The second article addresses certain specific aspects, such as the intended users of the device, the environment the device is intended to be used in, and also the user interface of the product. 

 

 

 

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 applying human factors and usability engineering to medical devices. The document is intended to provide medical device manufacturers and other parties involved with additional clarifications on the matter, as well as recommendations to be considered to achieve and sustain compliance with the respective regulatory requirements. It is important to mention that FDA guidance documents are not intended to introduce new rules or requirements to be followed, so the provisions thereof are non-binding in their legal nature. 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. 

 

Regulatory Background

First of all, the authority emphasizes the importance of considering the device users, user environment, and user interface when developing the device. The aforementioned factors could impact significantly the safety and effectiveness of the device since when the device is used for its intended purpose, a user perceives information the device provides, interprets, and makes decisions based on it. Apart from this, a user may take some steps to change the way the device operates, and then the interaction flow will be reversed – the product itself will receive information (commands) from a user and take actions based on it. Then the initial flow repeats – a user perceives feedback from the device as information and interprets it. The aforementioned cycles repeat within the whole period the device is used. 

Based on the above, the factors to be considered by medical device manufacturers shall include, inter alia, the following ones: 

  • Device users (the category of users supposed to use the product (e.g., healthcare professionals or laypersons), their qualifications and knowledge, as well as any training they could undergo before using the device;
  • Device use environment (whether the device is intended to be used in healthcare settings or at home, as well as any special environment);
  • Device user interface (e.g., components and accessories, controls, visual displays, visual, auditory, and tactile feedback, alarms and alerts, logic and sequence of operation, labeling, training). 

The guidance further elaborates more on the factors listed hereinabove and outlines specific aspects to be considered about each of them. All these factors should be considered when developing a medical device to ensure it will be used safely and efficiently. 

Device Users 

Under the general rule, a medical device should be designed in a way ensuring that it will be used properly by its intended use for the initial purpose as prescribed by the manufacturer. The category of users depends on the nature of the device itself and its intended use and functionality. For instance, some of the medical devices could be used only by healthcare professionals since specific qualifications and experience are required to use them properly, while the others could be used by laypersons having no formal training. Moreover, even professional users could be divided into several groups (e.g., healthcare practitioners and laboratory professionals). A separate category covers the professionals who are dealing with deploying the device and making sure they are installed correctly. 

According to the guidance, the characteristics to be considered when analyzing the device users should include, inter alia, their physical size, and strength, sensory abilities; cognitive abilities; literacy and language skills; mental and emotional stage; and other aspects. The FDA mentions that a medical device manufacturer should duly conduct a rigorous assessment of all the characteristics of intended user groups and consider the results of such an assessment when developing the device to ensure its design is aligned with the limitations of users and other specific aspects. 

 

Device Use Environments 

Another important aspect relates to the device use environments – the ones in which the product is initially intended to be used. When assessing this factor, a manufacturer should take into consideration numerous factors, such as the lighting level, the noise level, presence of other medical devices that could interfere and impact the operations of the device in question. For instance, it is important to consider whether the device is intended to be used in a moving vehicle – in such a case, additional measures should be taken to prevent the adverse impact of vibration that could take place (it could be difficult to perceive information or conduct manipulations with controls). 

As in the case with device users, the medical device manufacturer should duly analyze and evaluate all the matters related to the intended use environment to identify the factors that could impact the safety and effectiveness. 

 

Device User Interface 

The last but not the least aspect to be taken into consideration when developing a medical device is its user interface which, according to the guidance, includes all points of interaction between the user and the device, including all elements of the device with which the user interacts. The assessment should cover such aspects as the physical dimensions of the device, displays and other elements used to provide information, graphic user interface (GUI) of the software which operates the product, the flow of interactions with the user, additional components and accessories, as well as labeling and instructions for use provided with the device. The authority also mentions that in most cases changes to the device user interface are needed to mitigate the risks associated with the use of the device. The FDA additionally emphasizes the importance of ensuring the interface is logical and intuitive. When developed properly, the device user interface will contribute to reducing the risks associated with user errors. Moreover, it is stated that addressing use-related hazards by modifying the device design is usually more effective than revising the labeling or training. 

The authority further explains that the way the information is presented, as well as the way the device is to be operated, should be as intuitive and logical as possible. When developing the user interface design, the manufacturer should consider the expectations of users and the ways they are more likely to act. In this regard, the manufacturer should pay special attention to ensuring consistency in controls and the way they are intended to be used. 

In summary, the present FDA guidance highlights the most important aspects to be taken into consideration by medical device manufacturers about intended users of the device, its intended use environment, and user interface to ensure that the device will be used safely and efficiently. The document provides additional recommendations related to certain specific matters, such as the factors to be considered when developing the design of controls and other elements.

Sources:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices 

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