Medical Device Users and Use Environments

Important characteristics of the medical device potential users for consideration during the device design process. 

The use environments of medical devices can vary significantly from one situation to another and can impact their usability significantly. The main factors with respect to device users that must be considered with care are as follows [2]  

In the case of noise and light, the effectiveness of auditory and visual displays (e.g., auditory alarms and light indicators) can be limited by the use environments if they are not designed properly. For example, in noisy environments, alarms may not be heard by the device users if they are not distinctive or sufficiently loud. In the case of vibration and motion, these two things can seriously affect device users ability to read displayed information, to carry out fine physical manipulations such as typing on the keyboard part of a medical device, and so on. 

Finally, physical workload is concerned with the use of the medical device and adds to user stress. Under high stress, the users of medical devices are distracted and have less time to make decisions (e.g., consider multiple device outputs). 

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Chapter 10 is devoted to medical device usability. It covers topics such as medical device users and use environments, medical device user interfaces, an approach to develop medical devices effective user interfaces, guidelines to reduce medical device user interface-related errors, guidelines for designing hand-operated devices with respect to cumulative trauma disorder, and useful documents for improving usability of medical devices. Chapter 11 presents three important topics relating to patient safety patient safety organizations, data sources, and mathematical models for performing probabilistic patient safety analysis. 

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