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U.S. Department of Health and Human Services

Medical Devices

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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

  1. Richard Morin, PhD, FACR, American College of Radiology, Mayo Clinic
  2. Jack Ziffer, MD, PhD, Society of Cardiovascular Computed Tomography
  3. Carolyn Cidis Meltzer, MD, FACR, Emory University School of Medicine
  4. Julian Nicholas, MD, The Scripps Clinic
  5. Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
  6. Paul Johnson, MS, Cleveland Clinic
  7. Donald Frush, Duke Medical Center
  8. Cynthia McCollough, PhD, Mayo Clinic
  9. Aaron Sodickson, MD, PhD, Brigham and Women's Hospital
  10. Michael McNitt-Gray, PhD, David Geffen School of Medicine at University of California, Los Angeles
  11. Robert Zeman, MD, FACR, Dept. of Radiology, George Washington University Hospital
  12. Thomas Priselac, Cedars-Sinai Medical Center
  13. Robert Smith, MD, JD, FDA/CDRH (Speaking as a Private Citizen) 
  14. Michael Pentecost, MD, National Imaging Associates
  15. Mark Hiatt, MD, MBA, MS, CPHIMS, HealthHelp, LLC
  16. Eric Bailey, NeuroLogica Corporation
  17. Charles Shaughnessy, PhD, Analogic Corporation
  18. Michael Harsh, GE Healthcare 
  19. Rich Mather, Toshiba
  20. Mark Olszewski, Philips Healthcare CT Business Unit
  21. Christianne Leidecker, Siemens Healthcare
  22. Stephen Vastagh, MITA

Round-Table Discussion 1:  Equipment Features for Computed Tomography (CT) Devices

  1. David Clunie, PixelMed Publishing
  2. Donald Frush, Duke Medical Center
  3. Bettye Wilson, ARRT
  4. John Jaeckle, GE Healthcare
  5. Rich Mather, Toshiba
  6. Richard Morin, PhD, FACR ,American College of Radiology, Mayo Clinic
  7. Charles Shaughnessy, PhD, Analogic Corporation
  8. Rebecca Smith-Bindman, MD, University of California, San Francisco
  9. Steven Vastagh, MITA
  10. Jack Ziffer, MD, PhD, Society of Cardiovascular Computed Tomography
  11. KishChakrabarti, PhD, FDA/CDRH
  12. Stan Stern, PhD, FDA/CDRH

Open Public Session 2:  Equipment Features for Fluoroscopic Devices

  1. James Goldstein, MD, FSCAI ,Society for Cardiovascular Angiography and Interventions
  2. Keith Strauss, MSc, FAAPM, FACR ,Children's Hospital Boston-Radiological Department
  3. Julian Nicholas, MD ,The Scripps Clinic
  4. James Duncan, MD, PhD, Washington University School of Medicine
  5. Libby Brateman, PhD ,University of Florida College of Medicine
  6. Stephen Balter, PhD, Columbia University Medical College
  7. Paul Johnson, MS, Cleveland Clinic
  8. Phil Rauch, MS, Henry Ford Hospital-Diagnostic Radiography K-3
  9. Michael Pentecost, MD, National Imaging Associates 
  10. Mark Hiatt, MD, MBA, MS, CPHIMS, HealthHelp, LLC
  11. David Lewis, PhD ,International Specialty Products
  12. David Gauntt, PhD, X-Ray Imaging Innovations, LLC
  13. Andrew Fay, Medical Imaging, North America Thales Components Corporation
  14. Edward Solomon, NovaRay Medical, Inc.
  15. Tyson Rugenstein, Cook Medical
  16. Michael Harsh, GE Healthcare
  17. Sjirk Boon, Philips Healthcare
  18. Markus Lendl, Siemens
  19. Stephen Vastagh, MITA

