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APPENDIX A - FY 2000 OST Publications

October 1, 1999 – September 30, 2000

Journal Articles

Beiden SV, Wagner RF, Campbell G. Components-of-variance models and multiple-bootstrap experiments: An alternative methodology for random-effects ROC analysis. Academy of Radiology 7:341-349, 2000.

Boorman GA, Owen RD, Lotz WG, Galvin MJ. Evaluation of in vitro effects of 50- and 60-Hz magnetic fields in regional EMF exposure facilities. Radiation Research 153:648-657, 1999.

Caperna TJ, Vossoughi J, Hilbert SL, Haudenshild CC, Zuckerman B. Effect of short-term growth hormone administration on aortic wall residual strain and morphology. International Journal of Cardiovascular Medicine and Science 2:147-151, 1999.

Cress LW, Owen RD, Desta AB. Ornithine decarboxylase activity in L929 cells following exposure to 60-hertz magnetic fields. Carcinogenesis 20: 1025-1030, 1999.

Desta AB, Owen RD, Cress LW. Ornithine decarboxylase activity in developing chicken embryos after exposure to 60 Hertz magnetic fields. Biochemical and Biophysical Research Communications 265:211-213, 1999.

Ediger MN, Landry RJ, Sliney DH. Optical radiation safety considerations for ocular glucose monitoring. Diabetes Technology and Therapeutics, 1:239, 1999.

Faaland RW, Grossman LW. Design and evaluation of a null lens for testing the optical performance of silicone intraocular lenses. Applied Optics, 39(16):2678-2682, 2000.

Gammell PM, Harris GR. Time delay spectrometry for hydrophone calibrations below 1 MHz. Journal of the Acoustic Society of America, 106(5):L41-L46, 1999.

Goering PL, Kuester RK, Neale AR, Chapekar MS, Zaremba TG, Hitchins VM. Effects of particulate and soluble cadmium species on biochemical and functional parameters in cultured murine macrophages. In Vitro and Molecular Toxicology 13:125-136, 2000.

Goering PL, Fisher BR, Noren B, Papaconstantinou A, Rojko J, Marler RJ. Mercury induces regional and cell-specific heat shock protein expression in rat kidney. Toxicological Sciences 53:447-457, 2000.

Grehan JF, Hilbert SL, Ferrans VJ, Droel JS, Salerno CS, Bianco RW. Development and evaluation of a swine model to assess the preclinical safety of mechanical heart valves. The Journal of Heart Valve Disease 9:710-720, 2000.

Harris GR, Preston RC, DeReggi AS. The impact of piezoelectric PVDF on medical ultrasound exposure measurements, standards, and regulations. IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, 47(6):1321-1335, 2000.

Harris GR. Early hydrophone work and measurement of output exposure limits at the U.S. Food and Drug Administration in W.L. Nyborg, Biological effects of ultrasound: development of safety guidelines, part 1: Personal histories, Ultrasound in Medicine and Biology 26(6):911-964, 2000.

Hellman KB, Asher DM. International workshop on clearance of TSE agents from blood products and implanted tissues. Biologicals 28:189-192, 2000.

Herman BA, Harris GR. Theoretical study of steady-state temperature rise within the eye due to ultrasound insonation. IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, 46(6):1566-1574, 1999.

Houn F, Bright RA, Bushar HF, Croft BY, Finder CA, Gohagan JK, Jennings RJ, Keegan P, Kessler LG, Kramer BS, Martynec LO, Robinowitz M, Sacks WM, Schultz DG, Wagner RF. Study design in the evaluation of breast cancer imaging technologies. Academy of Radiology 7:684-692, 2000.

Hutter JC, Long MC, Schroeder LW. A Monte Carlo Simulation of the degradation of cellulose acetate hemodialysis membranes. Proceedings of the 2000 Western Multi-Conference, Simulations in the Medical Sciences, San Diego CA, pp. 111-116, January 23-27, 2000.

