Medical Devices
Public Meeting - Device Improvements to Reduce the Number of Under-Doses, Over-Doses, and Misaligned Exposures From Therapeutic Radiation, June 9-10, 2010
The purpose of this meeting is to discuss steps that could be taken by manufacturers of linear accelerators, radiation therapy treatment planning systems, and radiation therapy simulators to help reduce misadministration and misaligned exposures. FDA is seeking input on this topic and requests comments on a number of related questions.
- Date, Time and Location
- Federal Register Notice
- Agenda
- Registration
- Contact Us
- Meeting Transcript: June 9, 2010
- Meeting Transcript: June 10, 2010
- Meeting Presentations
Date, Time and Location
The meeting will be held June 9-10, 2010, beginning at 8:00 a.m., at the following location:
Hilton Hotel Washington, DC
North/Gaithersburg, 620 Perry Pkwy
Gaithersburg, MD 20877
The meeting will not be videotaped or webcast.
Agenda
Day 1 | |
| 8:00-8:10 | Welcome and Opening Remarks |
| 8:10-8:30 | Structure of the Day and Logistics |
| 8:30-8:40 | Morning Session – Introduction |
| 8:40-9:45 | Open Public Session 1: Device Improvements and Reporting Speakers Robert Morton, Quality and Regulatory Services Michael Herman, AAPM Zoubir Ouhib, Lynne Cancer Institute Ken Buroker, Tomotherapy Bruce Thomadsen, American Society for Radiation Oncology Todd Pawlicki, American Society for Radiation Oncology Albert Blumberg, ACR Marilyn Sue Bogner, Institute for Study of Human Error Geoffrey Dalbow, Civco |
| 9:45 -10:00 | Break |
| 10:00-11:00 | Open Public Session 1: Device Improvements and Reporting (continued) Kenneth Russell,Calypso Prabhakar Tripuraneni, ASTRO Ulrich Beifusss, Brainlab AG LawrenceMarks, ASTRO Suzanne Schwaller, Sicel Technologies Stephen Vastagh, MITA Corey Zankowski, Varian Medical Systems David Neustadter, Navotek Industry Nasir Zaidi, PhRad Diagnositics |
| 11:00-11:15 | Break |
| 11:10-12:10 | Round-Table Discussion 1: Device Improvements and Reporting Selected participants Michael Herman, AAPM Bruce Thomadsen, American Society for Radiation Oncology Marilyn Sue Bogner, Institute for Study of Human Error Stan Mansfield, Varian Medical Systems Thomas Faris, Elekta Fanqing Guo, Yale-New Haven Hospital David Fisher, MITA Chris Amies, Siemens Eric Ford, Johns Hopkins University Robert Hill, Accuray PJ Hardy, FDA Jason Cheng, FDA |
| 12:10-1:40 | Lunch |
| 1:40-2:30 | Open Public Session 2: User Training Speakers James Galvin, AAPM Michael Meyer, Vertual James Hevezi, ACR Robert Morton, Quality and Regulatory Services LawrenceMarks, ASTRO Prabhakar Tripuraneni, ASTRO |
| 2:30-2:45 | Break |
| 2:45-3:25 | Open Public Session 2: User Training- (Continued) Speakers Christine Lung, ASRT Don Goer, IntraopMedical Kolleen Kennedy, Varian Medical Systems Stephen Vastagh, MITA |
| 3:25-3:40 | Break |
| 3:40-4:40 | Round-Table Discussion 2: User Training Selected participants James Galvin, AAPM James Hevezi, ACR LawrenceMarks, ASTRO Jon Hollon , Varian Medical Systems Derek Olender, Accuray Inc Zoubir Ouhib, Lynn Cancer Institute Fanqing Guo, Yale New Haven Hospital David Fisher, MITA Jennifer Elee, CRCPD Satya Bose, Howard University Nancy Wersto, FDA Paul Jones, FDA |
| 4:40 pm | Closing Remarks and Adjournment |
Day 2 | |
| 8:00-8:10 | Overview: Structure of the Day and Logistics |
| 8:10-8:20 | Morning Session – Introduction |
| 8:20-9:40 | Open Public Session 3: Quality Assurance Speakers Per Halvorsen, AAPM Benedick Fraass, ASTRO Jeff Michalski, ASTRO Indra Das, ACR Eric Ford, Johns Hopkins University Robert Morton, Quality and Regulatory Services Katrina Hansen, S&S Par Scientific Zoubir Ouhib, Lynn Cancer Institute NabilAdnani, D3 Radiation services |
| 9:40-9:55 | Break |
| 9:55-11:00 | Open Public Session 3: Quality Assurance- (CONTINUED) Speakers Dominic Siewko, Philips Healthcare Eleanor Harris, ASTRO Sasa Mutic, ASTRO Roman Wicha, Varian Medical Systems Jan Pursley, Sicel Technologies Satya Bose, Howare University Stephen Vastagh, MITA |
| 11:00-11:15 | Break |
| 11:15-12:15 | Round-Table Discussion 3: Quality Assurance Selected participants Per Halvorsen, AAPM Jeff Michalski, ASTRO Indra Das, ACR Eric Ford, Johns Hopkins University NabilAdnani, D3 Radiation services Yves Archambault, Varian Medical Systems Dhada Rajinder Singh, Elekta David Fisher, MITA Chris Amies, Siements Jennifer Elee, CRCPD Dan Kassiday, FDA Jason Cheng, FDA |
| 12:15 | Closing Remarks and Adjournment |
Registration
Registration is now closed, as of May 15, 2010.
If you wish to make an oral presentation and/or be a roundtable discussant during any of the sessions at the meeting, you must have indicated this at the time of registration. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.
FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the public meeting will be provided on a space-available basis beginning at 7:00 am.
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.
Contact Us
For further information about this meeting, contact:
Simon Choi, PhD, MPH
Network Leader, Radiological Products
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 66, rm. 5400
Silver Spring, MD 20993
301-796-5426
e-mail: simon.choi@fda.hhs.gov
