorders.Orders

shouldbesentdirectlytosmartpumps,

whichwouldeliminatetheneedfor

re-entry.Anotherkeyopportunityisto

linkthepumpswithmonitoringdevices

suchasend-tidalCO2,patientmovement

andrespiratorydata,whichcouldenable

thepumpstostopinfusionsifapatient’s

breathingappearstobeslowingorto

notifyanursetointervene.

Asnotedearlier,CPOEappearstobe

highlybeneficialintheaggregate,but

itclearlycancreatenewproblemsthat

needtobeidentifiedandengineeredout.

ThatalsoholdstrueforIVinfusionsafety

systems.Itisimportantnotonlytohavea

technologybutalsotoimplementitwell

andseriallyrefinethedecisionsupport.

AsEinsteinsaid,“Insanityisdoingthe

samethingsthesamewayandexpecting

differentresults.”Wehavetochangethe

waythatwearedoingthings,ifweare

toachievedramaticallydifferentresultsin

preventingharmfulADEs.

References

1 Hug BL, Witkowski D, Sox CM, et al. Adverse drug event rates in six community hospitals and the potential impact of computerized physician order entry for prevention. J Gen Intern Med 2010;25(1):31-8.

2 Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA : the journal of the American Medical Association. Jul 5 1995;274(1):29-34.

3 Jha AK, DesRoches CM, Kralovec PD, et al. A progress report on electronic health records in U.S. hospitals. Health Aff 2010;29(10):1951-7.

4 Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. Arch Intern Med 2003;163:1409-16.

5 Shamliyan TA, Duval S, Du J, et al. Just what the doctor ordered: Review of the evidence of the impact of computerized physician order entry system on medication errors. Health Serv Res 2008;43(1 Pt 1):32–53.

6 Wolfstadt JI, Gurwitz JH, Field TS, et al. The effect of computerized physician order entry with clinical decision support on the rates of adverse drug events: A systematic review J Gen Intern Med 2008;23:451-8.

7 ONC (The Office of the National Coordinator for Health Information Technology). 2012. Final Comment Summary for All Objectives and Questions: Health Information Meaningful Use Work Group. Washington DC.



8 Phansalkar S, Edworthy J, Hellier E, et al. A review of human factors principles for the design and implementation of medication safety alerts in clinical information systems. J Am Med Inform 2010:17(5):493-501.

9 Seidling HM, Phansalkar, Seger DL, et al. Factors influencing alert acceptance: a novel approach for predicting the success of clinical decision support. J Am Med Inform Assoc 2011;18:479-84.

10 Paterno MD, Maviglia SM, Gorman PN, et al. Tiering drug–drug interaction alerts by severity increases compliance rates. J Am Med Inform Assoc 2009;16:40-6.

11 Metzger J, Welebob E, Bates DW, et al. Mixed results in the safety performance of computerized physician order entry. Health Aff 2012;31(1):655-63.

12 Bates DW, Vanderveen T, Seger DL, et al. Variability in intravenous medication practices: implications for medication safety. Jt Comm J Qual Pt Safety 2005;31(4):203-10.

References (continued)



PROCEEDINGS

How Well Does Bar Code Medication Administration Address the IV Process?Mark Neuenschwander The Neuenschwander Company

Bellevue, WA

Barcodemedicationadministration(BCMA)

isoftenthoughtofintermsofhelping

preventmedicationerrorsandadverseevents

atthepointofcare.However,theneedfor

andbenefitsofusingthistechnologyextend

farbeyondmedicationadministrationitself.

Theideaisnotsimplytocatcherrorsatthe

pointofcarebuttopreventasmanyerrors

aspossiblebeforetheyeverreachpatients.

Inthisarticle,theimportanceofusingbar

codingonthepathtoinfusion,thevalueof

BCMAatthepointofinfusion,andsome

nuancesoftheinfusionprocesswithBCMA

willbeaddressed.

BCMA on the Path to Infusion

Theefficacyofbar-codingatthepoint

ofinfusionstartswiththeaccuracyof

IVmedicationpreparationandlabeling.

IVmedicationsarriveinhospital

pharmaciesfrommanufacturersand

outsourcedcompoundingserviceswith

bar-codedlabelsthatmustbemapped

tohospitaldrugformularies.Theuseof

bar-codescanninginthepharmacycan

helpensuretheaccuracyandefficiency

ofthestorageandretrievalprocessof

thesepre-mixedpreparations.

WhenIVmedicationsarepreparedinthe

pharmacy,itispossibleforIVmedications

toarriveatpointsofcarewithlabels

thatmatchthepatientsreceivingthem,

butwithIVmedicationsthathavebeen

inaccuratelymixed.Toavoidthis,bar-code

verificationsafeguardsareincreasingly

beingusedduringin-houseIVpreparation.

Pharmacypersonnelscaneachingredient

toensurethattherightcomponentsare

beingadmixedandthatmatchingorder

labelsaregeneratedautomatically.Itis

difficulttounderstandwhyanyhospital

woulddragitsfeetonexercisingthis

option;nopoint-of-caresystemcancatch

apharmacy’sadmixtureerror.

Inthefuture,scanningwillalsotobeused

tohelpvalidatetheintegrityofIVproducts

againstexpirationdates,lotnumbers,and

evencold-storagehistories.Thesimple,

printed,2Dbarcodesusedtodayinclude

lotnumberandexpirationdates.Other

industriesdemonstrateotherpossibilities.

TheDepartmentofTransportationand

theEnvironmentalProtectionAgency

requiremanufacturerstoputmore

detailedlabelsonnewcarwindowsfor

energyconsumptionratings.Thelabels

includequick-response(QR)codes,which,

whenscannedwithsmartphones,take

consumerstodetailedinformationabout

mileage,ratings,etc.Morecomplex

solutionssuchasradiofrequency

identification(RFID)canmonitorproduct

temperatures;however,lessexpensive

Key Points

• The need for and benefits of using bar code medication administration (BCMA) extend far beyond medication administration.

• In the pharmacy, bar-code scanning can help ensure accurate, efficient storage and retrieval of outsourced intravenous (IV) preparations, and for in-house preparations, help ensure that the right components are being admixed and matching labels are generated automatically.

• At the point of infusion, in addition to positive identification of patient and medication, mobile BCMA computing devices provide the means by which data are retrieved from and stored in the electronic medication administration record (eMAR), helping ensure accurate pump programming and infusion documentation.

• For “meaningful use,” BCMA can help ensure accurate reading and feeding of the eMAR portion of the larger electronic health record (EHR)

• For IV infusions, both BCMA and smart pumps are necessary: with smart pumps alone, nurses could administer the wrong medication the right way; with bar coding alone, the right medication the wrong way. Each technology is incomplete without the other.



andequallyeffectivesolutionsareon

thehorizon.Coorsismakingbeer-can

labelsthatchangecolorsastheproduct

temperaturehitsideal.Thegroceryindustry

istestingmeatandproduceproductlabels

printedwithtemperature-sensitiveinks.

Ifaproduct’stemperaturegoesoutside

saferanges,thebarcodeschangetoan

unreadablecolor.

BCMA at the Point of Infusion

Atthebedside,BCMAoffersfarmore

thanjustbarcodescanning.Mobile

BCMAcomputingdevicesgivecaregivers

accesstotheeMAR,andscanningis

themeansbywhichdataareretrieved

andstored.Scanningdevicesmaybe

handhelddevices,wall-mountedscreens,

orcomputersonwheels.iTouch,iPhone

andiPaddevicesarestartingtobeused,

aswell.

Itisworthnotingthathospitalsmayhave

eMARswithoutbar-coding,butitwould

besenselessandperhapsimpossibleto

havemedicationadministrationbar-coding

withouteMARs.InreferringtoBCMA,

eMARsareassumed.Somehospitalseven

calltheirbarcodeinitiatives“eMAR.”

Arguablythemostimportantvalueof

BCMAispositivepatientidentification.

BCMAassistscaregiversinpositive

patientidentification,inkeepingwith

thefirstNationalPatientSafetyGoal

fromTheJointCommissioncallingfor

hospitals“toimprovetheaccuracyof

patientidentification.”Byscanninga

patient’swristband,thecaregiverretrieves

thatpatienteMARs,whichdisplay

prospectivelywhatistobeadministered

andretrospectivelywhathasbeen

administeredtothatpatient.

Scanningamedicationconfirmsthat

whatisintheclinician’shandmatchesthe

patient’sorder.Thescreenalsoprovides

additionalinformationsuchaswhatthe

caregiveristodowiththedruginhand

(eg,givefiveofthe10mL,andthen

theotherfive).Thescreenalsoindicates

routeandsite.WhenIVmedications

areinvolved,thedose,rateandother

importantinformationforproperly

programmingtheinfusionpumpalsomay

beinvolved.

Finally,bar-codeenabledeMARsassistin

achievingmoreaccuratedocumentation.

BCMAdocumentsmedication

administrationwhereandwhenitactually

happened,ratherthandocumentingit

later,downthehall.Toooften,even

wheneMARswithoutbarcodingare

employed,nursesjotadministrationnotes

onscrapsofpaperatthepointofcare

andattempttorecallwhattheydid,later

inthedayatacomputer20yardsaway.

BCMA and Meaningful Use

Whilebarcodingisnotexplicitlyincluded

inthephaseoneandphasetwo

requirementsofMeaningfulUseofEHRs,

itisdifficulttoimaginehowhospitalscan

meettheexpectationsintheAmerican

RecoveryandReinvestmentAct(ARRA)

withouteMARs.Thequestionisnot

whetherornotuseofeMARswillbe

expected,thequestioniswhereeMARs

willbeutilizedandhowdatawillbe

retrievedandentered.Forhospitalsthat

haveeMARsdownthehallatnursing

stations,BCMAisatoolforbringing

themtothepointofcare,usingbarcode

scanningasadata-retrievalanddata-

entrymechanism.

Earlyinhiscommunicationson

MeaningfulUse,DavidBlumenthal,MD,

MPP,formerNationalCoordinatorfor

HospitalInformationTechnology,sent

acompellingmessage:“Byfocusing

onmeaningfuluse,werecognizethat

betterhealthcaredoesnotcomesolely

fromtheadoptionoftechnologyitself,

butthroughtheexchangeanduseof

healthinformationtobestinformclinical

decisionsatthepointofcare.Meaningful

useinthelongtermiswhenEHRsare

usedbyhealthcareproviderstoimprove

patientcaresafetyandquality.”This

referstobringingthiselectronicrecordto

thepointofcareandusingitduringthe

processofcare.BCMAcanbethought

ofasthe“synapse”betweenthepatient

andtheEHRforreadingandfeedingthe

electronicrecord.

BCMAenablesfaithfulrelianceuponand

reliablepopulationofthemedicalrecord.

WhateverMeaningfulUsedefinitionsCMS

mayevolve,forEHRstobemeaningful

theymustbefedreal-timeallthetime—

thoroughlyandaccurately.Andiftheyare

goingtobeusedmeaningfully,theyneed

tobeusedatthepointofcare.

BCMA and Smart Pumps

Inpastyears,therehasbeensomedebate

overwhichtechnologyhospitalsshould

implementfirst,BCMAorsmartpumps?

ThatseemsratherlikeOrvilleandWilbur

arguingatthedrawingboardoverwhich

wingoftheairplanewasmoreimportant.

Withsmartpumpsalone,nursescould

administerthewrongmedicationthe

rightway(withinthedosingparameters

forthatdrug).Withbarcodingalone,

caregiverscouldadministertheright

medicationthewrongway.Each

technologyisincompletewithoutthe

other.Theyinofscanningandtheyang

ofsmartpumpsarebothneeded.

Thegoodnewsisthatsmartpumpsare

becomingmorecommunicative.Notonly

arepumpdruglibrariesbeingupdated

remotely,somehospitalsareactually

auto-programmingsmartpumpsfrom

eMARsviamobilecomputingdevicesand

scanners.Intheseinstances,smartpump

systemsnotonlyarerespectingthedrug



library’sparametersforeachdrugbutalso

ensuringthattheexactorderissentto

thepumpfordose,rateandflow.Equally

exciting,thepumpisfeedingtheeMAR

withreal-timeinfusioninformation,which

canbereadnotonlyatthepointofcare

butalsoremotelybycaregivers,even

alertingpharmacywhenitistimeto

sendupmoreproduct.

Thegreatvalueofpatientsafety

technologiesisthattheymakeiteasier

forcaregiverstodotherightthingand

harderforthemtodothewrongthing.

InterfacingeMARsandsmartpumpsas

discussedabovealsomakesiteasierfor

caregiverstodotheirworkandremoves

theincentivesforthemtocreatework-

arounds,simplybecausedoingthingsthe

rightwayiseasierthandoingthemthe

wrongway.Theimpressivesafetyand

efficiencygainsrealizedwiththeWellSpan

BCMA/Pumpintegrationproject,discussed

elsewhereintheseproceedings,provide

excellentexamples.

Conclusion

Bar code medication administration (BCMA) is often thought about in terms of preventing errors and adverse events in administering medications at the point of care. However, BCMA provides benefits not only at the point of infusion but also in the pharmacy, between the point of care and the electronic record, for meaningful use, and for smart pump auto-programming and auto-documentation. BCMA provides a safety net at the point of care and also a means of helping ensure safe processes throughout the IV process.



Have Smart Infusion Pumps Reached Their Full Potential?Tim Vanderveen, PharmD, MS Vice President, Center for Safety and Clinical Excellence

CareFusion, San Diego, CA

PROCEEDINGS

Intravenous(IV)infusionpumpshave

beeninwidespreadclinicaluseforalmost

fourdecades,butcomputerizedinfusion

pumpswithdoseerrorreductionsoftware

(DERS)haveonlybeenavailableinthe

last10years.Commonlyreferredtoas

“smart”infusionpumps,thesedevices

haveaddedmanynewsafetyelements

toIVinfusiontherapy,andtheiradoption

acrossthehospitalmarkethasbeen

significantlyfasterthanthatofanyother

medicationsafetytechnology,suchasbar

codemedicationadministration(BCMA),

computerizedphysicianorderentry

(CPOE),etc.

Key points

• Early intravenous (IV) infusion pumps were one-size-fits-all devices that allowed a 10,000-fold range of infusion rates and a 100,000-fold range of volumes-to-be-infused that contributed to serious medication errors.

• In the last 10 years, computerized “smart” infusion pumps with dose error reduction software (DERS) have greatly improved IV infusion safety by providing more advanced technology and requiring hospitals to create comprehensive drug libraries with dose limits and other important safeguards.

• A major safety contribution has been the smart pumps’ continuous quality improvement (CQI) logs, which provide actionable data that can help hospitals improve practice and better manage their drug libraries, and help manufacturers improve the technology.

• Taking IV infusion safety to the next level will come through interoperability and system integration, as smart infusion pumps seamlessly become a fully functioning component of a hospital’s information technology (IT) systems.

Improving IV Infusion Safety

Toappreciatehowsmartpumpshave

improvedmedicationsafety,weneed

tobrieflydescribetheprevious“dumb”

infusionpumpsandhowtheywere

used.Forthefirst30years,thetypical

IVinfusionpumpwasaone-size-fits-all

devicedesignedtomeettheneedsof

theentirehospital,fromthesmallest

neonatetoanadultpatientinintensive

care.Unlikethemedicationstheyinfused,

thepumpswerenotindividualizedfor

eachpatient.Thetypicalpumpdispensed

bybiomedicalengineeringcoulddeliver

anywherefromafewdropstoafull

literoverthecourseofanhourwithno

safeguards,andanydoseorratewas

OK.The10,000-foldinfusion-rateranges

and100,000-foldvolumes-to-be-infused

rangesoftheseearlypumpscontributed

toseriousmedicationerrors.Amissed

decimalpoint,anextrazero,switchingthe

rateandvolumeentries—thesetypesof

errorscouldgoundetectedandresultin

seriousmedicationover-orunderdoses.

Unliketheadministrationoftabletsand

injections,whicharediscreetevents,

infusionsareaprocess.Infusions

oftencontinueforhoursordays,are

programmedbymultiplecaregiversand

subjecttostarts,stops,titrations,etc.Every

changeincreasestheopportunitiesfor

errors.Withoutadditionalsafetyfeatures

tohelpavertsucherrors,theentireIV

infusionsystemleftmuchtobedesired.

Smart Pumps’ Contributions

Tenyearsago,oneofthefirstimportant

contributionsofsmartpumpswasnot

thetechnologyitselfbuttherequirement

thathospitalscreatecomprehensivedrug

librariesfortheirpumps.Foreverydrug

inthelibrary,ahospitalhadtodetermine

whatdosewastoolowortoohigh,

andwhattypeofalertandsubsequent

clinicianactionshouldberequiredifa

programmeddoseexceededthedrug

librarylimits.Creatingthedruglibraries,

whichtodayincludevirtually100%ofIV

drugs,istypicallythemostchallenging

aspectofsmartpumpimplementation.



Recommendeddosesareavailablein

referencetextsandpackageinserts,

butthesesamesourcesdonotprovide

doselimits.Intitratingadrugtoincrease

bloodpressure,whenisthedosetoo

high?Tomeetthechallengeofmaking

suchdeterminations,clinicalpharmacists,

workingwithnursingandthemedical

staff,assumedresponsibilityforcreating

andmanagingthesmartpumps’

multipledruglibraries,includingthe

determinationofdoselimits,whether

theseshouldbe“soft”or“hard”(can

orcannotbeoverridden),whatdrugs

canbeusedsafelyinspecificcareareas,

whatconcentrationsanddosingunitsare

permitted,etc.StandardizingIVinfusion

therapyacrossthehospitalgreatly

reducedtheopportunitiesforserious

medicationerrors.

Asecond,oftenoverlookedcontribution

isthatinsteadofone-size-fits-all,smart

pumpsprovide10ormoreconfigurable

“profiles”thatarecustomizedfordifferent

patienttypesorcareareassuchasneonatal

intensivecareunit(NICU),adultICUor

medical-surgical.Whenasmartpump

ispoweredon,itrequirestheclinician

toselectaprofile.Thisautomatically

configuresthepumpforusewiththat

patienttypeorinthatpatientcarearea

withtheappropriatedruglibraryand40

ormorepump-performancesettingssuch

asmaximumflowrate,airdetectionlimit,

maximumocclusionpressure,alarmtone,

etc.Simplyselectingtheprofilecustomizes

thesmartpump’sconfigurationinwaysthe

engineeringdepartmentnevercould.

