設(shè)備管理指南Guideline-Medical Equipment Management

MedicalEquipmentManagement

Contents

Introduction 1

Objectives 1

EquipmentSelectionandPurchase/Acquisition 1

EquipmentManagement 3

InventoryManagementandDocumentation 4

EvaluationofEquipment 5

Testing 5

MaintenanceandUsage 6

EducationandTraining 7

IncidentResponseProcedure 7

EquipmentRecalls 8

Documentation 9

OnsiteLaboratory,Anesthesia,Sterilization,DialysisorRadiology

Services 10

Patient-SuppliedMedicalEquipment 11

Conclusion 12

Resources 13

Endnotes 13

AppendixA.SampleEquipmentInventory/TrackingLog 14

AppendixB.SampleLogofPreventiveMaintenanceandRepairs 15

Guideline:MedicalEquipmentManagement1

Introduction

Medicalequipmentplaysavitalroleinhealthcare;however,whenequipmentisnotproperlyusedormaintained,italsocancauseharm.Inmanyinstances,patientinjuriesoccurbecauseofassumptionsaboutwhomayuse,calibrate,modify,orrepairequipment.

Injuriesfrommedicalequipmentalsomightarisefromtraininggapsthatdon’taddresspre-usetesting,preventivemaintenance,malfunctionreports(andincidentreports),andrepairprocedures.

Acommitmenttosafetyisanessentialelementofanyprocessrelatedtotheuseofmedicalequipment—whetherthemedicalequipmentispurchased,rented,borrowed,orleased.

Objectives

Theobjectivesofthisguidelineareto:

?Reviewduediligenceconsiderationsforselectingandacquiringmedicaldevicesandequipment

?Definekeyaspectsofanequipmentmanagementprogramandofferriskstrategiestoconsiderwhendevelopingsuchaprogram

?Discussthenecessarycomponentsofawell-definedincidentresponseprocedure

?Offerguidancerelatedtorespondingtoequipmentrecallsanddocumentingessentialinformationaboutmedicaldevicesandequipment

?Providegeneralrecommendationsformanagingrisksassociatedwiththeoperationofonsitelaboratoryandradiologyequipment

?Reviewproactivestrategiesforaddressingpatient-suppliedmedicalequipment.

EquipmentSelectionandAcquisition

Theselectionofmedicalequipmentshouldnotbebasedonhastyorinsufficientdecision-making.Eachhealthcareorganization(e.g.,practices,hospitals,clinics,andlargehealth

systems)shouldformallyestablishateamthatisresponsibleforresearchingandrecommendingmedicalequipment.

Guideline:MedicalEquipmentManagement2

Oncerecommendationsaremade,prospectiveequipmentshouldbethoroughlyreviewedinacollaborativeeffortbyendusers—especiallyifitwillbeusedinthedirectdiagnosis,

treatment,orcareofpatients.Duediligencewhenselectingmedicalequipmentmightinclude:

?Aliteraturereview

?Consultationwithexperts

?Considerationofwhethertocontracttheservicesofabiomedicalengineeringcompany

?Requestsfordataandresearchresultsfromclinicaltrials

?Discussionswithotherhealthcareproviderswhousethesameequipment(follow-upofreferences)

?Areviewofthehistoryandfiscalstandingofpotentialvendors

Themedicalequipmentselectionprocessalsoshouldincludeaformalassessmentoftheanticipatedrisksandbenefitsassociatedwiththeequipment.Forexample,considerthefollowingquestions:

?Istheuseoftheequipmentconsistentwithyourhealthcareorganization’smissionandethicalpoliciesandprocedures?

?Doestheequipmentornewtechnologyreducetheriskofinjurytopatientsorstaffmemberswhomayberequiredtouseit(e.g.,exposuretolowerlevelsofradiation,latex,ormercury)?

?Dohealthbenefitsand/ortime-savingsforpatients,healthcareproviders,andstaffoutweighthecostassociatedwiththeequipment?

?Willtheequipmentrequireanycostlysoftwareupgrades?Canthemanufacturersupplyascheduleofupgrades?

?Willchargestothepatientthatareassociatedwiththisequipmentremainconsistentwithsimilarcommunitypricing?

Guideline:MedicalEquipmentManagement3

?Aretheproceduresforwhichtheequipmentisusedbillable?Doesyourelectronichealthrecord(EHR)systemorbillingsystemneedtobemodifiedtobillfortheseservices?

?Whatisthecommunitystandard?Aremarketpressuresinfluencingthedecisiontopurchasenewequipment(e.g.,“ourcompetitionoffersit”or“wedon’twanttobeleftbehind”)?

