医疗装备2024,Vol.37Issue(18) :55-57,62.DOI:10.3969/j.issn.1002-2376.2024.18.014

基于追溯信息化管理的全程质量监测在外来医疗器械管理中的应用

The Application of Full Process Quality Monitoring Based on Traceability Information Management in the Management of Foreign Medical Devices

童静
医疗装备2024,Vol.37Issue(18) :55-57,62.DOI:10.3969/j.issn.1002-2376.2024.18.014

基于追溯信息化管理的全程质量监测在外来医疗器械管理中的应用

The Application of Full Process Quality Monitoring Based on Traceability Information Management in the Management of Foreign Medical Devices

童静1
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作者信息

  • 1. 上饶市立医院 (江西上饶 334000)
  • 折叠

摘要

目的 探讨基于追溯信息化管理的全程质量监测在外来医疗器械管理中的应用效果.方法 选取 2021 年 1 月至 2023 年 5 月医院的 2 780 件外来医疗器械为研究对象,根据管理方式分为常规组(1 360 件)和质量监测组(1 420 件).常规组采用常规人工追溯管理方式,质量监测组采用基于追溯信息化管理的全程质量监测.比较两组的器械管理质量(标签打印合格率、参数记录合格率、清洗质量合格率)、接收操作耗时、资料查询耗时、管理效果(器械清洗评分、植入器械灭菌评分、灭菌监督效用评分)及满意度(工作人员态度评分、操作水平评分、器械供应及时性评分、器械结构功能评分、器械无菌性评分).结果 质量监测组标签打印合格率、参数记录合格率、清洗质量合格率高于常规组(P<0.05);质量监测组接收操作、资料查询耗时均少于常规组(P<0.05);质量监测组器械清洗、植入器械灭菌、灭菌监督效用、工作人员态度、操作水平、器械供应及时性、器械结构功能、器械无菌性评分均高于常规组(P<0.05).结论 基于追溯信息化管理的全程质量监测可提高外来医疗器械管理质量及效果,提升工作效率与医护人员满意度.

Abstract

Objective To explore the application effect of full process quality monitoring based on traceability information management in the management of foreign medical devices.Methods With the selection of 2 780 foreign medical devices from hospitals from January 2021 to May 2023 as the research subjects,these medical devices were divided into the routine group(1 360 pieces)and the quality monitoring group(1 420 pieces)according to their management methods.With the adoption of conventional manual traceability management methods in the conventional group,and full process quality monitoring based on traceability information management in the quality monitoring group,the quality of instrument management(label printing pass rate,parameter recording pass rate,cleaning quality pass rate),receiving operation time,data query time,management effectiveness(instrument cleaning score,implanted instrument sterilization score,sterilization supervision effectiveness score),and management satisfaction(staff attitude score,operation level score,instrument supply timeliness score,instrument structure function score,instrument sterility score)were compared.Results The qualified rates of label printing,parameter recording,and cleaning quality in the quality monitoring group were higher than those in the routine group(P<0.05);The receiving operation and data query time of the quality monitoring group were less than those of the conventional group(P<0.05);The scores of instrument cleaning,implanted instrument sterilization,sterilization supervision effectiveness,staff attitude,operational level,timeliness of instrument supply,instrument structure and function,and instrument sterility in the quality monitoring group were all higher than those in the conventional group(P<0.05).Conclusion Full process quality monitoring based on traceability information management can improve the quality and effectiveness of foreign medical device management,and enhance work efficiency and satisfaction of medical staff.

关键词

信息化管理/质量监测/外来医疗器械

Key words

Information management/Quality monitoring/Foreign medical devices

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出版年

2024
医疗装备
国家食品药品监督管理局北京医疗器械质量监督检验中心 北京市医疗器械检验所

医疗装备

影响因子:0.339
ISSN:1002-2376
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