applying human factors engineering (hfe) to produce safe ... · automated external defibrillator...
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UL and the UL logo are trademarks of UL LLC © 2013
Applying Human Factors
Engineering (HFE) to
Produce Safe and Effective
Medical Devices
Presented by:
Jon Tilliss
Design Director (US) – Human Factors Engineering
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My background
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Jon Tilliss
BS, Masters in Digital Media/Interactive Design
Design Director - US / New Business Manager
Joined Wiklund Research & Design in 2007 (acquired by UL in 2012)
Lecturer – Tufts University
Co-Author: Summative Usability Testing of Medical Devices, AAMI Horizons, 2010
Based in Concord, Massachusetts / USA
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Our business is human factors engineering (HFE)
We help clients ensure the quality of interaction between people and their devices / machines / systems.
• Safe
• Effective
• Efficient
• Satisfying
• Fun
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We focus on medical technology
• Therapeutic devices (e.g., insulin pump, heart assist device, dialysis machine, nerve stimulator, RF ablation catheter)
• Diagnostic devices (e.g., X-ray machine, ultrasound scanner, optical coherence tomography system )
• Critical care devices (e.g., ventilator, defibrillator, anesthesia machine, balloon pump)
• Combination products (e.g., auto-injector, inhaler, nebulizer)
• Lab instruments (e.g., blood analyzer, PSA tester, cancer cell screening system)
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HFE activities
Research
• Observations
• Interviews
• Surveys
Analyses of…
• Anthropometrics
• Use-related risks
• Functions and tasks
• Hazards
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HFE activities
Design and prototyping of…
• Software
• Hardware
• Documents
Evaluation / usability testing
• Critiques
• Usability tests
General
• HFE program development
• Adverse event analysis
• HFE education
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Anesthesia workstation
Auto-injector
Automated external defibrillator
Blood bag
Blood gas analyzer
Blood vessel imaging system
Cardiac ablation catheter
Catheter
Cerebral oximeter
CPR assist device
Drug vial
Drug reconstitution system
Endoscopic instrument
Glucose meter
Heart pump
Hemodialysis machine
Patient monitor
Patient warmer
Pen-injector
Peritoneal dialysis machine
Pill dispenser
Proton beam radiotherapy system
PSA analyzer
Pulse oximeter
Respiratory therapy system
Surgical robot
Surgical suction machine
Syringe pump
Telemetry system
Urinary catheter
Ventilator
X-ray machine
Medical device portfolio (sample)
Hospital bed and scale
Hospital intercom
Infusion pump
Infusion set
Inhaler
Insulin pump
IV solution bag
Left ventricular assist device
Metered dose inhaler
Microscope
Morcellator
MRI scanner
Nebulizer
Nerve stimulator
Nurses’ central monitor
OCT system
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Our publications Books, magazine articles, sections of HFE standards, webinars
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HUMAN FACTORS ENGINEERING
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Human factors engineering (HFE)
Sure, it’s part common sense.
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Human factors engineering (HFE)
Sure, it’s part common sense.
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Human factors engineering (HFE)
We see evidence of human factors
engineering all around us.
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Task: Open a tin can
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Can opener
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Can opener
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Task: Drill a hole
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Electric drill
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Electric drill
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Task: Deliver an injection
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Syringe
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Syringe
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Task: Induce anesthesia
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Anesthesia delivery system
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Anesthesia delivery system
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Task: Determine if patient has fractured skull
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X-ray machine
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X-ray machine
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Task: Deliver insulin on a continuing basis
28 Source:
http://socialportal.ballywhointeractive.com/images/uploads/Diabetes%20definition%28
1%29.jpg
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Insulin pump
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Insulin pump
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HFE specialists improve medical devices by…
• Studying how people interact with devices to
generate requirements and validate solutions.
• Matching devices to people’s bodies, for
example size, strength, and range of motion.
• Matching devices to people’s minds, for
example reaction time, memory capacity, and
processing pace.
• Presenting displays and controls in a task-
oriented manner.