Hutter JC, Kuehnert MJ, Wallis RR, Lucas AD, Sen S, Jarvis WR. Acute onset of diminished vision and hearing traced to hemodialysis treatment with aged dialyzers. JAMA 283:2128-2134, April 23, 2000.

Ilev IK, Waynant RW. Uncoated hollow taper as a simple optical funnel for laser delivery. Review of Scientific Instruments, 70(10):3840-3843, 1999.

Ilev IK, Waynant RW, Ediger MN, Bonaguidi MA. Ultraviolet laser delivery using an uncoated hollow taper. IEEE Journal of Quantum Electronics, 36:944-948, 2000.

Ilev IK, Waynant RW, Bonaguidi MA. Attenuation measurement of infrared optical fibers using a hollow-taper-based coupling method. Applied Optics, 39:3192-3196, 2000.

Lucas AD, Tomazic-Jezic VJ. Modification of the Lowry method for analysis of soluble latex proteins. Toxicology Methods 10:165-179, 2000.

Lucas AD, Kalson KA, Hutter JC, Wallis RR. Identifying toxic degradation products in cellulose acetate. Journal of Biomedical and Materials Research (Applied Biomaterals) 53:449-456, 2000.

Luu HMD, Hutter JC. Pharmacokinetic modeling of 4, 4'-methylenedianiline released from reused polyurethane dialyzer potting materials. Journal of Biomedical and Materials Research (Applied Biomaterials) 53:276-286, 2000.

Lyle DB, Bushar GS, Langone JJ (submitting authors). Standard practice for testing for whole complement activation in serum by solid materials. Annual Book of ASTM Standards 13.01:1427-1431, 2000.

Lytle CD, Thomas BM, Gordon EA, Krauthamer V. Electrostimulation for acupuncture: safety issues Journal of Alternative and Complementary Medicine 6(1):37-44, 2000.

Morehouse CA, Owen RD. Exposure of Daudi Cells to low-frequency magnetic fields does not elevate MYC steady-state mRNA lLevels. Radiation Research 153:663-669.

Morehouse CA, Owen RD. Exposure to low-frequency electromagnetic fields does not alter HSP70 expression or HSF-HSE Binding in HL60 Cells. Radiation Research 153: 658-662.

Myers MR, Lytle CD, Routson LB. Virus adsorption within pores in latex: assessment of reversibility effects. American Institute of Chemical Engineers Journal, 46(9):1894, 2000.

Owen RD. EMFs and cancer: an update on biological research. Radiological Protection Bulletin 225: 5-10.

Owen RD. Possible health risks of radiofrequency exposure from mobile phones (editorial). Epidemiology 11(2): 99-100.

Stern RS, Beer JZ, Mills DK. Lack of consensus among experts on the choice of UV therapy for psoriasis. Archives of Dermatology 135:1187-1192, 1999.

Walsh DL, Chwirut DJ, Kotz RM. Environmental degradation of natural rubber latex gloves: the effects of elevated temperature on tensile strength. Journal of Testing and Evaluation, 27(6):396-401, November 1999.

Wear KA. Computer simulation and experiments to investigate the effects of frequency dependent attenuation and dispersion on speed of sound estimates in cancellous bone. Computer Simulation and Modeling in Medicine, 1(2):123-129, 2000 (invited paper).

Wear KA. Anisotropy of ultrasonic backscatter and attenuation from human calcaneus: implications for relative roles of absorption and scattering in determining attenuation. Journal of the Acoustic Society of America, 107(6): 3474-3479, 2000.

Wear KA, Armstrong DW. The relationship between ultrasonic backscatter and bone mineral density in human calcaneus, IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control 47(4): 777-780, 2000.

Wear KA. Variations in transit-time-based ultrasonic velocity estimates in human calcaneus due to frequency-dependent attenuation and dispersion, Progress in Biomedical Optics and Imaging. 1(27): 187-195, 2000.

Wear KA. Measurements of phase velocity and group velocity in human calcaneus, Ultrasound in Medicine and Biology., 26(4): 641-646, 2000.

