properly玄幻小说排行榜2012前十名

TOP10HEALTHTECHNOLOGYHAZARDSFOR2014AdaptedfromVolume42Issue11November2013guidanceARTICLE1Adaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazards2013ECRIInstituteECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
Ensuringthesafeuseofhealthtechnologyrequiresidentifyingpossiblesourcesofdangerordifcultyinvolvingmedicaldevicesandsystemsandtak-ingstepstominimizethelikelihoodthatadverseeventswilloccur.
Withthevastarrayoftechnolo-giesinuseatamodernhealthcarefacility,however,decidingwheretocommitlimitedresourcesisacontinualchallenge.
Weintendthislisttobeastartingpointforpatientsafetydiscussionsandforsettinghealthtechnologysafetypriorities.
AboutThisListThisTop10listofhealthtechnologyhazards,devel-opedeachyearbyECRIInstitute'sHealthDevicesGroup,highlightsthetechnologysafetytopicsthatwebelievewarrantparticularattentionforthecom-ingyear.
Somearehazardsthatweseeoccurringwithregularity.
Someareproblemsthatwebelievewillbecomemoreprevalent,giventhewaytechnol-ogyisevolving.
Andsomearewell-knownrisksthatperiodicallywarrantrenewedattention.
Butalltheitemsonthelistrepresentproblemsthatcanbeavoidedorrisksthatcanbeminimizedthroughthecarefulmanagementoftechnologies.
Foreachhazardwedescribetherisk-mitigationstrategiesthatarecurrentlyavailable,makingthislistapracticaltoolforidentifyinghigh-impactstepsyoucantaketoimprovepatientcareatyourfacility.
Wepresenthereourlistfor2014.
Additionaldetailsabouteachtopic—includingourrecom-mendationsforaddressingeachhazardandalistofadditionalresources—areavailableintheNovember2013issueofHealthDevices.
CriteriaforInclusionECRIInstituteroutinelyaddressesmodel-specicdesign,use,andmaintenanceissuesthroughourTOP10HEALTHTECHNOLOGYHAZARDSFOR2014THISABRIDGEDVERSIONOFECRIINSTITUTE'SANNUALTOP10LISTOFHEALTHTECHNOLOGYHAZ-ARDSISPROVIDEDASACOURTESYOFECRIINSTITUTE.
AMORECOMPREHENSIVEDISCUSSIONOFEACHHAZARD,ADDITIONALRECOMMENDATIONSFORMINIMIZINGTHERISKS,ANDALISTOFUSEFULRESOURCESFORMOREINFORMATIONABOUTEACHTOPICAREPROVIDEDINTHEFULLARTICLE,PUB-LISHEDINTHENOVEMBER2013ISSUEOFHEALTHDEVICES.
THELISTFOR20141.
Alarmhazards2.
Infusionpumpmedicationerrors3.
CTradiationexposuresinpediatricpatients4.
DataintegrityfailuresinEHRsandotherhealthITsystems5.
OccupationalradiationhazardsinhybridORs6.
Inadequatereprocessingofendoscopesandsurgicalinstruments7.
Neglectingchangemanagementfornetworkeddevicesandsystems8.
Riskstopediatricpatientsfrom"adult"technologies9.
Roboticsurgerycomplicationsduetoinsufficienttraining10.
Retaineddevicesandunretrievedfragments22013ECRIInstituteAdaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazardsECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
technologyevaluation,problemreporting,acci-dentinvestigation,andalertingservices.
ForthisTop10list,wefocusonlyonwhatwecallgenerichazards—problemsthatresultfromtherisksinher-enttotheuseofcertaintypesorcombinationsofmedicaltechnologies.
Whennominatingtopicsforconsideration,ECRIInstitutestaff—engineers,scientists,nurses,physicians,andotherpatientsafetyanalysts—drawontheresourcesbuiltupthroughtheorganization's45-yearhistoryanalyzinghealthcaretechnologies,aswellastheirownexpertiseandinsightgainedthroughexamininghealth-technology-relatedproblemreports,evaluatingmedicaldevicesandsystems,investigatingincidents,observingandassessinghospitaloperationsandpractices,review-ingtheliterature,andspeakingwithhealthcareprofessionalsanddevicesuppliers.
Staffthenvoteonthenominatedhazards,weighingfactorssuchasthefollowing:Severity.
WhatisthelikelihoodthatthehazardcouldcauseseriousinjuryordeathFrequency.
HowlikelyisthehazardDoesitoccuroftenBreadth.
Ifthehazardoccurs,aretheconse-quenceslikelytospreadtoaffectagreatnumberofpeople,eitherwithinonefacilityoracrossmanyfacilitiesInsidiousness.
Istheproblemdifculttorec-ognizeCouldtheproblemleadtoacascadeofdownstreamerrorsbeforeitisidentiedorcorrectedProle.
IsthehazardlikelytoreceivesignicantpublicityHasitbeenreportedinthemedia,andisanaffectedhospitallikelytoreceivenegativeattentionHasthehazardbecomeafocusofregulatorybodiesoraccreditingagenciesPreventability.
Canactionsbetakennowtopre-venttheproblemoratleastminimizetherisksWouldraisingawarenessofthehazardhelpreducefutureoccurrencesAnyofthesecriteriacanwarrantincludingatopiconthelist—althoughallselectedhazardsmust,tosomedegree,bepreventable;thatis,mea-suresmustexistthathealthcarefacilitiescantaketoreducetherisks.
ForMoreInformationToaccessthefullarticle,forquestionsaboutECRIInstitute'sannuallistoftechnologyhazards,orforinformationaboutmembership,contactECRIInstitutebytelephoneat(610)825-6000,ext.
