Marvin C. Ziskin

International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine

Modern sophisticated ultrasonographic equipment is capable of delivering substantial levels of acoustic energy into the body when used at maximum outputs. The risk of producing bioeffects has been studied by international expert groups during symposia supported by the World Federation for Ultrasound in Medicine and Biology (WFUMB). These have resulted in the publication of internationally accepted conclusions and recommendations. National ultrasound safety committees have published guidelines as well. These recommendations and safety guidelines offer valuable information to help users apply diagnostic ultrasound in a safe and effective manner. Acoustic output from ultrasound medical devices is directly regulated only in the USA and this is done by the Food and Drug Administration (FDA). However, there is also a modern trend towards self-regulation which has implications for the worldwide use of diagnostic ultrasound. It has resulted in a move away from the relatively simple scheme of FDA-enforced, application-specific limits on acoustic output to a scheme whereby risk of adverse effects of ultrasound exposure is assessed from information provided by the equipment in the form of a real-time display of safety indices. Under this option, the FDA allows a relaxation of some intensity limits, specifically approving the use of medical ultrasound devices that can expose the fetus or embryo to nearly eight times the intensity that was previously allowed. The shift of responsibility for risk assessment from a regulatory authority to the user creates an urgent need for awareness of risk and the development of knowledgeable and responsible attitudes to safety issues. To encourage this approach, it is incumbent on authorities, ultrasound societies and expert groups to provide relevant information on biological effects that might result from ultrasonographic procedures. It is obvious from the continued stream of enquiries received by ultrasound societies that effective dissemination of such knowledge requires sustained strenuous effort on the part of ultrasound safety committees. There is a strong need for continuing education to ensure that appropriate risk/benefit assessments are made by users based on an appropriate knowledge of the probability of biological effects occurring with each type of ultrasound procedure. The primary purpose of this paper is to draw attention to current safety guidelines and show the similarities and areas of general agreement with those issued by the parent ultrasound organisation, the WFUMB. It is equally important to identify gaps in our knowledge, where applicable.

The sensitivity of biological tissue to ultrasound

Mammalian tissues have differing sensitivities to damage by physical agents such as ultrasound. This article evaluates the scientific data in terms of known physical mechanisms of interaction and the impact on pre- and postnatal tissues. Actively dividing cells of the embryonic and fetal central nervous system are most readily disturbed. As a diagnostic ultrasound beam envelopes a small volume of tissue, it is possible that the effects of mild disturbance may not be detected unless major neural pathways are involved. There is evidence that ultrasound can be detected by the central nervous system; however, this does not necessarily imply that the bioeffect is hazardous to the fetus. Biologically significant temperature increases can occur at or near to bone in the fetus from the second trimester, if the beam is held stationary for more than 30 s in some pulsed Doppler applications. In this way, sensory organs that are encased in bone may be susceptible to heating by conduction. Reports in animals and humans of retarded growth and development following frequent exposures to diagnostic ultrasound, in the absence of significant heating, are difficult to explain from the current knowledge of ultrasound mechanisms. There is no evidence of cavitation effects occurring in the soft tissues of the fetus when exposed to diagnostic ultrasound; however, the possibility exists that such effects may be enhanced by the introduction of echo-contrast agents.

The comet tail artifact.

A description and explanation of an unexpected echographic appearance in a patient who had sustained an abdominal shotgun wound is presented. In the B‐scans, a trail of dense continuous echoes, simulating a comet tail, is seen distal to each lead pellet. This comet tail appearance is shown to be a type of reverberation artifact. The effect of object size, shape, composition, and orientation on the appearance of this artifact is demonstrated.

Kinematics of the Beating Heart

We introduce a new approach to the quantification of myocardial strain. It utilizes the theoretical frame work of kinematics and can thus account for the large time-varying displacements present in the intact beating heart. For arbitrary small segments of myocardium, we show how these displacements can be described completely by a rotation tensor and a stretch tensor. We demonstrate the physiologic meaning of this analysis in an anesthetized dog. An epicardial region was seen to exhibit a local twist quantified by the rotation tensor and a segmental shortening quantified by the stretch tensor.

Fetal Thermal Effects of Diagnostic Ultrasound

Processes that can produce a biological effect with some degree of heating (ie, about 1°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.

American Institute of Ultrasound in Medicine consensus report on potential bioeffects of diagnostic ultrasound: Executive summary

The continued examination of potential biological effects of ultrasound and their relationship to clinical practice is a key element in evaluating the safety of diagnostic ultrasound. Periodically, the American Institute of Ultrasound in Medicine (AIUM) sponsors conferences bringing experts together to examine the literature on ultrasound bioeffects and to develop conclusions and recommendations related to diagnostic ultrasound. The most recent effort included the examination of effects whose origins were thermal or nonthermal, with separate evaluations for potential effects related to fetal ultrasound. In addition, potential effects due to the introduction of ultrasound contrast agents were summarized. This information can be used to assess risks in comparison to the benefits of diagnostic ultrasound. The conclusions and recommendations are organized into 5 broad categories, with a comprehensive background and evaluation of each topic provided in the corresponding articles in this issue. The following summary is not meant as a substitute for the detailed examination of issues presented in each of the articles but rather as a means to facilitate further study of this consensus report and implementation of its recommendations. The conclusions and recommendations are the result of several rounds of deliberations at the consensus conference, subsequent review by the Bioeffects Committee of the AIUM, and approval by the AIUM Board of Governors.

