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Received September 18, 2024, accepted June 23, 2025, date of publication September 16, 2025.

Review

Application of Usability Techniques in Medical Devices in 
Health Technology Management: A Rapid Review

Mariana Brandão†,* and Renato Garcia†

Institute of Biomedical Engineering (IEB-UFSC), Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.

† These authors contributed equally to this work.

* Corresponding Author Email: marianaribeirobrandao@gmail.com

ABSTRACT

The role of clinical engineering in health technology management (HTM), incorporating human factors engineering tools, 
such as usability techniques, allow for improvements in the development of safer, more effective, and quality use of technological 
solutions. This work resulted in a rapid review of the application of usability techniques to contribute to the development and 
use of technological solutions for health, so that the occurrence of adverse events can be mitigated. As a consequence, informa-
tion can be provided for improvements in health technology processes, in order to stimulate and highlight the importance of 
human factors in health. In order to understand the application of usability techniques in clinical engineering throughout the life 
cycle of HTM, an exploratory study was done on the literature involving medical devices. This work reinforces the importance of 
applying techniques to identify the problems faced in the use of technologies and thereby contribute to the activities of clinical 
engineering so as to reduce errors and failures. The integration and consideration of human factors in the life cycle of HTM is 
essential for the further advancement of clinical engineering in technology management throughout the healthcare ecosystem, 
and also in the discussion, construction, and validation of strategies that will help in preventing adverse events. 

Keywords—Clinical engineering, Human factors engineering, Usability techniques, Health technology management, 
Health technology assessment.    

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Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
Review

INTRODUCTION 

Technological advances have enabled a rapid increase 
in the use of medical equipment in healthcare facilities.1 
As a result of this growth in the frequency of use of health 
technologies, it has become necessary to incorporate pro-
cesses that help with technological management throughout 
the life cycle, from the development and manufacturing 
stages to incorporation and use in health services. Health 
technology management (HTM), in order to make patient 
care more effective and with greater safety and quality, 
must encompass and consider the entire context in which 
the technology is incorporated, and is essential to make 
its use more appropriate and reliable. The Institute of 
Biomedical Engineering at the Federal University of Santa 
Catarina (IEB-UFSC) has a management model based on 
three main pillars: infrastructure, human resources, and 
technology, thus providing a systemic assessment of the 
technological resource2. 

Health technologies are essential for monitoring, therapy, 
and diagnosis of diseases, but their use can cause adverse 
events for users. The main problems that could lead to 
adverse events are differences in functionality between 
technologies from different manufacturers; lack of stan-
dardization3; inefficient maintenance services; inadequate 
planning for incorporation; inefficient technology design; 
problems arising from hidden flaws; inadequate use; fail-
ure to take human factors and user ergonomics principles 
into account when developing technological solutions4; 
unsatisfactory instructions or training; improper storage 
and/or improper use; inadequately structured manage-
ment procedures5,6; incorrectly used accessories; displays 
showing results that are difficult to read; and incorrectly 
changed alarm settings.7

Studies that address technology–user interaction often 
neglect the human factors’ perspective, but because of an 
increase in technological complexity in healthcare, the 
need to implement research in this area has also grown 
proportionally.8 Usability and user experience is essential in 
healthcare8, and can solve usage problems, increase safety, 
reduce incidents that cause harm to patients, and provide 
greater reliability in the use of technology in healthcare 
environments.7,9 Applying usability techniques at different 
stages of the life cycle makes it possible to contribute to 

technological development more safely. In addition, they 
can be applied to different types of technology and help to 
improve use and mitigate likely risks to users in HTM.10 

One of the requirements to be considered in the 
process of evaluating and developing new technological 
solutions in healthcare is usability, which establishes a 
relationship between the characteristics of human factors 
with ease of use, efficiency, and user satisfaction during 
the use of technology.8,11,12 When considering human 
factors in clinical engineering, the ability of users to use 
technological resources in a safer and more effective way 
is considered, according to the real contexts of healthcare 
environments.13 The area of study of human interaction 
with other elements of a system to achieve adequate us-
ability is called human factors engineering (HFE), which 
is fundamental for analyzing human behavior in the face 
of new technologies and establishing improvements in 
protocols for use in health services.7,11,14 Investigating 
human behavior, considering their limitations, abilities, 
and interactions with the environment, helps to improve 
safety, efficacy, and quality in HTM.9,15

HFE

The area responsible for applying knowledge about the 
characteristics and limitations of people with technologies, 
processes, and environments is called HFE.7,9 The focus of 
HFE is to understand how people interact with technology 
and to study how design affects the interactions that people 
have with technology.9 It is therefore a strategic tool to be 
incorporated into the activities of clinical engineering in 
HTM. The tool used to evaluate human interaction with 
a product is usability, and its consideration in healthcare 
is fundamental.8 Most researchers agree that usability is 
a useful tool for evaluating the user experience,8 which 
consists of an approach that goes beyond the design of 
the interface, and encompasses the system, the user and 
their characteristics, and the context of use of the tech-
nologies or system.16 

Usability, as defined by the NBR ISO 9241-11:2011 
and NBR IEC 62366:2016 standards, is a metric used to 
measure how well a product can be used by certain users 
and achieve specific objectives, by considering param-
eters such as effectiveness, efficiency, and satisfaction in 
a given context of use.11,12 The interaction between the 



Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
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J Global Clinical Engineering Vol.7 Issue 3: 2025 62

components involved in establishing a usability metric 
describes the integration between the user, task, and 
equipment to achieve a common goal, by measuring the 
metrics of effectiveness, efficiency, and satisfaction.12 

There are five attributes that are involved: learnability, 
efficiency of use, ease of memorization, low error rate, 
and user satisfaction.17 Usability is attributed to effec-
tiveness, efficiency, satisfaction, usefulness, learnability, 
and accessibility.18 The different usability attributes are 
described on Table 1. 

There are several international standards and regula-
tions, presented in Table 2, which can be used to initiate 
a usability approach in HTM,5,8,9 and are important for 
demonstrating compliance with safety requirements.5 
HFE has a series of techniques that aim to study the in-
teractions between devices and their users, facilitating 
identification of problems and dangers related to use.9,10 

By incorporating usability evaluation methods into cyclical 
human-centered design processes in an iterative way, it 
is possible to develop designs that involve users, making 
products, systems, and/or services more usable.17 In this 
way, usability techniques enable users to understand the 
problems they face and thus contribute to the develop-
ment of technological solutions.