Wear KA. Temperature dependence of ultrasonic attenuation in human calcaneus, Ultrasound in Medicine and Biology., 26(3): 469-472, 2000.

Wear KA. The effects of frequency-dependent attenuation and dispersion on sound speed measurements: applications in human trabecular bone. IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control 47:265-273, 2000.

Wear KA. Frequency dependence of ultrasonic backscatter from human trabecular bone: theory and experiment, Journal of the Acoustic Society of America, 106(6): 3659-3664, 1999.

Witters DM. FDA concerns about medical device electromagnetic interference with electronic security systems. Medical Device and Diagnostic Industry Magazine, January 2000.

Woods TO. Cyclic loading and creep of intracranial aneurysm clips. Journal of Testing and Evaluation 28(5):337-344, 2000.

Book Chapters

Hellman KB, Solomon RR, Gaffey C, Durfor CN, Bishop JB III. Tissue engineering: regulatory considerations. In: Principles of Tissue Engineering, 2nd Edition, R. Lanza, R. Langer and J.P. Vacanti, eds., Academic Press, San Diego, California, April 2000.

Hellman KB. Tissue engineering - technology applications and FDA initiatives. In: Toxicity Assessment Alternatives: Methods, Issues, Opportunities. H. Salem, ed., Humana Press, Inc., 15-17, Totowa, New Jersey, 1999.

Hilbert SL, Yu ZX, Archuleta S, Ferrans VJ. Laser scanning confocal microscopy: an emerging technique for the pathologic evaluation of cardiovascular devices. In: Stent Graft Update, J Vossughi, et al (eds.), pp. 115-124, Medical and Engineering Publishers, Inc., Washington, DC, 2000.

Insana, MF, Myers KJ, Grossman LW. Signal modeling for tissue characterization. In: The Handbook of Medical Imaging: Volume 2, Medical Image Processing and Analysis, M. Sonka and JM Fitzpatrick, eds., p. 515-565, SPIE Press, Bellingham, WA, 2000.

Karanian JW. Stent graft development: preclinical and clinical perspectives. In: Stent-Graft Update J. Vossoughi, N. Kipshidze, and J.W Karanian (eds). Medical and Engineering Publishers, Inc., Washington, DC, 2000.

Miller SA. Noncoherent Sources. In: Electro-Optics Handbook, 2nd ed., Waynant RW, Ediger MN. eds., McGraw-Hill, Inc., New York, NY. ISBN 0-07-068716-1. 2000.

Waynant RW, Ediger MN, eds. Electro-Optics Handbook, second ed., McGraw-Hill, Inc., New York, NY, 2000.

Wray-Cahen D, Vossoughi J, Karanian J. Large animal models in preclinical trials. In: Stent-Graft Update. J. Vossoughi, N. Kipshidze, and J.W Karanian (eds) Medical and Engineering Publishers, Inc., Washington, DC, 2000.

Proceedings, Abstracts, Letters, Book Reviews, etc.

Beer JZ, Bushar GS, Chwirut DJ, Ediger MN, Lee W, Matchette LS, Miller SA, Lopez H, Weininger S, Zmudzka BZ, Jorgensen H, Korossy KS, Hearing VJ, Tadokoro T, Lenderink E. How to measure UV response in human skin (poster). FDA Science Forum, Washington, DC, February 14-15, 2000.

Beer JZ , Bushar HF, Chwirut DJ, Ediger MN, Lee W, Matchette LS, Miller SA, Lopez H, Weininger S, Zmudzka BZ. How to measure UV response in human skin? 2000 FDA Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, p. 54, February 14-15, 2000.

Beer JZ, Busick BD, Chwirut DJ, Cyr WH, Ediger MN, Lao NT, Matchette LS, Miller SA, Lopez H, Weininger S, Zmudzka BZ, Toombs E, Jorgensen H, Korossy KS, Hearing HJ, Kobayashi N, Tadokoro T, van der Leun JC, Lenderink E. Studies on parameters of UV response in human skin: a progress report. 13th International Congress on Photobiology, San Francisco, CA, July 1-6, 2000, Abstracts, p. 191-192.