Anunexpectedlypowerfulcontribution

ofthesmartpumpshasbeentheir

continuousqualityimprovement(CQI)

logs,whichhaveproventobeatreasure

troveofinformation.Thelogscapture

anypumpprogrammingthatresultsinan

alertandrecordtheclinician’ssubsequent

action.Inadditiontodocumenting“good

catches”wherebyunintendedunder-or

overdoseswereidentifiedandaverted,

thelogshelpcliniciansidentifypreviously

unrecognized,unsafeclinicalpractices;

helphospitalsimprovetheirdruglibraries

andhelpmanufacturersidentifywaysto

improvethetechnology.

Whensmartpumpswerefirstintroduced,

uploadingthedruglibraryanddownloading

CQIdatarequiredphysicallyconnecting

eachpumptoalaptop,onebyone.This

wasaverylabor-intensiveprocess,and

oftenCQIdatawerecollectedandlibraries

updatedonlyduringtheannualpreventive

maintenance.Wirelessconnectivity,which

hasbecomestandard,greatlysimplifiedthis

process.NowCQIdatacanbecollected

wirelesslyeveryday,anddruglibrariescan

easilybeupdatedasfrequentlyasrequired.

Opportunities for Further Improvements

Despitesmartpumps’manyimportant

contributions,theirfullpotentialhasnot

yetbeenrealized.Withfewexceptions,

today’ssmartpumpscannotyetensure

thetraditionalfive“rights”ofdrug

administration(rightpatient,rightdrug,

rightdose,rightrouteandrighttime)or

other“rights”suchasrightresponseand

rightdocumentation.

Pumpstypicallyarenotassignedto

individualpatientsandhavenopatient

informationbeyondlocationorpatient

type.Althoughthepumpsarewirelessly

connected,thephysician’sordersare

notsentdirectlytothepumps,and

programmedpumpsettingsarenot

comparedtothephysician’sorder.

Withfewexceptions,currentpumps

donotcommunicatewiththeelectronic

medicationrecord(EMR)orthehospital’s

BCMAsystems.

Giventheseissues,thecurrentpumpshave

advancedaboutasfarastheycan.However,

multipleadvancesarecreatingexciting

opportunitiestogofromsmartinfusion

pumpstosmartinfusionsystemsthatwill

takeinfusionsafetytothenextlevel.

Reaching the Next Level of Infusion Safety

Attainingthenextlevelofsafetyis

currentlyaworkinprogress,withamajor

focusoninteroperabilitybetweenmedical

devicesandinformationtechnology

(IT)systems.Amajorchallengeisthat

infusionpumpsareuniqueinthemedical

deviceworld.Unlikemonitorsandmany

otherdevices,IVinfusionpumpsare

programmedandtheirfuturecapabilities

dependonbidirectionalcommunication.

Futureinfusionsystemswillmostlikely

havethefollowingattributes:

• Everyinfusionpump,regardlessof

type,willbewirelesslyconnectedto

thehospital’sinformationnetwork,

enablingbi-directionalcommunication

withtheenterprise-wideITsystemand

othersystemsthatprovideuniqueand

limitedcapabilities.

• Infusionpumpprogrammingwillbegin

withimagerecognitionthatassignsa

pumptoanindividualpatientusingbar

codedruglabelsorradiofrequency

identification,whichwillhelpensure

thattherightmedication,concentration

anddosingunitsareselectedforthat

particularpatient.

• Infusionparameterswillbesent

wirelesslytothepumpand

automaticallyprogramtheinfusion,

withaclinicianconfirmingthe

programming.Oraclinician’smanual

programmingwillbeautomatically

comparedtothemedicationorder.

Clinicalalerts,recentlaboratoryvalues

andotherup-to-the-minutepatient

informationwillbeimmediately

communicatedtotheclinician,either

throughthepumporthroughother

avenuescurrentlybeingdeveloped.

Inaddition,allinfusionprogramming

willautomaticallybedocumented



inthepatientrecordelectronically,

eliminatingtheneedfornursesto

manuallyrecordcopiousamountsof

infusiondataandfreeingthemto

spendmoretimewithpatients.

• Anyinfusionprogrammingoutside

theDERSlimitswillautomaticallybe

senttoclinicalexpertsforevaluation

andpossibleaction.Patientsrequiring

extraordinaryamountsofmedications

willbeidentifiedas“highrisk”and

closelymonitoredfordrug-induced

adverseevents.

• Infusionpumpalarms,whichtoday

soundatthebedside,willbe

automaticallydirectedtoanassigned

clinician.Clinicianswillbeabletoview

alarmsremotelyandbefullyprepared

torespondassoonastheyreachthe

bedside.Clinicianswilllikelybeable

toresetalarmsremotely,sincethe

necessaryinformationwillbeavailable

toassesscorrectiveactionanddelay

visitingthebedsidejusttocancelan

alarm.Thiswillalsohelpsparepatients

thetoo-frequentalarmsthatdisrupt

patientcare.

• Assmartinfusionpumpsbecomepart

ofamuchlargersystem,manyother

issuescanalsobeaddressedinclose

torealtime.Theseincludedetecting

infusionsthathavenophysician’sorder,

thatarecontinuingdespiteordersto

bediscontinuedorthatareresultingin

physiologicorlaboratoryabnormalities,

andidentifyingthecurrentstatusof

infusionstohelpoptimizepharmacy

workloadscheduling.

Summary

Inthepastdecadetheinfusion

pumpindustryhasprovided

manysafetyandperformance

benefitsbyreinventingIVinfusion

technologyandenablingeach

hospitaltocustomizetheir

pumps’performanceattributes

anddrug-specificsafetylimits.

Continuingchallengeswiththe

currentpumpsincludeensuring

compliancewithsafetysoftware

use,eliminatingunnecessarydrug-

libraryvariationandusingtheCQI

datatoaggressivelymanagedrug

libraries.Withoutindividualpatient

information,thetechnologyhas

forthemostpartreacheditssafety

potential.Thenextdecadewill

focusoninteroperabilityandsystem

integration,assmartinfusion

pumpsseamlesslybecomeafully

functioningcomponentofeach

hospital’sITsystems.



PROCEEDINGS

Medication Administration from a Nurse’s Perspective: Prioritizing Making a Safety/Productivity DifferenceAnne Pohlman APN-CNS, CCRN, FCCM Critical Care Clinical Research

University of Chicago, Chicago, IL

Nursesplayanintegralroleincaringfor

hospitalizedpatients.Rapidadvancesin

healthcareandtechnologyhavechanged

howhospitalizedpatientsarecaredfor

andtherolesnursesplayinfacilitatingthis

complexcare.Nurses’abilitytokeeppace

withthelatesttechnologyandtoapply

advancestotheirbedsidepracticedirectly

affectspatientsafetyandoutcomes.

Recentstudiesfocusedonnursestaffing

inhospitalshavelinkedqualityofcare,

outcomes,jobdissatisfaction,andpatient

mortalitytopatient-nurseratios.More

nursingtimeperpatientdayisassociated

withbetterpatientoutcomes.1,2These

findingshaveseriousimplicationsfor

patientsafetyandqualityofcare,since

theincreasednursingworkloadandthe

growingworkforceshortagemayreduce

theamountofnursingtimeavailablefor

patientcareactivities.Itisimperativeto

prioritizeeffortsthatcanhelpoptimize

theessentialelementsofnursingpractice

timeyetalsoimproveefficiency.Such

effortsneedtostartbylookingathow

hospitalnursesspendtheirtime.

InarecentstudybyHendrichetal,3

nursesfrom36medical-surgicalunits

participatedinatimeandmotionstudy

toidentifydriversofinefficiencyin

nursingworkprocesses.Analyzingnursing

practicetimebylocationrevealedthat

thelargestproportionofnursingpractice

wasdoneatthenursingstationand

patientroom(Figure1).Furtheranalysis

showedthatthemajorityofthattimewas

consumedbydocumentation,medication

administration,andcarecoordination

(Figure2).Documentationaloneaccounted

for35.3%ofnursingtime.Cannew

technologyandsoftwaretoassociate

electronicmedicalrecordswithmedication

administrationdevicesmakedocumentation

moreefficientwhilealsoimprovingsafety?

Doesaddingnewtechnologyaddtothe

nursingworkloadbyrequiringdouble

documentation?Follow-upstudiesare

neededtoanswerthesequestions.

Medicationadministrationisahigh-risk

activitythatconsumesalargeportion

ofnursingtime.Keohaneetal4recently

studiedtheimpactofbedsidetechnologies

onnursingworkflowandnursingpractice

withregardtomedicationadministration

inalargeuniversityhospitalinvolving23

medical/surgicalunitsandsixintensivecare

units(ICUs).Theaveragepercentofnursing

timespentonmedication-relatedactivities

rangedfrom22.8%intheICUto29.1%

incombinedmedical/surgicalunits(Figure

3).Ofnote,thetimespentonmedication

administrationwasconsistentthroughout

the24-hrday.

Key Points

• Nurses are the primary hospital caregivers, and efficient use of their time and energy is critical to hospitals’ future.

• A growing body of evidence links more nursing time per patient day with better patient outcomes.1,2

• Medication administration is a high-risk activity that consumes a large portion of a nurse’s time.

• Consideration of nursing workflow and staffing is critical to the successful integration of technology into the healthcare bedside environment.

Figure 1. (4A. Location)



Theauthorsindicatethatbecausesuch

alargeproportionofnursingtimeis

spentonmedicationadministrationand

becauseitissuchahigh-riskactivity,

advancesintechnologyshouldbeaimedat

opportunitiestostreamlinetheprocessand

improveefficiency.

Figure 3.

Conclusion

Complex technology systems and software have changed the way nurses care for patients at the bedside. The importance of developing efficient tools to help optimize the critical thinking of bedside staff cannot be overemphasized. From the nursing perspective, priorities to be considered include integrating technology into hospital documentation systems (device-to-device); avoiding duplicate documentation; improving data functionality for multidisciplinary communication; and emphasizing patient safety along with increasing the efficiency and productivity of bedside staff.

References

1 Aiken LH, Clarke SP, Sloane DM, et al. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002;288(16):1987-93.

2 Needleman J, Buerhaus P, Mattke S, et al. Nurse-staffing levels and the quality of care in hospitals. NEJM. 2002;346(22):1715-22.

3 Hendrich A, Chow M, Skierczynski BA, et al. A 36-hospital time and motion study: how do medical-surgical nurses spend their time? Permanente J. 2008;12(3): 25-34.

4 Keohane CA, Bane AD, Featherstone E, et al. Quantifying nursing workflow in medication administration. JONA, 2008; 38(1):19-26.

Figure 2. (4B. Subcategory)



Intravenous (IV) Medication Infusion Device Integration: Readiness AssessmentMark H. Siska RPh, MBA/TM Assistant Director, Pharmacy Informatics & Technology

Pharmacy Services, Mayo Clinic Rochester

PROCEEDINGS

Medicationmanagementcomprises

ahighlycomplexgroupofprocesses

andsub-processeswithmultiplepoints

forpotentialbreakdown.Itinvolves

severalprofessionaldisciplines,requires

multiplemethodsofdocumentationand

communicationacrossavarietyofhealth

caresettings,anddemandsprecisionat

everypointofpreparation,entry,handoff

andtransitionincare.Inthiscontext,

theuseofinformationtechnology(IT)

hasbeenwidelypromotedasastrategy

toreducethehumancontribution

tomedicationerrorsbyeffectively

organizinginformation,linkingdiscrete

piecesofinformation,andperforming

repetitivetasks,includingtheassessment

formedication-relatedproblems.For

example,computerizedphysicianorder

entry(CPOE)andbarcode-enabled

medicationadministration(BCMA)

systemshavebeenshowntoreduceerrors

associatedwithmedicationorderingand

administration,andpharmacydispensing,

preparationandclinicalinformation

systemshavebeenshowntobevaluable

toolsforreducingmistakesrelatedto

medicationpreparationanddistribution.1

Theintroductionof“smart”(computerized)

IVmedicationinfusionpumptechnologies

hasalsoshowngreatpromiseinreducing

programmingerrorsthatCPOEandbar

codingmiss,bycomparinginformation

enteredduringprogrammingtohospital-

definedbestpractices.2Thenationaltrend

towardadoptingsmartpumptechnology

remainsstrong,withnearly65%ofall

hospitalsreportingsmartpumpuseand

63%ofthosewithoutsmartpumps

planningonimplementingthemwithin

thenextthreeyears.3

Despitethedocumentedbenefitsof

smartpumpuse,researchersbelieve

theirfullpotentialhasyettoberealized,

arguingthat,inordertoachievemaximum

protectionagainstallIVadministration-

relatederrors,seamless,multi-directional

communicationandintegrationamong

smartpumpsandelectronicmedicalrecord

(EMR)systemsneedtooccur.4Becauseof

itsperceivedandstudiedbenefits,such

integrationremainsthe“holygrail”for

medicationadministrationsafety;however,

foranumberofreasonsthemajorityof

healthcareorganizationshaveyettoadopt

thetechnology.

Inthisarticle,areadinessassessment

includingorganizationalanddepartmental

capacity,visionandbenefitsrealization,

financialandhumanresourcesrequired

forIVmedicationinfusiondevice

integrationwithinthecurrentstateof

EMR,andhospitalIT-enabled,closed-loop

medicationmanagement,arediscussed.

Current State of Medication Management Supporting Technologies

Overthelastthreetofiveyearsthetrend

towardimplementingcoreandancillary

medicationmanagementsupporting

technologiesandEMRshascontinuedto

risesteadily,asdepictedinFigure1.3The

most“wired”medicationuseprocesses

includepharmacyordertranscriptionand

dispensing,withnearly90%ofallhospitals

usingautomationfordispensingandnearly

95%usingapharmacyinformationand

ordermanagementsystemformedication

orderfulfillmentandreview.

Key Points

• The adoption rate of interoperable medication-management supporting technologies, including intravenous (IV) medication infusion devices (“smart pumps”), remains low.

• Current health system information technology (IT) priorities are focused on meeting meaningful use measures, optimizing existing clinical systems and building core medication-use process supporting systems.

• The indifference towards adopting IV medication infusion device integration is most likely due to competing IT priorities and the apparent risk and complexity of implementing this technology.



Althoughthetrendforadopting

automationandtechnologytosupport

medicationorderingandprescribing

continuestoriseoverall,in2010,except

infederalfacilities,thedeploymentrates

offullyintegratedCPOEandpharmacy

informationmanagementsystemswere

lessthan25%.3Whileimplementation

ofmedicationadministrationsystems

hasincreasedsignificantlyoverthepast

threetofiveyears,theintegrationof

thesesystemsremainslow,withonly

3%ofallhospitalsreportingsignificant

integrationofsmartpumpswiththeir

EMR.5,6Approximately8%ofallhospitals

regardlessofsizehaveimplemented

completeEMRs,withonly2%ofthem

havingasystemthatmeetsthefederal

government’s“meaningfuluse”criteria.7

Theintegrationofmedicaldevicesonto

hospitalITnetworksoffersenormous

promiseforreducingmedication-related

adverseevents;however,mosthealth

careorganizationshavestruggledtofully

leverageandintegratethesetechnologies

andfullyaddressthegrowingnumberof

operational,regulatory,safety,continuity

ofcareandqualityissues.Inaddition,as

hospitalITdepartmentsshifttheirfocus

fromadoptionanddeploymenttosystem

connectivityandappliedinformatics,finding

personnelwhopossessthenecessaryskill

mixtomeetthegrowingdemandfor

IT-deviceintegrationremainschallenging.8,9

Otherbarrierstodevice-ITintegration

include:10

• Uncertaintyaboutvendorsystems

• Lackofstandards

• Competingnon-ITpriorities

• Difficultychoosingamongvarious

HITsolutions

• Needtomakeessentialprocesses

morereliableandpredictable

• Needtooptimizeexistingsystems

• Regulatoryincentivesandpenalties

Competing IT Priorities

The2011HealthcareInformation

ManagementandSystemsSociety(HIMSS)

leadershipsurveyshowedthatforroughly

80%ofhealthcareorganizations,their

topprioritiesaremeetingthemeaningful

useobjectives,optimizingapplications,

andmaintainingexistingclinicalsystems

(Figure2).11Theseinitiativeshaveincreased

thedemandforfinancialandhuman

resourcesandhavecausedmore-targeted

ITsolutionssuchassmartpumpintegration

tofalloffthegrowinglistofpriorities.

Manyorganizationsarealsofindingit

hardtochooseamongallthepotential

IT-relatedsolutions,knowingthatthe

largeronestaketime,manyinvolve

significantinfrastructurecosts,andtherisk

offailureismuchhigherthanwithnon-IT

capitalexpenditures.

Evenlargerhealthcareorganizations

areexperiencingdifficultiesinmeeting

thedemandforhigh-priorityIT-related

projectsandarelookingtoimplement

moreprocess-relatedsolutions,including:1

• Standardizationandprocessreliability

• Checklistutilization

• Systemandproceduralredundancy

Figure 1. Current State of Medication Management Supporting Technologies3

0 50 100

Figure 2. 2011 Top IT Priorities: Next 2 Years11



Understandingthatlayeringnew

technologiesontobadprocessesdoes

notnecessarilyleadtobetteroutcomes,

manyhealthcareleadershavechosento

maintainthesafetygainsattainedfrom

stand-alonesmartpumpsandtoshore

upexistingprocessesandprocedures,

includingtheuseofstandardizedinfusion

medicationconcentrations.A2010ASHP

practicesurveyindicatedthatmorethan

70%ofallhospitalsimplementedtheuse

ofoneortwostandardizedIVinfusion

concentrationsincludedontheInstitute

forSafeMedicationPractices’listof

high-alertmedications.3

Risk/Value/Complexity Assessments

Inordertomoreeffectivelyassessthe

potentialimpactofagiventechnology,

manyhealthcareorganizationsareusing

businessproblem-solvingmethodologies

suchasmatrixmodelingtoguidethemin

determiningtherelativecomplexity,riskand

valueofanemergingtechnology.Realizing

thatthespeedoftechnologyadoptionis

abusinessproblem,notanITproblem,

theyaresteppingoutsidetheITrealmand

consideringatechnology’svaluefroma

purelybusinessperspectivebeforeadopting

it.Ifatechnologyistiedtoanyregulatory,

legalorcustomerrequirements,andifit

significantlyreducescostsandincreases

revenues,thenitsuseisregardedas

inevitable,makingearlyadoptionadvisable.

