Risk management in the sterilization process for reusable medical devices: Moroccan Hospital experience

Year 2025, Volume: 29 Issue: 5, 1994 - 2007, 01.09.2025

Fadela Benzag Omar Elhamdaoui Ali Cherif Chefchaouni Younes Rahali Yassir El Alaoui

https://doi.org/10.12991/jrespharm.1764962

Abstract

In the hospital environment, risk mapping aims to identify and assess the criticality of potential risks associated with each stage in the sterilization process for reusable medical devices (RMDs). Our approach aims to develop preventive and corrective measures to better control these risks. From September to December 2023, an a priori risk analysis was carried out in the central sterilization unit of Rabat's specialized hospital. The methodology used will be based on the FMEA method (Failure Modes, Effects and Criticality Analysis), enabling a qualitative and quantitative analysis of risks. A total of 37 failure modes were identified during the sterilization process, including 20 minor criticality risks, 13 medium criticality risks and 4 major criticality risks. The highest number of failures occurred in the cleaning/disinfection and packaging stages, while the riskiest process was recomposition, with two unacceptable risks identified. Once the criticality had been assessed, corrective measures were proposed for all unacceptable risks likely to have a significant impact on the safety of patients and hospital staff. In light of the results, the working group was able to implement a number of preventive and curative measures, and communication remains a crucial element in ensuring compliance with the DMR and the safety of patients and medical staff.

Keywords

Risk management , Sterilization , FMEA , Reusable medical device , Quality assurance system

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