Volume 8 Issue 3 - Australasian Society for Ultrasound in Medicine

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SOCIAL SCREENINGDraft of a letter sent from the President ofASUM to health departments, learned collegesand other medical and health organisationsI am writing to you on behalf of the Australasian Society ofUltrasound in Medicine regarding non medical 4D scanningof babies. ASUM is a peak body in ultrasound whose purposeis to promote excellence and safe practise in ultrasound. Ourmembership is comprised of Medical Imaging Specialists(mainly Obstetricians and Radiologists), Scientists involvedin the field, and technical personnel.Following similar trends in the United States, recentlyseveral entrepreneurial groups have begun setting up businesseswhose sole purpose is the non medical scanning ofbabies in utero to obtain 3D photographs and 4D video. Thereis no involvement of qualified medical or technical personnelto our knowledge. We understand clinics have been establishedin Adelaide and Melbourne, and undoubtedly more willfollow in other cities.The establishment of these clinics causes considerableconcern to ASUM. It has been an established policy of ourssince ultrasound scanning began, to keep fetal exposureto ultrasound as low as possible. Although no significant illaffects of ultrasound have yet been demonstrated, we feel wewould not be discharging our ethical responsibilities by notlimiting exposure. Clearly these clinics who are scanning forwhat could only be described as social reasons, contravenethis policy.Of greater concern however, is the very real probabilitythat patients will become confused as to what constitutes amedical scan and a non medical scan. The general populationmay in some circumstances believe they have had an ultrasoundscan of their baby and that all is satisfactory, confusingthis with a medical scan which actually looks at the developmentof the fetus. In addition, should abnormalities be found,the circumstances for the delivery of this news would be suboptimal,potentially disturbing, and probably quite unsafe.It is likely the Department of Health will see they have littlerole in this area as they will not be claimed upon for fundingin any way. They have indicated that they are not particularlyinterested by these developments.We are writing to request your consideration of this matter.We believe that if your members become involved in thisstyle of practise then they would be acting unethically byblurring the boundaries between medical imaging and nonmedical photography. We suggest it would be appropriate foryour board to censure any of your members who may becomeinvolved in this practise.We would appreciate you discussing this and formulatingan opinion. We believe we should renounce the development ofthese clinics, and should proceed with lobbying the Department ofHealth to legislate against the existence of such clinics. Attachedis a draft statement outlining our concerns.We look forward to hearing from you in the near future. Ifthere are any aspects to this matter or the statement youwould like to discuss, please do not hesitate to contact me.Dr David RogersPresident ASUMTo the EditorNon-medical applications of ultrasoundThe prudent use of medical ultrasound as advocated byASUM and other ultrasound societies usually refers to ‘medicallyindicated’ procedures, i.e., those where an improveddiagnostic outcome is expected from the procedure. The useof diagnostic imaging technology simply to view the fetus fordemonstration purposes or to obtain a personal photograph orvideo does not constitute a medical use, in its strictest sense.In response to increasing commercial interest in marketingnon-diagnostic ‘keepsake’ videos and photos, the AmericanInstitute of Ultrasound in Medicine (AIUM) issued cautionarystatements against what it describes as the non-medical use ofdiagnostic ultrasound (AIUM website).The FDA Centre for Devices and Radiological Healthhas also been quite outspoken, threatening regulatory actionagainst the practice of commercial imaging of fetuses for‘keepsake’ videos (FDA 2000). The FDA notified the medicalcommunity in the USA in 1994 regarding its concerns aboutthe misuse of diagnostic ultrasound equipment and sought todiscourage their patients from having sonograms for so-called‘non-medical’ reasons. The published FDA rationale states:‘Although there is no evidence that these physical effects canharm the fetus, public health experts, clinicians and industryagree that casual exposure to ultrasound, especially duringpregnancy, should be avoided. Viewed in this light, exposingthe fetus to ultrasound with no anticipation of medical benefitis not justified.’ (FDA 2000).The British Medical Ultrasound Society has publishedguidelines that permit the use of non-medical ultrasound,but only under conditions that significantly limit the ultrasoundoutput (BMUS 2000) and, hence reduce the risk tothe patient in the absence of known benefit. The BMUSdefines non-diagnostic use of ultrasound equipment as thatincluding repeated scans for operator training, equipmentdemonstration using normal subjects, and the productionof souvenir pictures or videos of a fetus. The BMUSguidelines for non-diagnostic uses of diagnostic ultrasoundprovide upper limits to the thermal index (TI < 0.5) andmechanical index (MI < 0.3). These are somewhat restrictivebut were chosen to provide a lower degree of risk forprocedures where there is no obvious clinical benefit. Notethat the FDA limits output on equipment (for use in theUSA) with an output display to MI < 1.9 for all examinationsexcept ophthalmic where MI < 0.23 applies. There isno limit on TI, but intensity (spatial peak temporal average)is limited to a maximum of 720 mW/cm2.It is a matter of debate whether, or not, live scanning maybe construed simply as an exercise in marketing the diagnosticability of a particular piece of ultrasound equipment.Stan BarnettChairman ASUM Safety CommitteeReferencesAIUM website. www.aium.org/stmts.htm#Prudent UseBMUS. British Medical Ultrasound Society, Guidelines for the safe useof diagnostic ultrasound equipment. BMUS Bulletin 2000; 8: 30–33.FDA CDRH. Centre for Devices and Radiological Health Consumerupdate on fetal keepsake videos. June 2000. www.fda.gov/cdrh/consumer/fetalvideos.htm36 ASUM Ultrasound Bulletin 2005 August; 8 (3)
Editor’s noteThe introduction by ultrasound operators in the USA andAustralia of a purely commercial ‘non-medical 3D ultrasoundimaging service to provide keepsake images of theunborn child has provoked a storm of controversy. TheAmerican Medical Association has weighed into the debatewith the following comments extracted from the article thatfollows.American Medical Association says ultrasoundin-utero ‘portraits’ are bad idea6/22/2005By: Reuters Health‘Recent advances in ultrasound technology, including3D image capacity, have made the ‘pre-birth’ portraitspopular, which prompted the Missouri delegation to theHouse of Delegates to ask the AMA to go public about therisks of the practice . . .The Missouri doctors said the ultrasound portraits areoften done by unqualified technicians in whose handsultrasound, which is generally a safe procedure, may haveunanticipated risks. During a reference committee hearing“testimony was overwhelmingly in support of this resolutioncalling for the responsible use of diagnostic ultrasoundduring pregnancy,” said Dr Daniel van Heeckeren, a thoracicsurgeon at University Hospitals, Cleveland, Ohio whochaired the Reference Committee . . .Dr Van Heeckeren noted that use of diagnostic ultrasoundfor ‘keepsake’ purposes puts the clinician at riskof potential legal liability since this imaging is often performedwithout parents receiving the standard counselingthat normally precedes ultrasound examinations.Editor’s noteASUM members also had plenty to say, including the followingedited comments extracted from various emailsto the Editor. Space precludes full publication of eachcommunication. Readers are invited to submit any furtherviews on this subject. ASUM does not endorse any of thesestatements. They are simply the opinions of individual correspondents.■ “How do bodies such as ASUM justify other non-medicaluses of ultrasound equipment, such as in live company-sponsoreddemonstrations and other ‘non-medical’activities? There is a far wider impact overall fromother non-medical uses compared to the 3D foetal photoscanner in [location omitted].If a 3D photo of the unborn child’s facial featuresduring pregnancy improves bonding (which it probablydoes on the face of it – no pun intended) and reducesthe incidence of postnatal family disruption by makingthe family-to-be appreciate the actuality of a child inthe making, or improves paternal postnatal care-giving(which it might), then a 3D photo has done more for thepregnancy than 99% of morphology scans, which seekto identify any abnormality which might prompt a latemid-trimester termination – an abhorrent 'treatment' inmy view. The reporting of an isolated so called ‘softmarker’ morphology scan finding which alone has nostatistical significance (such as an echogenic focus inthe heart, a choroid plexus cyst or a 5 mm renal pelvis)creates significant anxiety for many pregnant ladies andtheir partners and is arguably far more damaging than afew 3D images of an unborn baby’s face.”