Creating National Surveillance Infrastructure for Priority Medical Devices
为优先医疗器械创建国家监控基础设施
基本信息
- 批准号:9762574
- 负责人:
- 金额:$ 37万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-09-15 至 2021-08-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
The FDA's new post-market surveillance vision highlights the importance of national registries and linkages
with electronic health records (EHRs), administrative claims data, and with the Patient-Centered Outcomes
Research Institute's (PCORI) Clinical Data Research Networks (CDRN) to create national basis for post-
market surveillance. Orthopedic and vascular implants are particularly important to study. Osteoarthritis and
vascular disease are common, progressively debilitating diseases with a high prevalence in older Americans.
During the past 20 years, device-based hip and knee surgeries became the main treatment options for
advanced disease, leading to the use of orthopedic and vascular devices in millions of Americans annually.
Major evidence gaps in device performance exist, however, prompting international surveillance efforts jointly
by the FDA and the Weill Cornell Medical College. These include International Consortium of Orthopedic
Registries (ICOR) and International Consortium of Vascular Registries (ICVR) that are established as
distributed research and surveillance networks focusing on questions related to understanding device safety,
and effectiveness. While these consortia provide enormous value, each needs to strengthen their own national
systems. For Americans, devices used internationally are often not similar to those used in the U.S., creating a
critical knowledge gap about device benefits and risks. Moreover, U.S. registries are not always efficient;
virtually none capitalize on automated processes for data capture, storage, and export. Taking advantage of
growing national investments in EHRs to automate existing registry processes could result in costs savings,
gains in efficiency, and quality improvement.
In this proposal, we will capitalize on a novel partnership within the FDA's Medical Device Epidemiology
Network (MDEpiNet) to build national infrastructure. We will link registries with Medicare, commercial, and
state discharge billing claims, and CDRN data to develop an innovative infrastructure enabling post-market
surveillance for orthopedic and vascular devices. In addition, through the use of EHRs data, we will showcase
pilots for automation in registry creation and provide tools to stakeholders for successful creation of efficient
registries. Finally, we will develop, implement, and distribute new methodological approaches that address key
data issues emerging from the large linked databases. While the networks are separate, centralized knowledge
sharing will support cross-specialty and technology learning. Hence, we have several aims: 1) Develop a
national device surveillance network for orthopedic devices, 2) Develop a national device surveillance network
for vascular devices, 3) Pilot an approach to create efficient registries using EHRs using fully automated
processes, 4) Develop and implement novel methodology to address challenges emerging from creation of
registries. Through this initiative, we leverage national investments in variety of data assets to create
innovative, scalable models for post-market surveillance system that are sustainable and dynamic.
FDA新的上市后监督愿景强调了国家登记和联系的重要性
电子健康记录(EHR)、行政索赔数据以及以患者为中心的结局
研究所(PCRI)的临床数据研究网络(CDRN),以创建国家基础,
市场监督。骨科和血管植入物的研究尤为重要。骨关节炎和
血管疾病是常见的、进行性衰弱的疾病,在美国老年人中发病率很高。
在过去的20年里,基于器械的髋关节和膝关节手术成为主要的治疗选择,
晚期疾病,导致每年数百万美国人使用矫形和血管装置。
然而,器械性能方面存在重大证据缺口,促使国际社会共同开展监督工作
由FDA和威尔康奈尔医学院批准。其中包括国际骨科联盟
注册中心(ICOR)和国际血管注册中心联盟(ICVR),
分布式研究和监督网络,重点关注与理解器械安全性相关的问题,
和有效性。虽然这些财团提供了巨大的价值,但每个财团都需要加强自己的国家
系统.对于美国人来说,国际上使用的设备通常与美国使用的设备不同,创建
关于器械受益和风险的关键知识差距。此外,美国的注册并不总是有效的;
几乎没有一家公司利用自动化的数据采集、存储和导出流程。利用
增加国家对电子健康档案的投资,使现有的登记过程自动化,可以节省成本,
提高效率和质量。
在本提案中,我们将利用FDA医疗器械流行病学部门内的新型合作关系
建立国家基础设施的MDEPiNet网络。我们将把注册与医疗保险、商业和
国家排放计费索赔和CDRN数据,以开发创新的基础设施,
骨科和血管器械的监测。此外,通过使用EHR数据,我们将展示
登记册创建自动化试点,并向利益攸关方提供工具,
登记处。最后,我们将开发、实现和分发新的方法论方法,
从大型链接数据库中出现的数据问题。虽然网络是独立的,集中的知识
共享将支持跨专业和技术学习。因此,我们有几个目标:1)开发一个
骨科器械的国家器械监督网络,2)建立国家器械监督网络
对于血管器械,3)试验一种方法,使用全自动化的EHR创建有效的注册表
流程,4)开发和实施新型方法来解决创建过程中出现的挑战
登记处。通过这一举措,我们利用国家对各种数据资产的投资,
可持续和动态的创新、可扩展的上市后监督系统模型。
项目成果
期刊论文数量(78)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Impact of Pelvic Radiation Therapy on Inflatable Penile Prosthesis Reoperation Rates.
