HUMAN FACTORS ENGINEERING
REQUIREMENTS FOR COMBINATION
PRODUCTS
Ed Israelski PhD CHFP
Convener of Usability and Ergonomics Working
Groups IEC/ISO
Retired Director – Human Factors, AbbVie
Past Co-Chair HFE Committee, AAMI
HFE Consultant- [email protected] 847 224 3289
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What is Human Factors/Usability
Engineering
• Definition
– Applying data on human capabilities and
characteristics to the design and evaluation of systems
and devices
• Relies heavily on methods of the behavioral sciences and
engineering
• Goal is to make products efficient, safe, easy to learn and
use
•
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Synonyms: ergonomics, usability engineering, user experience design,
user centered design, cognitive ergonomics, macro ergonomics, cognitive
engineering, human engineering, etc.
User Interface Design is Important to Reduce Risk
User Interface Problems
UI Improvements
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Human Factors CoreMethods
Contextual Inquiry
User Profiles: Who?
Use Environment: Where?
Task Analysis: What?
Risk Analysis
Estimate Hazards & Risks
User Interface Specification
Acceptance Criteria
Quantified Usability Objectives
Iterative Design
Rapid Prototyping
Simulations
Usability Testing
Formative (Early Designs)
Summative at the End
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Human Factors Standards
– ANSI/AAMI US Domestic HF Standards [Design Principles
Standard]
• ANSI/AAMI HE 75:2009 Human factors engineering—Design of medical devices
– IEC 62366-1:2015 Medical devices – Part 1: Application of
usability engineering to medical devices [Process Standard]
– IEC TR 62366-2:2016 Medical devices – Guidance on the
application of usability engineering to medical devices
[Process Tutorial Technical Report]
Secondary
–
IEC 62366:2007 Ed 1, Medical devices - Application of usability engineering to medical devices
[Process Standard]
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•
•
–
IEC/ISO International HF Standards
•
–
IEC 60601-1-6:2010+A1:2013 Ed 3. Medical electrical equipment - Parts 1-6, General requirements for safety:
Collateral Standard: Usability –Issued (Temporary bridge to IEC 62366:2007)
IECEE – TRF (Test Report Forms)
•
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Annexes include: ANSI/AAMI HE 74:2001
Amendment K for Legacy Products (Now Annex C in 2015 standard)
EN 62366:2008 (Same as IEC)
Tests compliance with Standards
ANSI/AMMI HF Standards
• ANSI/AAMI HE 74:2001 – Human factors design
process for medical devices (incorporated into
AAMI/IEC 62366:2007)
• ANSI/AAMI HE 48—1993 (Replaced by HE
75:2009)
• ANSI/AAMI HE 75:2009 - Human factors
engineering - Design of medical devices
• FDA sponsored companion book to HE 75 published 2010
– Handbook of Human Factors in Medical Device Design, 2010, D.
