STP810: Tissue-Culture Methods for Determining Biocompatibility

    Fehn, J
    Supervisor in laboratory service and in vitro toxicology laboratory technician, Physiological Research Laboratories, Division of Medtronic, Inc., Minneapolis, Minn.

    Schottler, D
    Supervisor in laboratory service and in vitro toxicology laboratory technician, Physiological Research Laboratories, Division of Medtronic, Inc., Minneapolis, Minn.

    Pages: 6    Published: Jan 1983


    Abstract

    Tissue-culture test methods are used as acute screening for biocompatibility testing of materials and solutions used in the manufacture of our biomedical devices at Medtronic, Inc. Presently, we are capable of performing three methods, they are: agar overlay, minimal essential medium (MEM) elution, and low cell density. In all the test methods performed we use L-929 mouse fibroblasts as our cell line.

    Tissue-culture procedures are used for screening the safety of materials that are being evaluated in the following situation: (1) new material and vendor qualification, (2) process change or qualification or both, (3) vendor audit, and (4) incoming inspection. Medtronic basically follows the guidelines of the Health Industry Manufacturers Association (HIMA) Report 78-7, which classifies devices into four categories based upon usage. These are intended to be guidelines, but ultimately the criteria to classify materials and the testing done on the material are dependent upon (1) the intended end use of the material and its application, (2) whether it has direct or indirect body tissue, or fluid contact or both, (3) whether it will be short term or long term or both, and (4) if the material is put through a process that may change or affect the material or both.

    The decision as to which tissue-culture method to use by which to screen a material is determined by (1) the nature of the material, (2) information required of testing, and (3) history of material and which test method is most applicable. The results of tissue-culture testing are meant to be screening and do not replace in vivo testing. If the results of a tissue-culture test are questionable, it is the decision of the study director of how to proceed. Medtronic has been doing tissue-culture testing for more than ten years and has a good data base to support our test methods.

    Keywords:

    agar overlay, minimal essential medium elution, low cell density, screening methods, end use, application, cell culture


    Paper ID: STP30152S

    Committee/Subcommittee: F04.15

    DOI: 10.1520/STP30152S


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