Medical Engineering & Physics
Volume 30, Issue 10 , Pages 1338-1348 , December 2008

Hazards, risks and safety of diagnostic ultrasound

  • Francis A. Duck

      Affiliations

    • Department of Medical Physics and Bioengineering, Royal United Hospital Bath, Combe Park, Bath BA1 3NG, UK
    • Department of Physics, University of Bath, UK
    • Corresponding Author InformationCorrespondence address: Department of Medical Physics and Bioengineering, Royal United Hospital Bath, Combe Park, Bath BA1 3NG, UK. Tel.: +44 1225 8244085; fax: +44 1225 447535.

Received 1 March 2008 ,Revised 27 May 2008 ,Accepted 1 June 2008.

References 

  1. Echo sounding. Hydrogr Rev. 1924;II((November)1):51–91
  2. Wood RW. Supersonics. The science of inaudible sounds. The Colver lectures in Brown University 1937. vol. 20. Providence RI, USA: Brown University; 1939;
  3. World Federation for Ultrasound in Medicine and Biology. Third symposium in medical ultrasound. Issues and recommendations regarding thermal mechanisms for biological effects of ultrasound. Ultrasound Med Biol 1992;18:733–7.
  4. World Federation for Ultrasound in Medicine and Biology. Symposium on safety of ultrasound in medicine: conclusions and recommendations on thermal and non-thermal mechanisms for biological effects of ultrasound. Ultrasound Med Biol 1998;24(S1):1–55.
  5. National Council on Radiation Protection and Measurements. Exposure criteria for medical diagnostic ultrasound. I. Criteria based on thermal mechanisms. NCRP report no. 113. Bethesda, MD, USA: NCRP; 1992.
  6. National Council for Radiation Protection and Measurements. Exposure criteria for diagnostic ultrasound. II. Criteria based on all known mechanisms. Report no. 140. Bethesda, MD, USA: NRCP; 2002.
  7. Barnett SB, Ter Haar GR, Ziskin MC, Rott H-D, Duck FA, Maeda K. International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine. Ultrasound Med Biol. 2000;26:355–366
  8. In:  Ter Haar G,  Duck FA editor. The safe use of ultrasound in medical diagnosis. London: British Medical Ultrasound Society/British Institute of Radiology; 2000;
  9. Barnett SB, Kossoff G. (Eds.), Safety of diagnostic ultrasound. Progress in obstetric and gynecologoical sonography series. London: Parthenon; 1998.
  10. McKinlay A (Guest Editor), Effects of ultrasound and infrasound relevant to human health. Focussed Issue of Prog Biophys Mol Biol 2007;93(1–3):1–420.
  11. American Institute of Ultrasound in Medicine. AIUM Bioeffects Consensus Report. J Ultrasound Med. 2008;27:503–632
  12. ISO 14971: Medical devices—application of risk management to medical devices. International Organization for Standardization; 2000.
  13. Duck FA, Vella GJ, Barnett SB. Do air boundaries in soft tissue increase the expected ultrasound induced temperature rise?. Ultrasound Med Biol. 2006;32(5S):90–91
  14. Wu J. Temperature rise generated by ultrasound in the presence of contrast agent. Ultrasound Med Biol. 1998;24:267–274
  15. Carstensen EL, Child SZ, Norton S, Nyborg WL. Ultrasonic heating of the skull. J Acoust Soc Am. 1990;87:1310–1317
  16. ICRU Report 61. Tissue substitutes, phantoms and computational modelling in medical ultrasound. Bethesda, MD, USA: International Commission on Radiation Units and Measurements; 1998.
  17. Abbott JG. Rationale and derivation of MI and TI—a review. Ultrasound Med Biol. 1999;25:431–442
  18. FDA. Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. Division of Reproductive, Abdominal, Ear, Nose, Throat and Radiological Devices: Office of Device Evaluation. US Department of Health and Human Services: Food and Drug Administration; 1997. www.fda.gov/cdrh/ode/ulstran.pdf.
  19. Calvert J, Duck F. Self-heating of diagnostic ultrasound transducers in air and in contact with tissue mimics. Ultrasound. 2006;14:100–108
  20. Calvert J, Duck F, Clift S, Azaime H. Surface heating by transvaginal transducers. Ultrasound Obstet Gynecol. 2007;29:427–432
  21. IEC 60601 part 2–37 Ed 2. Medical electrical equipment: particular requirements for the safety of ultrasound diagnostic and monitoring equipment. Geneva: International Electrotechnical Commission; 2007.
  22. Duggan PM, Liggins GC, Barnett SB. Ultrasonic heating of the brain of the fetal sheep in utero. Ultrasound Med Biol. 1995;21:553–560
