Non-linear Wave Propagation and Safety Standards for Diagnostic Ultrasound Devices

Safety standards for clinical diagnostic ultrasonic devices were developed for use in relatively low-frequency systems (1–10 MHz), under the assumption that non-linear effects would be negligible. This article reviews ways in which neglecting non-linear wave propagation affects the measurements and calculations required to comply with safety standards and U.S. Food and Drug Administration guidance that recognizes these standards. An attempt is made to evaluate whether ignoring non-linear effects could result in significant error in the exposure quantities defined in these standards at either low or high frequencies, based on published literature. This article maintains that although non-linear effects have been considered in some parts of safety standards related to hydrophone requirements, the coverage is inadequate, especially for modern equipment with high working frequencies. A new approach is required to assess the magnitude of thermal heating for recently developed high-frequency systems to incorporate non-linear effects. In contrast, the current approach for evaluating the risk of cavitation can be used after appropriate modifications.     

Effect of body position on qualitative and quantitative ultrasound assessment of gastric fluid contents

We assessed the impact of raising the upper section of the bed, and patient positioning, on ultrasound assessment of gastric fluid contents. We performed ultrasound examinations in 25 subjects lying on their back, left and right sides at bed angles of 0°, 30°, 45° and 90°; this was carried out while the subjects were fasted, and repeated 10 min after drinking ≥ 50 ml water. After drinking, gastric contents were detected more frequently in the 45° semirecumbent position compared with the supine and 30° positions. The diagnostic performance of the Perlas qualitative grading scale to detect gastric fluid volume > 1.5 ml.kg⁻¹ was improved at 45°, compared with 0° and 30° angles. The use of a composite ultrasound grading scale at a 45° angle was associated with the best performance, with a sensitivity and specificity of 82%. Antral cross-sectional area was significantly increased when measured in the right lateral position, but there was no effect of raising the bed. In conclusion, raising the upper section of the bed significantly affected qualitative assessment of gastric fluid contents. Further studies are required to determine the most appropriate composite ultrasound grading scale and bed angle for fast and reliable qualitative ultrasound detection of fluid volumes > 1.5 ml.kg⁻¹.