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U.S. Department of Health and Human Services

Medical Devices

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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

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