An analytical approach to identifying potential use-related issues concerning a medical device under development.

Abstract

Identifying potential use-related issues at the onset of the design process of a medical device can reduce use errors, enhance safety and improve usability of the product. Regulatory bodies such as the US Food and Drug Administration (FDA) suggest manufacturers should investigate use-related problems that have occurred in the past with devices that are similar to the one under development. Publically available device incident databases, such as the FDA's Manufacturer and User Facility Device Exp