Work

Risk analysis applied to the sterilization process in a public health hospital center: Use of the “FMECA” method

Year: 2025

Type: article

Abstract: INTRODUCTION: The sterilization of reusable medical devices in healthcare establishments is an activity of enormous importance in the quality and safety of medical procedures. The methods of risk analysis are the means that will put into exercise the critical points of this process. OBJECTIVE: To identify by brainstorming the different failure modes, to prioritize by considering the average criticality indices, each step of this process, and to lead to the proposal of preventive and corrective operational actions. METHODS: To upgrade the sterilization circuit, an a priori risk analysis according to the Failure Modes, Effects and Criticality Analysis (FMECA) method was carried out. RESULTS: The application of the FMECA method made it possible to identify 135 of failure modes, and to classify, in descending order, the stages of the process, according to the average criticality index. The validation/storage stage was the most critical, followed by personnel, the packaging stage. CONCLUSION: Within a hospital establishment, the implementation of a risk analysis tool for the sterilization process of reusable medical devices will ensure the safety of the patient and the staff.

Source: La Tunisie Médicale

DOI: 10.62438/tunismed.v103i9.5981

Authors: Rania Ben Hammamia, Nour El Houda Ben Fatma, Mariem Lasmar, Nordine Abbes, Aïmen Abbassi

Institutions: University of Monastir, Hôpital Charles-Nicolle, Faculté de médecine de Tunis, Tunis El Manar University

Language: English

Topic: Medical Device Sterilization and Disinfection

Subfield: Microbiology

Field: Immunology and Microbiology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: diamond

OpenAlex ID: W7115569893

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