Risk Management Approach for a Secure and Performant Integration of Automated Drug Dispensing Systems in Hospitals

Authors: Hind Bouami, Patrick Millot

Abstract:

Medication dispensing system is a life-critical system whose failure may result in preventable adverse events leading to longer patient stays in hospitals or patient death. Automation has led to great improvements in life-critical systems as it increased safety, efficiency, and comfort. However, critical risks related to medical organization complexity and automated solutions integration can threaten drug dispensing security and performance. Knowledge about the system’s complexity aspects and human machine parameters to control for automated equipment’s security and performance will help operators to secure their automation process and to optimize their system’s reliability. In this context, this study aims to document the operator’s situation awareness about automation risks and parameters involved in automation security and performance. Our risk management approach has been deployed in the North Luxembourg hospital center’s pharmacy, which is equipped with automated drug dispensing systems since 2009. With more than 4 million euros of gains generated, North Luxembourg hospital center’s success story was enabled by the management commitment, pharmacy’s involvement in the implementation and improvement of the automation project, and the close collaboration between the pharmacy and Sinteco’s firm to implement the necessary innovation and organizational actions for automated solutions integration security and performance. An analysis of the actions implemented by the hospital and the parameters involved in automated equipment’s integration security and performance has been made. The parameters to control for automated equipment’s integration security and performance are human aspects (6.25%), technical aspects (50%), and human-machine interaction (43.75%). The implementation of an anthropocentric analysis system before automation would have prevented and optimized the control of risks related to automation.

Keywords: Automated drug delivery systems, hospitals, human-centered automated system, risk management.

References:

[1] IGAS, Le circuit du médicament à l'hôpital. Rapport RM2011-063P. Mai (2011).
[2] H. Bouami, P. Millot, Healthcare Delivery System Security: the orchestration of automated and organizational solutions, IFAC PapersOnLine 52-19 (2019) 127–132.
[3] K. Schmitt, Automations influence on nuclear power plants: A look at three accidents and how automation played a role, International Ergonomics Association World Conference. Recife, Brazil, February 2012.
[4] A. Yang, Wrong-Patient Medication Errors: An Analysis of Event Reports in Pennsylvania and Strategies for Prevention, Pa Patient Saf Advis; 10(2):41-9.. 2013.
[5] M. Lind, Functional Modeling of Complex Systems, p95, Risk Management in Life-Critical systems, edited by P. Millot, ISTE Ltd and John Wiley & Sons, Inc (2014).
[6] H. Bouami, P. Millot, L’automatisation du circuit du médicament : une conception systémique et centrée sur l’Humain, CIGI Qualita 2019
[7] P. Fitts, Human Engineering for an Effective Air Navigation and Traffic Control System. Washington, D.C. USA: National Research Council. (1951).
[8] G. Boy, A human-Centered Design Approach, Introductive chapter in G. Boy (ed), The handbook of Human Machine Interaction, A human-Centered Design Approach, pp.1-20, Ashgate, Farnham., 2011.
[9] F. Flemisch, Heesen M., Hesse T., Kelsch J., Schieben A., Beller, J., Towards a dynamic balance between humans and automation: authority, ability, responsibility and control in shared and cooperative control situation, Cognition Technology & Work 14:3–18, DOI 10.1007/s10111-011-0191-6, (2012).
[10] E. Châtelet, Vulnerability and Resilience Assessment of Infrastructures and Networks: Concepts an Methodologies, In Millot P., Risk management in Life-Critical Systems, ISTE Ltd and John Wiley & Sons, Inc (2014).
[11] R. Amalberti, “Optimum system safety and optimum system resilience:agonistic or antagonistic concepts”, in E. Hollnagel, D.D Woods, N. Leveson, Resilience Engineering concept and precepts, Ashgate, pp. 253-270, 2006.
[12] Cacciabue Pietro Carlo., Designing Driver Assistance Systems in a Risk-based Process, In Millot P., Risk management in Life-Critical Systems, ISTE Ltd and John Wiley & Sons, Inc (2014).
[13] H. Bouami, P. Millot, A systemic approach for a well-documented situation awareness in human-centered automation systems, 13th International Conference on Human System Interaction HSI 2020.
[14] M.R. Endsley: Toward a Theory of Situation Awareness in Dynamic Systems. Human Factors Journal 37(1), 32-64. March 1995.