Ultrasound Safety & ALARA
The information presented in this section is based primarily on Health Canada’s Guidelines for the Safe Use of Diagnostic Ultrasound (2001) [10]. Where applicable, additional sources have been cited to supplement or update specific recommendations.
Foundations of Ultrasound Safety
Diagnostic ultrasound has an excellent safety record and does not use ionizing radiation. However, ultrasound transfers energy into tissues and, under certain conditions, may produce biological effects. Understanding these effects helps clinicians use ultrasound safely.
Ultrasound energy can interact with tissue through two primary mechanisms: thermal effects and mechanical effects.
1) Thermal Effects
Thermal effects occur when tissues absorb ultrasound energy and convert it to heat. The amount of heating depends on both the ultrasound exposure and the type of tissue being scanned.
Bone absorbs ultrasound energy more readily than soft tissue, while fluids absorb very little. As a result, temperature increases are of greater concern when bone is present within the ultrasound beam, including fetal bone during pregnancy. Because bone absorbs ultrasound energy efficiently, less acoustic power is required to produce a temperature rise than in soft tissue [11].
Heat may also be generated by the transducer itself. Additional caution may be warranted during transvaginal, transrectal, and transesophageal examinations, as transducer heating may contribute to local tissue warming. Similar considerations apply when bone is located close (within 1cm) to the transducer surface, such as during cranial imaging.
2) Mechanical Effects
Mechanical effects are non-thermal interactions caused by pressure changes within the ultrasound wave. The primary concern is cavitation, which refers to the response of gas bubbles exposed to alternating pressure cycles. Cavitation may occur as stable cavitation, where bubbles repeatedly expand and contract, or inertial cavitation, where bubbles grow and collapse rapidly [11].
In routine diagnostic ultrasound, cavitation is considered unlikely in most tissues because naturally occurring gas bubbles are generally absent. The theoretical risk is greater in tissues containing gas, such as the lungs or bowel, and when ultrasound contrast agents containing microbubbles are used.
Figure 1. Ultrasound safety basics
Machine Parameters
Several parameters influence ultrasound exposure and are displayed on modern ultrasound systems.
Dwell Time
Dwell time refers to the amount of time the transducer actively transmits ultrasound while remaining over a particular area. Dwell time is one of the most important factors affecting tissue exposure and can be readily controlled by the operator.
Thermal Index
The Thermal Index (TI) is an indicator of the potential for tissue heating. It represents the ratio of the emitted ultrasonic power to the power required to raise tissue temperature by approximately 1°C under specific model conditions.
The TI indicator is displayed on the ultrasound screen.
Different TI’s are used depending on the tissue being examined:
· TIS (Soft Tissue):used when primarily soft tissue is within the ultrasound path.
· TIB (Bone):used when bone, including 2nd and 3rd trimester fetal bone, is within the beam.
· TIC (Cranial):used when bone is in contact or within 1cm of the transducer.
Because bone absorbs ultrasound energy more readily than soft tissue, TIB and TIC are particularly important when scanning fetal, neonatal, or cranial structures.
Mechanical Index
The Mechanical Index (MI) is an indicator related to the potential for mechanical effects, including cavitation. It reflects the relationship between ultrasound pressure and transducer frequency.
Modern diagnostic ultrasound systems are designed with a maximum attainable MI of 1.9, a limit intended to substantially reduce the likelihood of clinically significant mechanical injury.
The MI indicator is displayed on the ultrasound screen
Figure 2. MI and TIS as seen on a SonositePX PoCUS unit.
Output Power
Output power refers to the amount of ultrasound energy emitted by the transducer, or acoustic output. Increasing output power increases the amount of energy delivered to tissues and may increase the potential for thermal or mechanical effects.
Scanning tip: Gain vs Output Power
Gain and output power are not the same. Gain adjusts how returning echoes are displayed on the screen and affects image brightness without increasing patient exposure.
Output power changes the amount of ultrasound energy transmitted into the patient. Increasing the power directly on the machine is not recommended.
B-Mode and Doppler Modes
Different imaging modes produce different levels of acoustic output.