5891;bye-mailatclientservices@ecri.
org;orbyfaxat(610)834-1275.
Alsoseetheboxonpage13tolearnmoreaboutECRIInstitute'sproductsandservicesandtondouthowyoucanaccessouronlineself-assessmenttoolforgaugingyourfacility'srisksofexperiencingthehazardonthislist.
3Adaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazards2013ECRIInstituteECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
1.
1.
AlarmHazardsAlarmHazardsMedicaldevicealarmscanmakethedifferencebetweentimely,life-savinginterventionsandseriousinjuryordeath.
Physiologicmonitors,ventilators,infusionpumpsandmanyotherdevicesgenerateclinicalalarmstohelpcare-giverskeeppatientssafe.
However,itispossibletohavetoomuchofagoodthing.
Excessivenumbersofalarms—particularlyalarmsforconditionsthataren'tclinicallysignicantorthatcouldbepreventedfromoccurringintherstplace—canleadtoalarmfatigue,andulti-matelypatientharm.
Thatis:Caregiverscanbecomeoverwhelmed,unabletorespondtoallalarmsortodis-tinguishamongsimultaneouslysoundingalarms.
Theycanbecomedistracted,withalarmsdivertingtheirattentionfromotherimpor-tantpatientcareactivities.
Theycanbecomedesensitized,possi-blymissinganimportantalarmbecausetoomanypreviousalarmsprovedtobeinsignicant.
Beyondalarmfatigue,patientscouldbeputatriskifanalarmdoesnotactivatewhenitshould,ifthealarmsignalisnotsuccessfullycommunicatedtostaffordoesnotincludesuf-cientinformationaboutthealarmcondition,orifthecaregiverwhoreceivesthealarmsig-nalisunabletorespondorisunfamiliarwiththeproperresponseprotocol.
Inshort,anycircumstancethatresultsinthefailureofstaff(1)tobeinformedofavalidalarmconditioninatimelymanneror(2)totakeappropriateactioninresponsetothealarmcanbeconsid-eredaclinicalalarmhazard.
InanApril2013SentinelEventAlert,theJointCommissioncited98alarm-relatedeventsoverathree-and-a-half-yearperiod,with80ofthoseeventsresultingindeathand13inpermanentlossoffunction(www.
jointcommission.
org/sea_issue_50/).
InJune,theorganizationannouncedthatalarmmanagementwouldbeestablishedasaNationalPatientSafetyGoal,withcertainprovisionstakingeffectduring2014.
Addressingclinicalalarmhazardsrequiresacomprehensivealarmmanagementprograminvolvingstakeholdersfromthroughouttheorganization.
Goalsfortheprogramshouldinclude(1)minimizingthenumberofclini-callyinsignicantoravoidablealarmssothattheconditionsthattrulyrequireattentioncanbetterberecognizedand(2)optimizingalarmnoticationandresponseprotocolssothatthepatientreceivestheappropriatecareatthetimeit'sneeded.
FormoreinformationECRIInstituteoffersafree-accessAlarmSafetyResourceSite:https://www.
ecri.
org/Forms/Pages/Alarm_Safety_Resource.
aspx.
AdditionalresourcescanbepurchasedfromECRIInstitute;theseinclude:TheHealthDevicesalarmmanagementseries—acollectionofarticlestohelphealthcarefacilitiesdeveloprealisticallyimplementablestrategiestoreduceclinicalalarmhazards.
*ArecordingofECRIInstitute'swebconference"AnsweringtheCalltoAlarmSafety:GettingReadyforJointCommission'sNationalPatientSafetyGoal";fordetails,see:https://www.
ecri.
org/Conferences/AudioConferences/Pages/Alarm_Safety.
aspx.
*ECRIInstitute'sAlarmManagementStarterKit—asuiteoftoolsforaddressingtheJointCommission'sNationalPatientSafetyGoalonalarmmanagement(availablewithpurchaseofthewebconferencedescribedabove).
*Customized,on-siteassistanceisavail-ablethroughECRIInstitute'sAlarmManagementSafetyReviewservice.
OurAppliedSolutionsGroupcanidentifyyouralarmsystemvulner-abilitiesandproviderealistic,imple-mentablestrategiestohelpimprovealarmmanagementatyourfacility.
*FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
42013ECRIInstituteAdaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazardsECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
2.
2.
InfusionPumpMedicationErrorsInfusionPumpMedicationErrorsInfusionpumpsareinvaluabletohealthcare,deliveringspecieddosesofuidsandmedi-cationdirectlyintoapatient'sbloodstreamoveranextendedperiodoftime.
However,thesedevicesalsorepresentalargetechnol-ogymanagementburden:Ahospitalmayhavehundredsoreventhousandsofthesedevicesinitsinventory,anddevicefailures—orfail-urestousethedevicesproperly—arenotuncommonandcancausesignicantpatientharm.
Patientscanbehighlysensitivetotheamountofmedicationoruidtheyreceivefrominfusionpumps,andsomemedicationsarelife-sustaining—orlife-threateningifadministeredincorrectly.
Tominimizetheriskofuseerrors,werecommendthathealthcarefacilitiesdedicateresourcestoregulartrainingandassessment,bothforroutineusersandincomingstaff,sothatallusersreceiveadequateinstructionandkeeptheirskillsfresh.
Andwhenpurchasingnewpumps,werecommendthatfacilitiesconsiderusabilityissuesandinvolvefrontlinestaffinthedeviceevaluationprocess.
Thesemeasuresareparticularlyrelevantinlightoftherecentchangestotheinfusionpumpmarket,whichhaveresultedinseveralpopularmodelsofpumpsbecomingunavailablebecauseofregulatoryactionsormanufacturermarketingdecisions.
Suchchangesmayleadhealthcarefacilitiestoswitchtounfamiliarbrands.
