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Notice given 12 September 2005

1172  Senator Allison: To ask the Minister representing the Minister for Health and Ageing—With reference to the answer to question on notice no. 2018 (Senate Hansard , 10 February 2005, p. 19747), indicating that the Commonwealth Scientific and Industrial Research Organisation (CSIRO) no longer undertakes research in the area of diagnostic ultrasound, and that the National Measurement Laboratory was deferring ‘further investigation of the needs of this field pending the establishment of the new National Measurement Institute in July 2004’:

(1) Has this institute been established; if not, why not; if so, what work is being done in the area of ultrasound measurement by this institute.

(2) What, if any, safety standards or any other regulatory regime have been developed to monitor the application of ultrasound in obstetrics in Australia.

(3) Given that work done by the CSIRO in collaboration with centres in Australia and overseas found that, tissue heating to 5 degrees can easily be produced near foetal bone, and such increases can, after only 5 minutes, cause severe brain abnormalities in the developing foetus, embryonic growth is stopped and heat shock (stress) proteins are produced in laboratory exposures to pulsed Doppler ultrasound, and the use of echo-contrast agents can amplify biological effects and cause bleeding at power levels of orders that are orders of magnitude less than that required in the absence of contrast agents, does the Minister consider that the ultrasound regulatory regime is adequate.

(4) Is the Minister aware that in 2004, Professor Nagel from the University of Stuttgart said, ‘… it has not been verified whether the current regulations for the safe use of ultrasound equipment are valid at these frequencies. The biological effects of low frequency ultrasound have only recently been explored. According to our current knowledge they represent serious health hazards … possible negative effects of high-intensity ultrasound are hearing loss, impairment of the vestibular system, damage to peripheral sensory receptors, destruction of cells and fragmentation of DNA, and uncontrolled sonoporation’.

(5) Are there businesses in Australia that provide non-medical ultrasound procedures without a doctor’s referral; if so: (a) are they regulated; and (b) what qualifications are required of these practitioners.

(6) Does the Minister consider that the Australian medical profession should adopt the advice provided by the American Institute of Ultrasound in Medicine that it, ‘strongly discourage the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either 2D or 3D ultrasound to only view the foetus, obtain a picture of the foetus, or determine the gender without a medical intervention is inappropriate and contrary to responsible medical practice’; if not, why not.

(7) Given that the American Food and Drug Administration has banned the non-medical use of ultrasound, will the Government also consider such a ban.

(8) Given the epidemiological and laboratory evidence from around the world that indicates ultrasound treatment can result in learning difficulties, a significant rise in left-handedness in boys, auditory problems, autism, growth retardation, dyslexia and delayed speech development, will the medical profession in Australia be advised to warn women of the possible negative bio-effects before ultrasound treatment.