Usability Techniques

In order to assess usability, qualitative and/or quantitative 
techniques can be applied,8 in the pre-commercialization 
stages, in the processes of innovation, exploration, experi-
mentation, and evaluation of prototypes,20 as well as in 
post-commercialization, when technologies are already 
incorporated in their environment of use. Therefore, tak-
ing usability into account beyond development and use 
is essential for safety and reliability,21 which is why the 
methods can be applied throughout the life cycle.22 Us-
ability techniques aim to assist in testing and evaluation 
with users,7 enabling the construction of a collaborative 
and interdisciplinary ecosystem, in which the actors in-
volved with technological health resources interact with 
each other, enhancing the implementation of solutions 
and user-centered technological incorporation.23 

 The application of usability techniques is an additional 
tool for analyzing human factors in HTM.10 There are various 
ways of obtaining information regarding technology–user 
interaction: information and opinions related to usability 
can be collected with the aim of understanding users and 
the environment of use; observing people performing cer-
tain tasks associated with the product; discussing aspects 
of the project in user groups with the aim of obtaining 
new ideas; conducting structured studies with users us-
ing the technology in their own real environment or in 
simulated locations; including in a risk management plan 
for hazard identification; as well as using tools to model 
interfaces at different levels of reliability in the course of 
developing healthcare solutions.7,11

TABLE 1. Description of usability attributes.

Usability 
attributes Description

Effectiveness

Accuracy with which users have achieved certain 
established objectives,12 and thus consists of an 
important metric for measuring the risk of error 
during use and ensuring patient safety.19

Efficiency
Accuracy in relation to the resources spent by users 
to achieve a given objective.12 The system must be 
efficient and have the lowest possible error rate.17

Satisfaction

Absence of discomfort and positive attitudes 
toward the use of a product12 refer to perceptions, 
feelings, and opinions.17 The system must be 
pleasant from the user’s perspective.19

Usefulness Checks whether the product or service achieves 
its use objectives.17

Learning

Learning measures the ability of users to recall the 
system after a period of training or time without 
performing a particular task.17 The system must be 
easy to use from the user’s perspective.19

Accessibility

Easy access to the products needed to complete 
the objective by people with the widest range of 
abilities.12,17 Considering accessibility enables 
clarity and simplicity in design for people who 
may temporarily have some limitation or those 
who have it permanently.17



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There are various techniques specified in regulations,11,24 
international guidelines and guidance materials,5,9 and 
books and scientific publications, some of the main ones 
being, but not limited to, observational analysis, inter-
views, focus groups, task analysis, questionnaires, the 
Delphi method, heuristic evaluation, usability testing, 
and user error analysis. Figure 1 shows a comparative 
illustrative proposal for usability techniques, based on 
the classification between qualitative, quantitative, and 
mixed-method analysis, whether the application of the 
technique depends on direct contact with the technology, 

TABLE 2. Standards involving in the usability of medical devices.

Standard Title Main objective

ABNT NBR IEC 
62366:2016

Healthcare products—Application of usability engineering 
to healthcare products.

To specify the process for analysis, specification, development, 
verification, and validation of the safety-related usability of 
healthcare products. 

ABNT NBR ISO 
14971:2020

Medical devices—Application of risk management to 
medical devices.

To specify the principles of the process for risk management 
of health products, including aspects of usability.

ABNT ISO/TR 
16982:2014

Ergonomics of human-system interaction—Usability 
methods that support user-centered design.

To provide information about usability methods, advantages, 
disadvantages, and other factors relevant to the use of 
each usability method.

ABNT NBR IEC 
60601-1-6:2020

Medical electrical equipment
Part 1-6: General requirements for basic safety and 
essential performance.
Collateral standard: Usability

To specify the minimum usability requirements for medical 
electrical equipment.

ABNT NBR IEC 
60601-1-11:2012

Medical electrical equipment
Part 1-11: General requirements for basic safety and 
essential performance. Requirements for medical 
electrical equipment and medical electrical systems used 
in domestic health care environments.

Specifies requirements for electromedical equipment used in 
domestic environments, including usability aspects.

ABNT NBR ISO 
13485:2016

Health products
Quality management systems
Requirements for regulatory purposes

Specifies minimum requirements for quality management 
systems in healthcare products, considers usability aspects.

ABNT NBR ISO 
9241-210:2011 

Ergonomics of human–system interaction
Part 210: Human-centered design for interactive systems.

Specifying requirements and recommendations for human-
centered design for the entire life cycle.

ABNT NBR ISO 
9241-11:2011

Ergonomic requirements for working with visual 
interaction devices.
Part 11: Usability guidelines

Specifies minimum requirements to identify the necessary 
information to be considered in the specification or evaluation 
of usability.

AAMI/ANSI HE75 Human factors engineering—Design of medical devices. Reference covering general principles, managing the risk of 
use errors, design elements.

Each technique has specific principles and character-
istics that need to be known to ensure that the analysis of 
medical technologies is objective and with valid results.7,10 

No technique is best in all situations.11,24 Usability tech-
niques can be divided according to the type of data to 
be extracted from the research: quantitative, when the 
evaluation of parameters has a numerical perspective; 
qualitative, to extract choices and feelings from the user’s 
point of view8; as well as mixed methods, containing 
qualitative and quantitative data. 



Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
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J Global Clinical Engineering Vol.7 Issue 3: 2025 64

and whether the user’s perspective on the product or the 
researcher’s view when observing the technology–user 
interaction is considered predominantly. 

Usability techniques have been used at various stages 
of the life cycle of health technologies, from pre-commer-
cialization to post-commercialization processes,10 and 
are strategic HFE tools to support HTM. The choice of 
the usability technique depends on the information you 
want to extract.8 In addition, its results are only reliable 
when the participants are people who are representa-
tive of the population and who perform a certain task of 
interest.11 Primary knowledge of usability techniques, 
including an understanding of the differences and basic 
principles of application, is essential to choose the one 
that best meets the needs.24 

In order to understand the application of usability 
techniques in clinical engineering throughout the life cycle 
of HTM, an exploratory study was done on the literature 
involving medical devices.

MATERIALS AND METHODS

This research was conducted through a rapid review, 
which consists of a reliable and systematized methodology 

for synthesizing knowledge. This approach is used when 
steps in the process of a systematic review are simplified, 
or omitted, to produce information from the selection 
of research that is available in the literature, and that is 
of relevance to a topic of study.25 The rapid review was 
developed to ensure that decisions influencing the ap-
plication of usability techniques in medical equipment 
can be informed by an up-to-date and reliable account 
of the scientific evidence that is relevant in the context 
of the research.

This rapid review research was based on the Ministry 
of Health’s Methodological Guideline for the prepara-
tion of systematic reviews26 as well as the University of 
Oxford’s PRISMA methodology, which consists of a set of 
evidence-based items that aim to assist in the presenta-
tion of research results.27 The guiding question of the 
rapid review research proposed for this case study was: 

“What are the usability techniques that are ap-
plied to medical equipment over the course of the 
technological life cycle?” 

