Medical Devices
Public Meeting: Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging, March 30-31, 2010
Federal Register Notice
FDA has published a notice in the Federal Register announcing a public meeting on March 30-31, 2010, and requesting comments on a number of questions regarding steps that could be taken by manufacturers of devices used in computed tomography (CT) and in fluoroscopy that would help reduce unnecessary patient exposure to ionizing radiation during CT and fluoroscopic procedures.
Please see Docket No. FDA-2010-N-0080. Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging; Public Meeting, Request for Comments.
Comments are due by April 15, 2010.
Date, Time, and Location
The meeting will be held on March 30-31, 2010, from 8:00 a.m. to 5:30 p.m. at the following location:
Holiday Inn Gaithersburg
2 Montgomery Village Avenue
Gaithersburg , MD 20879
(301) 948-8900
http://www.higaithersburg.com/
Additional Information
Additional information and materials for the meeting, including a meeting agenda with a speakers’ schedule for each open comment session, will be posted on this site prior to the meeting.
I. Agenda
Day 1: Equipment Features for Computed Tomography (CT) and Fluoroscopic Devices
8:00-8:05 |
Welcome and Opening Remarks Jeff Shuren, MD, JD, Director, CDRH |
8:05-8:30 |
Structure of the Day, Logistics, and Medical Imaging Initiative Overview CDR Sean Boyd, Chief, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, CDRH |
8:30-8:40 |
Morning Session – Introduction CDR Sean Boyd, Chief, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, CDRH |
8:40-11:15
|
Open Public Session 1: Equipment Features for Computed Tomography (CT) Devices Confirmed Speakers |
11:15-11:30 |
Break |
11:30-12:30 |
Round-Table Discussion 1: Equipment Features for Computed Tomography (CT) Devices Selected Participants |
12:30-1:45 |
Lunch (on own) |
1:45-1:50 |
Afternoon Session – Introduction CDR Sean Boyd, Chief, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, CDRH |
1:50-4:15 |
Open Public Session 2: Equipment Features for Fluoroscopic Devices Confirmed Speakers |
4:15-4:30 |
Break |
4:30-5:30 |
Round-Table Discussion 2: Equipment Features for Fluoroscopic Devices Selected Participants |
5:30 |
Closing Remarks and Adjournment |
Day 2: User Training and Quality Assurance
8:00-8:10 |
Structure of the Day and Logistics CDR Sean Boyd, Chief, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, CDRH |
8:10-8:15 |
Morning Session – Introduction CDR Sean Boyd, Chief, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, CDRH |
8:15-10:30
|
Open Public Session 3: User Training Confirmed Speakers |
10:30-10:45 |
Break |
10:45-11:45 |
Round-Table Discussion 3: User Training Selected Participants |
11:45-1:00 |
Lunch (on own) |
1:00-1:05 |
Afternoon Session – Introduction CDR Sean Boyd, Chief, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, CDRH |
1:05-2:35 |
Open Public Session 4: Quality Assurance Confirmed Speakers |
2:35-2:50 |
Break |
2:50-3:50 |
Round-Table Discussion 4: Quality Assurance Selected Participants |
4:00 |
Closing Remarks and Adjournment |
II. Speakers and Round-Table Participants
Open Public Session 1: Equipment Features for Computed Tomography (CT) Devices
- Richard Morin, PhD, FACR, American College of Radiology, Mayo Clinic
- Jack Ziffer, MD, PhD, Society of Cardiovascular Computed Tomography
- Carolyn Cidis Meltzer, MD, FACR, Emory University School of Medicine
- Julian Nicholas, MD, The Scripps Clinic
- Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
- Paul Johnson, MS, Cleveland Clinic
- Donald Frush, Duke Medical Center
- Cynthia McCollough, PhD, Mayo Clinic
- Aaron Sodickson, MD, PhD, Brigham and Women's Hospital
- Michael McNitt-Gray, PhD, David Geffen School of Medicine at University of California, Los Angeles
- Robert Zeman, MD, FACR, Dept. of Radiology, George Washington University Hospital
- Thomas Priselac, Cedars-Sinai Medical Center
- Robert Smith, MD, JD, FDA/CDRH (Speaking as a Private Citizen)
- Michael Pentecost, MD, National Imaging Associates
- Mark Hiatt, MD, MBA, MS, CPHIMS, HealthHelp, LLC
- Eric Bailey, NeuroLogica Corporation
- Charles Shaughnessy, PhD, Analogic Corporation
- Michael Harsh, GE Healthcare
- Rich Mather, Toshiba
- Mark Olszewski, Philips Healthcare CT Business Unit
- Christianne Leidecker, Siemens Healthcare
- Stephen Vastagh, MITA
Round-Table Discussion 1: Equipment Features for Computed Tomography (CT) Devices
- David Clunie, PixelMed Publishing
- Donald Frush, Duke Medical Center
- Bettye Wilson, ARRT
- John Jaeckle, GE Healthcare
- Rich Mather, Toshiba
- Richard Morin, PhD, FACR ,American College of Radiology, Mayo Clinic
- Charles Shaughnessy, PhD, Analogic Corporation
- Rebecca Smith-Bindman, MD, University of California, San Francisco
- Steven Vastagh, MITA
- Jack Ziffer, MD, PhD, Society of Cardiovascular Computed Tomography
- KishChakrabarti, PhD, FDA/CDRH
- Stan Stern, PhD, FDA/CDRH
Open Public Session 2: Equipment Features for Fluoroscopic Devices
- James Goldstein, MD, FSCAI ,Society for Cardiovascular Angiography and Interventions
- Keith Strauss, MSc, FAAPM, FACR ,Children's Hospital Boston-Radiological Department
- Julian Nicholas, MD ,The Scripps Clinic
- James Duncan, MD, PhD, Washington University School of Medicine
- Libby Brateman, PhD ,University of Florida College of Medicine
- Stephen Balter, PhD, Columbia University Medical College
- Paul Johnson, MS, Cleveland Clinic
- Phil Rauch, MS, Henry Ford Hospital-Diagnostic Radiography K-3
- Michael Pentecost, MD, National Imaging Associates
- Mark Hiatt, MD, MBA, MS, CPHIMS, HealthHelp, LLC
- David Lewis, PhD ,International Specialty Products
- David Gauntt, PhD, X-Ray Imaging Innovations, LLC
- Andrew Fay, Medical Imaging, North America Thales Components Corporation
- Edward Solomon, NovaRay Medical, Inc.
