Presentation
HE13 - Systematic Root Cause Investigation of Fungal Meningitis Outbreaks Associated with Procedures Performed under Neuraxial Anesthesia in Mexico
DescriptionMedical errors are a leading cause of deaths in different countries. Every year, despite new innovations and robust risk management guidelines more than 3 million people die due to hazardous medical treatment, with one out of every ten patients suffering some sort of harm. Up to 4 out of 100 people in low- to middle-income nations die after receiving unsafe care. Developing more robust and systematic incident investigations to analyze the root causes of medical errors and harm and provide recommendations to address them is of paramount importance. Current systems are too complex to expect people to perform reliably, requiring leaders to put in place systems that support safe practice.
We report on an ongoing multistate outbreak of fungal meningitis investigation of 51 deaths in the two Mexican states of Durango and Tamaulipas. We demonstrate the likely contributing causes of the largest and most deadly fungal meningitis outbreak ever reported, using a systematic incident investigation framework called AcciMap, developed by Rasmussen in 1997. The fungus implicated in this outbreak (Fusarium Solani) is associated with a 50% case-fatality rate and was first reported on November 4, 2022, in Durango State and has resulted in 41 deaths so far. The affected patients underwent procedures, mainly obstetric deliveries, under epidural anesthesia in four private hospitals in this state. The second outbreak, with similar symptoms, started in May 2023 in the city of Matamoros, Tamaulipas State, approximately 600 miles away from Durango. This outbreak has resulted in 7 deaths thus far and many remain with neurological sequelae. The affected patients underwent cosmetic procedures under neuraxial anesthesia.
The AcciMap framework was developed to analyze fungal meningitis outbreaks and identify their common contributing causes. The AcciMap methodology was developed by Rasmussen in conjunction with his six-layer risk management framework. These 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. The framework focuses on the underlying unique situations in the clinical workplace and avoids the unfair blame of front-line operators. It provides a big-picture perspective and background about events and conditions that led to adverse incidents, while providing a systematic analysis of the major causes of these incidents with an eye towards preventing future adverse events.
We adjusted the layers of the AcciMap framework based on the analysis of patient adverse events in order to adapt to learn about the root causes of the meningitis case series. The updated layers, from top to bottom, are: government-level officials; state-level officials; best practice-setting organizations (e.g., The Joint Commission); education institutes; drug/medical supplies manufacturers; hospital; management; staff (e.g., surgeons, anesthesiologists, and nurses); and work processes, events, and environmental conditions.
We report on an ongoing and rapidly evolving multistate investigation in Mexico with incomplete information. The AcciMap framework helped to identify the emergent properties of the systemic risks that contributed to the meningitis outbreaks and strategies to mitigate future fungal risks. We found that the most probable sources of the multiple episodes of polymicrobial contamination of neuraxial components were: vial design and content (with one vial containing 10ml of Morphine when only 0.5ml is needed for one patient pain relief, leading to reusing a single vial for 10-15 patients), reuse of syringes, drug storage conditions (high humidity might have negatively affected the drug content), ineffective policies and procedures in hospitals regarding single-patient vial standard, regular carrying of narcotics from hospital to hospital in non-sterile and insecure conditions, ineffective training to ensure single usage of vials in hospitals, and ineffective monitoring system by regulatory agencies to ensure regulations are implemented.
Based on this detailed analysis and through the interactions and involvement of different experts, key players, and decision-makers in Mexico, we provided a series of recommendations to address patient safety in Mexico, for which responsibility currently is scattered across a multitude of agencies, with no single point of oversight. These recommendations would ensure that the voice of patients and families is heard. The impact so far of these recommendations has resulted in PiSA Farmacéutica, the main pharmaceutical company in Mexico, redesigning the Morphine vial for single-use by manufacturing 1ml vials; and law enforcement restricting narcotics being carried from hospital to hospital. Moreover, we helped develop a national campaign to raise clinician awareness of sterile drug handling and practices to avoid transmitted fungal infections and stop narcotic carrying outside hospitals. Prompt recognition and reporting of infections will also help ensure early identification of potential sources of contamination so that appropriate corrective actions can be taken. Mexican hospitals need to provide more effective infrastructure for training management and personnel and detailed policies and procedures in drug handling and sterile practices.
