Summit on Color in Medical Imaging 2013 Standards and Recommendations for Color Medical Displays A Review of Current Activities at AAPM and IEC Aldo Badano Division of Imaging and Applied Mathematics Office of Science and Engineering Laboratories Center for Devices and Radiological Health Food and Drug Administration
DISCLOSURES Equipment loans: RMD, EIZO/NANAO, PLANAR, CHIMEI-O. Collaborative R&D agreements (CRADAs) with FIMI/BARCO and VARIAN. Mention of commercial products herein is not to be construed as either an actual or implied endorsement of such products by DHHS.
1995 2015 Technologies Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies Standards and recommendations FDA events
1995 2015 1996 5MP CRT 1999 5MP LCD Technologies Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations FDA events
1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles 2007 8MP+ Standards and recommendations FDA events
2007 8MP+ 2010 Retina 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations FDA events
2007 8MP+ 2010 Retina 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations 2011 Stereo FDA events
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations 2007 TG18 2011 Stereo FDA events
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 IEC 62563-1:2009 Copyright International Electrotechnical Commission Provided by IHS under license with IEC INTERNATIONAL STANDARD NORME INTERNATIONALE IEC 62563-1 Edition 1.0 2009-12 colour inside Medical electrical equipment Medical image display systems Part 1: Evaluation methods Appareils électromédicaux Systèmes d imagerie médicale Partie 1: Méthodes d évaluation No reproduction or networking permitted without license from IHS --`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`--- Licensee=Food & Drug Administration /8853100001, User=badano, aldo Not for Resale, 12/17/2009 13:34:03 MST 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations FDA events 2007 TG18 2011 Stereo 2009 IEC Intl Std
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 IEC 62563-1:2009 Copyright International Electrotechnical Commission Provided by IHS under license with IEC INTERNATIONAL STANDARD NORME INTERNATIONALE IEC 62563-1 Edition 1.0 2009-12 colour inside Medical electrical equipment Medical image display systems Part 1: Evaluation methods Appareils électromédicaux Systèmes d imagerie médicale Partie 1: Méthodes d évaluation No reproduction or networking permitted without license from IHS --`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`--- Licensee=Food & Drug Administration /8853100001, User=badano, aldo Not for Resale, 12/17/2009 13:34:03 MST 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations FDA events 2000 FFDM approved 2007 TG18 2011 Stereo 2009 IEC Intl Std
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 IEC 62563-1:2009 Copyright International Electrotechnical Commission Provided by IHS under license with IEC INTERNATIONAL STANDARD NORME INTERNATIONALE IEC 62563-1 Edition 1.0 2009-12 colour inside Medical electrical equipment Medical image display systems Part 1: Evaluation methods Appareils électromédicaux Systèmes d imagerie médicale Partie 1: Méthodes d évaluation No reproduction or networking permitted without license from IHS --`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`--- Licensee=Food & Drug Administration /8853100001, User=badano, aldo Not for Resale, 12/17/2009 13:34:03 MST 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations 2007 TG18 2011 Stereo 2009 IEC Intl Std FDA events 2000 FFDM approved 2001 Soft-copy FFDM cleared
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 IEC 62563-1:2009 Copyright International Electrotechnical Commission Provided by IHS under license with IEC INTERNATIONAL STANDARD NORME INTERNATIONALE IEC 62563-1 Edition 1.0 2009-12 colour inside Medical electrical equipment Medical image display systems Part 1: Evaluation methods Appareils électromédicaux Systèmes d imagerie médicale Partie 1: Méthodes d évaluation No reproduction or networking permitted without license from IHS --`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`--- Licensee=Food & Drug Administration /8853100001, User=badano, aldo Not for Resale, 12/17/2009 13:34:03 MST 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations 2007 TG18 2011 Stereo 2009 IEC Intl Std FDA events 2000 FFDM approved 2001 Soft-copy FFDM cleared 2003 Mammo LCD cleared
