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Office of Science and Technology - Annual Report - Fiscal Year 1997

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Table Of Contents

PREFACE
OST MISSION AND FOCUS
OFFICE OF SCIENCE AND TECHNLOGY STAFF

A complete copy of this Annual Report can be downloaded as a Zipfile You will need to have or download an unzip program to be able to view the files.


OST PROJECT AREAS

BIOEFFECTS

In-vitro Safety Studies of Electrostimulation Devices
Temperature Rises in the Eye During Ultrasonic Insonation
Testing of Radiofrequency Cardiac Ablation Devices
Particulates: Mechanism of Cellular Degradation
Particulate Effects on Immunologic Function
Latex-associated Allergies
Effects of Fluoride on Development of Bone
Explant Pathology-Aortic Valve Allografts
Estrogenic Effects of Medical Device Materials
Measurements of Energy Deposition Rates Produced in the Vicinity of Electrodes of RF Cardiac-Ablation Systems and Implantable Cardioverter Defibrillators (ICDs)
Assessment of Device Effects on Human Vision

BIOEFFECTS - RADIATION

Biological Effects of Exposure to Electric and Magnetic Fields (EMF)
Noncoherent Optical Radiation Program
Risk Estimate of Squamous Cell Carcinoma from Sunlamp Exposures
Ultraviolet-A1 (UVA1) Phototherapy of Systemic Lupus Erythematosus
UVA1 Phototherapy and Skin Diseases: Apoptosis
Evaluation of the safety of UV-emitting medical devices as used in HIV infection
Determination of Susceptibility of Mucosa to UV Exposure
Ultraviolet Laser Tissue Interactions

ELECTROMAGNETIC INTERFERENCE

In-vitro Test Methods to Evaluate Potential Electromagnetic Interference of Implantable Cardiac Defibrillators from Wireless Digital Phones
Clinical Test Methods for Medical Device Electromagnetic Compatibility (EMC)
Hearing Aids and Wireless Digital Telephone Interference
"Electronic Article Surveillance Electromagnetic Field Mapping and Interaction with Implanted Cardiac Pacemakers, Forensics"
UV-emitting Sunlamp Products - Citizen's Petition

IMAGING

Optical Biosensor for Minimally-Invasive Detection of Silicone Implant Leakage
Tissue Characterization
Assessment of Classical and Neural-Net Classifiers
Optimized Mammography

INFECTION CONTROL

Comparative Testing of Agents Used to Disinfect/Sterilize Medical Devices
Hole Blockage Stops Viral Passage Through Holes in Condoms during Laboratory Testing
Evaluation of Tests for Determining Viral Barrier Qualities of Endoscope Sheaths
Evaluation of QA Tests for Detecting Small Tears in Condoms
Relative Importance of Holes in Medical Gloves Compared to Importance of Breaks During Use
Sterility Assurance Levels (SAL)
A Mathematical Model for Simulating Virus Transport through Synthetic Barriers
Environmental Degradation of Latex Gloves: the Effects of Elevated Temperature on Tensile Strength
Screening Medications for Their Ability to Inhibit PCR Detection of Mycobacterium Tuberculosis (Mtb)

LASERS

Therapeutic Laser Delivery Devices
Infrared Fibers for Laser Delivery

MATERIAL DEGRADATION

Pyrolytic-Carbon: Material Formulations and Cell Activation Leading to Degradation and/or Clot Formation
Polymer Profiles for Chemically Based Toxicological Assessments
PBPK Modeling of the Fate of TDA
Integrity of Package Seals
Characterization of the Static Mechanical and Fatigue Properties of Implant Metal
Cleaning of Devices for Re-Use
Abrasion Resistance of Coatings
Accelerated Aging of Suture Packaging and Adhesives
Cellulose Acetate Dialyzers

OPTICS

Ophthalmic Instrument Evaluation
Intraocular Lenses

RISK ASSESSMENT

Route-to-Route, Duration of Exposure and Interspecies Extrapolation Procedures
Sensitive Subpopulations
Risk Assessment Approach for Local Effects
Microbial Risk Assessment
Mixtures Risk Assessment

STANDARDS DEVELOPMENT

Tissue Engineering
Development of a Standard Guideline for Polymerase Chain Reaction (PCR)
GMP - Design Controls
Apnea Monitor Physiologic Wave form Test Method Development
Optical Radiation Standards
Ionizing Radiation Standards
Developing Standard Methods for Evaluating the Blood Damage Potential of Medical Devices
Analytical Method Developed to Quantify Leachable Latex Accelerators
Latex Chemical Sensitivity Standards Methods Development
Acoustic Technique to Detect Cavitation Near Prosthetic Heart Valves

TECHNICAL SUPPORT

Biomaterials Compendium Database
OST Activity Related to Recall of Exploding Infusion Pumps
Pressure and Flow Measurements in Vaginal Douches
X-ray Calibration Laboratory Computer System
Vacuum Loss in Electronic Resonating Components
Phacoemulsification
Spontaneous Combustion of Latex Gloves
Radiation Detection and Dosemetry
Calibration Support of Inspection Programs
Microwave Ovens Survey Instrumentation Calibration
Laser Compliance Program

IMMUNOTOXICOLOGY/TOXICOLOGY

Complement Activation
Target Tissue Molecular Bio-markers/Mercury Vapor Inhalation Exposure
Review Of Dental Amalgam Mercury Scientific Literature
Immunotoxicity Testing Guidance
Immunotoxicology Electronic Network
Immunological Effects of Silicone
Chemical Characterization/Risk Assessment Approach For Systemic Toxicity Assessment

ULTRASOUND

Visualizing Flow Patterns Around Cardiovascular Devices
Accuracy of Doppler Ultrasound

APPENDICES

Appendices

Appendix A - OST Publications
Appendix B - OST Presentations
Appendix C - Academic Affiliations
Appendix D - OST Patents
Appendix E - Research Seminars
Appendix F - Research Contracts and Interagency Agreements
Appendix G - Standards Organizations
Appendix H - Abbreviations and Acronyms

Keyword Index

Updated September 15, 1998

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