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HUMAN FACTORS
ENGINEERING
HUMAN FACTORS
ENGINEERING
WHAT IS HUMAN
FACTORS
ENGINEERING?
Human Factors Engineering is a
science that collects and applies
knowledge about the characteristics
and limitations of the intended users
and intended use environments to
systematically optimize the product’s
user interface towards use-related
safety, effectiveness and usability in
the scope of its intended use.
Source [1]
WHAT IS A USER
INTERFACE?
All points of interaction between the
user and the device, including all
elements of the device with which the
user interacts (i.e., those parts of the
device that users see, hear, touch).
All sources of information
transmitted by the device (including
packaging, labeling), training and all
physical controls and display
elements (including alarms and the
logic of operation of each device
component and of the user interface
system as a whole).
Source [1]
WHY HUMAN FACTORS
ENGINEERING?
USE ERRORS & SAFETY
In 2000, FDA received over 90.000 reports on device-related
errors, suggesting that one third involve use-related errors.
However, use errors depends on the analysis and classification
of adverse events: Root causes often remain unclear and
typically multiple factors lead to an adverse event.
REGULATORY REQUIREMENT
FDA‘s CDRH states that „it is increasingly clear that errors in
the use of medical device result in hundreds, if not thousands,
of patient deaths and serious injuries each year“ and further
takes the standpoint that “operator involvement and human
factors issues are inherent in virtually every (adverse) event”.
Source [3]
WHY HUMAN FACTORS
ENGINEERING?
SAFETY & EFFECTIVENESS
Reduced risk of use error, better
understanding of device status and
operation, better understanding of
patients’ medical condition, more
effective alarm signals, =
USABILITY & EASE OF USE
Easier to use devices, safer connections
between devices and components,
easier to read controls and displays,
easier maintenance and repair, reduced
reliance on user manuals, =
COST & RETURN ON INVESTEMENT
Reduced need for user training and
retraining, reduced risk of product recalls,
reduced customer complaints, improved
company reputation, easier device
maintenance and repair, =
Source [2]
HUMAN FACTORS ENGINEERING PROCESS
USE
SPECIFICATION
• User research
• Contextual inquiry
• Conceptual model
• Comparative analysis
GOALS: Confirm intended
use, identify intended users
and other users, specify the
intended use environments
incl. workflows, previous
and subsequent tasks
USE
SPECIFICATION
• User research
• Contextual inquiry
• Conceptual model
• Comparative analysis
GOALS: Confirm intended
use, identify intended users
and other users, specify the
intended use environments
incl. workflows, previous
and subsequent tasks
FUNCTIONAL
ANALYSIS
• Task analysis
• Cognitive task analysis
• Workload assessment
• Interviews
• Known use problems
GOALS: Identify required
task steps and potential for
optimization, identify user
interface characteristics
related to safety, identify
known and foreseeable
hazards and hazardous
situations
FUNCTIONAL
ANALYSIS
• Task analysis
• Cognitive task analysis
• Workload assessment
• Interviews
• Known use problems
GOALS: Identify required
task steps and potential for
optimization, identify user
interface characteristics
related to safety, identify
known and foreseeable
hazards and hazardous
situations
USE SCENARIO
SPECIFICATION
• Define use scenarios
• Define use-related
hazards
• Identify primary
operating functions
GOALS: Identify primary
operating functions and
identify safety critical use
scenarios, identify potential
to optimize user workflows
and specify workflows
USE SCENARIO
SPECIFICATION
• Define use scenarios
• Define use-related
hazards
• Identify primary
operating functions
GOALS: Identify primary
operating functions and
identify safety critical use
scenarios, identify potential
to optimize user workflows
and specify workflows
SPECIFY USER
INTERFACE
• Design specifications
• Prototyping
• Participatory design
• Usability acceptance
criteria
• Style guide
GOALS: Define user
interface and risk control
and risk mitigations incl.
packaging, labeling and
training
SPECIFY USER
INTERFACE
• Design specifications
• Prototyping
• Participatory design
• Usability acceptance
criteria
• Style guide
GOALS: Define user
interface and risk control
and risk mitigations incl.
