Diagnostic Ultrasound Safety Review for Point-of-Care Ultrasound Practitioners

Douglas L Miller, Alyssa Abo, Jacques S Abramowicz, Timothy A Bigelow, Diane Dalecki, Eitan Dickman, John Donlon, Gerald Harris, Jason Nomura, Douglas L Miller, Alyssa Abo, Jacques S Abramowicz, Timothy A Bigelow, Diane Dalecki, Eitan Dickman, John Donlon, Gerald Harris, Jason Nomura

Abstract

Potential ultrasound exposure safety issues are reviewed, with guidance for prudent use of point-of-care ultrasound (POCUS). Safety assurance begins with the training of POCUS practitioners in the generation and interpretation of diagnostically valid and clinically relevant images. Sonographers themselves should minimize patient exposure in accordance with the as-low-as-reasonably-achievable principle, particularly for the safety of the eye, lung, and fetus. This practice entails the reduction of output indices or the exposure duration, consistent with the acquisition of diagnostically definitive images. Informed adoption of POCUS worldwide promises a reduction of ionizing radiation risks, enhanced cost-effectiveness, and prompt diagnoses for optimal patient care.

Keywords: Food and Drug Administration regulation; as low as reasonably achievable; diagnostic ultrasound safety; mechanical index; output display standard; point-of-care ultrasound; safety of the eye, lung, and fetus; thermal index; ultrasound bioeffects.

© 2019 by the American Institute of Ultrasound in Medicine.

References

    1. Solomon SD, Saldana F. Point-of-care ultrasound in medical education: stop listening and look. N Engl J Med 2014; 370:1083-1085.
    1. Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med 2011; 364:749-757.
    1. Lumb P, Karakitsos D (eds). General chest ultrasound. In: Critical Care Ultrasound. Philadelphia, PA: Elsevier; 2015:105-137.
    1. Irwin Z, Cook JO. Advances in point-of-care thoracic ultrasound. Emerg Med Clin North Am 2016; 34:151-157.
    1. Sekiguchi H. Tools of the trade: point-of-care ultrasonography as a stethoscope. Semin Respir Crit Care Med 2016; 37:68-87.
    1. Hall MK, Hall J, Gross CP, et al. Use of point-of-care ultrasound in the emergency department: insights from the 2012 Medicare National Payment Data Set. J Ultrasound Med 2016; 35:2467-2474.
    1. Sferrazza Papa GF, Mondoni M, Volpicelli G, et al. Point-of-care lung sonography: an audit of 1150 examinations. J Ultrasound Med 2017; 36:1687-1692.
    1. Buerger AM, Clark KR. Point-of-care ultrasound: a trend in health care. Radiol Technol 2017; 89:127-138.
    1. Panebianco NL, Shofer F, Fields JM, et al. The utility of transvaginal ultrasound in the ED: evaluation of complications of first trimester pregnancy. Am J Emerg Med 2015; 33:743-748.
    1. Mandavia DP, Hoffner RJ, Mahaney K. Bedside echocardiography by emergency physicians. Ann Emerg Med 2001; 38:377-382.
    1. Kuhn M, Bonnin RL, Davey MJ. Emergency department ultrasound scanning for abdominal aortic aneurysm: accessible, accurate, and advantageous. Ann Emerg Med 2000; 36:219-223.
    1. Guttikonda SNR, Vadapalli K. Approach to undifferentiated dyspnea in emergency department: aids in rapid clinical decision-making. Int J Emerg Med. 2018; 11:21.
    1. Gottlieb M, Hollday D, Peksa GD. Point-of-care ocular ultrasound for the diagnosis of retinal detachment: a systemic review and meta-analysis. Acad Emerg Med 2019; 26:931-939.
    1. Melniker LA, Leibner E, McKenney MG. Randomized controlled clinical trial of point-of-care, limited ultrasonography for trauma in the emergency department; the first sonography outcomes assessment program trial. Ann Emerg Med 2006; 235:227-235
    1. Stachura M, Landes M, Aklilu F, et al. Evaluation of a point of care ultrasound scan list in a resource-limited emergency centre in Addis Ababa, Ethiopia. Afr J Emerg Med 2017; 7:118-123.
    1. Shah SP, Shah SP, Fils-Aime R, et al. Focused cardiopulmonary ultrasound for assessment of dyspnea in a resource-limited setting. Crit Ultrasound J 2016; 8:7.
    1. Dietrich CF, Goudie A, Chiorean L, et al. Point of care ultrasound: a WFUMB position paper. Ultrasound Med Biol 2017; 43:49-58.
