- Email: [email protected]
WFUMB symposium on safety of ultrasound in medicine: Conclusions and recommendations on biological effects and safety of ultrasound contrast agents, 2006
Ultrasound in Med. & Biol., Vol. 33, No. 2, pp. 233–234, 2007 Copyright © 2007 World Federation for Ultrasound in Medicine & Biology Printed in the USA. All rights reserved 0301-5629/07/$–see front matter
doi:10.1016/j.ultrasmedbio.2006.07.004
● Safety of Ultrasound Contrast Agents WFUMB SYMPOSIUM ON SAFETY OF ULTRASOUND IN MEDICINE: CONCLUSIONS AND RECOMMENDATIONS ON BIOLOGICAL EFFECTS AND SAFETY OF ULTRASOUND CONTRAST AGENTS, 2006 STANLEY B. BARNETT,* FRANCIS DUCK† and MARVIN ZISKIN‡ *School of Biomedical Sciences, University of Sydney, Australia; †Department of Physics, University of Bath, Bath, UK; ‡Center for Biomedical Physics, Temple University School of Medicine, Philadelphia, PA, USA
PREVIOUSLY PUBLISHED WFUMB RECOMMENDATIONS
also applies to endoscopic, transvaginal and transcutaneous applications. When tissue/gas interfaces or contrast agents are present, ultrasound exposure levels and durations should be reduced to the minimum necessary to obtain the required diagnostic information.
WFUMB Symposium on Safety of Ultrasound in Medicine: Published Recommendations on the Safe Use of Ultrasound (1998) The following is a selection of existing published recommendations that were approved by the WFUMB Executive Council in March 1997 and published in 1998, which are relevant to the safe use of ultrasound contrast agents in diagnostic ultrasonography. For more detail, refer to World Federation for Ultrasound in Medicine and Biology Symposium on Safety of Medical Ultrasound; Conclusions and Recommendations regarding thermal and nonthermal mechanisms for biologic effects of ultrasound. (Ultrasound Medicine Biol 1998;24(S1):1–55).
●
When tissue/gas interfaces or contrast agents are not present, and where there is no risk of significant temperature elevation, the use of diagnostic Doppler equipment need not be withheld because of concern for ultrasound safety. When any of the above conditions might be present, ultrasound exposure levels and durations should be reduced to the minimum necessary to obtain the required diagnostic information. ACKNOWLEDGMENTS: WORKSHOP PARTICIPANTS AND CONTRIBUTORS
Recommendations: Non-Thermal Effects ●
It has been shown experimentally that acoustic cavitation can alter mammalian tissues. It is therefore important to consider its significance in medical applications of ultrasound.
Organising committee/WFUMB safety committee Stan Barnett, PhD University of Sydney Faculty Biomedical Sciences, Australia Michel Claudon, MD Service de Radiologie Hôpital d’Enfants, Vandoeuvre Cedex, France Francis Duck, DSc Wessex Regional Medical Physics Service, Royal United Hospital, Bath, UK Karel Marsal, MD Department of Obstetrics and Gynecology University Hospital Lund, Sweden Marvin Ziskin, MD, Temple University, Center for Biomedical Physics, Philadelphia, USA
● Contrast Agents Gas bodies introduced by a contrast agent increase the probability of cavitation. A physician should take this into account when considering th e benefit/risk ratio of an examination. ●
Doppler
B-Mode Imaging
When tissue/gas interfaces or contrast agents are not present, the use of B-Mode imaging need not be withheld because of concern for ultrasound safety. This statement
Primary authors Martin Blomley, MD, Imperial College and Hammersmith Hospital, London, UK Diane Dalecki, PhD, Rochester Center for Biomedical Ultrasound, University of Rochester, USA Nico de Jong, PhD, Erasmus University Medical Center, Rotterdam, NL
Address correspondence to: Stanley B. Barnett, PhD, School of Biomedical Sciences, University of Sydney, Australia. E-mail: sbarnett@ usyd.edu.au 233
234
Ultrasound in Medicine and Biology