· B-mode generally produces the lowest acoustic output.
· M-mode may produce higher outputs than B-mode.
· Color Doppler and pulsed-wave Doppler typically generate higher acoustic outputs and have a greater potential for tissue heating.
Although M-mode and Doppler are valuable clinical tools, their use should be guided by the ALARA principle, particularly when imaging sensitive tissues [12].
Pulse Repetition Frequency (PRF):
PRF refers to the number of ultrasound pulses transmitted by the transducer each second. PRF is most commonly adjusted during Doppler examinations and contributes to the higher acoustic outputs associated with Doppler imaging. Increasing PRF increases the number of ultrasound pulses transmitted per second and may increase acoustic exposure.
Scanning tip: On many ultrasound systems, the Doppler scale control is the user-facing adjustment for PRF. Increasing the scale typically increases the PRF, allowing higher velocities to be displayed and reducing aliasing, while decreasing the scale lowers the PRF and improves sensitivity to slower flow.
Frequency
Lower-frequency transducers provide greater penetration but may increase TI and MI because more acoustic energy is required to image deeper structures. Use the highest frequency that adequately answers the clinical question.
Focus Position
The focal zone is the region where the ultrasound beam is narrowest and most concentrated. Moving the focus deeper requires the system to concentrate energy at greater depths, which may increase TI and MI [13]. Position the focal zone at or just below the structure of interest whenever possible.
Scan Area
Scan area refers to the width or size of the imaging field. Reducing the scan area concentrates ultrasound energy into a smaller region and may increase TI and MI. , particularly when the zoom box is narrow and deep [13].
Figure 3. Parameters affecting TI/MI and overall theoretical risk of ultrasound
ALARA and Practical Safety Behaviors
ALARA stands for As Low As Reasonably Achievable and is the guiding principle for safe ultrasound practice. The goal is to obtain the diagnostic information needed while minimizing unnecessary exposure.
In diagnostic ultrasound, ALARA refers to using the lowest combination of acoustic output and exposure time necessary to answer the clinical question [10].
Practical ALARA behaviors include:
· Minimize dwell time and avoid holding the transducer stationary longer than necessary.
· Remove the probe from the patient when real-time imaging is no longer required.
· Use freeze-frame and cine-loop functions to review images rather than continuing live scanning.
· Use Doppler modes only when clinically indicated.
· Restrict Doppler sampling to the area of interest by using the smallest practical Doppler box.
· Always select the pre-programmed scanning preset when possible.
· Monitor displayed TI and MI values throughout the examination.
· When monitoring TI values, consider the tissues within the ultrasound beam and use the TI indicator (TIS, TIB, TIC) that best reflects the tissue at greatest risk of heating.
· Use the lowest output settings that still provide diagnostically useful images.
If TI or MI values increase, exposure time should be minimized and output settings reduced whenever possible.
Special Safety Considerations
Pregnancy
Ultrasound is widely used during pregnancy and has an excellent safety record. However, additional caution is recommended because the developing embryo and fetus may be more susceptible to thermal effects.
During the first eight weeks after conception, organogenesis is occurring and developing tissues may be particularly sensitive to environmental influences. The fetal brain and spinal cord continue developing throughout pregnancy and into the neonatal period [12]. As fetal bone develops, absorption of ultrasound energy increases, potentially leading to greater tissue heating.
Different TI models are therefore used throughout pregnancy:
· TIS is most relevant during early pregnancy.
· TIB becomes increasingly important once fetal bone is present within the ultrasound beam, during the 2nd and 3rd [11,14].
When scanning pregnant patients, output power and exposure time should be kept as low as reasonably achievable. Obstetric examinations are typically performed using default settings that maintain a TI <0.7. If TI exceeds 0.7, scan duration should be minimized. An MI <0.7 is also recommended [11].
Particular caution should be exercised when using Doppler modes, especially during the first trimester, as Doppler generally produces higher acoustic outputs than B-mode imaging. Routine use of color and pulsed-wave Doppler during the first trimester is generally discouraged unless there is a specific clinical indication. When Doppler is indicated, exposure time should be minimized and TI values kept as low as possible (TI <1.0, no more than 5-10 minutes) [11].