Anotherimportantconsiderationistorec-ognizethelimitsofsafetytechnologies.
Manypumpstodayareequippedwithonboarddruglibrariesthattriggeralertlimitwarningsforgrossmisprogrammings.
Such"smart"technologiesdoagood(notperfect)jobofhelpingtogetthedosecorrect.
Thisrequires,however,thatappropriatedruglibrariesaredeveloped(andmaintained)andthatstaffusetheavailablesafeguardsappropriately.
Inaddi-tion,thesetechnologiesdon'thelppreventerrorssuchasadministeringanordertothewrongpatientorselectingthewrongdrug.
Infusionpumpintegration—thatis,con-nectingtheserversfortheinfusionpumpswithotherinformationsystems—canprovideadditionalprotections,suchashelpingverifythatboththerightpatientandtherightdrughavebeenselected.
Thus,werecommendthathealthcarefacilitiesbegin(orcontinue)toimplementinfusionpumpintegrationwithrelevantinformationsystems.
FormoreinformationAdditionalresourcescanbepurchasedfromECRIInstitute;theseinclude:NumerousHealthDevicesEvaluationsandGuidanceArticles,aswellasproductalerts,oninfusiontechnologies.
*ArecordingofECRIInstitute'swebconference"BuildingaSafeFrameworkforIntegratedInfusionPumps";fordetails,see:https://www.
ecri.
org/Conferences/AudioConferences/Pages/Integrated-Infusion-Pumps.
aspx.
*ECRIInstitutePSO'sDeepDive:MedicationSafety,publishedinDecember2011;forpurchasedetails,see:https://eshop.
ecri.
org/p-142-pso-deep-dive-medication-safety-events.
aspx.
***FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
**FreetoECRIInstitutePSOmemberorganizations.
5Adaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazards2013ECRIInstituteECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
3.
3.
CTRadiationExposuresinCTRadiationExposuresinPediatricPatientsPediatricPatientsComputedtomography(CT)systemshaveproventobeavaluabletoolfordiagnosingseriousinjuriesandillnesses.
However,thisdiagnosticimagingtechnologyisnotwithoutrisk—especiallytopediatricpatients,whoareinherentlymoresensitivetotheeffectsofion-izingradiationthanareadults.
Whiletheriskhasalwaysbeenhardtoquantify,newlypublishedempiricalstudiesaddtotheevidencethatexposuretoionizingradiationfromdiagnosticimagingatayoungagecanincreaseaperson'sriskofdevelopingcancerlaterinlife.
Asaresult,effortsshouldbemadetominimizeachild'sexposuretohighdosesofionizingradiation.
Practicesthatcanplacechildrenneedlesslyatriskincludetheinappropriateuseofanytechnologythatusesionizingradiation,aswellasthefailuretoproperlycontroltheradia-tiondoseduringsuchprocedures—whichcanoccur,forexample,ifanadultprotocolisusedforpediatricpatients.
However,CTscansareofparticularconcernbecausetheydeliveracomparativelyhighdoseofradiationandarewidelyused.
Tominimizeachild'sexposuretohighdosesofionizingradiation,healthcareprovid-erscantakeactionssuchasthefollowing:Usingsaferdiagnosticoptionswhenappropriate.
Whentimeisnotoftheessenceandthepatient'sconditiondoesnotspecicallynecessitateaCTscan,cliniciansshouldconsiderlower-dosealternativeslikex-rays,ortechnologieslikemagneticresonanceimaging(MRI)orultrasound,whichdon'tuseionizingradia-tion.
(Aradiologistshouldbeconsultedtodeterminethebestoption.
)Avoidingrepeatscanning.
Ifapatienthasalreadybeenscannedatanotherinstitu-tion,thefacilitycantrytoobtaintheexist-ingimagesfromthepreviousscan,ratherthanconductingarepeatscan.
FollowingtheALARAprinciple.
Thatis,usingadosethatis"aslowasreasonablyachievable"toacquirethedesireddiag-nosticinformationduringanyimagingprocedurethatusesionizingradiation.
Inparticular,healthcareprovidersshouldcus-tomizescanningprotocolstotheneedsofpediatricpatients—thatis,recognizethatsettingsdesignedforadultsarenotappro-priateforchildren.
FormoreinformationAdditionalresourcescanbepurchasedfromECRIInstitute;theseincludenumerousHealthDevicesguidancedocumentsrelatedtoCTandradiationsafety.
*Customized,on-siteassistanceisavailablethroughECRIInstitute'sCTRadiationDoseSafetyReviewservice.
OurAppliedSolutionsGroupcanevaluateyourfacility'sCTserviceandrecommendmeasurestohelpyouminimizetherisks.
*FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
62013ECRIInstituteAdaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazardsECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
4.
4.
DataIntegrityFailuresinEHRsDataIntegrityFailuresinEHRsandOtherHealthITSystemsandOtherHealthITSystemsTheadoptionofelectronichealthrecords(EHRs)inU.
S.
hospitalshasmorethantripledfrom2009through2012.
ThisincreasecanbeattributedtothequalityandsafetybenetsthatEHRsareexpectedtooffercomparedwiththeirpaper-basedpredecessors,aswellasthenancialincentives(andpenalties)denedintheHealthInformationTechnologyforEconomicandClinicalHealth(HITECH)Act.
*AstheroleofEHRsandotherIT-basedsystemsinpatientcareincreases,theintegrityofthedatawithin(andpassedamong)thosesystemsbecomesanincreas-inglycriticalpatientsafetyconcern.
Whendesignedandimplementedwell,anEHRorotherIT-basedsystemwillprovidecomplete,current,andaccurateinformationaboutthepatientandthepatient'scaresothatthecliniciancanmakeappropriatetreatmentdecisions.
