北京市医务人员医疗器械不良事件监测认知度调查

The Survey of Healthcare Professionals on Awareness for Medical Device Administration Events Monitoring

目的了解北京市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知晓程度,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,对1897名医务人员进行问卷调查。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,二、三级医院对医疗器械不良事件监测报告要求、重点监测品种和报告规范的了解好于一级医院;医务人员对需报告的医疗器械不良事件认识模糊。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的发生。

Objec tive To investigate the knowledge level related to Medical Device Administration Events （MDAE） among healthcare professionals. Methods Stratified sampling, cluster sampling and random sampling were adopt together and a questionnaire survey was conducted among 1 897 subjects. Results Healthcare professionals had a low level about knowledge of MDAE and medical device post-market monitoring. There are difference between the healthcare professionals in different hospital. 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 MDAE monitoring, and to reduce the incidence rate of MDAE.