Ultrasound Obstet. Gynecol. 2 (1992) 366-374 Diagnostic ultrasound: bioeffects and safety CRB. Merritt, F. W. Kremkau* and J. C. Hobbinst Department of Radiology, Ochsner Clinic and the Alton Ochsner Medical Foundation, New Ork Medical Ultrasound, Bowman Gray School of Medicine, Wake Forest University, Winston sans; *Center for lem, North Carolina: and ‘Department of Ohstetrics and Gynecology, University of Colorado School of Medicine, Denver. Colorado, USA, Key words: DIAGNOSTIC ULTRASOUND, BIOEFFECTS, SAFETY INTRODUCTION Medical diagnostic ultrasound has been in use for over 40 years, having found widespread applications in ana- tomie imaging and blood flow velocity measurement in Virtually all areas of medicine', Particularly in obstetrics, where radiography is not generally used, ultrasound has provided an important means for fetal dating, evaluation of fetal development, and diagnosis of fetal, wterme and placental abnormalities. During its lifetime as a diagnos- tic procedure, ultrasound has established an enviable safety record, with no evidence of biological effects on patients at intensities typical of instruments in current use, Despite lack of evidence of harm from diagnostic levels of ultrasound, good medical practice requires the physician to consider issues of risk and bencfit in per- forming diagnostic ultrasound examinations, and to take all proper measures to ensure maximal benefit with minimal risk’. This is particularly true as the population exposed to diagnostic ultrasound is growing at a rapid rate, and new applications of ultrasound, including duplex and color Doppler. are being introduced into ‘obstetrical practice. Ultrasound is being used by increas ing numbers of individuals with limited training and experience, resulting in greater risk of unnecessary or inappropriate fetal exposure. Bioeffects and safety implications of ultrasound have been studied by many investigators, with the first report appearing in the literature in 1927. Much work has been conducted regarding mechanisms of interaction, in vitro cellular effects, in vivo experimental animal effects, and epidemiology. These areas will be reviewed along with the basics of acoustical output measurement. Conelu- sions and recommendations relevant to clinical obstetric practice will be presented, with emphasis an the principle fof ALARA (As Low As Reasonably Achievable), in which the user is made aware of exposure conditions and manages power output so as to keep exposures as low as reasonably achievable in keeping with diagnostic objectives. MEASUREMENT OF ACOUSTICAL OUTPUT ‘An understanding of the basie concepts and terms used in describing the acoustical power output of an ultra sound scanner is an essential predicate to a discussion of issues of bioeffects. Most clinical applications employ pulsed ultrasound, in which brief bursts of acauistical energy transmitted into the hody are propagated as waves of alternating compression and rarefaction through tissues (Figure 1). In pulsed operating modes, the pulse duration is the time from the beginning to the end of a pulse, while the reciprocal of the interval between pulses (the pulse repetition petiod) is the pulse repetition frequency or PRT’. The duty factor is the pulse duration divided by the pulse repetition period and is an important determinant of the amount of energy intro- duced in scanning. Devices operating in pulsed Doppler modes generally have significantly higher duty factors than imaging devices. This, as we shall see, has important consequences in terms of biveffect production. Each ultrasound pulse results in peak compressional and peak raretactional pressures within the tissne (Figure 2). These peak pressure values are of interest with respect to mechanical mechanisms for bioeffeets such as cavitation. As pulses of ultrasound are transmitted through tissue, work is performed. From a biveflect viewpoint, the most important result of this work is the heating of tissues. The capacity to perform work is determined by the quantity of acoustical energy pro- duced. Acoustical power (expressed in watts or mil watts) describes the amount of acoustical energy produced in a unit of time. Measures of acoustical power vary, depending on the time interval considered (Figure 3). For example, the peak power that occurs uring the time interval of a single pulse differs consid- erably from the average power which occurs over a series of pulses. The time-averaged acoustical power is obtained by averaging the energy output from the beginning of one pulse to the beginning of the next pulse. In the ease of pulsed ultrasound, the average power is the peak power times the duty factor. ‘ornespondence: Dr C. R, B. Merrit, Ochsner Clinic, [S14 Telfersnn Highway, New Orleans TA 7OIDI TSA 365 Received 1-9-92 Accepted 18-8Bioeffeets and safety Merritt, Kremkaw and