?Dostaffandprovidersneedtobeawareofanyregulatoryrequirementsrelatedtotheequipment(e.g.,onlylicensedindependentpractitionerscanoperatetheequipment,environmentalsafetyrequirements,etc.)?

?Areyouabletointegratedirectpatientcareequipment(e.g.,bloodpressuremonitorsandlaboratoryequipment)withyourEHR(ifappropriate)?Ifnot,whatadditional

resourceswouldberequiredtodoso?

?Doesthenewequipmentrequireadditionalsuppliesormaterialstouseormaintainit?Ifso,whataretheavailabilityandcostsoftheseitems?

?Isvendorsupportorothertechnicalsupportformaintenanceavailable?

?Haveyouconsideredthepurchase/leaserequirementsandoptions(e.g.,warranties,volumepurchasing,trade-inprograms,upgrades,indemnificationforinjuries/failures,contractterms,newversusused/refurbishedequipment,etc.)?

?Whatarethetrainingandongoingcompetencyconsiderations?

Theanswerstothesequestionsandtherationaleforpurchasingtheequipmentshouldbedocumentedandsavedforfuturereference.

EquipmentManagement

Apatientinjurycausedbyamedicaldeviceorpieceofmedicalequipmentmaytriggera

claimagainstapractitioner,healthcareorganization,and/oranequipmentmanufacturer.Toreducepatientsafetyandliabilityrisksassociatedwithmedicaldevicesandequipment,

healthcareorganizationsshouldhaveeffectiveprogramsformanagingequipmentusedinpatientcare.

Guideline:MedicalEquipmentManagement4

Considerationswhendevelopinganequipmentmanagementprogramincludeinventory

managementanddocumentation;evaluationofequipment;testing;maintenanceandusage;andeducationandtraining.

RiskTip

InventoryManagementandDocumentation

Afirststepindesigninganeffectiveequipment

Ifanorganizationoptstousea

biomedicalengineeringcontractor’sequipmentmanagementplan,

designatedpersonnelatthefacilityshouldreviewandadoptthatplan.

Languageintheplanshould

specificallyrefertotheorganization;itshouldnotbeaboilerplateplan

thatfailstointegrateservicesandresponsibilitiesbetweenthe

organizationandthecontractor.

managementprogramisdocumentingwhat

equipmentyouhave.Eachhealthcareorganizationshould:

?Maintainaninventoryofallmedical

equipment,whetheritisleasedorownedandwhetheritismaintainedaccordingto

manufacturerrecommendationsoran

alternativeequipmentmaintenance(AEM)program.

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?Includeaspartoftheinventoryarecordof

maintenanceactivities.(SeeAppendixAand

AppendixBforsampletrackingandmaintenance/repairlogs.)

?EnsurethatequipmentmanagedthroughanAEMprogramisclearlyidentifiableas

subjecttoAEM.Further,criticalequipment,whethersubjecttoAEMornot,mustbereadilyidentifiedassuch.

?Documentthefollowinginformationforallequipmentincludedintheinventory:

Uniqueidentificationnumber

Equipmentmanufacturer

Modelnumberandserialnumber

Descriptionoftheequipment

Locationoftheequipment(forequipmentgenerallykeptinafixedlocation)

Identityofthedepartmentconsideredto“own”theequipment

Guideline:MedicalEquipmentManagement5

EvaluationofEquipment

Inadditiontohavingawritteninventoryofmedicalequipment,healthcareprovidersandstaff

shouldunderstandthepurposeofeachpieceofequipment.Aspartoftheequipmentmanagementprogram,eachorganizationshould:

?Evaluateeachpieceofequipmenttodetermine:

Functionandclinicalapplication

Preventivemaintenancerequirementsandexpectedlifespan

Likelihoodofequipmentfailure;check

U.S.FoodandDrugAdministration(FDA)

reports,

consumerreviews,andliteraturereviews.

Compatibilitywithotherequipmentusedatthefacility

Spaceallocationforequipmentandsupplies

?Oncetheequipmenthasbeenevaluated,assigneachitematierlevel(1,2,or3)basedonhowcriticalitsfunctionistothepracticeorpatient.

Tier1isforthemostcriticalequipment,suchaslifesupportandemergencydevices(e.g.,anautomaticexternaldefibrillator).

Tier2isforcommonuseequipment,suchasbloodpressuremonitorsandheattherapyunits.

Tier3isforequipmentthathaslittletonorisk,suchasapatientscale.