To determine the choice of articles, inclusion and ex-
clusion criteria were established, which included popu-
lation parameters of the desired technology, the type of 
intervention used, the availability of the work, the date 
of publication, and the type of evaluation of the results, 
as presented in Table 3. To answer this question, a search 
strategy used was to define keywords to identify publica-
tions that respond to this theme: Usability; Human Factor; 
Medical Device; and Medical Equipment. The search was 
carried out in the following electronic databases: IEEE, 
Pubmed, and Scielo, which were used systematically, and 
Scopus, Scielo, Lilacs, Sage, and JMIR, in which searches 
were carried out independently. In order to determine the 
choice of articles, inclusion and exclusion criteria were 
established, which included the population parameters 
of the intended technology, the type of intervention used, 
the availability of the work, the date of publication, and 
the type of evaluation of the results. The use of the logical 
operators “AND” and “OR” helped in the literature search. 
The databases were searched using a combination of 
keywords: (Usability OR “human factor*”) AND (“Medical 
Equipment*” OR “Medical device*”).  

FIGURE 1.  Comparison of the usability technique.



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After the initial search, a publication date filter was 
applied, excluding articles with a publication date greater 
than 10 years ago. The titles and abstracts were read, and 
a total of 189 publications were selected. Reading these 
studies in full resulted in the exclusion of 124 articles that 
did not meet the established inclusion criteria. Thus, 65 
articles were eligible to compose the rapid review, which 
present the application of usability techniques in medical 
equipment. The studies were classified according to the 
techniques used, the type of medical equipment in which 
the evaluation was carried out, the stage of the technology 
life cycle in which the methods were applied, and whether 
or not there was a conflict of interest in the research. 
The usability techniques presented in the articles were 
applied by the researchers to observe user interaction 
with the medical equipment or to identify problems by 
observing and transcribing the opinions of the users of 
the technologies. 

RESULTS

The results of the review showed a variety of pos-
sibilities for applying usability techniques to medical 
equipment, from higher risk class devices, such as com-
puted tomography,28 to even less complex equipment for 
home use.29 Of the 65 studies, the medical equipment 
with the most research was the infusion pump, with six-
teen in total,30–35 followed by pulmonary ventilator with 
five,36,37 defibrillator with five,38,39 and vital signs moni-
tor, referenced in five studies.40–43 In addition to those 
already mentioned, usability techniques have also been 
applied to: glucometer,44–46 pulse oximeter,29 anesthesia 
machine,47,48 electrosurgical unit,49 endoscope,50 insulin 
infusion pump,51 operating table,52 ultrasound,53 among 
others, demonstrating the diversity in the application of 
usability techniques. In some selected studies, human 
factors methods were applied to more than one piece of 

TABLE 3. Rapid review inclusion and exclusion criteria.

Parameters 1. Exclusion Criteria 2. Inclusion Criteria

Population

1.1 Equipment/devices other than medical devices. 
Accessories and isolated parts will not be considered. 
Screening applications, medical records, and medical 
software will also not be considered. Studies that do not 
specify the technology will be disregarded.

2.1 Medical equipment used for diagnosis, monitoring, and/
or therapy of diseases.

Intervention 1.2 Does not apply usability engineering techniques and/
or does not describe the technique.

2.2 Studies that show results of the application of usability 
engineering techniques.

Availability of the 
work 1.3 Incomplete and/or unavailable texts. 2.3 Full texts available

Publication date 1.4 Works more than 10 years old from the date of 
publication. 2.4 Works up to 10 years old from the date of publication.

Assessment 

1.5 They do not present results of the application of 
usability techniques in medical equipment. They do not 
show the assessment of usability and the interference of 
human factors with technology.

2.5 They present results of the application of usability techniques 
in medical equipment to evaluate the usability of technology 
and the interference of human factors.

Type of work 1.6 Nonprimary studies (such as reviews, meta-analyses) 
and/or works from the same research project.

2.6 Primary studies and works not part of the same research 
project.



Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
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equipment, who applied the methodology to blood pres-
sure monitors and pulse oximeters.38 

The results show that usability techniques are being 
used for a variety of purposes, from design validation in 
the early stages of product development, to assisting in 
the processes of incorporating technology into a facil-
ity; to assessing the ergonomics of medical equipment; 
to analyzing usability problems through adverse event 
analysis; investigating product design problems; analyzing 
the instructions for use of a piece of equipment; and as-
sisting in identifying hazards and minimizing risks to the 
patient, even at the level of comparing usability between 
different types of make/model of a technology. 

An analysis of the selected papers showed that us-
ability techniques are being applied at different stages 
of the technology life cycle, from pre-commercialization 
to post-commercialization. Usability techniques were ap-
plied both individually and integrated with one or more 
other methods, with the integration of techniques being 
the most widely used methodology in the selected stud-
ies. The studies that applied more than one technique 
reinforce the importance of integrating different methods 
to extract information from different perspectives, as 
each technique has its advantages and limitations. An 
example of the presence of integrating techniques is the 
usability test, which was the method with the highest 
number of applications among the selected works, and 
which was generally accompanied by the implementation 
of questionnaires in the pre-test, to analyze the profile 
of the participants, and in the post-test, to quantify user 
satisfaction regarding the usability of the technology. In 
the post-test questionnaire, most of the time, the SUS 
Scale, a tool used to extract relevant information about 
how satisfied the user feels when interacting with the 
technology, was applied.

A complementary tool, also applied in some of the 
selected studies, was the use of eye tracking used to 
analyze the user’s eye movement when interacting with 
the product interface, to help assess the usability of users 
when using technologies.47,54 Another validated tool used 

in the selected studies was the NASA-TLX Scale, used to 
measure people’s mental workload. This scale was ap-
plied in all the studies in which this usability technique 
was used, and was applied through integration with other 
methods.28,36,37 Reducing the physical and mental work-
load is one of the recommendations, in which the authors 
cite the importance of manufacturers considering these 
scenarios for users and providing customizable options 
to meet the needs of the end operator.28

DISCUSSION

Human factors in health must be involved throughout 
the entire life cycle of the technology in the technology 
management processes of clinical engineering activities, 
from the pre-commercialization stages, based on a user-
oriented development of health technologies, to the post-
commercialization stages, involving the clinical staff in the 
processes of technological incorporation, investigation 
of problems in the use of technology to minimize harm 
to the patient, among many other activities that involve 
clinical engineering.7,10,13 

Interdisciplinary interaction in health technology 
processes is essential for identifying potential problems 
in the use of medical equipment in establishments, 
and thus establishing and implementing improvement 
actions. The implementation of a collaborative and in-
terdisciplinary living lab ecosystem has the potential to 
contribute to HTM, through the application of usability 
techniques with different actors involved with medical 
devices, including clinical engineering, end users, health 
professionals, industry, and government, among others. 
Usability techniques can be applied at different stages of 
the life cycle of health technologies, helping to identify user 
needs in order to develop and/or improve technological 
solutions. A program proposal was developed to cover 
the main activities considering human factors, as shown 
in Table 3. The objective to apply usability techniques for 
the consideration of the human factor in each life cycle 
stage is presented in Table 4. 



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TABLE 4. Objective to apply usability techniques for the consideration of the human factor in each life cycle stage. 

Life Cycle Stage Main Activities      Objective to Apply Usability Techniques for The 
Consideration of The Human Factor 

Design and 
development

- Innovation ideation.
- Design, prototyping, and development.
- Compliance with regulations.
- Regulations, good manufacturing practices, and 
certification.
- Production, distribution, storage, and marketing.

