AAMI/FDA Risk Management Summit
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For five years, AAMI and the U.S. Food and Drug Administration have joined forces to host summits on major issues that affect the healthcare technology community. That tradition continues with this summit on risk management, a seemingly benigh term that can elicit impassioned debate and sharp disagreement--even within one organization.

9/29/2015 to 9/30/2015
When: Sept 29-30
Where: Herndon, VA
Presenter: AAMI/FDA
Contact: Tirza Lofgreen
703-647-2774

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September 29 - 30, 2015

Herndon, VA

For five years, AAMI and the U.S. Food and Drug Administration have joined forces to host summits on major issues that affect the healthcare technology community. That tradition continues with this summit on risk management, a seemingly benign term that can elicit impassioned debate and sharp disagreement—even within one organization.  

This event will bring together leaders and risk management experts in the medical device industry and healthcare delivery, along with regulators, educators, and clinicians. Your input is essential to this effort. The summit will be professionally moderated, and extensive time will be dedicated to attendee participation and interaction.

Risk management is a sprawling subject, one that could go in a number of directions. The summit will focus primarily on the discipline of risk management as applied to regulated medical devices. The discussion will not touch on health information technology or interoperability, nor will it cover specific risks with medical devices.

The summit will be a multidisciplinary forum. AAMI strongly encourages risk experts from healthcare delivery to participate because that voice is important in the life cycle of risk management for medical devices.

The goals of the summit are to:

  • Build a shared perspective on risk management among the diverse stakeholders who have roles in its application in healthcare technology: clinicians, risk managers, healthcare technology management and IT professionals, systems engineers, regulators, and manufacturers.
  • Identify barriers that are holding us back from that shared perspective and generate ideas for removing the obstacles.
  • Develop a shared plan for growing the discipline and practice of risk management in healthcare technology.


Speakers confirmed include:

  • Jason Amaral, Thoratec
  • Steven W. Badelt, PhD, Suttons Creek
  • Pat Baird, Baxter Healthcare Corporation
  • Randall Brockman, MD, CDRH/ODE, U.S. Food & Drug Administration
  • Tony Carr, Boston Scientific Corporation
  • CDR Scott Colburn, MS, BSN, CDRH/OCD, U.S. Food & Drug Administration
  • Al Crouse, CVRx, Inc.
  • John Deadwyler, Summit Facilitator
  • Ginger Glaser, American Medical Systems
  • Donna Haire, MS, Bayer HealthCare
  • Kristin Hastings, Boston Scientific Corporation
  • Tina Krenc, Abbott Laboratories
  • Greg Lancaster, Philips Healthcare, AED Business
  • Lee Leichter, P/L Biomedical
  • Mary Logan, JD, CAE, President, AAMI
  • Robert C. Menson, PhD, Menson & Associates Inc.
  • CAPT Diane Mitchell, MD, CDRH/OCD, U.S. Food & Drug Administration
  • Jacque Mitchell, American Society for Healthcare Risk Management
  • Thomas Morrissey, MD, Edwards Lifesciences
  • Jeff Natterman, RRT, MA, JD, CPHRM, The Johns Hopkins Hospital
  • Susan Nicholson, MD, FIDSA, Johnson & Johnson
  • Tammy Pelnik, St. Vrain Group
  • Michael Robkin, Anakena Solutions
  • Ricky Rodriguez, ORA/CDRH, U.S. Food & Drug Administration
  • Susan Schrandt, JD, Patient-Centered Outcomes Research Institute (PCORI)
  • Nicole Schumacher, Deloitte & Touche LLP
  • Craig Shaffer, Applied Strategies
  • Tom Shoup, PhD, Foxburg LLC
  • David Sine, VA National Patient Safety Center
  • Weiping Zhong, GE Healthcare

- See more at: http://www.aami.org/events/eventdetail.aspx?ItemNumber=2595&navItemNumber=2428#sthash.SnXzH2X3.dpuf