Beiden SV, Campbell G, Meier KL, Wagner RF. On the problem of ROC Analysis without truth: The EM algorithm and the information matrix. Proceedings of SPIE Medical Imaging: Image Perception and Performance, vol. 3981 p. 126-134, 2000.

Brown SA. On methods used for corrosion testing of nitinol. Proceedings of the Shape Memory and Superelastic Technology Conference, Pacific Grove, CA, April 2000.

Brown SA, Merritt K, Woods TO, Hitchins VM. Effects of different sterilization methods on materials used for single use devices. FDA 2000 Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, February 14-15, 2000.

Brown SA, Merritt K, Woods TO, Hitchins VM. Effects of use and reprocessing a single use coronary catheter. FDA 2000 Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, February 14-15, 2000.

Brown SA, Merritt K, Woods TO, Hitchins VM. The effects of use and simulated reuse on PTCA balloons and catheters, Transactions of the 6th World Congress of Biomaterials, Kamuela, HI, p. 462, May 19, 2000.

Byrnes GA, Miller SA, Mazur DO, Grossman LW. Laser characteristics through fundus contact treatment lenses: risk potential for anterior segment complications. Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO), Ft. Lauderdale, FL, April 30 – May 4, 2000.

Caputa K, Stuchly M, Bassen H, Ruggera P. Electromagnetic interference from the cellular telephone with a hearing aid. Proceedings of the IEEE Engineering and Medicine and Biology World Congress on Medical Physics, July 2000.

Casamento JC. EMC of medical devices with anti-theft and security systems. IEEE Nepcon East/Electro 2000, Boston, MA, June 14, 2000.

Casamento JC. Interactions of medical devices with anti-theft systems and security systems. IEEE Electromagnetic Compatibility Society, Baltimore/Washington Chapter, January 18, 2000.

Chang IA, Sudmeier M, Pritchard WF, Wood B. Method for imaging heating dynamics for liver tumor ablation. Society of Cardiovascular and Interventional Radiology, 25th Annual Meeting, San Diego, CA, March 25-30, 2000.

Delclos KB, Blaydes B, Dalu A, Picciolo G, Kaplan DS. Investigation of sexual dimorphism in the inflammatory response to biomaterials. FDA 2000 Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, February 14-15, 2000.

Ediger MN. Optical diagnostic medical devices – considerations for market clearance in the U.S. "Shedding New Light on Disease: Optical Diagnostics for the Millennium." National Research Council, Winnepeg, Manitoba, Canada, June 26, 2000.

Gagne RM. Letter to the editor. Medical Imaging, 15(7):8 July 2000.

Hickman J, Ravenscroft M, Canavan H, Krauthamer V. Biocompatibility of cardiac cells on silane-modified surfaces. National Symposium of the American Vacuum Society, Seattle, WA, June 21, 2000.

Howard PC, Sams, II RL, Miller BJ, Allaben WT, Okerberg C, Bucci TJ, Wamer WG, Beer JZ. Response of SKH-1 mouse skin simulated solar and UV radiation. 2000 FDA Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, p. 55, February 14-15, 2000.

Hutter JC, Richardson DC, Malinauskas RA. A mathematical model of multi-component mass transfer in an extracorporeal membrane oxygenator. Presented at the FDA Science Forum, Washington, DC, February 15, 2000.

Ilev IK, Waynant RW. Ultraviolet visible and infrared laser delivery using laser-to-fiber coupling via a grazing incidence based hollow taper. Conference Proceedings, European Symposium on BIOS: Europe (EUROPTO, EBIOS-2000), Amsterdam, July 4-8, 2000.

Krauthamer V. Optical measures of voltage and calcium in heart cells during defibrillation. National Heart, Lung, and Blood Institute, National Institutes of Health, Biomedical Engineering Seminar, Bethesda, MD, October 21, 2000.

