Accession Number:

ADA409349

Title:

The Role of Usability Testing and Documentation in Medical Device Safety

Descriptive Note:

Corporate Author:

ILLINOIS INST OF TECH CHICAGO

Report Date:

2001-10-25

Pagination or Media Count:

4.0

Abstract:

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 andor development process. The FDAs 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.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE