AIUM Official Statement: Statement and Recommendations for Safety Assurance in Lung Ultrasound

Abstract

iagnostic ultrasound has made great strides since performance standards and recommended maximum exposure levels were set up in the 1980s and 1990s. Lung ultrasound (LUS) has advanced to become an important clinical tool. The pleura appears in the image as a hyperechoic line, and defects in the line shown by image artifacts, such as B lines, are used to facilitate a variety of diagnoses in patients from neonates to high-BMI adults. In addition to the older methods for pulmonary effusion and thoracentesis, LUS has been found to be valuable in the diagnosis of pneumonia, pulmonary edema, pulmonary embolism, atelectasis, diffuse parenchymal disease, respiratory distress syndrome, COVID-19, and lung cancer. [1][2][3][4] Lung ultrasound is particularly valuable in neonates at the point-of-care (POC) for diagnosis of respiratory distress syndrome, 5 assessing surfactant treatment, 6 pulmonary hemorrhage, 7 and the number of B lines correlates with computed tomography findings, 8 while avoiding any ionizing radiation exposure. An international review provides guidelines and 20 consensus statements on the use of LUS. 9 Neonatal POC LUS has been found to be valuable in many patient settings, and is often routinely performed daily to follow patient progress. 5,6 Neonatal exam guidelines noted the use of 10-15 MHz linear arrays at 10-12 positions on the neonatal chest, at birth and each week (ie, totaling 40-48 individual exams for scoring). 10 Use of presets was recommended if available with adjustment of parameters to recommended settings. 11 The concomitant evolution of ultrasound technology has provided simplified and handy devices that have revolutionized the practice of POC LUS, a major positive development in patient care.The development of diagnostic ultrasound performance standards to clear diagnostic ultrasound machines for marketing in the United States began with the 1976 Medical Device Amendments to the 1938 Food, Drug, and Cosmetic Act. These standards aimed to ensure that new machines entering the market would be substantially equivalent in terms of safety and effectiveness to machines on the market before enactment of the 1976 Medical Device Amendments. The possibility of bioeffects of ultrasound was accepted, and a means to communicate ultrasound exposure levels to the practitioner was deemed essential. The National Equipment Manufacturers Association developed an Output Display Standard (ODS), 12 with the aid of the American Institute of Ultrasound in Medicine, the US Food and Drug Administration, and the National Council on Radiation Protection and Measurements, among others, based on possible physical mechanisms for ultrasound bioeffects. The ODS is now maintained by the International Electrotechnical Commission. 13 Two exposure indices were created to provide the