Failure Mode and Effects Analysis in Reducing the Incidence of Sterilization Cycle Interruptions in Low-Temperature Hydrogen Peroxide Plasma Sterilizers.

Background This study aimed to investigate the efficacy of failure mode and effects analysis (FMEA) in optimizing the sterilization process for low-temperature hydrogen peroxide plasma sterilizers.

Methods Purposive sampling was used to select low-temperature hydrogen peroxide plasma sterilizers from a hospital in China as the study objects. The operational data for 1551 sterilization cycles in the low-temperature hydrogen peroxide plasma sterilizers, from May 2024 to November 2024, were classified into the control group. The operational data for 1492 sterilization cycles in the low-temperature hydrogen peroxide plasma sterilizers, from January 2025 to June 2025 following the implementation of the FMEA-based risk management scheme, were classified into the experimental group. The incidence of sterilization cycle interruptions, the risk priority number scores for high-risk failure modes, and the incidence of high-risk failure modes in both groups were investigated.

Results After the optimization of the operating procedures, the incidence of sterilization cycle interruptions decreased from 5.48% (85/1551) to 0.87% (13/1492); the risk priority number scores and the incidence of high-risk failure modes were also decreased (P < 0.05).

Conclusion The FMEA-based risk management scheme could optimize the sterilization process for low-temperature hydrogen peroxide plasma sterilizers and ensure the quality of medical device sterilization.