Presentation
Applying Systems Engineering and Human Factors Methodologies to Enhance Patient Safety: Analyzing the Largest World Cluster of Fungal Meningitis Incidents
DescriptionMedical errors are a leading cause of death globally. Every year, despite new innovations and robust risk management guidelines, more than 3 million people lose their life as a result of hazardous medical treatment and unsafe care, with one out of every ten patients suffering harm (Slawomirski & Klazinga, 2020). Poor-quality care is responsible for up to 15 percent of overall deaths in low- and middle-income countries (LMIC) (National Academies of Sciences, 2018). This underscores the urgent need to develop more rigorous and systematic approaches for analyzing the root causes of medical errors and patient harm, while also offering context-specific strategies to effectively address them.
Neuraxial anesthesia has greatly improved pain management, safe and reliable perioperative, and obstetric care, enhancing patient outcomes. However, its invasive nature still rarely results in complications, e.g., meningitis and paralysis due to inadequate aseptic conditions. In developed countries, advancements in anesthesia technology and protocols have reduced anesthesia-related mortality to approximately 1 in 10,000 patients. However, in less developed regions, mortality rates can reach alarming levels, as high as 51 per 10,000 patients, due to inadequate monitoring, lack of preparation, and insufficient training among anesthesia providers (Braz, 2009). This underscores the critical need for human factors-driven safety interventions and continuous improvements in anesthesia practices worldwide.
In the proposed panel, the panelists will discuss how to best support reliable perioperative outcomes using different systems engineering methodologies focused on less resourced settings either in high-income countries (HIC) or LMIC. These tools offer a cohesive toolkit for framing and analyzing adverse events and developing targeted interventions for enhancing patient safety in healthcare settings. The panel will showcase the application of a range of methods including accident mapping (AcciMap), failure mode and effects analysis (FMEA), process mapping, task analysis, and modified Delphi methods, for investigating the largest cluster of fungal meningitis incidents in the world, which occurred in 2022-2024 in Mexico. The first fungal meningitis outbreak emerged in October 2022, when patients exposed to neuraxial anesthesia developed meningitis caused by the Fusarium Solani species complex, an important plant pathogen and soil saprophyte, leading to 81 confirmed cases and 41 deaths (50% fatality rate) in the city of Durango in Mexico, mostly among young, healthy postpartum women. The second outbreak, which started in Matamoros, Tamaulipas, in May 2023, added 34 cases and seven fatalities. The two outbreaks exposed common and overlapping vulnerabilities in infection control and anesthesia safety protocols, particularly in regions with insufficient healthcare infrastructures and oversight mechanisms. The clusters emphasized the need for novel, robust safety measures and a deeper and more integrated systematic investigation of deficiencies in perioperative practices.
The Mexican Federation of Colleges of Anesthesiology (FMCA) established the Patient Safety Taskforce to address the public health ramifications of the fungal meningitis outbreaks in Mexico in early 2023. The Taskforce interviewed patients and families, analyzed case data reviews, engaged stakeholders, interacted with Mexican regulators, monitored the media, and conducted several ongoing research projects related to the underlying root causes of the meningitis clusters. The proposed panelists are core members of the FMCA Patient Safety Taskforce and will showcase the application of systematic analysis methodologies used in harmony and as complimentary tools to investigate the fungal meningitis outbreaks and their root causes. We will share a set of targeted recommendations being implemented in Mexico to improve the safety and reliability of anesthesia administration.
The AcciMap framework is a systematic accident investigation methodology, originally developed by Jens Rasmussen (1997) in conjunction with his six-layer risk management framework. The six layers, from top to bottom, are: government, regulators and associations, company, management, staff, and work. The methodology captures the socio-technical factors underlying an incident within an integrated framework and analyzes the contribution of these factors in causing the incident. Its hierarchical, graphical representation is useful in structuring the analyses of hazardous socio-technical work systems and in identifying the interactions between different levels of decision-makers, which shape the landscape in which incidents may “unfold” themselves.
Three pivotal sources were utilized to capture the contributing causes of the fungal meningitis outbreaks and develop the AcciMap framework: 1) interviews with patients and anesthesia providers involved in providing care in the meningitis cases; 2) a systematic literature and news articles reviews that specifically investigated the Durango and Matamoros outbreaks, to identify the outbreaks common contributing factors, enriching the analysis with broader public and political insights into causes and systemic weaknesses; 3) a comprehensive survey of a diverse group of Mexican Anesthesiologists and healthcare workers followed by a Delphi consensus process. We will share the triangulated results of our mixed methods research to develop the AcciMap framework for investigating the outbreaks. An earlier version of the AcciMap framework itself was presented at the 2024 HFES Healthcare Symposium (Tabibzadeh et al., 2024). We have submitted a proposal about the detailed methods including survey development and modified Delphi rounds for oral presentation to this (2025) HFES Healthcare Symposium (Guridi Orozco et al., accepted).