Thepresenceofincorrectdatainsuchsystems,however,canleadtoincor-recttreatment,potentiallyresultinginpatientharm.
AndreportsillustratemyriadwaysthattheintegrityofthedatainanEHRorotherhealthITsystemcanbecompromised.
Con-tributingfactorsinclude:patient/dataassociationerrors—thatis,onepatient'sdatafromamedicaldeviceorsystemmistakenlybeingassociatedwithanotherpatient'srecord;missingdataordelayeddatadelivery;clocksynchronizationerrors;inappropriateuseofdefaultvalues;useofdualworkows(paperandelectronic);copyingandpastingofolderinformationintoanewreport;andbasicdata-entryerrors(whichcanbepropagatedmuchfurtherthanwouldhaveoccurredwithpaper-basedsystems).
Keystepsinsafeguardingtheintegrityofelectronicpatientdataincludeassessingtheclinicalworkowtounderstandhowthedatais(orwillbe)usedbyfrontlinestaff;testingthesystemandtheassociatedinterfaces(pref-erablyinasimulatedsetting)toverifythatthesystemisfunctioningasintended;provid-ingsufcientusertrainingandsupport;andestablishingamechanismforuserstoreportproblemsastheyarediscovered.
*FromFarzadMostashari'sTestimonybeforetheSubcom-mitteeonOversightandInvestigationsCommitteeonEnergyandCommerce,U.
S.
HouseofRepresentatives.
2013Mar21[cited2013Oct1];seehttp://docs.
house.
gov/meetings/IF/IF02/20130321/100544/HHRG-113-IF02-Wstate-MostashariF-20130321-SD002.
pdf.
FormoreinformationAdditionalresourcescanbepurchasedfromECRIInstitute;theseinclude:NumerousHealthDevicesarticlesonhealthITandinteroperabilitytopics.
*ECRIInstitutePSO'sDeepDive:HealthInformationTechnology,publishedinJanuary2013;forpurchasedetails,see:https://eshop.
ecri.
org/p-140-pso-deep-dive-health-information-technology.
aspx.
**Customized,on-siteassistanceisavail-ablethroughECRIInstitute'sReadinessAssessmentforExchangeofHealthInformationservice.
OurAppliedSolutionsGroupcanhelpyouidentifygapsthatcouldaffecttheexchangeofhealthinformationwithinyourorgani-zationandwithoutsidegroups.
*FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
**FreetoECRIInstitutePSOmemberorganizations.
7Adaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazards2013ECRIInstituteECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
5.
5.
OccupationalRadiationHazardsOccupationalRadiationHazardsinHybridORsinHybridORsTheimplementationofhybridORsisagrowingtrendinhealthcarefacilities.
Theseoperatingsuitesbringadvancedimagingcapabilitiesintothesurgicalenvironmentviabuilt-in,full-scaleangiographysystems,whichcanbeusedtoguidecomplexminimallyinva-siveproceduresthatmayneedtotransitiontoopenprocedures.
However,astheseangiographysystemsareintroducedintotheOR,sotooaretheradia-tionexposurerisksassociatedwiththeuseofionizingradiation.
Patientexposurehazardsareofcourseaconcern.
ButperhapslessobviousaretheriskstoORstaff.
Personnelinradiologydepartmentsandcatheterizationlabs,whereimagingdeviceshavealonghistory,aregenerallywellversedintheoccupationalrisksassociatedwithion-izingradiationandwelleducatedinthesafetyprecautionsthatmustbetaken.
Outsidethosemorecontrolledenvironments,however,theknowledgeoftherisksandtheexperienceinexecutingprecautionsmaybelacking—asituationthatcouldleadtounnecessaryradia-tionexposurestothosecliniciansworkinginahybridORonadailybasis.
IfahybridORistobeimplemented,healthcarefacilitiesmusthaveinplacearadia-tionprotectionprogramthatprovidesstaffwiththeknowledgeandtechnologytheyneedtominimizeoccupationalradiationexposuresinthisuniqueenvironment:Therststepinanyradiationprotectionprogramistraining.
Anappropriatetrain-ingprogramwilladdressthespecicneedsofstaffwhomaynothaveextensiveexpe-riencewithimagingtechnologies.
Thesecondstepisshielding.
Leadapronsaretherstlineofdefenseforallstaffworkinginthevicinityoftheequip-ment.
Shieldingcanalsobeprovidedbyadditionalleadbarriers,suchasthosesuspendedfromtheceiling.
Ineithercase,suchprotectionsareeffectiveonlyiftheyareactuallyused.
Thethirdstepismonitoring.
Effectivemonitoringrequiresthatradiationmoni-toringbadgesbeproperlyworn,main-tained,andreviewed.
(Thesebadgestrackclinicianexposuretoradiationbyprovid-ingacumulativeradiationdosereadingwhenthebadgeislateranalyzed.
)Toaug-menttheuseoftraditionalbadges,facili-tiesmayalsochoosetoinstitutetheuseofelectronicbadgesthatprovidereal-timereadingsofthedoserate.
FormoreinformationECRIInstitute'sinfographic"HybridOperatingRooms:WithaFocusOnEndovascularHybridORs"isavailable,withregistration,from:https://www.
ecri.
org/Forms/Pages/Hybrid-Operat-ing-Rooms.
aspx.
Customized,on-siteassistanceisavail-ablethroughECRIInstitute'sMedicalRadiationSafetyReviewservice.
OurAppliedSolutionsGroupcanassessyourmedicalradiationserviceswiththegoalofreducingthelikelihoodofharmduetounnecessaryandexces-siveradiation.
82013ECRIInstituteAdaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazardsECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
6.
6.
