FDA Public Workshop on External Defibrillators, December 15-16, 2010
The Food and Drug Administration (FDA) is holding a public workshop to share FDA’s understanding of the risks and benefits of external defibrillators, to clarify FDA’s current expectations for how industry should identify, report, and take action on problems observed with these devices, and to promote innovation for next-generation devices that will bring safer, more effective external defibrillators to market.
This meeting will be held December 15, 2010, from 8:00 a.m. to 5:30 p.m., and December 16, 2010, from 8:00 a.m. to 12:00 p.m.
The public workshop will be held in the Great Room at the Food and Drug Administration, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993.
The meeting will be webcasted.
Webcast
These live webcasts will be available on the day of the event.
Transcripts
Wednesday, December 15
| 8:00 a.m. | OPENING REMARKS. Megan Moynahan, Senior Network Leader, Cardiac Electrophysiology Devices Network, FDA |
| 8:15 | KEYNOTE SPEAKER: William Maisel, Deputy Center Director for Science, Center for Devices and Radiological Health, FDA. |
| 8:30 | SESSION #1: QUALITY SYSTEMS PRACTICES AND ADVERSE EVENT REPORTING
Presentation 1-1: Recalls and Inspections. Melissa Torres, Office of Compliance, FDA/CDRH |
| 8:45 | Presentation 1-2: Adverse Event Reporting. Roberta Sullivan, Acting Branch Chief, Product Evaluation Branch, Office of Surveillance and Biometrics, FDA/CDRH |
| 8:55 | Presentation 1-3: Industry Perspective on MDRs. Paul Smolenski, Director, Quality and Regulatory Affairs, Philips Healthcare. |
| 9:05 | Presentation 1-4: Industry Perspective on Quality System Practices Brian Webster, President & CEO, Physio-Control, Inc., a Division of Medtronic |
| 9:15 | Presentation 1-5: John Collins, American Society of Healthcare Engineers. |
| 9:25 | DISCUSSION SESSION #1: Moderator: Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, FDA |
| 10:35 | OPEN PUBLIC COMMENTS (Topic 1) |
| 10:45 | BREAK |
| 11:00 | SESSION #2: ENGINEERING DESIGN PRACTICES
Presentation 2-1: Engineering Design Practices for External Defibrillators. Alford Taylor, Jr., Director of the Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories, FDA. |
| 11:15 | Presentation 2-2: Overview of Standards for External Defibrillators: Role of FDA. Charles Ho, Scientific Reviewer, Cardiac Electrophysiology and Monitoring Devices, Office of Device Evaluation, FDA. |
| 11:25 | Presentation 2-3: Standards for External Defibrillators. Willis A. Tacker, User Co-Chair, AAMI Defibrillator Committee. |
| 11:35 | Presentation 2-4: Industry Perspective on Engineering Design. Carl Morgan, Sponsored by Philips Healthcare. |
| 11:45 | Presentation 2-5: Industry perspective on standards. Brian Webster, President & CEO, Physio-Control, Inc., a Division of Medtronic |
| Noon | LUNCH |
| 1:15 | DISCUSSION SESSION #2: Moderator: Mitchell Shein, Branch Chief, Pacing Defibrillators and Leads Branch, Office of Device Evaluation, FDA |
| 2:35 | OPEN PUBLIC COMMENTS (Topic 2) |
| 2:45 | BREAK |
| 3:00 | SESSION #3: CLINICAL PRACTICES AND USER NEEDS
Presentation 3-1: Perspectives from the Hospital and Pre-Hospital Settings: Results of FDA’s MedSun User Experience Surveys. Antoinette Hazlett, FDA. |
| 3:10 | Presentation 3-2: Perspectives from Hospital Risk Managers. Jim Keller, ECRI. |
| 3:20 | Presentation 3-3: Defibrillator Priorities. Tim Price, NASEMSO |
| 3:30 | Presentation 3-4: Perspectives from the Home Use Setting. Mark Adelman, Good to Be Alive. |
| 3:40 | Presentation 3-5: External Defibrillator Maintenance and Training. Javed Butler, MD, MPH, Deputy Chief Science Advisor, American Heart Association. |
| 3:50 | DISCUSSION SESSION #3: Moderator: Oscar Tovar, Scientific Reviewer, Pacing Defibrillators and Leads Branch, Office of Device Evaluation, FDA |
| 5:00 | CLOSING REMARKS. Megan Moynahan, FDA |
Thursday, December 16
| 8:00 | OPENING REMARKS. Megan Moynahan, Senior Network Leader, Cardiac Electrophysiology and Monitoring Devices Network, FDA |
| 8:15 | KEYNOTE SPEAKER: Jonathan Sackner-Bernstein, Associate Center Director, Technology and Innovation, Center for Devices and Radiological Health, FDA. |
| 8:30 | SESSION #4: INNOVATION AND FUTURE DIRECTION
Presentation 4-1: The AED Wish List. Comilla Sasson, University of Colorado, Department of Emergency Medicine. |
| 8:45 | Presentation 4-2: Clinical Experience from Field Community Responders. Jules Scadden, National Association of Emergency Medical Technicians. |
| 8:55 | Presentation 4-3: Comments on Next Generation 9-1-1. Rick Jones, National Emergency Number Association. |
| 9:05 | Presentation 4-4: State of Wireless Medical Devices. Joseph Smith, West Wireless Foundation. |
| 9:15 | Presentation 4-5: “The Changing Landscape of Sudden Cardiac Arrest – Challenges Faced by AED Manufacturers in Addressing the Evolution in SCA Patients”. Gregory Cash, President and CEO, Heartsine Technologies. |
| 9:25 | DISCUSSION SESSION #4: Moderator: Megan Moynahan, Senior Network Leader, Cardiac Electrophysiology and Monitoring Devices Network, FDA |
| 10:35 | OPEN PUBLIC COMMENTS (Topic #4) |
| 10:45 | BREAK |
| 11:00 | SESSION #5: NATIONAL AED REGISTRY
Presentation 5-1: Closing the Knowledge Gap on External Defibrillation. Veronica Sansing, Division of Epidemiology, Office of Surveillance and Biometrics, FDA |
| 11:15 | Presentation 5-2: The CARES Registry. Bryan McNally, Emory University |
| 11:45 | Presentation 5-3 Atrus’ National AED Registry. Elliot Fisch, Atrus. |
| 11:30 | Presentation 5-3: A National AED Registry. Comilla Sasson, University of Colorado, Department of Emergency Medicine. |
| Noon | LUNCH |
| 1:00 | DISCUSSION SESSION #5 Moderator: Megan Moynahan, Senior Network Leader, Cardiac Electrophysiology and Monitoring Devices Network, FDA |
| 2:15 | OPEN PUBLIC COMMENTS (Topic #5) |
| 2:30 | CLOSING REMARKS. Megan Moynahan, FDA |
Online registration is closed as of December 3rd. On-site registration will be available on the day of the meeting.
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you wish to make an oral presentation during any of the open comment sessions at the meeting, you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the agenda from this meeting. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation to megan.moynahan@fda.hhs.gov. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.
For information regarding logistics, registration and special accommodations, contact:
Susan Monahan
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, MD 20993
phone: 301-796-5661
email: Susan.Monahan@fda.hhs.gov
For information regarding the program, contact:
Megan Moynahan
Office of the Center Director
Center for Devices and Radiological Helath
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, MD 20993
phone: 301-796-5435
Email: megan.moynahan@fda.hhs.gov
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