1. European Committee for Medical Ultrasound Safety (ECMUS) Ultrasound Imaging How do you know it’s SAFE? EFSUMB Safety Committee

2. European Committee for Medical Ultrasound Safety (ECMUS) Why are we concerned about safety? The range of clinical applications is becoming wider The number of patients undergoing ultrasound examinations is increasing New techniques with higher acoustic output levels are being introduced.

3. European Committee for Medical Ultrasound Safety (ECMUS) What are bio-effects? The result of ultrasound interacting with biological molecules as it passes through tissue

4. European Committee for Medical Ultrasound Safety (ECMUS) Safety Is a bioeffect likely to cause a problematic change (e.g. cell, gene or DNA damage) ?

5. European Committee for Medical Ultrasound Safety (ECMUS) Mechanisms of Action Heat (Ispta) Cavitation (P-)

6. European Committee for Medical Ultrasound Safety (ECMUS) Attenuation = Absorption + Scatter INCIDENT BEAM IMAGE Scatter 20-40% Absorption 60-80% HEAT

7. European Committee for Medical Ultrasound Safety (ECMUS) HEATING (Absorption) Increases with: frequency, exposure duration, pulse repetition frequency

8. European Committee for Medical Ultrasound Safety (ECMUS) 2 Pulsed Doppler Colour Doppler Harmonic imaging B-mode 2D,3D M-mode Power Heating potential

9. European Committee for Medical Ultrasound Safety (ECMUS) ATL UM 9 (Linear-Array L 10-5) Transducer Self Heating : International limits for probe surface temperature due to self-heating : T < 41 °C (in a water bath 2 l / 10 min)IEC 601-2-5 T < 43 °C (coupled to skin) T < 50 °C (emitting into air) IEC 60601-2-37 © CKollmann, Euroson 2010 Temperature distribution due to probe self-heating for diagnostic devices (maximum) : B-Mode Pulsed Doppler Colour Doppler I spta = 11 mW cm 2, MI = 0,5I spta = 533 mW cm 2, MI = 0,9I spta = 606 mW cm 2, MI = 0,3

10. European Committee for Medical Ultrasound Safety (ECMUS) Biological consequences of heat depend on temperature rise and duration. Thermal Effects

11. European Committee for Medical Ultrasound Safety (ECMUS) Thermal Effects Tissues containing a large component of actively dividing cells are most sensitive to the effects of heat.

12. European Committee for Medical Ultrasound Safety (ECMUS) ACOUSTIC CAVITATION

13. European Committee for Medical Ultrasound Safety (ECMUS)Cavitation

14. Formation/activity of gas filled bubbles in an ultrasound exposed medium At MHz frequencies bubble radius ~1 µm Stable cavitation – bubbles oscillate Inertial cavitation – bubbles expand too far then collapse very rapidly, releasing enough energy to damage tissue Acoustic Cavitation

15. European Committee for Medical Ultrasound Safety (ECMUS) Inertial Cavitation

16. European Committee for Medical Ultrasound Safety (ECMUS) How does the risk of heating & cavitation change with imaging conditions?

17. European Committee for Medical Ultrasound Safety (ECMUS) All modes Contact time Cavitation 2 Heating Cavitation 2 Heating Output Power Frequency Cavitation Heating Increase Increasing importance Decreasing importance

18. European Committee for Medical Ultrasound Safety (ECMUS) Imaging & M-mode M-mode Cavitation 2 Heating Sector format Heating Deeper/more focal zones 2 Heating Narrow Sector format 2 Heating

19. European Committee for Medical Ultrasound Safety (ECMUS) 2 Pulsed Doppler Other Factors which may influence Heating and cavitation Range Gate Width (pulse length may vary with gate width) Range Gate Depth (power may increase with depth) Doppler Velocity Range (pulse repetition frequency may increase)

20. European Committee for Medical Ultrasound Safety (ECMUS) 2 Receiver Gain NO has NO effect on heating or cavitation So ….. Maximise it!

21. European Committee for Medical Ultrasound Safety (ECMUS) A diagnostic exposure that produces a maximum in situ temperature rise of no more than 1.5  C above physiological levels (37  C) may be used clinically without reservation on thermal grounds WFUMB’98 - 01 Thermal Effects WFUMB 1992

22. European Committee for Medical Ultrasound Safety (ECMUS) A diagnostic exposure that elevates embryonic and fetal in situ temperature above 41 o C (by 4 o C) for  5 min should be considered to be potentially hazardous. WFUMB’98 - 01 Thermal Effects WFUMB 1992

23. European Committee for Medical Ultrasound Safety (ECMUS) “On Screen” Labelling Designed to provide safety related information AIUM/NEMA Output Display Standard

24. European Committee for Medical Ultrasound Safety (ECMUS) The Thermal index (TI) is an on-screen guide to the user of the potential for tissue heating. Estimate of the tissue temperature rise in ºC which might be possible under "reasonable worst-case conditions” THERMAL INDEX (TI)