Gardner-Bonneau, M. B. Weinger and M. Wiklund (Eds) New
York, NY: CRC Press
• Edition 2 planned for 2017
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ANSI/AAMI HE75: Human Factors
Principles for Medical Device Design
– Comprehensive design guidelines
• 465 pages in 25 sections
– Special issues related to medical practices and
process giving context to best design practices
– FDA sponsored companion book to HE 75
published by CRC/Taylor and Francis
– 850 pages
– Handbook of human factors in medical device design, (2010)
Gardner-Bonneau, D, Weinger, M.B.and Wiklund Michael (Eds)
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HE75: Scope
•
Organized in 3 General Areas (25 Sections)
• General Considerations and Principles
• Design Elements
• Integrated Solutions
•
Specific Design Guidance & Recommendations
• Authors are Human Factors Experts
• Vast HF Literature is Distilled and Summarized
• Intended to Save Design Time
• Specific Numbered Guidance Statements are Included
• Extensive References are Provided
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HE 75 at a glance…
Design Elements
General Considerations
General UI Design
Principles
Managing Risk of
Use Error
Basic Skills and Abilities
Anthropometry &
Biomechanics
Environmental
Considerations
Usability Testing
Integrated
Solutions
Signs, Symbols,
Markings
Use of Automation
Mobile Devices
User Documentation
Displays
Home Health Care
Considerations
Packaging Design
Cross-Cultural/ CrossNational Design
Controls Design
Connectors/
Connections
Workstation Design
Design of Hand Tools
Design for Post-Market
Alarm Design
Software User Interfaces
Accessibility
Considerations
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ANSI/AAMI HE 75:2009 – Human
factors engineering—Design of
medical devices – Update
• Work started to draft Updated HE-75 Edition 2
– New sections may include: Combination Products,
Integrated Systems
– Correct/Update/Expand current sections: Risk Analysis,
Usability Testing, Documentation, etc
– Expect Ed 2 in 2017
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Changes to IEC 62366:2007
• Normative standard (IEC 62366-1:2015)
– Streamlined
– Harmonized with draft FDA HFE/UE Guidance (June, 2011)
– Improved and simplified terminology
• Use Specification (not Application Specification)
– Eliminated Frequently Use Functions, demoted Primary Operation Functions as only
an input when available
• User Interface Specification (not Usability Specification)
– More thoroughly integrated with Risk Management (ISO
14971)
– Controversy over the name – HFE, UE or UE/HFE- Usability
Engineering is the accepted name
•
Informative tutorial (how to do) information moved to TR technical report (IEC TR
62366-2)- DRAFT (Expected 2016)
• More informative annexes
• More examples with illustrations
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Table of
Contents –
IEC 623661:2015
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1
Scope- Refined to Emphasize Safety
Standard (Basic Safety and Essential
Performance)
* Scope
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop
and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY . This USABILITY
ENGINEERING ( HUMAN FACTORS ENGINEERING ) PROCESS permits the MANUFACTURER to assess
and mitigate RISKS associated with CORRECT USE and USE ERRORS , i.e., NORMAL USE . It can be
used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE .
NOTE 1 S AFETY is freedom from unacceptable RISK . Unacceptable RISK can arise from USE ERROR , which can lead
to exposure to direct physical HAZARDS or loss or degradation of clinical functionality.
NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-2 1,
which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY .
If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been
complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be
acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.
NOTE 3
Such OBJECTIVE EVIDENCE can subsequently originate from POST - PRODUCTION surveillance.
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Clarifications in IEC 62366-1:2015
* Excerpted from draft of FDIS IEC 623661:2015
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Usability Engineering Process FlowHazard Related Use Scenarios
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UK MHRA HF Draft Guidance
• Human Factors and Usability Engineering –
Guidance for Medical Devices Including Drugdevice Combination Products, MHRA June
2016
– Mostly standard guidance on the need for HF/UE
– Two potentially burdensome requirements
• Recommended use of high fidelity hospital patient
simulators for usability testing
• Requirement to analyze competitors complaint files
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FDA Human Factors
• Guidance documents are consistent with HF
professional practices
• HF Professional Group of 3 in CDRH in ODE (HF
PMET)
• HF knowledgeable staff in CDER (DMEPA)
• HF Group goal is to educate FDA Staff and
