Medical Ultrasonography - Regulation

Regulation

Diagnostic and therapeutic ultrasound equipment is regulated in the USA by the FDA, and worldwide by other national regulatory agencies. The FDA limits acoustic output using several metrics. Generally other regulatory agencies around the world accept the FDA-established guidelines.

Currently New Mexico is the only state in the USA which regulates diagnostic medical sonographers. Certification examinations for sonographers are available in the US from three organizations: the American Registry for Diagnostic Medical Sonography, Cardiovascular Credentialing International and the American Registry of Radiologic Technologists.

The primary regulated metrics are MI (Mechanical Index) a metric associated with the cavitation bio-effect, and TI (Thermal Index) a metric associated with the tissue heating bio-effect. The FDA requires that the machine not exceed limits that they have established. This requires self-regulation on the part of the manufacturer in terms of the calibration of the machine. The established limits are reasonably conservative so as to maintain diagnostic ultrasound as a safe imaging modality.

In India, lack of social security and consequent preference for a male child has popularized the use of ultrasound technology to identify and abort female fetuses. India's Antenatal (US: Prenatal) Diagnostic Techniques act makes use of ultrasound for sex selection illegal, but unscrupulous Indian doctors and would-be parents continue to discriminate against the female child.

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