- Establishing project goals and requirements based on the 
problems identified by users when using the technologies.
- Collecting data on user needs.
- Developing solutions centered on user needs.
- Testing solutions with the user for validation, risk, usability 
analysis, and project adjustments.

Planning and 
selection

- Market analysis
- Health technology assessment (HTA)
- Sizing up the establishment’s profile by analyzing the 
technologies, infrastructure, and human resources to 
understand the need for incorporation.
- Checking that the technology has been regularized 
with the health agency and complies with regulations, 
ordinances...
- Carrying out economic analyses of the total cost of 
ownership.
- Specifying and selecting the technology.
- Purchasing process (bidding if necessary)

- Meeting user needs, combining clinical interest with the 
technologies available on the market.
- Consider usability aspects when specifying technology, 
check that technological development is user-centered and 
based on standards.
- Consider usability in technology selection.
- Consider human factors engineering principles and usability 
techniques to incorporate into HTA.

Receipt, 
verification, and 
acceptance

- Ensure that all equipment incorporated complies with 
what has been requested.
- Ensure that they are evaluated before first use through 
acceptance tests that attest the safety and performance 
of the technology.
- Document and implement criteria for supplier 
qualification.

- Test the incorporated technologies with users for final 
acceptability, checking that they meet the need.

Inventory

- Carry out the inventory (survey, registration, and 
identification) of the entire technology park with all 
the necessary information to ensure the accuracy and 
traceability of the data.
- The entire inventory process must be documented and 
conducted periodically.

- Involve the user who operates the technology in the inventory 
of the technology park, to understand the importance of 
identification and traceability for management.
- Identify possible flaws in the processes of incorrect and/or 
incomplete identification of the inventory, thereby hindering 
traceability.

Installation - Install the equipment in compliance with the 
manufacturer’s regulations and recommendations.

- Show users the impact of the infrastructure on performance 
and security with the technology.
- Evaluate the infrastructure to check the implications 
for users’ use of the technologies.
- Understand the difficulties faced by users when interacting 
with the infrastructure.

Training

- Ongoing and periodic training program to ensure that 
operators are able to carry out their activities.
- Drawing up and implementing good practice guidelines 
for the proper use of health technologies.

- Train users to operate the technology properly. Carry this out 
immediately after installation and inventory and periodically 
on an ongoing basis with the entire team.
- Develop training focused on solving problems faced by users.
- Develop good practice materials for proper use.



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Analysis of the Application of Usability Techniques in 
Pre-Commercialization

In processes involving the development of technological 
solutions, it is essential to include the user in the gathering 
of data on the need and validation of the product, enabling 
the prior identification of usability problems that the 
technology may pose.10 Therefore, user-centered design 
encompasses the active involvement of people during 
technological development, with a clear understanding 
between user requirements and tasks, providing solu-
tions through continuous interactions with users in an 
interdisciplinary team.15 

The pre-commercialization stage is the time when the 
technology is under development, and it is essential to 
include the user in gathering data on the need and vali-
dating the idea or product. This stage makes it possible 
to reduce future complications by anticipating possible 
usability problems that the technology may pose.

The studies in which usability techniques were ap-
plied in the pre-commercialization stages demonstrate 
the need to include users throughout the technological 
development process to ensure better usability results and 

greater patient safety,55,56 as well as making it possible 
to reduce costs.57 The application of usability techniques 
in the technological development process reduces the 
need for design modifications and more costly upgrades 
post-market introduction, which becomes a competitive 
advantage. In addition, there are considerable improve-
ments in safety, which minimize the likelihood of medical 
device recalls. When HFE approaches are used during 
the technology–user interface development process, es-
pecially taking into account the user’s perspective, there 
are considerable improvements in ease of use.9 

Analysis of the Application of Post-Marketing 
Usability Techniques

Usability techniques applied in post-marketing dem-
onstrate the relevance of studies considering human 
factors during the use of technologies, and thus assist 
manufacturers, researchers, among other actors, who 
wish to explore ergonomic studies after incorporation 
of technology into the market.58

The application of usability techniques in the process 
of incorporation in health establishments can obtain 

Life Cycle Stage Main Activities      Objective to Apply Usability Techniques for The 
Consideration of The Human Factor 

Use

- Risk management
- Draw up and implement standardized procedures and 
protocols for the use of technologies.
- Develop methodologies to ensure technological 
traceability.
- Analyze the history of failures and analyze the probable 
causes.
- Investigate the adverse events involved.

- Understand the problems of using the technology and 
understand the impact of human factors on the occurrence 
of failures and adverse events.
- Analyze the cause of failures incorporated into risk 
management in order to establish improvement strategies.
- Analyze usability problems in order to establish specific 
strategies and improvements in new technological solutions.

Technical 
interventions

- Define and implement procedures to ensure the 
metrological traceability and safety of technologies.
- Develop and implement procedures for inspection, 
testing, calibration, preventive and corrective maintenance, 
electrical safety tests, and qualification.

- Involve the user in the importance of carrying out calibration, 
maintenance, and other technical interventions for the safety 
and performance of the technologies.
- Analyze the impact of human factors on technical interventions 
in technologies.

Obsolescence, 
decommissioning, 
and final disposal

- Developing and implementing procedures describing 
the criteria for decommissioning technology, taking into 
account the technical, operational, financial, or strategic 
aspects of the establishment.
- Execution of the activity by issuing a decommissioning 
report.

- Analyze the effectiveness of using the technology. 
- Evaluate the needs of the clinical staff to ascertain the need 
for technological replacement.
- Researching technological advances that consider human-
centered aspects for technologies with better usability.



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include the difficulties faced by users in order to mitigate 
the occurrence of user errors. Therefore, a continuing 
education program should consider the problems faced 
by users in their day-to-day use of the technology, both 
when it is first introduced and throughout its life cycle. 
Usability techniques can be applied to analyze the impact 
of training to investigate its effectiveness and thus estab-
lish actions that can improve the use of the technology. 

Throughout the use of technology in healthcare environ-
ments, usability techniques can be applied continuously 
to analyze the users’ perspective on interaction with the 
technological resource. In this way, it is a strategy for 
identifying possible problems and planning preventative 
actions. Drawing up and monitoring indicators involving 
technologies is a clinical engineering activity that must 
also take human factors into account when critically 
analyzing the results of the metrics. Incorporating user 
evaluations of user satisfaction, error rate, effectiveness, 
and efficiency in performing certain tasks are important 
usability metrics to be considered in clinical engineering. 

Clinical engineering must incorporate the monitoring 
and analysis of adverse events in its activities. Analysis 
of failures and adverse events also requires attention to 
probable human errors, and applying usability techniques 
can help to investigate the probable causes, and thus 
establish strategies more assertively. Clinical engineer-
ing should also stimulate the environment for reporting 
adverse events, by implementing actions that minimize 
the main barriers that influence the deficiency in the re-
porting process by operators, which are fear of guilt, lack 
of time, nonperception of effectiveness when reporting, 
lack of knowledge of the reporting system, lack of feed-
back, and a complicated and time-consuming platform 
for reporting. Metrology in health is a strategic tool for 
identifying adverse events and hidden failures involving 
health technologies. Metrological problems can be associ-
ated with inaccurate diagnoses and inadequate treatment, 
as these factors are directly related to the prevalence of 
adverse events.

When assessing obsolescence, applying usability 
techniques can provide data to help clinical engineering 
make decisions on whether or not to discard technology, 
by understanding the problems faced and clinical needs, 

satisfactory results, as the use of technologies in envi-
ronments directly impacts the experience of staff and 
patients, and the selected equipment will normally be 
used for several years.59 Inadequate incorporation that 
does not meet local and operator needs can lead to disuse 
of the technology, as well as operating errors, resulting in 
problems for patient safety. In addition to the impacts on 
the establishment, considering usability in the process of 
incorporation also provides manufacturers with informa-
tion on users’ needs, and thus helps with feedback for the 
development of new products.59 Liu et al. also presented a 
usability evaluation methodology through the integration 
of techniques that can provide evidence to support the 
selection of more appropriate equipment, by considering 
the context of use of the technology.60 

By applying usability methods, it is possible to recom-
mend improvements to the technology–user interface 
and increase safety61; identify how the context of use can 
affect the usability of technology55; as well as understand 
educational needs60 and improve training strategies39 
and instructions for use.19

Studies have shown that the application of usability 
techniques through the analysis of adverse events makes it 
possible to identify sources of hazards and investigate the 
causes of these incidents associated with the use of medical 
devices,62 and thus assist in both the pre-marketing and 
post-marketing of technologies. Through the evaluation 
and analysis of adverse events in databases, it is possible 
to optimize risk control solutions in the use of medical 
equipment and achieve satisfactory results in usability 
to contribute to the development of public health and 
better user experiences.32

Another approach, little explored in other studies, is 
the use of technology by individuals with physical/sensory 
disabilities, demonstrating in their research that medical 
devices are often not designed to meet the needs of spe-
cific users.63 Clinical engineering needs to work toward 
managing health technologies that are more accessible 
to everyone.

Usability techniques can also be applied in the design 
and implementation of training programs, which are a 
stage in the technology’s life cycle, and should be car-
ried out periodically and continuously. Training should 



Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
Review

J Global Clinical Engineering Vol.7 Issue 3: 2025 70

     AUTHOR CONTRIBUTIONS

Conceptualization, M.B. and R.G.; Methodology, M.B. 
and R.G.; Formal Analysis, M.B.; Writing–Original Draft 
Preparation, M.B.; Writing–Review & Editing, M.B. and 
R.G.; Supervision, R.G.

ACKNOWLEDGMENTS

Not applicable.

FUNDING

This research received no external funding.

DATA AVAILABILITY STATEMENT

Not applicable.

CONFLICTS OF INTEREST

The authors declare they have no competing interests.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE

Not applicable.

CONSENT FOR PUBLICATION

Not applicable.

FURTHER DISCLOSURE

Not applicable.

  REFERENCES
1. Shukla, S., Gupta, M., Pandit, S., et al. Implementation of 

adverse event reporting for medical devices, India. Bull 
World Health Organ. 2019;98(3):206–211. https://doi.
org/10.2471/BLT.19.232785.

2. Signori, M.R. and Garcia, R. Clinical engineering incorporating 
human factors engineering into risk management. In Proceed-
ings of World Congress on Medical Physics and Biomedical 
Engineering, Munich, Germany. September 7–12, 2009:449–
452. http://doi.org/10.1007/978-3-642-03885-3_125.

as well as assessing the availability of new technologies 
on the market. Human factors must also be taken into ac-
count in the stages of technological substitution, so that 
the transition and incorporation of a new technology has 
minimal impact on the healthcare environment.

CONCLUSION

This work demonstrated that the application of usability 
techniques can assist clinical engineering in the develop-
ment and use of technological solutions that integrate the 
user in the processes throughout the life cycle, and that 
provide data with a more systemic view of the problem. 
Some of the actions of clinical engineering highlighted 
and discussed in these usability techniques consist of: 
development of technologies with better usability for 
users; process of incorporation of new technologies in 
establishments that meet clinical needs; preparation 
and implementation of training and qualifications in 
technologies; development of good practice materials 
for appropriate use; identification and monitoring of 
the occurrence of failures and adverse events to propose 
improvement actions; and performance evaluation as a 
metrological tool to preventively identify adverse events 
and hidden failures, as well as in the evaluation of tech-
nological obsolescence considering the users in these 
processes. Therefore, human factors must be considered 
throughout the life cycle, integrating a feedback system 
of information for continuous improvements.

The integration and consideration of human factors 
must be encouraged for the further advancement of clinical 
engineering throughout the healthcare ecosystem, in the 
discussion, construction, and validation of strategies that 
may assist in the prevention of adverse events. Incorporat-
ing usability techniques must be a tool applied throughout 
the life cycle of technologies as a strategic methodology to 
ensure safety, regulatory compliance, and cost reduction 
in healthcare environments. With these integrated and 
collaborative actions, the aim is to achieve an increas-
ingly humanized, inclusive, collaborative, sustainable 
management of health technologies, focused on the best 
user experience and focused on quality and safety for all 
people involved in the technological processes in health.

 https://doi.org/10.2471/BLT.19.232785
 https://doi.org/10.2471/BLT.19.232785
http://doi.org/10.1007/978-3-642-03885-3_125


71 J Global Clinical Engineering Vol.7 Issue 3: 2025

Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
Review

12. Associação Brasileira De Normas Técnicas. ABNT NBR ISO 
9241-210:2011: Ergonomia da interação humano-sistema 
Parte 210: Projeto centrado no ser humano para sistemas 
interativos. Brasil, 2011.

13. Hyman, W.A. and Wangler, V. Human factors: environment. 
In Clinical Engineering Handbook; Dyro, J.F. Elsevier; 2004; 
pp. 353–355.

14. Associação Brasileira De Normas Técnicas. ABNT NBR 
15943:2011: Diretrizes para um programa de gerenciamento 
de equipamentos de infraestrutura de serviços de saúde e 
de equipamentos para a saúde. Brasil, 2011.

15. Branaghan, R.J. Human factors in medical device design: 
Methods, Principles, and Guidelines. Crit Care Nurs Clin North 
Am Jun. 2018;30(2):225–236. http://doi.org/10.1016/j.
cnc.2018.02.005. 

16. Ritter, F., Baxter, G.D., Churchill, E.F. Foundations for Design-
ing User-Centered Systems. Springer: London, UK; 2014.

17. Nielsen, J. Usability Engineering. Morgan Kaufmann:California, 
USA; 1994. 

18. Rubin, J. and Chisnell, D. Handbook of Usability Testing: 
how to Plan, Design, and Conduct Effective Tests, 2nd ed. 
Wiley:Indianapolis, USA; 2008.

19. Noémie, C., Natacha, M., Emilie, L.E., et al. Impact of the 
format of user instructions on the handling of a wrist 
blood pressure monitor. Cog Process. 2021;1:29. http://
doi.org/10.1007/s10339-020-01006-1.

20. Picard, R. and Noury, N. The development of the living 
lab approach in the health and autonomy sector. 2015. In 
Proceedings of 17th International Conference On E-Health 
Networking, Application & Services (Healthcom), Boston, USA, 
October 14–17, 2015:182–188. http://doi.org/10.1109/
healthcom.2015.7454495.

21. Pelayo, S., Marcilly, R. Bellandi, T. Human factors engineer-
ing for medical devices: European regulation and current 
issues. Int J Qual Health Care. 2020;33(1):31–36. http://
doi.org/10.1093/intqhc/mzaa103.

22. Almeida, A.P.S.S. de, Almeida, R.M.A., Mello, C.H.P. In Manual 
de Tecnovigilância: uma abordagem sob a ótica da Vig-
ilância Sanitária; Agência Nacional de Vigilância Sanitária, 
Gerência-Geral de Monitoramento de Produtos Sujeitos 
à Vigilância Sanitária, Gerência de Tecnovigilância, Eds.; 
Brasília, DF, Brazil: Anvisa, 2021; pp. 800.

23. Landman, A.B., Redden, L., Neri, P., et al. Using a medical 
simulation center as an electronic health record usability 
laboratory. J Am Med Inform Assoc. 2014;21(3):558–563. 
http://doi.org/10.1136/amiajnl2013-002233.

3. Flewwelling, C.J., Easty, A.C.,Vincente, K.J., et al. The use 
of fault reporting of medical equipment to identify latent 
design flaws. J Biomed Inform. 2014;51:80–85. http://doi.
org/10.1016/j.jbi.2014.04.009. 

4. Rodziewicz, T.L., Houseman, B., Vaqar, S. et al. Medical Er-
ror Reduction and Prevention. In: StatPearls [Internet]. 
Treasure Island (FL): StatPearls Publishing; 2025. Available 
from: https://www.ncbi.nlm.nih.gov/books/NBK499956/. 

5. MHRA. Guidance on applying human factors and us-
ability engineering to medical devices including drug-
device combination products in Great Britain. 2nd ed. 
Medicines And Healthcare Products Regulatory Agency, 
2021. Available online: https://assets.publishing.
service.gov.uk/media/60521d98d3bf7f0455a6e61d/
Human-Factors_Medical-Devices_v2.0.pdf.

6. MHRA. Patient safety alert: improving medical device 
incident reporting and learning. Mar. 2014. NHS England. 
Available online: https://www.england.nhs.uk/publication/
patient-safety-alerts-improving-medical-device-incident-
reporting-and-learning/.

7. Cassano-Piché, A. Trbovich, P., Griffin, M., et al. Fatores 
Humanos para a Segurança da Tecnologia da Saúde: aval-
iando e melhorando o uso da tecnologia da saúde da saúde 
no mundo real. IFMBE:Canadá; 2015. Versão portuguesa 
do Livro “Human Factors For Health Technology Safety: 
Evaluating and Improving the Use of Health Technology 
In The Real World.” 

8. Bitkina, O.V., Kim, H.K., Park, J. Usability and user expe-
rience of medical devices: an overview of the current 
state, analysis methodologies, and future challenges. Int 
J Ind Ergon. 2020;76:10293. http://doi.org/10.1016/j.
ergon.2020.102932. 

9. Food & Drug Administration. FDA. Applying human factors 
and usability engineering to medical devices: guidance for 
industry and food and drug administration staff. EUA. 2016. 
Available online: https://www.fda.gov/media/80481/
download.

10. Brandão, M.R. and Garcia, R. Descriptive analysis of 
user-centered usability techniques to health technology 
management. In Proceedings of 2020 Congreso Nacional 
de Ingeniería Biomédica, virtual, October 15–17, 2020: 
335–342. https://memoriascnib.mx/index.php/memorias/
article/view/781.

11. Associação Brasileira De Normas Técnicas. ABNT NBR IEC 
62366:2016 Produtos para a saúde—Aplicação da engen-
haria de usabilidade a produtos para a saúde. Brasil, 2016.

http://doi.org/10.1016/j.cnc.2018.02.005
http://doi.org/10.1016/j.cnc.2018.02.005
http://doi.org/10.1007/s10339-020-01006-1
http://doi.org/10.1007/s10339-020-01006-1
http://doi.org/10.1109/healthcom.2015.7454495
http://doi.org/10.1109/healthcom.2015.7454495
 http://doi.org/10.1093/intqhc/mzaa103
 http://doi.org/10.1093/intqhc/mzaa103
http://doi.org/10.1136/amiajnl2013-002233
 http://doi.org/10.1016/j.jbi.2014.04.009
 http://doi.org/10.1016/j.jbi.2014.04.009
https://www.ncbi.nlm.nih.gov/books/NBK499956/
https://assets.publishing.service.gov.uk/media/60521d98d3bf7f0455a6e61d/Human-Factors_Medical-Devices_v2.0.pdf 
https://assets.publishing.service.gov.uk/media/60521d98d3bf7f0455a6e61d/Human-Factors_Medical-Devices_v2.0.pdf 
https://assets.publishing.service.gov.uk/media/60521d98d3bf7f0455a6e61d/Human-Factors_Medical-Devices_v2.0.pdf 
https://www.england.nhs.uk/publication/patient-safety-alerts-improving-medical-device-incident-reporting-and-learning/
https://www.england.nhs.uk/publication/patient-safety-alerts-improving-medical-device-incident-reporting-and-learning/
https://www.england.nhs.uk/publication/patient-safety-alerts-improving-medical-device-incident-reporting-and-learning/
http://doi.org/10.1016/j.ergon.2020.102932
http://doi.org/10.1016/j.ergon.2020.102932
https://www.fda.gov/media/80481/download
https://www.fda.gov/media/80481/download
 https://memoriascnib.mx/index.php/memorias/article/view/781
 https://memoriascnib.mx/index.php/memorias/article/view/781


Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
Review

J Global Clinical Engineering Vol.7 Issue 3: 2025 72

24. Associação Brasileira De Normas Técnicas. ABNT ISO/TR 
16982:2014: Ergonomia da interação humano-sistema—
Métodos de usabilidade que apoiam o projeto centrado no 
usuário. Brasil, 2014.

25. Tricco, A.C., et al. A scoping review of rapid review meth-
ods. BMC Med. 16 Sept. 2015;13(1):224. http://doi.org/ 
10.1186/s12916-015-0465-6.

26. MInistério Da Saúde. Diretrizes metodológicas: elaboração 
de revisão sistemática e metanálise de ensaios clínicos ran-
domizados. Brasília: Editora do Ministério da Saúde, 2021.

