As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.
The guidance, intended not just for manufacturers of all device classes and drug-device combination products but notified bodies too, offers a look at the UK’s regulatory framework, comparisons of different usability engineering strategies, stages of a usability engineering process, post-market surveillance and other considerations for a device’s life cycle and continuous improvement.
And although the guidance was written with reference to the three EU device directives that currently regulate devices and in vitro diagnostics (new regulations are taking force in the next three years), MHRA says, "This guidance should be equally useful in supporting the demonstration of compliance with the new regulations, recognising that specific details will be updated."
The second appendix of the guidance also includes tables comparing the new device and IVD regulations with the previous directives.
The term "human factors" often refers to how people interact with technology, which can depend on the design, a user's education and training and the environment in which the technology is used.
And the same is true for medical device technology, where a growing number of complex medical devices are used for monitoring and treating patients, and errors in use can lead to patient harm and be the result of poor device design.
"Medical devices, such as infusion pumps, ventilators, automatic electronic defibrillators and drug-device combination products (e.g. auto-injectors) are recognised as potentially having use-related design issues that can result in problems such as overdoses, incorrect therapy and dangerous delays or difficulties with delivery of medication," the guidance says.
Following an overview of the regulations and standards, the guidance explains safety considerations and principles that make a device "more pleasing to use" and can lead to better adherence to correct use.
"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," the guidance says, offering various engineering techniques with special considerations.
The user interface, for instance, may be under continual improvement throughout the life cycle of a device.
"Considering the wide range of medical devices and drug-device combination products, a flexible approach to the requirements is necessary, depending on the type of device, intended use and known use errors of similar devices. However, the approach taken should be risk-based, justified and appropriately documented throughout the life-cycle of the product," the guidance says.
And for both integral and non-integral drug-device combination products, the expectations for human factors and usability engineering considerations "will be similar to those for any other medical device and should be discussed in the application for a marketing authorisation and subsequent variations, where relevant," the guidance adds.
Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products