近三分之一的FDA医疗器械不良事件报告提交延迟-动脉网

Nearly a third of FDA medical device adverse event reports filed late

Medical Device Network 等信源发布 2025-03-13 11:38

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Manufacturers must disclose safety event details within 30 days, and the FDA relies on these disclosures to decide whether to communicate safety concerns or pursue other regulatory actions. Image credit: Fox_Ana / Shutterstock.

制造商必须在30天内披露安全事件的详细信息，FDA依靠这些披露来决定是否传达安全问题或采取其他监管行动。图片来源：Fox_Ana / Shutterstock。

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period, a new cross-sectional study has found.

一项新的横断面研究发现，在三年期间，几乎三分之一的医疗器械不良事件 (AE) 由制造商报告的时间晚于美国食品药品监督管理局 (FDA) 规定的30天期限。

Published in the

发布于

BMJ

英国医学期刊

，

the study

研究

analysed more than four million reports submitted to the FDA’s centralised Manufacturer and User Facility Device Experience (MAUDE) database between September 2019 and December 2022. The agency relies on such disclosures to inform decision-making over whether to communicate safety concerns or pursue other regulatory actions..

分析了2019年9月至2022年12月期间提交给FDA中央制造商和用户设施设备经验（MAUDE）数据库的四百多万份报告。该机构依靠这些披露来为是否通报安全问题或采取其他监管行动的决策提供依据。

The study researchers found that 4.5% of AEs were reported between 31 and 180 days and 9.1% after 180 days later than the FDA’s required window while 15.5% of reports had missing or invalid data provided by the manufacturer. In addition, 71% of AEs throughout the assessed period were reported within the required window..

研究人员发现，有4.5%的不良事件发生在31至180天内报告，9.1%在超过FDA规定窗口期180天后才报告，而15.5%的报告中制造商提供的数据缺失或无效。此外，在整个评估期间，71%的不良事件是在规定的窗口期内报告的。

Late AE reports were determined to be concentrated among a few manufacturers, with three manufacturers contributing towards 54.8% of late reports, with a mean late reporting rate at the manufacturer level of 23.4%.

晚期不良事件报告被确定集中在少数制造商，其中三家制造商的晚期报告占比达54.8%，制造商层面的平均晚期报告率为23.4%。

The top manufacturers with the highest level of late reports included Becton Dickinson, Medtronic, Abbott, and Boston Scientific.

报告延迟最严重的顶级制造商包括碧迪、美敦力、雅培和波士顿科学。

Similarly, 13 devices attributed to 50.4% of late reports. Researchers found that the top ten devices ranked by total late reports included Becton Dickinson’s infusion pumps, Abbott’s glucose monitors, and Medtronic’s insulin pumps.

同样，13种设备占迟报的50.4%。研究人员发现，按总迟报数量排名前十的设备中，包括碧迪公司的输液泵、雅培公司的血糖仪和美敦力公司的胰岛素泵。

Out of all reports filed to the MAUDE database across the period, 13,587 were deaths, around 1.5 million were injuries, and almost three million malfunctions, with the figures originating from 3,028 unique manufacturers and 88,448 unique medical devices. However, it was out of the scope of the study to determine the impact that the percentage of reports filed late may have had on onward action taken by the FDA..

在该期间内提交到MAUDE数据库的所有报告中，13,587例为死亡，约150万例为伤害，近300万例为故障，这些数据来自3,028家独特的制造商和88,448种独特的医疗设备。然而，研究范围并未包括评估延迟提交的报告比例对FDA后续行动可能产生的影响。

In an editorial accompanying the BMJ publication, Harvard Medical School-affiliated researchers W B Feldman and Aaron Kesselheim said that such delays and information gaps can “hinder regulatory action, undermine trust in the MAUDE system, and harm patients” if problems with sensitive diagnostic equipment or life-saving treatments are not swiftly addressed..

在《英国医学杂志》发表的随附社论中，哈佛医学院附属研究员W B Feldman和Aaron Kesselheim表示，如果敏感诊断设备或挽救生命的治疗存在问题而未能迅速解决，此类延迟和信息缺口可能会“阻碍监管行动，破坏对MAUDE系统的信任，并伤害患者”。

The research group stated that while an effective tool, MAUDE has known limitations, including a reliance on external individuals and organisations to report AEs, rather than systematically and prospectively collecting safety and outcome data.

研究小组表示，尽管 MAUDE 是一种有效的工具，但它存在已知的局限性，包括依赖外部个人和组织报告不良事件 (AE)，而不是系统地、前瞻性地收集安全性和结果数据。

To bolster its ability to improve corrective actions being taken over certain medical device recalls, the FDA’s Center for Devices and Radiological Health (CDRH)

为了增强其改进针对某些医疗设备召回所采取的纠正措施的能力，FDA的设备和放射健康中心（CDRH）

initiated a pilot

启动了一项试点计划

last year that centred on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls.

去年，重点是改善公司对被认为高风险召回设备采取的纠正措施向公众传达信息的及时性。

The FDA recently issued an early alert over a ‘potentially high-risk’ issue with

FDA最近就一个“潜在的高风险”问题发出了早期警告，

certain Baxter Sigma Spectrum and Spectrum IQ infusion pumps

某些百特西格玛光谱和光谱IQ输液泵

and tagged a recall of breathing circuits manufactured by Sentec/Percussionaire

并标记了由Sentec/Percussionaire制造的呼吸回路的召回

as Class I.

一类。

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