Round-Table Discussion 2:  Equipment Features for Fluoroscopic Devices

  1. Gary Barnes, PhD, American Hospital Association 
  2. James Brink, MD, Yale University School of Medicine
  3. James Goldstein, MD, FSCAI, Society for Cardiovascular Angiography and Interventions
  4. Michael Harsh, GE Healthcare
  5. Paul Johnson, MS, Cleveland Clinic
  6. Donald Miller, MD, National Council on Radiation Protection and Measurements
  7. Markus Lendl, Siemens
  8. Keith Strauss, MSc, FAAPM, FACR, Children's Hospital Boston-Radiological Department
  9. Ed Thieman, Virtual Imaging, Inc.
  10. Sjirk Boon, Philips Healthcare
  11. Jake Kyprianou, PhD, FDA/CDRH
  12. Robert Smith, MD, JD, FDA/CDRH

Open Public Session 3:  User Training

  1. E. Stephen Amis, Jr., MD, FACR, Representing the American College of Radiology
  2. Jack Ziffer, MD, PhD, Society of Cardiovascular Computed Tomography
  3. Greg Morrison, MS, RT, American Society of Radiologic Technologists
  4. Christine Lung, CAE, American Society of Radiologic Technologists
  5. Julian Nicholas, MD, The Scripps Clinic
  6. Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
  7. Libby Brateman, PhD, University of Florida College of Medicine
  8. Stephen Balter, PhD, Columbia University Medical College
  9. Marilyn Goske, MD, Cincinnati Children's Hospital Medical Center
  10. Keith Strauss, MSc, FAAPM, FACR, Children's Hospital Boston-Radiological Department
  11. Phil Rauch, MS, Henry Ford Hospital-Diagnostic Radiography K-3
  12. Aaron Sodickson, MD, PhD, Brigham and Women's Hospital
  13. Michael Graham, University of Iowa
  14. Christian Eusemann, PhD, Siemens Medical Solutions USA, Inc.
  15. William Denman, GE Healthcare

Round-Table Discussion 3:  User Training

  1. E. Stephen Amis, Jr., MD, FACR, Representing the American College of Radiology
  2. Libby Brateman, PhD, University of Florida College of Medicine
  3. William Denman, GE Healthcare
  4. Brenda Garofolo, RT (R) (CT), Philips Healthcare CT Business Unit
  5. Marilyn Goske, MD, Cincinnati Children's Hospital Medical Center
  6. Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
  7. Greg Morrison, MS, RT, American Society of Radiologic Technologists
  8. Bettye Wilson, ARRT
  9. Robert Wise, MD, The Joint Commission
  10. Sharon Yoon, Toshiba
  11. Charles Finder, MD, FDA/CDRH
  12. Thalia Mills, PhD, FDA/CDRH

Open Public Session 4:  Quality Assurance

  1. Lisa Grabert, American Hospital Association
  2. Sandra Katanick, CAE, Intersocietal Accreditation Commission 
  3. Julian Nicholas, MD, The Scripps Clinic
  4. Mahadevappa Mahesh, MS, PhD, Johns Hopkins University School of Medicine
  5. James Duncan, MD, PhD, Washington University School of Medicine
  6. Marta Hernanz-Schulma, MD, FAAP, FACR, Monroe Carell Jr Children's Hospital at Vanderbilt
  7. Cynthia McCollough, PhD, Mayo Clinic
  8. Dr Michael Graham, University of Iowa
  9. Ben Trafficana, Veterans Administration
  10. Roger Shaw, CHP, RADeCO Health, Inc.
  11. William Denman, GE Healthcare
  12. Christianne Leidecker, Siemens Healthcare

Round-Table Discussion 4:  Quality Assurance

  1. Stephen Balter, PhD, Columbia University Medical College
  2. Paul Biggins, Toshiba
  3. James Duncan, MD, PhD, Washington University School of Medicine
  4. Eric Grier, PhD, ARRT
  5. John Jaeckle, GE Healthcare
  6. Sandra Katanick, CAE, Intersocietal Accreditation Commission 
  7. Christianne Leidecker, Siemens Healthcare
  8. Aaron Sodickson, MD, PhD, Brigham and Women's Hospital
  9. Ben Trafficana, Veterans Administration
  10. Robert Wise, MD, The Joint Commission
  11. KishChakrabarti, PhD, FDA/CDRH
  12. 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