可吸收缝合线上市后不良事件风险分析研究

Risk Analysis and Study of Post-marketing Adverse Events for Absorbable Sutures

通过检索汇总美国FDA、中国知网数据库,及2019年1月至2022年10月浙江全省范围内通过事发地上报和注册人所属监测机构报告两个方面来源可吸收缝合线临床使用不良事件风险数据,进行调查、分析和评价,获取可吸收缝合线临床使用主要风险因素。结果显示,主要风险因素为产品质量失效类因素、产品设计和材料选择,以及产品临床选择和应用、术后康复护理以及患者自身。进一步提出风险控制策略建议,以降低或减少该产品不良事件发生造成伤害的风险。

Objective To investigate,analyze,and evaluate the risk data associated with the clinical use of absorbable sutures by retrieving and summarizing information from the databases of the US FDA and CNKI,as well as the adverse event reports related to absorbable sutures from January 2019 to October 2022 within Zhejiang province.The adverse event reports are obtained from both incident locations and monitoring organizations affiliated with the registrant.The aim is to identify the main risk factors associated with the clinical use of absorbable sutures.The key risk factors are potential product quality defects,product design and material selection,clinical selection and application,and postoperative recovery care including patient’s self-care.Risk control strategies are further proposed to reduce or minimize the risk of adverse events caused by this product.