Lübbeke Anne, Silman Alan J, Prieto-Alhambra Daniel, Adler Amanda I, Barea Christophe, Carr Andrew J
Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and Geneva University, Geneva, Switzerland.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
BMC Musculoskelet Disord. 2017 Oct 16;18(1):414. doi: 10.1186/s12891-017-1773-0.
The serious adverse events associated with metal on metal hip replacements have highlighted the importance of improving methods for monitoring surgical implants. The new European Union (EU) device regulation will enforce post-marketing surveillance based on registries among other surveillance tools. Europe has a common regulatory environment, a common market for medical devices, and extensive experience with joint replacement registries. In this context, we elaborate how joint replacement registries, while building on existing structure and data, can better ensure safety and balance risks and benefits.
Actions to improve registry-based implant surveillance include: enriching baseline and diversifying outcomes data collection; improving methodology to limit bias; speeding-up failure detection by active real-time monitoring; implementing risk-benefit analysis; coordinating collaboration between registries; and translating knowledge gained from the data into clinical decision-making and public health policy.
The changes proposed here will improve patient safety, enforce the application of the new legal EU requirements, augment evidence, improve clinical decision-making, facilitate value-based health-care delivery, and provide up-to-date guidance for public health.
金属对金属髋关节置换术相关的严重不良事件凸显了改进手术植入物监测方法的重要性。新的欧盟器械法规将强制要求基于注册系统及其他监测工具进行上市后监测。欧洲拥有统一的监管环境、医疗器械共同市场以及丰富的关节置换注册系统经验。在此背景下，我们阐述了关节置换注册系统如何在现有结构和数据基础上，更好地确保安全性并平衡风险与收益。
改进基于注册系统的植入物监测的行动包括：丰富基线数据并使结局数据收集多样化；改进方法以限制偏差；通过主动实时监测加快故障检测；开展风险效益分析；协调注册系统之间的合作；以及将从数据中获得的知识转化为临床决策和公共卫生政策。
此处提出的变革将提高患者安全性，强制实施欧盟新的法律要求，增加证据，改善临床决策，促进基于价值的医疗服务提供，并为公共卫生提供最新指导。
