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| 广东省5地区医务人员医疗器械不良事件监测认知度调查 |
| Survey on the Awareness of Monitoring for Medical Device Adverse Events among Healthcare Professionals in 5 Regions of Guangdong Province |
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| DOI： |
| 中文关键词: 医疗器械不良事件 监测 医务人员 认知度 |
| 英文关键词:Medical device administration events Monitoring Healthcare professionals Awareness |
| 基金项目:广东省药品不良反应监测中心和广东省科技基础条件建设项目（编号：2012B060500050） |
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| 中文摘要: |
| 摘 要 目的:了解广东省医疗机构医务人员对医疗器械不良事件及相关监测工作的认知程度，为深入开展医疗器械不良事件监测奠定基础。方法：采用分层与整群随机抽样相结合的方法，自行设计问卷对1 717名医务人员进行调查。结果：医务人员对医疗器械不良事件及相关监测工作认知程度较低；不同级别医院医务人员对医疗器械不良事件监测的认知情况存在差异，部分知识点表现为市/省级医院知晓率较高（P<0.05）；医务人员对需报告的医疗器械不良事件认识模糊；参加过培训的医务人员，其不良事件上报率高于未参加培训者(OR=3.459，95%CI: 2.430~4.924，P＜0.01)。结论：应加大宣传培训力度，加强宣传培训的覆盖率和针对性，提高医务人员对医疗器械不良事件监测的认知度，提高医疗器械不良事件监测能力，减少医疗器械不良事件发生率。 |
| 英文摘要: |
| ABSTRACT Objective:To investigate the knowledge level related to medical device administration events (MDAEs) among healthcare professionals in order to establish the basis of efficient monitoring for MDAEs. Methods:Stratified sampling, together with cluster sampling and random sampling were adopt for analysis on results of questionnaire survey conducted among 1 717 subjects. Results:Healthcare professionals were at relative low level about knowledge of MDAEs and medical device post market monitoring. Significant differences were among the hospitals at various levels about awareness of monitoring MDAEs, in which the healthcare professionals in city/province hospitals were the highest（P<0.05）. The reports of Medical Device Adverse Events were more from MDAEs trained Healthcare professionals than others (OR=3.459, 95%CI: 2.430 4.924，P＜0.01). Conclusion:The coverage and pertinence of training about MDAE for healthcare professionals should be enhanced to improve their perceptions, and to promote their abilities for MDAEs monitoring, and to reduce the incidence rate of MDAEs. |
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