Heating patterns in biological tissue phantoms caused by millimeter wave electromagnetic irradiation

Distribution of millimeter wavelength electromagnetic energy absorption in surface layers of biological tissue models was studied using methods of Infrared Thermography. 0.1 mm thin-layer phantoms were irradiated in the near field using different types of horn antennas in the 37-78 GHz frequency range. Heating patterns were recorded during microwave irradiation, and surface SAR distributions mere calculated. The temperature resolution was better than 0.05 K. It was found that horn antennas produced nonuniform heating patterns in irradiated objects. These nonuniform patterns were due to a geometrical resonance resulting from a secondary wave-mode interaction between an irradiated object and the corresponding critical cross-section of the horn antenna. Local SAR values in hot spots exceeded the spatially averaged values by over 10 times, and the widths of these hot spots at 5 times the average SAR were often 1 mm or less. The location, quantity, number and size of the local field absorption maxima of irradiated objects strongly depended on the frequency of electromagnetic irradiation, with equivalent Q-factors of 500 or more. These findings provide an explanation for a number of frequency-dependent effects of millimeter wave electromagnetic irradiation.<<ETX>>

Clinical manifestations of the comet tail artifact.

The comet tail artifact appears as a dense tapering trail of echoes just distal to a strongly reflecting structure. This reverberation type of artifact occurs when there is a marked difference in acoustic impedances between an object and its surround. This paper presents a spectrum of comet tail artifacts seen in clinical practice and discusses their usefulness in decision making.

Suppression of pain sensation caused by millimeter waves: a double-blinded, cross-over, prospective human volunteer study.

UNLABELLED We conducted a double-blinded, randomized, cross-over, prospective trial to evaluate the pain relief effect of millimeter waves (MW) under experimental conditions. The cold pressor test was used as a model of tonic aching pain. Twelve healthy male volunteers were exposed to an active medical MW generator and to a disabled sham generator with at least 24 h between exposures. Characteristics of continuous-wave electromagnetic output from the active generator were: wavelength 7.1 mm, incident power density 25 +/- 5 mW/cm2, and duration of exposure 30 min. MW produced a significant (P < 0.05) suppression of pain sensation, with an average 37.7% gain in pain tolerance and a 49.3% increase in pain sensitivity range (the latter being the difference between pain tolerance and pain threshold values). Of the 12 volunteers, 7 (58.3%) reacted to the active MW generator with an increased pain tolerance, and the individual reactions varied from 120% to 315% comparison with their own preexposure levels. MW therapy can potentially be used as a supplementary or alternative treatment for pain relief. IMPLICATIONS Pain management is still a significant medical problem. In a double-blinded, experimental setting, we confirmed that low-intensity millimeter wave therapy can reduce pain sensitivity in healthy human volunteers and can potentially be used as a supplementary or alternative treatment for pain relief.

Reflection and absorption of millimeter waves by thin absorbing films

Reflection, transmission, and absorption of mm-waves by thin absorbing films were determined at two therapeutic frequencies: 42. 25 and 53.57 GHz. Thin filter strips saturated with distilled water or an alcohol-water solution were used as absorbing samples of different thicknesses. The dependence of the power reflection coefficient R(d) on film thickness (d) was not monotonic. R(d) passed through a pronounced maximum before reaching its steady-state level [R(infinity)]. Similarly, absorption, A(d), passed two maximums with one minimum between them, before reaching its steady-state level [A(infinity)]. At 42.25 GHz, A(d) was compared with absorption in a semi-infinite water medium at a depth d. When d < 0.3 mm, absorption by the film increased: at d = 0.1 mm the absorption ratio for the thin layer sample and the semi-infinite medium was 3.2, while at d = 0.05 mm it increased up to 5.8. Calculations based on Fresnel equations for flat thin layers adequately described the dependence of the reflection, transmission, and absorption on d and allowed the determination of the refractive index (n), dielectric constant (epsilon), and penetration depth (delta) of the absorbing medium for various frequencies. For water samples, epsilon was found to be 12.4-19.3j, delta = 0.49 mm at 42.25 GHz, and epsilon = 9.0-19.5j, delta = 0.36 mm at 53.57 GHz. The calculated power density distribution within the film was strongly dependent on d. The measurements and calculations have shown that the reflection and absorption of mm-waves by thin absorbing layers can significantly differ from the reflection and absorption in similar semi-infinite media. The difference in reflection, absorption, and power density distribution in films, as compared to semi-infinite media, are caused by multiple internal reflections from the film boundaries. That is why, when using thin phantoms and thin biological samples, the specifics of the interaction of mm-waves with thin films should be taken into account.