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Journal of Healthcare Engineering
Volume 3, Issue 3, Pages 391-414
Research Article

Applying System Engineering to Pharmaceutical Safety

Nancy Leveson,1 Matthieu Couturier,1 John Thomas,1 Meghan Dierks,2 David Wierz,5 Bruce M. Psaty,3 and Stan Finkelstein1,4

1Engineering Systems Division, Massachusetts Institute of Technology, Cambridge, MA, USA
2Beth Israel Deaconness Medical Center, Boston, MA, USA
3Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle, WA, USA
4Harvard University Medical School, Boston, MA, USA
5Independent Consultant, Philadelphia, PA, USA

Received 1 December 2011; Accepted 1 March 2012

Copyright © 2012 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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. 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.