Escolar Documentos
Profissional Documentos
Cultura Documentos
TheFDAPerspectiveon
HumanFactorsinMedical
DeviceSoftwareDevelopment
MollyFolletteStory,PhD
FDA/CDRH/ODE
2012IQPCSoftwareDesignforMedicalDevicesEurope
Munich,Germany Februar 1,2012
2
Overview
Background
GuidanceforFDApremarketsubmissions
involvingmedicaldevicesoftware
GuidanceforFDApremarketsubmissions
involvinghumanfactorsdata
Humanfactors/usabilityvalidation
Human Factors Software HF/U Validation Background
3
DeviceUserInterface
User
Device
Information
Processing
Processing
Information
Perception
Input
Control
Actions
Output
INTERFACE INTERFACE
Human Factors Software HF/U Validation Background
4
DeviceUserInterface
ERROR
User
Device
Information
Processing
Processing
Information
Perception
Input
Control
Actions
Output
INTERFACE INTERFACE
E
R
R
O
R
E
R
R
O
R
Human Factors Software HF/U Validation Background
UseErrors
5
Source:
IEC62366:200710
andANSI/AAMIHE75:2009
Action
Unintended
Intended
Slip
Lapse
Mistake
Correct Use
Use Error
Attentional failure
Memory failure
Rule-based error
Knowledge-based
error
Ignorance-based
error
Abnormal Use
Human Factors Software HF/U Validation Background
CommonReasonsforUseErrors
6
Theuseenvironmenthasnegativeeffects
Thedemandsassociatedwithuseofthedevice
exceedtheuserscapabilities
Aspectsofdeviceuseareinconsistentwiththe
usersexpectationsorintuition
Thedeviceisusedinunexpectedways
Thedeviceisusedininappropriatebut
foreseeableways,forwhichadequatecontrols
werenotapplied
Human Factors Software HF/U Validation Background
7
CommonUserInterface(UI)Issues
UIcomplexitycausesuserconfusion,delayinuse,
orinabilitytousethedevice
UImakesitdifficultforusertocorrectdataentry
errorsormodifydevicesettingsinatimelyfashion
UIfalselycausestheusertobelieveacritical
situationexistswhenitdoesnot,orviceversa
UIdoesnotdrawattentiontodangerous
conditionsofdeviceoperationorpatientstatus
UIdoesnotpreventknown,likelydatainputerrors
Human Factors Software HF/U Validation Background
8
MedicalDeviceSoftware
PrimarystandardrecognizedbyFDA
GuidancedocumentsissuedbyFDA
GuidanceforFDApremarketsubmissions
involvingmedicaldevicesoftware
Human Factors Software HF/U Validation Background
9
SoftwareStandard
IEC62304:2006
Medicaldevicesoftware
Softwarelifecycleprocesses
SWdevelopment
SWmaintenance
SWriskmanagement
SWconfiguration
management
SWproblemresolution
Human Factors Software HF/U Validation Background
FDASWGuidance
10
GeneralPrinciplesof
SoftwareValidation
http://www.fda.gov/
MedicalDevices/
DeviceRegulationand
Guidance/
GuidanceDocuments/
ucm085281.htm
Note:issuedin2002
Human Factors Software HF/U Validation Background
FDASWGuidance
11
GuidancefortheContentof
PremarketSubmissionsfor
SoftwareContainedin
MedicalDevices
http://www.fda.gov/
MedicalDevices/
DeviceRegulationand
Guidance/
GuidanceDocuments/
ucm089543.htm
Note:issuedin2005
Human Factors Software HF/U Validation Background
12
FDASoftwareGuidance(1of7)
DeviceHazardAnalysis
Includeallforeseeablesoftwarerelatedhazards
Identificationofthehazard
Severityofthehazard
Cause(s)ofthehazard
Methodofcontrol(e.g.,hardware,software,alarm)
Correctivemeasures(e.g.,toeliminate,reduce,orwarn)
Verification
Validation
Human Factors Software HF/U Validation Background
13
FDASoftwareGuidance(2of7)
Softwarelevelofconcern
Estimate(intheabsenceofmitigations)oftheseverity
ofinjury
thatadevicefailureorlatentdesignflawcould
permitorinflict,eitherdirectlyorindirectly,ona
patientordeviceoperator:
Major:coulddirectlyresultindeathorseriousinjury
Moderate:coulddirectlyresultinminorinjury
Minor:unlikelytocauseanyinjury
DocumentationrecommendedforanFDA
submissiondependsonthelevelofconcern
Human Factors Software HF/U Validation Background
14
FDASoftwareGuidance(3of7)
Softwarerelateddocumentation:
Overview
Describethedesign
ofyourdevice
Describehowyourdesignwasimplemented
Demonstratehowthedevice,withyourdesign
implementation,wastested
Showthatyouidentifiedhazards
appropriatelyand
managedrisks
effectively
Providetraceability
tolinkthedesign,implementation,
testing,andriskmanagement
Human Factors Software HF/U Validation Background
15
FDASoftwareGuidance(4of7)
Softwarerelateddocumentation:
VerificationandValidation(V&V)
MINORlevelofconcern:
Softwarefunctionaltestplan
Pass/failcriteria
Testresults
Human Factors Software HF/U Validation Background
16
FDASoftwareGuidance(5of7)
Softwarerelateddocumentation:
VerificationandValidation(V&V)
MODERATElevelofconcern:
V&Vactivitiesattheunit,integration,andsystemlevel
Systemleveltestprotocol
Pass/failcriteria
Testresults
Human Factors Software HF/U Validation Background
17
FDASoftwareGuidance(6of7)
Softwarerelateddocumentation:
VerificationandValidation(V&V)
MAJORlevelofconcern:
V&Vactivitiesattheunit,integration,andsystemlevel
Unit,integrationandsystemleveltestprotocols
Pass/failcriteria
Testreport,summary,testresults
Human Factors Software HF/U Validation Background
18
FDASoftwareGuidance(7of7)
SoftwaredesignneedstoaddressHF
Weavehumanfactorsengineeringintoentiredesign
anddevelopmentprocess,includingdevicedesign
requirements,analyses,andtests
Considerdevicesafetyandusabilityissueswhen
developingflowcharts,statediagrams,prototyping
tools,andtestplans
Performtaskandfunctionanalyses,riskanalyses,
prototypetestsandreview,andfullusabilitytests
Includeparticipantsfromtheuserpopulation(s)
Human Factors Software HF/U Validation Background
19
MedicalDeviceHumanFactors
StandardsrecognizedbyFDA
GuidancedocumentsissuedbyFDA
GuidanceforFDApremarketsubmissions
involvinghumanfactorsdata
Human Factors Software HF/U Validation Background
20
HumanFactorsStandards(1of4)
AAMI/ANSIHE75:2009
Generalconsiderationsand
principles
Managingtheriskofuseerror
Usabilitytesting
Designelements
Controls
Software
Integratedsolutions
Mobilemedicaldevices
Homehealthcare
Human Factors Software HF/U Validation Background
21
HumanFactorsStandards(2of4)
ISO/IEC62366:2007
Medicaldevices
Application
ofusabilityengineeringto
medicaldevices
Usabilityengineeringprocess
Accompanyingdocument
Training
Human Factors Software HF/U Validation Background
22
HumanFactorsStandards(3of4)
ANSI/AAMI/ISO
14971:2007
Medicaldevices
Application
ofriskmanagementto
medicaldevices
Riskmanagement
Riskanalysis
Riskevaluation
Evaluationofoverallresidual
riskacceptability
Human Factors Software HF/U Validation Background
23
HumanFactorsStandards(4of4)
IEC6060118:2006
Medicalelectrical
equipment
Collateral
standard:alarmsystems
Alarmsystems
Alarmcondition
Generationofalarmsignals
Alarmpresets
Distributedalarmsystem
Etc.
Human Factors Software HF/U Validation Background
FDAHFGuidance
24
MedicalDeviceUseSafety:
IncorporatingHuman
FactorsEngineeringinto
RiskManagement
http://www.fda.gov/
MedicalDevices/
DeviceRegulationand
Guidance/
GuidanceDocuments/
ucm094460.htm
NOTE:issuedin2000
Human Factors Software HF/U Validation Background
t
FDAHFGuidance
25
ApplyingHF&UEtoOptimize
MedicalDeviceDesign
http://www.fda.gov/
MedicalDevices/
DeviceRegulationand
Guidance/
GuidanceDocuments/
ucm259748.htm
NOTE:issuedin2011 I is
notyetineffect
butit
reflectsFDACDRHscurrent
thinkingandapproachto
humanfactors
Human Factors Software HF/U Validation Background
26
2011Draft
HumanFactorsGuidance
Considerations:DeviceUsers,Use
EnvironmentsandUserInterfaces
PreliminaryAnalyses
ExploratoryHF/UsabilityEvaluations
HazardMitigationandControl
HumanFactors/UsabilityValidation
Human Factors Software HF/U Validation Background
HumanFactorsofDeviceUse
27
Human Factors Software HF/U Validation Background
28
Professionalornonprofessional
Jobtitleandresponsibilities
Knowledgeandexperiencelevels
Ageandfunctionalcapabilities
Physical,sensory/perceptual,cognitive/intellectual
Mentalandemotionalcondition
Users
Human Factors Software HF/U Validation Background
29
Clinicalenvironment
Hospital,clinic,etc.
