The analysis of test results of quality control for medical equipment with high risk / 中国医学装备

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.