Infectious Risk in the Sterilization Process for Reusable Medical Devices: Preliminary Risk Analysis

Abstract

Background: Patient safety is an area of health care that has emerged with the increasing complexity of health-care
systems. Indeed, there are several arguments for a comprehensive and coordinated approach to risk management.
This study determines all probable hazards, which may generate an infectious risk during the different steps of the
sterilization process. Materials and Methods: The study was conducted from November to December 2019 in
the central sterilization department of the IBN Sina Hospital in Rabat. The method adopted was the preliminary
risk analysis (PRA) applied to reusable medical devices (DM) circuits. Results: A total of 38 dangerous situations
generating an infectious accident were revealed, which will make 38 scenarios. The mapping of hazardous
situations relating to the different phases of the sterilization process showed 5 types of generic hazards. Among
these 38 scenarios, 9 are in criticality class 3, 21 situations are in criticality class 2, and 8 scenarios are in criticality
class 1. After the implementation of risk reduction actions, 31 scenarios remain in criticality 1, 7 in criticality 2,
and no scenario in criticality 3. Conclusion: The PRA method has enabled all phases of the sterilization process
to be analyzed and all the probable hazards that could lead to an infectious accident to be identified. The proposed
risk reduction measures are organizational and educational. After the implementation of these measures, all the
maximum risks are reduced to a tolerable zone under control, and the average risks are reduced.