Hobbins Pulse Aneation Pulse repetition period Figure 1_ With pulsed ultrasound, the pulse duration is the time from the beginning to the end of a pulse. The interval between pulses is the pulse repetition period and the reciprocal of this isthe pulse repetition frequency. The duty factor isthe pulse duration divided by the pulse repetition period, and 1s an important determinant of the amount of energy introduced in scanning Peak rarefactional pressure Figure 2 Each ultrasound pulse results in peak compressional and peak rarefactional pressures. Pressure is expressed in pascal Unlike the illustration, these are often not identical. Measurements of peak compressional and rarefactional pressures are measured ta specified point, usually where the value would be maximum. Peak pressure values are of interest with respect to mechanical mechanisms for bioeffects such as cavitation Pressure > Peak power —& Average power Pressure | Figure 3 The time-averaged acoustical power is obtained by averaging the energy output from the beginning of one pulse to the beginning of the next pulse. Inthe case of pulsed ultrasound, the average power is the peak power times the duty factor. In (a) the puke repetition factor is high, esulting ina high duty factor and higher average power than in (h) where a longer pulse repetition period results in lower duty factor and thus lower average power Peak power Average power Although measurement of power provides an indica tion of the energy as it relates to time, it does not take into account the spatial distribution of the energy. For bioeffect purposes, a measurement describing the spatial distribution of power is needed. This is particularly true when focused transducers are used, as the power may be concentrated in small areas. Intensity describes the spatial concentration of power and is used to describe the exposure conditions at the target of the ultrasound beam. Intensity (1) is calculated by dividing the power Ultrasound in Obstetrics and Gynecology 367Bioeffects and safety by the area over which the power is distributed (Equation 1): 1(Wiem*) = Power (Wy/Area (em’) ao In the region of the focal zone of a focused transducer. spatial peak intensities may he considerably higher than at the transducer face. In pulsed modes of operation. intensity may be calcu- lated in several different ways (Table 1)". These take into account different power measurements (e.g, peak oF average) and the spatial distribution of the energy. The spatial peak intensity (Jo) is the highest intensity at any point in the ultrasound beam. The spatial average inten sity (sa) is the average value of intensity over some specified area. The spatial average, temporal average intensity (Isara) is obtained by dividing the temporal average power by the area of the transducer face. The spatialeaverage pulse-average intensity (Isans) is the spatial average of the intensity during a pulse Uso = Keaxalduty factor). Time-averaged intensity is an indicator of thermal effects and is important in safety considerations. This is provided in the spatial peak, temporal average intensity (fsa), which is the time-aver- aged intensity at the position of the spatial peak sora = Hsara x fells}. final measurement is the spar tial-peak, pulsc-average intensity (Igy). This is the intensity that exists during a pulse at the position of the spatial peak and is the highest of the four intensities Urea = Isara x (oedsa)/duty factor]. Using measure ‘ments obtained in vitro and applying certain assumptions regarding attenuation of the ultrasound beam, these intensities may be estimated (with limited precision) for typical clinical conditions ‘The measurements which are most relevant to known bioefTect mechanisms are the fers and the Isers. The fsora is used to estimate thermal bioeffects of ultrasound. while the Jorn is related to the likelihood of mechanical bioeffects such as cavitation. The sre tends to be higher in imaging than in Doppler instruments, while the Jer, is gencrally highcr in Doppler modes. Both of these intensities have been used by the Food and Drug Ad- ministration (FDA) in the regulation of ultrasound devices BIOEKFECT MECHANISMS, Currently, two potential mechanisms for producing bio- logical effects with ultrasound are recognized. These include thermal mechanisms, which result from tissue Table 1 Measurement of ultrasound intcasity* Intensity term Definition Ip the highest intensity in the ultrasound bear hea the average value of intensity over some specilied area sata temporal average power area of aasucer Tear Tarn = Taralduty factor seta Kora = Isera-to los Tyres Korn = Isaa(Kells)/dty factor 368 Ultrasound in Obstetrics and Gynecology Merritt, Kromkau and Hobbins heating due to the absorption of ultrasound as it passes through tissue, and non-thermal (mechanical) effects such as cavitation and radiation forces. Cavitation refers to the formation and collapse of microbubbles around cavitation nuclei. At present, thermal mechanisms are understood better with respect to their relationship to mammalian hioeffects than are the non-thermal mecha- nisms. ‘Thermal mechanism Measurements of temperature rise in tissues under the influence of ultrasound are difficult to make, and rele vant data are just beginning to emerge. Calculations of expected temperature rise based on tissue absorption coefficients, taking into account blood perfusion, have been accomplished**. The potential for tissue heating depends upon the ultrasound frequency, intensity, the area of the nitrasonnd heam, the duration of exposure and the rate of removal of heat away from the target by blood flow or conduction. The intensity of ultrasound at the target is affected by the absorption coefficient of the tissue along the path of the ultrasound beam and the ammount of energy removed by the attenuating pathway from the transducer to the site of interest (usually the focal zone of the transducer). As a consequence of increasing attenuation at higher frequencies, transducer frequency is a material factor. The presence of bone in the ultrasound path is also an important factor, as absorption is significantly increased at soft tissue/bone interfaces, resulting in a greater potential for heating than in Soft tissues alone. This effect has been shown in recent data for live rat fetuses, for hnman fetal hone in vitro and for adult rats and fetal mice''. For a given frequency and intensity, broader beams produce higher tempera- tures, In the usual diagnostic whrasound frequency range of 2-10 MHZ, the estimated temperature rise will not exceed 1 °C if the in situ spatial-average, temporal-aver~ age (SATA) intensity does not exceed 200 or 300 mW/em®, depending on beam width’ All models for estimating the thermal effects of ultra- sound make assumptions regarding the attenuating path. ‘way of the ultrasound beam. Conditions of attenuation vary considerably from one ultrasound application to another, and models attempting to predict heating must generalize in making assumptions regarding attemation One approach is to assume a uniform rate of attenuation by soft tissue. In some obstetrical applications, however, the path of the beam through amniotic fluid requires Jifferent assumptions. Thus a model based om au formly attenuating fluid medium would be appropriate for estimating the thermal effects in a firstrimester obstetrical evaluation, but would be inappropriate for an examination of the adult abdomen. On the other hand, in the second and third trimesters, the ossification of fetal bone produces soft tissue/bone interfaces Where greater absorption is present, resulting in potential for greater thermal effects under worst case exposure conditions.Bioeffects and safety pec 43) He Heavy exercise Emotion Moderate exercise Normal resting Merritt, Kremkau and Hobbins Figure 4 The results of calculating the expression ¢= 4°~" for temperatures from 37°C to 43°C are shown. The length of the bar for each temperature indicates the estimated time of ultrasound exposure that would he necessary to exceed the conditions lunder which bioeffects due to hyperthermia hive been reported. ‘considerable variation in core temperature of normal individual Non-thermal (mechanical) mechanisms Currently, with non-thermal mechanisms, there is much less knowledge regarding the likelihood of clinically significant bioeffects. The occurrence of cavitation in tissues is a variable phenomenon with many contributing, factors. Cavitation potential is related to the higher- amplitude short pulses that are typically used with imaging rather than with Doppler modes, and, with the limited data currently available, it is difficult to specify ultrasound levels at which cavitation will occur in sna ‘mals with diagnostically relevant pulse lengths and re- petition frequencies”. Its known from observations with lithotriptors (for which fundamental frequencies are lower than those for diagnostic instruments) that re peated pulses with peak pressures corresponding to intensities greater than 3300 Wlcm?can induce cavitation in mammalsé!", With continuous wave exposures, evi- dence for cavitation in tissues has heen reported for physical therapy frequencies and intensities" and higher”. An approach to predicting cavitational activity involving a range of bubble sizes has been developed". Experimental animal data have provided some carly support for this approach” Theimal and mechanical mechanisms are cach capable of producing biological effects at high levels. From a mechanistic approach, heat is the more likely mechanism of interest at diagnostic intensity levels, SATA intensities above about 200 or 300 mWiem? (de- pending on beam width) are in the range that could Tn considering hyperthermia, i is important to keep in mind the Is under physiological conditions, such as exercise produce temperature rises of biological significance in soft tissues, BIOLOGICAL CONSEQUENCES OF HYPERTHERMIA Since thermal mechanisms for producing ultrasound bioeffects clearly exist, itis appropriate to consider the ‘biological consequences of heating, despite the problem that predicting the amount of heating produced by ultasound in a given clinical situation is difficult and depends on a number of conditions. Biological con- sequences of heating have been reviewed and found to occur above 39°C. With higher temperatures, biological consequences occur in less exposure time" In any consideration of thermal effects, it is important to note the considerable normal biological variation in human body temperature. Normal body temperatires may range from slightly less than 36°C: to around 40°C, with even greater variation occurring with exercise and in response to disease. In competitive athletic activities, core temperatures as great as 41°C have been recorded”. From data available, it seems almost cestain that nearly everyone experiences times with at least brief elevations of body temperature to 4°C above normal as a result of exercise or fever (Figure 4) Since the fetus is generally regarded os the most sensitive target of ultrasound, information related to teratogenesis is of particular interest. The scientific lit- erature contains a great deal of information describing Ultrasound in Obstetrics and Gynecology 369Bioeffects and safety Merritt, Kremkaw and Hobbins pv-ew i "(pus : PY (pulses) : 5 5 Caria (pulsed) p> § 2 10! SPTA 1 Ww 2 108 108 Dwell time (seconds) Figure 5 The output (SPTA inter ity) of various classes of Doppler struments is related to the threshold for producing a 1° Celsius temperature rise (dotted line) with various dwell times. Most imaging devices fall well below this 1° threshold, Some peripheral vascular Doppler instruments do, however, have the capacity to approach this threshold. PV. peripheral vascular: CW. continuous wave. (Modified from reference 22) thermal bioeffeets, and teratogenic effects of hyperther ‘mia have been extensively studied in a number of primate and non-primate animal models’, In_ general, these studies indicate that, for a given biological defect, the exposure time required to produce the defect decreases as the temperature elevation increases. Miller and Ziskin have published an excellent and comprehensive review of data related to effects of hyperthermia", Bioeffects aUtributed (0 hyperthermia in this discussion include embryonic death (guinea pig, hamster), increased fetal mortality (mice), microcephaly (guinea pigs, sheep, ham- ster), and exencephaly (sheep), In recording the lowest temperature reported in the literature to produce a given bioeffeet and the briefest exposure to that temperature evation associated with the effect, a boundary is ob- served below which effects are not reported. This bound- ary is described by Equation 2: 4-7 ® This equation states the relationship between exposure time (1) in minutes and temperature (T) in degrees Celsius to produce a detectable bioetTect by heating, These relationships are shown graphically in Figure 4, Miller and Ziskin have suggested that the boundary line given by this expression might serve as a guide for determining whether a biological effect due to hyperthermia would bbe likely or not'’. They note that combinations of temperature elevation and exposure duration falling below the boundary line would be considered unlikely to produce harm, while exposure conditions above this line 370 Ultrasound in Obstetrics and Gynecology would have a significant possibility of damage. Based on these data, Miller and Ziskin suggest that a temperature rise of 1-2°C in an afebrile patient would not be likely to have a damaging effect: however, for exposures resulting in temperature rises of greater than 2°C. the duration of exposure becomes an important considera- tion in risk/benefit assessment’ ‘The World Federation of Ultrasound in Medicine and Biology (WFUMB) las concluded recently a comprehen sive review of thermal biveffects, and has issued several recommendations regarding thermal mechanisms for biological effects of ultrasound?!, WEUMB experts have concluded that “Based solely on a thermal criterion, a diagnostic exposure that produces a maximum tempera ture rise of 15°C above normal physiological levels 37°C) may be used without reservation in clinical ex- aminations’; and ‘Any in situ temperature rise to or above 41°C: (4°C Above normal temperature) for 15 minutes, should be considered hazardous in embryonic and fetal exposures: the longer this temperature is maintained, the areater the likelihood for damage to occur.’ WFUMB recommendations also note ‘The possible influeace of potentiating factors should also be considered. This indicates that Doppler ultrasound in a febrile patient might present an additional embryonic and fetal risk.” It is reassuring to note that currently available ultra- sound devices operate well below the boundary described above, Figure 5 shows the output of current types of ultrasound instruments and their relationship to the threshold for producing a 1° Celsius temperature rise™Biveffects and safety Merritt, Kremkau and Hobbins wer TTT TTT igure 6 Real-time imaging usesa scanned mode of operation In scanned modes, pulses of ultrasound fiom the tausducer ace directed down lines of sight (dotied lines) that are moved or steered in sequence to generate the image. This means that the ‘number of ultrasound pulscs arriving at @ given point in the patient over a given interval of time is relatively few and relatively Fite energy is deposited at any given location Most imaging devices fall well below this 1° threshold, Some peripheral vascular Doppler instruments do, how= tevei, have the capacity to approach this threshold. It is important to note that, to produce these conditions i vivo, even near a highly absorptive soft tissuc/bone interface, the focal zone must be fixed on the target for some time. In most clinical scanning situations, these conditions are unlikely. At present, relatively little is known of the biological ‘consequences of non-thermal mechanism effects in mam- malian systems, at least at levels of intensity likely to be encountered clinically. OPERATING MODES: CLINICA\ IMPLICATIONS Ultrasound devices may operate in several modes, includ ing real-time imaging, color Doppler imaging, spectral Doppler and M-mode. Pulsed ultrasound is used for each of these operating modes. The nature of the ultrasound pulses and the resulting acoustical exposure differ signif- icantly among these operating modes, resulting in impor- tant bioeffect considerations. Imaging is produiced in a scanned mode of operation (Fignre 6). In scanned modes pues of ultrasound from the transducer are directed down lines of sight that are moved or steered in sequence Figure 7. Spectral Doppler is an unscanned mode of operation in which multiple ultrasound pulses are sent in repetition along, line to collect the Doppler data. In this mode, the beam is stationary, resulting in considerably greater potential for heat: ing that in imaging modes to generate the image. This means that the number of ultrasound pulses arriving atu given point it dre patient over @ given interval of time is relatively few and relatively litte energy is deposited at any given location. In contrast, spectral Doppler is an unscanned mode of ‘operation in which multiple ultrasound pulses are sent in repetition along a line to collect the Doppler data (Figure 7). In this mode, the beam is stationary, resulting in considerably greater potential for heating than in imaging modes. For imaging, the frequency at which the pulses are emitted (the pulse repetition frequency or PRE) is usually a few thousand Hz, with very short pulses. With Doppler. longer pulse durations are used than with imaging. In addition. in order to avoid aliasing and other artifacts with Doppler, itis often necessary (0 use higher-pulse repetition frequencies than with imaging applications. Longer pulse duration and higher pulse repctition frequency result in higher duty factors for Doppler modes of operation, and inerease the amount ‘of energy introduced in scanning. Color Doppler, al- though a scanned mode, produces exposure conditions between those of real-time imaging and Doppler, because color Doppler devices tend to send more pulses down each scan line and may employ longer pulse durations than imaging devices. Clearly, every user needs to be aware of the fact that, when he or she switches from an imaging to a Doppler mode. the exposure conditions and potential for bioeffects change Ultrasound in Obstetrics and Gynecology 371Bioeffects and safety With current devices operating in imaging modes, bioeffect concerns are minimal as intensities sufficient to produce measurable heating are seldom used. With Doppler, the potential for thermal effects is. greater Preliminary measurements on commercially available instruments suggest that at least some of these are capable of producing temperature rises of greater than 1°C at soft tissue/bone interfaces if the focal zone of the Uuansduecer is held stationary. Care is therefore warranted ‘when Doppler measurements are obtained at or near soft tissuc/bone interfaces, as may be the case in the second and third trimesters of pregnancy. In these situations, thoughtful application of the principle of ALARA is required. Under the principle of ALARA, the user should use the lowest possible acoustical exposure to ‘obtain the necessary diagnostic information, In obstetrical ultrasound, there