Examination of the mother’s uterine vessels safe when the fetus is outside the radiated field.
Additional caution may also be warranted when maternal temperature is elevated, as fetal temperature may be influenced by both maternal and ultrasound-related heating.
Ocular Ultrasound
The eye is particularly sensitive to thermal effects because the lens and intraocular fluids have limited cooling blood supply [12]. Because of this, it is essential to maintain a very low MI and TIS during ocular scanning to minimize the theoretical risk of tissue damage [11].
When performing ocular ultrasound:
· Use an ophthalmic preset when available.
· Maintain a MI of 0.23 or less.
· Maintain a TIS of 1.0 or less.
· Avoid colour and pulsed Doppler unless specifically indicated.
These precautions are particularly important in pediatric ocular examinations.
Neonatal and Pediatric Imaging
Additional caution is recommended when performing ultrasound examinations in neonates, infants and young children. Certain tissues and organs may be more susceptible to potential biological effects of ultrasound, either because they are still developing (such as the brain and spinal cord) or because they contain gas [12]. These considerations that are particularly relevant given the frequent use of cranial, lung, and bowel ultrasound in neonatal and pediatric practice.
When imaging pediatric patients, examinations should be clinically justified, performed efficiently, and exposure times kept as short as reasonably achievable.
Brain, head, and spine:
When performing neonatal transcranial or spinal ultrasound examinations, if the TIC exceeds 0.7, exposure time should be restricted, with progressively shorter scan times recommended as TIC increases.
Prolonged scanning of the central nervous system is not recommended [12].
Lungs:
If the MI exceeds 1.0, there is a small potential risk of capillary hemorrhage during ultrasound examinations involving the neonatal or infant chest [10].
More recent literature suggests that, in neonatal ultrasonography, there may be a potential risk of lung damage even at MI values of approximately 0.3, and that the risk of cavitation increases when MI exceeds 0.7 [11].
Scanning should therefore be as short as possible and performed in accordance with ALARA principles.
Bowel
The bowel is another gas-containing organ where mechanical effects are of theoretical concern. Ultrasonically induced capillary hemorrhaging of the intestine has been associated with conditions that inhibit intestinal peristalsis or promote intraluminal or submucosal gas collections. At current diagnostic ultrasound exposure limits (MI ≤ 1.9), clinically significant intestinal hemorrhage is considered unlikely; however, the likelihood may increase in pathological conditions associated with impaired intestinal motility or increased intraluminal gas [10].
Ultrasound Contrast Agents
Ultrasound contrast agents can contain gas-filled microbubbles that increase the potential for cavitation and other mechanical effects. As a result, additional attention should be paid to the MI when contrast agents are used, as the theoretical risk of cavitation increases in the presence of microbubbles. Although contrast-enhanced ultrasound is not routinely used in most PoCUS applications, clinicians should be aware of this consideration.
Communicating Safety to Patients and Families
Patients and families may have questions about ultrasound safety, particularly during pregnancy and pediatric examinations.
When discussing ultrasound safety:
· Explain that ultrasound does not use ionizing radiation.
· Emphasize that diagnostic ultrasound has a long history of safe clinical use.
· Explain that ultrasound energy is used at levels intended to provide diagnostic information while minimizing exposure.
· Reassure that ultrasound equipment is set to operate within established safety limits, and that output settings are continuously monitored throughout the examination.
· Reassure patients that clinicians follow ALARA principles and continuously monitor safety indicators during examinations.
· If the TI or MI is greater than 1, then the patient or caregiver should be informed of the anticipated exposure condition and how it compares in safety with conditions for normal diagnostic practice [10].
Clear communication can help address concerns while supporting informed participation in care.
Sample script:
“Ultrasound uses sound waves rather than ionizing radiation. It has been used safely for many years, including during pregnancy and in children. We use only the amount of ultrasound energy needed to answer our clinical question and keep the exam as brief and as focused as possible. Throughout the scan, we monitor the machine’s safety indicators and adjust the settings to minimize energy delivery, keeping exposure as low as reasonably achievable.”