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Let’s take a step back and discuss human
factors engineering.
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What is human factors engineering?
Human factors engineering (HFE) blends
engineering, design, and psychology.
Early work focused on manufacturing
efficiency.
For several more decades, focused on
hardware.
HFE discipline expanded as software
usability became an issue.
Adverse events in healthcare stimulated the
application of HFE in medical device
development.
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Adverse events stimulate interest in HFE
Adverse events in healthcare stimulated the
application of HFE in medical device
development.
Over the past 30 years…
"... anesthesiology has successfully reduced
anesthesia mortality rates from two deaths
per 10,000 anesthetics administered, to one
death per 200,000 to 300,000 anesthetics
administered.” IOM Report, 1999
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Let’s consider specific human factors
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Sample human factors
Vision
Inserting a guidewire in a catheter
Determining fluid level in collection bag.
Reading the vital signs on patient monitor.
Reading an injector’s dose setting.
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Normal Cataract Retinopathy
Glare on screen Deuteranope Macular Degeneration
Sample human factors
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Sample human factors
Normal view
Not wearing reading glasses
Dim lighting conditions
Color vision impaired
(deuteranope: red/green)
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Hearing
Detecting an alarm.
Detecting a change signal tone indicating a
patient’s oxygen saturation level is dropping.
Hearing the audible feedback produced by a
button press.
CLICK
Sample human factors
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250 Hz 500 Hz 1000 Hz
2000 Hz 4000 Hz 8000 Hz
Presbycusis, a form of age-related high frequency hearing loss, makes it
difficult to hear tones above 3000 Hz
Sample human factors
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Sample human factors
Source: http://hydrogen.physik.uni-
wuppertal.de/hyperphysics/hyperphysics/hbase/sound/imgso
u/audiom2.gif
High Frequency Hearing Loss
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Memory
Remembering the proper steps on how to
open a package and present the contents
to those working in the sterile field
Remembering to document parameter
values on patient record.
Setting alarm limits at the appropriate
level.
Finding the menu option that leads to a list
of dose delivery dates, times, and
amounts.
Sample human factors
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Try to remember these numbers:
4, 36, 92, 31
Sample human factors
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Sample human factors
Now try to remember these numbers:
44, 65, 11, 96, 28, 2, 20, 87
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It is important to recognize limits
When the numbers 1 through 9 appeared randomly on a screen and then disappeared,
the chimpanzee was able to recall the exact sequence and location of each number.
A select few humans have such abilities, but these are typically people with savant
syndrome, which is accompanied by severe mental disabilities; it's simply beyond the
powers of an ordinary human…
Source: http://www.huffingtonpost.com/2013/02/17/chimpanzee-memory-study-short-term_n_2703588.html
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Anthropometrics
Making catheters easy to grasp and
manipulate.
Fitting an oral endotracheal tube to a
patient’s face.
Reaching the controls on an X-ray machine.
Tearing open a disposable device’s
package.
Holding a pen injector comfortably using one
hand.
Grasping and manipulating the hand control
for a surgical robot.
Sample human factors
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Hand breadth:
5th %-tile female: 7.3 cm
95th %-tile male: 9.8 cm
Hand length:
5th %-tile female: 16.5 cm
95th %-tile male: 21.1 cm
Source:
http://upload.wikimedia.org/wi
kipedia/en/thumb/f/fc/HandAn
thropometry.JPG/563px-
HandAnthropometry.JPG
Sample human factors
Anthropometrics (continued)
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What is usability?
Source; http://blog.meekrocks.com/wp/wp-
content/uploads/2012/09/Man-Thinking.gif
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Usability:
Usability is a product attribute. It is the integrated
result of many design features that act collectively
to serve to smooth the interaction between user
and product. A usable product serves its intended
purpose well. Users feel satisfied when they use
the product. There is no perception of task
hindrance.
Usability can be quantified.
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THE IMPERATIVES
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In the absence of good HFE use errors
• Torn catheter
• Tube and cable misconnection
• Undetected alarm
• Incorrect data entry
• Components assembled wrong
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[User] interface is key to the user experience
Goal is to create a safe,
effective, usable, and
satisfying device.
