The UK’s Medicines and Healthcare products Regulatory Agency published new guidance on human factors and usability engineering for medical device manufacturers — pulling back the curtain on the UK’s regulatory structure, and showing how various usability engineering strategies stack up against each other.
The document also delves into the stages of a usability engineering process, post-market surveillance, and various concerns during the medical device lifecycle.
Aimed at manufacturers of all device classes and drug-device combination products, as well as notified bodies responsible for assuring the quality of those devices, the guidance focuses on ways human factors can be applied so products are optimized for the intended users.
MHRA said those involved in procurement and risk management of activities involving medical devices, as well as physicians and other stakeholders may also find the guidance relevant to their roles.
As devices become increasingly diverse in their capabilities and the environments in which they are used becomes busier, with new distractions and requirements for specialized training, the potential for user error also increases, the agency said, adding that as healthcare evolves and patient care is transferred to the home or public environment, “less skilled or even unskilled users, including patients and carers, must be able to use quite complex medical devices safely.”
Devices such as infusion pumps, ventilators, automatic electronic defibrillators and drug-device combination products (such as auto-injectors) are recognized 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, says the document.
Human factors take into account features of the intended user population, such as age, size, strength, cognitive ability and training. Also considered are factors such as potential competing distractions, lighting level, or urgency of use.
“This will very much depend on the design of that technology, what education and training that person has, and the environment in which they will be using the technology,” says the guidance.
The MHRA guidance is intended to be consistent with FDA guidance and other international standards. Although it aims to clarify regulatory expectations of medical devices marketed in the UK, it does not represent a compliance requirement. Alternative approaches to demonstrating safe and effective use could be proposed by applicants. The agency said the guidance applies to the design of future products and changes in user interfaces of existing products, rather than those already approved for the UK and EU market.
In addition, MHRA clarifies that usability engineering is an iterative process involving design, testing and validation of design stages. The agency calls for attention to the post-market phase, since “evidence may come to light while a device is being used in clinical practice that the design requires further improvement.”