Advertisement
Review| Volume 26, ISSUE 3, P355-366, March 2000

International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine

      Abstract

      Modern sophisticated ultrasonographic equipment is capable of delivering substantial levels of acoustic energy into the body when used at maximum outputs. The risk of producing bioeffects has been studied by international expert groups during symposia supported by the World Federation for Ultrasound in Medicine and Biology (WFUMB). These have resulted in the publication of internationally accepted conclusions and recommendations. National ultrasound safety committees have published guidelines as well. These recommendations and safety guidelines offer valuable information to help users apply diagnostic ultrasound in a safe and effective manner. Acoustic output from ultrasound medical devices is directly regulated only in the USA and this is done by the Food and Drug Administration (FDA). However, there is also a modern trend towards self-regulation which has implications for the worldwide use of diagnostic ultrasound. It has resulted in a move away from the relatively simple scheme of FDA-enforced, application-specific limits on acoustic output to a scheme whereby risk of adverse effects of ultrasound exposure is assessed from information provided by the equipment in the form of a real-time display of safety indices. Under this option, the FDA allows a relaxation of some intensity limits, specifically approving the use of medical ultrasound devices that can expose the fetus or embryo to nearly eight times the intensity that was previously allowed. The shift of responsibility for risk assessment from a regulatory authority to the user creates an urgent need for awareness of risk and the development of knowledgeable and responsible attitudes to safety issues. To encourage this approach, it is encumbent on authorities, ultrasound societies and expert groups to provide relevant information on biological effects that might result from ultrasonographic procedures. It is obvious from the continued stream of enquiries received by ultrasound societies that effective dissemination of such knowledge requires sustained strenuous effort on the part of ultrasound safety committees. There is a strong need for continuing education to ensure that appropriate risk/benefit assessments are made by users based on an appropriate knowledge of the probability of biological effects occurring with each type of ultrasound procedure. The primary purpose of this paper is to draw attention to current safety guidelines and show the similarities and areas of general agreement with those issued by the parent ultrasound organisation, the WFUMB. It is equally important to identify gaps in our knowledge, where applicable.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Ultrasound in Medicine and Biology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Abbott J.G
        Rationale and derivation of MI and TI —A review.
        Ultrasound Med Biol. 1999; 25: 431-442
      1. AIUM 1999. Official Statements and Reports of the American Institute of Ultrasound in Medicine. http://www.aium.org/stmts.htm.

      2. AIUM Medical ultrasound safety. AIUM Publications, 1994 American Institute of Ultrasound in Medicine, 14750 Sweitzer Lane, Suite 100, Laurel, MD 20707, USA.

      3. AIUM Safety Considerations for Diagnostic Ultrasound. Bioeffects Committee of the American Institute of Ultrasound in Medicine. 1991 AIUM Publications, 14750 Sweitzer Lane, Suite 100, Laurel, MD 20707, USA

      4. AIUM website. http://www.aium.org/

      5. AIUM/NEMA. Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. American Institute of Ultrasound in Medicine, 14750 Sweitzer Lane, Suite 100, Laurel, MD 20707, USA.

        • Barnett S.B
        • Kossoff G
        • Edwards M.J
        International perspectives on safety and standardisation of diagnostic pulsed ultrasound in medicine.
        Ultrasound Obstet Gynecol. 1993; 3: 287-294
        • Barnett S.B
        • Kossoff G
        • Edwards M.J
        Is diagnostic ultrasound safe?.
        Current international consensus on the thermal mechanism. Med J Australia. 1994; 160: 33-37
        • Barnett S.B
        • Rott H.D
        • ter Haar G.R
        • Ziskin M.C
        • Maeda K
        The sensitivity of biological tissue to ultrasound.
        Ultrasound Med Biol. 1997; 23: 805-812
        • Barnett S.B
        • ter Haar G.R
        • Ziskin M.C
        • Nyborg W.L
        • Maeda K
        • Bang J
        Current status of research on biophysical effects of ultrasound.
        Ultrasound Med Biol. 1994; 20: 205-218
        • Child S.Z
        • Hartman C.L
        • Schery L.A
        • Carstensen E.L
        Lung damage from exposure to pulsed ultrasound.
        Ultrasound Med Biol. 1990; 16: 817-825
        • Duck F.A
        • Henderson J
        Acoustic output of modern ultrasound equipment.
        in: Barnett S.B Kossoff G Safety of diagnostic ultrasound. Parthenon Publishing Group, New York1998: 15-26
        • Duck F.A
        Acoustic saturation and output regulation.
        Ultrasound Med Biol. 1999; 25: 1009-1018
      6. ECURS European Committee for Ultrasound Radiation Safety, Tutorial paper on Transvaginal ultrasonography - safety aspects. Eur J Ultrasound 1994;1:355–357.

        • EFSUMB Clinical safety statement for diagnostic ultrasound European committee for medical ultrasound safety
        Tours, France, March 1998.
        Eur J Ultrasound. 1998; 8: 67-68
      7. EFSUMB European Federation of Societies for Ultrasound in Medicine and Biology, Guidelines for the safe use of Doppler ultrasound for clinical applications. Report from the European Committee for Ultrasound Radiation Safety. Eur J Ultrasound 1995; 2:167–68.

      8. EFSUMB Tutorial paper: Thermal and mechanical indices. European Committee for Ultrasound Radiation Safety. Eur J Ultrasound 1996; 4:145–50.

      9. EFSUMB website, http://www.efsumb.org/safstat.htm

      10. FDA Revised 510(k) diagnostic ultrasound guidance for 1993. Centre for Devices and Radiological Health, US Food and Drug Administration 1993 Rockville, MD.

      11. FDA 510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound. 1985 Food and Drug Administration, Centre for Devices and Radiological Health, Rockville, M.D. (1992 updated Draft document).

        • Geschwind N
        • Galaburda A.M
        Cerebral lateralization.
        Biological mechanisms, associations, and pathology: 1. A hypothesis and a program for research. Arch Neurol. 1985; 42: 428-459
        • Henderson J
        • Whittingham T.A
        • Dunn T
        A review of the acoustic output of modern diagnostic ultrasound equipment.
        BMUS Bulletin. 1997; 5: 10-14
        • Henderson J
        • Willson J
        • Jago R
        • Whittingham T
        A survey of the acoustic outputs of diagnostic equipment in current clinical use.
        Ultrasound Med Biol. 1995; 21: 699-705
        • Holland C.K
        Ultrasound Bioeffects.
        in: Goldman L.W Fowlkes J.B Medical CT and Ultrasound Current Technology and Applications. Advanced Medical Publishing, Madison, Wisconsin1995: 211-228
      12. IEC 1157 Requirement for the declaration of acoustic output of medical diagnostic equipment. Standard 1157 Geneva, International Electrotechnical Commission, 1992.

        • Kieler H
        • Axelsson O
        • Haglund B
        • Nilsson S
        • Salvesen K.A
        Routine ultrasound screening in pregnancy and children’s subsequent handedness.
        Early Human Dev. 1998; 50: 233-245
        • Newnham J.P
        • Evans S.F
        • Michael C.A
        • Stanley F.J
        • Landau L.I
        Effects of frequent ultrasound during pregnancy.
        Lancet. 1993; 2: 887-891
      13. Salvesen KA Epidemiological studies of diagnostic ultrasound. In: ter Haar G, Duck FA, eds. The safe use of ultrasound in medical diagnosis. Br Med Ultrasound Soc/Br Inst Radiol. BIR Publications, London, U.K. 2000.

        • Salvesen K.A
        • Eik-Nes S.H
        Ultrasound during pregnancy and birthweight, childhood malignancies and neurological development.
        Ultrasound Med Biol. 1999; 25: 1025-1031
        • Salvesen K.A
        • Eik-Nes S.H
        Ultrasound during pregnancy and subsequent childhood non-righthandedness.
        Ultras Obstet Gynecol. 1999; 13: 241-246
        • Salvesen K.A
        • Vatten L.J
        • Eik-Nes S.H
        • Hugdahl K
        • Bakketeig L.S
        Routine ultrasonography in utero and subsequent handedness and neurological development.
        Br Med J. 1993; 307: 159-164
        • Shu X
        • Jin F
        • Linet M
        • et al.
        Diagnostic X-ray and ultrasound exposure and risk of childhood cancer.
        Br J Cancer. 1994; 70: 531-536
        • Sorahan T
        • Lancashire R
        • Stewart A
        • Peck I
        Pregnancy ultrasound and childhood cancer.
        Br J Obstet Gynecol. 1995; 102: 831-832
        • Tarantal A.F
        Effects of ultrasound exposure on fetal development in animal models.
        in: Barnett S.B Kossoff G Safety of diagnostic ultrasound. Parthenon Publishing Group, New York1998: 39-51
      14. WFUMB website. http://www.wfumb.org.au/reports.htm

      15. WFUMB World Federation for Ultrasound in Medicine and Biology Symposium on Safety and Standardisation in Medical Ultrasound: Issues and recommendations regarding thermal mechanisms for biological effects of ultrasound. Barnett SB, Kossoff G. eds. Ultrasound in Med Biol special issue Vol. 18, 1992.

      16. WFUMB World Federation for Ultrasound in Medicine and Biology Symposium on Safety of Ultrasound in Medicine: Conclusions and Recommendations on Thermal and Non-Thermal Mechanisms for Biological Effects of Ultrasound. (Barnett SB, ed.) Ultrasound Med Biol 1998; 24:1–55.

      17. Whittingham TA. Acoustic outputs of diagnostic machines. In: ter Haar G, Duck FA, eds. The safe use of ultrasound in medical diagnosis. Br Med Ultrasound Soc/Br Inst Radiol. Br Institute Radiol, London, 2000 BMUS.