Malin Truvé
Regulatory Affairs consultant, Usability expert
Are you about to perform a Usability evaluation for your medical device and are unsure of what usability documentation that are needed? There are three common mistakes that a lot of people make. This blog to help you avoid some of the pitfalls. The advice is based on fulfilment of the latest IEC 62366-1:2015 + AMD1:2020 edition.
The User Interface does not only consist of screens and buttons. Remember to include accompanying documents, such as IFU, installation manual and Quick reference guide in your evaluation. It is also important to indicate if medical device specific training is required. If so, what kind of training and material will be provided to the users? You want to make sure that training material and instructions for use can be successfully understood, as well as developing a device that is user friendly and intuitive.
You are required, in the Usability Engineering Process, to address user interactions with the medical device including transport, storage, installation, operation, maintenance and repair, and disposal. Address all the above-mentioned user interactions, and if you find one of them to not be applicable for your device, write a motivation as to why. Remember that the focus is on addressing user interactions. It is not enough to simply described that the product is shipped from point A to B. The standard request consideration of for example how the device is carried, can the carrying handles be improperly used? Can improper packaging prior to shipping lead to the device being faulty positioned and damaged during transportation? Can user interactions lead to hazardous situations and use errors occur? Find out if there are any potentially design-induced use errors for your product during these processes and how they are avoided.
Are all applicable parts covered in the correct document? The standard does have some very specific requirements such as “The Use Specification shall include: …”. Ensure that these requirements are listed in the Use Specification and not elsewhere. Aligning the name of the document and content with the standard can help you ensure all applicable parts are covered.
The IEC 62366-1 standard contains several terms and definitions that might not be used in everyday language. Notice for example that Hazard-Related Use Scenarios are not the same as Hazards or Hazardous situations. According to the Usability standard “Hazard-related use scenario” is a “Use Scenario that could lead to a hazardous situation or Harm”. You have probably listed the hazards and hazardous situations in your risk analysis, however this will not suffice when asked to describe the hazard-related use scenarios. The standard request that the use scenarios, divided into their different tasks, are described.
Another important Usability documentation term is “Tailoring”. Tailoring means that the width of the usability study can be minimized or extended depending on different factors (for example size and complexity of the user interface or severity of harm). If tailoring has been performed for your device, describe in detail on what basis and to which parts the tailoring was made. A product that is new on the market will most probably require a full usability evaluation. A product that has been developed prior to current standard version and has been several years on the market will only require a limited evaluation.
Keep track of all documents that belong to your Usability Engineering File (UEF). The easiest way to prove which documents that belong to your UEF might be to list all of them in a document. Another way would be by providing traceability from one Usability document to other Usability documents. Thereby making it possible to gather them.
While traceability might not be the fastest or easiest way to gather your Usability Engineering File, it is very important. Traceability is important both between the Usability documents as well as to other documents, such as the Risk Management File. Risk management and Usability are often intertwined. Output from one document is often used as input to another. Ensure that traceability can be followed and that reference lists are accurate.
Last, but not least, always keep track of the document revision history and file versions. Ensure that the files are signed, dated and officially released.
Missing resources and knowledge about the standard to perform evaluations? Do not worry, Key2Compliance are always happy to help. We can assist with planning, carrying out and documenting the Usability evaluation. We can perform a Gap analysis for existing documents and answer your questions. Ensuring that your device and accompanying documentation is user-friendly and easily understandable will not only be a step in the right direction to fulfil regulatory requirements. It will also support correct use and likely increase your sales. Discovering design flaws or improvements early on will save you time and money in the future.
