Surgical registries for advancing quality and device surveillance.
Surgical registries for advancing quality and device surveillance.
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用于提高质量和设备监控的手术注册。
DOI：
10.1016/s0140-6736(16)31402-7
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发表时间：
2016
期刊：
影响因子：
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通讯作者：
Cronenwett,JackL
中科院分区：
文献类型：
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作者：
Sedrakyan,Art;Campbell,Bruce;Graves,Stephen;Cronenwett,JackL
注册表参见http://www. icv倡议。医疗保健组织。 8 这些骨科登记处的经验启发了 2010 年美国关节置换登记处的创建。大多数创新手术（例如经导管主动脉瓣置换术）都以设备为核心。 9 注册机构允许对设备进行持续评估，为监管机构、付款人和制造商提供信息。注册表允许获取有关设备整个生命周期的数据。 10, 11 注册中心还具有跟踪渐进式创新的能力，例如，这些创新支撑着市场上数千个关节植入物。这些好处已得到国际医疗器械监管论坛注册工作组的认可，该工作组为器械监管中的注册实施提供了最务实的定义（小组）。美国为国家登记机构分配的联邦资金很少。 12 在这种环境下，监管机构、制造商和临床医生之间的合作对于发展和维持注册非常重要。国际设备理念、开发、探索、评估、长期研究 (IDEAL) 倡议的一项关键建议是，在首次人体体验时启动数据收集，并使用注册来嵌套临床研究，并随后监测技术的发展。 10 注册框架和 IDEAL 建议对于对长期器械性能感兴趣的利益相关者来说非常有吸引力。通过提供有关后续再干预或并发症的数据，登记处与医疗保险或私人保险公司索赔的联系进一步增加了其潜力。这种联系是协调登记网络概念的重点，该网络从多个来源获取数据，也是美国国家评估系统新愿景的基础。 11 建立强大的外科注册中心可以参与在监管机构鼓励下开始的重大国际合作。例如，国际骨科注册协会和国际血管注册协会已经成功创建了全球学习网络和国际研究合作。
Registries see http://www. icvrinitiative. org in health care. 8 Experience with these orthopaedic registries inspired the creation of the American Joint Replacement Registry in 2010. Most innovative procedures, such as transcatheter aortic valve replacement, have a device at their core. 9 Registries permit continuous assessment of devices to provide information for regulators, payers, and manufacturers. Registries allow acquisition of data about devices throughout their lifecycle. 10, 11 Registries also have the capacity to track incremental innovations that, for example, underpin the thousands of joint implants on the market. These benefits have been recognised by the International Medical Device Regulatory Forum’s registry workgroup, which has offered the most pragmatic definition for registry implementation within device regulation (panel). The USA allocates little federal funding for national registries. 12 In this environment, collaboration between regulators, manufacturers, and clinicians is important to develop and sustain registries. Initiation of data collection at the time of first-in-man experience, and use of registries to nest clinical studies with subsequent monitoring of technology as it evolves is a key recommendation of the international Idea, Development, Exploration, Assessment, Long-term study (IDEAL) initiative for devices. 10 The registry framework and IDEAL recommendations could be very attractive for stakeholders with interests in long-term device performance. Linkage of registries with Medicare or private insurer claims increases their potential still further, by providing data about subsequent re-intervention or complications. Such links are the focus of the concept of coordinated registry networks that pull data from multiple sources and are the basis for a new vision of national evaluation systems in the USA. 11 Development of strong surgical registries enables participation in major international collaborations that have been started with the encouragement of regulators. For example, the International Consortium of Orthopedic Registries and the International Consortium of Vascular Registries are already successful in creating global learning networks and international research collaborations.