Advertisement

Safety and U.S. Regulatory Considerations in the Nonclinical Use of Medical Ultrasound Devices

      Abstract

      Ultrasound imaging has been used for medical purposes for over 50 years and has an excellent safety record. Ultrasonic fetal scanning is generally considered safe and is properly used when medical information on a pregnancy is needed. However, ultrasound energy delivered to the fetus cannot be regarded as completely innocuous. Even though there are no demonstrated risks from ultrasound imaging, it can produce effects on the body. Laboratory studies have demonstrated that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations, rise in temperature and cavitation. A number of in vitro and in vivo (animal and human) biologic effects have been reported following exposure to diagnostic ultrasound devices and low intensity ultrasound used for therapeutic purposes. Most public health experts, clinicians and industry agree that exposure of the fetus to ultrasound for nonmedical purposes should be avoided. The U.S. Food and Drug Administration (FDA) supports this position. (E-mail: [email protected] )

      Key Words

      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

        • Abramowicz J.S.
        • Fowlkes J.B.
        • Skelly A.C.
        • Stratmeyer M.E.
        • Ziskin M.C.
        Conclusions regarding epidemiology for obstetric ultrasound.
        J Ultrasound Med. 2008; 27: 637-644
        • AIUM Bioeffects Committee
        American Institute of Ultrasound in Medicine consensus report on potential bioeffects of diagnostic ultrasound: Executive summary.
        J Ultrasound Med. 2008; 27: 503-515
        • Ang E.S.B.C.
        • Gluncic V.
        • Duque A.
        • Schafer M.E.
        • Rakic P.
        Prenatal exposure to ultrasound waves impacts neuronal migration in mice.
        Proc Nat Acad SciE. 2006; 103: 12903-12910
        • Barzelai S.
        • Sharabani-Yosef O.
        • Holbova R.
        • Castel D.
        • Walden R.
        • Engelberg S.
        • Scheinowitz M.
        Low-intensity ultrasound induces angiogenesis in rat hind-limb ischemia.
        Ultrasound Med Biol. 2006; 32: 139-145
        • Crisci A.R.
        • Ferreira A.L.
        Low-intensity pulsed ultrasound accelerates the regeneration of the sciatic nerve after neurotomy in rats.
        Ultrasound Med Biol. 2002; 28: 1335-1341
        • Fatemi M.
        • Ogburn P.L.
        • Greenleaf J.F.
        Fetal Stimulation by pulsed diagnostic ultrasound.
        J Ultrasound Med. 2001; 20: 883-889
      1. FDA, Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, Sept. 9, 2008.

        • Feril Jr., L.B.
        • Tachibana K.
        • Ogawa K.
        • Yamaguchi K.
        • Solano I.G.
        • Irie Y.
        Therapeutic potential of low-intensity ultrasound (Part 1): Thermal and sonomechanical effects.
        J Med Ultrason. 2008; 35: 153-160
        • Heckman J.D.
        • Ryaby J.P.
        • McCabe J.
        • Frey J.J.
        • Kilcoyne R.F.
        Acceleration of tibial fracture-healing by noninvasive, low-intensity pulsed ultrasound.
        J Bone Joint Surg [AM]. 1994; 76: 26-34
        • Ito M.
        • Azuma Y.
        • Ohta T.
        • Komoriya K.
        Effects of ultrasound and 1,25-dihydroxyvitamin D3 on growth factor secretion in co-cultures of osteoblasts and endothelial cells.
        Ultrasound Med Biol. 2000; 26: 161-166
        • Kristiansen T.K.
        • Ryaby J.P.
        • McCabe J.
        • Frey J.J.
        • Roe L.R.
        Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound.
        J Bone Joint Surg [AM]. 1997; 79-A: 961-973
        • Leung K.S.
        • Lee W.S.
        • Tsui H.F.
        • Liu P.P.L.
        • Cheung W.H.
        Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound.
        Ultrasound Med Biol. 2004; 30: 389-395
        • Newnham J.P.
        • Doherty D.A.
        • Kendall G.E.
        • Zubrick S.R.
        • Landau L.L.
        • Stanley F.J.
        Effects of repeated prenatal ultrasound examinations on childhood outcome up to 8 years of age: Follow-up of a randomized controlled trial.
        Lancet. 2004; 364: 2038-2044
        • Romano C.L.
        • Romano D.
        • Logoluso N.
        Low-intensity pulsed ultrasound for the treatment of bone delayed union or nonunion: A review.
        Ultrasound Med Biol. 2009; 35: 529-536
        • Sena K.
        • Leven R.M.
        • Mazhar K.
        • Sumner D.R.
        • Virdi A.S.
        Early gene response to low-intensity pulsed ultrasound in rat osteoblastic cells.
        Ultrasound Med Biol. 2005; 31: 703-708
        • Takakura Y.
        • Matsui N.
        • Yoshiya S.
        • Fujioka H.
        • Muratsu H.
        • Tsunoda M.
        • Kurosaka M.
        Low-intensity pulsed ultrasound enhances early healing of medial collateral ligament injuries in rats.
        J Ultrasound Med. 2002; 21: 283-288
        • Takikawa S.
        • Matsui N.
        • Kokubu T.
        • Tsunoda M.
        • Fujioka H.
        • Mizuno K.
        • Azuma Y.
        Low-intensity pulsed ultrasound initiates bone healing in rat nonunion fracture model.
        J Ultrasound Med. 2001; 20: 197-205
        • Warden S.J.
        • Bennell K.L.
        • McMeeken J.M.
        • Wark J.D.
        Acceleration of fresh fracture repair using the sonic accelerated fracture healing system (SAFHS): A review.
        Calcif Tissue Int. 2000; 66: 157-163
        • Zhang Z.J.
        • Huckle J.
        • Francomano C.A.
        • Spencer R.G.S.
        The effects of pulsed low-intensity ultrasound on chondrocyte viability, proliferation, gene expression and matrix production.
        Ultrasound Med Biol. 2003; 29: 1645-1651