Use Error Analysis in a Medical Device Product Development Cycle

Abstract

Product development organizations have well-established processes in assessing potential hazards for both process and design. However, these processes either do not apply to use error or they treat the human component of systems in a superficial, non-formal way. While some user-centered effort is directed at analyzing and reducing error, with a reliance on traditional user-centered activities, formal human factors methods that specifically address use error and regulatory needs are scarce. A formal Use Error Analysis (UEA) process was developed to identify potential use error during initial product design. This process generates an exhaustive, predictive list of use errors. Then potential users familiar with the product environment determine the frequency by which the error would occur and the severity of the effects. Once it is determined which errors should be mitigated, the process allows product risk assessment teams to determine the probable causes of the use error. These causes are directly addressed through system design or other mitigations as appropriate. The UEA process has been successfully incorporated into formal hazard analysis processes in an FDA regulated environment and used on numerous projects.