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The Risk of Exposure to Diagnostic Ultrasound in Postnatal Subjects

Thermal Effects

Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering (W.D.O.), and Department of Pathobiology (J.F.Z.), University of Illinois, Urbana, Illinois USA; Department of Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio USA (C.X.D.); US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, Maryland USA (G.R.H., B.A.H.); Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania USA (C.R.M.); Focus Surgery Inc, Indianapolis, Indiana USA (N.S.).

Address correspondence to William D. O’Brien, Jr, PhD, Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering, University of Illinois, 405 N Mathews, Urbana, IL 61801 USA. E-mail: wdo{at}uiuc.edu

Abstract

This review evaluates the thermal mechanism for ultrasound-induced biological effects in postnatal subjects. The focus is the evaluation of damage versus temperature increase. A view of ultrasound-induced temperature increase is presented, based on thermodynamic Arrhenius analyses. The hyperthermia and other literature revealed data that allowed for an estimate of a temperature increase threshold of tissue damage for very short exposure times. This evaluation yielded an exposure time extension of the 1997 American Institute of Ultrasound in Medicine Conclusions Regarding Heat statement (American Institute of Ultrasound in Medicine, Laurel, MD) to 0.1 second for nonfetal tissue, where, at this exposure time, the temperature increase threshold of tissue damage was estimated to be about 18°C. The output display standard was also evaluated for soft tissue and bone cases, and it was concluded that the current thermal indices could be improved to reduce the deviations and scatter of computed maximum temperature rises.

Key Words: Arrhenius analysis • nonfetal tissue • output display standard • temperature increase threshold • thermal mechanism

Abbreviations: AIUM, American Institute of Ultrasound in Medicine • ALARA, as low as reasonably achievable • FDA, Food and Drug Administration • HIFU, high-intensity focused ultrasoundI_SATA, spatial-average temporal-average intensity • I_SPPA.3, derated spatial-peak pulse-average intensity • I_SPTA.3, derated spatial-peak temporal-average intensity • MI, mechanical index • NCRP, National Council on Radiation Protection and Measurements • NEMA, National Electrical Manufacturers Association • ODS, output display standard • ROC, radius of curvature • TI, thermal index • TIB, thermal index for bone • TIC, thermal index for cranial bone • TIS, thermal index for soft tissue

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