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 Applying Human Factors
and Usability Engineering
to Medical Devices:
Guidance for Industry and
FDA Staff
Shannon Hoste, MSSE,MSM,RAC

Xin Feng, Ph.D.

Hanniebey Wiyor, Ph.D.

 Overview

• Relevant regulations and standards

• FDA’s Human Factors guidance
• List of highest priority devices for
human factors review – draft
guidance

3
 Regulatory Basis for HF at FDA
21 CFR 820.30…
(c) Design Input… design requirements “address the intended
use of the device, including the needs of the user and
patient”…

(f) Design Verification…“confirm that the design output

meets the design input requirements”…

(g) Design Validation…”ensure that devices conform to

defined user needs and intended uses and shall include
testing of production units under actual or simulated use
conditions. Design validation shall include software validation
and risk analysis, where appropriate.”
4
 Regulatory Basis for HF at FDA
Medical Devices; Current Good Manufacturing Practice (cGMP);
Quality System Regulation Preamble to Final Rule 21 CFR Parts
808, 812, and 820 (61 FR 52502)
i.72. …”when designing a device, the manufacturer should
conduct appropriate human factors studies, analyses, and tests
from the early stages of the design process until that point in
development at which the interfaces with the medical
professional and the patient are fixed..”
i.159. … “FDA emphasizes that any death, even if the
manufacturer attributes it to user error, will be considered
relevant by FDA and will have a high risk potentially associated
with it. User error is still considered to be a nonconformity
because human factors and other similar tools should have been
considered during the design phase of the device.”
5
 Human Factors Standards
AAMI/ANSI HE75:2009
• General considerations and
principles
– Managing the risk of use error
– Usability testing
• Design elements
– Controls
– Software
• Integrated solutions
– Mobile medical devices
– Home health care
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 Human Factors Standards

ANSI/AAMI/IEC 62366 1:2015

Medical devices – Part 1:
Application of usability
engineering to medical devices

• Usability engineering process

• Accompanying document
• Training

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 Human Factors Standards
ANSI/AAMI/ISO
14971:2007 [R2010]
Medical devices –
Application of risk
management to medical
devices
• Risk management
• Risk analysis
• Risk evaluation
• Evaluation of overall
residual risk acceptability
8
 2015 FDA HF Guidance
Applying Human Factors
and Usability
Engineering to Medical
Devices
As of April 3, 2016, this
document supersedes
“Medical Device Use-Safety:
Incorporating Human Factors
Engineering into Risk
Management” issued July 18,
2000.
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 Overview of changes from the 2011
Draft HF Guidance
Scope aims to clarify expectations around when to
submit a HF report with a premarket submission
“CDRH recommends that manufacturers consider human
factors testing for medical devices as a part of a robust
design control subsystem. CDRH believes that for those
devices where an analysis of risk indicates that users
performing tasks incorrectly or failing to perform tasks
could result in serious harm, manufacturers should
submit human factors data in premarket submissions
(i.e., PMA, 510(k)).”
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 Overview of changes from the 2011
Draft HF Guidance
Key terms (from Section 3 Definitions):
• Critical task - A user task which, if performed incorrectly
or not performed at all, would or could cause serious
harm to the patient or user, where harm is defined to
include compromised medical care.
• User interface - All points of interaction between the user
and the device… (including packaging, labeling, and
training) and all physical controls and display elements…

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 Define intended users, use
Device Users, Use Environments
environments and user
and User Interface (Section 5)
interface

Identify use-related hazards Preliminary Analyses and

Evaluations (Section 6)

Identify and categorize critical

tasks

Develop and implement risk Elimination or Reduction of Use-

mitigation/control measures Related Hazards (Section 7)

Validate use safety and Human Factors Validation Testing

effectiveness (Section 8)

Use-related
NO risks
acceptable?

YES

New use-
related risks YES
introduced?

NO

Document HFE/UE process Documentation (Section 9)

 Human Factors of Device Use

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 Device Use

20
Device User Interface (adapted from Redmill and Rajan, 1997)
 Define intended users, use
Device Users, Use Environments
environments and user
and User Interface (Section 5)
interface

Identify use-related hazards Preliminary Analyses and

Evaluations (Section 6)

Identify and categorize critical

tasks

Develop and implement risk Elimination or Reduction of Use-

mitigation/control measures Related Hazards (Section 7)

Validate use safety and Human Factors Validation Testing

effectiveness (Section 8)

Use-related
NO risks
acceptable?

YES

New use-
related risks YES
introduced?