27. Moher, D., Liberati, A., Tetzlaff, J., et al. Preferred report-
ing items for systematic reviews and meta-analyses: the 
prisma statement. PLos Med. 2009;6(7):1000097. http://
doi.org/10.1371/journal.pmed.1000097.

28. Aldoihi, S. and Hammami, O. Evaluation of CT scan us-
ability for Saudi Arabian users. In Proceedings of the 
2018 International Conference On Computer, Information 
And Telecommunication Systems (CITS), Alsace, Colmar, 
France, July 11–13, 2018:1–5. http://doi.org/10.1109/
cits.2018.8440165.

29. Chaniaud, N., Métayer, N., Megalakaki, O., et al. Effect of 
prior health knowledge on the usability of two home 
medical devices: usability study. JMIR Mhealth Uhealth. 
2020;8(9):e17983. http://doi.org/10.2196/17983.

30. Smith, E.A. and Gray, G. Developing a smart infusion pump 
dedicated to infusion safety. Ergon in Design. 2020;30(2):4–12. 
http://doi.org/10.1177/1064804620944760.

31. Elias, B.L., Moss, J.A., Dillavou, M., et al. Evaluation of nurs-
ing student perspectives of a simulated smart pump. Clin 
Simul Nurs. 2013;9(12):599–606. http://doi.org/10.1016/j.
ecns.2013.04.018. 

32. Gao, X., Wen, Q., Duan, X.L., et al. A hazard analysis of class I 
recalls of infusion pumps. JMIR Hum Factors. 2019;6(2):10366. 
http://doi.org/10.2196/10366.

33. Schnittker, R. Schmettow, M., Verhoeven, F., et al. Combining 
situated cognitive engineering with a novel testing method 
in a case study comparing two infusion pump interfaces. 
App. Ergon. 2016;55:16–26. http://doi.org/10.1016/j.
apergo.2016.01.004.

34. Waterson, J., AI-Jaber, R., Kassab, T., et al. Twelve-month 
review of infusion pump near-miss medication and dose 
selection errors and user-initiated “good save” corrections: 
retrospective study. JMIR Hum Factors. 2020;7(3):20364. 
http://doi.org/10.2196/20364. 

35. Schraagen, J.M. and Verhoeven, F. Methods for studying 
medical device technology and practitioner cognition: the 
case of user-interface issues with infusion pumps. J Biomed 
Inform. 2013;46(1):181–195. http://doi.org/10.1016/j.
jbi.2012.10.005.

36. Marjanovic, N. and L’Her. E. A comprehensive approach for 
the ergonomic evaluation of 13 emergency and transport 
ventilators. Resp Care. May;61(5):632-639.https://doi.
org/10.4187/respcare.04292.

37. Jiang, M.Y., Liu, S.L., Gao,  J.Q., et al. Comprehensive evalua-
tion of user interface for ventilators based on respiratory 
therapists’ performance, workload, and user experience. Med 
Sci Monit. 2018;24:9090–9101. http://doi.org/10.12659/
msm.911853.

38. Reeson, M., Kyeremanteng, K., D’Egidio, G. Defibrillator 
design and usability may be impeding timely defibrillation. 
Jt Comm J Qual Patient Saf. 2018;44(9):536–544. http://
doi.org/10.1016/j.jcjq.2018.01.005.

39. Fidler, R., Johnson, M., et al. Human factors approach to 
comparative usability of hospital manual defibrillators. 
Resuscitation. 2016;101:71–76. http://doi.org/10.1016/j.
resuscitation.2016.01.029.

40. Sowan, A.K., Vera A.G., Fonseca, E.I., et al. Nurse compe-
tence on physiologic monitors use: toward eliminating 
alarm fatigue in intensive care units. Open Med Inform J. 
2017;11(1):1–11. http://doi.org/10.2174/1874431101
711010001.

41. Andrade, E., Quinlan, L., Harte, R., et al. Novel interface 
designs for patient monitoring applications in critical 
care medicine: human factors review. JMIR Hum Factors. 
2020;7(3):15052. http://doi.org/10.2196/15052.

42. Reyes, P., Larée, D., Weinstein, A., al. Towards a conceptual 
model for the use of home healthcare medical devices: the 
multi-parameter monitor case. PLos One. 2018;13(12):0208723. 
http://doi.org/10.1371/journal.pone.0208723.

43. Marcilly, R., Bras Da Costa, S., Boog, C., et al. Impact of the 
context of use analysis for the extension of an existing medi-
cal device: an analgesia monitor case study. Stud Health. 
Technol Inform. 2013; 194.

44. Furniss, D., Masci, P., Curzon, P., et al. 7 Themes for guid-
ing situated ergonomic assessments of medical devices: 
a case study of an inpatient glucometer. Appl Ergon. 
2014; 45(6):1668–1677. http://doi.org/10.1016/j.
apergo.2014.05.012.

http://doi.org/ 10.1186/s12916-015-0465-6
http://doi.org/ 10.1186/s12916-015-0465-6
http://doi.org/10.1371/journal.pmed.1000097
http://doi.org/10.1371/journal.pmed.1000097
http://doi.org/10.1109/cits.2018.8440165
http://doi.org/10.1109/cits.2018.8440165
http://doi.org/10.2196/17983
http://doi.org/10.1177/1064804620944760
http://doi.org/10.1016/j.ecns.2013.04.018
http://doi.org/10.1016/j.ecns.2013.04.018
http://doi.org/10.2196/10366
http://doi.org/10.1016/j.apergo.2016.01.004
http://doi.org/10.1016/j.apergo.2016.01.004
http://doi.org/10.2196/20364
http://doi.org/10.1016/j.jbi.2012.10.005
http://doi.org/10.1016/j.jbi.2012.10.005
https://doi.org/10.4187/respcare.04292
https://doi.org/10.4187/respcare.04292
http://doi.org/10.12659/msm.911853
http://doi.org/10.12659/msm.911853
http://doi.org/10.1016/j.jcjq.2018.01.005
http://doi.org/10.1016/j.jcjq.2018.01.005
http://doi.org/10.1016/j.resuscitation.2016.01.029
http://doi.org/10.1016/j.resuscitation.2016.01.029
http://doi.org/10.2174/1874431101711010001
http://doi.org/10.2174/1874431101711010001
http://doi.org/10.2196/15052
http://doi.org/10.1371/journal.pone.0208723
http://doi.org/10.1016/j.apergo.2014.05.012
http://doi.org/10.1016/j.apergo.2014.05.012


73 J Global Clinical Engineering Vol.7 Issue 3: 2025

Brandão and Garcia: Application of Usability Techniques in Medical Devices in Health Technology Management: A Rapid 
Review

55. Grebin, S.Z., Echeveste, M.E.S., Magnago, P.F., et al. Es-
tratégia de análise para avaliação da usabilidade de 
dispositivos médicos na percepção do usuário: um 
estudo com pacientes em tratamento de hemodiálise. 
Cad Saúde Pública. 2018;34(8):e00074417. http://doi.
org/10.1590/0102-311X00074417.

