Mishali Meital, Sheffer Nadav, Mishali Oren, Negev Maya
University of Haifa, School of Public Health, Haifa.
Afeka -The Academic College of Engineering in Tel Aviv, Medical Engineering, Head, Afeka Center for Medical Engineering, Tel-Aviv, Israel.
Digit Health. 2025 Jan 23;11:20552076251314094. doi: 10.1177/20552076251314094. eCollection 2025 Jan-Dec.
Adverse event reporting for medical devices is critical for risk mitigation. The Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database serves as a key tool for post-market surveillance, receiving reports from various sources. Ensuring information integrity, especially across diverse reporting sources, is paramount. Periodic regulatory updates aim to enhance reporting.
Analyze reporting patterns, assess the potential contribution of 2015 and 2018 regulatory updates on reporting rates for varies reporters. Additionally, evaluating reporting schedule compliance by comparing average reporting times to regulatory requirements for these reporters.
Data from 1991-2022 was retrieved from the MAUDE database. Annual report counts were filtered by reporter and event type. Average reporting time was calculated as the difference between received and awareness dates.
The 2018 Voluntary Malfunction Summary Reporting (VMSR) program correlated with an increase in manufacturers' event reporting, peaking at 3,135,501 events in 2022. Distributors' reports surged post-2018, while voluntary reports steadily increased since 1997, spiking notably in 2015 with the Electronic Medical Device Reporting (eMDR) submission update. Reporting times for deaths averaged 80 days for manufacturers, far exceeding regulatory requirements, compared to 40 days for distributors and 46 days for user facilities. Malfunction events had longer average reporting times for manufacturers (89 days) compared to distributors (44 days).
Changes in reporting trends around 2015 and 2018 may be linked to regulatory updates. Tailoring regulatory changes for each reporter type, like user-friendly electronic forms, new reporting programs, and exemptions cancelations, can improve reporting. Balancing the volume of reports among different reporters is crucial for enhancing database integrity, transparency, and overall health outcomes.
医疗器械不良事件报告对于降低风险至关重要。美国食品药品监督管理局（FDA）的制造商和用户设施设备经验（MAUDE）数据库是上市后监测的关键工具，接收来自各种来源的报告。确保信息完整性，尤其是跨不同报告来源的信息完整性至关重要。定期的监管更新旨在加强报告工作。
分析报告模式，评估2015年和2018年监管更新对不同报告者报告率的潜在贡献。此外，通过将平均报告时间与这些报告者的监管要求进行比较，评估报告时间表的合规情况。
从MAUDE数据库中检索1991年至2022年的数据。年度报告计数按报告者和事件类型进行筛选。平均报告时间计算为收到日期与知晓日期之间的差值。
2018年的自愿故障总结报告（VMSR）计划与制造商事件报告的增加相关，在2022年达到3135501起事件的峰值。2018年后经销商的报告激增，而自愿报告自1997年以来稳步增加，在2015年电子医疗器械报告（eMDR）提交更新时显著飙升。制造商报告死亡事件的平均时间为80天，远远超过监管要求，相比之下，经销商为40天，用户设施为46天。与经销商（44天）相比，制造商的故障事件平均报告时间更长（89天）。
2015年和2018年左右报告趋势的变化可能与监管更新有关。为每种报告者类型量身定制监管变化，如用户友好的电子表格、新的报告计划和豁免取消，可以改善报告工作。平衡不同报告者之间的报告数量对于提高数据库的完整性、透明度和整体健康结果至关重要。