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 IEC 62563-1:2009 Copyright International Electrotechnical Commission Provided by IHS under license with IEC INTERNATIONAL STANDARD NORME INTERNATIONALE IEC 62563-1 Edition 1.0 2009-12 colour inside Medical electrical equipment Medical image display systems Part 1: Evaluation methods Appareils électromédicaux Systèmes d imagerie médicale Partie 1: Méthodes d évaluation No reproduction or networking permitted without license from IHS --`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`--- Licensee=Food & Drug Administration /8853100001, User=badano, aldo Not for Resale, 12/17/2009 13:34:03 MST 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations 2007 TG18 2011 Stereo 2009 IEC Intl Std FDA events 2000 FFDM approved 2001 Soft-copy FFDM cleared 2003 Mammo LCD cleared 2010 FFDM down-classified
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 IEC 62563-1:2009 Copyright International Electrotechnical Commission Provided by IHS under license with IEC INTERNATIONAL STANDARD NORME INTERNATIONALE IEC 62563-1 Edition 1.0 2009-12 colour inside Medical electrical equipment Medical image display systems Part 1: Evaluation methods Appareils électromédicaux Systèmes d imagerie médicale Partie 1: Méthodes d évaluation No reproduction or networking permitted without license from IHS --`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`--- Licensee=Food & Drug Administration /8853100001, User=badano, aldo Not for Resale, 12/17/2009 13:34:03 MST 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations 2007 TG18 2011 Stereo 2009 IEC Intl Std FDA events 2000 FFDM approved 2001 Soft-copy FFDM cleared 2003 Mammo LCD cleared 2010 FFDM down-classified 2011 First app cleared
2007 8MP+ 2010 Retina Assessment of display performance for medical imaging systems: Executive summary of AAPM TG18 report Chairman: Ehsan Samei a Duke Advanced Imaging Laboratories, Departments of Radiology, Physics, and Biomedical Engineering, Duke University, DUMC 3302, Durham, North Carolina 27710 TG18 Members: Aldo Badano FDA, CDRH Dev Chakraborty University of Pennsylvania (currently with University of Pittsburgh) Ken Compton Clinton Electronics (currently with National Display Systems) Craig Cornelius Eastman Kodak Company (currently a consultant) Kevin Corrigan Loyola University Michael J. Flynn Henry Ford Health system Bradley Hemminger University of North Carolina, Chapel Hill Nick Hangiandreou Mayo Clinic, Rochester Jeffrey Johnson Sarnoff Corp, NIDL (currently with Siemens Corporate Research) Donna M. Moxley-Stevens University of Texas, Houston, M.D. Anderson Cancer Center William Pavlicek Mayo Clinic, Scottsdale Hans Roehrig University of Arizona Lois Rutz Gammex/RMI Ehsan Samei Duke University Medical Center Jeffrey Shepard University of Texas, Houston, M.D. Anderson Cancer Center Robert A. Uzenoff Fujifilm Medical Systems USA Jihong Wang University of Texas, Southwestern Medical Center (currently with University of Texas, Houston) Charles E. Willis Baylor University, Houston, Texas Children s Hospital (currently with University of Texas, Houston) Received 27 August 2004; revised 4 December 2004; accepted for publication 23 December 2004; published 31 March 2005 1205 Med. Phys. 32 4, April 2005 0094-2405/2005/32 4 /1205/21/$22.50 2005 Am. Assoc. Phys. Med. 1205 IEC 62563-1:2009 Copyright International Electrotechnical Commission Provided by IHS under license with IEC INTERNATIONAL STANDARD NORME INTERNATIONALE IEC 62563-1 Edition 1.0 2009-12 colour inside Medical electrical equipment Medical image display systems Part 1: Evaluation methods Appareils électromédicaux Systèmes d imagerie médicale Partie 1: Méthodes d évaluation No reproduction or networking permitted without license from IHS --`,``,``,`,`,,``````,,,`,,,-`-`,,`,,`,`,,`--- Licensee=Food & Drug Administration /8853100001, User=badano, aldo Not for Resale, 12/17/2009 13:34:03 MST 1995 2015 1996 5MP CRT Technologies 1999 5MP LCD 2000 Dynamic LCD 2001 9MP LCD 2003 Tiled 2005 Projection 2006 Portables 2006 Flexibles Standards and recommendations 2007 TG18 2011 Stereo 2009 IEC Intl Std FDA events 2000 FFDM approved 2001 Soft-copy FFDM cleared 2003 Mammo LCD cleared 2010 FFDM down-classified 2011 First app cleared 2011 DBT mode approved
Outline 1 Reasons for standardization 2 The AAPM WGMD and TG196 3 The IEC 62B/MT51 4 Intercomparison overview 5 Summary
Reasons for standardization CDRH is invested in the development of medical device standards and participates significantly in the development process. Consensus and recognized standards facilitate regulatory review. CDRH participates in 550 national and international standard committees 250 staff experts 1061 recognized standards Facilitates a common ground for innovation Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 5/22
Reasons for standardization CDRH is invested in the development of medical device standards and participates significantly in the development process. Consensus and recognized standards facilitate regulatory review. CDRH participates in 550 national and international standard committees 250 staff experts 1061 recognized standards Facilitates a common ground for innovation Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 5/22
