MDEpiNet

From Good to Great: Advancing Innovation and Assessments of Medical Devices and Related Interventional Technologies at WCMC

 

The medical device field has grown drastically over the past few decades, as interventional procedures have evolved to include both device implantation and other non-implantable technologies. Given this evolution, the safety and effectiveness of medical devices currently affects about one quarter of the U.S. GDP. In recent years, over 1 million device adverse events have been reported to US regulators and the number of reports now exceeds those for drugs. The FDA MAUDE is one of the adverse event reporting systems and it is known that events are an underreported and unrecognized public health problem leading to disability and death often reaching epidemic proportions. The example of recent metal on metal device failure is only the tip of the iceberg. Importantly, the absence of unique device identification (UDI) internationally is camouflaging medical device problems under general health care safety and complications.

MDEpiNet Coordinating, Science, and Infrastructure Center

In 2011 Weill Cornell Medical College (WCMC) was designated by the FDA as an MDEpiNet Coordinating, Science, and Infrastructure Center, and was initially tasked with the goal of advancing the national application of unique device identifiers (UDI) and the application of UDIs within the context of the International Consortium of Orthopedic Registries (ICOR) and the International Consortium of Cardiovascular Registries (ICCR). The Center’s approach is based on conceptual frameworks that were developed in collaboration with the FDA and manufacturers. There are many focused projects within the initiatives that advance the conceptual framework of the MDEpiNet, including evidence generation, appraisal and synthesis, new international collaborative studies, and translation of the results for regulators.


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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