Medzus | Usability Engineering Human Factor
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We will gladly assist in the creation or improvement of your usability engineering procedure and facilitate the transfer of individual process steps, such as task analysis, risk analysis for application error, specification of the usability requirements, creation of validation plans, development-process usability tests, as well as verification and validation of the usability. In addition, we are glad to offer the creation of a standardized usability engineering file, including the closing report according to FDA requirements.

The aim of a usability engineering process is to deliver product of easy to use and safe in the intended context of use, and by intended users (whether by carers or patients themselves). Users should not have to read, understand and remember complex instructions for use and adapt to the requirements of the device, or use it in an uncomfortable, incorrect and possibly dangerous way: a well-designed product will be easy to use, and will have a user interface that is consistent with user experiences and expectations.

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 in order to optimize human well-being and overall system performance.’
Conscious, intentional act or intentional omission of an act that is counter to or violates normal use and is also beyond any further reasonable means of user interface-related risk control by the manufacturer. Examples: Reckless use or sabotage or intentional disregard of information for safety are such acts.
Human factors engineering application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability. Note Achieving adequate USABILITY can result in acceptable RISK related to use.
To a different result than that intended by the manufacturer or expected by the user.
Notes:-

Use error includes the inability of the user to complete a task

Use errors can result from a mismatch between the characteristics of the user, user interface, task, or use environment

Users might be aware or unaware that a use error has occurred

An unexpected physiological response of the patient is not by itself considered use error

A malfunction of a medical device that causes an unexpected result is not considered a use error.

Person interacting with (i.e. operating or handling) the medical device.
Notes:-

There can be more than one user of a medical device

Common users include clinicians, patients, cleaners, maintenance and service personnel.

Means by which the user and the medical device interact.
Notes:-

Accompanying documentation is considered part of the medical device and its user interface

User interface includes all the elements of the medical device with which the user interacts including the physical aspects of the medical device as well as visual, auditory, tactile displays and is not limited to a software interface.

References & Suitable Usability Point Description In Consideration:

EN 62366-1:2015 Medical devices, Part 1: Application of usability engineering to medical devices

IEC/TR 62366-2:2016. Medical devices, Part 2: Guidance on the application of usability engineering to medical devices

EN 15223-1 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

Using internationally recognised symbols consistently will improve usability and meet regulatory requirements.

ISO 13485: 2016 Medical devices. Quality management systems. Requirements for regulatory purposes

Requirements specifically for usability have been included in ISO 13485: 2016. Clause 7.3.3a) requires design and development inputs to include usability requirements according to the intended use. In addition, the significance of a change to usability is also added to clause 7.3.9 for the control of design and development changes.

The essential requirements (ER) in Annex I of the MDD [7] include requirements for human factors, which are highlighted below.

Risk management integrates into the usability engineering process detailed in EN 62366-1. Information or data for estimating risks can also be obtained from usability tests employing typical users;

or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include: - reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment* in which the device is intended to be used (design for patient safety), and - consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
ER 9.2 the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features ER 10.2 the measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device. ER 13.1 Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.’ * this includes hardware, software, labelling and other user interface features (including video, mobile apps, etc) Other ERs that may be affected to some degree by human factors include 2, 3, 6, 12.8, and 12.9

EN 1041: 2008 (and EN 1041:2008+A1:2013) Information supplied by the manufacturer of medical devices

Clause 5.1.1 requires that any means of provision of information with medical devices shall take into account the intended users, the conditions of use and any issues specific to individual device types that are necessary for the safe and effective use of the device.

EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices

Risk management integrates into the usability engineering process detailed in EN 62366-1. Information or data for estimating risks can also be obtained from usability tests employing typical users;Annex C of EN ISO 14971 considers questions to identify characteristics that could impact safety. These include considerations of usability including, can the user interface design features contribute to use error, is the medical device used in an environment where distractions can cause use error, will the medical device be used by persons with special needs, etc.