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References

(Some of the references were added to the text during revision, explaining their out-of-order appearance in the text; I don’t have the energy to redo the whole lot, and would almost certainly make a systemic mistake that would add confusion)

As of January 2012 articles (full text) from the Journal of Ultrasound in Medicine which are more than 12 months old are available free at www.jultrasoundmed.org .

1.  American Institute of Ultrasound in Medicine.  Bioeffects literature reviews.  Journal of Ultrasound in Medicine 2004; 23:1535-1542 (for acoustic intensity values for the ADR 2130 see pages 1535-1536)

2.  Fatemi M, Ogburn PL Jr, Greenleaf JF.  Fetal stimulation by pulsed diagnostic ultrasound.  Journal of Ultrasound in Medicine 2001; 20:883-889 (for acoustic intensity values for the Acuson 128xp see pages 884-885).

3.  Kremkau FW.  Technical Topics: Sound Levels.  Journal of Ultrasound in Medicine, Reflections Section R30-31, May 1983

4.  Sheiner E, Freeman J, Abramowicz JS.  Acoustic output as measured by mechanical and thermal indices during routine obstetric ultrasound examinations.  Journal of Ultrasound in Medicine 2005; 24:1665-1670
Medline abstract

5.  Willis CE, Slovis TL. The ALARA concept in pediatric CR and DR: Dose reduction in pediatric radiographic exams – a White Paper Conference.  American Journal of Roentgenology 2005; 184:373-374 (see recommendation 7)

6.  http://ortho.smith-nephew.com/us/node.asp?NodeId=2865 
     Select EXOGEN* mechanism of action

7.  http://www.smithnephew.com/US/Standard.asp?NodeId=3360 

8.  Heybeli N, Yesildag A, Oyar O et al.  Diagnostic ultrasound treatment increases the bone fracture-healing rate in an internally fixed rat femoral osteotomy model.  Journal of Ultrasound in Medicine 2002; 21:1357-1363

9. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Guidance for Industry and FDA staff: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers 2008. (Replaces 1997 Document)
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070911.pdf 
9a. p 40
9b.  p 43
9c.  p 27
9d.  pp 35-39

10.  Ang ESBC Jr, Gluncic V, Duque A et al.  Prenatal exposure to ultrasound waves impacts neuronal migration in mice.  Proceedings of the National Academy of Sciences 2006; 103: 12903-12910 (Open access article online – Aug 22, 2006)
http://www.pnas.org/cgi/content/full/103/34/12903

11.  Malone FD, Canick JA, Ball RH et al.  First-trimester screening or second-trimester screening, or both, for Down’s syndrome.  New England Journal of Medicine 2005; 353:2001-11

12.  Caviness VS, Grant PE.  Our unborn children at risk?   Proceedings of the National Academy of Sciences 2006; 103: 12661-12662 (not open access online)

13.  Alexandrov AV, Molina CA, Grotta JC et al.  Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke.  New England Journal of Medicine 2004; 351:2170-2178 
Medline abstract

14.  Polak JF.  Ultrasound energy and the dissolution of thrombus.  New England Journal of Medicine 2004; 351: 2154-2155

15. Health Canada. Guidelines for the Safe Use of Diagnostic Ultrasound 2001.   Accessible at http://www.hc-sc.gc.ca/ewh-semt/pubs/radiation/01hecs-secs255/rec_e.html
15a. Section 2.4
15b. Section 2.3

16.  O’Brien WD Jr., Abbott JG, Stratmeyer ME et al.  Acoustic output upper limits proposition: should upper limits be retained?  Journal of Ultrasound in Medicine 2002; 21:1335-1341

17.  AIUM Clinical Standards Committee.  AIUM Technical Bulletin.  How to interpret the ultrasound output display standard for higher acoustic output diagnostic ultrasound devices: Version 2.  Journal of Ultrasound in Medicine 2004; 23:723-726