  23. Duck FA. Physical properties of tissue. London: Academic Press; 1990;
  24. Dewey WC. Arrhenius relationships from the molecule and cell to the clinic. Int J Hyperthermia. 1994;10:457–483
  25. Edwards MJ, Shiota K, Smith MSR, Walsh DA. Hyperthermia and birth defects. Reprod Toxicol. 1995;9:411–425
  26. Church CC, Miller MW. Quantification of risk from fetal exposure to diagnostic ultrasound. Prog Biophys Mol Biol. 2007;93:331–353
  27. Miller MW, Nyborg WL, Dewey WC, Edwards MJ, Abramowicz JS, Brayman AA. Hypertheric teratogenicity, thermal dose and diagnostic ultrasound during pregnancy: implications of new standards on tissue heating. Int J Hyperthermia. 2002;18:361–384
  28. Leighton TG. The acoustic bubble. San Diego CA USA: Academic Press; 1994;
  29. Rooney JA. Shear as a mechanism for sonically induced biological effects. J Acoust Soc Am. 1972;52:1718–1724
  30. Rooney JA. Hydrodynamic shearing of biological cells. J Biol Phys. 1973;2:26–40
  31. Christman CL, Carmichael AJ, Mossaba MM, Riesz P. Evidence for free radicals produced in aqueous solutions by diagnostic ultrasound. Ultrasonics. 1987;25:31–34
  32. Price GJ, Duck FA, Digby M, Holland W, Berryman T. Measurement of radical production as a result of cavitation in medical ultrasound fields. Ultrasonics Sonochem. 1997;4:165–171
  33. Tachibana K, Uchida T, Ogowa K, Yamashita N, Tamra K. Induction of cell-membrane porosity by ultrasound. Lancet. 1999;353:1409
  34. Apfel RE, Holland CK. Gauging the likelihood of cavitation from short-pulse, low-duty cycle diagnostic ultrasound. Ultrasound Med Biol. 1991;17:179–185
  35. IEC 62359: Ultrasonics – field characterization – test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasound fields. Geneva: International Electrotechnical Commission; 2006.
  36. Church CC. Spontaneous, homogeneous nucleation, inertial cavitation and the safety of diagnostic ultrasound. Ultrasound Med Biol. 2002;28:1349–1364
  37. Barnett SB, Duck F, Ziskin M. Recommendations on the safe use of ultrasound contrast agents. Ultrasound Med Biol. 2007;33:173–174
  38. EFSUMB study group . Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS)—update 2008. Ultraschall Med. 2008;29:28–44
  39. Skyba DM, Price RJ, Link AZ, Skalak TC, Kaul S. Direct in vivo visualization of intravascular destruction of microbubbles by ultrasound and its local effects on tissue. Circulation. 1998;98:290–293
  40. Miller DL, Quddus J. Diagnostic ultrasound activation of contrast agent gas bodies induces capillary rupture in mice. Proc Natl Acad Sci. 2000;97:10179–10184
  41. Van der Wouw PA, Brauns AC, Bailey SE, Powers JE, Wilde AAA. Premature ventricular contractions during triggered imaging with ultrasound contrast. J Am Soc Echocardiogr. 2000;13:288–294
  42. Williams AR, Wiggins RC, Wharram BL, Goyal M, Dou C, Johnson K, et al. Nephron injury induced by diagnostic ultrasound imaging at high mechanical index with gas body contrast agent. Ultrasound Med Biol. 2007;33:1336–1344
  43. Wible JH, Galen KP, Wojdyla JK, Hughes MS, Klibanov AL, Brandenburger GH. Microbubbles induce renal hemorrhage when exposed to diagnostic ultrasound in anesthetized rats. Ultrasound Med Biol. 2002;28:1535–1546
  44. Miller DL, Gies RA. The interaction of ultrasonic heating and cavitation in vascular bioeffects on mouse intestine. Ultrasound Med Biol. 1998;24:123–128
  45. O’Brien WD. Ultrasound—biophysics mechanisms. Prog Biophys Mol Biol. 2007;93:212–255
  46. Miller DL, Thomas RM. Heating as a mechanism for ultrasonically-induced petechial hemorrhage in mouse intestine. Ultrasound Med Biol. 1994;20:493–503
  47. Stanton MT, Ettarh R, Arango D, Tonra M, Brennan PC. Diagnostic ultrasound induces change within numbers of cryptal mitotic and apoptotic cells in small intestine. Life Sci. 2001;68:1471–1475
  48. Dalecki D, Raeman CH, Child SZ, Carstensen EL. Intestinal hemorrhage from exposure to pulsed ultrasound. Ultrasound Med Biol. 1995;21:1067–1072
  49. Duck FA. Acoustic streaming and radiation pressure in diagnostic applications: what are the implications? In: Barnett SB, Kossoff G (Eds.), Safety of diagnostic ultrasound, Progress in obstetrics & gynaecology series. NY: Parthenon; 1998. p. 87–98 [Chapter 9].
  50. Duck FA. Radiation pressure and acoustic streaming. In:  Duck FA,  Baker AC,  Starritt HC editor. Ultrasound in medicine. Bristol: Institute of Physics Publishing; 1998;p. 39–56[Chapter 3]