25. European Committee for Medical Ultrasound Safety (ECMUS) TI = Acoustic Power Output (Acoustic Power to produce a 1 o C rise) THERMAL INDEX

26. European Committee for Medical Ultrasound Safety (ECMUS) Soft tissue index TIS Bone TIB TIC – bone near transducer THERMAL INDEX

27. European Committee for Medical Ultrasound Safety (ECMUS) The Mechanical index (MI) is an on-screen guide of the likelihood and magnitude of nonthermal effects. MECHANICAL INDEX

28. European Committee for Medical Ultrasound Safety (ECMUS) MI = p/  f P: in situ pressure f: frequency MECHANICAL INDEX (MI)

29. European Committee for Medical Ultrasound Safety (ECMUS) Power setting High power low gain Lower power high gain

30. European Committee for Medical Ultrasound Safety (ECMUS) Power setting High power low gain Lower power high gain

31. European Committee for Medical Ultrasound Safety (ECMUS) From scientific evidence of ultrasound- induced biological effects to date, there is NO REASON to withhold diagnostic scanning during pregnancy, provided it is 1. medically indicated 2. is used prudently by fully trained operators. This includes routine scanning of pregnant women.

32. European Committee for Medical Ultrasound Safety (ECMUS) Ultrasound exposure during pregnancy With increasing mineralisation of fetal bones, the possibility of heating sensitive tissues such as brain and spinal cord increases. So …. extra vigilance is advised

33. European Committee for Medical Ultrasound Safety (ECMUS) 3D imaging No additional safety considerations (particularly if there are significant pauses during scanning to study or manipulate the reconstructed images)

34. European Committee for Medical Ultrasound Safety (ECMUS) 4D imaging (real-time 3D) continuous exposure Involves continuous exposure Guard against prolonging examination times unduly to improve the recorded image sequence beyond that necessary for diagnostic purposes.

35. European Committee for Medical Ultrasound Safety (ECMUS) Contrast Agents (UCAs) Ultrasound Contrast Agents (UCAs) UCAs are not licensed for pregnancy Caution should be exercised when using in tissues for which damage to microvasculature may be important (eg. eye, brain, neonate) Exercise caution when using UCAs in patients with severe coronary artery disease and pulmonary hypertension. Keep MI low, and avoid long exposure times Refer to EFSUMB CEUS guidelines (2011)

36. European Committee for Medical Ultrasound Safety (ECMUS) http://www.bmus.org/policies-guides 0 0.51.0 1.52.0 2.53.0 0.7 RECOMMENDED RANGE PROVIDED ADEQUATE IMAGES CAN BE OBTAINED (especially in 1st trimester) Unlimited time Observe ALARA < 60 mins < 30 mins < 15 mins < 4 mins < 1 min NOT RECOMMENDED for OB scanning Recommended scanning time limits for these TIs (observe ALARA) THERMAL INDEX OBSTETRIC SCANNING Monitor TIS up to 10 weeks post-LMP, TIB thereafter.

37. European Committee for Medical Ultrasound Safety (ECMUS) Epidemiological safety studies Recent systematic reviews: Torloni MR. WHO systematic review of the literature and meta-analysis. UOG 2009;33:599-608 Whitworth M. Ultrasound for fetal assessment in early pregnancy. Cochrane Database Syst Rev 2010 Salvesen KÅ. Ultrasound in pregnancy and non-right handedness: meta-analysis of randomized trials. UOG 2011;38:267-71

38. European Committee for Medical Ultrasound Safety (ECMUS) Only one controversial issue Prenatal ultrasound is associated with left-handedness Published studies YearJournal1. authorType of study 1993BMJSalvesenRCT 1998Early Hum DevKielerRCT 2001EpidemiologyKielerCohort 2002 EpidemiologyKielerCohort 2011 Ultrasound Obstet GynecolHeikkiläRCT 2011 Ultrasound Obstet GynecolSalvesenMeta-analysis

39. European Committee for Medical Ultrasound Safety (ECMUS)Meta-analysis Forrest plot from Salvesen UOG 2011;38:267-71

40. European Committee for Medical Ultrasound Safety (ECMUS) We should worry – why? 5 epidemiological studies demonstrate an increased risk of left-handedness of 15-30% No other epidemiological study on ultrasound and handedness has been published Experimental studies indicate effects on the brain in some animal models Modern scanners produce higher outputs

41. European Committee for Medical Ultrasound Safety (ECMUS) We should not worry – why? Being left-handed is normal (10-15% of population) A statistical association does not imply a causal relationship The biological plausibility of this association is questionable

42. European Committee for Medical Ultrasound Safety (ECMUS) European Committee for Medical Ultrasound Safety www.efsumb.org/ecmus British Medical Ultrasound Society www.bmus.org World Federation for Ultrasound in Medicine & Biology www.wfumb.org Safety Statements