18.  http://www.cdc.gov/DES/consumers/about/history.html

19.  http://www.desaction.org/

20.  Abramowicz JS.  Ultrasound in obstetrics and gynecology; is this hot technology too hot?  Journal of Ultrasound in Medicine 2002; 21:1327-1323

21.  Toms DA.  The mechanical index, ultrasound practices, and the ALARA principle.  Journal of Ultrasound in Medicine 2006(April); 25:560-561

22.  Abramowicz JS, Sheiner E.  Acoustic output in obstetric ultrasound, ALARA and education.  Journal of Ultrasound in Medicine 2006(April); 25: 561-562

23.  National Research Council of the National Academies, Committee to Assess Health Risks from Exposure to Low Levels of Ionizing Radiation:  Health Risks from exposure to low levels of ionizing radiation. Biological Effects of Ionizing Radiation – BEIR VII Phase 2.  2006, National Academies Press. Washington DC www.nap.edu

24.  Radiological Society of North America.  RSNA News October 2006, volume 16, number 10.  Question and answer pages 1 and 12   

25.  Pretorius DH, Gattu S, Eun-Kyung Ji at al.  Preexamination and postexamination assessment of parental-fetal bonding in patients undergoing 3-/4-Dimensional obstetric ultrasonography.  Journal of Ultrasound in Medicine 2006(November); 25: 1411-1421
(Original study plus review)
    
 
26.  Benacerraf BR, Shipp TD, Bromley B.  How sonographic tomography will change the face of obstetric sonography: a pilot study.  Journal of Ultrasound in Medicine 2005; 24: 371-378 
Medline abstract

27.  http://www.cochrane.org/reviews/en/ab000182.html

28.  Toms DA.  The case against routine obstetrical ultrasound.  Annals of the Royal College of Physicians and Surgeons of Canada 1984; 17:225-229
Viewable Here (Publication no longer exists.)

29.  Malone PS.  Antenatal diagnosis of renal tract anomalies: has it increased the sum of human happiness?  Journal of the Royal Society of Medicine 1996; 89: 155-158

30.  http://news.bbc.co.uk/2/hi/south_asia/4855682.stm

31.  Afterthought “reference”:  A data sheet I obtained around 1984 for “ABSOLUTE MAXIMUM ULTRASOUND EMISSIONS:  ADR TRANSDUCERS” provides an interesting perspective on output evolution.  To clarify some information extracted from this sheet given below: I am reasonably certain that the 3.5 AA was the common initial linear probe and the 13mm EFT was a mechanical sector added to the product line later.  POWER refers to the total acoustic power emitted, SPTA to the (spatial-peak) time-averaged intensity and SPTP to (spatial-peak) temporal-peak intensity i.e. the pulse peak intensity.  While SPTP is usually given in W/cm2, on this sheet it is given in mW/cm2.  Values are for standard B-mode imaging.  Whatever the shortcomings of the measurement methodology were at that time it was presumably consistent, making the results comparable.  An approximately 300-fold increase in intensity is noted; this is before the major increase in regulatory limits.  The information thus provides support for the impression that there has been a 1000-fold increase from around 1980 to the late 1990’s. Data Sheet Visible Here

  3.5 AA 13 mm EFT
POWER  
(mW)
.11 23
SPTA   
(mW/cm2)
.025  7.8
SPTP   
(mW/cm2)
 1470 456,000

32.  I assume that the 1995 value for Ispta for the Acuson 128xp  in reference 2 is derated.  Even if is not, and were to be reduced fourfold to allow for attenuation before reaching a human fetus, it would still be much larger than 0.6 mW/cm2

33. Sheiner E, Shoham-Vardi I, Abramowicz JS.  What do clinical users know regarding safety of ultrasound during pregnancy?  Journal of Ultrasound in Medicine 2007; 26:319-325

34.  Eggers J, Konig IR, Koch B, Handler G, Seidel G.  Sonothrombolysis with transcranial color-coded sonography and recombinant tissue-type plasminogen activator in acute middle cerebral artery main stem occlusion.  Stroke.  2008; 39:1470-1475
 