Testing

Testingmedicalequipmentisanessentialelementofanequipmentmanagementprogramandvitalforpatientandstaffsafety.Eachorganizationshould:

?Testequipmentbasedonmanufacturerrecommendationsorthetierlevelassigned(whicheverismostfrequent):

EquipmentinTier1shouldbetestedonatleastasemi-annualbasis.

EquipmentinTier2shouldbetestedonatleastanannualbasis.

EquipmentinTier3mayonlyneedtobevisuallyinspectedonanannualbasis.

Guideline:MedicalEquipmentManagement6

?Ensurethatqualifiedpersonnelinspect,test,andmaintainallmedicalequipment(diagnostic,therapeutic,lifesupport,andmonitoring).

?Considercontractingtheservicesofanapprovedbiomedicalengineeringcompanytoassistwithequipmenttestingandmaintenance.

MaintenanceandUsage

Eachorganization’sequipmentmanagementprogramshouldincludeguidancerelatedtomaintainingandusingmedicalequipment.Forexample:

?Maintainanduseallequipmentaccordingtomanufacturers’recommendationsoraspecifiedAEMprogram.Documentallinspections,testing,preventivemaintenance,andrepairs—andincludetelephonenumbersfortheequipmentvendors.

?Ensuremaintenanceprocessesincludespecificaccountabilityandschedulesforpreventivemaintenanceandtesting.

?Aspartofmaintenanceguidance,includespecificinformationabout(a)disinfectingall

reusableequipmentaccordingto

FDAguidelines

and

CDCguidelines,

and(b)documentingequipmentdisinfectionprocesses.

?Developaplanformonitoringandupdatingsoftwareonmedicaldevices.Workcloselywiththeorganization’sinformationtechnologyteamtoresearchupdatesand

implementappropriatestrategies.

?Developacompetencyprocessforusingequipment.Makesuretheprocesstakesintoaccountjobdescriptionsandtraining(externalandin-service).

?Determinethehealthcareorganization’spointofcontactforreportinganyequipmentmalfunctionsorincidentsthatcouldcausepatientinjuries.

?Ensurestaffmemberswhoareresponsibleforaddressingreportsofequipment

malfunctionsorincidentsknowtheirresponsibilitiesandtimeframesfortakingaction.

?Neveruseapieceofmedicalequipmentthatshowssignsofdamageorhasbeen

partiallyrepairedorotherwisealteredfromitsoriginalconditionbynonqualifiedstaffmembers.

Guideline:MedicalEquipmentManagement7

EducationandTraining

Healthcareprovidersandstaffcannotbeexpectedtoproperlyuseandmaintainmedical

equipmentunlesstheyreceiveappropriateeducationandtraining.Eachorganizationshould:

?Provideallstaffmembers(includingtemporarystaff)withinitialtrainingandongoingannualtrainingonmedicalequipmentprocedures.Trainingshouldaddress:

Howtoreportapieceofmedicalequipmentthatisnotfunctioningproperly,whichcanincludevisualclueslikesmoking,sparking,ordisplayerrors.

Howtoremovethepieceofmedicalequipmentfromservice,tag-outthedevice,andnotifytheappropriaterepairserviceorbiomedicalengineeringcontractorforrepairs.

?Trainappropriatestaffonhowtoproperlysetup,use,calibrate,andcleanequipment.Ifastaffpersonhasnotbeentrained,orisnotappropriatelylicensed/certified,heorsheshouldnotbeallowedtousetheequipment.

?Educatestaffaboutback-upplansforwhenapieceofequipmentneedstobeservicedorrepaired.

?Providetimelytrainingandeducationforanyneworupdatedequipmentpriortoputtingtheequipmentintouse.

?Documentallequipmenttrainingandcompetencyforbothprovidersandstaffineachindividual’spersonnelfile.

IncidentResponseProcedure

Intheeventthatapieceofequipmentormedicaldevicecausespatientinjuryorharm,eachhealthcareorganizationshouldhaveawell-definedincidentresponseprocedure.Aspartofthisprocedure,appropriatestaffmembersshould:

?Stabilizethepatient.

?Removefromserviceandsecureanyequipmentinvolvedintheincident.

?Completeanincidentreportperorganizationalpolicy.

Guideline:MedicalEquipmentManagement8

RiskTip

Equipmentthathascausedaninjuryshouldneverbereturnedtothe

manufacturer.Additionally,a

manufacturer’srepresentative

shouldnotbeallowedtoexamineorattempttorepairtheequipment.

Theequipmentshouldbe

sequestered,renderedinoperable(locked,etc.),andexaminedbyacompanythatspecializesin

independenttestingofequipment.

?ReporttheincidentasrequiredbytheSafeMedicalDevicesAct(SMDA).