Buttheytendtostartsmall,allocating

enoughtimeandresourcestomakerevisions

orreversedirection,ifnecessary.Ifa

technologydoesnotpasstheinevitability

test,lateadoptionisusuallyconsidereda

betterapproach.12

Forsmartinfusionsystems,thefinancialand

safetybenefits,aswellasthecomplexity,

risk,valueandcomparativepaybackprofiles,

haveledtheuseofthistechnologytobe

consideredinevitable.Nearly65%ofall

hospitalshaveadoptedthistechnology,and

63%ofhospitalswithoutsmartpumpsare

planningonimplementingthemwithinthe

nextthreeyears.3

IVmedicationinfusiondevice-ITintegration,

however,hasyettopasstheinevitability

test.12Despiterecognizingthefuture

valueofreal-timeinteractionamong

monitors,pumps,apatient’sEMRand

decision-supporttools,mosthealthcare

organizationshavebeencomfortable

remainingonthesidelineswhenitcomes

todevice-ITintegration.Thecomplexity,

risk,valueandcomparativepaybackprofiles

arenotasfavorableasforstand-alone

smartinfusionsystems.Thisiscausing

healthsystemstotakeamorewaitand

seestrategy,preferringtousethelessons

learnedfromtheearlyadoptersand

observehowthetechnologywillimpact

thecompetitionandthemarketplace.12,13

IVmedicationinfusionsafetysystemsare

evolvingintoanintegratedcomponentof

anidealIT-enabledmedicationmanagement

strategy.Technicalbarriersarebeginning

tofall,allowingsuchdevicestosharedata

reliably,securelyandquicklyfromthepoint

ofcaretotheEMRanddecisionsupport

systems.Asaresult,manyhealthcare

systemsnolongerviewdevice-ITintegration

asanunnecessarydistractionbutasan

importantpiecetoclosethelooponthe

medication-usecycleandfurtherreduce

medicationerrors.However,despitethe

progressinovercomingthemanybarriers

andchallengesofdevice-ITintegration,

thevastmajorityofhealthcareinstitutions

havechosenawaitandseestrategywhen

itcomestoadoptingthistechnologydue

tocompetingITpriorities,limitedfinancial

andhumanresources,thepersistenceof

legacymedicationmanagementsupporting

systems,relativerisk,complexityandvalue.

References

1 California Health-Care Foundation (2001, July). Addressing medication errors in hospitals: A framework for developing a plan. 2001:July. Available at: http://quality.chf.org Retrieved August 1, 2011.

2 Sanborn M, Cohen T. Get smart: effective use of smart pump technology. Hosp Pharm. 2009;44:348-53.

3 Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: Prescribing and Transcribing – 2010. Am J Health-Syst Pharm. 2011;68:669-88.

4 Husch M., et al Insights from the sharp end of intravenous medication errors: implications for infusion pump technology. Qual Saf Health Care 2005;14;80-6.

5 Pedersen CA, Gumpper KF. ASHP national survey on informatics: assessment of the adoption and use of pharmacy informatics in U.S. hospitals—2007. Am J Health-Syst Pharm. 2008; 65:2244-64.

6 Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration—2008. Am J Health-Syst Pharm. 2009;66:378-88.

7 Jha AK, Blumenthal D, Campbell EG, et al. Use of electronic health records in U.S. hospitals. N Engl J Med. 2009;360:1628-38.

8 Gardner RM, Overhage JM, Steen EB, et al. Core content for the subspecialty of clinical informatics. J Am Med Inform Assoc. 2009;16:153-7.

9 Kilbridge PM, Classen DC. The informatics opportunities at the intersection of patient safety and clinical informatics. J Am Med Inform Assoc. 2008;15:397-407.

10 Siska MH, Tribble D. Opportunities and challenges related to technology in supporting optimal pharmacy practice models in hospitals and health systems. Am J Health-Syst Pharm. 2011;68:1116-26

11 2011 HIMSS Leadership Survey: Health system IT priorities – next 2 years (2011) Available at http://www.himss.org/2011survey/healthcareCIO_final.asp. Retrieved August 5, 2011.

12 Wright EW. The Rx for Electronic Health Records: Time, Not Incentives (2005) Available at: http:// sprouts.aisnet.org/119/1/959410.pdf Retrieved August 1, 2011

13 Thompson TG, Brailer DJ. The decade of health information technology: de livering consumer-centric and informa tion-rich health care. Framework for strategic action. Available at www.hhs.gov/healthit/documents/hitframework.pdf. Retrieved Aug 10, 2011.



CNIOs and IV Pump Interoperability: Is this a Must Have or a Nice to Have?Judy Murphy, RN, FACMI, FHIMSS, FAAN

At the time of this writing, Vice President, Information Technology

Aurora Health Care, Milwaukee, WI

June 2011

AuroraHealthCareisanintegrated,not-

for-profithealthcareproviderserving

communitiesthroughouteasternWisconsin

andnorthernIllinois.Itsextensiveexperience

withhospitalinformationtechnology(HIT)

canhelpshedlightonwhetherchiefnursing

informationofficers’(CNIOs)consider

intravenous(IV)pumpinteroperability

a“musthave”ora“nicetohave.”This

experienceisalsorelevanttosmaller

hospitalsandhealthsystems,whichface

equallychallengingissueswithfewresources.

PROCEEDINGS

Anationalleaderindevelopingand

implementingbestpracticesinclinical

improvementanddiseasemanagement,

theAuroraHealthCarenetworkincludes

15hospitals(60to850beds),3,400staff

physicians,1,500employedphysicians,

500,000inpatientdays/yearand$3.2billion

annualrevenue.Aurorabeganitselectronic

healthrecordimplementationjourneyin

1995,andtodayhasmaturefunctionality

suchasCPOEandbarcodedmedication

administrationandover17,000userlogins.

IT Department

TheaverageannualITcapitalbudgetis

about$35million,withanaverageannual

operatingbudgetof$56million(3%of

revenue).Demandsonthoseresourcesare

equallylarge.Evenspendingabout50%

oninfrastructure,therefreshcycleon

laptopsissevenyearsandaboutthesame

ondesktopcomputers.Withapproximately

20,000devices,includingprinters,personal

computersandabout8,000mobiledevices,

expendituresfornetworkanddesktop

upgrades,etc,quicklyconsumethe

department’sresources.

TheITdepartmenttypicallymanagesnine

to12strategicprojectseachyear,along

with100to200“departmental”projects,

whichcomeupasrequests,and50to

100“infrastructure”projects.Thesecan

rangefromupgradingtheuninterruptible

powersupply(UPS),whichtook$7million

andtwoyears,toupgradingclosetsin

thedifferentfacilities,whichtookmuch

lesstime.Havingtospendmoneyon

infrastructurecanbefrustrating,when

moreisneededfortheEHR;however,it

isimportanttoappreciatetheneedfor

expendituressuchasdisasterrecovery.

HavinganEHRwouldservenopurpose,

ifitcouldnotberecoveredquickly.

Determininghowpreciousdollarswill

bespentonrequiresbalancingmany

important,conflictingpriorities.

Key Points

• Aurora Health Care is a nationally recognized, 15-hospital, integrated delivery network headquartered in Milwaukee, WI, with an information technology (IT) department of 550 employees and an annual IT capital budget of about $35 million.

• IT governance structures help keep a strategic focus on how a particular IT project will support the higher-level goal.

• In the prioritization of possible IT projects, IV pump interoperability comes up against meaningful use and governmentally required changes in electronic data interchange (EDI) standards and ICD-10 coding and billing.

• Data for the US EMR Adoption ModelSM show that only about 19% of US hospitals have reached the higher stages where IV pump interoperability would be implemented.1

• For the majority of US hospitals, building core infrastructure will have to come before more complex undertakings such as IV pump interoperability.



IT governance

GoodITprojectgovernanceisessential.

WithintheAuroraITdepartment,a

“modified”projectmanagementoffice

(PMO)comprisedofprojectmanagers

andsupervisorsisresponsibleforintake,

portfoliomanagement,projectplanning,

timerecording,projectmonitoringand

controlling.Havingamoreformalstructure

inplace(Table1,Figure1)ensuresthat

whenanideabecomesanactualproject,it

hasstaffing,abudget,adefinedbeginning

andend,outcomes,evaluationcriteriaand

returnoninvestment(ROI),sothatitcan

befullyexecutedandcompleted.

Aboutsixyearsagothestaffrealized

thatthebestIT-projectisprobably

notanITbest-project;itisprobablya

clinicallyorientedprojectthathasclear

goals,investmentcriteriaandROI.Then

ITbecomestheenablerfortheclinical

project,ratherthanbeingtheprojectitself.

Forexample,inconsideringimplementation

ofcomputerizedprescriberorderentry

(CPOE),thefocushastobeonchanging

thewaycareisdelivered,ratherthan

onthetechnologyandhowitwillbe

implemented.Governancestructures

helpkeepthefocusonthestrategythe

organizationistryingtoexecuteandhow

aparticularITprojectwillsupportthat

higher-levelgoal.

Prioritizingincomingpotentialprojects

isessential.Inagivenyearonlyabout

10%to15%ofsuggestedprojectscan

beaccomplished.Consideringwhatcan

actuallybedoneisextremelyimportant.

Forstrategicprojects,ITgovernance

createsanoverallroadmaptodetermine

wheretheywillfitinwiththemany

projectsuggestionscomingupfromstaff.

TheITgovernancecouncilrecently

reviewedtheircurrentroadmapand

performedagapanalysiswiththeHealth

InformationTechnologyforEconomic

andClinicalHealth(HITECH)Act(partof

theAmericanRecoveryandReinvestment

Act)thatrevealedtwoareasthatwere

notbeingconsidered:patientinvolvement

andhealthinformationexchange.Asa

result,theroadmapwasrevised,sothat

allpossiblegovernmentincentivesfor

EHRimplementationcouldbeobtainedas

earlyaspossible.

Intravenous (IV) Pump Iteroperability - Considerations

Ifanursingorpharmacygroupsuggested

thatIVpumpinteroperabilityshouldbe

considered,thatsuggestionwouldgo

throughthegovernanceprocessandbe

evaluated.Someofthequestionsthat

wouldbeaskedinclude:Whatisthe

businessvalue?Isitverifiable?Whatis

theobjective?Howdoestheidearank

intermsofstrategy?Arethebenefits

quantifiable?Whatisitgoingtocost,

whataretherisks?Howdifficultwill

itbetoimplement?WhatistheROI?

Thatinformationisthenusedtocreatea

proposaltoseehowitfitsintheportfolio.

Isitgoingtorequirefivenewinterfaces?

Willitrequirenewexpertise?Will

additionalstaffneedtobehired?After

theproposalhasbeenthoroughlyvetted,

itgoesbacktothegovernancecouncilfor

prioritizationandthen,ofcourse,possible

approvalandfunding.

Byfollowingthisprocess,peoplefeel

thattheirideasarethoroughlyvettedand

broughtforward.Clinicianinvolvement

iscrucial,becausethatwillberequired

forsuccess.Whenthefinalcandidates

forprojectsareidentified,thesponsors

cometopresenttheirthoughtsontheir

project’svalue,cost,andimportance.

Somebottom-uprequestsendup

Table 1. Governance for IT

• Allocate capital and operating budgets for IT (determine allocations for new projects vs. maintenance and support)

• Prioritize incoming IT requests

• Create IT roadmap and set strategic direction for IT projects based on organizational goals, mission and vision

Figure 1. Governance for IT



US EMR Adoption ModelSM

Stage Cumulative Capabilities 2011 Final 2012 Q1

Stage 7Complete EMR; CCD transactions to share data; Data warehousing; Data continuity with ED, ambulatory, OP

1.2% 1.2%

Stage 6Physician documentation (structured templates), full CDSS (variance and compliance), full R-PACS

5.2% 6.2%

Stage 5 Closed loop medication administration 8.4% 9.4%

Stage 4 CPOE, Clinical Decision Support (clinical protocols) 13.2% 13.2%

Stage 3Nursing/clinical documentation (flow sheets), CDSS (error checking), PACS available outside Radiology

44.9% 43.9%

Stage 2 CDR, Controlled Medical Vocabulary, CDS, may have Document Imaging; HIE capable 12.4% 12.1%

Stage 1 Ancillaries - Lab, Rad, Pharmacy - All Installed 5.7% 5.5%

Stage 0 All Three Ancillaries Not Installed 9.0% 8.4%

Data from HIMSS Analytics™ Database ©20121 N = 5,337 N = 5,318

becomingintegratedintotheoverall

strategicroadmap.Havingsome

transparencyaroundprojecttrackingand

dashboardsontheorganization’sinternet

sitesalsomakessense,sothateveryone

understandswhatprojectsarebeing

implemented,ornot.

IV Pump Interoperability - Status?

“Smart”IVpumpshavebeeninstalledat

Aurora,butarenotintegratedwiththe

EHR.Thathasnotbeenbroughtforward

asaprojectrequestbutissomething

thatthestaffwantstodo.However,as

possibleITprojectsareprioritized,IV

pumpinteroperabilitycomesupagainst

meaningfuluse,whichrepresentsabout

a$110millionrevenueopportunityfor

Aurora.Otherhigh-level,conflicting

needsarethechangesinelectronicdata

interchange(EDI)standardsandICD-

10codingandbilling.Governmental

regulatorychangesarerequirementsthat

mustbeputontheroadmap.Another

pressureistoprovideclinicianswith

mobiledevicestobeabletoaccessthe

EHRanytime,anywhere.Asaresult,

medicaldeviceinterfacewillprobablyend

uplowonthelist.

Nation-wide,datafortheUSEMRAdoption

ModelSM(Table21)showthatonlyabout

19%ofUShospitalsareinthehigher

stageswhereprojectssuchasIVpump

interoperabilitywouldbeimplemented.

Eighty-onepercentofhospitalsarein

lowerstagesorjustbeginning.1Thus,for

themajorityofUShospitals,buildingcore

infrastructurewillhavetocomebefore

morecomplexundertakingssuchassmart

pumpintegration.

1 HIMSS Analytics (2012). EMR Adoption ModelSM. Retrieved April 24, 2012 from http://www.himssanalytics.org/hc_providers/emr_adoption.asp

Table 2. US EMR Adoption ModelSM



PROCEEDINGS

Between Now and the “Big Bang”: Interim Technology Applications to Help Achieve IV-IT InteroperabilityNathaniel M. Sims, MD Cardiac Anesthesiologist

Medical Advisor to Biomedical Engineering, Massachusetts General Hospital

Assistant Professor of Anesthesia, Harvard Medical School, Boston, MA

The “Big Bang”

Thenotionofa“BigBang”refersto

afuturestatewherecontinuous,

electronic,two-waycommunication

betweenintravenous(IV)infusionsystems,

enterpriseclinicalinformationtechnology

Key Points

• The “Big Bang” refers to a future state when full integration between intravenous (IV) infusion systems and hospitals’ enterprise clinical information technology (IT) systems functions optimally, permitting a seamless intelligent digital pathway between provider order entry and the patient vein. It has been generally accepted that “Big Bang” meant “automated programming of infusion pumps from the pharmacy information system”; here we articulate and examine a broader interpretation of the term.

• Desirable characteristics of the “Big Bang” include: (a) elimination of manual order entry and of transcription of the same information into a succession of different, loosely-coupled systems; (b) robust, patient-aware clinical decision support; (c) some form of assisted caregiver programming of drug infusion pumps; (d) auto-documentation of each infusion pump’s status into electronic acute care documentation and anesthesia information systems, and (e) enhanced alerts and second-checks. Since this future state does not yet exist, several provocative implementations and ‘practical roadmaps to the future’ are discussed.

• Academic medical centers and other institutions have advanced toward their own unique visions of the “Big Bang”: examples include Intermountain Healthcare and the Partners Healthcare System.

• In the future, as more and more clinical information is maintained electronically and becomes immediately available to front-line caregivers, the role of computerized intravenous (IV) infusion systems (“smart pumps”) may dramatically change.

(IT)andelectronichealthrecords(EHR)

systemsbecomesthenormandfunctions

optimally.Itiswidelyanticipatedthat

achievementofthe“BigBang”will

reducetheincidenceofdevicefailures

andmedicationadministrationerrorsand

increasecaregiverproductivity,patient

safety,andpatientsatisfaction.

Suchinterconnectivitycan“closetheloop”

inIVmedicationadministration,sending

physician’sordersfromcomputerized

providerorderentry(CPOE)systemsto

automaticallyprogramtheinfusionpumps,

andthensendinginfusiondatafromthe

pumpsbacktotheEHRtoclosetheloopin

realornear-realtime.Essentialelementsof

the“BigBang”areshowninTable1.

Inthisarticle,thecurrentstateofIV-IT

interoperability,deviceinformation

acquisition(DIA),enhancednotification

oferrors,acrawl-walk-runroadmapto

thefuture,andanemerging’mobile-

computing-centric’approachtomedical

deviceconnectivityarediscussed.

Thequestionofhowthedesignand

functionalityofsmartpumpsshould

logicallyevolveovertime,asmoreand

moreclinicalinformationisavailable,is

alsoposedforconsideration.

Current State of IV-IT Interoperability

Thesignificantproblemsassociatedwith

theabsenceoffullintegrationhavebeen

welldocumentedinnumerousstudies,

notablythelandmarkethnographicstudy

byHuschetal.1Manyinstitutionshere

andabroadhaveworkeddiligentlyto

reducethegapsininterconnectivity.The

statusandevolutionofIVmedication

safetysystemsattwointegratedhealth



deliverynetworks(IHDN)—Intermountain

Healthcare(Utah)andPartnersHealthcare

System(Massachusetts)—provide

noteworthyexamples.

