Scientific Publications by FDA Staff

J Ultrasound Med 2013 Nov;32(11):1921-32

Trends in Diagnostic Ultrasound Acoustic Output From Data Reported to the US Food and Drug Administration for Device Indications That Include Fetal Applications.

Cibull SL, Harris GR, Nell DM

Objectives- A survey was conducted of acoustic output data received by the US Food and Drug Administration for diagnostic ultrasound devices whose indications for use include fetal applications to assess trends in maximum available acoustic output over time. Methods- Data were collected from 124 regulatory submissions received between 1984 and 2010. Data collection excluded transducers not indicated for diagnostic fetal imaging. The output parameters of ultrasonic power, mean center frequency, and bone thermal index (TIB) were extracted or computed from the submissions for 3 periods: 1984-1989, 1992-1997, and 2005-2010. The data were stratified according to the following imaging modes: M-mode, B/M-mode, pulsed wave Doppler, color flow Doppler, and continuous wave Doppler. Results- Ultrasonic power and maximum TIB values have increased roughly an order of magnitude from pre-1991 to post-1991 periods; the center frequency has decreased somewhat (4.2 to 3.4 MHz). The percentage of Doppler-mode transducers has increased substantially over time, with the majority of the diagnostic fetal imaging transducers currently designed to operate in Doppler modes; this increase is particularly important, since Doppler modes generate much higher TIB levels than B/M-modes. Color flow Doppler ultrasound currently operates at the highest mean ultrasonic power level (with a 14-fold increase over time). Conclusions- The observed trends in increased acoustic output for both Doppler and non-Doppler modes underscore the widely recognized importance of adherence to the ALARA (as low as reasonably achievable) principle and prudent use in fetal ultrasound imaging.