FDAnews Device Daily Bulletin


Dec. 13, 2005

The American Institute of Ultrasound in Medicine (AIUM) is warning against inappropriate personal use of ultrasound machines in the aftermath of actor Tom Cruise purchasing such a device.

The group says that it supports a three-pronged approach to safety in using this device: prudent use; FDA enforcement; and certification, accreditation and education. AIUM is concerned that there could be future biological side effects to excessive use of the device, although there are no confirmed adverse effects thus far.

The group argues that an ultrasound is designed for diagnostic use by a trained medical professional and should not be used for private, at home use. AIUM is also urging the FDA to investigate improper use of ultrasounds. Specifically, the group wants the agency to investigate "commercial enterprises offering ultrasound devices without medical benefit and the purchase or sale of ultrasound devices for home use."

Furthermore, AIUM is recommending that licensed physicians, certified/registered sonographers, or sonography registry candidates perform ultrasound examinations. Using these individuals is important, the group says, because they have been "trained to recognize medically important conditions, recognize artifacts that can mimic or obscure pathology, and use techniques to minimize ultrasound exposure."