盆腔放射治疗对充气阴茎假体再手术率的影响。
- DOI:10.1016/j.jsxm.2018.09.009
- 发表时间:2018
- 期刊:
- 影响因子:0
- 作者:Golan,Ron;Patel,NealA;Sun,Tianyi;Barbieri,ChristopherE;Sedrakyan,Art;Kashanian,JamesA
- 通讯作者:Kashanian,JamesA
Regional Variation in Postoperative Myocardial Infarction in Patients Undergoing Vascular Surgery in the United States.
美国接受血管手术的患者术后心肌梗死的区域差异。
- DOI:10.1016/j.avsg.2016.07.099
- 发表时间:2017
- 期刊:
- 影响因子:1.5
- 作者:Steely,AndreaM;Callas,PeterW;Neal,Daniel;Scali,SalvatoreT;Goodney,PhilipP;Schanzer,Andres;Cronenwett,JackL;Bertges,DanielJ;VascularQualityInitiative
- 通讯作者:VascularQualityInitiative
Trends in surgical management and pre-operative urodynamics in female medicare beneficiaries with mixed incontinence.
混合性尿失禁女性医疗受益人的手术管理和术前尿动力学趋势。
- DOI:10.1002/nau.22946
- 发表时间:2017
- 期刊:
- 影响因子:2
- 作者:Chughtai,Bilal;Hauser,Nicholas;Anger,Jennifer;Asfaw,Tirsit;Laor,Leanna;Mao,Jialin;Lee,Richard;Te,Alexis;Kaplan,Steven;Sedrakyan,Art
- 通讯作者:Sedrakyan,Art
Surgical registries for advancing quality and device surveillance.
用于提高质量和设备监控的手术注册。
- DOI:10.1016/s0140-6736(16)31402-7
- 发表时间:2016
- 期刊:
- 影响因子:0
- 作者:Sedrakyan,Art;Campbell,Bruce;Graves,Stephen;Cronenwett,JackL
- 通讯作者:Cronenwett,JackL
Conceptualizing treatment of uncomplicated type B dissection using the IDEAL framework.
使用 IDEAL 框架概念化治疗不复杂的 B 型解剖。
- DOI:10.1016/j.jvs.2017.10.054
- 发表时间:2018
- 期刊:
- 影响因子:4.3
- 作者:Wang,GraceJ;Goodney,PhilipP;Sedrakyan,Art
- 通讯作者:Sedrakyan,Art
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Art Sedrakyan其他文献
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{{ truncateString('Art Sedrakyan', 18)}}的其他基金
Novel Approaches to Advance Coordinated Registry Networks (CRNs).
推进协调注册网络 (CRN) 的新方法。
- 批准号:
10209943 - 财政年份:2020
- 资助金额:
$ 37万 - 项目类别:
Novel Approaches to Advance Coordinated Registry Networks (CRNs).
推进协调注册网络 (CRN) 的新方法。
- 批准号:
10405497 - 财政年份:2020
- 资助金额:
$ 37万 - 项目类别:
Creating National Surveillance Infrastructure for Priority Medical Devices
为优先医疗器械创建国家监控基础设施
- 批准号:
9552616 - 财政年份:2015
- 资助金额:
$ 37万 - 项目类别:
Global Consortium of Cardiovascular Registries: Transcatheter Valve initiative
全球心血管登记联盟:经导管瓣膜倡议
- 批准号:
8915909 - 财政年份:2013
- 资助金额:
$ 37万 - 项目类别:
Global Consortium of Cardiovascular Registries: Transcatheter Valve initiative
全球心血管登记联盟:经导管瓣膜倡议
- 批准号:
8682413 - 财政年份:2013
- 资助金额:
$ 37万 - 项目类别:
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