The new article provides details regarding various methods that could be used to identify use-related safety issues.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to human factors and usability engineering for medical devices. The document highlights the most important aspects to be considered by the manufacturers when developing medical devices to ensure the safety and effectiveness of the products created. The authority also mentions that the guidance is non-binding in its legal nature, so the provisions thereof should be construed as recommendations to be followed, but not the rules or requirements to be implemented as is. Moreover, an alternative approach could be applied, provided such an approach is in line with the relevant legislation and has been agreed with the authority in advance.
In particular, the guidance describes analytical approaches that could be used to identify critical tasks. The concept covers the approaches based on a rigorous review and analysis of the ways the user interacts with the product. As explained by the FDA, such approaches should be applied during the initial design and development of a medical device. The authority also mentions that analytical approaches can also be used for studying use-related hazardous situations that are too dangerous to study in simulated-use testing. According to the guidance, the concept of analytical approaches covers the assessment of customers’ needs, and also the analysis of the information available about similar devices. The document further describes in detail the main analytical approaches to be used.
The task analysis provides that the process of using a medical device should be divided into several tasks placed in the appropriate sequence. At the next step, all these tasks should be subject to a rigorous analysis to identify (a) specific UI elements used and (b) use errors that could take place, as well as potential consequences thereof. The authority also provides an example of such analysis describing the way the use of a hand-held blood glucose meter should be analyzed.
According to the guidance, the following questions should be answered during the assessment:
- What use errors might users make on each task?
- What circumstances might cause users to make use of errors on each task?
- What harm might result from each use error?
- How might the occurrence of each use error be prevented or made less frequent?
- How might the severity of the potential harm associated with each use error be reduced?
In general, the idea behind the task analysis approach is to identify the way the customer will use the device, what errors can appear due to this, and what are the potential consequences thereof. This includes a rigorous analysis of all interactions with the device, including perceptual inputs, cognitive processing, and physical actions involved in performing the step. Apart from this, the details to be considered in the course of the task analysis are:
- The effort required by the user to perform each task correctly;
- The frequency that the user performs each task;
- The characteristics of the user population that might cause some users to have difficulty with each task;
- The characteristics of the use environment that might affect the test results or the user’s ability to perform each task; and
- The impact of user errors on the accuracy, safety, or effectiveness of the devices’ subsequent operations.
Another type of analysis covered by the scope of the present guidance is the heuristic analysis which stands for the analysis of the user interface concerning the general design principles. The purpose of such an analysis is to identify potential vulnerabilities and weaknesses, especially the ones that could potentially expose patients or customers to additional hazards and result in the harm caused. According to the document, heuristic analyses include careful consideration of accepted concepts for user interface design.
The third type of analysis addressed in the document is an expert review to be carried out by a qualified professional having the necessary knowledge and experience in the relevant sphere. In comparison to the heuristic analysis, expert review is based mostly on applying specific knowledge, hence, its actual effectiveness would depend significantly on the level of qualification of the persons involved, and also on their ability to identify potential use scenarios and risks associated thereto. The authority also encourages engaging multiple experts to ensure that all the important aspects are covered.
Empirical Approaches to Identifying Critical Tasks
The document also describes the empirical approach that could be applied when assessing the safety and effectiveness of medical devices. The method stands for collecting information regarding the potential issues and consequences thereof by analyzing the customers’ experience from the use of the device. According to the guidance, such approaches include such methods as:
- Contextual inquiry;
- Interview techniques; and
- Simulated-use testing.
The authority additionally emphasizes that persons participating in such testing should be representatives of the intended users to ensure the accuracy and reliability of the results. Moreover, it is also important to ensure that the testing results are not affected by any factor.
The document further describes all the aforementioned methods in detail:
- Contextual Inquiry stands for observing representatives of the intended users interacting with a currently marketed device (similar to the device being developed) as they normally would and in an actual use environment. The main goal of such an analysis is to identify the way the UI impacts the safety and performance of the product, and which changes are needed (if any). Apart from observation itself, the process could include asking questions or interviewing upon completion of use. For instance, users could be asked about the way they are using the device and about the specific actions taken to collect important information regarding the way the user treats the device, and also to identify potential risks associated with such use.
- Interviews, according to the guidance, are intended to generate qualitative information regarding the perceptions, opinions, beliefs, and attitudes of individuals or groups of device users and patients. For instance, this includes asking users about the issues they had when using the device for its intended purpose.
In summary, the present FDA guidance describes various methods and approaches that could be applied to collect additional information regarding the way users interact with medical devices to identify potential risks and consequences thereto. The document provides additional recommendations regarding the way each method should be applied.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.