Meeting this goal rides on
producing a high-quality
user interface
Image source: FDA
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HFE Process Characteristics (one example)
• Iterative
• Increasing level of
prototype fidelity
• Multiple formative
usability tests
• Addresses use-related
risks early and repeatedly
• Culminates in claim that
residual, use-related risk
associated with device is
acceptable
Note: Illustrated process is a simplified depiction.
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A need to integrate HFE and risk analysis
• User interactions with a medical
device may be safe or pose risks.
• Developers must consider a wide
range of possibly harmful use errors
and their potential consequences.
• Developers must implement risk
control measures and prove that they
work.
Image source: FDA
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Adverse outcome – overdose
55
On Sunday, May 28, 2000, the Tallahassee
Democrat (FL) reported that a 19-year-old
mother died hours after a routine cesarean
section when a nurse accidentally mis-
programmed an Abbott Lifecare PCA Plus
II Infusion pump.
The nurse apparently set the pump’s
concentration setting lower than the
concentration of the narcotic loaded into
the pump. For every 1 mL of narcotic
solution that the pump delivered, the
patient received an amount of drug that
was severalfold greater than prescribed.
Source: Institute for Safe Medication Practices, June 2000. “Death by decimal.”
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Adverse outcome – electrocution
56
Five cases of electrical injury to
young children caused by
misuse of components of home
cardiorespiratory monitors are
reported. The injuries, which
included one electrocution,
occurred when partially or
completely disconnected
electrode wires were inserted,
by an older monitored child or
preschool-aged sibling, into a
live power cord or an uncovered
wall outlet.
Source: Pediatrics, Nov. 1986.
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Adverse outcome – cardiac arrest
57
Injuries and deaths have been reported
due to excessive ultrafiltration (fluid being
removed from the patient's body). This
problem can occur when a user (nurse)
repeatedly overrides alarms triggered by
the machine’s fluid exchange measuring
system. In one case, the nurse overrode
over two dozen alarms, while the patient
became hypovolemic, hypotensive, and
ultimately died.
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Adverse outcome – fatal lung damage
58
Stryker Instruments has received two
reports of serious injury as a result of
tissue damage associated with the use of
the Neptune 2 device, including an event in
which one customer connected the
Neptune 2 System to a passive chest
drainage tube postoperatively resulting in a
fatality. (FDA)
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Business impacts
• Higher development costs
• Increased time to market
• Recalls, embargos, bans
• Damaged reputation
• Lost sales
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Imperative to apply HFE
Now, the FDA and other regulatory agencies
expect that medical devices will reflect good HFE.
Applying HFE is a cornerstone of overall risk
management.
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REGULATORY PERSPECTIVE
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Timeline
1993: ANSI/AAMI HE48:1993 (design guidelines)
1995: Joint AAMI and FDA conference on HF
1996: Quality System Regulation (QSR); indirect requirements for HFE added
1997: End of “grace period” to incorporate HFE in medical device design process
1999: IOM report on medical error
2001: ANSI/AAMI HE74:2001 (HFE process standard)
2006: IEC 60601-1-6 collateral standard (AAMI HE74 is informative annex)
2007: ISO/IEC 62366:2007 (AAMI HE74 included as informative annex)
2008: EU adopts ISO/IEC 62366:2007 as basis for CE mark
2008: FDA’s HFE team moves into Office of Device Evaluation
2009: ANSI/AAMI HE75:2009 (HFE methods and design guidelines)
2011: FDA publishes draft HFE guidelines
2012: Adoption of 3rd edition of IEC 60601 by Europe and Canada
2013: Adoption of 3rd edition of IEC 60601 by USA
2015: ISO/IEC 62366-1: 2015 (conformance clauses)
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FDA’s Draft Guidance
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IEC 62366 February 2015
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New IEC 62366 has two parts
Part 1
• Conformance clauses
• Released in March 2015
• TRF (Technical Review Form) not yet released
Part 2
• Tutorial on applying HFE to medical devices (best
practices)
• Expected to be released in late 2015 or early 2016
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Key changes
• Focused on use-safety
• No longer focused on usability per se
• Need for an HFE program plan no longer explicit
• “Application Specification” is now “Use Specification”
• “Usability Specification” is now “User Interface
Specification”
• No requirement to identify primary and frequent functions
• No suggestion to set usability goals, acceptance criteria
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Basic expectations
• Implement an HFE program
• Define intended users, use environments, potential hazards,
potential use errors, and use-related risk
• Mitigate use-related risk
• Validate user interface designs, proving risk control measures work
• Document HFE activities and outcomes
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Subpart C -- Design Controls, § 820.30 Design controls. The need for human
factors techniques or data in the design process is implicit in paragraphs c, f, and
g of Section 820.3.