Intermountain Healthcare

IntermountainHealthcare(IHC)haslong

exhibitedstrongleadershipintheuseof

computersinthepracticeofmedicine.

ThepioneeringworkbyHomerWarner,

MD,atLDSHospitalinSaltLakeCity

from1950to1980indevelopingclinical

decisionsupportforcardiologysetthe

stagefortheemergenceofthefieldof

medicalinformatics.2Anearlyelectronic

medicalrecord(EMR)wasimplemented

atLDSinthe1970s.Their“informatics-

centricperspective”tohealthcare

computingledtoearlyrecognitionthat

databeingsenttoandfrommedical

devicesareimportantelementsinclinical

informationrepositories.Thesedata

repositoriescouldprovidethebasisfor

clinicalmanagement,sophisticatedquality

managementsystems,andanalysisof

variationandtheeffectivenessofprocess

improvementinitiatives.

IHCinitiativesaroundmedical-devicedata

flowsincludedoutstandingachievements

involvingIVmedicationadministration

safety.Theseachievementshavebeen

publishedinseveralvenuesandare

summarizedinvideopresentationsavailable

online.Thefollowingachievementsare

arguablythemostsignificant.3,4

Barcode “license plate” for pump. Clinicalengineersandtheinformatics

teamcreatedahybridbarcode/pump

identifierlabelthatisputonthefront

ofeachdruginfusionpump,allowing

theusertolinkaspecificinfusionpump

toanindividualpatient.Thisassociation

betweenpumpandpatientisacritical

steptoadvanceIVmedicationsafetyat

IHCandbeyond.

Displaying a patient-specific infusion order on the infusion pump.Onceabedsidecaregiverassociatesaparticular

pumpwithapatient’smedicationorder,

thepumpreceivestheorderinformation

overthewirelessnetworkanddisplaysthe

informationasascrollingtextmessage

acrossthetopofthescreen.Thisscrolling

messageassiststhecaregiverinnavigating

thepump’smenupromptsbyrepeating

thekeyspecificsofthemedicationorder,

suchas“Nitroglycerine250mgin250

ccs;50ug/kg/min”or“Heparin500U/

ml;800U/hr”.Thiscouldbedescribed

as“auto-programming”ora“clinician-

programming-assistfunction.”

Device information acquisition (DIA).IHChasimplementedauto-documentationfrompatient-connected

medicaldevicessuchasdruginfusion

pumpsintotheelectronicflowsheets

thatserveasthebasisforthemoment-to-

momentcareofcriticallyillpatients.DIA

providessophisticatedsoftwarethatfilters

device-statuschangestocaptureonly

clinicallysignificantdatasuchasdrug-

doserates,dose-ratechanges,andalerts.

Thisreducesthemanualdocumentation

burdenandpermitsahighlygranular

remoteviewofpatientstatus.

Enhanced alert notification.IHChasenhancedthevendor-suppliedsmart-

pumpfeaturesbyconnectingthesmart

systemwiththeEMRandproviding

“enhancednotificationofinfusionpump

programmingerrors.”3,4Asophisticated

surveillancesystemtracksthepatient’s

drug-doserateandassociatedlaboratory

valuesovertime,recognizeswhena

clinicianhasprogrammeda“step-change,”

Table 1. The “Big Bang”: Elements of Ideal IV-IT Interoperability

• Software versioning: The onboard software and safety features for every device are always fully up-to-date.

• Perfect connectivity: Wirelessly connected patient-care devices can rely on perfect connectivity 100% of the time.

• No latency: There is no clinically significant delay between the time patient-care information is generated and its availability to all hospital systems and devices.

• Seamless digital pathway: There is perfect information fidelity between the provider’s order and any device’s need for order elements.

- Standardized terminology: All providers, clinicians, devices and systems use the same vocabulary and syntax—units of measure, rates/time, default dose rates, etc.

- Computerized prescriber order entry (CPOE): Except in emergent situations, CPOE is the only way to an order can be placed.

- CPOE personalized clinical decision support: Every order is electronically checked for safety—drug interactions, dosing limits, allergies, etc.—as it is created, and the provider makes all corrections.

- Automatic identification: Patient-care devices use electronic recognition to identify drug, dose, concentration, etc. of all doses. Tags point to information that resides elsewhere.

- Auto-programming: Patient-care devices receive all initial dosing instructions directly from the verified provider order via the network.

- Auto-documentation: Smart-pump infusion data are automatically sent from the pump to electronic acute care documentation (ACD or “eChart”).



andpromptlyalertsasecondexpert

(eg,aunit-basedpharmacistoranother

clinician)tochecktheinfusionandvalidate

whetherthenewprogrammeddoserate

iscorrectandsafeforthepatient.Such

enhancednotificationofinfusionpump

programmingerrorsappearstobea

significantadvanceinIVmedicationsafety

surveillance,andseemspromisingfor

validationatotherproviderorganizations,

whichcouldleadtowideradoption.

TheseDIA-enabledachievements

representnoteworthysuccessthat

isdirectlyalignedwiththestrategic

perspectiveofIHC’sleadership.AsBrent

James,MD,IHC’schiefqualityofficer,

hassaid,“Thecomplexityofmodern

medicineexceedsthecapacityofthe

unaidedexpertmind.Goodpractice

meansgoodfocus.Goodfocusmeans

therightinformationandtherightformat

attherighttime.Thatrequirescarefully-

designedsystems,acontextinwhich

physiciansandnursescanwork.”2,6

Partners HealthCare System (PHS)/Massachusetts General Hospital (MGH)

Recognizingtheimportanceof

informationconnectivity,PHSconvened

amultidisciplinaryConnectivityTaskForce

todeveloparoadmapforthetransition

ofIVdrugadministrationsystemsfrom

stand-alonesmartpumpstonetworked

intelligentinfusiondevices(IIDs).The

connectivity/integrationvisionisrobust,

correctandofstrategicimportance.

However,farfrombeingobviousor

easy,thetransitionfrominteroperability

tofullintegrationisexpectedtorequire

significantdesignplanning,prototyping

andvalidation,aswellasadvocacyand

collaborationwithpumpvendors.A

systematicroadmapwasdefinedand

metricsarticulatedtomeasuresuccess

alongtheway.

History of medication safety initiatives at PHS/MGH

ThefirstpriorityofHighPerformance

MedicineatPartnersHealthCarewas

toimplementCPOE,newpharmacy

informationsystems,barcoding,barcode

medicationadministration(BCMA)systems,

andsmartpumpsateverypatientcare

bedsideatPHS.Theseeffortsextended

from2004to2009andwerefacilitatedby

pay-for-performanceincentivesstructured

collaborativelybyPHS,itsinsurersand

theCenterforMedicareandMedicaid

Services(CMS).Thesecondpriority(stillin

process)istoeffectivelylinkeverysmart

pumptothehospital’ssecurewireless

network,adoptingandimplementing

themostrigorousstandardsforsecurity

andauthenticationofthemedicaldevices

onthePHSwirelessnetwork.After

implementingmechanismstoassociate

eachpumpwithapatient’smedication

order,asatIHC,thenextprioritylikelywill

betoautomaticallydocumentinfusiondata

inelectronicacutecaredocumentation

(ACDor“eChart”).5,7–11Afurtherstepwill

betocreate“middle-ware”thatcancheck

whetherapatient’smedicationorder

(asenteredintothepharmacyprofile)is

correctlyimplementedbytheinfusion

pumpand,ifnot,providenecessaryalerts.

Thisprovidesasecondsafetycheckofthe

pump'sprogrammingagainstanactual

medicationorder,augmentingthevisionof

“makingtherightthingeasiertodo.”For

selectedhigh-riskmedications,asecond-

nursepump-programmingcheck(with

electronicsignature)willberequired,not

asafunctionalitythatresideswithinthe

infusionpumpbutasapromptwithin

thehospital’sBCMAsystem.

PHS design considerations to achieve full integration of infusion devices

CurrentlyallIVinfusionpumpsatPHS

aresmartpumps.Thefuturevisionisto

proceedasshowninTable2,startingwith

theeasiertasksshownatthetopofthe

tableandworkingdowntotheultimate

goalofinfusionpumpauto-programming.

Eachtaskmayevolveintoastrategic

adoptionmetricthatcanbetracked

acrossthemanycooperatingPHSprovider

organizations.Determiningwhichtasksare

harder,easier,highestandlowerpriorityis

inevitablyamovingtarget.Someofthese

nuancedissuesarediscussedmorefullyin

theReport(availableuponrequesttoDr.

SimsatPHS).

Table 2. PHS’ Connectivity Task Force for Wireless Infusion Pumps: PHS’ Current State

Smart Pump Wireless Integration with Clinical Systems

• Association of pump to patient

• Pump status data to pump server

• Back office safety check—pump settings vs. med order—Not likely to be subject to FDA regulation; non-real time

• Auto-documentation—pump settings auto-filled into EMAR—Likely FDA Class 1 device; non-real time

• Auto-programming pumps—Likely FDA Class 2 or 3 device; real-time

* No PHS infusion pumps are here yet. Pre-pilot considerations: buy-in, resources, scale-up, regulatory/PHS IS network issues.

EASY

HARD



Designconsiderationsthatwereviewedby

PHSas“nuanced,butcriticaltoquality”

includethefollowingfourkeyissues.

• ThefirstPHSconsiderationforclinically

desirabledesignisahazardanalysis

requirement.Hazardanalysesare

designedtoavoidtheintroductionof

newproductsorservicesthatinitially

seemusefulbutmayhaveunintended

negativeconsequences.Potential

hazardsaretypicallyscreenedfor

severity,detectability,andeaseof

designmitigation.

• ThesecondPHSconsiderationisto

considerdesignswhichincludeddata

flowsthatwouldnotrequireeye-blink-

speednetworklatencyinordernotto

interferewithclinicianworkflow.For

example,untilperfectwirelessnetwork

performancecanbeguaranteed,it

maynotbeadvisabletoauto-program

infusionpumpsbutrathertoconcentrate

onauto-documentation,wherenetwork

delaysofsecondsorminuteswouldnot

likelybenoticeableorbothersometo

front-lineclinicians.

• ThethirdPHSdesignconsideration

hastodowithallocationofliability.

Itiswidelyassumedthatcustomized

druglibrariesanddrug-dosing

algorithmsenhancepatientsafety

whileimprovingefficiencyofcare.

Thelibraryframeworkisdesignedby

themanufacturer,whilethecontent

ofthedruglibraries(oftencontaining

off-labeldrugadministrationpractices)

istheresponsibilityoftheprovider

organization.Thisapproachplacesthe

burdenofresponsibilityontheprovider

andallowsforacustomizationof

practicepresumablybasedonsound

clinicaldecisionmaking.A“back-

officesafetycheck”(middlewarethat

checkswhetheraninfusionpump’s

programmingcorrespondswiththe

uniquemedicationorder)mayhavea

moredefensiblesafetyassurancecase.

Thecontentoftheclinicaldecision

supportisimplementedbytheprovider

organizationitself,ratherthanbya

devicemanufacturer.Theprovider

organizationappropriatelywouldhave

totakeresponsibilityforwritingthe

back-officesafetycheck,aspectsof

whichrelatetocodificationofmedical

practicewithinamedicaldevice.

• ThefourthPHSdesignconsideration

iseaseofimplementation:howto

designanaddedfeatureorcapability

thatimprovessafetyorproductivityfor

front-linecaregivers,whileminimizing

impactoncurrentclinicalpracticeor

workflow.Theapproachrecommended

tofacilitateIV-ITcommunicationwas

toleveragerecentlyinstalledBCMA

infrastructure,whichincludedwall-

mountedbedsidecomputers;portable,

wireless,bar-code-scanners;andan

intenseprogramofcaregivertraining.

Leveragingexistinginfrastructureand

routineworkflowarenecessities.

Alternative Approaches

ProviderorganizationssuchasIHCand

PHSareproceedinginasystematicfashion

towardsthe“BigBang”offullIVinfusion

pumpintegrationwithclinicalinformation

systems.Theimplementationrates

amonginstitutionsarenothomogenous,

however,andinstitutionalresourcesand

commitmentaretwoimportantrate-

limitingfactors.Asaresult,alternative

approacheshaveemergedthattake

advantageoflocalresourceavailability

andreflectthecrawl-walk-runapproach.

Future Directions

Giventhevarietyofmethodsthatcan

beusedtoachievetrueconnectivity,

multipleapproacheslikelywillevolve.It

isreasonabletoassumethatmanyof

theapproacheswilltakeadvantageof

existinginfrastructure(smartpumps,

BCMAsystemsandthelike)andmany

willstrikeoutontounchartedwaters.

Anongoingdiscussionisthefutureneed

forsmartpumps.Willdeviceintelligence

increase,orwillfuturedevelopments

leadtoasimplerdevicewithincreasing

systemconnectivity?Regardlessofthe

pathchosen,opportunitiesaboundfor

structuralimprovementstowhatmost

wouldargueisastillimperfectsystem.

References

1 Husch et al, “Insights from the Sharp End of intravenous medication errors: implications for infusion pump technology. Qual Saf Health Care. 2005;14:80-86.

2 Intermountain Healthcare. Intermountain opens new informatics research center in salt lake city. Press release. 2/16/2011. Retrieved June 5, 2012 from http://intermountainhealthcare.org/about/news/pages/home.aspx?newsid=665.

3 Evans RS, Carlson R, Johnson KV, et al. Enhanced notification of infusion pump programming errors. Stud Health Technol Inform. 2010;160(1):734-8.

4 Carlson R, Clemmer TP, Evans RS, et al. Enhanced notification of infusion pump programming errors. Intermountain Healthcare. October 2010. Retrieved October 27, 2011 from http://www.aami.org/infusionsummit/Presentations/Carlson.pdf.

5 MacLean S, Knapp P, Cohen SF. Medication Safety at Newton-Wellesley Hospital: Electronic Medication Management Projects from Home-to-Hospital and Hospital-to-Home. Journal of Healthcare Information Management Vol 24, number 4, Fall 2010. Pp 34-38. Retrieved October 27, 2011 from www.himss.org/content/files/jhim/24-4/JHIM_FALL_FULL_ISSUE.pdf.

6 Baker GR, MacIntosh-Murray A, Porcellato C, et al. C. Porcellato, L. Dionne, K. Stelmacovich and K. Born. “Intermountain Healthcare.” High Performing Healthcare Systems: Delivering Quality by Design. 2008:151–78. Toronto: Longwoods Publishing.

7 Improvement Stories: Safe Medication Administration Partners Healthcare High Performance Medicine. “Smart Bar Codes” Retrieved October 27, 2011 from http://qualityandsafety.partners.org/stories/story.aspx?id=17.

8 Partners Healthcare: RVL Spotlights: “Smart” Drug Infusion Pumps. Retrieved October 27, 2011 from http://rvl.partners.org/about_rvl/rvl_spotlights/smart-drug-infusion-pumps.



9 Sims N, Hampton R. Convergence of Medical Devices with Clinical Information Systems: Innovative Health Information Technology Pilot Projects with a Focus on Patient Medication Safety. Center for Integration of Medicine & Innovative Technology. CIMIT Forum. Retrieved October 27, 2011 from http://www.cimit.org/forum/forum-csi-04.06.10.simsandhampton.html.

10 Manolopoulos H, Hudson S. Safer patient medication administration: Lessons from Mass General. In: HIBCC, Hospitals, and Patient Safety. Health Industry Business Communications. 2007:4,5,12,13 Retrieved June 14, 2012 from http://www.hibcc.org/PUBS/LINES/HIBCC_LINES_HopitalPatientSafety.pdf.

11 Churchill WW, Paoletti RD, Fortier C. Integrating Technology to Improve Medication-Use-Safety: Making it Happen in Your Institution: Improving Your Medication-Use Process with Closed-Loop Technologies. Retrieved from http://ashpmedia.org/symposia/technology/overview.html.



Intravenous (IV) Infusion Pump Device Wireless Connectivity: Development, Current Status and Requirements for SuccessDan Pettus Vice-President of IT and Connectivity

CareFusion, San Diego, CA

From Smart Pumps to Smart Integrated Systems

“Smart”intravenous(IV)infusion

pumpswithsophisticateddose-error-

reductionsoftware(DERS)helpavert

high-riskmedicationerrorsand,just

asimportantly,providepreviously

unavailabledatathatcanhelphospitals

withcontinuousqualityimprovement

(CQI).Nowwirelessconnectivitygreatly

increasesthevalueandutilityofthese

devicesbymakingitpossibletointegrate

smartpumpsonahospital’sinformation

technology(IT)infrastructure.

Withwirelessconnectivity,hospitalstaff

caneasilyuploadsoftwareupdatesand

downloadCQIdata,withouthavingto

manuallyinteractwithindividualpumps.

Easieraccesstothedataallowsstaffto

moreeasilyanalyzeusage,assessvariations

inpracticeandidentifyopportunitiesto

improvepatientsafetyandqualityofcare.

Connectivityalsoprovidesthenecessary

foundationforadvancedapplicationssuch

asautomaticsmartpumpprogramming

andautomaticdocumentationofinfusion

dataintheelectronicmedicalrecord

(EMR),closingtheloopforcomplexIV

ordermanagement.

Theroadtoachievingscalableinfusion

pumpconnectivitywaslongandcomplex,

anddebatecontinuesastowhether

hospitalshavethenecessarytechnology

andresourcestofullyintegrateIVinfusion

pumpsintothecomplexITecosystem.

Inthisarticle,thedevelopmentofIV

infusionpumpwirelessconnectivity,

real-worldrequirements,anidealwireless

smartpumpsystem,successfulintegration,

futureneeds,andrecommendationsfor

hospitalsconsideringdeploymentofsmart

pumpintegrationarediscussed.

Development

Inthemid-1980sseveraldifferent

technologieswerebeingevaluatedas

potentialsolutionstoinfusionpump

connectivity(Table1).Atthesame

time,severalcompetingtechnologies

werebeingevaluatedforhospitalIT

connectivity(Table2).