Douglas Miller, PhD, Research Professor, Department of Radiology University of Michigan Kresge III, R3315 200 Zina Pitcher Place Ann Arbor, USA Wesley Nyborg, PhD, Dept. Physics, University of Vermont, Burlington, USA Tony Whittingham, PhD, Regional Medical Physics Department, Newcastle General Hospital, UK Participants and contributors Jacques S. Abramowicz, MD Professor, Obstetrics & Gynecology, Rush University Medical Center, 1653 West Congress Parkway, Chicago, IL Ughetta Del Balzoa, E-mail: [email protected] Ayache Bouakaz, Erasmus University Medical Center, Rotterdam, NL Anne Broillet Head, Echo Ultrasound Imaging Animal Lab, Bracco Research, Plan Les Ouates-Genève, Switzerland Harald Becher MD, Consultant, Cardiology Dept, John Radcliffe Hospital, Oxford, UK Stephen Bly, PhD, Consumer and Radiation Protection Bureau, Ottawa, Canada Peter Burns, PhD, E-mail: [email protected]. utoronto.ca Anne Hall, GE, USA E-mail: Anne.Hall@med. ge.com Robert Mattrey, E-mail: [email protected], USA Mark Monaghan, PhD, Director of Echocardiography, Cardiology Dept, Kings, College Hospital, London, UK Petros Nihoyannopoulis, MD, Echocardiography Dept, Cardiology, Imperial College, and Hammersmith Hospital, UK Charles Church, PhD, Centre for Physical Acoustics University of Mississippi, USA David Cosgrove, MD, Imaging Sciences Dept, Imperial College and Hammersmith Hospital, UK Marc Engelhadt, E-mail: marc.engelhardt@diag. bracco.com Loreto Feril, E-mail: [email protected] Brian Fowlkes, PhD, Assoc. Professor of Radiology, University of Michigan Health System, Kresge III, R3315, 200 Zina Pitcher Place, Ann Arbor, MI, USA. Christy Holland, PhD, University of Cincinnati Dept. of Radiology, USA Takashi Kondo, PhD, E-mail: [email protected] George Kossoff, DSc, University of NSW, Australia Fred Kremkau, PhD, Wake Forest University, USA Nobuki Kudo, PhD, Hokkaido University School
Volume 33, Number 2, 2007
ofEngineering,Japan,E-mail:[email protected]. ac.jp Hector Lopez, PhD, Food and Drug Administration, Rockville, USA Thomas H Marwick, Princess Alexandra Hospital, University of Queensland, Australia Wilson Mathias, MD, E-mail: wmathias@incor. usp.br Morton Miller, PhD, University of Rochester, USA G Wayne Moore, PhD, SONORA, E-mail: gwm@ 4sonora.com Michiya Natori, MD, National Ohokura Hospital, Japan Jeff Powers, PhD, PHILIPS E-mail: jeff.powers@ philips.com Helmut Reichenberger, PhD, Siemens AG, Erlangen, Germany David Sahn, MD, Pediatric Cardio Clinical Care Center, Oregon Health Science University, Portland, USA. Paul Smolenski, PhD, Philips Medical Systems, Andover, MA, USA Mel Stratmeyer, PhD, Food and Drug Administration, Rockville, USA Glenn Tickner, E-mail: [email protected] Volkmar Uhlendorf, PhD, Paul Scherrer Institute, Center for Radiopharmacy, CH-5232 Villigen (PSI), Switzerland Kittipong Vairojanavong, MD, E-mail: kittipon@ health.moph.go.th Jiefen Yao, “Jiefen Yao” E-mail: Jiefen.Yao@diag. bracco.com Michael Zomack, Schering AG, Clinical Development Diagnostics, Germany THE WFUMB ORGANISING COMMETTEE GRATEFULLY ACKNOWLEDGES THE COMMENTS AND CONTRIBUTIONS TO THE REVIEW PROCESS PROVIDED BY: American College of Cardiology Foundation (ACCF) Echocardiography Committee, Bethesda, USA American Institute of Ultrasound in Medicine (AIUM) Bioeffects Committee, USA American Society of Echocardiography (ASE), USA Australasian Society of Ultrasound in Medicine (ASUM) Safety Committee, Australia Food and Drug Administration (FDA) Centre for Devices and Radiologic Health, USA British Society of Echocardiography Policy Committee, UK European Federation of Ultrasound Societies in Medicine (EFSUMB)
doi:10.1016/j.ultrasmedbio.2006.07.004
● Safety of Ultrasound Contrast Agents WFUMB SYMPOSIUM ON SAFETY OF ULTRASOUND IN MEDICINE: CONCLUSIONS AND RECOMMENDATIONS ON BIOLOGICAL EFFECTS AND SAFETY OF ULTRASOUND CONTRAST AGENTS, 2006 STANLEY B. BARNETT,* FRANCIS DUCK† and MARVIN ZISKIN‡ *School of Biomedical Sciences, University of Sydney, Australia; †Department of Physics, University of Bath, Bath, UK; ‡Center for Biomedical Physics, Temple University School of Medicine, Philadelphia, PA, USA
PREVIOUSLY PUBLISHED WFUMB RECOMMENDATIONS
also applies to endoscopic, transvaginal and transcutaneous applications. When tissue/gas interfaces or contrast agents are present, ultrasound exposure levels and durations should be reduced to the minimum necessary to obtain the required diagnostic information.
WFUMB Symposium on Safety of Ultrasound in Medicine: Published Recommendations on the Safe Use of Ultrasound (1998) The following is a selection of existing published recommendations that were approved by the WFUMB Executive Council in March 1997 and published in 1998, which are relevant to the safe use of ultrasound contrast agents in diagnostic ultrasonography. For more detail, refer to World Federation for Ultrasound in Medicine and Biology Symposium on Safety of Medical Ultrasound; Conclusions and Recommendations regarding thermal and nonthermal mechanisms for biologic effects of ultrasound. (Ultrasound Medicine Biol 1998;24(S1):1–55).
●
When tissue/gas interfaces or contrast agents are not present, and where there is no risk of significant temperature elevation, the use of diagnostic Doppler equipment need not be withheld because of concern for ultrasound safety. When any of the above conditions might be present, ultrasound exposure levels and durations should be reduced to the minimum necessary to obtain the required diagnostic information. ACKNOWLEDGMENTS: WORKSHOP PARTICIPANTS AND CONTRIBUTORS
Recommendations: Non-Thermal Effects ●
It has been shown experimentally that acoustic cavitation can alter mammalian tissues. It is therefore important to consider its significance in medical applications of ultrasound.
Organising committee/WFUMB safety committee Stan Barnett, PhD University of Sydney Faculty Biomedical Sciences, Australia Michel Claudon, MD Service de Radiologie Hôpital d’Enfants, Vandoeuvre Cedex, France Francis Duck, DSc Wessex Regional Medical Physics Service, Royal United Hospital, Bath, UK Karel Marsal, MD Department of Obstetrics and Gynecology University Hospital Lund, Sweden Marvin Ziskin, MD, Temple University, Center for Biomedical Physics, Philadelphia, USA
● Contrast Agents Gas bodies introduced by a contrast agent increase the probability of cavitation. A physician should take this into account when considering th e benefit/risk ratio of an examination. ●
Doppler
B-Mode Imaging
When tissue/gas interfaces or contrast agents are not present, the use of B-Mode imaging need not be withheld because of concern for ultrasound safety. This statement
Primary authors Martin Blomley, MD, Imperial College and Hammersmith Hospital, London, UK Diane Dalecki, PhD, Rochester Center for Biomedical Ultrasound, University of Rochester, USA Nico de Jong, PhD, Erasmus University Medical Center, Rotterdam, NL
Address correspondence to: Stanley B. Barnett, PhD, School of Biomedical Sciences, University of Sydney, Australia. E-mail: sbarnett@ usyd.edu.au 233
234
Ultrasound in Medicine and Biology
Douglas Miller, PhD, Research Professor, Department of Radiology University of Michigan Kresge III, R3315 200 Zina Pitcher Place Ann Arbor, USA Wesley Nyborg, PhD, Dept. Physics, University of Vermont, Burlington, USA Tony Whittingham, PhD, Regional Medical Physics Department, Newcastle General Hospital, UK Participants and contributors Jacques S. Abramowicz, MD Professor, Obstetrics & Gynecology, Rush University Medical Center, 1653 West Congress Parkway, Chicago, IL Ughetta Del Balzoa, E-mail: [email protected] Ayache Bouakaz, Erasmus University Medical Center, Rotterdam, NL Anne Broillet Head, Echo Ultrasound Imaging Animal Lab, Bracco Research, Plan Les Ouates-Genève, Switzerland Harald Becher MD, Consultant, Cardiology Dept, John Radcliffe Hospital, Oxford, UK Stephen Bly, PhD, Consumer and Radiation Protection Bureau, Ottawa, Canada Peter Burns, PhD, E-mail: [email protected]. utoronto.ca Anne Hall, GE, USA E-mail: Anne.Hall@med. ge.com Robert Mattrey, E-mail: [email protected], USA Mark Monaghan, PhD, Director of Echocardiography, Cardiology Dept, Kings, College Hospital, London, UK Petros Nihoyannopoulis, MD, Echocardiography Dept, Cardiology, Imperial College, and Hammersmith Hospital, UK Charles Church, PhD, Centre for Physical Acoustics University of Mississippi, USA David Cosgrove, MD, Imaging Sciences Dept, Imperial College and Hammersmith Hospital, UK Marc Engelhadt, E-mail: marc.engelhardt@diag. bracco.com Loreto Feril, E-mail: [email protected] Brian Fowlkes, PhD, Assoc. Professor of Radiology, University of Michigan Health System, Kresge III, R3315, 200 Zina Pitcher Place, Ann Arbor, MI, USA. Christy Holland, PhD, University of Cincinnati Dept. of Radiology, USA Takashi Kondo, PhD, E-mail: [email protected] George Kossoff, DSc, University of NSW, Australia Fred Kremkau, PhD, Wake Forest University, USA Nobuki Kudo, PhD, Hokkaido University School
Volume 33, Number 2, 2007
ofEngineering,Japan,E-mail:[email protected]. ac.jp Hector Lopez, PhD, Food and Drug Administration, Rockville, USA Thomas H Marwick, Princess Alexandra Hospital, University of Queensland, Australia Wilson Mathias, MD, E-mail: wmathias@incor. usp.br Morton Miller, PhD, University of Rochester, USA G Wayne Moore, PhD, SONORA, E-mail: gwm@ 4sonora.com Michiya Natori, MD, National Ohokura Hospital, Japan Jeff Powers, PhD, PHILIPS E-mail: jeff.powers@ philips.com Helmut Reichenberger, PhD, Siemens AG, Erlangen, Germany David Sahn, MD, Pediatric Cardio Clinical Care Center, Oregon Health Science University, Portland, USA. Paul Smolenski, PhD, Philips Medical Systems, Andover, MA, USA Mel Stratmeyer, PhD, Food and Drug Administration, Rockville, USA Glenn Tickner, E-mail: [email protected] Volkmar Uhlendorf, PhD, Paul Scherrer Institute, Center for Radiopharmacy, CH-5232 Villigen (PSI), Switzerland Kittipong Vairojanavong, MD, E-mail: kittipon@ health.moph.go.th Jiefen Yao, “Jiefen Yao” E-mail: Jiefen.Yao@diag. bracco.com Michael Zomack, Schering AG, Clinical Development Diagnostics, Germany THE WFUMB ORGANISING COMMETTEE GRATEFULLY ACKNOWLEDGES THE COMMENTS AND CONTRIBUTIONS TO THE REVIEW PROCESS PROVIDED BY: American College of Cardiology Foundation (ACCF) Echocardiography Committee, Bethesda, USA American Institute of Ultrasound in Medicine (AIUM) Bioeffects Committee, USA American Society of Echocardiography (ASE), USA Australasian Society of Ultrasound in Medicine (ASUM) Safety Committee, Australia Food and Drug Administration (FDA) Centre for Devices and Radiologic Health, USA British Society of Echocardiography Policy Committee, UK European Federation of Ultrasound Societies in Medicine (EFSUMB)