【奥译言】美国FDA就4.1万例手术缝合器及缝合钉相关不良事件报告致函医护人员

2019-03-21 11:55 阅读数：3464 标签：

3月8日，美国食品药品监督管理局（FDA）就越来越多的与外科缝合器和植入式缝合钉相关的不良事件致函医护人员

FDA经过对医疗器械报告的持续分析发现，在2011年1月1日至2018年3月31日期间，共收到了4.1万多份描述了与外科缝合器和缝合钉体内使用相关不良事件的医疗器械报告。其中，涉及366人死亡，近9000人重伤，还有32000多起故障。

信中还指出，FDA认识到“同一时间段内还收到了更多的器械故障报告”，而这些器械故障报告是以替代性总结报告的形式提交的。此外，FDA仍在分析这些器械故障报告和医疗器械报告。

此前，凯泽健康新闻（Kaiser Health News，KHN）于3月7日发布了一份调查报告，详细介绍了FDA针对医疗器械的替代性总结报告计划。KHN调查发现，该信息库包含大约100个医疗器械造成的严重伤害和故障事件，尽管这两种事件类型都不在FDA替代性报告计划的豁免范围之内。

该计划于2017年进行了修订，成为自愿故障总结报告计划，作为以总结概述的格式提交合格季度报告的替代方案。尽管2017年经修订的计划提案被推迟，但该计划在2018年8月扩大到包括组合产品。

FDA表示，“KHN调查报告称，‘隐藏的信息库’包括手术缝合器。但这些器械目前不符合替代性总结报告或自愿故障总结报告的条件”。

在许多已评估的医疗器械报告中，通常涉及的不良事件包括不当击发、缝钉变形和缝合器发生故障、缝合器无法击发缝合钉。美国FDA表示，“我们认为这些报告中发现的许多问题主要归因于用于体内的手术缝合器，因为缝钉能否正确就位很大程度上取决于缝合器的功能和使用是否恰当。”

FDA打算今年发布一份指南草案，旨在就器械标签方面提出相关建议。

FDA还计划召开医疗器械咨询委员会普通外科与整形外科器械专家小组公开会议，就是否适合将用于体内的手术缝钉从目前的I类医疗器械分类重新分类为II类进行公开讨论。通过重新分类,从而将允许FDA通过建立强制性的特殊控制并实施510(k)程序，减轻该器械设备类型的已知风险。

此外，FDA还向医护人员提出了七项建议，包括建议他们遵循缝合器制造商提供的使用说明书，采用有一系列可用尺寸的缝合钉，考虑其他缝合方案，避免将缝合器和缝合钉用于大血管，以及其他一些建议。

英文原文

FDA Flags 41,000 Adverse Event Reports Linked to Surgical Staplers, Staples

The US Food and Drug Administration (FDA) sent a letter to health care providers Friday over a growing body of adverse events associated with surgical staplers and implantable staples.

The agency’s ongoing analysis of medical device reports (MDRs) found that it received more than 41,000 individual MDRs that describe adverse events associated with the use of surgical staplers and staples for internal use between 1 January 2011 and 31 March 2018.

These include 366 deaths, almost 9,000 serious injuries and over 32,000 malfunctions. The letter also notes FDA is aware “many more device malfunction reports” were submitted during this same time frame as alternative summary reports and is still analyzing both these reports and the MDRs.

The letter follows on the heels of a Kaiser Health News (KHN) investigation released Thursday and detailing the agency’s alternative summary reporting program for medical devices. The KHN investigation found that the repository has reportedly “included serious injury and malfunction reports for about 100 medical devices,” though neither of these event types are covered by the scope of the exemption of FDA’s alternative reporting program.

The program was revamped in 2017 as the Voluntary Malfunction Summary Reporting Program as an alternative for eligible quarterly report submissions in summary formats. It was expanded last August to include combination products, despite pushback on the 2017 program proposal.

KHN investigation reported the “hidden repository” included surgical staplers. But “these devices are not currently eligible for alternative summary reporting or Voluntary Malfunction Summary Reporting,” FDA said.

Commonly reported adverse events in the evaluated MDRs include misfiring, staple malformation and failure of the stapler to fire the staple. FDA said it “believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler.” It intends to issue draft guidance this year to propose device labeling recommendations.

The agency also plans to hold a public meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel for open discussion around whether it would be appropriate to reclassify surgical staples for internal use from its current class I medical device classification into class II. The reclassification would in turn allow FDA to mitigate known risks of the device type by establishing mandatory special controls and requiring 510(k) submissions.

Health care providers were offered seven recommendations. These relate to following the stapler manufacturer’s instructions for use, having of a range of staple sizes available, considering other suturing options and avoiding use on large blood vessels, among several other recommendations.

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/3/fda-flags-41000-adverse-event-reports-linked-to-s

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