Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network.
Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network.
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DOI：
10.1136/bmjsit-2021-000113
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发表时间：
2022
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来自FDA、医师专业协会、行业和学术界的利益相关者于2017年11月9日在FDA白色橡树园区召开会议，评估当前集中在急性缺血性卒中血栓切除术的数据状况，并确定DAISI-CRN将解决的差距。然后将利益攸关方组成治理理事会。治理理事会的任务是监督数据收集的协调和跨数据源的使用。在治理理事会会议期间，决策的法定人数被定义为有超过30%的代表出席。一旦达到法定人数，就以多数票作出决定。管理理事会由三名临床联合主席和一名代表FDA的联合主席领导（在线补充文件1）。这些共同主席负责制定定期会议时间表，并与FDA CDRH工作人员一起沿着领导CDE讨论。利益相关者从他们的角度参与讨论，并提供有关CDE的意见、建议和问题。基础设施支持由康奈尔大学医疗器械流行病学网络科学和基础设施中心提供。
MethodsStakeholders from the FDA, physician specialty societies, industry, and academia convened on November 9, 2017 at the FDA White Oak Campus to assess the current data landscape focused on acute ischemic stroke thrombectomy and identify gaps that the DAISI-CRN would address. The group of stakeholders was then organized into a governance council. The governance council was tasked with overseeing the coordination of data collection and use across data sources. During governance council meetings a quorum for decision-making was defined as having> 30% of representatives present. Once a quorum was achieved decisions were made by majority vote. The governance council was led by three clinical co-chairs and a co-chair representing the FDA (online supplemental file 1). These co-chairs were charged with establishing a regular meeting schedule and leading discussions on CDE along with FDA CDRH staff. Stakeholders participated in discussions from their perspectives and provided comments, recommendations, and concerns regarding the CDE. Infrastructure support was provided by the Medical Device Epidemiology Network Science and Infrastructure Center at Cornell University.