揭示手术器械故障范围：对“隐藏”的美国食品和药物管理局器械数据库的分析。

Revealing the scope of surgical device malfunctions: Analysis of the "hidden" Food and Drug Administration device database.

机构信息

Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA.

出版信息

Am J Surg. 2021 Jun;221(6):1121-1126. doi: 10.1016/j.amjsurg.2021.03.017. Epub 2021 Mar 13.

DOI:10.1016/j.amjsurg.2021.03.017

PMID:33745689

Abstract

BACKGROUND

We compared surgical device malfunction reports in the Food and Drug Administration (FDA) public Manufacturer and User Facility Device Experience (MAUDE) with those in the FDA nonpublic Alternative Summary Reporting (ASR).

METHODS

General surgery device product code categories in MAUDE and ASR from 1999 to 2018 were identified. Changes in the rates of categories and adverse events were evaluated by Poisson regression.

RESULTS

There were 283,308 (72%) general surgical device malfunctions in MAUDE and 109,954 (28%) in ASR. Reports increased annually in ASR versus MAUDE, particularly for surgical staplers and clip devices (p < 0.05). ASR contained approximately 80% of these reports; MAUDE 20%. In MAUDE, 42.9% of surgical device malfunctions and 20.2% of stapler/clip malfunctions resulted in patient injury or death. ASR listed no injury or death information.

CONCLUSIONS

ASR contained a significant portion of surgical device malfunctions hidden from public scrutiny. Access to such data is essential to safe surgical care.

摘要

背景

我们比较了食品和药物管理局（FDA）公开的制造商和用户设施设备经验（MAUDE）与 FDA 非公开的替代摘要报告（ASR）中的手术器械故障报告。

方法

确定了 1999 年至 2018 年 MAUDE 和 ASR 中的普通外科设备产品代码类别。通过泊松回归评估类别的变化率和不良事件。

结果

MAUDE 中有 283,308 份（72%）普通外科设备故障报告，ASR 中有 109,954 份（28%）。ASR 中的报告逐年增加，而 MAUDE 中的报告则呈下降趋势，尤其是对于手术吻合器和夹装置（p<0.05）。ASR 包含了这些报告的大约 80%；MAUDE 为 20%。在 MAUDE 中，42.9%的手术器械故障和 20.2%的吻合器/夹故障导致患者受伤或死亡。ASR 未列出任何伤害或死亡信息。