Reasons for standardization CDRH is invested in the development of medical device standards and participates significantly in the development process. Consensus and recognized standards facilitate regulatory review. CDRH participates in 550 national and international standard committees 250 staff experts 1061 recognized standards Facilitates a common ground for innovation Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 5/22
Reasons for standardization CDRH is invested in the development of medical device standards and participates significantly in the development process. Consensus and recognized standards facilitate regulatory review. CDRH participates in 550 national and international standard committees 250 staff experts 1061 recognized standards Facilitates a common ground for innovation Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 5/22
Reasons for standardization CDRH is invested in the development of medical device standards and participates significantly in the development process. Consensus and recognized standards facilitate regulatory review. CDRH participates in 550 national and international standard committees 250 staff experts 1061 recognized standards Facilitates a common ground for innovation Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 5/22
Reasons for standardization CDRH is invested in the development of medical device standards and participates significantly in the development process. Consensus and recognized standards facilitate regulatory review. CDRH participates in 550 national and international standard committees 250 staff experts 1061 recognized standards Facilitates a common ground for innovation Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 5/22
Why standardize image display? The diagnostic imaging chain is as effective as its weakest component! Poor display quality can: Reduce effectiveness of diagnostic or screening test Cause inconsistent clinical decisions Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 6/22
Why standardize image display? The diagnostic imaging chain is as effective as its weakest component! Poor display quality can: Reduce effectiveness of diagnostic or screening test Cause inconsistent clinical decisions Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 6/22
AAPM AAPM: The American Association of Physicists in Medicine, professional organization in the field of medical physics, ie, physics in biology and medicine. Mission: To advance the science, education and professional practice of medical physics. Goals:... To disseminate scientific and technical information in the discipline, and to promote standards for the practice of medical physics. Board of Directors/Science Council/Imaging Physics/Imaging Informatics SC/Work Group on Medical Display/TG196 - Requirements and methods for color displays in medicine. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 7/22
AAPM AAPM: The American Association of Physicists in Medicine, professional organization in the field of medical physics, ie, physics in biology and medicine. Mission: To advance the science, education and professional practice of medical physics. Goals:... To disseminate scientific and technical information in the discipline, and to promote standards for the practice of medical physics. Board of Directors/Science Council/Imaging Physics/Imaging Informatics SC/Work Group on Medical Display/TG196 - Requirements and methods for color displays in medicine. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 7/22
AAPM AAPM: The American Association of Physicists in Medicine, professional organization in the field of medical physics, ie, physics in biology and medicine. Mission: To advance the science, education and professional practice of medical physics. Goals:... To disseminate scientific and technical information in the discipline, and to promote standards for the practice of medical physics. Board of Directors/Science Council/Imaging Physics/Imaging Informatics SC/Work Group on Medical Display/TG196 - Requirements and methods for color displays in medicine. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 7/22
AAPM AAPM: The American Association of Physicists in Medicine, professional organization in the field of medical physics, ie, physics in biology and medicine. Mission: To advance the science, education and professional practice of medical physics. Goals:... To disseminate scientific and technical information in the discipline, and to promote standards for the practice of medical physics. Board of Directors/Science Council/Imaging Physics/Imaging Informatics SC/Work Group on Medical Display/TG196 - Requirements and methods for color displays in medicine. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 7/22