Adesignatedstaffmembershould

completetherequiredformand

forwardit(oranelectronicequivalent)totheappropriatepartyasrequiredbylaw.

Ifanincidentresultsindeath,itshouldbe

reportedtotheFDA

andthe

equipment/devicemanufacturer.

Seriousinjuries/illnessesshouldbe

reporteddirectlytothemanufacturer.Ifthemanufacturerisnotknown,the

userorganizationshouldreportdirectlytotheFDA.

?Notifytheorganization’sprofessionalliabilityclaimsspecialistimmediately(he/shewilladviseyouif/whenyoushouldreleasetheequipment).

EquipmentRecalls

Ifahealthcareorganizationorabiomedicalengineeringcontractorreceivesarecallorhazardnoticefromamanufacturerordistributor,theorganizationisresponsiblefortaking

RiskTip

appropriateaction,asoutlinedinthenotification.

Toensureaccountability,healthcare

organizationsshouldconsiderassigningonepersonwithintheorganizationtheresponsibilityofreceivingandmanagingequipmentrecallsandalerts.

Ifthenotificationdoesnotclearlystatewhat

stepstotake,adesignatedstaffmembershouldcontacttheentitythatissuedtherecall/hazardnotificationforguidance.Untiltheprocessis

clarified,ceaseuseoftheequipment.

Iftheorganizationfailstotakeappropriateactioninthefaceofsuchnoticeandthe

defectivedeviceinjuresapatient,theorganizationmightbefoundnegligent.Additionally,

Guideline:MedicalEquipmentManagement9

theorganizationmightbearlegalresponsibilityforimproperrevisionsormodificationsmadetomedicaldevicesasaresultofarecallnotice.

Manufacturersmayspecifyhowtheywillconductarecallofequipment.Somecontracts,

especiallythoseaddressingthepurchaseofequipmentwithhighpotentialforpatientoruserinjury,mayspecifyhowandwithinwhattimeframeamanufacturerwillnotifyusersof

possiblerisksthathaveprecipitatedarecall.

Documentation

Documentationrelatedtomedicalequipmentuseandmanagementshouldincludewrittenpoliciesandproceduresfor:

?Procurementofequipment(purchase,acquire,lease,borrow)

?Disposalofequipment(sale,recycle,destroy)

?Pre-usetesting,calibration,anduse

?Developmentandimplementationoftrainingprograms,aswellasperiodictrainingupdates

?Responsesto,andreportingof,equipment-relatedincidents

Additionaldocumentationmightberequiredandshouldbeconsideredwiththepurchaseofnewequipment.Forexample,contractsrelatedtotheleaseofequipmentormaintenance

agreementsshouldbekeptinacentrallocation.Theappropriateindividualsshouldassumeresponsibilityforreviewingandaskingquestionsabouttheagreementsbeforetheyaresigned(includinglegalcounselasneeded).Vendorsmaynotbeaccountablefor“assumptions”thatweren’tincludedinacontract.

Preventivemaintenanceandrepairrecordsshouldbeavailableforallprocuredequipment

(leased,borrowed,used,etc.).Further,documentationrelatedtowhoinsurestheequipmentshouldbemaintained.

Ifnecessaryforproperpre-usetestingorcalibration,informationfromthemanufacturer

shouldbeusedtodeveloptrainingandin-servicestaffupdates.Thesematerialsshouldalso

Guideline:MedicalEquipmentManagement10

beavailableforreference,andoriginalsofthesedocumentsshouldbefiledwithcontractualarrangements.

Manufacturers’specifications,schematics,testing,andcalibrationdirections—andanyotheruserinstructions—shouldberetainedinamasterfile.Copiesshouldbeavailable,asneeded,forequipmentusers.Manufacturers’warranties(andinformationaboutactionsthatmight

voidwarranties)alsoshouldberetained.

Codesorstickersplacedonequipmentforthepurposesofidentification,inventory

management,andpreventivemaintenanceshouldbeconsistentlycolor-codedthroughouttheorganizationandshouldcomplywithstateregulations.

Allcommunicationsregardingdamagedornonfunctionalequipmentshouldbemaintained,

includinglogsoftelephoneconversations.Whendisposingofequipment,allprotectedhealthinformationshouldbewipedfromtheequipmentmemory.

OnsiteLaboratory,Anesthesia,Sterilization,DialysisorRadiologyServices

Ifyourhealthcareorganizationperformslaboratory,anesthesia,sterilization,dialysisor

radiologyservices,constantvigilancetoensurethesafetyandaccuracyofequipmentisnecessary.

