PROJECTS

MDEpiNet projects span clinical areas and combine resources from the entire network and partners. Visit the individual project pages to learn more.


Collaborative Projects

AUDI

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.

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Featured Projects

PASSION Projectspassion3

PASSION (Predictable And SuStainable Implementation Of National) 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.

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RAPIDrapid

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.

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BUILDsmart2

The Building UDI into Longitudinal Data for Medical Device Evaluation(BUILD) Initiative encompasses efforts to demonstrate, implement, and apply unique device identification (UDI) in health care.

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Additional Projects

DELTA Project

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.

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ICCR Projects

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.

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ICOR Projects

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.

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CBRI Projects

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.

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Mercy UDI Demonstration Project

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.

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SMART Projects

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.
VANGUARD: Venous Access: National Guideline and Registry Development
Electronic Health Record (EHR) Minimum Data Set

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ICOR-USA Collaboration

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.

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VISION in USA

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.

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