35.   Abramowicz JS, Fowlkes JB, Skelly AC, Stratmeyer ME, Ziskin MC.  Conclusions regarding epidemiology for obstetric ultrasound.  Journal of Ultrasound in Medicine  2008; 27:637-644
 
36.  Stratmeyer ME, Greenleaf JF, Dalecki D, Salvesen KA.  Fetal Ultrasound: Mechanical effects.  Journal of Ultrasound in Medicine.  2008; 27:597-605
 
37.  Gluckman PD, Hanson MA, Cooper C, Thornburg KL.  Effect of in utero and early-life conditions on adult health and disease.  New England Journal of Medicine.  2008; 359:61-73

38. Abujudeh HI, Kaewlai R, Kagan A et al. Nephrogenic systemic fibrosis after gadopentetate dimeglumine exposure: Case series of 36 patients. Radiology 2009;253: 81-89

39. Talbert DJ, Dewhurst J, Southall DP. New transducer for detecting fetal heart sounds: Use of compliance matching for maximum sound transfer. Lancet 1984, Vol 1: 426-427

40. Tubiana M, Feinendegen LE, Yang C, Kaminski JM. The linear no-threshold relationship is inconsistent with radiation biologic and experimental data. Radiology 2009; 251: 13-22

41. Goodman LS, Gilman A (editors). The Pharmacological Basis of Therapeutics. New York, Macmillan Publishing, Fifth Edition, 1975: Page 142 (I have obtained the book and verified this quotation.)

42. Krasovitski B, Frenkel V, Shoham S, Kimmel E. Intramembrane cavitation as a unifying mechanism for ultrasound-induced bioeffects. PNAS 2011; 108 (8): 3258-3263

43. Church CC, Carstensen EL, Nyborg WL et al. The risk of exposure to diagnostic ultrasound in postnatal subjects – nonthermal mechanisms. J Ultrasound Med 2008; 27: 565-592

44. Suresh R, Ramesh Rao T, Davis EM at al. Effect of diagnostic ultrasound during the fetal period on learning and memory in mice. Annals of Anatomy 2008; 190: 37-45

45. Schneider-Kolsky ME, Ayobi Z, Lombardo P et al. Ultrasound exposure of the foetal chick brain: effects on learning and memory. International Journal of Developmental Neuroscience 2009; 27; 677-683

46. Hoover RN, Hyer M, Pfeiffer RM et al. Adverse health outcomes in women exposed in utero to diethylstilbestrol. New England Journal of Medicine 2011 (Oct 6); 365: 1304-14. (Free summary can be accessed at NEJM site and is worth reading.)

47. Toms DA. Risks of cardiac imaging (Letter). Canadian Medical Association Journal 2011: 183: 1885

This letter to the editor was an attempt to extract clarification from the authors of an article which found a twelvefold increased risk of radiation-induced cancer in older adults compared to that of atomic bomb survivors; by some miracle it was published in the print edition of the Nov 8, 2011 CMAJ. The authors’ response, published on the same page, contained a couple of factual errors and was predictably dismissive. There were also several e-letters on the subject, some from expert sources, with pertinent criticisms: reported cancers were occurring earlier than the recognized latency for radiation-induced solid tumors, and there was no attempt at correlating organs exposed to diagnostic radiation and those that developed tumors. Risk overestimates can be as annoying as risk rejection.

48. Little JB. Biological effects of low-level radiation exposure. Volume l, Chapter 13, page1. In: Taveras JM, Ferucci JT editors; Radiology: Diagnosis, Imaging, Intervention. JB Lippincott Company. (This chapter was a 1993 update in a multi-volume loose-leaf textbook designed for chapter replacements as needed.)

49. Go to www.aium.org and click on Official Statements on the right. On subsequent drop-down menu go to: Statement on Measurement of Fetal Heart Rate.