Ultrasound experts have challenged their colleagues and regulatory agencies to scientifically validate the benefits and risks of clinical sonography.
Ultrasound experts have challenged their colleagues and regulatory agencies to scientifically validate the benefits and risks of clinical sonography.
An American Institute of Ultrasound in Medicine consensus report calls on the FDA to open a scientifically valid process for modifying current regulatory restrictions on the clinical use of ultrasound.
The AIUM has approved a comprehensive consensus report covering key issues of ultrasound safety. The final conclusions, dealing with issues such as thermal and nonthermal effects and the impact of contrast agents on living tissue, were published in a recent issue of the Journal of Ultrasound in Medicine.
The AIUM has overseen the evaluation of ultrasound safety for several decades through its Bioeffects Committee and special panels it periodically convenes. Publication of the conclusions of these groups has provided important guidance to the medical ultrasound community, said the AIUM's immediate past president Dr. Lennard Greenbaum in a foreword to the latest consensus guidelines.
The current report comprises separate articles on five bioeffects categories: postnatal thermal effects, fetal thermal effects, postnatal mechanical effects, fetal mechanical effects, and bioeffect considerations for ultrasound contrast agents. Each article includes analysis, conclusions, and recommendations for use.
The consensus report represents the culmination of a three-year review process started in 2005 in Keystone, CO. The three-day conference assembled a panel of 37 experts to examine ultrasound's bioeffects. The document validates recent findings suggesting that excessive temperature increases can result in adverse effects in living subjects, and that the biological effects depend on such factors as the duration of exposure, type of tissue exposed, and cell reproduction rate and its potential for regeneration (J Ultrasound Med 2008;27:502-632).
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