    1. American College of Emergency Physicians. Ultrasound guidelines: emergency, point of care, and clinical ultrasound guidelines in medicine. Ann Emerg Med 2017; 69:e27-e54.
    1. Frankel HL, Kirkpatrick AW, Elbarbary M, et al. Guidelines for the appropriate use of bedside general and cardiac ultrasonography in the evaluation of critically ill patients, part I: general ultrasonography. Crit Care Med 2015; 43:2479-2502.
    1. Levitov A, Frankel HL, Blaivas M, et al. Guidelines for the appropriate use of bedside general and cardiac ultrasonography in the evaluation of critically ill patients, part II: cardiac ultrasonography. Crit Care Med 2016; 44:1206-1227.
    1. Marin JR, Abo AM, Arroyo AC, et al. Pediatric emergency medicine point-of-care ultrasound: summary of the evidence. Crit Ultrasound J 2016; 8:16.
    1. Miller DL, Smith NB, Bailey MR, Czarnota GJ, Hynynen K, Makin IR; Bioeffects Committee of the American Institute of Ultrasound in Medicine. Overview of therapeutic ultrasound applications and safety considerations. J Ultrasound Med 2012; 31:623-634.
    1. United States Food and Drug Administration. FDA Guidance for Industry and FDA Staff: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. White Oak, MD: United States Food and Drug Administration; 2008.
    1. American Institute of Ultrasound in Medicine. Statement on prudent use and clinical safety. American Institute of Ultrasound in Medicine website; 2012. .
    1. World Federation for Ultrasound in Medicine and Biology. WFUMB clinical safety statement for diagnostic ultrasound: an overview. World Federation for Ultrasound in Medicine and Biology website; 2018, .
    1. Nyborg WL, Carson PL, Carstensen EL, et al. Exposure Criteria for Medical Diagnostic Ultrasound, II: Criteria Based on All Known Mechanisms. Report No. 140. Bethesda, MD: National Council on Radiation Protection and Measurements; 2002.
    1. O'Brien WD Jr, Deng CX, Harris GR, et al. The risk of exposure to diagnostic ultrasound in postnatal subjects: thermal effects. J Ultrasound Med 2008; 27:517-535.
    1. Nyborg WL. Biological effects of ultrasound: development of safety guidelines, part I: personal histories. Ultrasound Med Biol 2000; 26:911-964.
    1. American Institute of Ultrasound in Medicine, National Electrical Manufacturers Association. Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. Revision 2. Laurel, MD: American Institute of Ultrasound in Medicine; Rosslyn, VA: National Electrical Manufacturers Association; 2004
    1. Abbott JG. Rationale and derivation of MI and TI: a review. Ultrasound Med Biol 1999; 25:431-441.
    1. Bigelow TA, Church CC, Sandstrom K, et al. The thermal index: its strengths, weaknesses, and proposed improvements. J Ultrasound Med 2011; 30:714-734.
    1. Starritt HC. Radiation force and its possible biological effects. In: Ter Haar G (ed). The Safe Use of Ultrasound in Medical Diagnosis. 3rd ed. London, England: British Institute of Radiology; 2012;chap 7.
    1. Simon JC, Sapozhnikov OA, Wang YN, Khokhlova VA, Crum LA, Bailey MR. Investigation into the mechanisms of tissue atomization by high-intensity focused ultrasound. Ultrasound Med Biol 2015; 41:1372-1385.
    1. Chatterton BE, Spyropoulos P. Colour Doppler induced streaming: an indicator of the liquid nature of lesions. Br J Radiol 1998; 71:1310-1312.
    1. Sigrist RMS, Liau J, Kaffas AE, Chammas MC, Willmann JK. Ultrasound elastography: review of techniques and clinical applications. Theranostics 2017; 7:1303-1329.
    1. Apfel RE, Holland CK. Gauging the likelihood of cavitation from short-pulse, low-duty cycle diagnostic ultrasound. Ultrasound Med Biol 1991; 17:179-185.
    1. American Institute of Ultrasound in Medicine, Medical Ultrasound Safety. 3rd ed. Laurel, MD: American Institute of Ultrasound in Medicine; 2014.
    1. American Institute of Ultrasound in Medicine. As low as reasonably achievable (ALARA) principle. American Institute of Ultrasound in Medicine website; 2014. .
    1. World Federation for Ultrasound in Medicine and Biology. WFUMB policy and statements on safety of ultrasound. Ultrasound Med Biol 2013; 39:926-929.
    1. American Institute of Ultrasound in Medicine, Statement on mammalian biological effects in tissues with gas body contrast agents. American Institute of Ultrasound in Medicine website; 2015. .