InadequateReprocessingofInadequateReprocessingofEndoscopesandSurgicalEndoscopesandSurgicalInstrumentsInstrumentsEveryday,healthcarefacilitiescleananddisinfect(orsterilize)thousandsofreus-ablesurgicalinstrumentsanddevicessothattheycanbeusedforsubsequentprocedures.
Whenperformedproperly,thisreprocessingremovesresidueandpotentiallyinfectiousmaterials(e.
g.
,tissue,bodyuids)anddisin-fectsorsterilizestheinstrumentsothatitcanbesafelyusedonthenextpatient.
Whenreprocessingisnotperformedprop-erly,however,patientcross-contaminationispossible,potentiallyleadingtothetrans-missionofinfectiousagentsandthespreadofdiseasessuchashepatitisC,HIV,andtuberculosis.
Discussionsofreprocessingfailuresfre-quentlycenteronexibleendoscopes,devicesthatcanbeguidedthroughnarrowwindingroutes,suchasthedigestivetract,respiratorytract,andbloodvessels,toallowphysicianstoviewandaccessinternalbodystructureslessinvasivelythanwouldotherwisebepossible.
Becauseexibleendoscopesarecomplexdeviceswithnarrow,hard-to-cleanchan-nels,theycanbeparticularlychallengingtodecontaminate.
However,endoscopesarenottheonlydevicessubjecttoreprocessingfailures.
IncidentsreportedtoECRIInstitutePSOdescribeotherinstrumentsanddevices(e.
g.
,arthroscopyshouldercannulas,surgicalinstru-menttrays)thatwereused,orwerepresentedforuse,despitestillbeingcontaminatedwithpotentiallyinfectiousbiologicalmatter.
Successfulreprocessingofanydevicerequiresconsistentadherencetoamultistepprocedure.
Failuretoproperlyperformanystep,includingsomenecessarymanualtasks,couldcompromisetheintegrityoftheprocessandleadtosignicantpatientharm.
Further,incidentsinvolvingimproperlyreprocessedinstrumentscandamageanorganization'sreputation,reducepatientsatisfaction,promptreviewbyaccreditingagencies,andleadtocitationsandnesfromregulatorybodiesorlawsuitsfrompatients.
Consistent,effectivereprocessingofendoscopesandotherinstrumentsrequiresthatappropriatereprocessingprotocolsbedeveloped,documented,andfollowedforallrelevantinstrumentmodelsinafacility'sinventory.
Staffneedtobetrainedintheseprotocols,andtheyneedadequatespace,equipment,andinstructionalmaterials,aswellassufcienttimetoperformtheprocedurecorrectly.
FormoreinformationAdditionalresourcescanbepurchasedfromECRIInstitute;theseinclude:TheHealthDevicesGuidanceArticle"ClearChannels:EnsuringEffectiveEndoscopeReprocessing.
"*ECRIInstitutePSO'sarticle"SterileProcessingDepartment'sRoleinPatientSafety.
"***FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
**FreetoECRIInstitutePSOmemberorganizations.
9Adaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazards2013ECRIInstituteECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
7.
7.
NeglectingChangeManagementNeglectingChangeManagementforNetworkedDevicesandforNetworkedDevicesandSystemsSystemsThegrowinginterrelationshipbetweenmedicaltechnologyandITofferssignicantbenets.
However,oneunderappreciatedconsequenceofsysteminteroperabilityisthatupdates,upgrades,ormodicationsmadetoonedeviceorsystemcanhaveunintendedeffectsonotherconnecteddevicesorsystems.
ECRIInstituteisawareofincidentsinwhichplannedandproactivechangestoonedeviceorsystem—relating,forexample,toupgradingsoftwareandsystems,improvingwirelessnetworks,oraddressingcybersecu-ritythreats—haveadverselyaffectedothernetworkedmedicaldevicesandsystems.
Forexample:Afacility-widePCoperatingsystemupgradecausedthelossofremote-displaycapabilityforahospital'sfetalmonitoringdevices.
Movingafacility'sobstetricaldatamanage-mentsystemserveroff-siteledtoprob-lemsdisplayingfetalmonitordataatthenurses'station.
AnEHRsoftwareupgraderesultedinchangestocertainradiologyreports,caus-ingeldsforthedateandtimeofthestudytodropfromthelegalrecord.
Topreventsuchdownstreameffects,alterationstoanetworkorsystemmustbeperformedinacontrolledmannerandwiththefullknowledgeofthepersonnelwhomanageorusetheconnectedsystems.
Initia-tivesthatoncemayhavebeenconsidered"ITprojects"mustinsteadbeviewedas"clinicalprojectsthatrequireITexpertise.
"Softwareupgrades,securitypatches,servermodica-tions,changestoorreplacementofnetworkhardware,andothersystemchangescanadverselyaffectpatientcareifnotimple-mentedinawaythataccommodatesbothITandmedicaltechnologyneeds.
Unfortunately,changemanagement—astructuredapproachforcompletingsuchalterations—appearstobeanunderutilizedpractice.
Appropriatechangemanagementpoliciesandprocedures,asoutlinedintherecommen-dationsinthefullarticle,canhelpminimizetherisks.
Justasimportant,however,istocultivateanenvironmentinwhichIT,clinicalengineering,andnursing/medicalpersonnel(1)areawareofhowtheirworkaffectsotheroperations,patientcare,andworkprocesses—particularlyclinicalworkprocesses—and(2)areabletoworktogethertopreventIT-relatedchangesfromadverselyaffectingnetworkedmedicaldevicesandsystems.
FormoreinformationAdditionalresourcescanbepurchasedfromECRIInstitute;theseinclude:NumerousHealthDevicesarticlesonhealthIT,medicalandinformationtechnologyconvergence,andinteroperabilitytopics.
