The FDA (CDRH) Workshop on
Medical Device Interoperability: achieving safety and effectiveness
THE CONTINUA HEALTH ALLIANCE
THE CENTER FOR INTEGRATION OF MEDICINE & INNOVATIVE TECHNOLOGY (CIMIT)
Medical Device "Plug-and-Play" Interoperability Program (MD PnP)
January 25-27, 2010
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, Acting 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?
- Any other issues relevant to assuring the safety and effectiveness of interoperable 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.