    1. Muskula PR, Main ML. Safety with echocardiographic contrast agents. Circ Cardiovasc Imaging 2017; 10:pii:e005459.
    1. American Institute of Ultrasound in Medicine. Statement on mammalian biological effects of ultrasound in vivo. American Institute of Ultrasound in Medicine website; 2015. .
    1. American Institute of Ultrasound in Medicine. Statement on the safe use of Doppler ultrasound during 11- to 14-week scans (or earlier in pregnancy). American Institute of Ultrasound in Medicine website; 2016. .
    1. American Institute of Ultrasound in Medicine. Recommended maximum scanning times for displayed thermal index (TI) values. American Institute of Ultrasound in Medicine website; 2016. .
    1. Barnett SB, Abramowicz JS, Ziskin MC, Marsál K, Claudon M. WFUMB symposium on safety of nonmedical use of ultrasound. Ultrasound Med Biol 2010; 36:1209-1212.
    1. American Institute of Ultrasound in Medicine. Safety in diagnostic ultrasound educational activities using nonpregnant subjects. American Institute of Ultrasound in Medicine website; 2019. .
    1. American Institute of Ultrasound in Medicine. Safety in diagnostic ultrasound educational activities using pregnant subjects. American Institute of Ultrasound in Medicine website; 2019. .
    1. Nobel VE, Nelson BP. Manual of Emergency and Critical Care Ultrasound. 2nd ed. Cambridge, England: Cambridge University Press; 2011.
    1. Piscaglia F, Nolsøe C, Dietrich CF, et al. The EFSUMB guidelines and recommendations on the clinical practice of contrast enhanced ultrasound (CEUS): update 2011 on non-hepatic applications. Ultraschall Med 2012; 33:33-59.
    1. Claudon M, Dietrich CF, Choi BI, et al. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) in the liver-update 2012: a WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS, and ICUS. Ultrasound Med Biol 2013; 39:187-210.
    1. Miller DL, Averkiou MA, Brayman AA, et al. Bioeffects considerations for diagnostic ultrasound contrast agents. J Ultrasound Med 2008; 27:611-636.
    1. Kummer T, Oh L, Phelan MB, Huang RD, Nomura JT, Adhikari S. Emergency and critical care applications for contrast enhanced ultrasound. Am J Emerg Med 2018; 35:1287-1294.
    1. Lv F, Ning Y, Zhou X, et al. Effectiveness of contrast enhanced ultrasound in the classification and emergency management of abdominal trauma. Eur Radiol 2014; 24:2640-2648.
    1. Griffith JF, Rainer TH, Ching AS, Law KL, Cocks RA, Metreweli C. Sonography compared with radiography in revealing acute rib fracture. AJR Am J Roentgenol 1999; 173:1603-1609.
    1. Harris GR, Church CC, Dalecki D, Ziskin MC, Bagley JE; American Institute of Ultrasound in Medicine, Health Canada, British Medical Ultrasound Society. Comparison of thermal safety practice guidelines for diagnostic ultrasound exposures. Ultrasound Med Biol 2016; 42:345-357.
    1. Kilker BA, Holst JM, Hoffmann B. Bedside ocular ultrasound in the emergency department. Eur J Emerg Med 2014; 21:246-253.
    1. Kendall CJ, Prager TC, Cheng H, Gombos D, Tang RA, Schiffman JS. Diagnostic ophthalmic ultrasound for radiologists. Neuroimaging Clin N Am 2015; 25:327-365.
    1. van Rhoon GC, Samaras T, Yarmolenko PS, Dewhirst MW, Neufeld E, Kuster N. CEM43°C thermal dose thresholds: a potential guide for magnetic resonance radiofrequency exposure levels? Eur Radiol 2013; 23:2215-2227.
    1. Abramowicz JS, Barnett SB, Duck FA, Edmonds PD, Hynynen KH, Ziskin MC. Fetal thermal effects of diagnostic ultrasound. J Ultrasound Med 2008; 27:541-559.
    1. Herman BA, Harris GR. Theoretical study of steady-state temperature rise within the eye due to ultrasound insonation. IEEE Trans Ultrason Ferroelectr Freq Control 1999; 46:1566-1574.
    1. King RL, Liu Y, Harris GR. Quantification of temperature rise within the lens of the porcine eye caused by ultrasound insonation. Ultrasound Med Biol 2017; 43:476-481.
    1. British Medical Ultrasound Society. Guidelines for the safe use of diagnostic ultrasound equipment. Ultrasound 2010; 18:52-59.