is increasing use of Doppler and color Doppler instruments. As a result, fetuses are now being exposed to conditions quite differ ent than before and in some cases at higher acoustical ‘output chan before, In obstetrical applications, the need for prudent use is emphasized. Users should attempt (0 prevent unnecessary exposure and refrain from perform- ing examinations under high-exposure conditions unless they are clinically warranted. Examination skill and experience in performing the study are important to permit efficient collection of diagnostic information with, minimal exposure. THE FDA AND OUTPUT DISPLAY Any discussion of ultrasound power output and bioef- fects must include comment on the role of the US Food. and Drug Administration, as the FDA has been involved intimately with these issues through its regulation of ultrasound devices. For over 15 years, ultrasound devices, have been subject to restrictions in maximum acoustical output by regulation of the Food and Drug Administra- tion. The Medical Devices Amendment enacted by Con- gress on May 28, 1976 provided for premarket approval of medical devices, based on the demonstration of substantial equivalence in safety and efficacy of new devices to devices on the market before May 28, 1976. For ultrasound devices, the FIDA has used as its test of equivalent safety the requirement that acoustical output levels measured according to certain specifications fall within arbitrary limits derived from the maximum inten- sities in use before May, 1976. This approach has been criticized by the technical, scientific and medical profes- sions and by the ultrasound industry, because the process by which ultrasound equipment has been regulaicd is not, based on any objective evaluation of the potential for ultrasound bioeffects by medical devices. The FDA approach implies a relationship between ultrasound bioeffects and the arbitrary output limits used for regu- latory purposes, which has not been proven. Another objection is that the arbitrary limits used for regulation have the potential for retarding the introduction of promising applications of ultrasound, particularly those involving deep Doppler, in which higher acoustical out- 372 Ultrasound in Obstetrics and Gynecology Merritt, Kremkau and Hobbins puts may be necessary for maximal clinical benefit. Since the limits used in the approval of ultrasound devices by the FDA have been arbitrary and not directly related to the mechanisms hy which bioeffects might he produced, fr the levels necessary to produce them, many users of ultrasound, being properly informed that the risk for bioeffects with diagnostic instruments is extremely low. have had litle interest or need co understand bivefTect mechanisms or their implications in clinical practice. Since 1986, at the urging of the American Institute of | Ultrasound in Medicine (ATUM) and other professional organizations, the FDA has shown interest in exploring new pathways for approval of instrumentation using an alternate procedure for determination of substantial equivalence in safety. Based on the incorporation of certain user feedback features into ultrasound devices, the EDA has reversed an earlier position by allowing, fetal Doppler devices into the market through the pre- market notification process. The FDA also indicated its, willingness t0 implement a new policy for determining substantial equivalence of diagnostic ultrasound devives, based on the incorporation of instrument display features to provide user feedback related to acoustical exposure, the provision of certain low-power default output levels, and the provision of override controls for certain modes, of operation. This approach, based on the display of acoustical output information to the user, rests on the premise that an educated user, when provided with appropriate exposure feedback and default safeguards, is in the best position to make a proper risk-benefit assessment with respect to the performance of an ultrae sound examination in a given clinical setting. With FDA support, a voluntary standard for the display of acous- tical output information for the ultrasound user has been developed and approved or endorsed by a number of professional organizations”. This standard provides for the real-time display of indices related to thermal and mechanical mechanisms, for the production of ultra- sound biveffeets intended to aid users in keeping expo- sures as low as reasonably achievable in keeping with the diagnostic objectives (the concept of ALARA). Since current data indicate that the most relevant ‘mechanisms for production of bicefects with ultrasound are the thermal and mechanical mechanisms, the ontput display will provide indices related to the potential for these thermal and mechanical effects. The display is meant to be visible to the user at all times during