AAPM s WGMD Purpose: The Working Group on Medical Displays provides guidelines to clinicians, medical physicists, developers, and engineers as to the use of display devices for image viewing across a variety of disciplines and specialties. WGMD identifies display use and performance testing methodologies that would benefit from increase communication between industry and medical professionals, and from tutorial and guideline documents. Chair: A Badano. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 8/22
AAPM s WGMD Purpose: The Working Group on Medical Displays provides guidelines to clinicians, medical physicists, developers, and engineers as to the use of display devices for image viewing across a variety of disciplines and specialties. WGMD identifies display use and performance testing methodologies that would benefit from increase communication between industry and medical professionals, and from tutorial and guideline documents. Chair: A Badano. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 8/22
AAPM s WGMD Purpose: The Working Group on Medical Displays provides guidelines to clinicians, medical physicists, developers, and engineers as to the use of display devices for image viewing across a variety of disciplines and specialties. WGMD identifies display use and performance testing methodologies that would benefit from increase communication between industry and medical professionals, and from tutorial and guideline documents. Chair: A Badano. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 8/22
AAPM s TG196 Provide guidelines to clinicians, medical physicists, developers, and engineers for proper implementation, utilization, and performance testing of color displays for medical use. The specialties of interest include radiology, cardiology, pathology, dermatology, and other medical disciplines that use color images. Co-Chairs: A Badano, E Samei, and H Roehrig. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 9/22
AAPM s TG196 Provide guidelines to clinicians, medical physicists, developers, and engineers for proper implementation, utilization, and performance testing of color displays for medical use. The specialties of interest include radiology, cardiology, pathology, dermatology, and other medical disciplines that use color images. Co-Chairs: A Badano, E Samei, and H Roehrig. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 9/22
AAPM s TG196 Provide guidelines to clinicians, medical physicists, developers, and engineers for proper implementation, utilization, and performance testing of color displays for medical use. The specialties of interest include radiology, cardiology, pathology, dermatology, and other medical disciplines that use color images. Co-Chairs: A Badano, E Samei, and H Roehrig. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 9/22
Previous and current work at AAPM - I TG18: Assessment of display performance for medical imaging systems. Guidelines and acceptance criteria for acceptance testing and quality control of medical display devices. deckard.mc.duke.edu/ samei/tg18 1 Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 10/22
Previous and current work at AAPM - II Limitations of TG18 Widely used in radiology. Grayscale-centered. Only color aspect: multi-head consistency. Already somewhat obsolete in terms of display technology - needs revising. TG196: Color displays First task- gray tracking Intercomparison of color meters Report out by end of 2013 Other areas might include handhelds and 3D. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 11/22
Previous and current work at AAPM - III gray tracking color coordinates, expressed in CIE chromaticity (u, v ) pairs, of a set of display pixel values corresponding to equal driving levels for all subpixel elements, spanning the entire range of luminance of a calibrated display device. This is also referred to as white point or grayscale tracking performance. Distance plot for gray, red, green, and blue color patterns with respect to a common reference standard ( truth ). 1 E. Samei et al., Med Phys 32, 1205 1225 (2005). Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 12/22
IEC The International Electrotechnical Commission prepares and publishes international standards for electrical and electronic technologies. Over 10,000 experts from industry, government, test and research labs, academia and consumers. 95 Technical Committees and 77 Subcommittees SC62B Diagnostic imaging equipment (27 countries, 17 working groups) prepares publications for safety and performance of medical diagnostic imaging equipment. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 13/22
IEC The International Electrotechnical Commission prepares and publishes international standards for electrical and electronic technologies. Over 10,000 experts from industry, government, test and research labs, academia and consumers. 95 Technical Committees and 77 Subcommittees SC62B Diagnostic imaging equipment (27 countries, 17 working groups) prepares publications for safety and performance of medical diagnostic imaging equipment. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 13/22
IEC The International Electrotechnical Commission prepares and publishes international standards for electrical and electronic technologies. Over 10,000 experts from industry, government, test and research labs, academia and consumers. 95 Technical Committees and 77 Subcommittees SC62B Diagnostic imaging equipment (27 countries, 17 working groups) prepares publications for safety and performance of medical diagnostic imaging equipment. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 13/22
IEC The International Electrotechnical Commission prepares and publishes international standards for electrical and electronic technologies. Over 10,000 experts from industry, government, test and research labs, academia and consumers. 95 Technical Committees and 77 Subcommittees SC62B Diagnostic imaging equipment (27 countries, 17 working groups) prepares publications for safety and performance of medical diagnostic imaging equipment. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 13/22
IEC62B/MT51 MT51 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods. 7 countries: US, BR, BE, JP, SE, CN, DE (2009). Convenor: A Badano. Limitations of IEC62563-1: Grayscale only. Maintenance plan: First amendment: gray tracking, following the work of TG196 (2013) Second amendment: color space or white point coordinates, tbd (2014) Second edition: major revision (2015) Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 14/22
IEC62B/MT51 MT51 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods. 7 countries: US, BR, BE, JP, SE, CN, DE (2009). Convenor: A Badano. Limitations of IEC62563-1: Grayscale only. Maintenance plan: First amendment: gray tracking, following the work of TG196 (2013) Second amendment: color space or white point coordinates, tbd (2014) Second edition: major revision (2015) Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 14/22
IEC62B/MT51 MT51 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods. 7 countries: US, BR, BE, JP, SE, CN, DE (2009). Convenor: A Badano. Limitations of IEC62563-1: Grayscale only. Maintenance plan: First amendment: gray tracking, following the work of TG196 (2013) Second amendment: color space or white point coordinates, tbd (2014) Second edition: major revision (2015) Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 14/22
IEC62B/MT51 MT51 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods. 7 countries: US, BR, BE, JP, SE, CN, DE (2009). Convenor: A Badano. Limitations of IEC62563-1: Grayscale only. Maintenance plan: First amendment: gray tracking, following the work of TG196 (2013) Second amendment: color space or white point coordinates, tbd (2014) Second edition: major revision (2015) Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 14/22
IEC62B/MT51 MT51 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods. 7 countries: US, BR, BE, JP, SE, CN, DE (2009). Convenor: A Badano. Limitations of IEC62563-1: Grayscale only. Maintenance plan: First amendment: gray tracking, following the work of TG196 (2013) Second amendment: color space or white point coordinates, tbd (2014) Second edition: major revision (2015) Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 14/22
IEC62B/MT51 MT51 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods. 7 countries: US, BR, BE, JP, SE, CN, DE (2009). Convenor: A Badano. Limitations of IEC62563-1: Grayscale only. Maintenance plan: First amendment: gray tracking, following the work of TG196 (2013) Second amendment: color space or white point coordinates, tbd (2014) Second edition: major revision (2015) Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 14/22
IEC62B/MT51 MT51 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods. 7 countries: US, BR, BE, JP, SE, CN, DE (2009). Convenor: A Badano. Limitations of IEC62563-1: Grayscale only. Maintenance plan: First amendment: gray tracking, following the work of TG196 (2013) Second amendment: color space or white point coordinates, tbd (2014) Second edition: major revision (2015) Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 14/22
Intercomparison of color meters Process: Goal: What are the achievable levels of characterization for grayscale tracking for reference and non-reference instruments? Gather performance data for reference and non-reference sensors used in labs and field One display sent to all participants Every participant measures and reports to central lab Central lab collects, anonymizes, and processes all measurements Results discussed and published as technical note in Medical Physics Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 15/22
