Failure Mode and Effects Analysis in Reducing the Incidence of Sterilization Cycle Interruptions in Low-Temperature
Liangying Yi1,2, Ling You3, Wei Pan1,2
1Department of Sterile Processing Nursing, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.
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.
More Related Videos
Related Concept Videos
01:30Methods of Sterilization II: Chemical Methods
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...
01:29Methods of Sterilization I: Physical Methods
Steam sterilization uses non-toxic, low-cost moist heat in the form of saturated steam under pressure, which is fast, microbicidal, and sporicidal, and quickly warms and penetrates fabrics. Autoclaves, or steam sterilizers, expose each item to direct steam contact for a predetermined time at the necessary...
01:26Physical Methods for Controlling Microbial Growth: Radiation and Filtration
01:30Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
01:23Physical Methods for Controlling Microbial Growth: Temperature