眼用透明质酸钠凝胶产品不良事件分析研究

Analysis and Study of Adverse Event about Ophthalmic Sodium Hyaluronate Gel

目的调查和分析浙江省范围内出现的医疗器械产品眼用透明质酸钠凝胶的临床使用多次不良事件。方法将浙江省内从2009年1月1日至2014年6月30日期间发生的与眼用透明质酸钠凝胶产品相关的不良事件反馈情况,按照不良事件陈述和事件发生初步原因进行了分析和评价。结果报告主要涉及四个方面。结论应在保证产品质量不断提升、产品物流措施得到有效控制、眼科专业人员的专业素养和操作技能水平不断提高的前提下,防止该产品使用过程中严重不良事件的重复发生和蔓延。

Objective To investigate and analysis the multiple medical adverse events about Ophthalmic Sodium Hyaluronate Gel during clinical using in Zhejiang Province.Methods Analysis,evaluation of the related adverse events about the Ophthalmic Sodium Hyaluronate Gel according to adverse events and event primary reason statement which happened in the period from January 1,2009 to June 30,2014 in Zhejiang province.Results Reports mainly lelates to four aspects.Conclusions On the premise of the quality of the products will be continuously upgraded,and measures of products logistics will be effectively controlled,professional qualities and skills of department of ophthalmology will be constantly improved,prevent recurrence and spread of the serious adverse events during the using of process.