Validation Engineering in the Ergonomics of Medical Systems: Application Perspectives

Abstract

As discussed in the foregoing companion presentation, Validation Engineering (VE) provides a structured, systematic approach to risk reduction that is more cost-effective than ad hoc methods and maximizes the likelihood that design efforts will yield safe and effective products or processes. Here we discuss issues that arise in applying this VE approach to ergonomic problems in the design of medical systems. To demonstrate its value, several well-known incidents of medical error will be interpreted in terms of how the application of a systematic VE approach might have mitigated or avoided the adverse outcomes. In so doing, the importance of measurement in dealing with such ergonomic problems is emphasized and examples will be shown of metrics that can help cast these problems, and possible interventions, in a VE framework. This will be followed by a discussion of a number of software tools that are available to help manage the practical implementation of a VE process.