The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has provided a guidance on the human factors aspects of design for medical devices to ensure patient and user safety.
Intended for manufacturers, developers and notified bodies, the guidance focuses on the importance of human factors influence on safety risks.
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The guidance includes design and optimisation of medical devices, as well as device components of drug-device combination products that are regulated as medicines.
A Human Factors Task and Finish group has been formed to support the initiative for patient safety and includes members from MHRA, academia, industry, NHS Improvement, NICE, notified bodies, professional associations, and trade bodies.
MHRA Devices director John Wilkinson said: “Medical devices are becoming ever more complex and diverse, encompassing drug-device combinations and companion diagnostics.
“As these developments occur, the potential for user error increases. We recognise this and have collaborated with partners to produce the first UK guidance on human factors.”
The guidance applies to the design of new devices and changes in user interfaces of existing products.
In addition to design, the guidance advises on testing and validation of design stages, as well as the post-market phase that might suggest certain design improvements during clinical practice.
It urges device manufacturers to apply a usability engineering process to identify, assess and reduce potential patient and user safety risks.
The process can also be applied during the analysis of prior incidents for identification and implementation of corrective actions to improve device design.
