Hazards, risks and safety of diagnostic ultrasound

Medical Engineering and Physics

Volumn 30, Issue 10, 2008, Pages 1338-1348

  Duck, Francis A ^a,b  

^a ROYAL UNITED HOSPITAL   (United Kingdom)

^b University of Bath   (United Kingdom)

Author keywords

Acoustic cavitation; Gas body effects; Heating; Radiation pressure; Risk assessment; Ultrasound safety

Indexed keywords

ACOUSTIC WAVES; ACOUSTICS; BIOLOGICAL RADIATION EFFECTS; CAVITATION; DECISION MAKING; HYDRODYNAMICS; PRESSURE; RADIATION EFFECTS; RISK MANAGEMENT; RISK PERCEPTION; RISKS; ULTRASONIC IMAGING; ULTRASONIC TRANSMISSION; ULTRASONICS;

ACOUSTIC CAVITATION; ACOUSTIC CAVITATIONS; ACOUSTIC OUTPUTS; BODY EFFECTS; CELL RESPONSES; CONTRAST AGENTS; CURRENT PRACTICES; DIAGNOSTIC ULTRASOUNDS; DOPPLER; RADIATION PRESSURE; RADIATION PRESSURES; STRUCTURED APPROACHES; TEMPERATURE RISES; ULTRASOUND SAFETY; ULTRASOUND SCANNERS;

RISK ASSESSMENT;

CONTRAST MEDIUM;

CLINICAL PRACTICE; DIAGNOSTIC IMAGING; DOPPLER ECHOGRAPHY; EXPOSURE; GAS; HAZARD ASSESSMENT; HEALTH HAZARD; HIGH TEMPERATURE; HUMAN; OBSTETRIC CARE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROBABILITY; RADIATION EXPOSURE; REVIEW; RISK ASSESSMENT; RISK REDUCTION; SAFETY; THERMAL EXPOSURE; ULTRASOUND; ULTRASOUND SCANNER;

ANIMALS; BURNS; COMPUTER SIMULATION; HUMANS; MODELS, BIOLOGICAL; RADIATION INJURIES; RISK ASSESSMENT; ULTRASONOGRAPHY;

EID: 56249088601     PISSN: 13504533     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.medengphy.2008.06.002     Document Type: Review

References (76)