*ECRIInstitutePSO'sDeepDive:HealthInformationTechnology,publishedinJanuary2013;forpurchasedetails,see:https://eshop.
ecri.
org/p-140-pso-deep-dive-health-information-technology.
aspx.
**TheRiskManagementReporterarticle"RiskManagers'10StrategiesforHealthITSuccess";freelyavailableforalimitedtimeat:https://www.
ecri.
org/EmailResources/PSRQ/RMRep0613-HIT.
pdf.
*FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
**FreetoECRIInstitutePSOmemberorganizations.
102013ECRIInstituteAdaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazardsECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
8.
8.
RiskstoPediatricPatientsfromRiskstoPediatricPatientsfrom"Adult"Technologies"Adult"TechnologiesHealthcaretechnologiesareoftendevelopedwiththeneedsofadultpatientsinmind,leavingclinicianswithlittlechoicebuttorelyon"adult"technologiesinthediagnosisandtreatmentofpediatricpatients.
Butduetotheirsmallersizeandongoingphysiologicchanges,childrenmaysufferadverseeffectswhensubjectedtoadult-orientedhealthcaretechniques.
Thefollowingarejustafewexamplesofhowthecareofpediatricpatientscanbecom-promisedwhenapplying"adult"healthcaretechnologies:Exposuretoionizingradiation,suchasthatusedinCTandx-rayimaging,hasbeenassociatedwithanincreasedcancerrisk.
Becausechildrenarestilldeveloping,theyareespeciallysusceptibletolong-termdamagefromsuchexposures.
Usingadultscanningtechniquesonpediatricpatientscancompoundthisproblem,exposingchildrentoanunnecessarilylarge"adult"doseandpotentiallyexposingregionsofthebodyoutsidetheareaofinterest.
Wecoverthistopicashazardnumber3inthisyear'slist.
Ahealthcarefacility'sEHRmaynotbeconguredtooptimallysupportthecareofchildren.
Forexample,thesystemmaynotfacilitatetherecordingandreviewofimportantpediatric-specicdata,suchasvaccinations.
Medicationdosingerrorscanbeparticu-larlyharmfultochildrenbecauseofthepatient'ssmallsize.
Thissusceptibilitytoharm,coupledwiththeuseoftechnolo-giesthataren'toptimizedforpediatricpatients,canleadtotragicresults.
Evenadeviceassimpleasascalecancontrib-utetosignicantharm:scalesthatreportweightsinbothkilogramsandpoundshavecontributedtoerrorsinwhichtheincor-rectgurewasusedforweight-baseddosecalculations(e.
g.
,thepoundsvaluehadbeenmistakenlyrecordedintheEHRasthekilogramvalue).
Wheneverpossible,healthcareprovidersshouldusepediatric-specictechnologies,ratherthanusingadult-orientedtechnologyoff-labeloremployingworkarounds.
Unfor-tunately,pediatric-specicdevicescanbeslowtoreachthemarketbecauseofthesmallnum-bersofpatientsavailabletostudy,thedevices'high-risknature,andhighdevelopmentcosts.
Thus,healthcareprovidersareoftenputinthepositionofhavingtouseatechnologydesignedforadultstodiagnoseortreatcondi-tionsinchildren.
Healthcarepersonnelmustexerciseparticularcarewhenthisisnecessary.
11Adaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazards2013ECRIInstituteECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
9.
9.
RoboticSurgeryComplicationsRoboticSurgeryComplicationsduetoInsufficientTrainingduetoInsufficientTrainingRobot-assistedsurgeryinvolvestheuseofroboticarmsthatarefullycontrolledbythemovementsofasurgeon,whoislocatedatacontrolconsoleseveralfeetfromthepatient.
Thepastdecadehasseenariseintheimple-mentationofsuchsystemstoreplaceopensurgeryandtraditionalminimallyinvasivesur-gery(MIS)techniquesforcertainprocedures.
Thepastyear,however,hasseenariseinthenumberofmediareportsthatarecriti-calofrobot-assistedsurgery.
Someofthereports,whichdescribecomplicationsthatindividualpatientshaveexperienced,sug-gestthatroboticsystemsarebeingusedforagreaternumberofcasesorforadditionalkindsofprocedureswithoutadequatecon-siderationofthesurgicalteam'sprociencyinusingthesystemfortheproceduresperformed.
Thesereportsdon'tspeaktotheefcacyofrobot-assistedsurgery:Thearticlesdonotmeetthestandardsofevidence-basedresearchstudies,andproponentsofthesesys-temscanpointtomanysuccessfuloutcomes.
However,thereportsdodrawattentiontothecriticalneedforappropriatetraining,detailedcredentialing,andongoingsurgicalteamcom-petencyassessmentstominimizepatientrisk.
Initialtrainingprovidedbythedevicesup-pliercanhelpusersbecomefamiliarwiththesystem,butitdoesnotteachtraineeshowtoperformspecicsurgicalprocedures.
Thus,itisuptothehospitaltoverifythatsurgicalstaffhavethenecessaryprocedure-specicskills.
Forthistohappen,surgeonsandstaffwillneedtocompleteamultifaceted,detailedtrainingprogramtodevelopprociencyandexpertisewithamultipurposeroboticsurgerysystem.
Theprogramshouldrequirethataspeciednumberofproctoredsurgeriesbeperformed,andsuccessfulcompletionoftheprogramshouldleadtocredentialingwithinthehospital/system.
Considerationmustalsobegiventohowthesurgicalteamwillmain-tainitscompetencywiththesystemovertime.
Currently,nowidelyrecognizedrequire-mentsexistforroboticsurgerytrainingandcredentialingprograms,sohospitalswillneedtomaketheirowndecisions.
