对2006-2015年美国FDA召回的神经调控类医疗器械产品分析

摘要

目的：重点分析美国FDA对神经刺激类产品的召回情况，尤其是对深部脑刺激器（DBS）和脊髓刺激器（S C S）这两类高风险的神经调控类医疗器械产品召回信息的特点进行了剖析。方法：对召回级别，召回原因等进行归类分析。结果：Medtronic神经调控部门2006.10.20-2015.1.12，D B S和S C S相关的召回共23条，占Medtronic神经调控部门总召回事件的21.9%。S C S和D B S召回事件集中体现在：设计，生产制造，包装和标签，以及非长期植入辅助部分。其中，非长期植入辅助部分召回事件共7条（30.4%），包装和标签召回事件共6条（26.1%），设计召回事件共6条（26.1%），生产制造召回事件共4条（17.4%）。DBS和SCS总体召回事件维持在较低的水平。St. Jude Medical涉及的召回大部分与充电在神经刺激类产品中的这一新应用相关，其中充电发热值得关注，生产制造的问题也稍显突出。因此，要加强生产制造过程控制。Boston Scientific 充电发热和元件失效值得关注。在DBS和SCS产品召回事件中，植入部分软件问题并不突出，但要加强对体外配套产品软件的重视。结论：应加强对医疗器械召回信息的利用，总结FDA召回事件的规律。为我国高端医疗器械产品的审评，检测监测，相关领域研究和产品化提供参考。%Objectives:Analyze FDA neuromodulation device recal information, especial y DBS and SCS. Method:For each recal event, the recal class and reason for recal were classiifed for analysis. Results:The total number of DBS and SCS recal events from October 20th, 2006 to January 12th, 2015 is 23, 21.9%of the total recal s by Medtronic neuromodulation division. The reasons for recal s are manufacturing, design, package and label, as wel as the auxiliary parts. The number of auxiliary parts recal events is 7, 30.4%of the total recal s by Medtronic neuromodulation division. The number of package and label recal events is 6, 26.1%of the total recal s by Medtronic neuromodulation division. The number of design recal events is 6, 26.1% of the total recal s by Medtronic neuromodulation division. The number of manufacturing recal events is 4, 17.4%of the total recal s by Medtronic neuromodulation division. DBS and SCS productions are rarely involved in FDA recal events in conclusion. The recal events for St. Jude Medical mainly focus on new rechargeable neuromodulation device and overheat is a mat er of concern, manufacturing is also slightly prominent. Recharging overheat and component failure is a mat er of concern. The recal events for implantable software are rarely observed, but correspondingly, non-implantable software needs to be considered. Conclusion:Usage of FDA medical device recal events should be strengthened in order to provide reference for review, supervision, related research and production.