    1. Silverman RH, Lizzi FL, Ursea BG, et al. Safety levels for exposure of cornea and lens to very high-frequency ultrasound. J Ultrasound Med 2001; 20:979-986.
    1. Cucevic V, Brown AS, Foster FS. Thermal assessment of 40-MHz pulsed Doppler ultrasound in human eye. Ultrasound Med Biol 2005; 31:565-573.
    1. Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill: lung sliding. Chest 1995; 108:1345-1348.
    1. Sartori S, Tombesi P. Emerging roles for transthoracic ultrasonography in pleuropulmonary pathology. World J Radiol 2010; 2:83-90.
    1. Ahmad S, Eisen LA. Lung ultrasound: the basics. In: Lumb P, Karakitsos D (eds). Critical Care Ultrasound. Philadelphia, PA: Elsevier; 2015:106-110.
    1. Copetti R, Cattarossi L, Macagno F, Violino M, Furlan R. Lung ultrasound in respiratory distress syndrome: a useful tool for early diagnosis. Neonatology 2008; 94:52-59.
    1. Liu J, Liu F, Liu Y, Wang HW, Feng ZC. Lung ultrasonography for the diagnosis of severe neonatal pneumonia. Chest 2014; 146:383-388.
    1. Pereda MA, Chavez MA, Hooper-Miele CC, et al. Lung ultrasound for the diagnosis of pneumonia in children: a meta-analysis. Pediatrics 2015; 135:714-722.
    1. Volpicelli G, Elbarbary M, Blaivas M, et al. International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med 2012; 38:577-591.
    1. Liu J, Copetti R, Sorantin E, et al. Protocol and guidelines for point-of-care lung ultrasound in diagnosing neonatal pulmonary diseases based on international expert consensus [published online March 6, 2019]. J Vis Exp. doi:.
    1. Chen SW, Fu W, Liu J, Wang Y. Routine application of lung ultrasonography in the neonatal intensive care unit. Medicine (Baltimore) 2017; 96:e5826.
    1. Oktem A, Yigit S, Oğuz B, Celik T, Haliloğlu M, Yurdakok M. Accuracy of lung ultrasonography in the diagnosis of respiratory distress syndrome in newborns [published online ahead of print April 22, 2019]. J Matern Fetal Neonatal Med. doi:.
    1. Liu J, Chi JH, Ren XL, et al. Lung ultrasonography to diagnose pneumothorax of the newborn. Am J Emerg Med 2017; 35:1298-1302.
    1. Martelius L, Heldt H, Lauerma K. B-lines on pediatric lung sonography: comparison with computed tomography. J Ultrasound Med 2016; 35:153-157.
    1. Child SZ, Hartman CL, Schery LA, Carstensen EL. Lung damage from exposure to pulsed ultrasound. Ultrasound Med Biol 1990; 16:817-825.
    1. Meltzer RS, Adsumelli R, Risher WH, et al. Lack of lung hemorrhage in humans after intraoperative transesophageal echocardiography with ultrasound exposure conditions similar to those causing lung hemorrhage in laboratory animals. J Am Soc Echocardiogr 1998; 11:57-60.
    1. Miller DL. Induction of pulmonary hemorrhage in rats during diagnostic ultrasound. Ultrasound Med Biol 2012; 38:1476-1482.
    1. Miller DL, Dou C, Raghavendran K. Pulmonary capillary hemorrhage induced by fixed-beam pulsed ultrasound. Ultrasound Med Biol 2015; 41:2212-2219.
    1. Miller DL, Dong Z, Dou C, Raghavendran K. Pulmonary capillary hemorrhage induced by different imaging modes of diagnostic ultrasound. Ultrasound Med Biol 2018; 44:1012-1021.
    1. Miller DL, Dong Z, Dou C, Raghavendran K. Influence of scan duration on pulmonary capillary hemorrhage induced by diagnostic ultrasound. Ultrasound Med Biol 2016; 42:1942-1950.
    1. Miller DL, Dou C, Dong Z, Raghavendran K. The influence of dexmedetomidine on ultrasound-induced pulmonary capillary hemorrhage in rats. Ultrasound Med Biol 2016; 42:964-970.
    1. Miller DL, Dong Z, Dou C, Raghavendran K. Pulmonary capillary hemorrhage induced by diagnostic ultrasound in ventilated rats. Ultrasound Med Biol 2018; 44:1810-1817.
    1. O'Brien WD Jr, Simpson DG, Ho MH, Miller RJ, Frizzell LA, Zachary JF. Superthreshold behavior and threshold estimation of ultrasound-induced lung hemorrhage in pigs: role of age dependency. IEEE Trans Ultrason Ferroelectr Freq Control 2003; 50:153-169.