We report on an ongoing multistate outbreak of fungal meningitis investigation of 51 deaths in the two Mexican states of Durango and Tamaulipas. We demonstrate the likely contributing causes of the largest and most deadly fungal meningitis outbreak ever reported, using a systematic incident investigation framework called AcciMap, developed by Rasmussen in 1997. The fungus implicated in this outbreak (Fusarium Solani) is associated with a 50% case-fatality rate and was first reported on November 4, 2022, in Durango State and has resulted in 41 deaths so far. The affected patients underwent procedures, mainly obstetric deliveries, under epidural anesthesia in four private hospitals in this state. The second outbreak, with similar symptoms, started in May 2023 in the city of Matamoros, Tamaulipas State, approximately 600 miles away from Durango. This outbreak has resulted in 7 deaths thus far and many remain with neurological sequelae. The affected patients underwent cosmetic procedures under neuraxial anesthesia.
The AcciMap framework was developed to analyze fungal meningitis outbreaks and identify their common contributing causes. The AcciMap methodology was developed by Rasmussen in conjunction with his six-layer risk management framework. These 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. The framework focuses on the underlying unique situations in the clinical workplace and avoids the unfair blame of front-line operators. It provides a big-picture perspective and background about events and conditions that led to adverse incidents, while providing a systematic analysis of the major causes of these incidents with an eye towards preventing future adverse events.
We adjusted the layers of the AcciMap framework based on the analysis of patient adverse events in order to adapt to learn about the root causes of the meningitis case series. The updated layers, from top to bottom, are: government-level officials; state-level officials; best practice-setting organizations (e.g., The Joint Commission); education institutes; drug/medical supplies manufacturers; hospital; management; staff (e.g., surgeons, anesthesiologists, and nurses); and work processes, events, and environmental conditions.
We report on an ongoing and rapidly evolving multistate investigation in Mexico with incomplete information. The AcciMap framework helped to identify the emergent properties of the systemic risks that contributed to the meningitis outbreaks and strategies to mitigate future fungal risks. We found that the most probable sources of the multiple episodes of polymicrobial contamination of neuraxial components were: vial design and content (with one vial containing 10ml of Morphine when only 0.5ml is needed for one patient pain relief, leading to reusing a single vial for 10-15 patients), reuse of syringes, drug storage conditions (high humidity might have negatively affected the drug content), ineffective policies and procedures in hospitals regarding single-patient vial standard, regular carrying of narcotics from hospital to hospital in non-sterile and insecure conditions, ineffective training to ensure single usage of vials in hospitals, and ineffective monitoring system by regulatory agencies to ensure regulations are implemented.
Based on this detailed analysis and through the interactions and involvement of different experts, key players, and decision-makers in Mexico, we provided a series of recommendations to address patient safety in Mexico, for which responsibility currently is scattered across a multitude of agencies, with no single point of oversight. These recommendations would ensure that the voice of patients and families is heard. The impact so far of these recommendations has resulted in PiSA Farmacéutica, the main pharmaceutical company in Mexico, redesigning the Morphine vial for single-use by manufacturing 1ml vials; and law enforcement restricting narcotics being carried from hospital to hospital. Moreover, we helped develop a national campaign to raise clinician awareness of sterile drug handling and practices to avoid transmitted fungal infections and stop narcotic carrying outside hospitals. Prompt recognition and reporting of infections will also help ensure early identification of potential sources of contamination so that appropriate corrective actions can be taken. Mexican hospitals need to provide more effective infrastructure for training management and personnel and detailed policies and procedures in drug handling and sterile practices.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives