UDI政策對高風險植入式醫療器械不良事件趨勢的影響

Abstract

為加強醫療器械的識別追蹤和上市後監管，美國食品和藥物管理局實施了唯一設備標識（Unique Device Identification，UDI）制度，以提升器械可追溯性和不良事件監測。然而，針對高風險植入式醫療器械的UDI政策效果尚缺乏實證評估。本研究以Mentor公司生產的MemoryGel乳房植入體（III類高風險醫療器械）為例，評估UDI實施對其不良事件報告趨勢的影響。我們提取了FDA不良事件資料庫（MAUDE）2010–2020年的報告資料，聚焦“受傷”類事件，採用中斷時間序列分析框架並結合SARIMA模型進行分析，將2014年10月設為干預時點。結果顯示，UDI實施後不良事件報告數出現顯著的立即增加：自2014年10月起，MemoryGel植入體相關“受傷”事件的月報告數躍升約116例（p<0.001）。此外，不良事件報告的長期趨勢由實施前的逐月緩升（約+0.95例/月）轉為實施後的逐月下降（約-0.85例/月），斜率淨變化約-1.80（p<0.001）。這些發現表明，UDI制度通過強化器械層級可追溯性，提高了不良事件報告的完整性和準確性。更重要的是，追溯能力的提升使監管者和製造商及時發現並糾正器械缺陷（如定向召回或技術改進），從源頭減少不良事件發生並提高患者安全。綜上，UDI政策顯著強化了高風險植入式醫療器械的可追溯性和上市後安全監測，為這一監管舉措的有效性提供了有力實證支援。

Medical device-associated adverse events have raised serious patient safety concerns, prompting regulatory initiatives to improve device identification and tracking. The U.S. Food and Drug Administration (FDA) implemented the Unique Device Identification (UDI) system, which assigns a unique code to each medical device to enhance traceability and post-market surveillance. However, empirical evidence on UDI’s impact on safety outcomes for high-risk implantable devices remains limited. This study provides an empirical evaluation of the UDI policy’s effect on adverse event reporting trends for a high-risk implantable medical device: the Mentor MemoryGel breast implant. Adverse event records from January 2010 through December 2020 were extracted from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. We focused on reported patient injuries associated with this device and employed an interrupted time series design using a seasonal autoregressive integrated moving average (SARIMA) model. The analysis considered October 2014—when UDI compliance became mandatory for Class III devices—as the intervention time point. Results indicate that UDI implementation was associated with a statistically significant immediate increase in adverse event reports. In particular, the monthly count of injury-related reports for MemoryGel breast implants jumped by approximately 116 cases immediately after UDI enforcement began (p < 0.001). Moreover, the long-term trend of adverse events reversed direction following UDI: prior to late 2014, monthly injury reports were gradually increasing (by about +0.95 per month), whereas after UDI implementation they showed a gradual decline (by about –0.85 per month). This change in slope (approximately –1.80 reports per month) was statistically significant (p < 0.001). These findings suggest that the UDI system improved the completeness and accuracy of adverse event reporting by greatly enhancing device traceability, thereby strengthening post-market monitoring and early risk detection. More importantly, improved traceability enabled manufacturers and regulators to more rapidly identify and correct device defects (e.g., through targeted recalls or technical modifications), which likely contributed to a reduced incidence of adverse events over time and improved patient safety. In conclusion, the UDI policy has had a markedly positive impact on the traceability and safety monitoring of high-risk implantable medical devices, providing strong empirical support for this regulatory initiative and its important role in protecting public health.