    1. O'Brien WD Jr, Yang Y, Simpson DG, et al. Threshold estimation of ultrasound-induced lung hemorrhage in adult rabbits and comparison of thresholds in mice, rats, rabbits and pigs. Ultrasound Med Biol 2006; 32:1793-1804.
    1. Miller DL. Mechanisms for induction of pulmonary capillary hemorrhage by diagnostic ultrasound: review and consideration of acoustical radiation surface pressure. Ultrasound Med Biol 2016; 42:2743-2757.
    1. Church CC, Carstensen EL, Nyborg WL, Carson PL, Frizzell LA, Bailey MR. The risk of exposure to diagnostic ultrasound in postnatal subjects: nonthermal mechanisms. J Ultrasound Med 2008; 27:565-592.
    1. Wax DB, Leibowitz AB. Radiologic assessment of potential sites for needle decompression of a tension pneumothorax. Anesth Analg 2007; 105:1385-1388.
    1. Abramowicz JS. Benefits and risks of ultrasound in pregnancy. Semin Perinatol 2013; 37:295-300.
    1. Ondeck CL, Pretorius D, McCaulley J, et al. Ultrasonographic prenatal imaging of fetal ocular and orbital abnormalities. Surv Ophthalmol 2018; 63:745-753.
    1. Forward H, Yazar S, Hewitt AW, et al. Multiple prenatal ultrasound scans and ocular development: 20-year follow-up of a randomized controlled trial. Ultrasound Obstet Gynecol 2014; 44:166-170.
    1. Brenner DJ, Hall EJ. Computed tomography: an increasing source of radiation exposure. N Engl J Med 2007; 357:2277-2284.
    1. Pearce MS, Salotti JA, Little MP, et al. Radiation exposure from CT scans in childhood and subsequent risk of leukemia and brain tumors: a retrospective cohort study. Lancet 2012; 380:499-505.
    1. Zacharias C, Alessio AM, Otto RK, et al. Pediatric CT: strategies to lower radiation dose. AJR Am J Roentgenol 2013; 200:950-956.
    1. Goske MJ, Applegate KE, Bulas D, et al; Alliance for Radiation Safety in Pediatric Imaging. Image gently: progress and challenges in CT education and advocacy. Pediatr Radiol 2011; 41:461-466.
    1. Brody AS, Frush DP, Huda W, Brent RL; American Academy of Pediatrics Section on Radiology. Radiation risk to children from computed tomography. Pediatrics 2007; 120:677-682.
    1. Kucharzik T, Maaser C. Intestinal ultrasound and management of small bowel Crohn's disease. Ther Adv Gastroenterol 2018; 11:1756284818771367.
    1. Sauer CG, Kugathasan S, Martin DR, Applegate KE. Medical radiation exposure in children with inflammatory bowel disease estimates high cumulative doses. Inflamm Bowel Dis 2011; 17:2326-2332.
    1. Beal EW, Sigmond BR, Sage-Silski L, Lahey S, Nguyen V, Bahner DP. Point-of-care ultrasound in general surgery residency training: a proposal for milestones in graduate medical education ultrasound. J Ultrasound Med 2017; 36:2577-2584.
    1. Deshpande R, Montealegre-Gallegos M, Matyal R, Belani K, Chawla N. Training the anesthesiologist in point-of-care ultrasound. Int Anesthesiol Clin 2016; 54:71-93.
    1. Abo AM, Alade KH, Rempell RG, et al. Credentialing pediatric emergency medicine faculty in point-of-care ultrasound: expert guidelines [published online ahead of print January 7, 2019]. Pediatr Emerg Care. doi:.
    1. Stolz LA, Muruganandan KM, Bisanzo MC, et al. Point-of-care ultrasound education for non-physician clinicians in a resource-limited emergency department. Trop Med Int Health 2015; 20:1067-1072.
    1. Society of Point of Care Ultrasound. Guidelines for point of care ultrasound utilization in clinical practice. Society of Point of Care Ultrasound website; 2017. .
    1. Vinayak S, Sande J, Nisenbaum H, Nolsøe CP. Training midwives to perform basic obstetric point-of-care ultrasound in rural areas using a tablet platform and mobile phone transmission technology: a WFUMB COE project. Ultrasound Med Biol 2017; 43:2125-2132.
    1. Gharahbaghian L, Anderson KL, Lobo V, Huang RW, Poffenberger CM, Nguyen PD. Point-of-care ultrasound in austere environments: a complete review of its utilization, pitfalls, and technique for common applications in austere settings. Emerg Med Clin North Am 2017; 35:409-441.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe