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14 June 2024


IMPORTANCE OF HUMAN FACTORS ENGINEERING IN MEDICAL DEVICE DOMAIN

Ergonomics (or human factors) is the scientific discipline concerned with the
understanding of interactions among humans and other elements of a system, and
the profession that applies theory, principles, data, and methods to design to
optimize human well-being and overall system performance.



Human Factors Engineering is the application of knowledge about human behaviour,
abilities, limitations, and other characteristics of medical device users to the
design of medical devices including mechanical and software driven user
interfaces, systems, tasks, user documentation, and user training to enhance and
demonstrate safe and effective use.

The terms Human factors engineering (HFE) and usability engineering (UE) can be
considered to be synonymous.

Human Factors Engineering = “Integrating human factors requirements into design”

INTRODUCTION

The usability engineering process aims to deliver products that are
user-friendly and safe when used according to their intended purpose, by
intended users, and in the intended use environment. Ideally, users should not
have to struggle with complex instructions for use or adapt to the device's
requirements, nor should they use it incorrectly or in a potentially dangerous
manner. Therefore, a well-designed product should be easy to use and have a user
interface that aligns with user experiences and expectations.

This article provides a concise overview of the Usability Engineering/ Human
Factors Engineering process, emphasizes the crucial role of Human Factors
Engineering in the medical device domain and its profound implications for
patient safety, and delves into the regulatory framework associated with these
aspects.

HISTORY

The term "Human Factors" came into prominence during World War II, marking a
significant transformation in the approach to design thinking. It took the
experiences of two world wars for designers to recognize the critical role of
the Human Factor. Before World War I, the prevailing objective was to adapt
humans to machines. However, the advent of aircraft in warfare introduced the
concept of aviation psychology, which aimed to tailor machines to fit human
capabilities.

Many practitioners who served in World War II witnessed numerous system designs
that were challenging to operate and posed safety risks. This realization led to
a shift in focus, emphasizing user-friendly designs rather than excessive
reliance on training, with the expectation that users would become more capable
over time. Although initially applied in the aviation and aerospace industry,
human factors principles have now permeated various sectors, including
healthcare, software, oil and gas, chemicals, and automobile manufacturing.

HUMAN FACTORS: WHY THEY MATTER FOR PATIENT SAFETY

The increased utilization of medical devices for diagnostic, monitoring, and
therapeutic purposes has resulted in a rise in usage errors that can harm
patients. Such errors often stem from inadequate device design, particularly in
devices with complex user interfaces. Examples of medical devices prone to
potential design issues include ventilators, infusion pumps, automatic
electronic defibrillators (AEDs), and auto-injectors. These design issues can
lead to problems such as medication overdoses, incorrect therapy, and challenges
in delivering medication.

As medical devices continue to advance in their capabilities and are used in
increasingly busy environments with new distractions and specialized training
requirements, the likelihood of usage errors also escalates. Moreover, with the
evolving healthcare landscape, including the transfer of patient care to home
settings, there is a need to ensure that even less skilled or unskilled users,
such as patients and caregivers, can safely operate complex medical devices.

REGULATORY FRAMEWORK

The absence of human factors considerations in the design of medical devices can
result in counter-intuitive interfaces that are difficult to learn, comprehend,
interpret, and use. Consequently, this can lead to errors and have adverse
effects on patient safety. Over the past two decades, medical errors of this
nature have caused adverse events, including severe injuries and patient
fatalities. There has been an alarming upward trend in post-market events
associated with user interface (UI) design issues.

In response to the increasing occurrence of adverse events caused by UI-related
factors, the US Food and Drug Administration (FDA) now mandates human factors
and usability engineering reviews as a routine part of their pre-market approval
process. This review process is conducted by the Office of Device Evaluation
within the Centre for Devices and Radiological Health (CDRH). In December 2022,
FDA. released a draft guidance document titled "Content of Human Factors
Information in Medical Device Marketing Submissions." This guidance serves as a
complement to the previous one and specifically focuses on the type of human
factors data that manufacturers should include in their marketing submissions.

In a similar vein, the International Electrotechnical Commission (IEC) has
incorporated IEC 62366-1, which replaces IEC 62366 and pertains to the
application of usability engineering in medical devices. Both the FDA guidance
and IEC 62366-1 outline a process that encompasses activities throughout device
development, including validation testing of the final user interface (UI)
design in simulated use environments.



OVERVIEW OF THE HFE/UE PROCESS

According to the FDA guidance [4], human factors engineering (HFE), and
usability engineering (UE) primarily focus on understanding how people interact
with technology and studying the impact of UI design on those interactions.

The development of medical devices with HFE/UE considerations involves three
main components:

 * device users,
 * device use environments, and
 * device user interfaces.

The interactions among these components are illustrated in Figure 1, where human
factors influence the outcomes of using medical devices.

 



Figure 1 Human factors affect outcomes of using medical devices (MHRA guidance)



Use-related hazards associated with user interactions with medical devices
should be addressed in the risk management process. These hazards arise from
aspects of the user interface design that may cause users to inadequately
perceive, read, interpret, understand, or respond to information from the
device. Some use-related hazards are more critical than others, depending on the
potential harm to the user or patient.

HFE/UE activities need to be carried out at every stage of the design and
development process for a medical device. This includes initial task and risk
analysis, designing and evaluating the user interface (UI), and conducting final
summative validation testing using simulated scenarios. This process needs to
align with the overall risk management approach for the device. To determine the
acceptability of use-related risks, decisions should be based on the outcomes of
simulated use testing involving representative users.

This assessment should focus on identifying any persistent patterns of failures
or difficulties in tasks that have significant risk implications. The provided
flowchart (Figure 2) exemplifies the iterative nature of the usability
engineering process, as outlined in the MHRA guidance.



Figure 2 Example of usability engineering process (MHRA guidance)



CONCLUSION

Human factors engineering and usability engineering are becoming integral to the
development of medical devices, ensuring their safety and ease of use.
Regulators now follow a systematic approach to review manufacturers' compliance
with usability engineering standards. Professionals from diverse disciplines are
actively leveraging their unique skills and abilities to study how people
interact with devices. As technology continues to advance, the field of human
factors will continuously expand, contributing to advancements in patient safety
within the clinical environment.



REFERENCES

 1. IEC 62366-1 Medical devices — Part 1: Application of usability engineering
    to medical devices
 2. IEC 62366-2 Medical devices – Part 2: Guidance on the application of
    usability engineering to medical devices
 3. FDA Guidance: Medical Device Use-Safety: Incorporating Human Factors
    Engineering into Risk Management.
 4. FDA Guidance: Applying Human Factors and Usability Engineering to Medical
    Devices
 5. FDA Guidance: Applying Human Factors Engineering to Combination Products
 6. AAMI/ANSI HE75: Human Factors Engineering – Design of Medical Devices
 7. MHRA Guidance on applying human factors and usability engineering to medical
    devices including drug-device combination products in Great Britain
 8. BSI Whitepaper: The growing role of human factors and usability engineering
    for medical devices

 9. https://assets.publishing.service.gov.uk/media/60521d98d3bf7f0455a6e61d/Human-Factors_Medical-Devices_v2.0.pdf



This blog is written by Deepareddy G, Sr. Systems Engineer (Human Factors) at
Decos. She is expert in Systems, Human Factors, RA&QA and comes with wealth of
experience in medical device regulations, R&D, Usability/ Human Factors.

Decos is a cutting-edge technology services partner ready to meet your software
needs in the medical domain. If you have a question on one of our projects or
would like advice on your project or a POC, just contact Devesh Agarwal. We’d
love to get in touch with you!
 

Send an email




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