The UK Medicines & Healthcare products Regulatory Agency has issued new guidance for medical device makers when taking human factors into account.
Human Factors
The new publication is intended to help medical device manufacturers ensure their products are able to be used safely and effectively by any intended users.
The publication was made in reference to the three directives that currently regulate EU medical devices. It includes a transition period of three years for the EU Medical Devices Regulations (MDR) and a five year period for the In Vitro Diagnostics Devices Regulations (IVDR).
Medical device manufacturers must consider how people interact with their products, what education and training the person has and what environment the product will be used in. MHRA states that the guidance looks at how ‘human factors can be applied to medical devices, so that they are designed and optimised for use by intended users, in the environment in which they are likely to be used, for safe and effective performance’.
Human factors considers aspects of the intended user population, including age, size, strength, cognitive ability and training. It also examines what other aspects might affect the use of the device including the intended environment and potential distractions such as lighting or urgency of use.
MHRA says that considerations into human factors for medical devices ‘are more pleasing to use, and are therefore likely to lead to better adherence to correct use’.
To achieve the correct standards the guidance states that ‘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’.
More so the guidance recommends that ‘a flexible approach to the requirements is necessary’ and that the user interface could be under continual improvement throughout the life cycle of a device’.