Best Practices of Safety Information Presentation in IFUs

Copyright©2017HumanFactorsMD.Allrightsreserved.Confidential.

BestPracticesofSafetyInformationPresentationinIFUsEricF. Shaver,PhDDirectorofHumanFactors

6March2017


Overview

1. Challengesofdesigningsafetyinformation.

2. IssuescommonlyseeninIFUs.

3. Bestpracticesfordesigningsafetyinformation.

4. Designresourcesforfuturereference.

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Copyright©2017HumanFactorsMD.Allrightsreserved.Confidential. 3

WhyisitdifficulttodevelopsafetyinformationforIFUs?


DevelopmentChallenges

Numerousdifferentpotentialconsumersofthesafetyinformation.

Oftenhavetodealwithlanguagebarriers.

Devicelabeling- includingsafetyinformation- isoftenlefttothelastminute.

Resourcesareoften limited.

Manypossibledesignfeaturescanbeimplemented.

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DevelopmentChallenges,cont.

Havetoconsiderdevicecomplexity.

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DevicelabelingismorethanjusttheIFU.



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Moretoconsiderthansafetyinformation.



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Lotsofresearch;littledesignguidance.

Issue#1IncorrectSignalWordforaHazard


Issue#1

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Issue#1,cont.

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Issue#1,cont.

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BestPractice#1

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Reference:ANSIZ535.6(2011)


BestPractice#1,cont.

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Useariskassessmentprocesstoidentifyhazardsanddeterminewhensafetyinformationiswarranted.

Ensuresafetyinformationisidentifiedwiththecorrectsignalword.

Donotdownplayhazardsbyselectingasignalwordthatconnotesadecreasedlevelofhazardseriousness.

Followdesignconventionsforpresentationofsignalwords.

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Issue#2OverlyVerboseSafetyInformation


Issue#2

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BestPractice#2

Beconcisewhenpresentingsafetyinformation.

Minimizethecombiningofinstructionswithsafetyinformation.

Testcomplexsafetyinformationearlywithintendedusers.

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Issue#3UseofConfusingSafetySymbols


Issue#3

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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#4NotIncludingASupplementalDirective


Issue#4

Directsuserstoneworuniquesafetyinformation.

Directsuserstosafetyinformationwithinadocument.

Informsusersthatsafety-relatedinformationislocatedwithinthedocument.

Decreasestheneedtorepeatgenericconsequenceinformationregardingfailuretoreadthedocument.

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BestPractice#4

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Issue#5OveruseofBox-StyleDesign


Issue#5

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Issue#5,cont.

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Issue#5,cont.

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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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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.






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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.




AdditionalBestPractices


AdditionalBestPractices

1. Knowyouraudience.

2. Makeuseofaprocess.

3. Asktherightquestions.

4. IFUsarepartofanecosystem.

5. Usealternativedesignformats.

6. Maintainconsistencywithin- andacross- products.

7. Testearlyandoften.

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DesignResources



Questions?


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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Healthcare

Best Practices of Safety Information Presentation in IFUs