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

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