1. Echo sounding. Hydrogr Rev II (November)1 (1924) 51-91
2. Wood R.W. Supersonics. The science of inaudible sounds. The Colver lectures in Brown University 1937 vol. 20 (1939), Brown University, Providence RI, USA
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 S.B., Ter Haar G.R., Ziskin M.C., Rott H.-D., Duck F.A., and Maeda K. International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine. Ultrasound Med Biol 26 (2000) 355-366
8. In: Ter Haar G., and Duck F.A. (Eds). The safe use of ultrasound in medical diagnosis (2000), British Medical Ultrasound Society/British Institute of Radiology, London
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 27 (2008) 503-632
12. ISO 14971: Medical devices-application of risk management to medical devices. International Organization for Standardization; 2000.
13. Duck F.A., Vella G.J., and Barnett S.B. Do air boundaries in soft tissue increase the expected ultrasound induced temperature rise?. Ultrasound Med Biol 32 5S (2006) 90-91
14. Wu J. Temperature rise generated by ultrasound in the presence of contrast agent. Ultrasound Med Biol 24 (1998) 267-274
15. Carstensen E.L., Child S.Z., Norton S., and Nyborg W.L. Ultrasonic heating of the skull. J Acoust Soc Am 87 (1990) 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 J.G. Rationale and derivation of MI and TI-a review. Ultrasound Med Biol 25 (1999) 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., and Duck F. Self-heating of diagnostic ultrasound transducers in air and in contact with tissue mimics. Ultrasound 14 (2006) 100-108
20. Calvert J., Duck F., Clift S., and Azaime H. Surface heating by transvaginal transducers. Ultrasound Obstet Gynecol 29 (2007) 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 P.M., Liggins G.C., and Barnett S.B. Ultrasonic heating of the brain of the fetal sheep in utero. Ultrasound Med Biol 21 (1995) 553-560
23. Duck F.A. Physical properties of tissue (1990), Academic Press, London
24. Dewey W.C. Arrhenius relationships from the molecule and cell to the clinic. Int J Hyperthermia 10 (1994) 457-483
25. Edwards M.J., Shiota K., Smith M.S.R., and Walsh D.A. Hyperthermia and birth defects. Reprod Toxicol 9 (1995) 411-425
26. Church C.C., and Miller M.W. Quantification of risk from fetal exposure to diagnostic ultrasound. Prog Biophys Mol Biol 93 (2007) 331-353
27. Miller M.W., Nyborg W.L., Dewey W.C., Edwards M.J., Abramowicz J.S., and Brayman A.A. Hypertheric teratogenicity, thermal dose and diagnostic ultrasound during pregnancy: implications of new standards on tissue heating. Int J Hyperthermia 18 (2002) 361-384
28. Leighton T.G. The acoustic bubble (1994), Academic Press, San Diego CA USA
29. Rooney J.A. Shear as a mechanism for sonically induced biological effects. J Acoust Soc Am 52 (1972) 1718-1724
30. Rooney J.A. Hydrodynamic shearing of biological cells. J Biol Phys 2 (1973) 26-40
31. Christman C.L., Carmichael A.J., Mossaba M.M., and Riesz P. Evidence for free radicals produced in aqueous solutions by diagnostic ultrasound. Ultrasonics 25 (1987) 31-34
32. Price G.J., Duck F.A., Digby M., Holland W., and Berryman T. Measurement of radical production as a result of cavitation in medical ultrasound fields. Ultrasonics Sonochem 4 (1997) 165-171
33. Tachibana K., Uchida T., Ogowa K., Yamashita N., and Tamra K. Induction of cell-membrane porosity by ultrasound. Lancet 353 (1999) 1409
34. Apfel R.E., and Holland C.K. Gauging the likelihood of cavitation from short-pulse, low-duty cycle diagnostic ultrasound. Ultrasound Med Biol 17 (1991) 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 C.C. Spontaneous, homogeneous nucleation, inertial cavitation and the safety of diagnostic ultrasound. Ultrasound Med Biol 28 (2002) 1349-1364
37. Barnett S.B., Duck F., and Ziskin M. Recommendations on the safe use of ultrasound contrast agents. Ultrasound Med Biol 33 (2007) 173-174
38. EFSUMB study group. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS)-update 2008. Ultraschall Med 29 (2008) 28-44
39. Skyba D.M., Price R.J., Link A.Z., Skalak T.C., and Kaul S. Direct in vivo visualization of intravascular destruction of microbubbles by ultrasound and its local effects on tissue. Circulation 98 (1998) 290-293
40. Miller D.L., and Quddus J. Diagnostic ultrasound activation of contrast agent gas bodies induces capillary rupture in mice. Proc Natl Acad Sci 97 (2000) 10179-10184
41. Van der Wouw P.A., Brauns A.C., Bailey S.E., Powers J.E., and Wilde A.A.A. Premature ventricular contractions during triggered imaging with ultrasound contrast. J Am Soc Echocardiogr 13 (2000) 288-294
42. Williams A.R., Wiggins R.C., Wharram B.L., 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 33 (2007) 1336-1344
43. Wible Jr. J.H., Galen K.P., Wojdyla J.K., Hughes M.S., Klibanov A.L., and Brandenburger G.H. Microbubbles induce renal hemorrhage when exposed to diagnostic ultrasound in anesthetized rats. Ultrasound Med Biol 28 (2002) 1535-1546