Transitionalcareenvironment
Rehabilitation,assistedliving,longtermcare,etc.
Homeenvironment
House,mobilehome,townhouse,apartment,etc.
Communitysetting
Office,school,retail,outdoors,etc.
Mobileenvironment
Car,plane,train,bus,ambulance,medevac,etc.
UseEnvironment
Human Factors Software HF/U Validation Background
30
Examplesoftwareinteractiontasks
Dataentry(initial)
Datareview
Datarevision
Interactions(devicehardware)
Input
Knobs/dials,switches,buttons,keyboards,touchscreens,etc.
Output
Visual:displays(GUI),lights,controlsettings,etc.
Auditory:alerts/alarms,beeps,voice,motors,fans,etc.
UserInterface
Human Factors Software HF/U Validation Background
31
QualitySystemregulation:
21CFR820.30,DesignControls
Theneedforhumanfactorsisimplied:
c)
Designinput
includesneedsoftheuserandpatient
f)
Designverification
performancecriteriamet
g)
Designvalidation
devicesconformto
defineduser
needsandintendeduses
andshallinclude
testingof
productionunits
underactualorsimulateduse
conditions.
Designvalidationshallincludesoftware
validation
andriskanalysis.
[incl.userelatedrisks]
RegulatoryBasisforHFatFDA
Human Factors Software HF/U Validation Background
Humanfactors
engineering
processfor
medical
devices
32
Source:
ANSI/AAMI
HE75:2009
Human Factors Software HF/U Validation Background
33
PreliminaryAnalyses:Inquiries
Analyzeneedsofcurrentsystemusers
Whowillusethesystem?
Wherewilltheybeworking?
Whattaskswilltheyperform?
Analyzesystemuserinteractions
Howwilltheusersinteractwiththesystem?
Whatuseerrorsandfailuresmightoccur?
Howmighterrorsandfailuresbepreventedorthe
severityofanynegativeconsequencesbereduced?
Human Factors Software HF/U Validation Background
34
PreliminaryAnalyses:Methods(1of3)
Contextualinquiry
Userdemonstrates;researcherobserves,inquires
Interviewsandfocusgroups
Discussionsaretargeted;researcherisneutral
Functionandtaskanalyses
Breakdowndeviceuseintodiscretesteps
Identifyuserelatedhazardsassociatedwitheachstep
ofuse
Identifypotentialcausesandconsequencesofuser
encounteringeachhazard
Developriskmitigationstrategies,ifneeded
Human Factors Software HF/U Validation Background
35
Heuristicanalysis
Formallyevaluateuserinterfaceagainstwell
establisheddesignrulesorheuristicguidelines
Expertreview
Useclinicalandhumanfactorsexperts
Expertsprovidepersonalopinionsofusabilityand
safetyofuserinterface,basedonprofessional
knowledgeandexperience
PreliminaryAnalyses:Methods(2of3)
Human Factors Software HF/U Validation Background
36
PreliminaryAnalyses:Methods(3of3)
Twowaystodiscoveruserelatedhazards:
1.
Analyticaltechniques
Toidentifyuserelatedhazardsandrisks
Userelatedhazardsanduserbehaviorcanbedifficulttopredict
Tofocustheprocessandprioritizeresources
2.
Humanfactors/usabilityevaluations
Conductexploratory,handsontestingtodiscoverand
exploreunanticipated
hazards
SometimescalledUsabilityTesting
orUseTesting
orUser
Testing
orFormative
Evaluations
Human Factors Software HF/U Validation Background
37
ExploratoryHF/UStudies(1of2)
Donewhilethedeviceisunderdevelopment
Conductstudiesiterativelytooptimizethedevice
designandensurethehumanfactors/usability
validationtestingresultswillbesuccessful
Testingcaninvolvesimpleproductmockupsorearly
prototypes,orevenpartialdesigns(e.g.,components)
operatinginsimulatedusemodes
Testparticipantsshouldberepresentativeofthe
intendeduserpopulation(s)
Atearlystages,userelatedproblemscanbeaddressed
moreeasilyandlessexpensively
Human Factors Software HF/U Validation Background
ExploratoryHF/UStudies(2of2)
38
Conductseparatestudiesonlabelingand
training:
Assesstheclarityandeffectivenessofalllabeling(e.g.,
instructionsforuse,otherdocumentation,packaging)
Determinethelevelandnatureoftrainingthatwillbe
necessary(ifany)
Human Factors Software HF/U Validation Background
39
RiskMitigation
Developriskmitigationstrategiesasneeded:
Modifytheinterfacedesign,userinstructions,and/or
trainingtoaddresstheproblemsfound
Retesttoassesswhethermitigationstrategies:
Effectivelyreducedtheknownrisksand
Didnotintroduceanynewrisks
Residualrisk
isacceptableifitis:
Reasonablylimited,notcapableofeliminationorfurther
reduction,andoutweighedbythedevicesbenefits
Human Factors Software HF/U Validation Background
820.30(f)DesignVerification
820.30(g)DesignValidation
40
DesignVerification:
DidImaketheproductright?
