The new article describes in detail the particular methods to be applied by medical device manufacturers when identifying use-related issues and evaluating potential risks associated thereto. 




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 in the context of medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. At the same time, the document itself does not introduce new rules or requirements the parties involved should follow, and the provisions thereof are non-binding. Moreover, an alternative approach could be applied, provided such an approach complies with existing legislation and has been agreed with the authority in advance. 


Preliminary Analyses and Evaluations: Key Points 

According to the guidance, preliminary analyses and evaluations are performed to identify user tasks, user interface components, and use issues early in the design process. In other words, they are useful for ensuring the focus on the most important aspects related to the safety and effectiveness of medical devices. In particular, this allows the manufacturer to identify and categorize user tasks properly. 

The aspects addressed in the guidance are related to the approaches the manufacturer may apply to assess the ways users interact with medical devices in question. When deciding on the particular method of assessment to be applied, the manufacturer shall make its decisions based on the device itself and also on the technologies incorporated therein. The methods described in the guidance could be used to identify the issues related to the use of medical devices that took place before. They include both analytical and empirical methods to be applied to identify use-related hazards and hazardous situations. The authority additionally mentions that any of the methods described herein could be applied independently, while the result of assessment should be taken into consideration when deciding on risk management and further testing to be performed. 

Critical Task Identification and Categorization 

According to the guidance, first of all, it is important to identify the most important tasks that should be properly completed by users to ensure the device operates safely and efficiently. As further explained by the FDA, all the tasks should be categorized depending on the harm that could be potentially caused, and in such a way to identify specific tasks inappropriate performance of which could result in significant harm caused to patients. The document defines them as “critical tasks”. To achieve this purpose, the manufacturer may apply failure modes effects analysis (FMEA) and fault tree analysis (FTA). The authority also mentions that all risks associated with the warnings, cautions, and contraindications in the labeling should be included in the risk assessment. It is also stated that the manufacturer should consider the cases when the device is used inappropriately, or not by the intended user, to identify potential consequences of such use and risks associated thereto. The appropriate information should be duly reflected in the labeling of the device, including warnings, cautions, and contradictions to be added to communicate important safety-related information to intended users. However, the authority acknowledges that this is almost impossible to foresee and evaluate potential abnormal use cases. Furthermore, the Agency mentions that the list of critical tasks could be subject to changes due to the respective changes to the design of the product and new information received. Some of the aspects could be identified and assessed only by the virtue of human factors validation testing. Hence, the appropriate studies should be reflected in test protocols. 

The guidance further describes some of the key directions of analysis, namely:

  1. Failure mode effects analysis, which stands for an approach to the analysis of user safety, is most successful when performed by a team consisting of people from relevant specialty areas. As explained by the FDA, it would be beneficial if the group involved in the assessment of this kind will include both engineers responsible for design and patients who have certain experience in using the device. In such a way, the assessment will cover more viewpoints, which is beneficial for ensuring the accuracy and reliability of the results achieved. At this stage, the workgroup could analyze the tasks by describing and investigating the way a potential user interacts with the device in question. 
  2. Fault tree analysis. As explained by the FDA, fault tree analysis (FTA) differs from FMEA in that it begins by deducing and considering “faults” (use-related hazards) associated with device use (a “top-down” approach), whereas FMEA begins with the user interactions (a “bottom-up” approach) and explores how they might lead to failure modes. The same as in the previous case, it would be beneficial to have a team of participants with diverse backgrounds, including engineers specializing in the design and human factors, and also the patients who have used similar medical devices before. The authority also mentions that the actual effectiveness of the approaches described hereinabove would depend on the ability of the assessment team to identify potential issues and consequences thereof. 

Even though the above mentioned methods could be construed as valuable sources of information, their results would not provide sufficient details to complete the assessment. Hence, these results should be used to develop and conduct additional studies, including simulated-use testing, to assess whether the preliminary findings are correct. 


Identification of Use-Related Problems 

The Agency also encourages medical device manufacturers to identify the issues faced by customers who have previously used medical devices similar to the one subject to review. All such issues should be assessed carefully and taken into consideration when developing a new design. It is also important to mention that such an approach could be applied even concerning products of other manufacturers. For this purpose, the manufacturer may analyze complaints submitted by the users and records associated thereto, as well as any other information about use-related errors, including the results of previous studies dedicated to the same matters. 

In summary, the present FDA guidance describes the approaches to be applied to identify and categorize potential use-related issues associated with a medical device. The document clarifies the way such approaches should be applied, and the most important aspects to be considered in this respect. 



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