44. Miller D.L., and Gies R.A. The interaction of ultrasonic heating and cavitation in vascular bioeffects on mouse intestine. Ultrasound Med Biol 24 (1998) 123-128
45. O'Brien Jr. W.D. Ultrasound-biophysics mechanisms. Prog Biophys Mol Biol 93 (2007) 212-255
46. Miller D.L., and Thomas R.M. Heating as a mechanism for ultrasonically-induced petechial hemorrhage in mouse intestine. Ultrasound Med Biol 20 (1994) 493-503
47. Stanton M.T., Ettarh R., Arango D., Tonra M., and Brennan P.C. Diagnostic ultrasound induces change within numbers of cryptal mitotic and apoptotic cells in small intestine. Life Sci 68 (2001) 1471-1475
48. Dalecki D., Raeman C.H., Child S.Z., and Carstensen E.L. Intestinal hemorrhage from exposure to pulsed ultrasound. Ultrasound Med Biol 21 (1995) 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 F.A. Radiation pressure and acoustic streaming. In: Duck F.A., Baker A.C., and Starritt H.C. (Eds). Ultrasound in medicine (1998), Institute of Physics Publishing, Bristol 39-56 [Chapter 3]
51. Beyer R.T. Radiation pressure-the history of a mislabelled tensor. J Acoust Soc Am 63 (1978) 1025-1030
52. Nyborg W.L. Acoustic streaming. In: Hamilton M.F., and Blackstock D.T. (Eds). Nonlinear acoustics (1998), Academic, NY 207-231 [Chapter 7]
53. Starritt H.C., Duck F.A., and Humphrey V.F. An experimental investigation of streaming in pulsed diagnostic ultrasound fields. Ultrasound Med Biol 15 (1989) 363-373
54. Starritt H.C., Hoad C.L., Duck F.A., Nassiri D.K., Summers I.R., and Vennart W. Measurement of acoustic streaming using magnetic resonance. Ultrasound Med Biol 26 (2000) 321-333
55. Pohl P., Antonenko Y.N., and Rosenfeld E. Effect of ultrasound on the pH profiles in the unstirred layers near planar bilayer lipid membranes measured by microelectrodes. Biochim Biophys Acta 1152 (1993) 155-160
56. Nightingale K.R., Palmeri M.L., Nightingale R.W., and Trahey G.E. On the feasibility of remote palpation using acoustic radiation force. J Acoust Soc Am 110 (2001) 625-634
57. Bercoff J., Chaffai S., Tanter M., and Fink M. Ultrafast imaging of beamformed shear waves induced by the acoustic radiation force in soft tissue: application to transient elastography. Proceedings of the IEEE ultrasonics symposium (2002) 1899-1902
58. World Federation for Ultrasound in Medicine and Biology. Other non-thermal mechanisms: acoustic radiation force and streaming. Ultrasound Med Biol 24 S1 (1998) S23-S28
59. Starritt H.C., Duck F.A., and Humphrey V.F. Forces acting in the direction of propagation in pulsed ultrasound fields. Phys Med Biol 36 (1991) 1465-1474
60. Yamada H. In: Evans F.G. (Ed). Strength of biological materials (1970), Williams and Wilkins, New York, USA
61. Dalecki D., Child S.Z., Raeman C.H., and Cox C. Hemorrhage in murine fetuses exposed to pulsed ultrasound. Ultrasound Med Biol 25 (1999) 1139-1144
62. Bigelow T.A., Miller R.J., Blue J.P., and O'Brien W.D. Hemorrhage near fetal rat bone exposed to pulsed ultrasound. Ultrasound Med Biol 33 (2007) 311-317
63. Huang H., Kamm R.D., and Lee R.T. Cell mechanics and mechanotransduction: pathways, probes and physiology. Am J Cell Physiol 287 (2003) C1-C11
64. Davies P.F. Flow-mediated endothelial mechanotransduction. Physiol Rev 75 (1995) 519-556
65. Van Bavel E. Effects of shear stress on endothelial cells: possible relevance for ultrasound applications. Prog Biophys Mol Biol 93 (2007) 374-383
66. Butler P.J., Tsou T.C., Li A.T., Usami S., and 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 16 (2002) 216-218
67. Farge E. Mechanical inductionof twist in the Drosophilia foregut/stomodeal primordium. Curr Biol 13 (2003) 1365-1377
68. Dalecki D., Child S.Z., Raeman C.H., and Carstensen E.L. Tactile perception of ultrasound. J Acoust Soc Am 97 (1995) 3165-3170
69. Dalecki D., Raeman C.R., Child S.Z., and Carstensen E.L. Effects of pulsed ultrasound on the frog heart. III. The radiation force mechanism. Ultrasound Med Biol 23 (1997) 275-285
70. Ang E., Gluncic V., Duque A., Schafer M., and Rakic P. Prenatal exposure to ultrasound waves impacts neuronal migration in mice. PNAS 103 (2006) 12903-12910
71. Duarte L.R. The stimulation of bone growth by ultrasound. Arch Orthop Trauma Surg 101 (1983) 153-159
72. Heckman J.D., Ryaby J.P., McCabe J., Frey J.F., and Kilcoyne R.F. Acceleration of tibial fracture healing by non-invasive, low intensity pulsed ultrasound. J Bone Joint Surg 76 (1994) 26-34
73. Parvisi J.P., Wu C.C., Lewallen D.G., Greenleaf J.F., and Bolander M.E. Low-intensity ultrasound stimulates proteoglycan synthesis in rat chondrocytes by increasing aggrecan gene expression. J Orthop Res 17 (1999) 488-494
74. Dyson M., Pond J.B., Joseph J., and Warwick R. Stimulation of tissue regeneration by pulsed plane-wave ultrasound. IEEE Trans Sonics Ultrasonics SU-17 (1970) 133-139
75. Fatemi M., Ogburn P.L., and Greenleaf J.F. Fetal stimulation by pulsed diagnostic ultrasound. J Ultrasound Med 20 (2001) 883-889
76. Magee T.R., and Davies A.H. Auditory phenomena during transcranial Doppler insonation of the basilar artery. J Ultrasound Med 12 (1993) 747-750