EFSUMB Clinical Safety Statement for Diagnostic Ultrasound – (2019 revision)

Abstract

This document is the updated 2019 revision of the EFSUMB Clinically Safety Statement. A Safety Statement has been published by EFSUMB annually since 1994 by the Safety Committee (ECMUS) of the federation. The text is deliberately brief and gives a concise overview of safety in the use of diagnostic ultrasound.

Safety Indices of Ultrasound: Adherence to Recommendations and Awareness During Routine Obstetric Ultrasound Scanning

“…Doppler since in routine settings [8] the TIb is as high as 2.1, 2.6, and 3.0 in the first, second, and third trimester, respectively. In addition to aspects of operator awareness, there have been some reported concerns over the ability of the bioeffect indices to predict the intensity of ultrasound [17,34].…”

“…However, that study monitored a selected population of high-risk women in the second half of pregnancy only [29]. To simplify the approach to safe use of diagnostic ultrasound, the ALARA (As Low As Reasonably Achievable) principle has been proposed [8,30]. ALARA encourages scans to be restricted to medical indications, by trained professionals, using the lowest intensity power and the shortest duration of scanning that is compatible with an accurate diagnosis.…”

“…In the United Kingdom, color Doppler and pulsed-wave Doppler are not routinely employed as a part of first-trimester screening for trisomies [17]. Nevertheless, some operators are familiar with such advanced sonographic screening strategies [18] and may, therefore, choose to use Doppler and pulsed-wave Doppler as part of first-trimester screening [19][20][21][22].…”

“…In obstetrics, TI is reported in two variants: Thermal Index in soft tissue (TIs), which assumes that sound is traveling only in soft tissue and is monitored in early pregnancy when bone ossification is low; Thermal Index in bone (TIb), which assumes that sound is at or near the bone. The presence of bone within the ultrasound beam increases the likelihood of an increase in temperature due to direct absorption in the bone itself and conduction of heat from bone to adjacent tissue [7,8]. Therefore, after ten weeks of gestation, it is recommended that TIb is used [9].…”

Is ultrasound in pregnancy perhaps dangerous after all? A never-ending discussion for over 40 years!

“…The number of studies and publications on this topic, particularly epidemiological statistics and experimental studies, has since become so vast that the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) set up a permanent committee for reviewing and evaluating all of these studies years ago. This "European Committee for Medical Ultrasound Safety" (ECMUS) produces an annual publication of the results of these reviews in the form of statements and recommendations regarding limit values, mode-specific sound emissions, and safe examination techniques [1]. Similar evaluations and statements have also been published by the American Institute for Ultrasound in Medicine, the British Medical Ultrasound Society, the Society of Obstetricians and Gynaecologists of Canada and the ISUOG [2][3][4][5].…”