In January 2021, the British medicines agency, MHRA, issued new guidance on the importance of human factors and usability engineering in the development of medical devices. The guidance is intended to assist manufacturers of medical devices on issues of particular significance for patient safety.
In January 2021, the MHRA, issued its updated guidance on how to ensure patient safety to the furthest possible extent when using medical devices. The guidance clarifies how to construe and apply British legislation on medical devices, which to a very high degree is based on EU legal acts. This article provides a brief outline of the most important issues in the guidance.
General scope of the guidance
The guidance concerns medical devices on the British market (England, Wales, Scotland), but since British legislation in this area is highly based on EU Directives, the principles may be advantageously applied to construe European rules.
The guidance is intended for developers and manufacturers of all types of medical devices and for UK approved bodies that are responsible for quality assurance of such devices.
The term "human factors" encompasses considerations as to, for instance, ergonomics and usability. In the guidance, the process of developing usable devices that will address the user's needs and fit with their practices is referred to as "usability engineering" (UE).
The guidance thus focuses on suggesting methods that make it possible to construct and optimise the devices to be operated by the intended users in the most suitable situations and in the most safe and effective manner.
According to the guidance, optimum usability is achieved by including knowledge of human behaviour, abilities, limitations and other human characteristics when constructing medical devices.
According to the guidance, UE should be an iterative process, involving construction as well as testing of the devices, and final validation of the construction. An important part of the process is to focus on the stage after the device has been placed on the market, as being used in clinical practice it will often reveal whether the device requires further improvement.
The main object of the UE process is to develop devices that are easy for users to operate, and users should not be required to read, understand and remember complicated instruction manuals.
The MHRA further points out that devices developed with a view to human factors are more comfortable to use and as such to a further extent will ensure that they are used in the correct and intended manner. This reduces the risk of accidents in connection with using the devices.
UE process stages
The guidance includes an illustration of all the stages usually involved in a UE process.
The process begins with gathering insight into who will typically operate the device and how it will typically be operated. This information may be gathered through interviews, ethnographic research and other relevant investigation.
Then it is important to assess the greatest risks connected with operating the device. This involves complaints about similar devices and surveillance of other comparable devices already placed on the market by competitors. Other observation studies may be performed as well.
The device is further tested and developed in a number of stages, particularly emphasising task and expert reviews. If new errors are identified in this process, steps must be taken back to earlier stages in the process, reassessing the risks connected with operating the device.
When no more errors or risks can be identified, the final design of the device is fixed and summative testing is performed.
The final stage is the drafting of a summary report, describing the typical operation of the device, known operation errors and the human factors included in the development. Then the device will be launched on the market.
The guidance also includes an overview of the most widely used techniques in connection with UE, aligning them with the relevant stages in the process. Reference is made to page 15 of the guidance, to which is linked at the end of this article.
Comments by Bech-Bruun
To an increasing degree, human factors are considered an important issue within the healthcare sector. From a legal perspective, it should be noted that issues such as effect, safety and usability are requirements that must be observed in order to place a medical device on the market in the European Union. In this light, the guidance is a positive supporting tool for all developers of medical devices.
Click here to read more about the guidance.