Merritt K, Hitchins VM, Brown SA, Woods TO. Reprocessing single use biopsy forceps for reuse. FDA 2000 Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, February 14-15, 2000.

Robinson RA, Malinauskas RA. A simple validation model for quantifying 2-D flows in medical devices. Presented at the FDA Science Forum, Washington, DC, February 15, 2000.

Schwerin MR, Walsh DL, Richardson DC, Lytle CD, Kisielewski RW, Routson LB, Kotz R. Biaxial flex-fatigue and viral permeability of oven aged natural rubber latex gloves. FDA 2000 Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, February 14-15, 2000.

Silberberg JL. Update on the draft second edition of international standard IEC 60601-1-2 for EMC of medical electrical equipment. 2000 IEEE International Symposium on EMC, Workshops and Tutorials, abstract, Washington, DC, August 21-25, 2000.

Soykan O, Silberberg JL. The effect of excitation frequency on transthoracic impedance measurement. Digest of papers of the 2000 World Congress on Medical Physics and Biomedical Engineering and the Proceedings of the 22nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, abstract, July 23-28, 2000.

Stratmeyer ME, Brown RP. Risk assessment-based approach for the biological evaluation of medical device materials. Society of Toxicology Annual Meeting, Philadelphia, PA, March 19-23, 2000.

Tadokoro T, Kobayashi N, Beer JZ, Zmudzka BZ, Korossy KS, Hearing VJ. Analysis of UV-induced DNA damage in skin within racial/ethnic groups. Pigment Cell Research 13:216, 2000.

Tadokoro T, Kobayashi N, Beer JZ, Zmudzka BZ, Korossy KS, Hearing VJ. Examination of DNA damage induced by ultraviolet irradiation of human skin within racial/ethnic groups. Pigment Cell Research, 13: 399, 2000.

Tadokoro T, Kobayashi N, Beer JZ, Zmudzka BZ, Korossy KS, Hearing VJ. Analysis of UV-induced DNA damage in skin within racial/ethnic groups. The 9th Meeting of the Pan American Society for Pigment Cell Research, College Station, TX, June 25-28, 2000.

The Photosciences Network (with contributors in CDER, CDRH, CFSAN, NCTR and NCI/NIH). Quantitative, biologically relevant parameters for testing and standardization of skin response to UV. 2000 FDA Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC. p. 54, February 14-15, 2000.

Wear KA. A model for ultrasonic backscatter from trabecular bone. Proceedings of the IEEE Symposium on Ultrasonics 2:1307-1310, 1999.

Witters DM. Planning for the future: addressing electromagnetic interference (EMI) risks with the new dedicated wireless medical telemetry service. NCHES 4th Annual Conference, Bethesda, MD, May 2, 2000.

Witters DM. Wireless medical telemetry: the FDA perspective fore the proposed wireless medical telemetry service. ACCE/AAMI 2000, San Jose, CA, June 3, 2000.

Witters DM. Medical device electromagnetic compatibility: reducing the risks of EMI in healthcare facilities in the wireless age. New England Healthcare Engineering Society Workshop, Boston, MA, November 2, 2000.

Woods TO, Brown SA, Merritt K, Hitchins VM. The effect of repeated ethylene oxide sterilization on the mechanical strength of synthetic absorbable sutures. FDA 2000 Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, February 14-15, 2000.

Woods TO, Brown SA, Merritt K, Hitchins VM. The effect of reprocessing on single use electrophysiology catheters. FDA 2000 Science Forum, FDA and the Science of Safety: New Perspectives, Washington, DC, February 14-15, 2000.

Zmudzka BZ, Lao NT, Miller SA, van der Leun JC, Beer JZ. UV-induced erythema vs. skin type and race/ethnicity: visual and instrumental explorations. 13th International Congress on Photobiology, San Francisco, July 1-6, 2000, Abstracts, p.195.

OST Internal Reports

Busick DN. Laboratory evaluation of the system 02 portable oxygen delivery system. DMMS Report #00-03, August 2000.