DesignValidation:
DidImaketherightproduct?
Source:
KimberlyA.Trautman,FDA
Human Factors Software HF/U Validation Background
41
HumanFactors/UsabilityValidation
Demonstratesandprovidesevidencethata
medicaldevice,asdesigned,canbeusedsafely
andeffectively:
Bypeoplewhoarerepresentativeoftheintendedusers
Underexpecteduseconditions
Foressentialandcritical(highrisk)tasks
Includesbothobjectiveandsubjectivedata:
Useerrorsandfailuresareobservedandrecorded
Userfeedbackiscollectedafteruseregardingessential
andcriticaltaskerrors,failuresanddifficulties
Human Factors Software HF/U Validation Background
42
DeviceTestingConditions
Usefinalizeddevicedesignandlabeling
Identifyexpecteduseconditions
E.g.,lighting,sound,andactivity(distraction)levels
Allowrealisticdeviceuserinteractions
Provideparticipantswithdeviceastheywouldreceiveit
(e.g.,initsoriginalpackaging,withalldocumentation)
Allowparticipantstousethedeviceastheynormally
would(e.g.,withoutinterferencefromtestfacilitator)
Human Factors Software HF/U Validation Background
43
SelectionofTasksTested(1of2)
IncludeintheHF/Uvalidationstudyprotocol
andreportarationaleforthetasksyouchoose
toincludeinyourtesting
Basetaskselectiononresultsofpreliminaryanalyses
E.g.,taskanalysesandassessmentofuserelatedrisks
IncorporatefindingsofexploratoryHF/Ustudies
E.g.,tasksfoundtobeproblematicforusers
Human Factors Software HF/U Validation Background
44
SelectionofTasksTested(2of2)
Taskstestedinvalidationdonotnecessarily
includeeverythingintheinstructionsforuse
Includeessential
tasks
i.e.,tasksnecessaryfor
successfuluseofthedevice
Includesafetycriticaltasks
i.e.,tasksonwhichusers
couldmakeerrorsorcouldfailtocomplete,which
wouldhavenegativeclinicalimpact
Allwarningsandmostcautionstatementsinthedevice
labelingimplysafetycriticaltasks
Alltasksrequiringresponsestoalarmsaresafetycritical
Human Factors Software HF/U Validation Background
45
InstructionsandTraining
Participantinteractionwithinstructionsand
trainingshouldapproximatereality
Labelingusedindevicevalidationshouldbefinalversions
Trainingusedindevicevalidationshouldbecomparable
tothetrainingthatactualuserswillreceive
Human Factors Software HF/U Validation Background
46
ValidationTestData
Assessmentofdeviceuserinteractions
Userperformance
Throughobservation,automateddatacollection,etc.
Essentialandcriticaltasks
Userknowledge
Throughquestionnaireorinterview(wordedneutrally)
Essentialandcriticalknowledge
E.g.,warningsandcautions
Usersubjectivefeedback
Throughinterview,afteruserhascompletedalltesttasks
Overalluse,essential/criticaltasks,allperformancefailures
Human Factors Software HF/U Validation Background
Humanfactors
engineering
processfor
medical
devices
47
Source:
ANSI/AAMI
HE75:2009
Human Factors Software HF/U Validation Background
48
Advice:ConsultFDAEarly
Discussproductdevelopmentplanswith
FDAbeforeyourdesignisconsidered
final
(andchangeswouldbedifficult)
StaffinCDRH,CDERandCBERcanadvise
E.g.,onsoftwarelevelofconcern
FDAwillreviewhumanfactors/usabilitytesting
protocolsonrequest
Beforeimplementationisrecommended!
49
FDA/CDRHHumanFactorsProgram
http://www.fda.gov/
humanfactors
PremarketInfo
Design&Documentation
PostmarketInfo
Surveillance&Reporting
InfoforConsumers,
Patients,Caregivers
GeneralHumanFactors
InfoandResources
50
NewHFESAAMIWebSite
http://
www.medicaldevice
humanfactors.org
Resources
ConsultantDirectory
Organizations
Events
AcknowledgmentandQuestions
51
51
Contact:
Molly Follette Story: molly.story@fda.hhs.gov
FDA/HF web site: www/fda.gov/humanfactors
My thanks to:
Ron Kaye, FDA / CDRH / ODE / DAGID