FDA Workshop
Date: January 25–27, 2010
Historical Perspective: This FDA workshop was a seminal event in the medical device interoperability timeline. It was the result of a collaboration between: The FDA, the Continua Healthcare Alliance, the Center for Integration of Medicine & Innovative Technology (CIMIT), and the MD PnP Program
The FDA (CDRH) Workshop on Medical Device Interoperability: Achieving Safety and Effectiveness
The Food and Drug Administration (FDA) Center for Devices and Radiological Health, in co-sponsorship with Continua Health Alliance and the Center for Integration of Medicine & Innovative Technology (CIMIT) held a public workshop entitled ‘‘Medical Device Interoperability: achieving safety and effectiveness.’’ The purpose of the workshop was to facilitate discussion among FDA, industry, academia, professional societies, clinical investigators and other interested parties on issues related to safe and effective interoperable medical devices.
The 200 participants included broad representation from stakeholders both in-person and by web.
Opening Plenary Speakers Included:
Charles P. Friedman, PhD, Chief Scientific Officer, Office of the National Coordinator for Health Information Technology
Jeffrey Shuren, MD, JD, Director, FDA/CDRH
Donna-Bea Tillman, PhD, Director, Office of Device Evaluation, FDA/CDRH
Doug Rosendale, D.O.F.A.C.O.S, Veterans Health Administration, Office of Health Information, Joint Interoperability Ventures
Among the issues discussed at the workshop were:
What are the types of clinical scenarios that would make use of medical device interoperability?
What are the issues associated with premarket and postmarket studies for interoperable medical devices?
What tools (e.g. standards, guidances) are in place or need to be developed to assure safety and effectiveness of interoperable medical device systems; what issues should they address?
What organizations are in place to assure safety and effectiveness of interoperable medical device systems and what are their roles?
What are the risks associated with medical device interoperability and “systems of systems” composed of medical devices?
Participation had been invited for submission of interoperability scenarios and for discussion panels (see call for presentations). The list of submitted use case presentations is available for download.
Related Links
Workshop Itinerary + Slides
Note: Workshop videos are linked to presentations in the final workshop agenda
Day 1 – January 25, 2010
Donna-Bea Tillman, PhD – Director, ODE, FDA/CDRH
Welcome
Charles Friedman, PhD – ONC for HIT
Device Interoperability and the National HIT Agenda
Jeff Shuren, MD, JD – Director FDA/CDRH
Safety and Effectiveness Challenges in Interoperability
Doug Rosendale, DO, FACOS – VHA
Setting the Stage: Device, Local, Regional, and National Perspectives on Medical Device Interoperability
Julian M. Goldman, MD – Mass General Brigham/CIMIT/MGH
Clinical Perspective on Interoperable Medical Device Systems
Dave deBronkart
Consumer and Patient Perspective on Innovation and Interoperability in Healthcare
Session 1: Lessons Learned from Existing Regulatory Practices
Brad Thompson – Moderator
Maureen Baker – NHS
Yi Zhang – FDA (CDRH/OSEL/DESE)
Mary Brady – FDA (CDRH/OSB)
Session 2: Enterprise Issues
Michael Robkin – Moderator – Anakena Solutions
Douglas Grey, Tom Judd, Tom MacGrane – Digital Operating Room – KaiserTim Gee- Converged Medical Device and Enterprise Network – Medical Connectivity Consulting
Session 3: Systems-of-Systems Issues
Julian M. Goldman, MD – moderator
Frank E. Block, Jr., MD – Systems of Systems Issues – – VCU
Dick Moberg – Using Standard Communications Protocols to Implement Medical Device Plug-and-Play — Moberg Research Inc.George Samaras, PhD – Wrangling the human element of interoperability – Samaras & Associates, Inc.