We have also developed a comprehensive task analysis to identify the major phases of administering epidural, using spinal anesthesia administration as an example, as well as the steps within each of those major phases. We used a FMEA to identify the most critical failure modes associated with epidural administration based on the risk priority number (RPN) scores assigned to each failure mode. We will share the context-specific safety measures and interventions for reducing risks of anesthesia administration. This has been submitted as another oral presentation proposal to this (2025) HFES Healthcare Symposium (Chejfec-Ciociano et al., accepted).
Our systematic data collection revealed several critical deficiencies that compromised patient safety in Mexico. A notable concern was lack of hygiene practices and the repeated use of single-use vials across multiple patients, driven by inadequate resource management and design-related human factors, such as the large vial sizes that led providers to avoid wastage. We also uncovered significant vulnerabilities in the anesthetic drug distribution system, with anesthesiologists transporting drug vials between different hospitals and institutions, creating unnecessary sterility and safety risks and inconsistencies in drug safety. Moreover, the presence of counterfeit and black-market drugs further exacerbated the safety challenges, adding a serious layer of risks to anesthesia administration in these regions.
References
Braz, L. G., Braz, D. G., Cruz, D. S., et al. (2009). Mortality in Anesthesia: A Systematic Review. Clinics, 64(10), 999–1006.
Chejfec-Ciociano, J., Guridi Orozco, A., et al. (accepted). Reducing Medical Errors and Patient Harm During Epidural Anesthesia Through Failure Mode and Effects Analysis. International Symposium on Human Factors and Ergonomics in Health Care, Toronto, Ontario, March 30 – April 2, 2025.
Guridi Orozco, A., Chejfec-Ciociano, J., et al. (accepted). A Modified Delphi Approach to Patient Safety Challenges in Mexico: An In-Depth Analysis of the Largest Cluster of Perioperative Adverse Events. International Symposium on Human Factors and Ergonomics in Health Care, Toronto, Ontario, March 30 – April 2, 2025.
National Academies of Sciences, Engineering, and Medicine (2018, Aug. 28). Crossing the Global Quality Chasm: Improving Health Care Worldwide. National Academies Press. Washington, D.C.
Rasmussen, J. (1997). Risk management in a dynamic society: a modeling problem. Safety Science, 27: 183–213.
Slawomirski, L. & Klazinga, N. (2020). The Economics of Patient Safety: from analysis to action. Organisation for Economic Co-operation and Development (OECD). Retrieved from https://www.oecd.org/health/health-systems/Economics-of-Patient-Safety-October-2020.pdf (Accessed October 2, 2023)
Tabibzadeh, M., Chejfec-Ciociano, J., et al. (2024). Systematic Root Cause Investigation of Fungal Meningitis Outbreaks Associated with Procedures Performed under Neuraxial Anesthesia in Mexico, Poster presentation at the International Symposium on Human Factors and Ergonomics in Health Care, Chicago, IL, March 24 – 27.
Neuraxial anesthesia has greatly improved pain management, safe and reliable perioperative, and obstetric care, enhancing patient outcomes. However, its invasive nature still rarely results in complications, e.g., meningitis and paralysis due to inadequate aseptic conditions. In developed countries, advancements in anesthesia technology and protocols have reduced anesthesia-related mortality to approximately 1 in 10,000 patients. However, in less developed regions, mortality rates can reach alarming levels, as high as 51 per 10,000 patients, due to inadequate monitoring, lack of preparation, and insufficient training among anesthesia providers (Braz, 2009). This underscores the critical need for human factors-driven safety interventions and continuous improvements in anesthesia practices worldwide.
In the proposed panel, the panelists will discuss how to best support reliable perioperative outcomes using different systems engineering methodologies focused on less resourced settings either in high-income countries (HIC) or LMIC. These tools offer a cohesive toolkit for framing and analyzing adverse events and developing targeted interventions for enhancing patient safety in healthcare settings. The panel will showcase the application of a range of methods including accident mapping (AcciMap), failure mode and effects analysis (FMEA), process mapping, task analysis, and modified Delphi methods, for investigating the largest cluster of fungal meningitis incidents in the world, which occurred in 2022-2024 in Mexico. The first fungal meningitis outbreak emerged in October 2022, when patients exposed to neuraxial anesthesia developed meningitis caused by the Fusarium Solani species complex, an important plant pathogen and soil saprophyte, leading to 81 confirmed cases and 41 deaths (50% fatality rate) in the city of Durango in Mexico, mostly among young, healthy postpartum women. The second outbreak, which started in Matamoros, Tamaulipas, in May 2023, added 34 cases and seven fatalities. The two outbreaks exposed common and overlapping vulnerabilities in infection control and anesthesia safety protocols, particularly in regions with insufficient healthcare infrastructures and oversight mechanisms. The clusters emphasized the need for novel, robust safety measures and a deeper and more integrated systematic investigation of deficiencies in perioperative practices.
