Safety and U.S. regulatory considerations in the nonclinical use of medical ultrasound devices

Ultrasound in Medicine and Biology

Volumn 36, Issue 8, 2010, Pages 1224-1228

  Phillips, Robert A ^a   Stratmeyer, Mel E ^a   Harris, Gerald R ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Fetal keepsake videos; Low intensity biologic effects; Over the counter (OTC) devices

Indexed keywords

DIAGNOSTIC ULTRASOUND; FOOD AND DRUG ADMINISTRATION; IN-VITRO; LABORATORY STUDIES; LOW INTENSITY ULTRASOUND; LOW-INTENSITY; MECHANICAL VIBRATIONS; MEDICAL INFORMATION; MEDICAL ULTRASOUND; PHYSICAL EFFECTS; PUBLIC HEALTH EXPERTS; REGULATORY CONSIDERATIONS; SAFETY RECORDS; ULTRASOUND ENERGY; ULTRASOUND IMAGING;

HEALTH RISKS; MEDICAL IMAGING; ULTRASONIC DEVICES; ULTRASONIC TRANSMISSION; VIBRATIONS (MECHANICAL);

ULTRASONICS;

FETUS ECHOGRAPHY; FETUS HEART RATE; FOOD AND DRUG ADMINISTRATION; FRACTURE NONUNION; GOVERNMENT REGULATION; HEALTH HAZARD; HIGH TEMPERATURE; HUMAN; LEFT HANDEDNESS; LIMB ISCHEMIA; NONHUMAN; PRENATAL EXPOSURE; PRIORITY JOURNAL; RADIATION EXPOSURE; REVIEW; RISK BENEFIT ANALYSIS; SAFETY; STETHOSCOPE; ULTRASOUND; ULTRASOUND THERAPY; UNITED STATES; VIBRATION;

CONSUMER PRODUCT SAFETY; EQUIPMENT SAFETY; FEMALE; GOVERNMENT REGULATION; HUMANS; PREGNANCY; PRODUCT SURVEILLANCE, POSTMARKETING; ULTRASONOGRAPHY, PRENATAL; UNITED STATES;

EID: 77955669146     PISSN: 03015629     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ultrasmedbio.2010.03.020     Document Type: Review

References (19)

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Fatemi M., Ogburn P.L., Greenleaf J.F. Fetal Stimulation by pulsed diagnostic ultrasound. J Ultrasound Med 2001, 20:883-889.
7. FDA, Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, Sept. 9, 2008.
8. Feril 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.
9. 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.
10. 3 on growth factor secretion in co-cultures of osteoblasts and endothelial cells. Ultrasound Med Biol 2000, 26:161-166.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.