Auditors
• Work with Manufacturers
• Active in AAMI , IEC , ISO HF Standards
development
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Implications of external standards and
FDA guidances
•
Bar is being raised for quality of Human Factors Engineering
Work
– US FDA expects more
• FDA Recognizes major HFE/UE Standards ( ANSI/AAMI HE75:2009, IEC 62366-1:2015 and IEC TR 62366-2:2016)
• CDRH New Final Guidance on Medical Devices
• CDER New Final Guidance on Minimizing Med Errors
• CDER Draft Guidances for all Medical Products
– Packaging/Labeling
– Drug Naming
– Combination Product HF DRAFT Guidance issued
Feb, 2016
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FDA Guidances 2016
• Applying Human Factors and Usability Engineering to
Medical Devices – FINAL CDRH:
http://www.fda.gov/downloads/MedicalDevices/.../UCM259760.pdf
• List of Highest Priority Devices for Human Factors
Review- DRAFT CDRH:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationan
dGuidance/GuidanceDocuments/UCM484097.pdf
• Human Factors Studies and Related Clinical Study
Considerations in Combination Product Design and
Development- DRAFT CDER/CDRH:
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afdagen/documents/document/ucm484345.pdf
Previous FDA Guidances for Human
Factors
• CDRH HF Guidance Documents
• Applying Human Factors and Usability Engineering to Optimize Medical
Device Design , DRAFT June 22, 2011
• Medical device use safety: Incorporating HFE into risk management, July 18,
2000
• Design Considerations for Devices Intended for Home Use, 2014
• CDER HF Related Guidance Documents
• Safety Considerations for Product Design to Minimize Medication Errors,
FINAL April, 2016
• Safety Considerations for Container Labels and Carton Labeling Design to
Minimize Medication Errors, DRAFT April 2013
• Best Practices in Developing Proprietary Names for Drugs, DRAFT May 2014
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FDA Increasing Expectations for HF
New CDRH Guidance Applying Human Factors and Usability Engineering to Medical
Devices (Feb 3, 2016) requires (8 section summary report):
– Conclusions (Residual Risk Assessment)
– Contextual Inquiry (Intended Use, Users, Use Environment, Task
Analysis)
– UI Description
– Known Use Errors (Complaints, CAPA, MDR’s)
– Use Error Risk Analysis Required (Israelski book chapter cited)
– Summary of Formative Usability Evaluations and Design Modifications
– Identify and Categorize Critical Tasks (related to safety and serious harm)
– Validation of Usability
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Rational (Users, Use Environment, Simulated Use vs. Clinical Evaluation)
Tasks Prioritized by Risk Analysis
Sample size (15 minimum per distinct user group)
Training decay addressed by delay between training and usability testing
Explain All Task Failures (Safety Critical Tasks Require No Task Failures with Negative Clinical Impact)
Subjective Assessment of Safety (Especially for failures, close calls and use difficulties)
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CDER HF Guidances
• CDER published guidances relevant to Human Factors:
– Safety Considerations for Product Design to Minimize
Medication Errors, FINAL April, 2016
• Study User Profiles and Use Environment
• Perform Risk Analysis – Use-FMEA recommended (Israelski book
chapter cited as useful reference)
• Perform HF Simulated Use Testing
– Safety Considerations for Container Labels and Carton
Labeling Design to Minimize Medication Errors, DRAFT
April, 2013
• Good labeling/packaging HF practices
– Examples of poor HF in labeling and packaging (things to avoid)
– Best Practices in Developing Proprietary Names for Drugs,
DRAFT May, 2014
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Human Factors Studies and Related
Clinical Study Considerations in
Combination Product Design and
Development
Draft Guidance for Industry and FDA Staff
Issued Feb 3, 2016
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Table of Contents
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Industry Comments on Draft HF
Combination Products Guidance
• Needs clarity on if and when HF Actual Use
studies are required after HF Simulated Use
Studies
• Needs clarity on timing of HF Validation Study
vs. Phase 3 clinical studies
– FDA says ideally before but, it could be in
parallel or after (desire option of post
approval)
– Uses Production Equivalent and not final
product (when done after Phase 3 trial)
Industry Comments on Draft HF
Combination Products Guidance
• Critical Tasks defined inconsistently: CDRH uses serious
harm, CDER uses any harm
• Clarity on FDA requiring HF re-validation after they ask
for label IFU changes based on new requirements or
new non-public FDA knowledge
• Need assurance that worst case no-training arm is well
defined.
• Consistency needed with CDRH on sample size, report
format
• Clarify expectations on Knowledge Task Studies (Label
Comprehension Studies) e.g. Sample size, timing of
study.