浅议骨科植入性医疗器械不良事件及其报告工作

任何医疗器械产品都会有缺陷，对其所致不良事件进行有效监测，是产品安全有效的保证。使用者对不良事件的搜集和报告则是监测的基础环节。因骨科植入物应用量大面广，不良事件发生率高居前列，原因为：产品设计制造的固有风险；上市前研究的局限性；使用说明书的误导；产销企业管理不规范；产品质量问题；使用不当；患者不遵医嘱或意外受伤。因监测工作尚处起步阶段，漏报率较高而报告质量不高。故应加强监管、强制报告，健全机构、专人负责，宣传培训、提高认识，建章立制、奖惩分明。还应讲究策略、维护稳定，对发生在外院的“不良事件”，续诊医院应策略地了解患者资料和“不良事件”及其器械情况，并代填报，避免引发或加重外院的医患纠纷。

Discussion and Report on the Medical Device Adverse Event of Orthopedic Implants

Generally speaking, any medical instrument has defect. Monitoring the adverse events is the effect guarantee for the safety of products. It is the basic link of monitoring for the users to collect and report the adverse events. The extensive application of orthopedic implants makes the incidence of the bad affairs range the top level. The innate risk of the design and manufacture of the product, the limitation of study before marketing, misleading of the product manual, the irregular management of the production and marketing enterprises, the improper use and perhaps not following the doctor＇ s advice or injured by accidents may be responsible for the high incidence of the adverse events with the wide application of the orthopedic implants .The missing rate of report is high and the quality is poor because the monitoring work is still at the initial stage. It is required to strengthen supervision, report mandatorily, perfect agency, be charged by special messenger, improve knowledge, establish rules and clear system of rewards and punishments. The aspect of hospital should investigate the data of the patient, the information of the instrument and the adverse event which happened outside of the hospital tactfully and report them to avoid the initiation and aggravation of the doctor-patient dispute.