MDEpiNet projects span clinical areas and combine resources from the entire network and partners. Visit the individual project pages to learn more.
The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Initiative aims to develop a U.S. national device surveillance network in the vascular device space. VISION is a collaborative effort between the FDA’s MDEpiNet-Weill Cornell Medicine Science and Infrastructure Center, and vascular registries such as the Vascular Quality Initiative and the NYC Coordinated Data Registry Network.
There is a growing demand for evidence that better reflects the patient experience during routine care. Registries can help meet this demand by collecting data on real-world patient care.
The Registry Assessment of Peripheral Interventional Devices (RAPID) project is focused on devices for peripheral arterial intervention as an archetype of the envisioned TPLC ecosystem.
Two International Consortium of Cardiovascular Registries (ICCR) initiatives, The International Consortium of Transcatheter Valve Registries (ICTVR) and The International Consortium of Vascular Registries (ICVR), provide a collaborative platform through which registries and other stakeholders around the world can start a dialog, discuss data/methodology issues, and use aggregate level innovative analytic methods for conducting worldwide studies.
This registry represents a multi-institutional effort to prospectively obtain real-world clinical data on prostate-sparing ablative devices including high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and future technologies.
The Data Extraction and Longitudinal Trend Analysis (DELTA) System is designed to provide near real-time active safety surveillance of clinical (EHR) or clinical registry data.
International Consortium of Orthopedic Registries (ICOR) is working to classify orthopedic devices and develop new methodological approaches to implement and harmonize unique device identifier (UDI) information.
Cornell Claims Based Research Initiative (CBRI). Research within this program evaluates current and innovative devices and device-based interventions in medicine. Current research from CBRI focuses on four major areas of clinical medicine: urology, cardiovascular medicine, thoracic surgery and obstetrics & gynecology.
Unique Device Identifier (UDI) Implementation in the Electronic Information of a Single Health System: An MDEpiNet Demonstration.
Mercy Health designed and implemented a system for capturing prototype coronary stent UDIs by means of barcode scanning in its cardiac catheterization laboratories (cath labs) and incorporating them in its supply chain management, inventory management, billing, and cath lab clinical systems.
Predictable And SuStainable Implementation Of National (PASSION) Registries for Cardiovascular Devices is an MDEpiNet program that is building the national medical device evaluation system and addressing cardiovascular issues. The PASSION projects are the result of the October 15, 2014 MDEpiNet annual meeting. This MDEpiNet Think Tank launched three projects that have matured and been funded from a variety of sources.
Specific, Measurable, Achievable, Results-oriented, Time-bound. SMART is a working group focused on supporting pilot projects that will result in improved capture and exchange of unique device identifiers (UDIs) and other structured device data across the medical device ecosystem.
The International Consortium of Orthopedic Registries’ USA Collaboration (ICOR-USA) aims to develop a U.S. national device surveillance network in the orthopedic device space. ICOR-USA is a collaborative effort between the FDA’s MDEpiNet-Weill Cornell Medicine Science and Infrastructure Center, and orthopedic registries such as the American Joint Replacement Registry, Kaiser Permanente’s Total Joint Replacement Registry, the FORCE-TJR project, and HealthEast.
The VANGUARD initiative has been developed to provide a comprehensive, stakeholder-driven environment to define, gather, synthesize and distribute information related to patients who require chronic central venous access. As a SMART Thinktank Workgroup, VANGUARD was adopted by MDEpiNet in 2015 as one of several related initiatives to develop a national pathway to evaluation of medical device safety and effectiveness.
Piloting Women’s Health Registries in EHRs – the ULTRA Study at UCSF: ULTRA study is a pilot study for Uterine Fibroid led by Dr. Vanessa Jacoby (https://fibroids.ucsf.edu/). This collaborative effort aims to help patients and doctors understand how the treatment changes fibroid symptoms, affects fertility and pregnancy, and impacts the need for additional fibroid treatment in the future.
Augmented Unique Device Identifier (AUDI) is one of three working groups from a collaboration between the SMART and PASSION projects. Hosted by MDEpiNet, the mission of the AUDI workgroup is to provide the framework for expanding the FDA GUDID system to manage additional data about medical devices.
Core Variable Assessment Towards a National Evaluation Program (CATNIP) is designed to advance the foundational elements of a total product lifecycle (TPLC) approach for the evaluation of bariatric and metabolic weight-loss devices, focusing on endoscopically placed devices or procedures designed for weight loss and/or metabolic treatment (diabetes).