Current Trends in the Durability Testing of Medical Products


WORKSHOP

J.C. Conti1, E.R. Strope


Dynatek Dalta Scientific Instruments, P.O. Box 245, Galena, MO 65656

1 Southwest Missouri State University, Dept. of Physics and Astronomy, 901 S. National Ave., Springfield, MO 65804-0094


Last year's workshop covered the history and more recent approaches used to evaluate the durability of a variety of medical products in vitro. The general theory and approach to high speed testing was reviewed. This year's workshop will focus primarily on those testing techniques that have been developed or upgraded during the last twelve months. In particular, the latest approaches to the testing of stents, stent/grafts, septal defect closure devices, bifurcated grafts, left ventricular assist devices, adhesive bonds, and packaging will be reviewed. This workshop will give attendees a broad understanding of the issues that must be considered when designing and carrying out high speed dynamic testing, as well as very recent information uncovered during the last year with regard to individual product types. The Dynatek Biomaterials Society Workshop has a reputation for minimal commercialization and maximal technical training.

Workshop

Current Trends in the Durability Testing of Medical Products

J.C. Conti1, E.R. Strope


Dynatek Dalta Scientific Instruments, P.O. Box 245, Galena, MO 65656

1 Southwest Missouri State University, Dept. of Physics and Astronomy, 901 S. National Ave., Springfield, MO 65804-0094

Outline

Introduction
     Accelerated Testing
        General theory
        Pros
        Cons
        Cycle rates
        Monitoring

     Stents
        Durability
            Goals
            Protocols
            Mock Vessels
            Cycle rates
            Monitoring

        Corrosion
            Electrochemistry
            Protocols

     Septal Defect Closure Devices
        Durability
            Goals
            Protocols
            Synthetic Septum
            Cycle rates
            Monitoring

     Stent-Grafts
        General concerns
            Goals
            Mock vessels
            Inserts
            Protocols
            Cycle rates

        Bifurcated Devices
            Mock vessels
            Characterization
            Cycle rates

        Report from the IS0

     Left Ventricle Assist Devices
            General approach
            Know your device
            Know your patients
            Flow studies
            Durability studies

     Adhesive Bonds
            General theory
            Failure
            Dynamic peel testing
            Packaging
                  A special case