packaging, labeling and
training
FORMATIVE
EVALUATION
• Expert reviews
• Heuristic analysis
• Design audits
• Cognitive walkthroughs
• Simulated and actual
use testing
GOALS: Answer open
questions from previous
steps, assess whether or
not the product supports
safe and effective use,
identify further use-related
hazards and unmet needs
FORMATIVE
EVALUATION
• Expert reviews
• Heuristic analysis
• Design audits
• Cognitive walkthroughs
• Simulated and actual
use testing
GOALS: Answer open
questions from previous
steps, assess whether or
not the product supports
safe and effective use,
identify further use-related
hazards and unmet needs
SUMMATIVE
EVALUATION
• Human factors
validation through
simulated use or actual
use testing
GOALS: Demonstrate that
the product can be used by
the intended users without
serious use errors or
problems, for the intended
uses and under the
expected use conditions
SUMMATIVE
EVALUATION
• Human factors
validation through
simulated use or actual
use testing
GOALS: Demonstrate that
the product can be used by
the intended users without
serious use errors or
problems, for the intended
uses and under the
expected use conditions
Source [4]
FDA RECOGNIZED
STANDARDS ON
HUMAN FACTORS
Standard Title Main Purpose
AAMI/ANSI HE75:2009 Human Factors Engineering – Design of
Medical Devices
Comprehensive reference that
includes general principles,
management of use error risk,
design elements, integrated
solutions
ANSI/AAMI/IEC 62366-1:2015 Medical devices – Part 1: Application of
usability engineering to medical devices
HFE/UE process applied to all
applying HF/usability to medical
device design, with consideration
of risk management
ANSI/AAMI/ISO
14971:2007/(R)2010
Medical Devices – Application of risk
management to medical devices
Risk management process for
medical devices
IEC 60601-1-6:2010 Medical electrical equipment –
Part 1-6: General requirements for basic
safety and essential performance –
Collateral standard: Usability
Provides a bridge between IEC
60601-1 and ANSI/AAMI/IEC
62366
IEC 60601-1-8 Edition 2.1
2012-11
Medical electrical equipment — Part 1-
8: General requirements for basic safety
and essential performance — Collateral
Standard: General requirements, tests
and guidance for alarm systems in
medical electrical equipment and
medical electrical systems
Design standard for alarm systems
in medical electrical equipment and
systems
IEC 60601-1-11:2010 Medical electrical equipment –
Part 1-11: General requirements for
basic safety and essential performance
– Collateral Standard: Requirements for
medical electrical equipment and
medical electrical systems used in the
home healthcare environment
Requirements for medical electrical
equipment used in non-clinical
environments, including issues
involving medical device use by lay
users.
Source [2]
LIST OF
SOURCES USED
IN THIS
PRESENTATION
• [1] Applying Human Factors and Usability Engineering to Medical Devices. Guidance for
Industry and Food and Drug Administration Staff. Issued: February 3rd, 2016. CDRH, FDA.
• [2] https://www.fda.gov/medicaldevices/deviceregulationandguidance/humanfactors/,
retrieved on October 24, 2018.
• [3] J. Ward & P. J. Clarkson, 2004. An analysis of medical device-related errors: prevalence
and possible solutions. Journal of Medical Engineering and Technology, 28(1): 2-21.
• [4] ANSI/AMMI/IEC 62366-1:2015. Medical devices – Part 1: Application of usability
engineering to medical devices.
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Dr. Andreas Baier | Director and Principal Human Factors ConsultantErgonomics Factory | Chemin de la Pepiniere 48 | 1095 Lutry | Switzerland
Phone: +41 213 11 11 00 | Mobile: +41 762 69 73 32
The information contained in this document is confidential and it is intended solely for the presentation of its contents through Ergonomics
Factory. Any dissemination, distribution, copying or disclosure of this document or its contents is strictly prohibited unless the prior written
consent of Ergonomics Factory GmbH has been obtained.