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Medical Device Usability

Medical device usability is also known as human factors engineering. This is the application of information about human behavior, capabilities, shortcomings, and other features to the design of medical devices like software, systems, tasks to achieve adequate usability.

Three major elements of medical device usability is User Interface, and Use Environment. The interaction of these 3 elements with device in Use results in either safe and effective use or correct use or unsafe or ineffective use or user error.

Usability medical device is the characteristics of the User Interface that facilitate Use, to make it easier for the users to perceive the information presented by the User Interface, to understand and make a decision based on that information.

To interact with the medical device to achieve specified goals in the intended use environment. These factors can influence safety to various degrees. Medical device usability refers to the user interface characteristic which establishes user learning and user satisfaction, effectiveness, efficiency, and ease.

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Medical Device Usability Study Process

It is a process which provides safety for the patient, user and others related to medical device usability. This process mitigates the risks associated with the correct use and use errors due to usability problems. This process helps manufacturer to:

Identify hazards and hazardous situations related to the user and user interface
Design and implement risk control measures related to the user interface
Evaluate the risk control measures

The process is as follows:

Prepare use specification,
Identify frequently used functions,
Identify known or foreseeable hazards and hazardous situation (ISO 14971-foreseeable misuse)
Identify device primary operating function,
Develop Usability specification,
Prepare usability validation plan,
Design and implement user interface,
Verify user interface,
Validate usability of medical device

Medical Device Usability Engineering

All aspects of medical device usability should be documented in a usability engineering file. It should have the following aspects:

Independent file
Part of product design file or risk management file
Should contain references and pointers to all required documents
Should enable efficient auditing of the design and development process

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Medical Device Usability Standards as per EU MDR

As per Annex I of EU MDR 2017/745, the Usability requirements are mentioned in the following GSPRs: 5, 14.2, 14.6. The latest EU harmonized standard for medical device usability is EN 62366:2008, Medical Devices: Application of Usability Engineering Medical Devices. This is a process-based standard for usability analysis, design, verification, and validation through the medical device development cycle as it relates to their safety

This is an adopted standard from the international standard IEC 62366:2007

There is a collateral standard for Medical Electrical Equipment which is IEC 60601-1-6:2010 harmonized with EN 60601-1-6:2010. Clauses 7.3.3(a) and Cl. 7.3.9 state about usability in EN ISO 13485:2016 Quality Management System

Importance of Medical Device Usability

It reduces the use error, reduces the training efforts needed, improves performance in using devices, reduces stress of the user. It should be conducted throughout all phases of design and development of medical devices.

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Medical Device Usability FAQ's

What is Primary Operating Functions means?

A primary operating function is a function that is directly related to the safety of the medical device. Primary operating functions are identified in some product-specific medical device safety standards which require those identified primary operating functions to be an input to the usability engineering process

What is Usability Engineering?

Application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of medical devices (including software), systems, and tasks to achieve adequate usability

What is Usability Test?

Method for exploring or evaluating a user interface with intended users within a specified intended use environment

What is Use Environment?

Method for exploring or evaluating a user interface with intended users within a specified intended use environment

What is Use Error?

Use Errors often can be an indication of user interface design flaws that affect the interaction of a user with a medical device.

What is Use Scenario?

The specific sequence of tasks performed by a specific user in a specific use environment and any resulting response of the medical device. A task in a hazard-related use scenario, in which a use error can lead to significant harm, can be thought of as a ‘critical task’.

What is User, User group and User Interface?

User: Person interacting with (i.e. operating or handling) the medical device
User groups are subsets of users who are differentiated from other users by factors that are likely to influence their interactions with the medical device. Attributes of USER GROUPS can include age, culture, expertise
User Interface: The means by which a user and medical device interact