( c ) Design input: "Each manufacturer shall establish and maintain procedures to
ensure that the design requirements relating to a device are appropriate and
address the intended use of the device, including the needs of the users and
patient.”
( f ) Design verification: "Each manufacturer shall establish and maintain
procedures for verifying the design input. Design verification shall confirm that
the design output meets the design input requirements.”
( g ) Design validation:Design validation shall ensure that devices conform to
defined user needs and intended uses, and shall include testing of production
units under actual or simulated use conditions."
Quality System Regulation (Effective Date: June 1, 1997)
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FDA provides more detailed HFE guidance
In Applying Human Factors and Usability Engineering to Optimize Medical Device Design, issued on June 22, 2011, FDA states: The intent is to improve the quality of the device user interface such that errors that occur during use of the device are either eliminated or reduced.
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• FDA now expects manufacturers to
submit an HFE Report that takes
stock of the entire HFE process.
• FDA outlines the report in Applying
Human Factors and Usability
Engineering to Optimize Medical
Device Design, Draft Guidance,
June 2011, Appendix A.
Human Factors Engineering Report
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HFE applicability
FDA expects manufacturers to follow good HFE practices when:
• Developing a device for clinical trial (IDE)
• Enhancing an existing device (510(k))
• Developing a next generation device (510(k))
• Developing an altogether new device (PMA)
• Analyzing an adverse event (post-market surveillance)
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HFE PROCESS
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Usability engineering activities
• Prepare use specification
• Identify user interface characteristics related to safety and potential use errors
• Identify known or foreseeable hazards and hazardous situations
• Identify and describe hazard-related use scenarios
• Select hazard-related use scenarios for summative evaluations
• Establish user interface specification
• Establish user interface evaluation plan
• Perform user interface design, implementation, and formative evaluation
• Perform summative evaluation of the usability of the user interface
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Scaling based on complexity and risk
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Scaling based on complexity and risk
Functional Complexity
Po
tential fo
r H
arm
ful U
se E
rrors
Low High
Lo
w
Hig
h
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Scalable HFE activities and decision factors
User research
• Number of users, use environments,
and use scenarios warranting
investigation
• Number of locations in which to
conduct research
• Number of research types
Usability specification and
verification
• Number of user requirements
Risk analysis
• Number of users, use environments,
and use scenarios to consider
User interface design
• Extent of user interactions
• Number of risks requiring mitigation
• Number of design iterations
Usability testing
• Number of formative usability tests
• Size of test participant sample (i.e.,
number of distinct user groups)
• Number of locations in which to
conduct research
• Number of tasks performed with
hardware, software, and/or learning
tools
• Extent of report
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Sample user profile: registered nurses
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Sample user profile: registered nurses
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Use environment description (sample)
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Use environment description (sample)
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Pediatric intensive care unit
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Operating room
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Ambulance
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Dialysis clinic
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Doctor’s office
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Home – living room
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Home - bathroom
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Office
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Automobile
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Task analysis
Deconstruct an overall user interactions with a device into
its myriad components: perceptions (P), cognitive processes
(C), and actions (A). Yields: PCA analysis.