Medicaldevicecompaniesandhospital

ITdepartmentshadthesamegoal:to

makeitpossibleforsmartpumpdatato

beeasilysharedandanalyzed,andfor

smartpumpstoremainconnectedto

theITinfrastructureregardlessoftheir

locationinthehospital.Unfortunately,

forthemostpartthecompanies’and

hospitalITconnectivitysolutionswere

evolvingindependently.Mosthospitals

wererunasacollectionofdepartments

suchasbiomedical/clinicalengineering

andITthatsharedcertainstrategiesbut

notmuchelse.Notsurprisingly,medical

devicecompaniesrarelyconsideredwhat

hospitalITwasdoingandvice-versa.But

ultimatelythedemandfordevicemobility

PROCEEDINGS

Key Points

• In the early 21st Century the sudden surge in demand for wireless connectivity required the market to quickly accept 802.11 “WiFi” technology that is not a perfect match for mission-critical or roaming wireless clients applications and devices.

• Matching the demands of various wireless functions with the required wireless infrastructure demands (Table 3) is of primary importance.

• The development of real-time, mission-critical functions goes beyond what either infusion vendors or hospital IT can accomplish alone; wireless infrastructure vendors and hospital IT departments must work collaboratively for these efforts to succeed.

• The increasing convergence of biomedical/clinical engineering and hospital IT roles and responsibilities will mandate new ways of thinking and acting, which that can make a huge difference in the successful deployment of wireless infusion pumps on hospital IT networks.



anddatasharingforcedaconvergenceof

medicaldeviceswithhospitalITandthe

developmentofwirelessconnectivity.

Thedemandforhospital-widedatamobility

explodedintheearlypart21stcentury

withtheimplementationofhospitalIT

applicationssuchascomputerizedprescriber

orderentry(CPOE)andbarcodemedication

administration(BCMA).Unfortunately,

thesuddensurgeindemandforwireless

connectivityrequiredthemarkettoquickly

accept802.11“WiFi”technologythatis

notaperfectmatchformission-critical

orroamingwirelessclientsapplications

anddevices.

In2001CareFusion(thenALARISMedical

Systems,Inc.)introducedthefirstsmart

pump,awhichincludedaserialaRS232

interface,andwastheonlycompanyto

offertheoptionofIEEE1073Medical

InformationBusconnectivity.Asearly

as2002,thecompanybeganworkto

developtechnologythatwouldenable

connectivitythroughtheemerging

IEEE802.11wirelessstandards,which

havebecomethedefactostandards

forhospitalITnetworks.Althoughthis

setofstandardsisnotthebestfor

integratingcommercialmedicaldevices,

solongasclientandserversoftware

aredevelopedappropriately,amedical

devicecanexistnicelyonthesenetworks.

TodayCareFusionhasimplementedwell

over300,000suchIEEE802.11wireless

infusionchannelsrunninginover600

hospitals,deliveringmorethan200million

infusiondatamessageseveryday.

Real-World Demands

Thejourneytowidespreaduseofsmart

pumpwirelessconnectivityhasprovided

many“lessonslearned.”Thesestart

withavendor’scommitmenttoreal-

worldconnectivity.Intherealworld,as

soonasthedataleavethepumpona

hospitalwirelessnetwork,theyareno

Infusion Pump Connectivity

Comments

RS232 SerialTraditional “PC” type of serial interface with attached cable. A single point-to-point interface.

RS449 SerialHigh-speed serial interface allowing greater distance using an attached cable. A single point-to-point interface.

Current-Loop A low-powered, long-distance interface with attached cable.

IEEE 488

Traditional “bench lab” type of serial interface with several control elements allowing pumps to be “daisy chained” using an attached cable. More than one pump on a single cable. Cables are large multi-conductor type and not appropriate for multi-room connections.

IEEE 1073

First attempt to provide a standard that could connect all medical devices, including infusion pumps. A complex infrastructure of device connections and hubs allowed multiple device integration and time sequencing. Sometimes referred as the Medical Information Bus or MIB.

IEEE 802.11

IEEE 802.11 is a set of standards for implementing wireless local area network (WLAN) computer communication in the 2.4, 3.6 and 5 GHz frequency bands. The standards are created and maintained by the IEEE LAN/MAN Standards Committee (IEEE 802) and provide the basis for wireless network products using the Wi-Fi brand. The original version of the standard—IEEE 802.11-2007—has had subsequent amendments. The current version is IEEE 802.11-2012.

Table 1. Infusion pump connectivity: potential technology solutions

Table 2. IT connectivity: potential technology solutions

IT Connectivity Comments

Token-Ring

Devices connected in a loop where a data “token” is generated and passed from one client to another until an address match is made. Promoted heavily by IBM as the best standard for computer connectivity

Linear-Bus

First large-scale implementation of “collision detection – collision avoidance,” now considered a protocol standard. All devices listen and transmit on a single coax cable bus with tap feeds for each client. This is the basis of today’s “Ethernet”

Star Ethernet protocol using a hub or switch in a star pattern connecting to each client individually. The star topology is emerging as the most common network layout used today.



longerunderthecontrolofthepump

vendor.Thiswasaforeignconceptmany

yearsago,particularlyformostmedical

devicevendors.Itiscriticallyimportantto

recognizethatthewirelessthroughway

isasharedhighway.In-depthknowledge

ofbandwidthutilization,roaming,and

securityarefundamentalrequirements

foravendortobeabletodesignanideal

wirelessdevicethatsharesthewireless

highwayasa“goodneighbor.”

Ideal System

AnidealIVinfusionsafetysystemwould

haveasinglewirelesscommunication

linkthatisindependentofthenumber

ortypeofinfusionmodulesattachedto

apoint-of-careunit’scomputer“brain.”

Withacommontechnologyplatform,

anycombinationoflarge-volume,syringe,

patient-controlledanalgesia(PCA),

capnography(EtCO2),andpulseoximetry

(SpO2)modulescouldbesupportedby

asinglewirelesslink,asingledatabase

andsingleserveradministration.Having

alldevicesonacommonplatformwitha

commonwirelessprotocolgreatlyreduces

variabilityandgreatlyenhanceswireless

securityandbandwidthutilization.This

cannotbeeasilyachievedwithmultiple

infusionplatformsfromthesameor

differentvendors,allrunningdifferent

wirelessprotocolswithdifferentsecurity,

administration,anddatabasebehaviors.

Need for Industry-Healthcare Collaboration

Thedemandforfaster,moresecure

wirelessinfrastructuresinhospitalITwill

continuetogrow.Onlybyusingwireless

connectivitytoclosetheloopwithIV

ordersmanagementwillitbepossible

tomovesafelyfromasinglehuman

interface(anurseprogrammingapump)

tocomplex,integratedfunctionssuch

asCPOEandauto-programming.As

showninTable3,thedevelopmentof

real-time,mission-criticalfunctionsgoes

beyondwhateitherinfusionvendorsor

hospitalITcanaccomplishalone;wireless

infrastructurevendorsandhospitalIT

departmentsmustworkcollaboratively

fortheseeffortstosucceed.

Currentwirelessdesigncanbe“tweaked”

toaccomplishfullyfunctional,closed-

looped,infusionpump-connectivity

integration.However,astheindustry

evolves,thereareamazingopportunities

forcompaniessuchasCISCOtostep

inwithatruemedical-grade,wireless

networkbasedontheneedsofthese

connectedinfusionpumps.

Inthefuture,medicaldeviceintegration

maytakeanewturnwiththeavailability

forhospitaluseofcapabilitiessuchas

themetropolitanareanetworkcurrently

usedincellphonetechnology.Fornow

theburdenisonthemedical-device

Requirements for Successful Integration

Evenwithanidealdevice,integration

remainsachallengebecauseofthe

enormousvariabilityofhospitalIT

networks.Ithasbeensaidthat“Ifyou’ve

seenonehospitalnetwork…you’ve

seenonehospitalnetwork.”Successful

implementationofwirelessconnectivity

requiresin-depthknowledgeofhospitalIT

andwhatisneededforsuccess.

Asuccessfulapproachhasbeenfora

vendortoestablishadedicatedfield

IT-supportteamanddeployallserver-based

applicationswithinthehospitalITdata

center.Usingsubjectexpertswithakeen

understandingofthehospital’sstrategicIT

goalsallowstheinstallationteamtopartner

withthehospital’sITdepartment,while

settingperformanceexpectationsbased

onrealneeds.Matchingthedemandsof

variouswirelessfunctionswiththerequired

wirelessinfrastructuredemands(Table3)

isofprimaryimportance.

Eventhoughtheperformanceandsecurity

ofthesehospitalwirelesssystemshave

continuedtoevolve,itremainsuncertain

whetherthe802.11“WiFi”wireless

infrastructurescansustaincontinuous

medicaldeviceconnectivitywiththe

HITnetwork,muchlesstheinterconnectivity

amongmultipledevicesnecessaryfor

thefuture.

Table 3. Wireless Functions and Required Infrastructure

Wireless Function What’s Needed Comments

Infusion pump drug library update Batch data pushReal-time not required. Batch updates can be optimized in software

Infusion pump status (Flowsheet and status board population)

Semi Real-time A few minutes between updates acceptable

Infusion pump alarms push Almost real-time. High QoS mission critical Less than one minute end-to-end. Validate and display connectivity status

Infusion pump auto programming Near Real-time. High QoS mission criticalWithin seconds end-to-end. Validate and display connectivity status



Table 4. Recommendations for Hospitals Considering Deployment of Wireless Infusion Technology

• Develop a long-term strategy for medical device wireless integration

- Ask: Will what I’m doing today enhance or block the future value of a connected strategy?

• Promote the convergence of clinical engineering and IT domains

- This takes unique skills and may require new job descriptions/titles.

• Validate security and performance

- Ask: Has there been qualified validation of wireless security and performance?

• Be flexible – be ready

- Value of wireless connectivity is high for greater safety and efficiency.

developertotakethenecessarysteps

toensurethatitswirelesssoftwareand

hardwarearedesignedtomeetthe

demandingneedsofamobilemedical

deviceinthehospitalsetting.

Continuing Convergence of Clinical Engineering and IT

Hospitalswillalsobefacedwithchallenges

andopportunitiesofthecontinuing

convergenceofwhatwereonceconsidered

separatedomains.Therolesofbiomedical/

clinicalengineeringandhospitalITare

mergingandresponsibilitiesbecoming

blurred.Thisconvergence–orcollision–

ofdisciplineswillmandatenewwaysof

thinkingandacting,whichcanmake

ahugedifferenceinthesuccessful

deploymentofwirelessinfusionpumps

onhospitalITnetworks.

Recommendations

Drawnfromthereal-worldexperience

ofmorethan300,000wirelessinfusion

channelsinuse,therecommendations

listedinTable4shouldhelpany

organizationthinkingofdeploying

wirelessinfusiontechnology.

Footnotes

Alaris® (formerly Medley™) System from CareFusion Corporation (at that time ALARIS Medical Systems, Inc.)



Medical Device Data Systems, IEC 80001 and Managing Networked Medical TechnologyTodd Cooper Principal, 80001 Experts, LLC, San Diego, CA

Co-chair, ISO/IEC “80001” Joint Working Group 7

PROCEEDINGS

Theever-increasingroleofnetworked

medicaltechnologiesinday-to-day

healthcareactivitiespromisesimproved

Key Points

• Networked medical technology is increasingly used in day-to-day health care, promising not only improved safety, care and efficiency but also new regulatory oversight and risk management requirements.

• The Food and Drug Administration (FDA) final rule for Medical Device Data Systems (MDDS) provides for regulatory oversight of information technology (IT) network components and software applications used to handle medical-device information.

• The MDDS rule clearly states that health care delivery organizations (HDO) are considered medical device manufacturers (MDM) if they create an MDDS system, even if it is made available only for “internal” use.

• MDDS and IEC 80001: Implementing IEC 80001 can support key requirements of the FDA MDDS rule’s Quality System Regulation provisions.

• The IEC 80001-1 standard for risk management of IT-networks that incorporate medical devices provides a framework for addressing the safety, effectiveness and security aspects of networked medical technology.

• IEC 80001 provides for:

- Multi-stakeholder collaboration—both within the HDO and with external technology suppliers—to manage the risk of medical IT-networks;

- Information sharing—disclosure and dialog—that is fundamental to the risk management of networked medical technology;

- HDO roles and responsibilities— including executive management responsibilities and a new medical IT-network (MITNet) risk manager role—that are necessary to support risk management activities; and

- Full network life cycle management—from initial creation to change management, live network monitoring and eventual decommissioning.

patientsafety,qualityofcareand

efficiency.However,theuseofthese

integratedsystemsoftenhasunintended

consequenceswhentheiroperation

doesnotgoaccordingtoplan.Examples

includenothavingaccesstoinformation

whenneeded,havinganentireenterprise-

widewirelessnetworkbecomeinoperable

fordays,andhavinginformationmixed

betweenpatientsresultinmisdiagnoses

andmedicationerrors.Inmostcases,

theresultingharmtothepatientand

careorganizationisminor,butthereare

increasingreportsofpermanentpatient

harmandevendeath.

AsJeffreyShuren,MD,JD,Director,

FDACenterforDevicesandRadiological

Health,notedinhistestimonytothe

OfficeoftheNationalCoordinatorfor

HealthInformationTechnology(ONCHIT)

PolicyCommittee,“Inthepasttwoyears,

wehavereceived260reportsofHIT-

relatedmalfunctionswiththepotential

forpatientharm—including44reported

injuriesand6reporteddeaths.Because

thesereportsarepurelyvoluntary,they

mayrepresentonlythetipoftheiceberg

intermsoftheHIT-relatedproblemsthat

exist.”1ArecentTJCSentinelAlertalso

notedtheincreaseintechnology-related

adverseeventsandstated,“Notonlymust

thetechnologyordevicebedesignedto

besafe,itmustalsobeoperatedsafely

withinasafeworkflowprocess.”2

OneofthePriorityIssuesfromthe2010

AssociationfortheAdvancementof

MedicalInstrumentation(AAMI)/FDA

InfusionDeviceSummitwastheneed



to“Improvetheintegrationofinfusion

deviceswithinformationsystemsand

druglibraries,”3includingbridging

differencesinwirelessnetworking,HIT

systems,formularyanddruglibrary

standards,etc.Thisisachallengefor

anyorganizationandraisesimportant

questions:Inthepushtogetnetworked

solutionsdeployed,whatorganizationis

performinganoverallriskassessmentof

thenetworkedcomponentsanddeploying

riskcontrolmeasuresthatmitigatethe

potentialharmthatcouldresultfrom

unexpectedhazards?

Twokeydevelopmentsprovidehelpin

addressingtheseproblems:theFDA’s

reclassificationofMDDSasClassIregulated

systems,4andthepublicationofICE80001-1,

anewinternationalstandardfortherisk

managementofmedicalIT-networks.5

FDA MDDS Rule

MDDScomponentspreviouslywere

thoughttobegenericHIT-networking

components,butplayaroleinthetransfer,

storage,conversionanddisplayofdata

thatareacquiredfrommedicaldevices.4

IfanMDDSdoesnotfunctionproperly,the

resultingunintendedconsequencesmaybe

significant;thus,thequalityandcontinued

reliableperformanceofMDDSareessential

forthesafetyandeffectivenessofhealth

caredelivery.

TheFDAfinalruleannouncedonFebruary

14,2001,4clearlystatesthatifahospital

createsanMDDS,itbecomesanMDM

andhastocomplywithClassIregulatory

requirements.Thisisthecase,forexample,

whenahealthcareprovidertakesoff-the-

shelfITcomponentsandaddssoftware

“glue”specificallytoprovidetheMDDS

functionslistedabove,apracticethattodayis

usedextensivelyinthehealthcareindustry.

ClassIrequirementsforbothcompanies

andhospitalsincluderegistrationofthe

developerasanMDM,adverseevent

reporting,andgoodmanufacturing

practice(eg,qualitysystemrequirements).4

AsshowninFigure1,manyoftherisk

managementrequirementsforanMDDS

arealsoaddressedbythequalitysystem

designcontrolsoftheIEC80001standard.

IEC 80001

IEC80001-1appliestosystemsafterthey

havebeenmadeavailableforuseand

targetsunintendedconsequencesand

adverseeventsresultingfromnetworked

medicaltechnology.Itprovidesthebasisfor

communicatingpotentialhazardsandrisk

controlstoendusersfromdeveloperssothat

networked-technologyriskmanagementmay

beproperlyperformedduringintegration/

deploymentandafter"golive."

Thisrequiresthatallstakeholders,bothHDO

internalandexternaltechnologysuppliers,

cooperatearoundasharedvisionofsafe,

effectiveandsecurenetworkedmedical

technology.Thestandardaddressesall

theseentities,notonlyHDOs.TheIEC

80001-1standardappliestoanymedical

IT-network,definedasageneral-purpose

networktowhichoneormoreregulated

medicaldevicesisattached.Thisincludes

physicalequipmentandstand-alone

softwareapplicationsthatperformfunctions

meetingthelegaldefinitionofamedical

device.IEC80001-1doesnotapplyto

networkswhereasinglevendorassumes

controloftheentirenetwork,includingwhen

thenetworkisdefinedasamedicaldevice.

Instead,itfocusesonthemostprevalent

case,inwhichanHDObringstogether

differenttechnologiestocreateanetwork

thatbestmeetsitsorganizationalneeds.

IEC 80001: The Basics

IEC80001focusesonthreemain

aspectsofnetworkedmedical

technologymanagement:

1. RolesandResponsibilities—bothof

theHDOthatownsandoperates

thenetworkandofitstechnology

suppliers

2. Activities—theprocessofrisk

managingmedicalIT-networks

3. Documentation—allinformation

collectedaspartof80001-basedrisk

managementactivities

Figure 1. Risk Management, 80001-1 and MDDS Compliance

Copyright © 2011. 80001 Experts, LLC



Figure2,oftencalledthe“Houseof

80001,”showshowthesemainaspects

arerelated.5AnHDO—called“responsible

organization”inthestandard—hasultimate

responsibilityforthedefineduseand

operationofnetworkedmedicaltechnology.

