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Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment.

Publication ,  Journal Article
Nightingale, KR; Church, CC; Harris, G; Wear, KA; Bailey, MR; Carson, PL; Jiang, H; Sandstrom, KL; Szabo, TL; Ziskin, MC
Published in: Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine
July 2015

The mechanical index (MI) has been used by the US Food and Drug Administration (FDA) since 1992 for regulatory decisions regarding the acoustic output of diagnostic ultrasound equipment. Its formula is based on predictions of acoustic cavitation under specific conditions. Since its implementation over 2 decades ago, new imaging modes have been developed that employ unique beam sequences exploiting higher-order acoustic phenomena, and, concurrently, studies of the bioeffects of ultrasound under a range of imaging scenarios have been conducted. In 2012, the American Institute of Ultrasound in Medicine Technical Standards Committee convened a working group of its Output Standards Subcommittee to examine and report on the potential risks and benefits of the use of conditionally increased acoustic pressures (CIP) under specific diagnostic imaging scenarios. The term "conditionally" is included to indicate that CIP would be considered on a per-patient basis for the duration required to obtain the necessary diagnostic information. This document is a result of that effort. In summary, a fundamental assumption in the MI calculation is the presence of a preexisting gas body. For tissues not known to contain preexisting gas bodies, based on theoretical predications and experimentally reported cavitation thresholds, we find this assumption to be invalid. We thus conclude that exceeding the recommended maximum MI level given in the FDA guidance could be warranted without concern for increased risk of cavitation in these tissues. However, there is limited literature assessing the potential clinical benefit of exceeding the MI guidelines in these tissues. The report proposes a 3-tiered approach for CIP that follows the model for employing elevated output in magnetic resonance imaging and concludes with summary recommendations to facilitate Institutional Review Board (IRB)-monitored clinical studies investigating CIP in specific tissues.

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Published In

Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine

DOI

EISSN

1550-9613

ISSN

0278-4297

Publication Date

July 2015

Volume

34

Issue

7

Start / End Page

1 / 41

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Ultrasonography
  • Pressure
  • Practice Guidelines as Topic
  • Nuclear Medicine & Medical Imaging
  • Models, Theoretical
  • Humans
  • Equipment Safety
  • Animals
 

Citation

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Nightingale, K. R., Church, C. C., Harris, G., Wear, K. A., Bailey, M. R., Carson, P. L., … Ziskin, M. C. (2015). Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment. Journal of Ultrasound in Medicine : Official Journal of the American Institute of Ultrasound in Medicine, 34(7), 1–41. https://doi.org/10.7863/ultra.34.7.15.13.0001
Nightingale, Kathryn R., Charles C. Church, Gerald Harris, Keith A. Wear, Michael R. Bailey, Paul L. Carson, Hui Jiang, Kurt L. Sandstrom, Thomas L. Szabo, and Marvin C. Ziskin. “Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment.Journal of Ultrasound in Medicine : Official Journal of the American Institute of Ultrasound in Medicine 34, no. 7 (July 2015): 1–41. https://doi.org/10.7863/ultra.34.7.15.13.0001.
Nightingale KR, Church CC, Harris G, Wear KA, Bailey MR, Carson PL, et al. Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine. 2015 Jul;34(7):1–41.
Nightingale, Kathryn R., et al. “Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment.Journal of Ultrasound in Medicine : Official Journal of the American Institute of Ultrasound in Medicine, vol. 34, no. 7, July 2015, pp. 1–41. Epmc, doi:10.7863/ultra.34.7.15.13.0001.
Nightingale KR, Church CC, Harris G, Wear KA, Bailey MR, Carson PL, Jiang H, Sandstrom KL, Szabo TL, Ziskin MC. Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine. 2015 Jul;34(7):1–41.

Published In

Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine

DOI

EISSN

1550-9613

ISSN

0278-4297

Publication Date

July 2015

Volume

34

Issue

7

Start / End Page

1 / 41

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Ultrasonography
  • Pressure
  • Practice Guidelines as Topic
  • Nuclear Medicine & Medical Imaging
  • Models, Theoretical
  • Humans
  • Equipment Safety
  • Animals