在降低低温过氧化等离子体灭菌器中灭菌周期中断的发生率方面的故障模式和影响分析
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.
Risk management and healthcare policy
|February 25, 2026
概括
失效模式和影响分析 (FMEA) 显著优化了低温过氧化等离子体灭菌过程. 这种风险管理方法减少了灭菌周期中断和故障模式,确保了更好的医疗器械灭菌质量.
科学领域:
- 医疗器械灭菌 医疗器械灭菌
- 提高质量 提高质量
- 风险管理 风险管理
背景情况:
- 灭菌过程对于医疗器械安全至关重要.
- 低温过氧化等离子体灭菌被广泛使用.
- 优化这些过程对于预防感染和确保患者安全至关重要.
研究的目的:
- 评估故障模式和影响分析 (FMEA) 在增强低温过氧化等离子体灭菌方面的有效性.
- 识别和减轻与绝育过程相关的风险.
主要方法:
- 通过使用低温过氧化等离子体灭菌器的操作数据进行了一项比较研究.
- 分析了对照组 (1551个周期) 和实验组 (1492个周期) 的FMEA后实施.
- 关键指标包括灭菌周期中断和故障模式的风险优先次数 (RPN) 评分.
主要成果:
- 在FMEA实施后,绝育周期中断的发生率显著下降,从5.48%降至0.87%.
- 风险优先数得分和高风险故障模式的发生率大幅降低 (P < 0.05).
结论:
- 基于FMEA的风险管理有效优化了低温过氧化等离子体灭菌.
- 实施FMEA可确保医疗器械灭菌的质量和可靠性.
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