- Tyson Rugenstein, Cook Medical
- Michael Harsh, GE Healthcare
- Sjirk Boon, Philips Healthcare
- Markus Lendl, Siemens
- Stephen Vastagh, MITA
Round-Table Discussion 2: Equipment Features for Fluoroscopic Devices
- Gary Barnes, PhD, American Hospital Association
- James Brink, MD, Yale University School of Medicine
- James Goldstein, MD, FSCAI, Society for Cardiovascular Angiography and Interventions
- Michael Harsh, GE Healthcare
- Paul Johnson, MS, Cleveland Clinic
- Donald Miller, MD, National Council on Radiation Protection and Measurements
- Markus Lendl, Siemens
- Keith Strauss, MSc, FAAPM, FACR, Children's Hospital Boston-Radiological Department
- Ed Thieman, Virtual Imaging, Inc.
- Sjirk Boon, Philips Healthcare
- Jake Kyprianou, PhD, FDA/CDRH
- Robert Smith, MD, JD, FDA/CDRH
Open Public Session 3: User Training
- E. Stephen Amis, Jr., MD, FACR, Representing the American College of Radiology
- Jack Ziffer, MD, PhD, Society of Cardiovascular Computed Tomography
- Greg Morrison, MS, RT, American Society of Radiologic Technologists
- Christine Lung, CAE, American Society of Radiologic Technologists
- Julian Nicholas, MD, The Scripps Clinic
- Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
- Libby Brateman, PhD, University of Florida College of Medicine
- Stephen Balter, PhD, Columbia University Medical College
- Marilyn Goske, MD, Cincinnati Children's Hospital Medical Center
- Keith Strauss, MSc, FAAPM, FACR, Children's Hospital Boston-Radiological Department
- Phil Rauch, MS, Henry Ford Hospital-Diagnostic Radiography K-3
- Aaron Sodickson, MD, PhD, Brigham and Women's Hospital
- Michael Graham, University of Iowa
- Christian Eusemann, PhD, Siemens Medical Solutions USA, Inc.
- William Denman, GE Healthcare
Round-Table Discussion 3: User Training
- E. Stephen Amis, Jr., MD, FACR, Representing the American College of Radiology
- Libby Brateman, PhD, University of Florida College of Medicine
- William Denman, GE Healthcare
- Brenda Garofolo, RT (R) (CT), Philips Healthcare CT Business Unit
- Marilyn Goske, MD, Cincinnati Children's Hospital Medical Center
- Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
- Greg Morrison, MS, RT, American Society of Radiologic Technologists
- Bettye Wilson, ARRT
- Robert Wise, MD, The Joint Commission
- Sharon Yoon, Toshiba
- Charles Finder, MD, FDA/CDRH
- Thalia Mills, PhD, FDA/CDRH
Open Public Session 4: Quality Assurance
- Lisa Grabert, American Hospital Association
- Sandra Katanick, CAE, Intersocietal Accreditation Commission
- Julian Nicholas, MD, The Scripps Clinic
- Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
- James Duncan, MD, PhD, Washington University School of Medicine
- Marta Hernanz-Schulma, MD, FAAP, FACR, Monroe Carell Jr Children's Hospital at Vanderbilt
- Cynthia McCollough, PhD, Mayo Clinic
- Dr Michael Graham, University of Iowa
- Ben Trafficana, Veterans Administration
- Roger Shaw, CHP, RADeCO Health, Inc.
- William Denman, GE Healthcare
- Christianne Leidecker, Siemens Healthcare
Round-Table Discussion 4: Quality Assurance
- Stephen Balter, PhD, Columbia University Medical College
- Paul Biggins, Toshiba
- James Duncan, MD, PhD, Washington University School of Medicine
- Eric Grier, PhD, ARRT
- John Jaeckle, GE Healthcare
- Sandra Katanick, CAE, Intersocietal Accreditation Commission
- Christianne Leidecker, Siemens Healthcare
- Aaron Sodickson, MD, PhD, Brigham and Women's Hospital
- Ben Trafficana, Veterans Administration
- Robert Wise, MD, The Joint Commission
- KishChakrabarti, PhD, FDA/CDRH
- Charles Finder, MD, FDA/CDRH
III. Transcript
Contacts
For further information about this meeting, contact:
Simon Choi, PhD, MPH
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 66, rm. 5400
Silver Spring , MD 20993
Phone: 301-796-5426
E-mail: CDRHImagingInitiative@fda.hhs.gov