NO

Document HFE/UE process Documentation (Section 9)

 Preliminary Analyses and
Evaluations
• Critical tasks identification and categorization:
– Categorize the user tasks based on the severity of the
potential harm
– Warnings, precautions and contraindications in the
labeling should be included in the risk assessment
– Examples of risk analysis tools
• Failure mode effects analysis (FMEA)
• Fault tree analysis

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 Preliminary Analyses and
Evaluations
• Sources of known use-related problems
– Customer complaint files, knowledge of training and
sales staff familiar with use-related problems
– Previous HFE/UE studies
– Current device users, journal articles, relevant
internet sites, such as:
• FDA’s Manufacturer and User Facility Device
Experience (MAUDE) database
• FDA’s MedSun: Medical Product Safety Network
23 • CDRH Medical Device Recalls
 Preliminary Analyses and
Evaluations
• Analytical approaches involve review and assessment
of user interactions with the devices
– Task analysis
– Heuristic analysis
– Expert review
• Empirical approaches derive data from users’
experiences interacting with the device or device
prototypes or mock-ups
– Contextual inquiry
– Interviews
– Formative evaluations (e.g. cognitive walk-through,
24 simulated-use testing, etc.)
 Define intended users, use
Device Users, Use Environments
environments and user
and User Interface (Section 5)
interface

Identify use-related hazards Preliminary Analyses and

Evaluations (Section 6)

Identify and categorize critical

tasks

Develop and implement risk Elimination or Reduction of Use-

mitigation/control measures Related Hazards (Section 7)

Validate use safety and Human Factors Validation Testing

effectiveness (Section 8)

Use-related
NO risks
acceptable?

YES

New use-
related risks YES
introduced?

NO

Document HFE/UE process Documentation (Section 9)

 Elimination or Reduction of Use-
Related Hazards
• Address use-related hazards by applying risk management
strategies
– Inherent safety by design
– protective measures
– information for safety
• Design modifications are generally the most effective
means for controlling eliminating or reducing use-related
hazards
• Test to assess whether mitigation strategies:
– Effectively reduced the known risks and did not introduce any
26 new risks
 Define intended users, use
Device Users, Use Environments
environments and user
and User Interface (Section 5)
interface

Identify use-related hazards Preliminary Analyses and

Evaluations (Section 6)

Identify and categorize critical

tasks

Develop and implement risk Elimination or Reduction of Use-

mitigation/control measures Related Hazards (Section 7)

Validate use safety and Human Factors Validation Testing

effectiveness (Section 8)

Use-related
NO risks
acceptable?

YES

New use-
related risks YES
introduced?

NO

Document HFE/UE process Documentation (Section 9)

 Human Factors Validation Testing

• Demonstrates that the device can be used by the

intended users, under expected use conditions, without
serious use errors or problems
• Testing should be designed as follows:
– The test participants represent the intended (actual)
users of the device.
– All critical tasks are performed during the test
– The device user interface represents the final design
– The test conditions are sufficiently realistic to
represent actual conditions of use
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 Test Participants
• Test participants should represent the population of
intended users
• In general, the minimum number of participants
should be 15 for each distinct population;
– examples of distinct populations: Pediatric and adult,
Healthcare providers and lay users
• Your employees should not serve as test participants
• The test participants should reside in the U.S.
Exceptions to this are considered on a case-by-case
basis.

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 Tasks and Use Scenarios
• Tasks that logically occur in sequence when using the
device can be grouped into use scenarios
• Use scenarios in the testing should be organized to
represent a natural workflow
• Prior to testing, you should define user performance that
represents success for each task
• Critical tasks that have a low frequency of occurrence
require careful consideration and should be included in
the testing
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 Instructions for Use
• The labeling used in the human factors validation testing
should represent the final designs
• The human factors validation testing can indirectly assess
the instructions for use for the device, but only in the
context of use of the device
• Stating that you mitigated the risks by modifying the
instructions for use is not acceptable, unless you provide
additional test data demonstrating that the modified
elements were effective in reducing the risks to
acceptable levels
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 Participant Training
• The training provided to the human factors validation test
participants should approximate the training that actual
users would receive
• Stating your intention to mitigate the risks by providing
“additional training” is not acceptable unless you provide
additional data that demonstrates that it would be
effective in reducing the risks to acceptable levels
• Minimum one hour training decay should be included;
longer time would be appropriate when it is necessary to
evaluate training decay as a source of use-related risk
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 Data Collection (Objective)
• Observational data
– observations of participants’ performance of all the
critical use scenarios (which include all the critical
tasks)
• Knowledge task data
– Comprehension of interface components involved in
knowledge tasks are usually the user manual, quick
start guide, labeling on the device itself, and training

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 Data Collection (Subjective)
• Interview data
– Participant feedback considering the overall device and
then focused on each critical task or use scenario
– Participant assessment of any use difficulties,
confusions or errors that were experienced during the
test
– Participant assessment of root cause for any observed
or participant reported use difficulties, confusions or
errors
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 Analysis of Human Factors
Validation Test Results
• Analyze qualitatively by aggregating objective and
subjective data to:
– Identify potential use errors
– and determine the root causes
• Address use errors and problems through risk
management strategies
• Conduct human factors (re-)validation testing on the
modified user interface elements

