Risk Management Associated with the Cleaning–Disinfection of Dental Medical Devices in the Sterilization Process: Application of the FMECA Method

Objective This study aimed to identify and analyze failure modes associated with the cleaning–disinfection stage of reusable medical devices within the sterilization process in a dental care setting, using the Failure Modes, Effects, and Criticality Analysis (FMECA) method, in order to propose appropriate corrective actions and enhance patient safety. Methods A prospective study was conducted at the Dental Consultation and Treatment Center between January and March 2023. The FMECA approach was implemented by a multidisciplinary team to assess the cleaning–disinfection process. The workflow was mapped and broken down into subprocesses and tasks. Failure modes were identified using an Ishikawa diagram based on the 5M (Manpower, Machine, Method, Material, and Environment) approach. Each failure mode was evaluated according to three criteria (severity, occurrence, and detectability), allowing the calculation of a criticality index and the prioritization of risks. Results and Discussion A total of 24 failure modes were identified across six process steps. The overall criticality reached a cumulative score of 354, with an average of 14.75 per failure mode. Nine failures (37.5%) were classified as critical, requiring immediate corrective actions, while 37.5% were considered tolerable and 25% acceptable. The preparation of the cleaning system and the cleaning phase were identified as the most critical steps. The relatively high mean severity (2.79), combined with suboptimal detectability (2.29), was identified as the main driver of risk, rather than the frequency of occurrence. Infectious risk predominated (approximately 46%), highlighting its direct impact on patient safety. These findings are consistent with the literature and underscore the need for improved process standardization and enhanced staff training. Conclusion The application of the FMECA method enabled the identification of critical control points within the cleaning–disinfection process and the implementation of targeted corrective actions. This approach represents a valuable tool for strengthening risk management and improving the quality of care in dental settings. A post-implementation reassessment is recommended to evaluate the effectiveness of the corrective measures within a continuous improvement framework.