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Use errors derived from task analysis
• User inserts wrong test strip
• User inserts test strip in wrong
orientation
• User inserts test strip in wrong port
• User damages test strip during handling
• User applies blood to wrong part of test
strip
• User applies too much blood to test strip
• User applies too little blood to test strip
• User does not select re-test when
prompted
• User does not remove used strip from
meter
• User misreads the blood glucose
readout
• User mistakes units of measure as
mmol/L versus mg/dL
•
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Risk analysis steps
Source: IEC 62366, Figure F.1 – Pictorial representation
of the relationship of HAZARD , sequence of events,
HAZARDOUS SITUATION and HARM
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Use-FMEA
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Advisory message
Audible feedback
Clear instructions
Color coding
Confirmation message
Emergency power cutoff
Familiar symbol
Lack of parting lines
Large label
Interlock
Needle guard
Non-glare display
Orientation cue
Quick reference card
Resistance force
Setting limits
Shape coding
Size coding
Switch cover
Tactile feedback
Textured grip
Training
Warning label
Warning light
Wider pushbutton spacing
Cable/tube strain relief
Sample risk mitigations
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Matching requirements to UI features
Requirement User interface feature
The device shall have
an immediately
accessible emergency
stop button.
Red switch on front
panel
Audible alarms shall be
audible in noisy
environments
80 dBA, 2000 Hz, saw
tooth waveform
The device shall
continuously indicate the
battery power level
Battery icon displayed
on all screens
Hardware key centers
shall be spaced at least
0.75 inches apart
Hardware key centers
spaced ≤ 0.75 inches
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Life of a use error
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Usability Test Basics
Representative users
+
Representative tasks
+
Representative environment
+
Representative device
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Formative usability testing
Formative / formation / form
Focuses on a design-in-
progress, identifying
interactive strengths and
opportunities for further
improvement.
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Summative (validation) usability testing
Summative / summation /
sum
Focuses on a production-
equivalent device (i.e.,
refined prototype).
Serves primarily to
determine if use-related risk
mitigations are effective.
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Select a sample size
• Formative tests typically involve ≤12
participants, yielding excellent insights
while preserving resources for
additional tests.
• Summative tests typically involve
either 15 participants per distinct user
group.
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Usability testing scenes
101
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Validation
A manufacturer should ensure that the user interface design
is valid satisfying all criteria stated in the validation plan; that
the device is the right one to serve its intended purpose.
A manufacturer must generate evidence that a device (a) is
not vulnerable to potentially harmful use errors and patterns
of operational difficulties that reduce its effectiveness, and
(b) meets the established usability goals (i.e., acceptance
criteria).
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Excerpted from: Applying Human Factors and Usability Engineering to
Optimize Medical Device Design
FDA’s guidance calls for an HFE/UE report
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• FDA specifically describes
the content that belongs in
a HFE Report.
• Manufacturers not required
to comply with HFE Report
outline, but the report
should include the
requested contents.
HFE report outline
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Good HFE Process
Good HFE Report
Poor HFE Process
Poor HFE Report
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“device is adequately safe and effective for
the intended users, its intended uses, and use
environments.”
Claim
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Conclusion
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Experience suggests…
• HFE is cost-effective
• Existing staff can perform a substantial amount of HFE
work, but specialists are needed at times
• HFE, if implemented in a timely manner, is not a
paperwork exercise. It leads to better devices.
• HFE offers commercial advantages.
• Today, HFE is a mandate rather than an option.
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UL and the UL logo are trademarks of UL LLC © 2013
Questions?
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Contact information
UL – Wiklund R&D
300 Baker Avenue
Concord, Massachusetts 01742 USA
Telephone: 001 (978) 371–2700
URL: www.ul.com/ul-hfe
Management team:
Michael Wiklund General Manager – Human Factors Engineering, E: [email protected] Jonathan Kendler Design Director – Human Factors Engineering, E: [email protected] Jon Tilliss Design Director (US) – Human Factors Engineering, E: [email protected] Allison Strochlic Research Director – Human Factors Engineering, E: [email protected]