  51. Beyer RT. Radiation pressure—the history of a mislabelled tensor. J Acoust Soc Am. 1978;63:1025–1030
  52. Nyborg WL. Acoustic streaming. In:  Hamilton MF,  Blackstock DT editor. Nonlinear acoustics. NY: Academic; 1998;p. 207–231[Chapter 7]
  53. Starritt HC, Duck FA, Humphrey VF. An experimental investigation of streaming in pulsed diagnostic ultrasound fields. Ultrasound Med Biol. 1989;15:363–373
  54. Starritt HC, Hoad CL, Duck FA, Nassiri DK, Summers IR, Vennart W. Measurement of acoustic streaming using magnetic resonance. Ultrasound Med Biol. 2000;26:321–333
  55. Pohl P, Antonenko YN, Rosenfeld E. Effect of ultrasound on the pH profiles in the unstirred layers near planar bilayer lipid membranes measured by microelectrodes. Biochim Biophys Acta. 1993;1152:155–160
  56. Nightingale KR, Palmeri ML, Nightingale RW, Trahey GE. On the feasibility of remote palpation using acoustic radiation force. J Acoust Soc Am. 2001;110:625–634
  57. Bercoff J, Chaffai S, Tanter M, Fink M. Ultrafast imaging of beamformed shear waves induced by the acoustic radiation force in soft tissue: application to transient elastography. In: Proceedings of the IEEE ultrasonics symposium. 2002;p. 1899–1902
  58. World Federation for Ultrasound in Medicine and Biology . Other non-thermal mechanisms: acoustic radiation force and streaming. Ultrasound Med Biol. 1998;24(S1):S23–S28
  59. Starritt HC, Duck FA, Humphrey VF. Forces acting in the direction of propagation in pulsed ultrasound fields. Phys Med Biol. 1991;36:1465–1474
  60. Yamada H. In:  Evans FG editors. Strength of biological materials. New York, USA: Williams and Wilkins; 1970;
  61. Dalecki D, Child SZ, Raeman CH, Cox C. Hemorrhage in murine fetuses exposed to pulsed ultrasound. Ultrasound Med Biol. 1999;25:1139–1144
  62. Bigelow TA, Miller RJ, Blue JP, O’Brien WD. Hemorrhage near fetal rat bone exposed to pulsed ultrasound. Ultrasound Med Biol. 2007;33:311–317
  63. Huang H, Kamm RD, Lee RT. Cell mechanics and mechanotransduction: pathways, probes and physiology. Am J Cell Physiol. 2003;287:C1–C11
  64. Davies PF. Flow-mediated endothelial mechanotransduction. Physiol Rev. 1995;75:519–556
  65. Van Bavel E. Effects of shear stress on endothelial cells: possible relevance for ultrasound applications. Prog Biophys Mol Biol. 2007;93:374–383
  66. Butler PJ, Tsou TC, Li AT, Usami S, Chien S. Rate sensitivity of shear-induced changes in the lateral diffusion of endothelial membrane lipids: a role for membrane perturbation in shear-induced MAPK activation. FASEB J. 2002;16:216–218
  67. Farge E. Mechanical inductionof twist in the Drosophilia foregut/stomodeal primordium. Curr Biol. 2003;13:1365–1377
  68. Dalecki D, Child SZ, Raeman CH, Carstensen EL. Tactile perception of ultrasound. J Acoust Soc Am. 1995;97:3165–3170
  69. Dalecki D, Raeman CR, Child SZ, Carstensen EL. Effects of pulsed ultrasound on the frog heart. III. The radiation force mechanism. Ultrasound Med Biol. 1997;23:275–285
  70. Ang E, Gluncic V, Duque A, Schafer M, Rakic P. Prenatal exposure to ultrasound waves impacts neuronal migration in mice. PNAS. 2006;103:12903–12910
  71. Duarte LR. The stimulation of bone growth by ultrasound. Arch Orthop Trauma Surg. 1983;101:153–159
  72. Heckman JD, Ryaby JP, McCabe J, Frey JF, Kilcoyne RF. Acceleration of tibial fracture healing by non-invasive, low intensity pulsed ultrasound. J Bone Joint Surg. 1994;76:26–34
  73. Parvisi JP, Wu CC, Lewallen DG, Greenleaf JF, Bolander ME. Low-intensity ultrasound stimulates proteoglycan synthesis in rat chondrocytes by increasing aggrecan gene expression. J Orthop Res. 1999;17:488–494
  74. Dyson M, Pond JB, Joseph J, Warwick R. Stimulation of tissue regeneration by pulsed plane-wave ultrasound. IEEE Trans Sonics Ultrasonics. 1970;SU-17:133–139
  75. Fatemi M, Ogburn PL, Greenleaf JF. Fetal stimulation by pulsed diagnostic ultrasound. J Ultrasound Med. 2001;20:883–889
  76. Magee TR, Davies AH. Auditory phenomena during transcranial Doppler insonation of the basilar artery. J Ultrasound Med. 1993;12:747–750

PII: S1350-4533(08)00104-5

doi: 10.1016/j.medengphy.2008.06.002

Medical Engineering & Physics
Volume 30, Issue 10 , Pages 1338-1348 , December 2008