Best Practices of Safety Information Presentation in IFUs
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Transcript of Best Practices of Safety Information Presentation in IFUs
Copyright©2017HumanFactorsMD.Allrightsreserved.Confidential.
BestPracticesofSafetyInformationPresentationinIFUsEricF. Shaver,PhDDirectorofHumanFactors
6March2017
Copyright©2017HumanFactorsMD.Allrightsreserved.Confidential.
Overview
1. Challengesofdesigningsafetyinformation.
2. IssuescommonlyseeninIFUs.
3. Bestpracticesfordesigningsafetyinformation.
4. Designresourcesforfuturereference.
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DevelopmentChallenges
Numerousdifferentpotentialconsumersofthesafetyinformation.
Oftenhavetodealwithlanguagebarriers.
Devicelabeling- includingsafetyinformation- isoftenlefttothelastminute.
Resourcesareoften limited.
Manypossibledesignfeaturescanbeimplemented.
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DevelopmentChallenges,cont.
Havetoconsiderdevicecomplexity.
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DevelopmentChallenges,cont.
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DevicelabelingismorethanjusttheIFU.
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DevelopmentChallenges,cont.
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Moretoconsiderthansafetyinformation.
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DevelopmentChallenges,cont.
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Lotsofresearch;littledesignguidance.
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BestPractice#1
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Reference:ANSIZ535.6(2011)
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BestPractice#1,cont.
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Reference:ANSIZ535.6(2011)
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BestPractice#1,cont.
Useariskassessmentprocesstoidentifyhazardsanddeterminewhensafetyinformationiswarranted.
Ensuresafetyinformationisidentifiedwiththecorrectsignalword.
Donotdownplayhazardsbyselectingasignalwordthatconnotesadecreasedlevelofhazardseriousness.
Followdesignconventionsforpresentationofsignalwords.
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BestPractice#2
Beconcisewhenpresentingsafetyinformation.
Minimizethecombiningofinstructionswithsafetyinformation.
Testcomplexsafetyinformationearlywithintendedusers.
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Issue#3,cont.
Seo,etal.(2016)had86healthcareprovidersevaluate38symbolsfromAAMI/ANSI/ISO15223-1.
Only6of38metmodifiedacceptancecriteriafromANSIZ535.3.
Fiveof6containedtextinthevisual.
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BestPractice#3
Provideanexplanationofthesafetysymbolsinaglossary.
Testsymbolsearlywithintendedusers.
Iflowcomprehensionsymbolsarerequired,providecorrespondingtextualexplanation.
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Issue#4
Directsuserstoneworuniquesafetyinformation.
Directsuserstosafetyinformationwithinadocument.
Informsusersthatsafety-relatedinformationislocatedwithinthedocument.
Decreasestheneedtorepeatgenericconsequenceinformationregardingfailuretoreadthedocument.
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Reference:ANSIZ535.6(2011)
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BestPractice#5
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To Clean and Disinfect the System
1. Press the power button to turn the system off.
2. Unplug the power cord from the electrical outlet. WARNING! Failure to unplug the power cord before cleaning and disinfecting could result in serious injury or death.
3. Disconnect the collapsible arm from the system.
4. Detach the end piece from the collapsible arm.
5. Inspect and remove debris from the end piece.
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BestPractice#5,cont.
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To Clean and Disinfect the System
1. Press the power button to turn the system off.
2. Unplug the power cord from the electrical outlet. Failure to unplug the power cord before
cleaning and disinfecting could result in serious injury or death.
3. Disconnect the collapsible arm from the system.
4. Detach the end piece from the collapsible arm.
5. Inspect and remove debris from the end piece.
Copyright©2017HumanFactorsMD.Allrightsreserved.Confidential.
BestPractice#5,cont.
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To Clean and Disinfect the System
1. Press the power button to turn the system off.
2. Unplug the power cord from the electrical outlet. Failure to unplug the power cord before
cleaning and disinfecting could result in serious injury or death.
3. Disconnect the collapsible arm from the system.
4. Detach the end piece from the collapsible arm.
5. Inspect and remove debris from the end piece.
Copyright©2017HumanFactorsMD.Allrightsreserved.Confidential.
AdditionalBestPractices
1. Knowyouraudience.
2. Makeuseofaprocess.
3. Asktherightquestions.
4. IFUsarepartofanecosystem.
5. Usealternativedesignformats.
6. Maintainconsistencywithin- andacross- products.
7. Testearlyandoften.
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References
ANSIZ535.6(2011).ProductsSafetyInformationinProductManuals,Instructions,andOtherCollateralMaterials.NewYork:AmericanNationalStandardsInstitute.
Seo,D.C.,Landoni,M.,Brunk,E.,Becker,M.W.,&Bix,L.(2016).Dohealthcareprofessionalscomprehendstandardizedsymbolspresentonmedicaldevicepackaging?:Animportantfactorinthefightoverlabelspace.PackagingTechnologyandScience.Advanceonlinepublication.10.1002/pts.2199.
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ContactInformation
EricF.Shaver,PhDDirectorofHumanFactorsHumanFactorsMD
Email:[email protected]:www.humanfactorsmd.comLinkedIn:https://www.linkedin.com/company/human-factors-md/Phone:1.800.639.7941
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