Fetal thermal effects of diagnostic ultrasound.

Processes that can produce a biological effect with some degree of heating (ie, about 1 degrees C above the physiologic temperature) act via a thermal mechanism. Investigations with laboratory animals have documented that pulsed ultrasound can produce elevations of temperature and damage in biological tissues in vivo, particularly in the presence of bone (intracranial temperature elevation). Acoustic outputs used to induce these adverse bioeffects are within the diagnostic range, although exposure times are usually considerably longer than in clinical practice. Conditions present in early pregnancy, such as lack of perfusion, may favor bioeffects. Thermally induced teratogenesis has been shown in many animal studies, as well as several controlled human studies; however, human studies have not shown a causal relationship between diagnostic ultrasound exposure during pregnancy and adverse biological effects to the fetus. All human epidemiologic studies, however, were conducted with commercially available devices predating 1992, that is, with acoustic outputs not exceeding a spatial-peak temporal-average intensity of 94 mW/cm2. Current limits in the United States allow a spatial-peak temporal-average intensity of 720 mW/cm2 for fetal applications. The synergistic effect of a raised body temperature (febrile status) and ultrasound insonation has not been examined in depth. Available evidence, experimental or epidemiologic, is insufficient to conclude that there is a causal relationship between obstetric diagnostic ultrasound exposure and obvious adverse thermal effects to the fetus. However, very subtle effects cannot be ruled out and indicate a need for further research, although research in humans may be extremely difficult to realize.

Live scanning at ultrasound scientific conferences and the need for prudent policy.

The practice of using live models to demonstrate ultrasonographic imaging equipment at scientific meetings has gained popularity in recent years. However, different medical conferences organisers take different positions, possibly due to differences in interpretation of the safety issue and their definition of medically relevant use of diagnostic ultrasound (US). Some offer little, or no, restriction and other US societies have produced policy that is subject to various interpretations. For example, some justify the practice of scanning live models on the basis of an assumed "educational" benefit, but this is virtually impossible to measure in an objective sense. One issue that seems to have largely universal agreement is that nonmedical use of diagnostic US should be discouraged. The AIUM has published a statement that this is "contrary to responsible medical practice." However, the definition of "nonmedical" application is somewhat less certain. The scanning of live models to display equipment on exhibit areas may be considered "nonmedical." In fact, the BMUS has published guidelines with quite restrictive output limits to be applied for various "nondiagnostic" purposes. Although this safety issue remains debatable, the ASUM maintains a conservative unambiguous policy that prohibits scanning of live models in the exhibition area at scientific meetings. Issues such as biosafety, ethics and medicolegal implications require careful consideration by US organizations and professional conference organisers.

The cooling effect of liquid flow on the focussed ultrasound-induced heating in a simulated foetal brain.

There is a need to investigate the thermal effects of diagnostic ultrasound (US) to assist the development of appropriate safety guidelines for obstetric use. The cooling effect of a single liquid flow channel was measured in a model of human foetal brain and skull bone heated by a focussed beam of simulated pulsed spectral Doppler US. Insonation conditions were 5.7 micros pulses, repeated at 8 kHz from a focussed transducer operating with a centre frequency of 3.5 MHz, producing a beam of -6 dB diameter of 3.1 mm at the focus and power outputs of up to 255 +/- 5 mW. Brain perfusion was simulated by allowing distilled water to flow at various rates in a 2 mm diameter wall-less channel in the brain soft tissue phantom material. This study established that the cooling effect of the flowing water; 1. was independent of the acoustic source power, 2. was more effective close to the flow channel, for example, there was a marked cooling at a distance of 1 mm and negligible cooling at a distance of 3 mm from the channel; and 3. initially increased at low flow rates, but further increase above normal perfusion had very little effect.

Ultrasound-induced heating in a foetal skull bone phantom and its dependence on beam width and perfusion.

The cooling effect of single and multiple perfusing channels has been measured in a model of human foetal skull bone heated by wide and narrow beams of simulated pulsed spectral Doppler ultrasound (US). A focussed transducer operating with a centre frequency of 3.5 MHz, that emitted pulses of 5.7 micros duration with a repetition frequency of 8 kHz, was used. This produced a beam of power 100 +/- 2 mW with -6 dB diameters of 3.1 mm and 7.8 mm at 9 cm and 6 cm, respectively, from the transducer face. Arterial perfusion was simulated by allowing distilled water to flow in a large single channel or a grid of fine channels near the heated bone target. This study has established that: 1. perfusion-induced cooling is significantly enhanced when the bone phantom is heated by a wide rather than a narrow beam; 2. irrespective of the US beam width, a grid of small channels is more effective in cooling a heated bone target than a single larger diameter channel with the same volume flow rate; 3. the measured temperature rise and rate of temperature rise support the prediction of inverse proportionality to the US beam width; and 4. the perfusion time constants determined in our phantom model are 2 to 30 times larger than that assumed for the thermal index (TIB) algorithm.

Routine ultrasound scanning in first trimester: what are the risks?

Acoustic exposure from modern ultrasonographic devices is capable of disturbing biological tissue to varying extent depending on the type of ultrasound examination and the particular tissue under investigation. There is no strong evidence that these biological effects present a serious health hazard, however, knowledge is incomplete, particularly from human studies. Although ultrasound induced heating can be significant in later pregnancy, it is unlikely that diagnostic ultrasound poses a significant thermal risk to the developing embryo when used according to published safety guidelines. Nevertheless, uncertainties remain, particularly for nonthermal effects in early pregnancy where shear stresses from radiation pressure may become an important factor. The likelihood of producing some biological effects can be enhanced by new procedures such as the use of gas encapsulated echo-contrast agents. The particular sensitivity of the embryo to physical damage together with uncertainties of both risk and benefit suggest that caution should be applied to the scanning of early first trimester uncomplicated pregnancy.