the ultrasound examination and will be continually updated as exposure conditions change, The thermal index (TT) is the ratio of total acoustic power to the acoustic power required to raise tissue temperature through 1 °C under certain assumptions. Thus a TI of 2 indicates the poten- tial of a 2° heating effect, a TI of 4 a 4? rise, etc. If a system is not capable of exceeding a TI of 1.0, then it will not be required to display values of the TI. A TI is used to indicate the worst case potential for heating under actual examination conditions. Since the potential for heating is affected by the attenuating pathway and the presence of bone and soft tissue interfaces, three attenuation models have been used in calculation of theBioeffects and safety TI. For non-obstetric studies in which soft tissues are the primary attenuating structures, a soft tissue attenuation ‘model is indicated. In first-trimester obstetric examina- tions, where there isa significant path through amniotic fluid, a uniform attenuation model based on the presence of fluid is to be used. In second- and third-trimester obstetric examinations, a model taking into account bone/soft tissue interfaces should be used. In imaging modes, a mechanical index (MI) will be provided as a relative indicator of the potential for non-thermal bioeffects such as cavitation. The MI is, defined as the spatial peak of the peak rarefaction pressure, derated by 0.3 dB/cm MHz, at each point along, the beam axis, divided by the square root of the center frequency. If a system is not capable of exceeding an MI of 1.0, then it will not be required to display values of the ML To use properly the feedhack provided by display of the TI and MI, users must understand the basies of the mechanisms by which ultrasound bioeffects are known to occur and the situations in which the indices are likely to overestimate (and rarely underestimate) exposure conditions in viva, Atmed with this inforntation, the user will be then adequately prepared to implement the principles of ALARA. The goal of these measures is to ensure the continuation of the outstanding safety record of diagnostic ultrasound without impeding the develop- ‘ment of useful diagnostic applications of new techniques. In order to meet this challenge, itis essential that all users of ultrasound are prudent users ~ users who understand the potential risks and henefits of ultrasound examina- tions as well as the risks and benefits of alternate approaches; who know the output of their equipment; who are skilled in the performance and interpretation of examinations; and who understand and observe the principles of ALARA, CONCLUSIONS REAL ISSUE? Although there is clearly a need for users of ultrasound {o be aware of bioeffect concerns, it is equally important to place bioeffect concerns in perspective by considering, another key element in the safe use of ultrasound ~ the user. The knowledge and skill of the user are a major determinant of the risk/benefit implications of the use of ultrasound in a specific clinical situation, For example, an unrealistic emphasis on risks may discourage an appropriate use of ultrasound, resulting in harm to the patient by preventing the acquisition of useful informa- tion or by subjecting the patient to another more haz~ ardous examination. The skill and experience of the individual performing and interpreting the examination are likely to have a major impact on the overall benefit, of the examination. In view of the rapid growth of ultrasound and its proliferation into the hands of mini- ‘mally trained clinicians, it is likely that far more patients, are likely to be harmed by misdiagnosis resulting from improper indications, poor examination technique and RE BIOEFFECTS THE Merritt, Kremkau and Hobbins errors in interpretation than from biological effects. The failure to diagnose significant anomaly or misdiagnosis of an ectopic pregnancy are real dangers and poorly- trained users may in fact turn out to be the greatest rent hazard of diagnostic ultrasound. In conclusion, an understanding of biceffects is essen- tial for the prudent use of diagnostic ultrasound and is, important in ensuring that the excellent risk/benefit performance of diagnostic ultrasound is preserved. All users of ultrasound shoukd be prudent users, under- standing as fully as possible the potential risks as well as the obvious benefits of ultrasound examinations as well as those of alternative diagnostic methods. Users should bbe well trained in performing and interpreting their examinations and should implement ALARA. REFERENCES 1. Goldberg, B. B. and Kimmelman, B.A. (1988). Medical Diagnostic Ultrasound: A Retrospective on its 40th Anniver sary, pp. 1-49. (Rochester: Eastman Kodak Company) American Institute of Ultrasound in Medicine (1988). 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