Inthefullarticle,wepresentrecommendationsthatarebasedontheexperiencesofwell-establishedroboticsurgeryprogramstohelphospitalsthatneedtodevelopaprogram.
FormoreinformationAdditionalresourcescanbepurchasedfromECRIInstitute;theseinclude:TheHealthDevicesGuidanceArticle"DaVinciDecisions:FactorstoConsiderBeforeMovingForwardwithRoboticSurgery.
"*ArecordingofECRIInstitute'swebconference"TheSurgicalRobotInvasion:TrainingandSafety,"aswellastrainingandcredentialingguidessharedbythewebconferenceparticipants;fordetails,see:https://www.
ecri.
org/Conferences/AudioConferences/Pages/Surgical-Robots.
aspx.
**FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
122013ECRIInstituteAdaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazardsECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
10.
10.
RetainedDevicesandRetainedDevicesandUnretrievedFragmentsUnretrievedFragmentsTheunintendedretentionofasurgicaliteminapatientaftersurgeryorafteraninter-ventionaldiagnosticprocedureisthekindofmedicalerrorthatcanlargelybeprevented.
Buteventsthatshouldn'thappensometimesdo.
Forexample:Inthelastfouryearsalone,ECRIInstitute'sAccidentandForensicInvestigationGrouphasinvestigatednineretainedsurgicalitem(RSI)incidents.
A2012analysisofthePennsylvaniaPatientSafetyReportingSystemdata-baseshowedthathealthcarefacilitiesinthecommonwealthreported452eventsinvolvingRSIsin2011—one-thirdofthoseeventsreportedlycausedpatientharm(http://patientsafetyauthority.
org/ADVISORIES/AdvisoryLibrary/2012/Sep;9(3)/Pages/106.
aspx).
InOctober2013,theJointCommissionissuedaSentinelEventAlertontheunin-tendedretentionofforeignobjects,notingthat772suchincidentswerereportedtoitsSentinelEventDatabasefrom2005to2012,including16thatresultedindeath.
Thesereportshavepromptedustoagainincludethetopiconourlist.
(Itlastappearedonourlistfor2010.
)Inadditiontobeingapatientsafetyconcern,RSIsareclassiedbytheCentersforMedicare&MedicaidServices(CMS)asahospital-acquiredcondition;thus,CMSwithholdspaymentforthetreatmentofthiscondition.
Reportsofsurgicalitemsunintentionallyleftinsidepatientsfollowingsurgeryoraninterventionaldiagnosticproceduretypicallyinvolveoneofthefollowing:Aretaineddevice,inwhichanentiredevice(includingsoftgoodslikeasurgicalspongeortowel)isunknowinglyleftbehind.
Unretrieveddevicefragments,inwhichaportionofadevice(e.
g.
,cathetertip,for-cepsjaw)breaksawayandremainsinsidethepatient.
(Cliniciansmaybeawarethatadevicefragmenthasbeenleftinthepatient,butdecidethatthefragment'sloca-tionwithintheanatomymakesretrievaltoorisky.
)Riskstothepatientcanincludeprolongedoradditionalsurgery,aswouldoccurwhenanRSIisdiscoveredanditsremovalisdeemedappropriate,orfuturecomplications,somepotentiallyserious,ascouldoccurwhenanRSIleadstoinfectionorcausesdamagetothesurroundingtissue.
VisuallyinspectingdevicesbeforeandafteruseandadheringtoacceptedsurgicalcountproceduresarekeymeasuresforpreventingRSIincidents.
FormoreinformationAdditionalresourcescanbepurchasedfromECRIInstitute;theseinclude:TheHealthDevicesEvaluation"Radio-FrequencySurgicalSpongeDetection.
"*ECRIInstitutePSOPatientSafetyE-lertsonretainedforeignobjectsduringroboticsurgery(2012May31)andretainedguidewires(2010Aug31).
**TheRiskManagementReporterarticle"TheCaseoftheMissingSponge:PracticeVariationIstheCulprit.
"****FreetomembersoftheHealthDevicesSystem,HealthDevicesGold,andSELECTplusprograms.
**FreetoECRIInstitutePSOmemberorganizations.
***FreetomembersoftheHealthcareRiskControlprogram.
13Adaptedfrom:HealthDevicesNovember2013www.
ecri.
org/2014hazards2013ECRIInstituteECRIInstituteencouragesthedisseminationoftheregistrationhyperlinktoaccessadownloadofthisreport,butprohibitsthedirectdissemination,posting,orrepublishingofthiswork,withoutpriorwrittenpermission.
KEYSAFETYRESOURCESFROMECRIINSTITUTEECRIInstituteisanindependent,nonprofitorganizationthatresearch-esthebestapproachestoimprovingthesafety,quality,andcost-effectivenessofpatientcare.
Ourunbiased,evidence-basedhealthcareresearch,information,andadvicehelpshealthcareorganizations:Assessandaddresspatientsafety,quality,andriskmanagementchallengesSelectthesafest,mosteffectivemedicaldevices,procedures,anddrugsProcurehealthcaretechnologyinthemostcost-effectivemannerDevelopevidence-basedhealthcoveragepoliciesAligncapitalinvestmentswithstrategictechnologyneedsFollowingareafewoftheproductsandservicesweoffertohelphealthcareorganizationsaddressthekindsofhealthtechnologyhazardsdescribedinthisreport.
OnlineHazardSelf-AssessmentToolAsacomplementtothisreport,ECRIInstitutehasdevelopedanon-lineHealthTechnologyHazardSelf-AssessmentTooltohelphealth-carefacilitiesgaugetheirrisksofexperiencinganyofthehazardsonthelist.