The Mexican Federation of Colleges of Anesthesiology (FMCA) established the Patient Safety Taskforce to address the public health ramifications of the fungal meningitis outbreaks in Mexico in early 2023. The Taskforce interviewed patients and families, analyzed case data reviews, engaged stakeholders, interacted with Mexican regulators, monitored the media, and conducted several ongoing research projects related to the underlying root causes of the meningitis clusters. The proposed panelists are core members of the FMCA Patient Safety Taskforce and will showcase the application of systematic analysis methodologies used in harmony and as complimentary tools to investigate the fungal meningitis outbreaks and their root causes. We will share a set of targeted recommendations being implemented in Mexico to improve the safety and reliability of anesthesia administration.
The AcciMap framework is a systematic accident investigation methodology, originally developed by Jens Rasmussen (1997) in conjunction with his six-layer risk management framework. The six layers, from top to bottom, are: government, regulators and associations, company, management, staff, and work. The methodology captures the socio-technical factors underlying an incident within an integrated framework and analyzes the contribution of these factors in causing the incident. Its hierarchical, graphical representation is useful in structuring the analyses of hazardous socio-technical work systems and in identifying the interactions between different levels of decision-makers, which shape the landscape in which incidents may “unfold” themselves.
Three pivotal sources were utilized to capture the contributing causes of the fungal meningitis outbreaks and develop the AcciMap framework: 1) interviews with patients and anesthesia providers involved in providing care in the meningitis cases; 2) a systematic literature and news articles reviews that specifically investigated the Durango and Matamoros outbreaks, to identify the outbreaks common contributing factors, enriching the analysis with broader public and political insights into causes and systemic weaknesses; 3) a comprehensive survey of a diverse group of Mexican Anesthesiologists and healthcare workers followed by a Delphi consensus process. We will share the triangulated results of our mixed methods research to develop the AcciMap framework for investigating the outbreaks. An earlier version of the AcciMap framework itself was presented at the 2024 HFES Healthcare Symposium (Tabibzadeh et al., 2024). We have submitted a proposal about the detailed methods including survey development and modified Delphi rounds for oral presentation to this (2025) HFES Healthcare Symposium (Guridi Orozco et al., accepted).
We have also developed a comprehensive task analysis to identify the major phases of administering epidural, using spinal anesthesia administration as an example, as well as the steps within each of those major phases. We used a FMEA to identify the most critical failure modes associated with epidural administration based on the risk priority number (RPN) scores assigned to each failure mode. We will share the context-specific safety measures and interventions for reducing risks of anesthesia administration. This has been submitted as another oral presentation proposal to this (2025) HFES Healthcare Symposium (Chejfec-Ciociano et al., accepted).
Our systematic data collection revealed several critical deficiencies that compromised patient safety in Mexico. A notable concern was lack of hygiene practices and the repeated use of single-use vials across multiple patients, driven by inadequate resource management and design-related human factors, such as the large vial sizes that led providers to avoid wastage. We also uncovered significant vulnerabilities in the anesthetic drug distribution system, with anesthesiologists transporting drug vials between different hospitals and institutions, creating unnecessary sterility and safety risks and inconsistencies in drug safety. Moreover, the presence of counterfeit and black-market drugs further exacerbated the safety challenges, adding a serious layer of risks to anesthesia administration in these regions.
References
Braz, L. G., Braz, D. G., Cruz, D. S., et al. (2009). Mortality in Anesthesia: A Systematic Review. Clinics, 64(10), 999–1006.
Chejfec-Ciociano, J., Guridi Orozco, A., et al. (accepted). Reducing Medical Errors and Patient Harm During Epidural Anesthesia Through Failure Mode and Effects Analysis. International Symposium on Human Factors and Ergonomics in Health Care, Toronto, Ontario, March 30 – April 2, 2025.
Guridi Orozco, A., Chejfec-Ciociano, J., et al. (accepted). A Modified Delphi Approach to Patient Safety Challenges in Mexico: An In-Depth Analysis of the Largest Cluster of Perioperative Adverse Events. International Symposium on Human Factors and Ergonomics in Health Care, Toronto, Ontario, March 30 – April 2, 2025.
National Academies of Sciences, Engineering, and Medicine (2018, Aug. 28). Crossing the Global Quality Chasm: Improving Health Care Worldwide. National Academies Press. Washington, D.C.
Rasmussen, J. (1997). Risk management in a dynamic society: a modeling problem. Safety Science, 27: 183–213.
Slawomirski, L. & Klazinga, N. (2020). The Economics of Patient Safety: from analysis to action. Organisation for Economic Co-operation and Development (OECD). Retrieved from https://www.oecd.org/health/health-systems/Economics-of-Patient-Safety-October-2020.pdf (Accessed October 2, 2023)
Tabibzadeh, M., Chejfec-Ciociano, J., et al. (2024). Systematic Root Cause Investigation of Fungal Meningitis Outbreaks Associated with Procedures Performed under Neuraxial Anesthesia in Mexico, Poster presentation at the International Symposium on Human Factors and Ergonomics in Health Care, Chicago, IL, March 24 – 27.
Moderators
Panelists
Event Type
Discussion Panel
TimeTuesday, April 110:30am - 12:00pm EDT
LocationQueens Quay
Patient Safety and Research Initiatives (PS)