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OPTIMIZATION OF THE STERILIZATION CIRCUIT FOR SURGICAL INSTRUMENTS USING THE FMECA RISK ANALYSIS METHOD: EXPERIENCE OF THE CENTRAL STERILIZATION DEPARTMENT AT TANGIER UNIVERSITY HOSPITAL

European Statement

Patient Safety and Quality Assurance

Author(s)

Hamza TAJRI, Abdelhafid BENOMAR, Houda ATTJIOUI, Majda BENABBES, Madiha ALAMI CHENTOUFI

Why was it done?

The sterilization of reusable medical devices is important for ensuring patient safety in hospital environments. However, the complexity of this process poses significant risks. The Failure Modes, Effects, and Criticality Analysis (FMECA) method offers a systematic approach to identify and mitigate these risks, thus enhancing the overall safety of sterilization practices.

What was done?

This work aimed to optimize the sterilization process at our hospital by applying the FMECA method. The focus was on evaluating each stage of the sterilization process, from pre-disinfection to storage and distribution.

How was it done?

A comprehensive FMECA was conducted on the eight main stages of the sterilization process: pre-disinfection, washing, rinsing, drying, packaging, sterilization, batch control and release, and storage and distribution. Each potential failure mode was evaluated in terms of severity (G), occurrence (O), and detectability (D) on a scale from 1 to 5, enabling the calculation of the Risk Priority Index (RPI).

What has been achieved?

The analysis revealed that contamination during drying and ineffective sterilization had the highest Risk Priority Numbers (RPNs), indicating the most critical risks in the process. As a result, these stages require special attention and priority corrective actions. The study also highlighted significant risks in other sterilization steps, underlining the importance of a comprehensive approach to risk management.

What next?

The application of FMECA has enabled us to identify critical areas within the sterilization circuit. Moving forward, we will implement targeted improvement strategies focusing on increased monitoring, preventive maintenance of instruments, and enhanced staff training, particularly regarding drying and sterilization processes.

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