Professional Documents
Culture Documents
Ed Israelski PhD,
Director of Human Factors
Abbott
Abbott Park, IL, USA
Outline
FDA’s
Intended Use
5: Usability Engineering Process
– 5.1: Application Specification FDA’s
– 5.2: Frequently Used Functions Preliminary
– 5.3 Ident. Hazardous Situations Evaluation
• 5.3.1 Identify characteristics related to
safety
• 5.3.2 Identify known or foreseeable hazards FDA’s Formative
– 5.4: Primary Operating Functions Evaluation & Design
– 5.5: Usability Specification Mods
– 5.6 Usability Validation Plan
– 5.7 User Interface Implementation FDA’s
– 5.8 Usability Verification Validation
Testing
– 5.9 Usability Validation
6: Accompanying Document
7: Training/Training Materials
ANSI/AAMI HE74:2001: Human Factors Design
Process For Medical Devices
– Main Features
• Shows relationship of all HFE processes to design
cycle (Design Controls, etc.)
• Provides detail on recommended analysis and
testing methods with examples
– HE-74 has been incorporated into IEC 62366 as an
annex. It is no longer a stand-alone standard.
– Revisions to the HE-74 HFE process will be
incorporated in future revisions to IEC 62366
Future Revisions to IEC 62366:2007
Normal Use
Company Confidential 12
© 2009 Abbott
Example of a Fault Tree (FTA)
Incorrect Rx
programmed
AND
Reviewed/
Press Start Misprogrammed
Confirmed
Key Rx
incorrect Rx
OR
OR
OR
Initial Loading
Delivery Mode PCA Dose Lockout Rate Dose Limit Concentration Units
Dose
Additional
Delivery Mode PCA Dose Lockout Rate Dose Limit
Loading Dose
Company Confidential 14
© 2009 Abbott
Example of a Fault Tree
Free T4 drift resulting in
falsely elevated FT4 result
Gate1
Q:1.00004e-006
Q:3.75615e-011 Q:1e-006
Q:1.87808e-005 Q:2e-006
*Usage rate < 100 tests per Instrument left in Users/ lab consistently Controls run-- failed to
Insufficient agitation Reagent(s) left on-board
month or <500 test per month continuous run mode failed to run controls detect drift
Gate7 Event5 Event10 Event15 Event3 Event4
Q:0.0312 Q:0.024102
Swirl- insufficient Swirl done infrequently, Users failed to perform Electrical or mechanical Daily maintenance repeatedly interrupted Automatic swirl (within daily Automatic swirl failed to
magnitude intermittent deposition manual swirl failure- agitation failure before swirl completion maintenance) not performed. remove deposition
Event7 Event8 Gate12 Event11 Event12 Gate10 Event16
Users did not receive User failed to read instructions Automatic swirl software Operator failed to perform
notification. or forgot to manually swirl not installed. daily maintenance
Event18 Event19 Event13 Event14
Company Confidential 15
© 2009 Abbott
Example of Use Error FMEA
Task Effectiveness Risk
# TASK Hazard Faults Prob Crit RI Method of Control of Control Acceptability Reference Category Notes
Message
User fails to seat displayed/alarm/will
Delay in vial fully into not function if not Reduces to
Set-up therapy bottom bracket Occ Mod Med properly seated Low Acceptable
User fails to
squeeze cradle
release while Message
Damage pushing down on Displayed/alarm/will
to vial or top bracket to not function if not Will not
device seat vial. Rare Mod Low properly seated change Acceptable
Company Confidential 16
© 2009 Abbott
Summary
Human Factors Standards have been expanded, revised,
replaced
• Process Standards: (IEC 62366: 2007, HE-74)
• 62366 is now the usability engineering standard as 60601-
1-6:2010 (3rd ed.) is a “pointer” to it
• HE-74 has been phased out, incorporated into IEC 62366
as annex
• Design Principles: HE-75 replaces HE-48
• There are individual standards for Alarms, Symbols, Home
Devices and Risk Management that relate to HF
• More Standards being written (HF Complaints, Contextual
Inquiry, Healthcare IT)
• IEC 62366 will be split and updated by 2014