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Office of Science and Technology - Annual Report - Fiscal Year 1996

October 1, 1995 - September 30, 1996

Tables of Contents

Preface

Office of Science and Technology Staff

Introduction

OST Project Areas

Keyword Index

1. Biomaterial Characterization

Biomaterials Compendium Database

Biotechnology

Explant Pathology-Aortic Valve Allografts

2. Device Mechanical Performance Analysis

Characterization of the Static Mechanical and Fatigue Properties of Implant Metal

Particulates: Mechanism of Cellular Degradation

3. Diagnostic Imaging

Advanced Performance Assessment Techniques

Effects of Fluoride on Development of Bone

Mammography

Tissue Characterization

X-ray Fluoroscopy

Computed Tomography

4. Electromagnetic Interference (EMI) Testing of Medical Devices

EMC Testing of Implantable Cardiac Pacemakers In Vitro for EMI from Digital Cellular Telephones

Interference of Medical Devices by Electronic Article Surveillance

Electromagnetic Compatibility in the Hospital Setting

Testing of Hearing Aid Interference from Digital Cellular Telephones

5. Evaluation of the Safety and Effectiveness of Electrical Stimulation Devices

System for Evaluating Radiofrequency Cardiac Ablation Devices

Live-Tissue Studies of Electrostimulation Devices

Evaluation of Energy Deposition by Implantable Defibrillator and RF Cardiac Ablation Leads

Computerized Laboratory Testing of Implantable Cardioverter Defibrillators

6. Fluid Mechanics

Plasma Hemoglobin Assays for In Vitro Medical Device Testing

Hemolysis Testing of Cardiopulmonary Bypass Components

Reliability Testing of Total Artificial Hearts

Color Doppler Evaluation of Heart Valve Regurgitation

Doppler Study of Vascular Grafts

Virus Transport Model

Thermal Model of Endometrial Ablation

Phase Contrast Magnetic Resonance Imaging of Vascular Flow

Physics of Ballon Dilatation

7. Guidance Development

GMP Rewrite - Design Controls

8. Infection Control

A Comparison of Silk and Polyester Suture Loops: Implications for Sporicide Testing

Barriers

Comparative Testing of Agents Used to Disinfect/Sterilize Medical Devices

9. Intelligent Medical Device Evaluation

Automatic External Defibrillator Test System Development

Apnea Monitor Physiologic Waveform Test Method Development

Pulse Oximeter Performance Assessment

10. In Vitro Diagnostics

Deficiencies of PCR Diagnosis of Mycobacterium Tuberculosis (Mtb)

Overview of International PCR Standardization Efforts

Monitoring the Human Genome Project for Impact on Developments in Medical Devices

11. Ionizing Radiation Metrology

Radiation Metrology Research

Ionizing Radiation Standardization Activities

X-ray Calibration Laboratory Computer System

Calibration Support of Inspection Programs

12. Lasers

Optical and Thermal Performance Characteristics of Sidefiring Optical Fibers

Risk of Induced Cataract from Laser Contact Lenses

Broadband Waveguides and Fibers for FEL Delivery

In Vitro Optical Spectroscopic Determination of Silicone Concentration in Turbid Phantoms

13. Medical Device Interactions with the Immune System

Immunological Effects of Silicone

14. Medical Device Materials Toxicology

Analytical Method Developed to Quantify Leachable Latex Accelerators

Complement Activation

Examination of the Cytotoxic Potential of Biomaterials Breakdown Products

Genotoxic Effects of Nitric Oxide

Immunotoxicity Testing

Latex Chemical Sensitivity Standards Methods Development

PBPK Modeling of the Fate of TDA

Polymer Profiles for Chemically-Based Toxicological Assessments

Tissue/Material Interactions

Toxicology Methods Development

15. Optics

Improved Quality Assurance Testing for Silicone Intraocular Lenses

Ophthalmic Instrument Evaluation

Optical Biopsy - A Noninvasive Tool to Diagnose a Diseased Tissue In-Vivo

Optical Product Evaluations

16. Prediction of Material Biostability

Abrasion Resistance of Coatings

Accelerated Aging of Suture Packaging and Adhesives

Environmental Degradation of Latex Gloves: The Effects of Elevated Temperature on Tensile Strength

Pyrolytic Carbon: Material Formulations and Cell Activation Leading to Degradation and/or Clot Formation

17. Radiation Biology Research

Biological Effects of Exposure to Electric and Magnetic Fields (EMF)

Evaluation of the Safety of UV-Emitting Medical Devices as Used in HIV Infection

Ultraviolet A1 Phototherapy of Autoimmune Diseases

18. Ultrasound

Hazard Analysis of Phacoemulsification

Temperature Rises in the Eye During Ultrasonic Insonation

Hydrophone Calibration at Low Frequencies

Accuracy Testing of Pulsed and Color Doppler Ultrasound

Ultrasound Bioeffects

19. Field Support Activities

Nonionizing Radiation Compliance

Spontaneous Combustion of Latex Gloves

20. Workshops and On-Site Visits

Wireless Communications

Bioelectromagnetics Society Workshop

Management Training

Appendix A

Publications

Appendix B

Presentations

Appendix C

Academic Affiliations

Appendix D

Patents

Appendix E

Research Seminars

Appendix F

Research Contracts and Interagency Agreements

Appendix G

Standards Organizations

Appendix H

Abbreviations and Acronyms

Continue on to the Preface.

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