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Creating National Surveillance Infrastructure for Priority Medical Devices

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:
9762574
负责人:
Art Sedrakyan
金额:
$37.0万
依托单位国家:
美国
项目类别:
财政年份:
2015
资助国家:
美国
项目状态:
已结题
起止时间:
2015-09-15 至 2021-08-31

项目摘要

项目成果

Art Sedrakyan的其他基金

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相关文献

中文摘要
翻译
FDA新的上市后监督愿景强调了国家注册和联系的重要性
英文摘要
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.
期刊论文(78)
专著(0)
科研奖励(0)
会议论文
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: The journal of sexual medicine
影响因子: --
作者: [Golan,Ron, Patel,NealA, Sun,Tianyi, Barbieri,ChristopherE, Sedrakyan,Art, Kashanian,JamesA]
通讯作者: Kashanian,JamesA
DOI: 10.1016/j.avsg.2016.07.099
发表时间: 2017
期刊: Annals of vascular surgery
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: Neurourology and urodynamics
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: Lancet (London, England)
影响因子: --
作者: [Sedrakyan,Art, Campbell,Bruce, Graves,Stephen, Cronenwett,JackL]
通讯作者: Cronenwett,JackL
共 29 条
    Novel Approaches to Advance Coordinated Registry Networks (CRNs).
    Novel Approaches to Advance Coordinated Registry Networks (CRNs).
    Creating National Surveillance Infrastructure for Priority Medical Devices
    Global Consortium of Cardiovascular Registries: Transcatheter Valve initiative
    海外基金