Intercomparison of color meters Process: Goal: What are the achievable levels of characterization for grayscale tracking for reference and non-reference instruments? Gather performance data for reference and non-reference sensors used in labs and field One display sent to all participants Every participant measures and reports to central lab Central lab collects, anonymizes, and processes all measurements Results discussed and published as technical note in Medical Physics Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 15/22
Intercomparison of color meters Process: Goal: What are the achievable levels of characterization for grayscale tracking for reference and non-reference instruments? Gather performance data for reference and non-reference sensors used in labs and field One display sent to all participants Every participant measures and reports to central lab Central lab collects, anonymizes, and processes all measurements Results discussed and published as technical note in Medical Physics Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 15/22
Intercomparison of color meters Process: Goal: What are the achievable levels of characterization for grayscale tracking for reference and non-reference instruments? Gather performance data for reference and non-reference sensors used in labs and field One display sent to all participants Every participant measures and reports to central lab Central lab collects, anonymizes, and processes all measurements Results discussed and published as technical note in Medical Physics Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 15/22
Intercomparison of color meters Process: Goal: What are the achievable levels of characterization for grayscale tracking for reference and non-reference instruments? Gather performance data for reference and non-reference sensors used in labs and field One display sent to all participants Every participant measures and reports to central lab Central lab collects, anonymizes, and processes all measurements Results discussed and published as technical note in Medical Physics Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 15/22
Participating Labs Laboratories JP1, JP2, JP3, BE, US1, US2, BR. Instruments i1, Spec, CAS140, CS100A, CS1000, CA310, CS2000, PR730, Topcon SR3... Data showed per lab/meter combination. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 16/22
Sample results I Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 17/22
Sample results II Distance plot for gray, red, green, and blue color patterns with respect to a common reference standard ( truth ). Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 18/22
Other efforts in standards and guidelines Display Metrology Committee of Video Electronics Standards Association (VESA) for third version of Flat Panel Display Measurements Standard 2. ICDM (International Committee for Display Metrology) is charged with setting standards for display metrology. Publishes the Information Display Measurements Standard, with 140 display measurements (http://icdm-sid.org/). Professional guidelines with general recommendations/requirements for the practice. 2 VESA, Flat Panel Display Measurements Standard, Version 2.0, technical report (VESA, 2003). Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 19/22
What one step, if any, would you suggest we take in order to improve the handling of color in medical imaging systems within your area of expertise? Coordination of efforts and recommendation/guidelines across disciplines with more involvement from vendors. Consistent approaches for multi-component analyses. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 20/22
What one step, if any, would you suggest we take in order to improve the handling of color in medical imaging systems within your area of expertise? Coordination of efforts and recommendation/guidelines across disciplines with more involvement from vendors. Consistent approaches for multi-component analyses. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 20/22
Final remarks More work is needed but requires more resources and increased participation of stakeholders (homework assignment). Not to hinder innovation in devices, it s the standard approach/methodology that allows for different and novel implementations. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 21/22
Final remarks More work is needed but requires more resources and increased participation of stakeholders (homework assignment). Not to hinder innovation in devices, it s the standard approach/methodology that allows for different and novel implementations. Badano Summit on Color in Medical Imaging, 4/2013 Imaging Physics Laboratory, DIAM/OSEL/CDRH/FDA 21/22
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