AAMI and the FDA convened a summit to identify and address challenges associated with medical device interoperability, on October 2-3, 2012 in Herndon, VA. This intensive, two-day event delved into the complex issues surrounding interoperability and identify steps that will be taken to improve device interoperability and enhance patient safety.
Following the same format as other successful summits recently convened by AAMI and the FDA, this event brought together leaders from the IT and medical device industries, regulatory bodies, and associations; clinicians from healthcare institutions; subject experts; patient safety officers; researchers; and others to identify, discuss, and formulate strategic initiatives and priorities focused on getting patient safety right.
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- Agreement on a participant-developed, moderator-led priority list of safety-oriented issues that need to be addressed to “getting patient safety right” with integration
- Agreement on what’s needed to move from interoperability to integration, safely
- Research agenda to identify knowledge gaps
- List of useful, practical actions healthcare organizations can take now without waiting for research, design changes, and the like
- Participant determination of what groups in healthcare are primarily responsible for addressing each issue and commitment from attendees to participate in follow-up work
- Pathway to Patient Safety from Current State of Interoperability and Integration: Challenges and Opportunities from the Value Proposition
- Aligning Stakeholder Needs and Priorities
- System-Level Design Considerations for Safety-Critical Technologies
- Learning from Lead Innovators: Case Studies From the Field
- Learning from Other Industries
- What Don’t We Know: Research Gaps
- Are We Wired for Wireless: Wireless Considerations around Interoperability of Safety-Critical Devices
- Who’s Watching the Wild, Wild West: Regulatory Considerations
- The Interoperability Petri Dish: Test Methods for Systems
- What Does Success Look Like?