Symposium Overview: Validation Engineering Approaches for Reducing Medical Errors

Abstract

Validation engineering (VE) is a structured, systematic approach to risk reduction and user hazard mitigation. This series of presentations will espouse the use of a VE framework in considering the ergonomics of medical systems. The first presentation will set the stage by arguing that medical errors should be viewed from a context-of-care perspective, in order to shift the focus from assigning blame to identifying and correcting the precipitating causes of adverse events. VE provides a means of being proactive in this regard, thereby avoiding the conditions that can lead to medical errors. The second presentation will describe the VE framework from a theoretical perspective, mapping out the typical VE lifecycle as a series of feedback and feed forward loops that ensure the systematic assessment of needs, the translation of needs to requirements, the derivation of quantifiable engineering specifications, the accurate translation of specifications to implementation, and then to deployment of the medical product or process. The third presentation will discuss issues that arise in applying this VE approach to ergonomic problems in the design of medical systems. We will emphasize the importance of observation-based measurement in dealing with VE processes and will show examples of metrics, methods, and software tools that can be used to manage a VE implementation.