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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities, September 11, 2012

The Food and Drug Administration (FDA) is announcing a public workshop entitled: "MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities." The topic to be discussed is setting strategic priorities and implementing an action plan for sustainable partnership toward improving regulatory science and the public health.

Date, Time and Location

This meeting was held September 11, 2012 beginning at 8:00 a.m. - 5:00 p.m. at the following location:

Greenbelt Marriott
6400 Ivy Lane
Greenbelt, MD 20770
301-614-8202

The meeting is available by Webcast.

Webcast

The webcast is available at:

Transcript

Agenda

TimeSubject
8:00Welcome, Introduction, and Goals for the Day
8:05MDEpiNet Partnership: A Pathway to Harness Global Capabilities for Epidemiology and Surveillance, Danica Marinac-Dabic
 Session I: MDEpiNet: Aligning, Leveraging and Promoting Innovative Approaches
8:20MDEpiNet as a Public-Private Partnership, Benjamin Eloff
8:30Stakeholder Engagement in MDEpiNet Partnership, Daniel Gregory
8:40Professional Societies Perspective, Mitchell Krucoff
8:50Role of Industry in Innovative Partnerships
9:00NIH Perspectives on Medical Device Epidemiology and Surveillance
9:10AHRQ Initiatives and Potential for Strategic Collaborations, Elise Berliner
9:20Engaging Patients in Setting the MDEpiNet Priorities, Anna Slipp
9:30Innovation in Device Surveillance in the Veterans Health Administration, John Rumsfeld
9:40Panel Discussion
10:00Break
10:15MDEpiNet Methodology Center : Current Projects and Future Directions
10:45Panel Discussion
11:45Lunch
12:30MDEpiNet Science and Infrastructure Center: Current Projects and Future Directions: Vision and Progress, Art Sedrakyan
1:00Panel Discussion
2:00Break
 Session IV: MDEpiNet – Focus on Methodology and Infrastructure for Active Postmarket Risk Identification
2:15Beyond Passive Surveillance : Unique Needs and Approaches for Medical Devices, Thomas Gross
2:25FDA Sentinel Initiative, Patrick Deacon
 Contemporary Device Surveillance Efforts for Devices
2:35Hospital Surveillance, Julian Goldman
2:45Active Cardiovascular Device Surveillance: the VA Experience, John Rumsfeld
2:55Claims Based Surveillance, J. Matthew Brennan
3:05Learning Curve and Beyond: The Context and Opportunities
3:15ASTER-D: New Models in Surveillance, Terrie Reed
3:25Panel Discussion
Questions:
  • What does active postmarket risk identification look like for devices?
  • What are the attributes for an effective "active surveillance" system for devices?
  • Does this differ by device type?
  • What efforts can be pursued under MDEpiNet that would augment active surveillance in general and Sentinel efforts in specific?
  • What methods and infrastructure issues does this present for MDEpiNet?
5:00Adjourn

Contact Us

For questions regarding workshop content please contact:

Danica Marinac-Dabic
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO-66 Room 4110
Silver Spring, MD 20993
301-796-6689
email: Danica.Marinac-Dabic@fda.hhs.gov