Statement on Data Needed to Characterize Ultrasound System Output

The AIUM Board of Governors believes that it is in the interest of the ultrasound community that acoustical output characteristics of ultrasound systems be well documented and openly available. This information is necessary for the prudent and informed clinical use of ultrasound. The Board strongly encourages manufacturers to provide this information.

Because the acoustic output of a transducer may change over time, detailed information on the ultrasound insonation parameters and the field location of interest needs to be provided to those performing bioeffects and other studies dependent on acoustic output. Users should be aware that neither the acoustic output indices displayed on the device (TI and MI) nor the “worst-case” output data provided in manufacturers’ Users’ Manuals are sufficient to characterize the acoustic output of ultrasound systems under the specific conditions and settings selected by a user for a given study or examination. Users of ultrasound systems who intend to report on bioeffects studies and other studies that depend on acoustic output are encouraged to employ the assistance of those trained in acoustic output measurement and characterization and the manufacturers of their systems to ensure adequate hydrophone-based calibration and sufficiently accurate estimates or measurements of pertinent acoustic output parameters. Ultrasound insonation parameters and acoustic output information must be reported in subsequent publications. Because of the variability of information that could be relevant in bioeffects studies, it is important to provide the most relevant and complete information. Guidance on what information to include is described in the editorial and “Guidelines for Journal of Ultrasound in Medicine Authors and Reviewers on Measurement and Reporting of Acoustic Output and Exposure,” J Ultrasound Med 2005; 24:1169–1179 ( https://onlinelibrary.wiley.com/doi/full/10.7863/jum.2005.24.9.1171), as well as in “Guidance on Reporting Ultrasound Exposure Conditions for Bioeffects Studies,” Ultrasound Med Biol 2011; 37:177–183 ( https://doi.org/10.1016/j.ultrasmedbio.2010.10.021) and its supplement “Recommendations for reporting therapeutic ultrasound treatment parameters,” Ultrasound Med Biol 2022; 48:1299–1308. ( https://doi.org/10.1016/j.ultrasmedbio.2022.03.001)