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46 PART I Physics

1. Current ultrasound systems can produce cavitation in vitro

and in vivo and can cause blood extravasation in animal tissues.

2. he MI can gauge the likelihood for cavitation and apparently

works better than other ield parameters in predicting

cavitation.

3. Several interesting results have been observed concerning

animal models for lung damage, which indicate a potential

very low threshold for damage, but the implications for human

exposure have not yet been determined.

4. In the absence of gas bodies, the threshold for damage is

much higher. (his is signiicant because ultrasound examinations

may be performed predominantly in tissues with no

identiiable gas bodies.)

The AIUM Statement on Mammalian

Biological Effects in Tissues With Naturally

Occurring Gas Bodies 86

APPROVED MARCH 25, 2015

Biologically signiicant adverse nonthermal effects have been

identiied in tissues containing stable bodies of gas for

diagnostically relevant exposure conditions. Gas bodies occur

naturally in postnatal lungs and in the folds of the intestinal

mucosa. This statement concerns naturally occurring gas

bodies encountered in pulmonary and abdominal ultrasound,

whereas a separate statement deals with the use of gas

body contrast agents.

1. The outputs of some currently available diagnostic

ultrasound devices can generate levels that produce

capillary hemorrhage in the lungs 60 and intestines 50 of

laboratory animals.

2. Thresholds for adverse nonthermal effects associated

with naturally occurring gas bodies depend on tissue

characteristics and the physiologic status, including

anesthesia, 87 and on physical ultrasound parameters,

including attenuation by intervening tissue, exposure

duration, ultrasonic output, frequency, pulse duration,

and pulse repetition frequency. 50

3. A mechanical index (MI) a has been formulated to assist

users in evaluating the likelihood of mechanical

(nonthermal) adverse biological effects for diagnostically

relevant exposures, and its value is displayed on screen

in accordance with output display speciications.

4. The minimum threshold value of the experimental MI

(the in situ value of the peak rarefactional pressure

amplitude divided by the square root of the frequency)

for pulmonary capillary hemorrhage in laboratory

mammals is approximately 0.4. The corresponding

threshold for the intestine is MI = 1.4.

5. The implications of these observations for human exposure

during thoracic or abdominal ultrasound examinations are

yet to be determined.

a The MI is equal to the derated peak rarefactional pressure (in

megapascals) at the point of the maximum derated pulse intensity

integral divided by the square root of the ultrasonic center frequency

(in megahertz). 12

AIUM, American Institute of Ultrasound in Medicine.

Reproduced with permission from American Institute of Ultrasound in

Medicine. AIUM Statement on Mammalian Biological Effects of Heat:

AIUM; 2015. Available from: http://www.aium.org/

oficialStatements/6. 86

OUTPUT DISPLAY STANDARD

Several groups, including the FDA, AIUM, and NEMA, have

developed the Standard for Real-Time Display of hermal and

Mechanical Acoustical Output Indices on Diagnostic Ultrasound

Equipment, which introduces a method to provide the user with

information concerning the thermal and mechanical indices.

Real-time display of the MI and TI will allow a more informed

decision on the potential for bioefects during ultrasound examinations

(Fig. 2.10). he standard requires dynamic updates of

the indices as instrument output is modiied and allows the

operator to learn how controls will afect these indices. Important

points to remember about this display standard include the

following:

• he MI should be clearly visible on the screen (or the operator

should be alerted by some other means) and should begin to

appear when the instrument exceeds a value of 0.4. An exception

is made for instruments incapable of exceeding index

values of 1; these are not required to display the bioefects

indices such as MI.

• When the indices are required to be displayed, both indices

are to be displayed at all times.

• he standard also requires that appropriate default output

settings be in efect at power-up, at new patient entry, or

when changing to a fetal examination. Ater that time the

operator can adjust the instrument output as necessary to

acquire clinically useful information while attempting to

minimize the index values.

• As indicated previously, the bioefects indices do not include

any factors associated with the time taken to perform the

scan. Eicient scanning is still an important component in

limiting potential bioefects.

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FIG. 2.10 Display of Bioeffects Indices. Typical appearance of an

ultrasound scanner display showing (right upper corner) the thermal

index in the Bone Thermal Index (TIB) and mechanical index (MI) for an

endocavitary transducer.

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