56. Pickup, L., Lang, A., Shipley, L., et al. Development of a 
clinical interface for a novel newborn resuscitation device: 
human factors approach to understanding cognitive user 
requirements. JMIR Hum Factors. 2019;6(2):12055. http://
doi.org/10.2196/12055.

57. Muthya, P., Raja, A., Meghana, A. Leveraging simulation for 
usability engineering of medical devices. In proceedings 
of 2018 10th International Conference On Communica-
tion Systems & Networks (Comsnets), Bengaluru, India, 
January 03-07, 2018:693–698. http://doi.org/10.1109/
comsnets.2018.8328297.

58. Furniss, D., Masci, P., Curzon, P. et al. 7 Themes for guiding 
situated ergonomic assessments of medical devices: a case 
study of an inpatient glucometer. Appl Ergon. 2014;45(6):1668–
1677. http://doi.org/10.1016/j.apergo.2014.05.012.

59. Vincent, C.J. and Blandford, A. How do health service 
professionals consider human factors when purchasing 
interactive medical devices? A qualitative interview study. 
Appl Ergon. 2017;59:114–122. http://doi.org/10.1016/j.
apergo.2016.08.025.

60. Liu, K., Chan, F.Y., Or, C.K., et al. Heuristic evaluation and 
simulated use testing of infusion pumps to inform pump 
selection. Int J Med Inform. 2019;131:103932. http://doi.
org/10.1016/j.ijmedinf.2019.07.011.

61. Chan, A.J., Islam, M.K., Rosewall, T., et al. Applying us-
ability heuristics to radiotherapy systems. Radiother & 
Oncol. 2012;102(1):142–147. http://doi.org/10.1016/j.
radonc.2011.05.077.

62. GIuliano, K.K. Intravenous smart Pumps: Usability Issues, 
Intravenous Medication Administration Error, and Patient 
Safety. Crit Care Nurs Clin North Am. 2018;30(2):215–224. 
http://doi.org/10.1016/j.cnc.2018.02.004.

63. Fung, C.H., Igodan, U., Alessi, C., et al. Human factors/usability 
barriers to home medical devices among individuals with 
disabling conditions: in-depth interviews with positive airway 
pressure device users. Disabil Health J. 2015;8(1):86–92. 
http://doi.org/10.1016/j.dhjo.2014.06.002. 

45. Macdonald, C., Lunt, H., Downie, M., et al. How satisfied 
are patients when their choice of funded glucose meter is 
restricted to a single brand? J Diabetes Sci Technol. 2017; 
11(5):1001–1006. http://doi.org/10.1177/1932296817693016.

46. Mandl, K.D., McNabb, M., Marks, N., et al. Participatory 
surveillance of diabetes device safety: a social mediabased 
complement to traditional FDA reporting. J Am Med Inform 
Assoc. 2014;21(4):687–691. http://doi.org/10.1136/
amiajnl-2013-002127.

47. Spaeth, J., Schweizer, T., Schmutz, A., et al. Comparative us-
ability of modern anaesthesia ventilators: a human factors 
study. Br J Anaesth. 2017;119(5):1000–1008. http://doi.
org/10.1093/bja/aex226.

48. Santos, A.L.R. Wauben, L.S.G.L., Guilavogui, S., et al. Human 
factors perspective on the safety environment of nurse 
anaesthetist training in Haiti. In Proceedings of the 8th 
International Conference Appropriate Healthcare Tech-
nologies for Low Resource Settings - AHT2014. London, UK, 
September 17–18, 2014:43–47. http://doi.org/10.1049/
cp.2014.0771.

49. Estock, J.L., Li, A., Casey, M.C., et al. Assessing use errors 
related to the interface design of electrosurgical units. AORN 
J. 2018;107(1):72–82. http://doi.org/10.1002/aorn.12006.

50. Jolly, J.D., Hildebrand, E.A., Branaghan, R.J. Better instruc-
tions for use to improve reusable medical equipment (RME) 
sterility. Hum Factors. 2013;55(2):397–410. http://doi.
org/10.1177/0018720812456393.

51. Schaeffer, N.E. The role of human factors in the design and 
development of an insulin pump. J Diabetes Sci Technol. 
2012;6(2):260–264. http://doi.org/10.1177/193229681200600208.

52. Surma-Aho, A., Hölttä-Otto, K., Nelskylä K., et al. Usability issues 
in the operating room—towards contextual design guidelines 
for medical device design. Appl Ergon. 2021;90:103221. 
http://doi.org/10.1016/j.apergo.2020.103221.

53. Taggart, R., Langer, M.D., Lewis, G. Human factors engineer-
ing and testing for a wearable, long duration ultrasound 
system self-applied by an end user. In Proceedings of 
2014 36th Annual International Conference of the IEEE 
Engineering in Medicine and Biology Society. Chicago,USA, 
August 26–30, 2014: 554-557. http://doi.org/10.1109/
embc.2014.6943651.

54. Wegner, S., Lohmeyer, Q., Wahlen, D., et al. Value of eye-tracking 
data for classification of information processing–intensive 
handling tasks: quasi-experimental study on cognition and 
user interface design. JMIR Hum Factors. 2020; 7(2):15581. 
http://doi.org/10.2196/15581.

http://doi.org/10.1590/0102-311X00074417
http://doi.org/10.1590/0102-311X00074417
http://doi.org/10.2196/12055
http://doi.org/10.2196/12055
http://doi.org/10.1109/comsnets.2018.8328297
http://doi.org/10.1109/comsnets.2018.8328297
http://doi.org/10.1016/j.apergo.2014.05.012
 http://doi.org/10.1016/j.apergo.2016.08.025
 http://doi.org/10.1016/j.apergo.2016.08.025
http://doi.org/10.1016/j.ijmedinf.2019.07.011
http://doi.org/10.1016/j.ijmedinf.2019.07.011
http://doi.org/10.1016/j.radonc.2011.05.077
http://doi.org/10.1016/j.radonc.2011.05.077
http://doi.org/10.1016/j.cnc.2018.02.004
http://doi.org/10.1016/j.dhjo.2014.06.002
http://doi.org/10.1177/1932296817693016
http://doi.org/10.1136/amiajnl-2013-002127
http://doi.org/10.1136/amiajnl-2013-002127
http://doi.org/10.1093/bja/aex226
http://doi.org/10.1093/bja/aex226
http://doi.org/10.1049/cp.2014.0771
http://doi.org/10.1049/cp.2014.0771
http://doi.org/10.1002/aorn.12006
http://doi.org/10.1177/0018720812456393
http://doi.org/10.1177/0018720812456393
http://doi.org/10.1177/193229681200600208
http://doi.org/10.1016/j.apergo.2020.103221
http://doi.org/10.1109/embc.2014.6943651
http://doi.org/10.1109/embc.2014.6943651
http://doi.org/10.2196/15581

