From Nancy Leveson’s site at MIT
Applying System Engineering to Pharmaceutical Safety by Nancy Leveson, Matthieu Couturier, John Thomas, Meghan Dierks, David Wierz, Bruce Psaty, Stan Finkelstein. Journal of Healthcare Engineering, Sept. 2012.
While engineering techniques are used in the development of medical devices and have been applied to individual healthcare processes, such as the use of checklists in surgery and ICUs, the application of system engineering techniques to larger healthcare systems is less common. System safety is the part of system engineering that uses modeling and analysis to identify hazards and to design the system to eliminate or control them. In this paper, we demonstrate how to apply a new, safety engineering static and dynamic modeling and analysis approach to healthcare systems. Pharmaceutical safety is used as the example in the paper, but the same approach is potentially applicable to other complex healthcare systems.
One use for such modeling and analysis is to provide a rigorous way to evaluate the efficacy of potential policy changes as a whole. Less than effective changes may be made when they are created piecemeal to fix a current set of adverse events. Existing pressures and influences, not changed by the new procedures, can defeat the intent of the changes by leading to unintended and counterbalancing actions by system stakeholders. System engineering techniques can be used in re-engineering the system as a whole to achieve the system goals, including both enhancing the safety of current drugs while, at the same time, encouraging the development of new drugs.
Read this an other papers about this new model of incident investigation here
Safety Dog's Blog 