RESUMEN
Objective:To master the quality control status of high-risk medical equipment of medical institutions in Zhejiang province, and to put forward improvement measures to promote the quality control level of high-risk medical equipment.Methods:All the tertiary public hospitals, second-class public hospitals and private hospitals in Zhejiang were investigated. A questionnaire survey was conducted on the quantity, quality control methods and quality control specifications of high-risk medical equipment used by the medical institutions. Excel was used for data collation and descriptive statistical analysis of the questionnaire.Results:The quality control methods of high-risk medical equipment in 96 medical institutions in Zhejiang had different tendencies. The tertiary public hospitals tended to conduct quality control on their own, and the second-class public hospitals and private hospitals tended to choose third-party testing institutions for quality control. In addition, there were irregularities in quality control of some medical institutions. 16% of the quality control equipment in self-control mode was not traceable, and 2% of the third-party testing organizations had no relevant qualifications.Conclusions:Medical institutions in Zhejiang generally have a strong awareness of quality control of high-risk medical equipment. But there are some unsolved problems remained in quality control. In the future, we should continue to improve the quality control level of high-risk medical equipment based on medical measurement, as well as to focus on the improvement of the technical ability of medical equipment management departments, the traceability of quality inspection equipment, and the supervision and spot check of third-party testing institutions.
RESUMEN
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.