医疗器械制造商向美国食品和药物管理局报告的晚期不良事件，这一成果由加州大学Sanket S Dhruva研究组经过不懈努力而取得。这一研究成果于2025年3月12日发表在国际顶尖学术期刊《英国医学杂志》上。

目的:描述制造商向美国食品和药物管理局（FDA）制造商和用户设施设备体验（MAUDE）数据库报告不良事件的程度，以及制造商和器械特征协会之间延迟报告的分布情况。

设计:横断面研究。

设置:2019年9月1日至2022年12月31日期间，FDA MAUDE数据库是美国医疗器械上市后安全监测的中央工具。

参与者:2019年9月1日至2022年12月31日期间向FDA提交初步不良事件报告的医疗器械制造商。

主要结果测量s从制造商收到事件通知到FDA收到不良事件报告之间的天数，延迟报告的比例（在FDA规定的30天窗口之后），以及延迟报告在制造商和医疗器械之间的分布情况。

结果:在三年半的时间里，美国食品药品监督管理局收到了来自3028家独特制造商和88448台独特医疗器械的13587份死亡报告、1552268份受伤报告和2866693份故障报告。在4432548份纳入的报告中，71.0%（n=3146957）的不良事件在30天内（按时）报告，4.5%（n=197606）在31至180天内（延迟）报告，9.1%（n=402891）在180天后（延迟）报道。15.5%的报告（n=685094）缺少或制造商提供的日期数据无效。三家制造商和13家医疗器械占迟交报告的54.8%。

研究结果表明，近三分之一的医疗器械不良事件制造商报告没有在监管截止日期内提交给FDA，大多数迟交的报告是在制造商通知后六个多月提交的。大多数最新报告是由少数制造商提交的。较晚的不良事件报告可能会阻止患者安全问题的早期发现。

Title: Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study

Author: Alexander O Everhart, Pinar Karaca-Mandic, Rita F Redberg, Joseph S Ross, Sanket S Dhruva

Issue&Volume: 2025/03/12

Abstract: Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as well as the distribution of late reporting among manufacturers and associations with device characteristics.

Design Cross sectional study.

Setting The FDA MAUDE database, a central postmarket safety surveillance tool for US medical devices, from 1 September 2019 to 31 December 2022.

Participants Medical device manufacturers that submitted initial adverse event reports to the FDA between 1 September 2019 and 31 December 2022.

Main outcome measures Time in days between date manufacturer was notified of event and date of FDA receipt of adverse event reports, proportion of reports reported late (after the required 30 day window as required by FDA regulation), and distribution of late reporting among manufacturers and medical devices.

Results 13587 reports were of deaths, 1552268 of injuries, and 2866693 of malfunctions received by the FDA from 3028 unique manufacturers and 88448 unique medical devices in the three and a half year period. Of 4432548 included reports, 71.0% (n=3146957) of adverse events were reported within 30 days (on time), 4.5% (n=197606) were reported between 31 and 180 days (late), and 9.1% (n=402891) were after 180 days (late). 15.5% of reports (n=685094) had missing or invalid date data provided by the manufacturer. Three manufactures and 13 medical devices were attributed to 54.8% of late reports.

Conclusions Nearly a third of manufacturer reports of medical device adverse events were not demonstrably submitted to the FDA within the regulatory deadline, with most late reports being submitted more than six months after manufacturer notification. Most late reports were submitted by a small number of manufacturers. Late adverse event reporting may prevent early detection of patient safety concerns.

DOI: 10.1136/bmj-2024-081518

Source: https://www.bmj.com/content/388/bmj-2024-081518