SOCIAL SCREENINGDraft of a letter sent from the President ofASUM to health departments, learned collegesand other medical and health organisationsI am writ<strong>in</strong>g to you on behalf of the <strong>Australasian</strong> <strong>Society</strong> of<strong>Ultrasound</strong> <strong>in</strong> Medic<strong>in</strong>e regard<strong>in</strong>g non medical 4D scann<strong>in</strong>gof babies. ASUM is a peak body <strong>in</strong> ultrasound whose purposeis to promote excellence and safe practise <strong>in</strong> ultrasound. Ourmembership is comprised of Medical Imag<strong>in</strong>g Specialists(ma<strong>in</strong>ly Obstetricians and Radiologists), Scientists <strong>in</strong>volved<strong>in</strong> the field, and technical personnel.Follow<strong>in</strong>g similar trends <strong>in</strong> the United States, recentlyseveral entrepreneurial groups have begun sett<strong>in</strong>g up bus<strong>in</strong>esseswhose sole purpose is the non medical scann<strong>in</strong>g ofbabies <strong>in</strong> utero to obta<strong>in</strong> 3D photographs and 4D video. Thereis no <strong>in</strong>volvement of qualified medical or technical personnelto our knowledge. We understand cl<strong>in</strong>ics have been established<strong>in</strong> Adelaide and Melbourne, and undoubtedly more willfollow <strong>in</strong> other cities.The establishment of these cl<strong>in</strong>ics causes considerableconcern to ASUM. It has been an established policy of ourss<strong>in</strong>ce ultrasound scann<strong>in</strong>g 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 discharg<strong>in</strong>g our ethical responsibilities by notlimit<strong>in</strong>g exposure. Clearly these cl<strong>in</strong>ics who are scann<strong>in</strong>g <strong>for</strong>what 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 <strong>in</strong> some circumstances believe they have had an ultrasoundscan of their baby and that all is satisfactory, confus<strong>in</strong>gthis with a medical scan which actually looks at the developmentof the fetus. In addition, should abnormalities be found,the circumstances <strong>for</strong> the delivery of this news would be suboptimal,potentially disturb<strong>in</strong>g, and probably quite unsafe.It is likely the Department of Health will see they have littlerole <strong>in</strong> this area as they will not be claimed upon <strong>for</strong> fund<strong>in</strong>g<strong>in</strong> any way. They have <strong>in</strong>dicated that they are not particularly<strong>in</strong>terested by these developments.We are writ<strong>in</strong>g to request your consideration of this matter.We believe that if your members become <strong>in</strong>volved <strong>in</strong> thisstyle of practise then they would be act<strong>in</strong>g unethically byblurr<strong>in</strong>g the boundaries between medical imag<strong>in</strong>g and nonmedical photography. We suggest it would be appropriate <strong>for</strong>your board to censure any of your members who may become<strong>in</strong>volved <strong>in</strong> this practise.We would appreciate you discuss<strong>in</strong>g this and <strong>for</strong>mulat<strong>in</strong>gan op<strong>in</strong>ion. We believe we should renounce the development ofthese cl<strong>in</strong>ics, and should proceed with lobby<strong>in</strong>g the Department ofHealth to legislate aga<strong>in</strong>st the existence of such cl<strong>in</strong>ics. Attachedis a draft statement outl<strong>in</strong><strong>in</strong>g our concerns.We look <strong>for</strong>ward to hear<strong>in</strong>g from you <strong>in</strong> 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 ‘medically<strong>in</strong>dicated’ procedures, i.e., those where an improveddiagnostic outcome is expected from the procedure. The useof diagnostic imag<strong>in</strong>g technology simply to view the fetus <strong>for</strong>demonstration purposes or to obta<strong>in</strong> a personal photograph orvideo does not constitute a medical use, <strong>in</strong> its strictest sense.In response to <strong>in</strong>creas<strong>in</strong>g commercial <strong>in</strong>terest <strong>in</strong> market<strong>in</strong>gnon-diagnostic ‘keepsake’ videos and photos, the AmericanInstitute of <strong>Ultrasound</strong> <strong>in</strong> Medic<strong>in</strong>e (AIUM) issued cautionarystatements aga<strong>in</strong>st what it describes as the non-medical use ofdiagnostic ultrasound (AIUM website).The FDA Centre <strong>for</strong> Devices and Radiological Healthhas also been quite outspoken, threaten<strong>in</strong>g regulatory actionaga<strong>in</strong>st the practice of commercial imag<strong>in</strong>g of fetuses <strong>for</strong>‘keepsake’ videos (FDA 2000). The FDA notified the medicalcommunity <strong>in</strong> the USA <strong>in</strong> 1994 regard<strong>in</strong>g its concerns aboutthe misuse of diagnostic ultrasound equipment and sought todiscourage their patients from hav<strong>in</strong>g sonograms <strong>for</strong> 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, cl<strong>in</strong>icians and <strong>in</strong>dustryagree that casual exposure to ultrasound, especially dur<strong>in</strong>gpregnancy, should be avoided. Viewed <strong>in</strong> this light, expos<strong>in</strong>gthe fetus to ultrasound with no anticipation of medical benefitis not justified.’ (FDA 2000).The British Medical <strong>Ultrasound</strong> <strong>Society</strong> has publishedguidel<strong>in</strong>es 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 <strong>in</strong> the absence of known benefit. The BMUSdef<strong>in</strong>es non-diagnostic use of ultrasound equipment as that<strong>in</strong>clud<strong>in</strong>g repeated scans <strong>for</strong> operator tra<strong>in</strong><strong>in</strong>g, equipmentdemonstration us<strong>in</strong>g normal subjects, and the productionof souvenir pictures or videos of a fetus. The BMUSguidel<strong>in</strong>es <strong>for</strong> non-diagnostic uses of diagnostic ultrasoundprovide upper limits to the thermal <strong>in</strong>dex (TI < 0.5) andmechanical <strong>in</strong>dex (MI < 0.3). These are somewhat restrictivebut were chosen to provide a lower degree of risk <strong>for</strong>procedures where there is no obvious cl<strong>in</strong>ical benefit. Notethat the FDA limits output on equipment (<strong>for</strong> use <strong>in</strong> theUSA) with an output display to MI < 1.9 <strong>for</strong> all exam<strong>in</strong>ationsexcept ophthalmic where MI < 0.23 applies. There isno limit on TI, but <strong>in</strong>tensity (spatial peak temporal average)is limited to a maximum of 720 mW/cm2.It is a matter of debate whether, or not, live scann<strong>in</strong>g maybe construed simply as an exercise <strong>in</strong> market<strong>in</strong>g the diagnosticability of a particular piece of ultrasound equipment.Stan BarnettChairman ASUM Safety CommitteeReferencesAIUM website. www.aium.org/stmts.htm#Prudent UseBMUS. British Medical <strong>Ultrasound</strong> <strong>Society</strong>, Guidel<strong>in</strong>es <strong>for</strong> the safe useof diagnostic ultrasound equipment. BMUS Bullet<strong>in</strong> 2000; 8: 30–33.FDA CDRH. Centre <strong>for</strong> Devices and Radiological Health Consumerupdate on fetal keepsake videos. June 2000. www.fda.gov/cdrh/consumer/fetalvideos.htm36 ASUM <strong>Ultrasound</strong> Bullet<strong>in</strong> 2005 August; 8 (3)
Editor’s noteThe <strong>in</strong>troduction by ultrasound operators <strong>in</strong> the USA andAustralia of a purely commercial ‘non-medical 3D ultrasoundimag<strong>in</strong>g service to provide keepsake images of theunborn child has provoked a storm of controversy. TheAmerican Medical Association has weighed <strong>in</strong>to the debatewith the follow<strong>in</strong>g comments extracted from the article thatfollows.American Medical Association says ultrasound<strong>in</strong>-utero ‘portraits’ are bad idea6/22/2005By: Reuters Health‘Recent advances <strong>in</strong> ultrasound technology, <strong>in</strong>clud<strong>in</strong>g3D 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 <strong>in</strong> whose handsultrasound, which is generally a safe procedure, may haveunanticipated risks. Dur<strong>in</strong>g a reference committee hear<strong>in</strong>g“testimony was overwhelm<strong>in</strong>gly <strong>in</strong> support of this resolutioncall<strong>in</strong>g <strong>for</strong> the responsible use of diagnostic ultrasounddur<strong>in</strong>g 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 ultrasound<strong>for</strong> ‘keepsake’ purposes puts the cl<strong>in</strong>ician at riskof potential legal liability s<strong>in</strong>ce this imag<strong>in</strong>g is often per<strong>for</strong>medwithout parents receiv<strong>in</strong>g the standard counsel<strong>in</strong>gthat normally precedes ultrasound exam<strong>in</strong>ations.Editor’s noteASUM members also had plenty to say, <strong>in</strong>clud<strong>in</strong>g the follow<strong>in</strong>gedited comments extracted from various emailsto the Editor. Space precludes full publication of eachcommunication. Readers are <strong>in</strong>vited to submit any furtherviews on this subject. ASUM does not endorse any of thesestatements. They are simply the op<strong>in</strong>ions of <strong>in</strong>dividual correspondents.