Ultrasound technology can diagnose illness or injury, guide surgeons during invasive procedures and monitor the growth and development of a fetus in utero. Handheld transducers placed against the patient's skin emit high-frequency sound waves that reflect off of internal soft tissues, muscles and organs, and display images of these structures on a computer screen. Although ultrasound does not emit ionizing radiation like x-rays, the Food and Drug Administration (FDA) has developed safety recommendations for its use.
Prescription Use
The FDA approves ultrasound devices for use with a prescription, and recommends that healthcare providers follow the information accompanying the devices to determine approved uses for the devices. Although the FDA approves ultrasound devices for sale, and monitors reports of adverse events associated with ultrasound equipment, it has not issued regulations on how medical professionals can actually use the equipment.
Limit Usage
According to the FDA, ultrasound does not present any known health risks. However, ultrasound can raise the temperature of some body tissues. In addition, ultrasound can produce cavitation, or small gas bubbles in tissues or body fluids. The long-term risks of heating body tissues and cavitation are unclear; therefore, the FDA does not recommend frequent or extended use of ultrasound.
Avoid "Keepsake" Images
The FDA cautions consumers against getting "keepsake" images or videos from non-medical ultrasound providers. The FDA has only approved ultrasound imaging devices for medical use with a prescription; using one of these devices for non-medical procedures is an unapproved use. The risks of exposing a fetus to ultrasound for extended periods are unclear, so the FDA recommends that parents exercise caution when deciding to have non-medical ultrasounds. Also, non-medical ultrasound providers are not subject to regulation, so there are no controls on how many ultrasounds a pregnant woman may have, or how long the ultrasound can last.
Use Low Exposures
The FDA advises medical professionals to use ultrasound only when medically necessary, and to use the lowest exposure setting that will allow them to make an accurate diagnosis.
Safety and Labeling Rules
All manufacturers of ultrasound equipment must gain FDA approval before selling their devices on the U.S. market. The FDA requires manufacturers of ultrasound devices to meet detailed safety requirements. In addition, all devices sold in the United States must include labels with specific instructions for use, as well as instructions for cleaning and sterilizing the equipment between uses.
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