The Medicines and Healthcare Products Regulatory Agency (MHRA) published its comprehensive guidance titled “Applying Human Factors and Usability Engineering to Medical Devices.” This document, tailored for the UK market, emphasizes the integration of human factors engineering (HFE) into the lifecycle of medical devices to enhance user safety, usability, and effectiveness.
Human factors engineering is critical in designing devices that account for user behavior, cognitive abilities, and environmental conditions. This guidance applies to manufacturers of all device classes and those involved in drug-device combination products in Great Britain.
It outlines ways to mitigate risks arising from use errors. Manufacturers are encouraged to adopt iterative usability engineering processes, encompassing design validation and post-market surveillance. Recommended standards include EN 62366-1:2015 and EN ISO 14971:2019, which address usability engineering and risk management for medical devices.
The process involves multiple stages:
Identification of user needs, operational contexts, and training.
Risk assessment of potential use errors.
Formative and summative testing to refine device design.
Validation of user interfaces and training protocols.
Human factors studies, such as Failure Modes and Effects Analysis (FMEA) and usability testing, are outlined as best practices for risk mitigation.
Manufacturers must establish a system to review device performance post-market, report adverse events, and implement necessary corrective actions. Vigilance data, including user feedback, should inform ongoing improvements to device design and usability. Specific guidance is provided for integral and non-integral drug-device combinations. Human factors considerations for these products ensure proper differentiation between presentations (e.g., strengths or dosing devices) and prevent medication errors.
The guidance stresses that poor design, particularly in complex devices like infusion pumps or auto-injectors, can lead to significant use errors. Human factors engineering not only ensures user safety but also enhances device usability, promoting better adherence and overall effectiveness.
Complementary MHRA Press Release
In alignment with this guidance, the MHRA also announced new requirements for Medical Devices Post-Market Surveillance (PMS) to further enhance device safety and performance monitoring. The PMS requirements, as part of a robust lifecycle approach, mandate active and systematic evaluations of device usage and associated risks.
This guidance and the associated press release highlight the UK's commitment to fostering innovation in medical devices while prioritizing public health and safety.
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