■ “How do bodies such as ASUM justify other non-medicaluses of ultrasound equipment, such as <strong>in</strong> 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 <strong>in</strong> [location omitted].If a 3D photo of the unborn child’s facial featuresdur<strong>in</strong>g pregnancy improves bond<strong>in</strong>g (which it probablydoes on the face of it – no pun <strong>in</strong>tended) and reducesthe <strong>in</strong>cidence of postnatal family disruption by mak<strong>in</strong>gthe family-to-be appreciate the actuality of a child <strong>in</strong>the mak<strong>in</strong>g, or improves paternal postnatal care-giv<strong>in</strong>g(which it might), then a 3D photo has done more <strong>for</strong> thepregnancy than 99% of morphology scans, which seekto identify any abnormality which might prompt a latemid-trimester term<strong>in</strong>ation – an abhorrent 'treatment' <strong>in</strong>my view. The report<strong>in</strong>g of an isolated so called ‘softmarker’ morphology scan f<strong>in</strong>d<strong>in</strong>g which alone has nostatistical significance (such as an echogenic focus <strong>in</strong>the heart, a choroid plexus cyst or a 5 mm renal pelvis)creates significant anxiety <strong>for</strong> many pregnant ladies andtheir partners and is arguably far more damag<strong>in</strong>g than afew 3D images of an unborn baby’s face.”■ “Advocates perhaps might produce some evidence<strong>for</strong> the statements made about the benefits of 3Dultrasound <strong>for</strong> families. One of our research Psychstudents has just concluded a randomised studywhich surprised us all by show<strong>in</strong>g that comparedwith 2D scann<strong>in</strong>g there is no difference <strong>in</strong> bond<strong>in</strong>gas judged by the psychologic test<strong>in</strong>g 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 certa<strong>in</strong>ly do create angst but the softmarker chaos was <strong>in</strong>itiated by well mean<strong>in</strong>g groupsma<strong>in</strong>ly <strong>in</strong> the USA extrapolat<strong>in</strong>g from high risk tolow risk groups. What I th<strong>in</strong>k worries most peopleabout enterta<strong>in</strong>ment scann<strong>in</strong>g is [that] it is demean<strong>in</strong>gof the profession and the <strong>in</strong>ference that what isgood <strong>for</strong> the greedy entrepreneurs [offer<strong>in</strong>g these 3Dservices] is necessarily good <strong>for</strong> their customers andtheir babies <strong>in</strong> utero.”■ “The BMUS guidel<strong>in</strong>es <strong>for</strong> non-diagnostic uses of diagnosticultrasound provide upper limits to the thermal<strong>in</strong>dex (TI < 0.5) and mechanical <strong>in</strong>dex (MI < 0.3). Theseare somewhat restrictive but were chosen to provide alower degree of risk <strong>for</strong> procedures where there is noobvious cl<strong>in</strong>ical benefit.”■ “Medicare is solely a payment system. It has noth<strong>in</strong>gto do with sett<strong>in</strong>g standards of practice. There is noMedicare payment <strong>in</strong>volved [<strong>in</strong> 3D ‘enterta<strong>in</strong>ment’ultrasound] so there is little <strong>in</strong>terest [from legislators] <strong>in</strong>curb<strong>in</strong>g the practice.”■ “ASUM must take the lead here as the peak ultrasoundbody <strong>in</strong> advis<strong>in</strong>g legislators and the publicthat this practice [of 3D ‘enterta<strong>in</strong>ment’ ultrasound]is <strong>in</strong>appropriate. The ALARA [as low as reasonablyachievable] rule applies to ultrasound as it does toother imag<strong>in</strong>g modalities. It should only be per<strong>for</strong>medwhere there is an appropriate medical <strong>in</strong>dicationand exposure should be m<strong>in</strong>imised. Just becausethere is no demonstrated effect to date, it does notmean ultrasound exposure is safe."■ “3D scann<strong>in</strong>g is a commercial contract creat<strong>in</strong>g aduty of care. If the mother is warned of material biodangers(of which none are established) and understandsthat the scan is not <strong>for</strong> medical purposes, theduty of care is discharged. Where the operator doesnot hold themselves out to be provid<strong>in</strong>g a medicalservice, the provisions of the various State basedlegislative <strong>in</strong>struments controll<strong>in</strong>g doctors and otherswho deliver medical care do not apply.”■ “[In relation to the concern of abnormalities either be<strong>in</strong>gfound or missed on these social scans] the operators hadbetter be careful with the way they structure their bus<strong>in</strong>ess,get good legal advice and have good <strong>in</strong>surance!”■ “What about the right of the foetus to determ<strong>in</strong>e itsexposure to unnecessary risk [such as 3D ‘enterta<strong>in</strong>ment’ultrasound] <strong>for</strong> the enjoyment of others [its parentsand grandparents]”.ASUM <strong>Ultrasound</strong> Bullet<strong>in</strong> 2005 August; 8 (3)37