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高风险医疗设备质量控制检测结果与分析

龙云玲 姜楠

中国医学装备2018,Vol.15Issue(1):47-50,4.
中国医学装备2018,Vol.15Issue(1):47-50,4.DOI:10.3969/J.ISSN.1672-8270.2018.01.014

高风险医疗设备质量控制检测结果与分析

The analysis of test results of quality control for medical equipment with high risk

龙云玲 1姜楠1

作者信息

  • 1. 首都医科大学附属北京天坛医院医学工程处 北京 100050
  • 折叠

摘要

Abstract

Objective:To investigate the existing problems and solutions in the use procedure of medical devices with high-risk of hospital so as to ensure the safety and effectiveness of the operation of them in hospitals.Methods: Based on guidelines of the quality control of the Beijing municipal administration of hospital (On trail) for first aid, life support and high risk equipment, the detections of some high risk medical equipments, such as high frequency electric knife, ventilator and defibrillator, were carried out. And the relevant detected data were analyzed and summarized so as to put forward a plan of quality control.Results: A total of 56 defibrillators were detected, and the unqualified rate was 62.5%. Among them, the time accuracy of defibrillator was the main problem, and the proportion of time accuracy in whole fault problem points was about 73%. And the breakage rate of attachment was 15%, missing rate of annex was 13% and the rate of other faults was 2%. For 56 ventilators, the unqualified rate was 41.07%. The main reasons of unqualified rate included annex of consumable (75.20%), appearance of equipment (9.7%) and equipment failure (15.1%). About the performance and electrical safety of 49 high frequency electric knives, the unqualified rate was 10.2%, and the main reasons of unqualified rate included parametric fault (33.30%), fault of annex (61.60%) and appearance of equipment (5.10%). Through analyzed the reason of disqualification and formulated the corresponding pertinence measurement, their qualities were enhanced in clinical practice.Conclusion:The quality control of high-risk medical equipment can ensure the quality and safety of these equipments. Therefore, it is benefit to ensure the safety and effectiveness of medical equipment of first-aid and life-support in long-time running from engineering technique.

关键词

高风险医疗设备/质量控制/原因分析/安全性/有效性

Key words

High risk medical equipment/Quality control/Cause analysis/Safety/Effectiveness

分类

医药卫生

引用本文复制引用

龙云玲,姜楠..高风险医疗设备质量控制检测结果与分析[J].中国医学装备,2018,15(1):47-50,4.

中国医学装备

OACSTPCD

1672-8270

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