Workshop on Medical Device Interoperability: Achieving Safety and Effectiveness
January 25-27, 2010 | Cambridge, Massachusetts
http://www.mdpnp.org/FDA_Workshop.html
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.
Among the issues discuss 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.
PROGRAM AGENDA
| MONDAY, JANUARY 25, 2010 | |
| 0800 - 0900 | Contintental Breakfast |
| Morning Session | |
| 0900 - 0920 | Opening, Logistics, Welcome Donna-Bea Tillman - FDA/CDRH |
| 0920 - 1000 | Device interoperability and the National Health IT Agenda Charles P. Friedman, PhD. - Office of the National Coordinator for Health IT |
| 1000 - 1030 | Safety and Effectiveness Challenges in Interoperability Jeff Shuren, MD, JD - FDA/CDRH |
| 1030 - 1050 | Setting the Stage: Device, Local, Regional, and National Perspectives on Medical Device Interoperability Doug Rosendale, D.O. F.A.C.O.S. - Veterans Health Administration |
| 1050 - 1120 | BREAK |
| 1120 - 1140 | Clinical Perspective on Interoperable Medical Device Systems Julian M. Goldman, MD Director, MD PnP Program and CIMT Program on Interoperability Medical Director, Partners HealthCare Biomedical Engineering Attending Anesthesiologist, Massachusetts General Hospital/Harvard Medical School |
| 1140 - 12:00 | Consumer and Patient Perspective on Innovation and Interoperability in Healthcare Dave deBronkart "e-Patient Dave", e-patients.net; Co-Chair, Society for Participatory Medicine |
| 1200-1300 | LUNCH |
| Afternoon Session | |
| 1300 - 1310 | Introduction to Presentations |
| 1310 - 1350 | Session 1: Lessons Learned from Existing Regulatory Practices |
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Moderator NHS Diabetes and Home Management FDA |
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| 1350 -1430 | Session 2: Enterprise Issues |
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Moderator Digital Operating Room |
|
| 1430 - 1450 | BREAK |
| 1450 - 1530 | Session 3: Systems-of-Systems Issues |
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Moderator Systems of Systems Issues Using Standard Communications Protocols to Implement Medical Device Plug-and-Play Wrangling the human element of interoperability: Defending |
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| 1530 - 1610 | Session 4: Mass Interoperability |
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Moderator Mobile Health “Tooling” Communities to Advance Community Resilience The Do’s and Don’ts of Creating an ULP Wireless Network |
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| 1610 - 1650 | Session 5: System Level Risk Analysis |
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Moderator Multi-parameter data integration to support clinical decision making FiO2 Control in Preterm Infants – A Case for Device Interoperability The Building Blocks of Clinical Systems Managing Risk in Systems of Systems |
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| 1650 - 1700 | Day 1 Closing Session |
| 1800 - 2000 | Reception at Sheraton Washington North Hotel Sponsored by the Continua Health Alliance |
| TUESDAY, JANUARY 26, 2010 | |
| 0800 - 0900 | Contintental Breakfast |
| Morning Session | |
| 0900 - 0920 | A Short History of Interoperability Michael Robkin - Anakena Solutions |
| 0920 - 0940 | Pieces of the Puzzle: Actors in Interoperability Sandy Weininger, PhD - FDA/CDRH/Office of Science and Engineering |
| 0940 - 1000 | Making it Happen: Manufacturer Perspectives on Medical Device Interoperability Scott Thiel, MBA, MT (ASCP), RAC Roche Diagnostics, Global Regulatory Affairs Diabetes Care |
| 1000 - 1020 | BREAK |
| 1020 - 1100 | Session 6: Software Issues |
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Moderator General Hospital Safety and Effectiveness Medical Device Data Patient Context Challenges |
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| 1100 - 1140 | Session 7: Integration and Interoperability Issues in a Regulated Environment |
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Moderator Interoperability through integration Universal interface between medical devices and IT / Communications systems Toward a plug-and-play system for medical devices: lessons from case studies |
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| 1140 - 1240 | Session 8: Standards, Interfaces and Interoperability Issues |
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Moderator Impact of ARRA/HITECH on Device Connectivity: Safe? Effective? Say what?! Connectivity? Integration? Plug and Play? What is the Interoperability end game? Semantic Interoperability for Medical Device Data Interchange Helping the Cause of Medical Device Interoperability ICE-PAC Approach to Understanding Clinical Requirements |
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| 1240 - 1330 | LUNCH |
| Afternoon Session | |
| 1330 - 1340 | Introduction to Breakout Working Sessions |
| 1340 - 1500 | Breakout Working Sessions #1 (concurrent) |
|
High Acuity Regulated Manufacturer Breakout Session |
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| 1500 - 1540 | BREAK |
| 1540 - 1700 | Breakout Working Sessions #2 (concurrent) |
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High Acuity Regulated Manufacturer Breakout Session |
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| WEDNESDAY, JANUARY 27, 2010 | |
| 0800 - 0900 | Contintental Breakfast |
| Morning Session | |
| 0900 - 0910 | Housekeeping |
| 0910 - 1015 | Breakout Sessions Report Back |
| 1015 - 1045 | FDA Report Back |
| 1045 -1115 | Wrap-Up Panel Session: When is my Smartphone a Medical Device? John Murray - FDA Brad Thompson - Epstein Becker Green |
| 1115 - 1130 | FDA CDRH UDI Update Terrie Reed - FDA / CDRH |
| 1130 - 1145 | Organizing Committee Wrap Up |
| 1145 | ADJOURNMENT |