一次性活检针类医疗器械不良事件风险研究

Study on the Risk of Adverse Events of Medical Devices with Disposable Biopsy Needles

目的:通过来源于“浙械警戒”系统获取的一次性活检针不良事件信息,探究一次性活检针类医疗器械不良事件风险种类、发生原因及应对措施。方法:通过检索“浙械警戒”系统、国家药品监督管理局等一次性活检针类产品不良事件信息源,研究其风险种类,分析风险发生因素并提出应对措施。结果:一次性活检针类产品不良事件主要涉及产品固有风险、注册人产品生产质量控制风险、临床操作使用风险和患者风险4个方面。发生风险原因主要包括注册人产品材质选择和结构设计、生产质量控制程度,临床实际操作方法,患者个体差异、患者及家属配合程度等。应对措施包括注册人改进产品、加强质量管理体系建设、规范临床操作、严格把握适用范围、充分沟通与宣教。结论:一次性活检针类产品存在可能导致人体伤害的已知和非预期风险,应在该类产品生产、使用和监管环节加强风险监测和风险管理,降低和减少同类不良事件的再发生。

Objective:Through the adverse event information of disposable biopsy needles obtained from the“Zhejiang Device Alert”system,the risk types,causes and countermeasures of adverse events of disposable biopsy needles were investigated.Methods:By searching the“Zhejiang Equipment Alert”system,the State Drug Administration(NMPA)and other disposable biopsy needle products adverse event information sources,study the risk categories,analyze the risk factors and propose countermeasures.Results:Adverse events of disposable biopsy needles are mainly related to four aspects,namely,inherent product risk,registrant’s product production quality control risk,clinical operation and use risk and patient risk.The reasons for the risk mainly include the registrant’s choice of product materials and structural design,the degree of production quality control,the actual operation of clinical methods,individual differences in patients,patients and their families to cooperate with the degree.Countermeasures include product improvement by the registrant,strengthening of quality management system construction,standardization of clinical operation,strict grasp of the scope of application,and adequate communication and education.Conclusion:Disposable biopsy needle products have known and unintended risks that may lead to human injury,and risk monitoring and risk management should be strengthened in the production,use and regulation of such products to reduce and minimize the recurrence of similar adverse events.