Warnings and Instructions: Design Factors for Medical Devices and Systems

Abstract

The development and widespread use of sophisticated medical devices to help patients has also hurt patients through operator error. Some of this error may be attributable to the quality of the labeling instructions that accompany these devices. Lessons learned from two decades of research on warnings may serve as a guide to development of effective medical device labeling practices. In this article, we highlight some of the issues associated with poor medical device labeling practices, suggest a framework for guiding development of medical device labeling practices based on the communication-human information processing model, and finally, present an example of a medical device for which better labeling and instructions are needed.