AllradiologicaltestingandservicesmustbeincompliancewithNuclearRegulatory

Commission(NRC)rulesandregulations,aswellasstateandprivatelicensingand

certificationrequirements.Similarly,alllaboratory,anesthesia,sterilization,anddialysisequipmentmustbemaintainedbasedonfederal,state,andprivatelicensingand

certificationsrequirements.

Therefore,eachorganization’spersonnelshouldbeknowledgeableaboutthelawsandensurethatonsiteequipmentoperatesincompliancewithalloftheapplicablerulesandregulations.

Guideline:MedicalEquipmentManagement11

Thefollowinggeneralrecommendationsareintendedtohelpmanagerisksassociatedwiththeoperationofonsitediagnostics:

?Retainlicensingdocumentswithinyourorganization’spermanentfiles.

?Train,supervise,andperiodicallytesttheproficiencyofallpersonnelperforminglaboratoryorradiologyservices.

?Maintainaninventorylogofalldiagnosticequipmentanduseittomonitorequipmentmaintenance,recalibration,andservicing(asrecommendedbythemanufacturer).

?Maintainandrevisewritteninstructionsandprocedures,includingmaintenanceandreportingresults,onanannualbasis.

Patient-SuppliedMedicalEquipment

Patientsmightbringtheirownmedicalequipmenttouseduringinpatientstays,suchas

canes,heatingpads,insulinpumps,homedialysismachines,continuouspositiveairway

pressure(CPAP)units,andCPAPmasks.Theircomfortlevelwiththeequipmentordesiretoavoidfeesrelatedtousingthefacility’sequipmentmightmotivatethesedecisions.

However,patient-suppliedmedicalequipmentcomeswithrisks.TheECRIInstitutenotesthat“Healthcareorganizationshaveadutytoensurethesafetyofequipmentanddevicesusedintheirinstitutions.Whentheyallowtheuseofpatient-suppliedequipment,theymayalso

assumeresponsibilityfortheequipment'sperformanceandsafety.”

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Healthcareorganizationscanproactivelyaddresspatient-suppliedmedicalequipmentbydevelopingandfollowingapolicyforhowtomanagethesesituations.Whendevelopingapolicy,considerthesequestions:

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?Hasyourorganizationconductedanassessmenttodeterminewhattypesofmedical

equipmentpatientsaremostlylikelytobringwiththem?Haveyouconsideredtherisksversusbenefitsassociatedwiththeidentifiedtypesofequipmentandthesteps

requiredtoevaluateandmaintaintheequipment?

Guideline:MedicalEquipmentManagement12

?Hasyourorganizationdevelopedawrittenpolicythatclearlystateswhichtypesofpatient-suppliedmedicalequipmentareallowed(ifany)andwhichtypesare

prohibited?

?Arehealthcareproviders,staffmembers,patients,andfamilieseducatedaboutthe

organization’spolicyonpatient-suppliedequipment?Arepatientsmadeawareoftheirresponsibilityforanyequipmentthatispermittedandtheychoosetobring?

?Isphysicianapprovalrequiredforallpatient-suppliedmedicalequipment?

?Isarequirementinplacethatbiomedicalorengineeringstaffinspectallpatient-suppliedmedicalequipmenttomakesureitisingoodworkingcondition?Istheequipmenttaggedfollowinginspection,andistheinspectiondocumented?

?Inurgentortime-sensitivecases,donursesorotherfrontlinestaffmembersinspecttheequipmentforobviousdefectsorproblemsuntilbiomedicalorengineeringstaffcanfullyevaluatetheequipment?

?Dostaffmemberswhowillbecaringforthepatientknowhowtooperatetheequipment?

?Doesyourorganizationplantousewaiverstoaddressliabilityassociatedwithpatient-suppliedmedicalequipment?Haslegalcounselreviewedtheseforms?

Onceyourhealthcareorganizationhasdevelopedapolicyforpatient-suppliedmedical

equipment,makesurethathealthcareprovidersandstaffmembersareawareofthepolicyandproceduresforhandlingthesetypesofrequests.

Conclusion

Medicalequipmentprovidesmanyvaluableservicestosupportandenhancepatientcare,butitsuseisneverwithoutrisk.Whileappreciatingthebenefitsthatmedicalequipmentcan

provide,healthcareprovidersandstaffalsoshouldremaincognizantofpotentialsafety

issues.Riskmanagementstrategiescanhelphealthcarepersonnelproactivelymanage

medicalequipment.Whenequipmentisproperlytested,used,andmaintained,itismorelikelytoworkproperly,whichcanhelpavoiddelaysincare,reducetheriskofpatientandstaffinjuries,andoptimizepatientoutcomes.

Gu