Yang Cui,1,* Yu Wang,2,* He Liu,3 Shaojie Xu,4 Xue Zhang5 

1Department Medical Affairs, Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People’s Republic of China; 2Department of Respiratory Medicine, Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People’s Republic of China; 3Department Medical Affairs, The Second Affiliated Hospital of Qiqihar Medical College, Qiqihar, Heilongjiang, People’s Republic of China; 4Department of Human Resources, Harbin Medical University, Harbin, Heilongjiang, People’s Republic of China; 5The School of Humanities and Social Sciences, Harbin Medical University, Harbin, Heilongjiang, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Xue Zhang, Email zhangxheb@126.com

Objective: This study aimed to explore the correlation between medical safety adverse events and patient safety culture through the lens of Failure Mode and Effect Analysis (FMEA).
Methods: Sixty patients from a hospital were selected as the research subjects, alongside 440 medical staff members (including clinical, medical technology, and management personnel) who participated in the study. The general demographic characteristics of medical staff, patient safety culture, and adverse medical safety events were investigated. FMEA was employed to analyze the relationship between medical safety adverse events and patient safety culture, using the risk priority number (RPN) as a key metric.
Results: A comparison of RPN values before and after FMEA intervention revealed that the RPN values of each failure mode significantly decreased post-intervention. Correlation analysis showed significant relationships between medication errors and several factors: “incident reporting frequency” (OR=0.706), “manager expectations and actions to promote patient safety” (OR=0.733), and “management support for patient safety” (OR=0.755). Pressure ulcers were significantly correlated with “manager expectations and actions to promote patient safety” (OR=0.729) and “shift and transfer” (OR=0.707). Falls were notably associated with “interdepartmental cooperation” (OR=0.735), “feedback and communication about errors” (OR=0.756), and “shift and transfer” (OR=0.660). Additionally, a strong correlation was identified between adverse events and “management support for patient safety” (OR=0.701).
Conclusion: Utilizing FMEA to analyze the correlation between medical safety adverse events and patient safety culture is effective in identifying specific dimensions of these events related to safety culture. This enables the development of targeted interventions to mitigate adverse events and enhance patient safety.

Keywords: failure mode and effect analysis, healthcare, medication errors, correlation