IEC80001recognizesthiskeyroleand

providesthetoolsneededtomanage

thesenetworks.“TopManagement”refers

totheexecutive,C-levelfunctionsofan

organizationthathavetoestablishtherisk

managementpolicyandprocesses,ensure

thatsufficientresourcesareavailableto

performthepolicy,anddesignatekeyroles

suchastheMITNetriskmanager,define

theprobabilityandseverityscalesthatare

usedtodetermineacceptableriskwithinthe

organization,andapproveallchangesto

themedicalIT-networkbeforeitisallowed

to“golive.”5

An“MITNetRiskManager”isanindividual

whoactsasthecentralcoordinatorforall

80001-basedriskmanagementactivities

foragivennetwork.Dependingonits

sizeandneed,anorganizationmayhave

oneormoreMITNetriskmanagers,who

ensurethatthepolicyandproceduresare

properlyfollowedandfullyperformed,and

coordinatewithTopManagement,clinical

management,purchasing,biomedical

engineering,ITandothers.TheMITNetrisk

manageralsointerfaceswithtechnology

suppliersandthird-partyserviceproviders

toensurethatrequiredinformationis

providedtosupporttheriskmanagement

process,andthatcommunicationlinesare

inplacetoensurethatwhenproblems

arise,thesupplierswillrespondinatimely

mannertoresolvetheissues.5

Requireddocumentationincludes

thedefinedpolicies,processesand

proceduresthatarefollowedbythe

organizationtomanagetheriskoftheir

medicalIT-networks.TheMITNetrisk

managementfile(RMF)isthecentral

Figure 2. The “House of 80001”: Roles, Responsibilities, Activities and Documentation5

Reprinted from ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT- networks incorporating medical devices – Part 1: Roles, responsibilities and activities with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2010 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited.

TOP MANAGEMENT

Biomedical engineering

area of expertise

IT area of expertise

Clinical area of expertise

Other...

Residual Risk

Risk Management

File

MEDICAL IT-NETWORK RISK MANAGEMENT

FILE

Sub-contractorMedical

device manufacturer or provider of

other IT technology

B

ProceduresProcesses

Policies

Medical device

manufacturer or provider of

other IT technology

A

MEDICAL IT-NETWORK

RISK MANAGER

Supervises creation of

Approv

es

Prov

ides

inpu

t to

Pro

vide

s in

put t

o Provides input to

AppointsGuide activities of

Prov

ides

expe

rts to

Prov

ides

expe

rts to

Provides

experts to

Providesexperts to

The RESPONSIBLE ORGANIZATION



repositoryforallinformationconsumed

andcreatedbyriskmanagementactivities.

Thisdoesnotneedtobeasinglefile

cabinet(physicalorvirtual)thatcontains

allinformation;however,allinformation

shouldbereferencedusingasingleRMF

repositoryforeachmedicalIT-network.

Throughoutthe80001standard,

compliancestatementsrefertheauditorto

reviewtheRMFforevidencethatrequired

activitieshavebeenperformed.5

Asimplifiedversionofthebasic80001

riskmanagementprocessandkeyterms

usedduringtheprocessareshown

inFigure3.Forexample,real-time

physiologicmonitoringinformationmay

bedelayed(hazard)duetowireless

networkdropoutsoroverloading(root

causes)thatcouldoccurwhenapatient

experiencesasystole(hazardoussituation),

potentiallyresultingin(probability)

delayedtreatmentorevenpatient

death(severity).(Risk=acombination

ofprobabilityandseverity.)Toreduce

theriskofharmor“unintended

consequence”anorganizationmight

deploynetworkmonitoringtools(risk

controlmeasures)thatwouldnotify

appropriatepersonnelwhenapotential

sourceofharm(hazard)ispresent,

allowingappropriateactiontobetaken

beforeahazardoussituationdevelops.

CoordinationwithbestHITservice

activitiesisfactoredintotheIEC

80001fulllifecycleprocess,including

change/releasemanagement,network

configurationmanagementandissue/

problemresolutionmanagement.

Finally,IEC80001isahigh-levelprocess

standard—itdoesnotprovideallthe

answersforagiventypeofnetwork,

medicaldeviceororganizationpersonnel.

Itestablishesanoverallframeworkthat

mustbeappliedtoaddressthespecific

needsandlimitationsofanyspecificHDO. Copyright © 2011. 80001 Experts, LLC

Figure 3. 80001: Basic Risk ManagementProcess and Key Terms7

Collaboration: Disclosure & Dialog

IEC80001isfoundedoncollaboration

amongallstakeholdersinvolved

innetworkedmedicaltechnology

developmentanddeployment,including

externaltechnologysuppliers,both

medicalandIT.Disclosureofthe

informationneededforriskmanagement

ofasupplier’ssystem(s)whenusedwith

thosefromothersuppliersismandatory.

Withoutthat,theentireriskmanagement

processiscrippledfromthebeginning.

Theremustalsobedialogbetween

supplieranduserabouttheunique

requirementsofthedeployment

environmentandwhatisandisnot

feasible,forexample,withregardtothe

securityrequirementsofagivensystem.

Eachvendorprovideswhatitseesas

thebestwaytosecureitssystem.Often

thisconflictswiththepoliciesandtools

alreadydeployedinaspecificorganization

andIT-network.Forthisreason,the

supplierhastodiscloseitssystem’s

securityneedsandrisks,alongwiththe

associatedcontrols.Theend-usermust

thenevaluatehowthesecontrolsmayor

maynotsupportitsownsecurityneeds,

risksandcapabilities,anddialogwiththe

suppliertoachieveanacceptablelevelof

overallsecurityriskforthosesystems.2

Theendgoalofall80001-basedrisk

managementistomanagenetworked

medicaltechnologytoachieveacceptable

levelsofriskwithregardtosafety,

effectivenessandsecurity,inorderto

improveoutcomesforboththepatient

andtheorganization.Unless80001

becomesbusiness-as-usualwithinthe

healthcareindustry,unintendedharm

topatientsandcareproviderswillonly

increaseastechnologyisintegratedmore

andmoreintoclinicalpractice.

CopiesoftheIEC80001standard5and

publicationswithpracticalguidancefor

“GettingStaredwithIEC80001”6are

availablefromAAMI.TheISO/IECJoint

WorkingGroup7(JWG7)continues

todevelopfollow-onstandardsand

technicalreports.7AAMIalsocanprovide

informationonhowtofollowandengage

intheseefforts.



References

1 Shuren, J; Testimony to the Office of the National Coordinator for Health Information Technology, Policy Committee, Adoption / Certification Workgroup; February 25, 2010.

2 Sentinel Event Alert – Issue 42: Safely implementing health information and converging technologies. The Joint Commission; December 11, 2008.

3 Infusing Patients Safely – Priority Issues from the AAMI/FDA Infusion Device Summit. Association for the Advancement of Medical Instrumentation; 2010. Retrieved December 31, 2011 from www.AAMI.org/infusionsummit/

4 Medical Devices: Medical Device Data System (MDDS) Final Rule. Federal Register;76(31). U.S. Department of Health and Human Services, Food and Drug Administration; February 15, 2011. Retrieved March 27, 2012 from http://www.gpo.gov/fdsys/pkg/FR-2011-02-15/pdf/2011-3321.pdf

5 ANSI /AAMI /IEC 80001-1:2010. Application of risk management for IT- networks incorporating medical devices – Part 1: Roles, responsibilities and activities. 2010 AAMI www.aami.org.

6 ANSI /AAMI /IEC 80001-2-2. Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls. Draft available from AAMI; scheduled to be published in 2012.

7 Cooper T, David Y, Eagles S. Getting Started with IEC 80001: Essential Information for Healthcare Providers Managing Medical IT-Networks. Association for the Advancement of Medical Instrumentation; AAMI; 2011. Retrieved March 19, 2012 from http://www.aami.org/news/2011/020211.press.80001.html



Considerations in Multi-Hospital Wireless IntegrationWilliam A. Spooner Senior Vice President, Chief Information Officer

Sharp HealthCare, San Diego, CA

SharpHealthCare,thelargesthealth

caresysteminSanDiego,CA,with

2060licensedbeds,isoneoftheleading

hospitalsintheUnitedStates.Selectedas

a“100MostWired”healthcaresystem

for11years,SharpisrankedbyModern

Healthcarein2010asthemostintegrated

healthcarenetworkinCaliforniaand

sixthinthenation.SharpMemorialand

SharpGrossmontHospitalshavereceived

MAGNET®recognitionfromtheAmerican

NursesCredentialingCenter(ANCC).

In2003,aspartofitspatientsafety

improvementefforts,Sharppurchased

1407intravenous(IV)infusion“smart

pumps.”aThefollowingyearSharp

implementedthesmartpumpsinits

fiveacutecarehospitalsandinstalled

wirelessconnectivitytointegratethem

ontothehealthsystem'sinformation

technology(IT)network.In2007the

improvementsachievedthroughthese

effortsplayedamajorroleinSharp’s

receivingtheprestigiousMalcolmBaldrige

NationalQualityAward,thenation's

highestpresidentialhonorforqualityand

organizationalperformanceexcellence.

Inthisarticle,theenterprise-wide

implementationofthesmartpump

safetysystemsandwirelessconnectivity,

continuingtechnologyimprovements,

representativeresultsofsmartpumpuse,

currentstateandfuturevisionarereviewed.

Technology to Improve Patient Safety

Thesmartpumps’dose-error-reduction

software(DERS)providesalertswhenevera

programmedIVinfusionexceedshospital-

establishedparameters.Inaddition,the

softwarelogspreviouslyunavailabledata

on“goodcatches,”whenaclinician

reprogramsorcancelsaninfusionin

responsetoanalert.Analyzingthesedata

helpsstaffidentifycontinuousquality

improvement(CQI)opportunitiestofurther

refinethesoftwareorclinicalpractice.

Addingwirelessconnectivityhelps

optimizethesmartpumps’useand

maximizetheirsafetybenefit.Connecting

thesmartpumpsafetysystemstoa

wirelessservermakeitpossibleforstaffto

downloadCQIdataanduploadsoftware

changeswithouthavingtophysically

toucheverypump.

Step-Wise Integration

Implementationofwirelessconnectivity

atSharpproceededinstages.The

smartpumpsystemswereinstalled

firstina25-bedunitinonehospital,

thenthroughoutthathospitaland

finally,enterprise-wide.Atthattime

adultandinfantdevicesneededtobe

separated.Initialplanscalledforthe

PROCEEDINGS

Key Points

• As part of its patient safety improvement efforts, in 2004 Sharp HealthCare implemented more than 1400 intravenous (IV) infusion “smart pumps” and wireless connectivity, first in one unit, then throughout that hospital and finally enterprise-wide.

• Wireless connectivity made it possible to upload smart pump safety software changes and download continuous quality improvement (CQI) data without having to physically touch every pump, greatly improving safety and efficiency.

• Even without being able to attach the infusion data to specific patients, the use of advanced analytics with the general CQI data has helped identify high-risk-of-harm medications and practices and address significant issues.

• Sharp is now moving towards bi-directional connectivity, which will lay the necessary foundation for auto-programming of the smart pumps and auto-documentation of infusion data.

• To realize the full potential of these new technologies, vendors need to work together to optimize the wireless integration of their various devices and systems onto hospital IT networks.



implementationofasingleservertofeed

theentireorganization;however,security

andencryptionissuespreventedthat

approachandaserverwasinstalledin

eachhospital.Patient-controlledanalgesia

(PCA)pumpswereaddedtothesystem

in2006.

Sharpstaffcontinuedtorefinethe

softwaredruglibrariesbasedontheCQI

datafromthepumps,andthecompany

continuedtoupgradethesystem.The

numberofentriesinthedruglibraries

wasgreatlyincreasedandthesoftware

architecturechangedsothatadultand

infantdruglibrariesnolongerneeded

tobeseparated.Smartpumpsecurity

improvedtowhereSharpwasvery

comfortablewiththeencryption.This

allowedSharptoinstallasingleserver

inthedatacentertosupportthewhole

organizationtomanagethesystemmore

effectivelyandefficiently.

Itstillwasnotpossibletoassociatea

smartpumpdevicewithaparticular

patient;nonetheless,theuseofadvanced

analyticswiththegeneralCQIdata

providedvaluableinsights(Figures1and

2).Variousreportsgeneratedbythe

upgradedsystemhelpedstaffidentify

high-risk-of-harmmedicationsand

practicesandaddressissuessuchas:

Werethedruglimitssetproperly?What

typesofalertswerebeinggenerated?

Thesmartpumpreportingcapabilities

allowedstafftorefinethedruglimits,

softstops(canbeoverridden),hardstops

(cannotbeoverridden),etc.Asaresult,

Sharpwasabletomakesignificantsafety

improvements,evenwithoutbeingableto

attachtheinformationtospecificpatients.

Current State

In2011nextversionofthesafetysoftware

willexpandthedruglibrariesfrom1500

to2500items.Insteadofrelyingon

theirown,independentserver,Sharpis

Figure 1. Smart Pump CQI Data: Sample Report

“Event” = when clinician cancels or reprograms an infusion in response to a smart pump alert.

Figure 2. Smart Pump CQI Data: Sample Report

Override – when a clinician receives an alert and proceeds anyway.



movingtotheuseofvirtualservers.Most

significantly,theorganizationismoving

towardbi-directionalconnectivity,which

willallowfortwo-waycommunication

betweenthesmartpumpsandthe

electronicmedicalrecord(EMR).This

laysthenecessaryfoundationforboth

auto-programming(orderstransmitted

fromtheEMRtothepump)andauto-

documentation(infusiondatatransmitted

fromthepumptotheEMR).

Future

Majorissueswillneedtoberesolvedas

infusionsafetyandwirelessconnectivity

continuetoevolve.Findingawayto

associateadevicewithapatientis

necessaryforauto-programmingand

auto-documentation.Debatecontinues

withregardtothetypeandamountof

datathatareneededforanalyticsand

howmedicationdatacanbeintegratedin

theEMR,sotheycanbeassociatedwith

otherdata,suchasapatient’svitalsigns.

Anotherchallengeistheneedtointegrate

differentmodelsofdatanetworks(eg,

CiscoSystemsorBrocade) anddifferent

wirelessdevices,especiallywithregard

tosecurity.Vendorsneedtodevelop

amore“generic”modelthatcanbe

easilyintegratedwithothersystems.

Tomeettheseandotherchallenges,it

isessentialthatvendorsworktogether

tooptimizethewirelessintegrationof

theirvariousdevicesandsystems.For

example,resolvingdifferencesamong

competinggatewaysiscriticaltomaking

thetrafficthemostefficientandthemost

falltolerant.Finally,ofcourse,amajor

considerationinmulti-hospitalwireless

integrationiscost.

Conclusion

Wireless integration of medical devices, EMR and a hospital IT network presents major technology and process challenges. However, meeting these challenges holds the promise of greatly improving patient safety, quality of care, financial performance and clinician satisfaction.

Footnote:

a. The Alaris® System with the Guardrails® Suite, CareFusion Corporation, San Diego, CA.



What is IHE Doing About Pump Integration?Erin Sparnon, MEng Senior Project Engineer, Health Devices Group

ECRI Institute, Plymouth Meeting, PA

PROCEEDINGS

IntegratingtheHealthcareEnterprise(IHE)

isaglobalnonprofitorganizationwith

activearmsinNorthAmerica,Europe

andAsia-Oceania.IHENorthAmericais

organizedintoseveralapplication-specific

"domains"fromCardiologytoRadiology.

Infusionpumps,alongwithotherbedside

devicessuchaspatientmonitorsand

ventilators,fallunderthePatientCare

Devices(PCD)domain,sponsoredbythe

HealthcareInformationManagement

SystemsSocietyandtheAmerican

CollegeofClinicalEngineering.ThePCD

planningandtechnicalcommitteesare

staffedbyvolunteers,includingclinical

engineers,softwareexpertsfromdevice

andelectronichealthrecord(EHR)and

electronicmedicalrecord(EMR)suppliers,

andintegrationexpertswithexperience

withstandardslikeHL7andIEEE11073.

OnegroupwithinPCD,thePoint-of-care

InfusionVerification(PIV)workgroup,is

specificallytaskedwithsupportingthe

integrationofinfusionpumpserversand

EHR/EMRsystems.

IHEsupportsintegrationofmedical

devicesandsystemsthroughthe

developmentofIntegrationProfilesthat

spellouttherulesofengagementtosolve

aparticularintegrationproblem.Tostart

theprocess,aclinicalintegrationproblem

issubmittedtoarelevantdomainbya

supplier,anend-useroranotherinterested

party.Thedomainthendraftsan

IntegrationProfile,sendsitoutforinternal

andexternalreviewandthentestsitina

Connectathoneventtoseeifrevisionsare

necessary.Thisreview-test-refineprocessis

repeatedinayearlycycleuntiltheProfile

reaches‘finaltext’statusandremains

relativelystable(and,therefore,readyfor

inclusioninsuppliersystems).

Wheneverpossible,IHEdomainsuse

existingstandardslikeHL7forlanguage

structureandIEEE11073nomenclature

formedicaldeviceinformationtransfer.

Forexample,bothHL7andIEEE11073

allowawiderangeofimplementation

options,whichmeansthattwosystemsthat

conformtobothstandardsmaynotbeable

tointerfacewitheach-other.However,if

twosystemsbothconformtothestructure

andnomenclaturespelledoutinaspecific

IHEintegrationprofile,afacilitycanexpect

acertainlevelofinteroperability.

EachIntegrationProfilehasadescriptive

nameandincludesspecifictransactions

thatspelloutmessagesthataresent

betweenactors(Table1).

• Asingleprofilemayincludeseveral

differenttransactions,andnewprofiles

trytouseexistingtransactionswhenever

possible,addingnewtransactionsonly

whenanewtypeofmessageisneeded.

• Thetransactionnameincludesan

identificationnumberandabrief

description.Forexample,thetransaction

“PCD-01CommunicatePCDData”is

aperiodicmessagethatcanhandle

numericaldeviceinformation(eg,“I’m

monitor5intheICUandI’mmonitoring

Mr.Smith,whoseheartrateis110BPM”),

andshowsupinseveralPCDProfiles.

Key Points

• Standards-based approaches to integration can reduce the time and costs involved with planning, building and maintaining interfaces between and among devices and information systems.

• Integrating the Healthcare Enterprise (IHE) Profiles define standardized messages and standardized roles and responsibilities for the systems that send and receive these messages.

• IHE-Patient Care Devices (PCD) has written Profiles that cover the programming and documenting information sent between infusion pump servers and other systems like pharmacy information system (PhIS) and electronic medication administration record (eMAR) to allow for closed-loop infusion management.

• Hospitals can purchase pump servers and information systems that support these infusion management profiles by using drop-in request for proposal (RFP) language from IHE.



• Themessagespecifiestheexact

order(structure)andlanguage

(nomenclature)oftheinformation

sentbyatransaction.Forexample,the

messageofthePCD-01transactionwill

tellthesupplier,“Filloutastandard

HL7messageasfollows:putthedevice

IDinfieldW,thepatientIDinfield

X,andtheheartrate(whichmustbe

awholepositivenumber)infieldY,

beingsuretostatetheunitofmeasure

(whichmustbeBPM)infieldZ”.

• Theactorspecifieswhichtypeofactivity

aparticularsystemwillperformwith

respecttothetransaction.Actorsfall

intothreegeneralcategories:provider

orreporter(sendsinformation),

consumer(receivesinformation),or

filter(receives,modifies,andthen

transmitsinformation);andasingle

deviceorsystemcansupportmore

thanoneactor.Forexample,consider

acomputerizedprescriberorderentry

(CPOE)system.Itmayreceivepatient

datafromanadmit/discharge/transfer

(A/D/T)system(fulfillingtheroleofthe

‘consumer’actor),andsendmedication

orderstoapharmacyinformation

systemforreview(fulfillingtheroleof

the‘provider’actor).

Asking for Integration

Supplierstesttheintegrationcapabilities

oftheircommerciallyavailableproducts

withthesameNISTwebtoolsused

ontheirdemonstrationsystemsduring

Connectathons.Onceoutgoingmessages

arecheckedbythewebtoolsforformat,

structure,andexpectedvalues,suppliers

markettheirintegrationcapabilities

intermsoftransactionsandactorsin

standardizedreportscalledIntegration

Statements(Table2).Forexample,if

aninfusionpumpsupplierclaimsinan

integrationstatementthatitspump

server“supportsthePCD-03transaction,

Table 1. What’s in an IHE Profile?

Table 2. Integration Statements

CommunicateInfusionOrder,asthe

InfusionOrderConsumeractor”,itmeans

thatafacilitycanreasonablyexpect

thispumpservertobeabletoreceive

medicationorderinformation(patient

name,ordernumber,drug,rate,etc.)

cominginfromanexternalsourcelikea

pharmacyinformationsystem(provided,

ofcourse,thatthispharmacysystem

supportsPCD-03astheInfusionOrder

Provideractor).

HealthcarefacilitiescanuseIntegration

ProfilesinRequestforProposal(RFP)

languagetospecifyconnectivityby

requiringsupplierstospecifywhether(and

howwell)theirproposedproductsupports

aparticularActorinaprofile.PCDis

currentlydevelopingRFPguidancetohelp

facilities(1)identifywhichprofiles,actors,

andtransactionsapplytoaspecificclinical

applicationand(2)requiresupportofthese

transactionsandactorsinlanguagethatis

meaningfultothesuppliersandallowsfor

aminimumofwiggleroomincompliance.



The PIV Profile Now

ThePoint-of-careInfusionVerification

profile(PIV)hasbeenrevisedyearly

since2008andisheadingintofinaltext

thisyear.ThePIVcommitteeincludes

volunteersfrommostinfusionpump

suppliersandseveralEHRsuppliers,

andlastyear’sHealthcareInformation

andManagementSystemsSociety

(HIMSS)Showcaseincludedauto-

programmingandauto-documentation

withdemonstrationplatforms(not

availableforcommercialpurchase).The

currentversionofPIVsupportstwo-way

communicationofinfusionorder(for

auto-programming)andpumpstatus(for

documentation)informationbetweena

pumpserverandanenterprisesystem

suchaspharmacy,EMR,orEHR.Asof

rightnow,thetransactionscansupport

continuousinfusion(includingsecondary

orpiggybackandkeepveinopen[KVO]),

clinician-programmedboluses(eg,loading

doses),andsingle-admixturesolutions

(eg,dopamineinnormalsaline).

BecausePIVisheadingintofinaltext,

hospitalsshouldstartaskingsuppliers

forPIV-conformingsystemsintheirRFPs

thisyearandlookforupdatesintheyears

tocome.

The PIV Profile Later

PIV’snextstepsaretotacklemore

complexorderssuchaspatient-controlled

analgesia(withpatient-administered

bolusesandlockoutintervals),total

parenteralnutrition(withrampingand

tapering),andintermittentadministration.

PIVwillalsoneedtotacklemultiple-

admixturesolutions,suchasthose

usedforepidural(eg,bupivacaineplus

ropivicaine)ornutrition(eg,lipidsplus

carbohydrates)administration.

To Get Involved

[email protected]

PCDPlanningorTechnicalCommitteesat

http://www.ihe.net/pcd.



The Role of Middleware in Medical Device InteroperabilityBrian McAlpine Director of Strategic Products

Capsule Tech, Inc., Andover, MA

PROCEEDINGS

Middlewareisoftenreferredtoasthe

“glue”thattiestogethersystemsand/

orapplications;itisessentiallysoftware

thatcantakeonmanydifferentforms

andcanbeimplementedtoaddress

manytypesofinformationtechnology

(IT)issues.Inthespecificcaseofdevice

connectivity,middlewareisusedto“glue”

orintegratemedicaldevicedataonto

enterpriseinformationsystemssuchas

electronicmedicalrecords(EMRs),alarm-

managementsystemsandothertypesof

MedicalDeviceDataSystems(MDDS).

Thistypeofmiddlewareisnotnew;in

fact,deviceconnectivitymiddlewarehas

beensuccessfullydeployedinhospitalsfor

morethan12to15years.

Mostofthecurrentlyimplemented

connectivitymiddlewaresolutions

connectandintegratedatafromthe

diversemixofdevicesthathospitals

currentlyuse,traditionallystartingwith

patientmonitors.Thesesolutionsalso

integrateamixofolderlegacymedical

devicessuchasventilators.However,

connectivityneedsareevolving.Newer

andmoreadvanceddevicessuchas

smartintravenous(IV)infusionpumps

andinfusionmanagementsystemsnow

requireintegration.Interoperabilityof

smartIVpumpswithenterprisesystems

suchaspharmacyITandEMRsisalso

rapidlyevolvingasahospitalrequirement.

InUShospitalstheinitialdeployments

ofsmartpump-EMRintegrationhas

generallybeenaccomplishedwithdirect

interfaces;however,goingforwardthis

approachwillnotaddresssomeimportant

usabilityandworkflowrequirements.

Connectivitymiddlewareisrecognized

bytheindustryasasolutionfor

addressingthecomplexrequirementsof

interoperabilityandtheneedtooptimize

clinicalworkflowandaddresspatient

safetyrequirements.Challengessuchas

thesemeanthattheindustrywillneedto

cometogethertocollectivelyanalyzeand

addresstheissuesandcreatesolutions

thatmeettheshort-andlong-termneeds

ofhospitals.

Connectivity Requirements Should Support a Broad Integration Strategy

IndevelopingtheirIVpumpconnectivity

strategyandevaluatingoptionsfor

connectivity,mosthospitalsthinkmore

broadlythanasingleclassofdevices.

Mostfocusonrequirementsfortheir

entirehealthcareenterprise,which

includesabroadrangeofmedicaldevices.

Thefollowinglistincludessomeofthe

detailedrequirementsthathospitals

submittoconnectivityvendorsintheir

requestsforproposals(RFPs)andthat

shouldbeconsideredbyanyhospital

consideringabroad-rangeintegration

strategy:

• Connectalllegacyandcurrentmedical

devicesacrossallcareareas—including

intensivecareunits(ICUs),emergency

department,operatingroom,medical-

surgicalandspecialtycareareas—to

handlebothcontinuousandperiodic

datafromvariousdevices.

• Connect,manageandintegratedataand

alarmstoexistingandfutureplanned

EMRandalarmmanagementsystems.

• Provideamethodtomanagepositive

Key Points

• Hospitals today are leveraging device connectivity middleware as part of a hospital-wide strategy to connect all medical devices, including intravenous (IV) pumps.

• Middleware not only facilitates the integration of the medical device’s data but also helps meet the increasing requirements for the integration of alarms and waveforms.

• Designing an optimized clinical workflow is a key factor to consider when implementing device connectivity and ultimately enabling device interoperability.

• Designing a workflow for managing patient-to-device association for all wireless and mobile devices remains a key focus and challenge.



patientidentification(PPID)andan

abilitytomanagepatient-to-device

(P2D)associationatthebedside.

• Provideameansforcliniciansto

havereal-timeaccesstoinformation

onthestatusofdevicesandtheir

stateofconnectivity.

• Provideameansforthehospital

todesigntheoptimizedclinical

workflowsrequiredforcliniciansto

safelyandeffectivelymanagePPID,

P2Dassociationandvariousaspects

ofdeviceconnectivity.

ThislistmightsuggestthatmanagingIV

pumpconnectivityissimplyonepartofa

broaderstrategytointegrateallmedical

devices;however,thisisnotthecase.

Whilemanycomponentsofabroader

integrationstrategyremainthesame,IV

pumpintegrationhasanumberofunique

requirementsthatneedtobeconsidered.

Thisisimportanttounderstand,because

determiningearlyonhowIVpumpsfit

intoabroaderstrategywillsavehospitals

alotoftimeandmoneyinnothavingto

undoasolutionbecauseitdoesnotmeet

theirlonger-termneeds.Inthisarticle,

therequirementforbasicconnectivity

versuswirelesssmartpumpconnectivity

willbeexplored,inordertounderstand

whatisnecessarytomeethospitals’

long-termneeds.

The Role of Device Connectivity Middleware for Basic Connectivity (One–Way)

Onceplanningshiftsfromtacticalto

strategic,itbecomesmoreevidentthat

connectivitymiddlewareisnecessaryto

meetallthediverserequirements.Figure

1showsthegeneralflowofdatafrom

devicestoenterpriseapplicationssuchas

anEMR.Italsoshowsthemainfunctions

ofamiddlewaresolutionwithregard

totheclinicalworkflowandtechnical

featuresrequired.

Itisimportanttonotethateventhough

connectivitymiddlewareisgenerally

thoughtofasasoftwareplatform,typically

hardwareandcablingarealsorequiredto

implementabasicconnectivitysolution.

Table1showsthekeyfunctionsandvalue

providedbyconnectivitymiddleware.

Why Smart IV Pumps are Different

from Other Medical Devices

SmartIVpumpsafetysystemsarepartof

auniqueclassofdevicethatposessome

interestingchallenges.Fromanintegration

perspective,thefollowingcharacteristics

mustbeconsidered:

• MultipleIVpumpsareoftendeployed

perpatient.InsomeICUsapatient

canhaveupto20ormoreseparate

IVlinesdrivenbymanypumps.Often

thepumpsareidentical,exceptforthe

medicationsorfluidsbeingdispensed.

• Mostsmartpumpsarewirelessand

lackawayforclinicianstoeasily

capturetheroomID,patientIDorthe

IDoftheclinicianprogrammingthe

pump.Thesemissingdataelements

arecriticaltomakingintegration

workseamlesslyandassistingwith

documentationintheEMR.

• SomeIVpumpsaremodularunitsthat

canbecombinedonasinglesoftware

platform.Individualmodulescanbe

addedorremoveddynamicallyandcan

includedifferenttypesofpumps(large-

volume,syringe,andpatient-controlled

analgesia[PCA]).

• Smartpumpintegrationisatthe

intersectionofseveraldifferent

workflows,includingmedication

administration(ofinfuseddrugs),

positivepatientID(PPID)andthe

5-rightsofmedicationadministration,

andclinicians’managementofthe

physicaldevices(setup,programming,

monitoringstatus,etc.).

• Smartpumpsareattheforefrontof

bidirectionaldevicecommunications.

Forexample,integratedsmartpumps

canreceiveamedicationprogramming

order(asetofauto-programming

instructions)tofurtheroptimizethe

processofmedicationadministration.

Figure 1. Integration of Medical Devices: Overview



Standards Help but are Not a Panacea for Solving Device Integration

Inconsideringmedicaldeviceintegration,

oftenthequestionofstandardscomesup.

Standardscertainlyaddresssomeimportant

issues,andwillultimatelyhelpdrivedown

costsandmakeconnectivityeasier.Many

industryeffortsarecurrentlyunderwayto

improvestandardization.Butitisimportant

torememberthathospitalshavelegacy

devicesthatwillnotbeabletoincorporate

standardsforsometimetocome;

therefore,hospitalscannotbasetheirdevice

connectivitystrategysolelyonstandards.

Inaddition,standardseffortstodaydonot

addressmostoftheissuesoutlinedabove

regardingthenecessaryfunctionsofa

completeconnectivitymiddlewaresolution.

(SeetheJanuary2011articlebyBikramDay1

formoreinformationonstandards.)

Table 1. Key Functions and Value Provided by Connectivity Middleware

• Physical connectivity in patient room. There will almost always be a requirement to connect a “legacy” or older device with a serial connector (RS-232). These devices are connected to something in the room, typically a personal computer (PC) or dedicated serial concentrator box with multiple serial ports.

• Networked or logical connectivity. In addition to serial devices, often there are requirements to connect a networked device such as a patient monitor that is connected to a patient monitoring network. A monitoring gateway is often the most effective means to collect the data from this class of devices.

• Data aggregation and single HL7 feed. One of hospitals’ key requirements is to simplify the management of all of the discrete data feeds and interfaces. This can be accomplished by directing all of the collected device data to a centralized aggregation server. The data can then be centrally managed and a single data feed configured to feed the receiving enterprise system (EMR).

• Data management and filtering. Data often are collected from medical devices in raw, unfiltered format. Especially for continuous data collection, the data always require some form of filtering, conversion of units of measure, normalization, etc. Middleware can provide such data-management capabilities, thereby simplifying the configuration and integration requirements for systems such as EMRs.

• Data protection and high reliability. In designing a device-connectivity solution, vendors need to address how data will be protected in the case of a fault or outage in either the hardware (server or bedside concentrator) or the network. Middleware and related hardware components need to be configured to provide data caching in the event of an outage.

• Bedside/point of care status. Clinicians need to always be in control of the patient care environment. They can be much more efficient at the bedside when they have access to real-time information on the status of various devices. One way to provide this information is to have the middleware provide a real-time status indication of device connectivity.

• Manage P2D association. Clinicians need to be able to efficiently establish the association between stand-alone medical devices and a patient by confirming the right patient ID and the devices that should be associated to that patient. Middleware can provide the necessary capabilities for hospitals to establish optimal workflows for managing devices and the required association to the patient.

IV Pump Interoperability Requires Advanced Middleware Features

Morethanjustone-waydatatransferfrom

anIVpumpsystemtoanEMRforclinical

documentationpurposes,itisgenerally

understoodthatinteroperabilityrefersto

two-wayorbidirectionalcommunication

betweentheIVpumpsystemandother

enterprisesystems.Akeybidirectional

featureisthetransferofapump

programmingorderfromtheEMRtothe

IVpumpsystem.Thissendsasetofspecific

instructionsthatautomaticallyprogramsthe

pumpwithapatient-specificorder.

AsshowninFigure2,middlewarecan

providekeyfeaturesforboththenurseat

thebedsideandthepharmacytechnician.

• Atthebedside,nursesneedtohave

real-timeinformationaboutthe

statusofeachpump.Middlewarecan

providethisinformation,whereasthe

pumpscannot.Isthepumpcurrently

connected?Acliniciancannoteasilytell

bylookingatawirelesspumpwhether

itiscommunicatingitsdataviathe

WiFinetwork.Iseverypumpproperly

associatedtotherightpatient?Again,

acliniciancannottellbylookingatthe

pump.Withoutaconfirmedassociation

totherightpatient,errorsarelikely

tooccur.Middlewarecanalsohelp

manageP2Dassociationusingavariety

ofmethods,includingbarcodingand

radiofrequencyidentification(RFID).



Conclusion - What Should Hospitals Do Now?

Hospitals must realize that IV pump connectivity and interoperability are in the very early stages of development. Even one-way communication of pump data to EMRs is still in the pilot stages for most EMR vendors. Hospitals planning for pump connectivity and interoperability (closed-loop auto-programming) should consider taking the following actions:

• Map out and plan a complete strategy that includes an evaluation of all medical devices. Without a comprehensive middleware solution, a lot of extra or custom work will be required to make an end-to-end solution that is usable for all clinicians in the workflow.

• Start with a plan for basic one-way connectivity. First get the data from the pump gateway into the EMR. Bi-directional functions can be added later.

• Include nursing in the decision-making process and examine what the desired workflows should be.

• Examine the requirements for managing P2D association and the role of PPID at the bedside.

• Evaluate what real-time status information the nurse will require at the bedside and how middleware can help provide that information.

• Middlewarecanalsodisplayreal-

timestatusofeachinfusionforthe

pharmacytechnician.Pharmacycan

bealertedwhenacriticalinfusionis

abouttorunout.Or,ifthereareissues

withanycurrentlyrunninginfusions,

pharmacycaninterveneaccordingly.

• IVpumpsgeneratemanydifferent

typesofalertsoralarms,andmanaging

thesealarmsiscritical.Middlewarecan

provideawaytofeedthesealarmsto

otherenterprisesystemssuchasan

alarmmanagementsystem.

Figure 2. Role of Middleware in Closed-loop IV Pump Programming

Note: Using the BCMA appl, the order getting to the right individual pump is dependant on the clinician deciding which pump to use based on availability and status of each pump.