■ “Advocates perhaps might produce some evidencefor the statements made about the benefits of 3Dultrasound for families. One of our research Psychstudents has just concluded a randomised studywhich surprised us all by showing that comparedwith 2D scanning there is no difference in bondingas judged by the psychologic testing methodsshe employed. And not all foetal anatomy scans arepart of a search and destroy campaign. But we coulddebate the value of foetal abnormality scans (FAS)ad nauseam. We certainly do create angst but the softmarker chaos was initiated by well meaning groupsmainly in the USA extrapolating from high risk tolow risk groups. What I think worries most peopleabout entertainment scanning is [that] it is demeaningof the profession and the inference that what isgood for the greedy entrepreneurs [offering these 3Dservices] is necessarily good for their customers andtheir babies in utero.”■ “The BMUS guidelines for non-diagnostic uses of diagnosticultrasound provide upper limits to the thermalindex (TI < 0.5) and mechanical index (MI < 0.3). Theseare somewhat restrictive but were chosen to provide alower degree of risk for procedures where there is noobvious clinical benefit.”■ “Medicare is solely a payment system. It has nothingto do with setting standards of practice. There is noMedicare payment involved [in 3D ‘entertainment’ultrasound] so there is little interest [from legislators] incurbing the practice.”■ “ASUM must take the lead here as the peak ultrasoundbody in advising legislators and the publicthat this practice [of 3D ‘entertainment’ ultrasound]is inappropriate. The ALARA [as low as reasonablyachievable] rule applies to ultrasound as it does toother imaging modalities. It should only be performedwhere there is an appropriate medical indicationand exposure should be minimised. Just becausethere is no demonstrated effect to date, it does notmean ultrasound exposure is safe."■ “3D scanning is a commercial contract creating aduty of care. If the mother is warned of material biodangers(of which none are established) and understandsthat the scan is not for medical purposes, theduty of care is discharged. Where the operator doesnot hold themselves out to be providing a medicalservice, the provisions of the various State basedlegislative instruments controlling doctors and otherswho deliver medical care do not apply.”■ “[In relation to the concern of abnormalities either beingfound or missed on these social scans] the operators hadbetter be careful with the way they structure their business,get good legal advice and have good insurance!”■ “What about the right of the foetus to determine itsexposure to unnecessary risk [such as 3D ‘entertainment’ultrasound] for the enjoyment of others [its parentsand grandparents]”.ASUM Ultrasound Bulletin 2005 August; 8 (3)37
Page 1 and 2: ISSN 1441-6891Volume 8 Number 3 Aug
Page 3 and 4: PresidentDr David RogersImmediate P
Page 5 and 6: ientific Meeting of ASUMe r 2005 Ad
Page 7 and 8: ASM 2005 PROFFERED PAPERSFriday 30t
Page 9 and 10: THE EXECUTIVEPresident’s messageD
Page 11 and 12: THE EXECUTIVEAdelaide ASMLooking ah
Page 13 and 14: The DMU (Asia) will deliver high te
Page 15 and 16: THE EXECUTIVEMember ServicesSonogra
Page 17 and 18: ASUM Ultrasound Bulletin 2005 Augus
Page 19 and 20: D Fauchon, S Watson and R Benzieor
Page 21 and 22: ASUM Ultrasound Bulletin 2005 Augus
Page 23: Fetal upper abdominal masses; a pre
Page 26 and 27: RP Davies, T McClymont and D Boshel
Page 28 and 29: RP Davies, T McClymont and D Boshel
Page 30 and 31: CASE REPORTASUM Ultrasound Bulletin
Page 32 and 33: HS Wong, K Burns, L Strand and S Pa
Page 34 and 35: Justin O’learyFigure 3 Figure 4co
Page 36 and 37: POLICIES and STATEMENTSFetal struct
Page 40 and 41: SOCIAL SCREENINGSonographerMelbourn
Page 42 and 43: THE SOCIETYSUMCertified ISO 9001:20
Page 44 and 45: THE SOCIETYDiploma of Medical Ultra
Page 46 and 47: EDUCATIONExamination dates for 2005
Page 48 and 49: THE SOCIETYThe 2004 Beresford Butte
Page 50 and 51: OBITUARYJames Robert Syme MD, FRACP
Page 52 and 53: THE SOCIETYCorporate Members 2005Au
Page 54 and 55: CALENDARContact Byung Ihn Choi MDCo
Page 56: ASUM ULTRASOUND BULLETIN VOLUME 8 N

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