Major grant from FDA to build national infrastructure for devices

We have received a 13M+ grant from the FDA (2016-2021) to 1) Develop a national device surveillance network for orthopedic devices; 2) Develop a national device surveillance network for vascular devices; and 3) Develop a national device surveillance network for other priority medical devices. We will link registries with Medicare, commercial, and state discharge billing claims, and New York State all payer data to develop an innovative infrastructure enabling post-market surveillance for orthopedic and vascular devices. In addition, 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. As part of this major national initiative, we will bring together data access and data collaborator partners to create an unprecedented national surveillance system. The collaborators include:

    • Harvard University Medical School’s Department of Healthcare Policy as the MDEpiNet Methodology Center
    • Kaiser Permanente (KP, over 10 national registries related to interventions)
    • American Joint Replacement Registry (AJRR)
    • Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR, an AHRQ funded 12M registry of functional outcomes)
    • Vascular Quality Initiative (VQI, main vascular surgery registry in the USA)
    • AUGS and ACOG for Women’s health initiative (WHI)
    • Institute for surgical Excellence for robotic registry initiative
    • Multiple organizations for Study of Prostate Ablation Related Energy Devices (SPARED) Registry
    • The New York City Clinical Data Research Network (NYC-CDRN funded by Patient-Centered Outcomes Research Institute)

CONTACT US

  • Dr. Art Sedrakyan
    Department of Healthcare Policy & Research
    402 East 67th Street New York, NY 10065
    (646) 962-8072
    ars2013@med.cornell.edu
  • Courtney Baird
    Department of Healthcare Policy & Research
    402 East 67th Street
    New York, NY 10065
    (646) 962-8099
    ceb3003@med.cornell.edu
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