AAMI/FDA Risk Management Summit

September 29 - 30, 2015

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 brought together leaders and risk management experts in the medical device industry and healthcare delivery, along with regulators, educators, and clinicians. Discussions focused primarily on the discipline of risk management as applied to regulated medical devices.

The goals of the summit were 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.

Resources

Supporting Organizations

  • ASQ Biomedical Division
  • American Society of Anesthesiologists
  • Anesthesia Patient Safety Foundation
  • Healthcare Information and Management Systems Society
  • INCOSE
  • Life Science Alley
  • Medical Device Innovation, Safety and Security Consortium
  • Medical Device Manufacturers Association
  • Medical Imaging & Technology Alliance
  • The Joint Commission
  • UL LLC