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 Actual Use Testing

• When actual-use testing is determined to be necessary

(rare) to ensure safe use of the proposed device, an
Investigational Device Exemption (IDE) may be required.
– Actual-use testing can also be conducted as part of a
clinical study.
– it is inadequate to depend solely on self-reports data
since these data can be incomplete or inaccurate

39
 Define intended users, use
Device Users, Use Environments
environments and user
and User Interface (Section 5)
interface

Identify use-related hazards Preliminary Analyses and

Evaluations (Section 6)

Identify and categorize critical

tasks

Develop and implement risk Elimination or Reduction of Use-

mitigation/control measures Related Hazards (Section 7)

Validate use safety and Human Factors Validation Testing

effectiveness (Section 8)

Use-related
NO risks
acceptable?

YES

New use-
related risks YES
introduced?

NO

Document HFE/UE process Documentation (Section 9)

 Human Factors Recommended
Report Outline
1. Conclusion
2. Description of Intended device users, uses,
environments and training
3. Description of device user interface
4. Summary of known use problems
5. Analysis of risks associated with use of the device
6. Summary of preliminary analyses and evaluations
7. Description and categorization of critical tasks
8. Details of human factors validation testing
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 When to submit…

From the 2015 HF Guidance scope:

“In an effort to make CDRH’s premarket submission
expectations clear regarding which device types should
include human factors data in premarket submissions,
CDRH is issuing a draft guidance document List of Highest
Priority Devices for Human Factors Review, Draft
Guidance for Industry and Food and Drug Administration
Staff. When final, this document will represent the
Agency’s current thinking on this issue.”

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 List of Highest Priority Devices for
Human Factors Review Draft Guidance
• FDA is issuing this guidance document in order to inform
medical device manufacturers which device types should
have human factors data included in premarket
submissions (i.e., for PMA, 510(k) and related Pre-
submissions).
• For devices that should include human factors data in
premarket submissions, as listed here, manufacturers
should provide FDA with a human factors report

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 List of Highest Priority Device Types
• Ablation generators (associated with • Hemodialysis and peritoneal dialysis
ablation systems, e.g., LPB, OAD, OAE, systems (e.g., FKP, FKT, FKX, KDI, KPF, ODX,
OCM, OCL) ONW)
• Anesthesia machines (e.g., BSZ) • Implanted infusion pumps (e.g., LKK, MDY)
• Artificial pancreas systems (e.g., OZO, OZP, • Infusion pumps (e.g., FRN, LZH, MEA, MRZ)
OZQ) • Insulin delivery systems (e.g., LZG, OPP)
• Auto injectors (when CDRH is lead Center; • Negative-pressure wound therapy (e.g.,
e.g., KZE, KZH, NSC ) OKO, OMP) intended for use in the home
• Automated external defibrillators (e.g., • Robotic catheter manipulation systems
MKJ, NSA ) (e.g., DXX)
• Duodenoscopes (on the reprocessing; e.g., • Robotic surgery devices (e.g., NAY)
FDT) with elevator channels • Ventilators (e.g., CBK, NOU, ONZ)
• Gastroenterology-urology endoscopic • Ventricular assist devices (e.g., DSQ, PCK)
ultrasound systems (on the reprocessing;
45 e.g., ODG) with elevator channels
 How this List Should be Used for
Premarket Submissions
• For device types on the list: Any premarket submission for
the device types listed above should include either a
human factors test report and data or should provide a
detailed rationale that supports the conclusion that
human factors data are not necessary.

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 How this List Should be Used for
Premarket Submissions
• For device types not on the list: ODE may also determine
that human factors data are needed in a specific
premarket submission on a case-by-case basis when one
or more of the following apply:
– Submission type
– User interface modification
– Different users
– Recalls, adverse events, and problem reports
– Device modifications
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 Advice: Consult FDA Early

• Discuss product development plans with FDA before your

design is finalized (and changes would be difficult)
• FDA encourages manufacturers to submit a draft of the
human factors testing protocol prior to conducting the
test. The premarket mechanism for this is a Pre-
submission.

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 Questions

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 Questions?
General questions about human factors and usability engineering
processes?
Contact CDRH's Division of Industry and Consumer Education (DICE)
at [email protected], 1-800-638-2041, or 301-796-7100

Questions about following appropriate human factors and usability

engineering processes in a specific device?
Contact CDRH Human Factors team at [email protected]

Slide Presentation, Transcript and Webinar Recording will be

available at:
http://www.fda.gov/training/cdrhlearn
Under “Specialty Technical Topics” Heading 50