Making Sure Critical Alarms are Heard: Promoting Critical Alarms from Bedside to Caregiver and Central StationAnn Holmes, MS, RN Nurse Manager, Munson Medical Center Traverse City, MI

PROCEEDINGS

InOctober2006,theAnesthesiaPatient

SafetyFoundation(APSF)hosteda

workshoponpatient-controlledanalgesia

(PCA)andopioidadministrationfor

post-operativepatients.Asnotedinthe

workshopreport,1thereisasignificant,

under-appreciatedriskofseriousinjury

fromPCAinthepost-operativeperiod,

includingalow,unpredictableincidence

oflife-threateningrespiratorydepression

eveninyoung,healthypatients.Ratesof

respiratorydepressionarehigheramong

patientsreceivingcontinuousopioid

infusions.Inlightofthesefindings,the

APSFurgedhealthcareprofessionalsto

considerthepotentialsafetyvalueof

continuousmonitoringofoxygenation

(pulseoximetry)andventilationinpatients

receivingPCAorneuraxialopioidsinthe

postoperativeperiod.Thereportfurther

notedthatitiscriticalthatanymonitoring

systembelinkedtoareliableprocess

tosummonacompetenthealthcare

professionaltothepatient’sbedsidein

atimelymanner.1

MunsonMedicalCenter(MMC)in

TraverseCity,MI,partofaneight-hospital

system,isknownforitscultureofpatient

safetyandhigh-qualitycareandhas

receivednationalrecognitionsuchasthe

2008AmericanHospitalAssociation-

McKessonQuestforQualityPrize®,

inclusionontheTop100Hospitals®list

11times,anddesignationasaMagnet

hospitalfornursingexcellenceanda

BariatricSurgeryCenterofExcellence.

In2010MMClaunchedaMunsonPatient

SafetyInitiativetoimprovethemedication

safetyforthemanypatientswhorequired

opioidtherapyinthepost-operativesetting.

Inkeepingwithitscultureofsafety,the

initiativeenabledMMCtofollowtheAPSF

recommendationsandtoimprovethe

safety,qualityandcost-effectivenessof

post-operativepainmanagement.Inthis

article,theneedforcontinuousrespiratory

monitoringofpost-operativepatients

receivingopioidtherapy,theMunsonPatient

SafetyInitiative,thetechnologiesselected

andresultsachievedarebrieflyreviewed.

Munson Patient Safety Initiative

Patientsreceivingopioidanalgesicsin

thepost-operativesettingincludedthose

withsleepapnea,healthypost-operative

patientsreceivingopioidsthroughpatient-

controlled-analgesia(PCA)orepidural

Key Points

• The Anesthesia Patient Safety Foundation (APSF) has noted a significant, under-appreciated risk of serious injury from patient-controlled analgesia (PCA) in the post-operative period.1

• The APSF has urged health care professionals to consider the potential safety value of continuous respiratory monitoring in patients receiving PCA or neuraxial opioids in the postoperative period, with any monitoring system linked to a reliable process to summon a competent health care professional to the patient’s bedside in a timely manner.1

• In 2010, Munson Medical Center (MMC), a nationally recognized Top 100 Hospital in Traverse City, MI, implemented a PCA safety system with “smart” (computerized) PCA infusion, capnography and pulse oximetry modules on a single platform wirelessly integrated with central surveillance and alarm management.

• Capnography was found to be much more effective than pulse oximetry in identifying patients with opioid-related respiratory distress.

• Implementation of the continuous respiratory monitoring system allows patients at risk of opioid-related respiratory depression to be cared for safely and effectively in the medical-surgical unit, reducing the intensive care unit (ICU) and step-down ICU census by approximately 2 patients per day, leading to an annual savings of $1.28 million per year.



analgesia(PCEA),theopioid-naïve,the

elderlyandpatientsreceivingconcomitant

central-nervous-systemdepressants.

Atthattime,patientswithuntreated,

diagnosedsleepapneaweresenttothe

intensivecareunit(ICU)post-operatively

justtobemonitoredforthefirst12hours.

Thechallengewastokeeppatientsout

oftheICUandtoprovideoptimalcareto

patientsreceivinghighdosesofnarcotics.

In2009,amultidisciplinaryteam

developedaMunsonPatientSafety

Initiativewiththefollowingobjectives:

• Identifysafetyrisksrelatedtorespiratory

depressionandopioidadministration

• Improvepatientsafetyrelatedtopain

managementwhilestandardizing

clinicalpracticeanddosing

• Decreasetheriskforrespiratory

depressionbycontinuouslymonitoring

end-tidalcarbondioxide(EtCO2)or

oxygenation(SpO2)andhavingthe

abilitytoautomaticallystopopioid

infusionsifpre-establishedrespiratory

parameterswereexceeded

• Investintechnologythatsupports

clinicaldecision-making(amonitoring

systemwithanintegratedplatform

foropioidinfusionandrespiratory

monitoringwithtrenddata)

Inselectingarespiratorymonitoring

system,itwasveryimportanttoMMC

nursingmanagementthatthesystem

wouldalarmnotonlyatthebedsidebut

alsoatacentralmonitorandthenurse’s

pager,cellphoneorsomeotherdevice.

Ifanalarmweresoundingfrombehinda

doororthepatient’snursewereoutof

theroom,noonewouldknowthepatient

wasgoingintorespiratorydistress.Thus,

remotesurveillancewithacentralmonitor

andalarmmanagementwerecritical

selectionrequirements.

Technology

Followingextensiveevaluations,a“smart”

(computerized),modularPCAsafetysystem

wasselected(Figure1).Atthebedsidethe

systemcomprisesapoint-of-careunit(PCU,

“brain”)withPCA,capnographyandpulse

oximetrymodulesonasingleplatform.aA

gatewayserverwirelesslytransmitsdatato

andfromthePCU.bAcentralsurveillance

serverwitharulesenginesendsremote

alarmnotificationsinrealtimeviawireless

communicationtothecentralstation

andtheclinician’spager,allowingquick

responsetorespiratoryalerts.cIfapatient’s

respiratoryvaluesfallbelowhospital-

definedlimits,thesystemgeneratesan

alertandtheunique“pauseprotocol”

automaticallypausesthePCAinfusionand

deactivatesthedose-requestcord.The

systemprovidesupto24hoursofPCA

dosinghistorywithcorrespondingtime-

basedvaluesfromcapnographyand/or

pulseoximetrymonitoring.

PCA and SpO2 or EtCO2

monitoring started

Wireless updates

Central Monitoring Software

• Interface for alarms management, monitoring data, and reporting

Server and Gateway sockets:

• SpO2 / EtCO2 data received

• Critical thresholds transmitted from bedside IV

• Pumps PCA module Paused as necessary, low RR or low SpO2

Figure 1. Technology Application: Systems Manager and Gateway Monitoring



Central Surveillance

Wirelessconnectivityallowsnursesatthecentralstationto

monitorupto12patientsinrealtime(Figure2).Ifapatient

setsoffanalarmwiththeEtCO2orSpO2monitor,thealarm

soundsatthestationandtheboxonthetouch-screenmonitor

withpatient’sinformationturnsred.Thealarmalsogoestothe

nurse’spocketpager.ThePCAinfusionisautomaticallypaused.

Trenddata(Figure3)canbeprintedandputintothepatient’s

medicalchart,sostaffcanreviewinstancesoflowrespiratory

ratesorSpO2.

Patient Selection

Capnographywasfoundtobemuchmoreeffectivethanpulse

oximetryinidentifyingpatientswithopioid-relatedrespiratory

distress.Pulseoximetryvaluesmaybemisleadingifapatientis

receivingsupplementaloxygen.Moreover,pulseoximetrydoes

notdetectcriticalmarkersofrespiratorydepression:respiratory

rate,pausesintherespirationcycle,increasedexhaledCO2and

inadequaterespirations;capnographydoes.Forthesereasons,

allpatientsreceivingopioidanalgesicsaremonitoredwith

capnography,exceptforpatientswhoareoncontinuousor

bi-levelpositiveairwaypressure(CPAPorBi-PAP)orwhohave

hadnasopharyngealsurgery(Table1).

Results

Clinicalexperience,safety-systemcontinuousqualityimprovement

(CQI)andalarmmanagementdataconfirmthatpatientsatriskof

opioid-relatedrespiratorydepressioncanbecaredforsafelyand

effectivelyinthemedical-surgicalunitanddonotneedtobesent

toanICU.Becauseofthis,theimplementationofthemonitoring

systemhasreducedtheICUandstep-downICUcensusby

Table 1. Continuous respiratory monitoring: patient selection

• Postoperative patients receiving PCA or PCEA therapy

• Sleep apnea confirmed by a sleep study not treated with a CPAP or Bi-PAP

• OSA screening score ≥ 5

• Risk of de-oxygenation observed by nurse or respiratory therapist as evidenced by loud snoring, periods of apnea, decreased level of consciousness or seizures

• All patients are monitored with capnography (EtCO2 and respiratory rate) unless on CPAP or Bi-PAP or following nasal/oral surgery; oximetry (SpO2 and heart rate) are used to monitor these patients.

Figure 2.

2 2"

2 2"



Figure 3. Printed Patient-specific Respiratory Reports

Table 2. Continuous respiratory monitoring: economic impact

• Prior to implementation of continuous respiratory monitoring with central surveillance, postoperative patients with suspected or known sleep disordered breathing were admitted to ICU or ICU step-down unit

• Patient cost on a post-operative unit is 56% less than on an ICU unit

• The implementation of the monitoring system has reduced the ICU and step-down ICU census by approximately 2 patients per day

• At MMC this represents an annual savings of $1.28 million per year

approximately2patientsperday.Given

thelowercostofcaringforpatientsin

non-intensivecare,atMMCthischangein

practicehasresultedinanannualsavings

of$1.28millionperyear(Table2).

Abefore-and-afterresearchstudy(250

patientsbeforeimplementation;500,after)

showeddecreaseduseofNarcan,medical

responseteam,fewerpatienttransfersto

ICUfortreatmentofrespiratorydepression,

anincreaseinnursinginterventionto

stimulatepatients,anddecreaseduseof

supplementaloxygen.Nursescanmake

appropriate,patient-specificadjustmentsto

opioiddosingsafely,basedonthepatient’s

abilitytobreathecorrectlyandmaintain

agoodrespiratoryrate.

Discussion

ImplementationofPCAsafetysystemwith

continuousrespiratorymonitoringintegrated

withcentralsurveillancehasallowedMMC

tofollowtheAPSFrecommendationsto

improvethesafetyofpost-operativeopioid

therapy.Patientsalsoseemtoexperience

muchbetterpaincontrol.

Thesystemsupportsnurses’clinical

decision-makinginseveralways.Nurses

useclinicalassessmentdataalongwiththe

technologydatatobetterassessapatient’s

responsetoPCAtherapy.Thetrenddata

areusedtoreviewopioiddosingand

patientresponseduringnursingrounds,

forend-of-shiftreportsandasneeded.

Thecomprehensivereportingtoolallows

nursestoreviewhowmanytimesa

patient’srespiratoryratedecreasedto4or

5breathsperminute(bpm).Thishasalso

beenusefulwhenpatientsdonotbelieve

theyhavesleepapneaandnursescan

showthemthattheystoppedbreathing

12timesinthelasthour.

Narcanisnolongerneededasfrequently,

becauseapatient’sPCAinfusioncanbe



adjustedlongbeforethepatientbeginsto

experiencerespiratoryproblems.Now,if

apatient’srespiratoryratesuddenlydrops

to4bpm,anursewillstopthecontinuous

infusionandstimulatethemtoresume

normalbreathing.Automaticdeactivation

ofthedose-requestcordhasprovedto

beverybeneficial,especiallywithpatients

whohavebeengiven“PCAbyproxy,”

wherebyafamilymemberorfriendis

pushingthebuttonwithoutassessing

thepatient’scondition.

Conclusion

The use of using continuous respiratory monitoring, especially capnography, allows clinicians obtain a more accurate evaluation of the patient’s respiratory status in response to opioid therapy, leading to more cost-effective post-operative care on a medical/surgical unit, without any increase in adverse events as compared to post-operative care in an ICU. Clinicians can use nursing assessment and safety-system trend data, leading to more appropriate nursing interventions.

Promoting critical alarms from the bedside to the central station and the nurse’s pager helps ensure that critical alarms are heard and appropriate interventions made in a timely manner, thus avoiding the need for more intensive care. The system’s unique “pause protocol” also helps improve the safety of PCA opioid delivery. Safety system CQI data are beneficial to measure improvements in practice and compliance. Most importantly, continuous respiratory monitoring with a PCA “pause protocol,” central surveillance and alarm management leads to safer patient care during PCA opioid delivery in the post-operative setting.

Footnotes

a. The Alaris® System with the Guardrails® Suite of safety software, CareFusion Corporation, San Diego, CA, with Nellcor OxiMax™ pulse oximetry technology and Oridion’s Microstream® capnography technology.

b. Alaris® Gateway from CareFusion

c. Bernoulli® Enterprise, Cardiopulmonary Corp.,

Milford, CT [CORRECT?]

References

1 Weinger, M.B. APSF Newsletter, Winter 2006-2007; 21(4):63-7.

Center for Safety and Clinical Excellence Infusion Therapy and Information Technology: Taking IV Therapy to New Levels of Safety with IT Integration San Diego, CA June 2-3, 2011

Attendees

Jeanette Adams, PhD, RN, CRNI, ACNS, BCAssistant Professor -and-Infusion Nurses Society President-ElectNew York, N Y

David Bates, MDChief, Division of General Internal Medicine and Primary CareBrigham and Women’s HospitalBoston, MA

Jack Bond, MHS, RPh, MSDirector, Pharmacy and Respiratory TherapyWesley Medical CenterWichita, KS

Todd CooperPrincipal 80001 Experts, LLCSan Diego, CA

Christopher R. Fortier, PharmDManager, Pharmacy Support & OR ServicesClinical Assistant ProfessorDepartment of Pharmacy ServicesMedical University of South CarolinaCharleston, SC

Mary Gannon, RN, BSNSr. Strategist, Nursing and Care DeliveryCernerKansas City, MO

Tim GeePrincipal and FounderMedical Connectivity ConsultingBeaverton, OR

Karl F. Gumpper, RPh, BCPS, FASHPDirector, Section of Pharmacy Informatics & Technology American Society of Health-System Pharmacists® Bethesda, MD

Ann Holmes, MS, RNNurse ManagerMunson Medical CenterTraverse City, MI

Marla Husch, RPhDirector, OperationsCentral DuPage HospitalWinfield, IL

Jamie KellyPresidentEntropy ResearchSan Diego, CA

Stuart Levine, PharmD Informatics SpecialistInstitute for Safe Medication PracticesHorsham, PA

Mary Logan, JD, CAEPresidentAssociation for the Advancement of Medical InstrumentationArlington, VA

Ray Maddox, PharmDDirector, Clinical Pharmacy, Research & Pulmonary MedicineSt. Joseph CandlerSavannah, GA

Brian McAlpineDirector, Product Management CapsuleAndover, MA

Tapan MehtaSenior Manager, Global Healthcare SolutionsCiscoSan Jose, CA

Judy Murphy, RN, FACMI, FHIMSSFormerly Vice President, Information TechnologyAurora Health CareMilwaukee, WI

Mark NeuenschwanderThe Neuenschwander CompanyBellevue, WA

Rosemary O'Malley, RN, MSN, MBAProgram Manager Massachusetts General HospitalBoston, MA

Kristen O’Shea, RN (via webex)Clinical Transformation OfficerWellspanYork, PA

Attendees (continued)

Dan PettusVP, Infusion IT and ConnectivityCareFusionSan Diego, CA

Anne Pohlman, APN-CNS, CCRN, FCCMClinical Nurse SpecialistUniversity of ChicagoChicago, IL

Nancy Pratt, RN, MSNSr. VP, Clinical EffectivenessSharp HealthcareSan Diego, CA

Rita Shane, Pharm.D., FASHPDirector, Pharmacy ServicesCedars-Sinai Medical CenterLos Angeles, CA

Nathaniel M. Sims, MDMassachusetts General HospitalBoston, MA

Mark H. Siska, BS Pharm, MBA/TMAssistant Director Informatics & TechnologyPharmacy ServicesMayo Clinic RochesterRochester, MN

Ronald H. Small, RPh, MBA, Sc.D.VP Quality and Chief Pharmacy OfficerWake ForestWinston Salem, NC

Erin Sparnon, MEngSenior Project EngineerECRI Institute HeadquartersPlymouth Meeting, PA

Bill SpoonerSVP, CIOSharp HealthcareSan Diego, CA

Tina M. Suess, BSN, RN (via webex) Bridge System Administrator Lancaster General Hospital Lancaster, PA

Coray Tate, RNDirector, Clinical ResearchKLASOrem, UT

Kim Thomas, RN, BSN, MSM, CCRN Team Leader Delnor HospitalGeneva, IL

Alana J. Urban, MSN, RN, CCRNInfusion Safety PractitionerUPMC - Donald D. Wolff, Jr. Center for Quality Improvement and Innovation Pittsburgh, PA

Tim Vanderveen, PharmD, MSVice President, Center for Safety and Clinical ExcellenceCareFusionSan Diego, CA

Mary Kaye Van Huis, RN, MSNClinical Implementation PremierCharlotte, NC

Jim Welch (via webex)VP, Patient Safety InitiativeMasimoIrvine, CA

Mike WiszWisz and AssociatesSan Diego, CA

CareFusion

• Jim Alwan, Director, R&D

• Gail Berglund, RN, MSN, Director, Infusion Marketing

• Sally Graver, Medical Writer

• Greg Gulden, VP, R&D

• Monica Obsheatz, RPh, MPM, Clinical Practice Consultant

• Carlos Nunez, MD, Chief Medical Officer

• Robert Schad, Connectivity Manager

• Patrick Ward, Director, R&D

Center for Safety and Clinical Excellence Infusion Therapy and Information Technology: Taking IV Therapy to New Levels of Safety with IT Integration San Diego, CA June 2-3, 2011


Conference Report Published by the Center for Safety and Clinical Excellence

carefusion.com

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