TheSelf-AssessmentToolenablesuserstoinvitemultipleindividualsanddepartmentstorespondtoashortsurveyonanyofthehazardtopics;oncethesurveysarecompleted,thetoolgeneratesareportratingyourlevelofriskforeachhazard(fromlowtohigh)andidentifyingspecificpracticesthatcouldhelpreduceyourrisk.
MembersofseveralECRIInstituteprogramscanaccesstheHealthTechnologyHazardSelf-AssessmentToolfromtheirmemberhomepageatwww.
ecri.
org.
Ifyouarenotamemberandwouldliketolearnmoreaboutusingthetool,seethecontactinformationbelow.
TechnologyManagementServicesMorein-depthinformationonawiderangeofmedicaltechnologyissuesisavailablethroughprogramssuchasthefollowing:TheHealthDevicesprogramisbestknownforitscomparative,brand-nameevaluationsofmedicaldevicesandsystems.
Basedonextensivelaboratorytesting,ECRIInstitute'sevaluationsfocusonthesafety,performance,efficacy,andhumanfactorsdesignofspecificmedicaldevicesandtechnologies.
SELECTplus,ECRIInstitute'sindustry-leadingadvisoryserviceforsupplychainandmaterialsmanagementprofessionals,assistswiththesafe,cost-effectiveprocurementofcapitalmedicalequipmentandhealthinformationtechnologies.
Inaddition,ECRIInstitute'sAppliedSolutionsGroupprovidescustomizedservicesandon-siteassistancetohelphealthcarefacili-tiesandhealthsystemsaddresschallengesrangingfrommanagingmedicalequipmentneedsforamajorconstructionprojecttoidentify-ingandaddressingpatientsafetyvulnerabilities.
PatientSafety,Quality,andRiskManagementECRIInstitutealsooffersavarietyofprogramsdesignedtomeettheneedsofpatientsafety,quality,andriskmanagementprofessionals;theseinclude:ECRIInstitutePSO,acomponentofECRIInstitutededicatedtocollectingandanalyzingpatientsafetyinformationandsharinglessonslearnedandbestpractices,operatesunderthePatientSafetyandQualityImprovementAct.
ThisactcreatedaframeworkforhealthcareproviderstosharedatawithPSOs,whointurncanprovideanalysisandfeedbackregardingpatientsafetymattersinaprotectedlegalenvironment.
Additionally,PSOscancollecttheinformationinastandardizedformatinordertoaggregatethedataandlearnfromit.
ForinformationaboutbecominganECRIInstitutePSOmemberorganization,refertowww.
ecri.
org/pso.
HealthcareRiskControl(HRC)isamembershipprogramprovidingaccesstoawealthofpracticalresources,includingmorethan300unbiased,in-depthriskanalyses;dozensofself-assessmenttools;morethan500policiesandproceduresthatcanbetailoredtoyourneeds;ready-to-useeducationandtrainingtools;standardsandbestpractices;andbimonthlyandonlinenewsletters.
ToLearnMoreThisexecutivebriefingofECRIInstitute'sannualTop10listofhealthtechnologyhazardsisprovidedasacourtesyofECRIInstitute.
Amorecomprehensivediscussionofeachhazard,additionalrecom-mendationsforminimizingtherisks,andalistofusefulresourcesformoreinformationabouteachtopicareprovidedintheNovember2013issueofHealthDevices,availableforpurchaseatadiscountedrateathttps://eshop.
ecri.
org/p-160-health-devices-journal-novem-ber-2013.
aspx.
Formoreinformationaboutthisreport,theself-assessmenttool,oranyofourmembershipprograms,contactECRIInstitutebytele-phoneat(610)825-6000,ext.
5891;bye-mailatclientservices@ecri.
org;orbyfaxat(610)834-1275.
Youcanalsovisitusonlineatwww.
ecri.
org.
Alarmeventsareaccidentswaitingtohappen—theresultofaperfectstorminanerror-pronesystem.
Patientdeathsandotheralarm-relatedeventsplaguehospitalsandmakethenews.
And,theypersistonECRIInstitute'sannuallistofTop10HealthTechnologyHazards.
ECRIInstitute'sAlarmManagementSafetyReviewscanhelp.
Ourexperiencedhealthcareconsultantscomeonsitetoassessyourorganization'sculture,infrastructure,practices,andtechnology.
Ourapproachidentifiesandaddressesyourpatientsafetyvulnerabilitiesandprovidesimplementablealarmmanagementstrategies.
XDon'twaitforaperfectstorm.
Takestepsnowtoimprovealarmsafety.
Visitwww.
ecri.
org/alarmsafetyMS12071UNITEDSTATES5200ButlerPike,PlymouthMeeting,PA19462-1298,USATelephone+1(610)825-6000Fax+1(610)834-1275EUROPESuite104,29BroadwaterRoadWelwynGardenCity,Hertfordshire,AL73BQ,UKTelephone+44(1707)871511Fax+44(1707)393138ASIAPACIFIC11-3-10,Jalan3/109F,DanauBusinessCentre,TamanDanauDesa,58100KualaLumpur,MalaysiaTelephone+60379881919Fax+60379881170MIDDLEEASTOfficeNo.
1101,11thFloor,AlShafarTower1,TECOMP.
O.
Box128740Dubai,UnitedArabEmiratesTelephone+97143638335Fax+97143637364OBJECTIVESOFTHEHEALTHDEVICESSYSTEMToimprovetheeffectiveness,safety,andeconomyofhealthservicesby:Providingindependent,objectivejudgmentforselecting,purchasing,managing,andusingmedicaldevices,equipment,andsystems.
Functioningasaninformationclearinghouseforhazardsanddeficienciesinmedicaldevices.
Encouragingtheimprovementofmedicaldevicesthroughaninformedmarketplace.