Role of Usability Testing and Documentation in Medical Device Safety.

摘要

Usability testing is a technique that can be used to identify problems users have with a device. If usability testing is employed early in the development cycle it can identify potential use-related problems and hazards so that they can be addressed early in the design and/or development process. The FDA's Center for Devices and Radiological Health has published a document that provides guidance on medical device use-safety and describes the benefits of usability testing to identify potential hazards. This paper describes the application of usability testing to the design development and use of a functional neuromuscular (cough) stimulator and the accompanying documentation. The purpose of the user testing has to observe participants using a device in a realistic situation. Iterative design and user testing is an effective way to (1) reduce or eliminate use-related hazards, (2) make an interface intuitive, (3) alert users to errors and (4) provide aids for safe operation.