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危害分析与关键控制点体系在可重复使用医疗器械组装中的作用

Effect of hazard analysis critical control points system in the assembly of reusable medical devices.

作者信息

Huang Yongdeng, Li Na, Luo Biru, Yi Liangying, Pan Wei, Hu Ting

机构信息

Department of Sterile Processing Nursing, West China Second University Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan, China.

Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, Sichuan, China.

出版信息

Sci Rep. 2025 Mar 18;15(1):9234. doi: 10.1038/s41598-025-93615-z.

DOI:10.1038/s41598-025-93615-z
PMID:40097635
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11914213/
Abstract

This study aimed to investigate the effect of hazard analysis critical control points (HACCP) system in the assembly of reusable medical devices. A total of 35,841 packages containing reusable medical devices assembled in our hospital's CSSD before implementation of the HACCP system (from January 2023 to June 2023) were classified into the control group, and 36,159 packages containing reusable medical devices assembled in our hospital's CSSD after implementation of the HACCP system (from July 2023 to December 2023) were classified into the experimental group. The incidences of assembly defects in the devices and satisfaction rates among device users before and after implementation of the HACCP system were compared. After improvement in staff training, work processes and traceability system during the application of the HACCP system, the incidence of assembly defects decreased from 2.59 to 0.24% (P < 005). Satisfaction rates among device users increased from 95.52 to 97.61% (P < 0.05). Application of the HACCP system to the assembly of reusable medical devices could effectively reduce the rate of assembly defects and improve satisfaction among device users. This could help improve the supply quality of these devices.

摘要

本研究旨在探讨危害分析与关键控制点（HACCP）系统在可重复使用医疗器械组装中的作用。在HACCP系统实施前（2023年1月至2023年6月），我院消毒供应中心组装的35841个装有可重复使用医疗器械的包装被归入对照组；在HACCP系统实施后（2023年7月至2023年12月），我院消毒供应中心组装的36159个装有可重复使用医疗器械的包装被归入实验组。比较HACCP系统实施前后器械组装缺陷发生率及器械使用者的满意度。在HACCP系统应用过程中，通过改进人员培训、工作流程及追溯系统后，组装缺陷发生率从2.59%降至0.24%（P＜0.05）。器械使用者的满意度从95.52%提高至97.61%（P＜0.05）。将HACCP系统应用于可重复使用医疗器械的组装，可有效降低组装缺陷率，提高器械使用者的满意度，有助于提升此类器械的供应质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/5dc8e1d634d0/41598_2025_93615_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/74012447a676/41598_2025_93615_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/236cb0bb6683/41598_2025_93615_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/d3ac384961fd/41598_2025_93615_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/5dc8e1d634d0/41598_2025_93615_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/74012447a676/41598_2025_93615_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/236cb0bb6683/41598_2025_93615_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/d3ac384961fd/41598_2025_93615_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/576b/11914213/5dc8e1d634d0/41598_2025_93615_Fig4_HTML.jpg

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本文引用的文献

1
Observed rates of surgical instrument errors point to visualization tasks as being a critically vulnerable point in sterile processing and a significant cause of lost chargeable OR minutes.观察到的手术器械错误率表明，可视化任务是无菌处理中一个极其脆弱的环节，也是导致失去可计费手术室时间的一个重要原因。
BMC Surg. 2024 Apr 15;24(1):110. doi: 10.1186/s12893-024-02407-1.
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Optimizing Sterilization Packaging through Root Cause Analysis: An Exploration into Sealing Defects of Paper-Plastic Pouches.通过根本原因分析优化灭菌包装：纸质-塑料复合袋封口缺陷的探讨。
Med Sci Monit. 2023 Jul 25;29:e940342. doi: 10.12659/MSM.940342.
3
Current status and frontier tracking of the China HACCP system.
中国HACCP体系的现状与前沿追踪
Front Nutr. 2023 Mar 14;10:1072981. doi: 10.3389/fnut.2023.1072981. eCollection 2023.
4
Errors in packaging surgical instruments based on a surgical instrument tracking system: an observational study.基于手术器械追踪系统的手术器械包装错误：一项观察性研究。
BMC Health Serv Res. 2019 Mar 19;19(1):176. doi: 10.1186/s12913-019-4007-3.