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    Biocompatibility Protocols for Medical Devices and Materials
    Biocompatibility Protocols for Medical Devices and Materials
    Biocompatibility Protocols for Medical Devices and Materials
    Ebook500 pages4 hours

    Biocompatibility Protocols for Medical Devices and Materials

    By Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran

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    About this ebook

    Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing.

    Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices.

    • Explains the biocompatibility test protocols for medical devices
    • Provides an overview about chemical characterization
    • Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies
    • Discusses the basic points needed to leverage the data from another device
    LanguageEnglish
    PublisherAcademic Press
    Release dateApr 7, 2023
    ISBN9780323984928
    Biocompatibility Protocols for Medical Devices and Materials
    Author

    Prakash Srinivasan Timiri Shanmugam

    Prakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME–Biocompatibility at Baxter International, Inc. in Round Lake, IL, United States, and at Johnson & Johnson Medical Device Sector. He has an MSc and a PhD in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras, Tamil Nadu, and completed his postdoctoral research at Tulane University and LSUHSC-Shreveport, Louisiana. He has authored 5 books, contributed several book chapters, and published research articles in various peer-reviewed international journals and conference proceedings/abstracts.

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      Book preview

      Biocompatibility Protocols for Medical Devices and Materials - Prakash Srinivasan Timiri Shanmugam

      Chapter 1: Cytotoxicity

      Prakash Srinivasan Timiri Shanmugam ¹ , Thamizharasan Sampath ² , Indumathy Jagadeeswaran ³ , Sandhiya Thamizharasan ⁴ , Safura Fathima ⁵ , and Krithaksha V. ⁶       ¹ Senior Toxicologist, Avanos Medical, Inc., Alpharetta, GA, United States      ² Professor, Department of Pharmacology & Toxicology, Shri Balaji Institute of Medical Sciences, University of Health Sciences, Raipur, Chhattisgarh, India      ³ Senior Research Associate, Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX, United States      ⁴ Saasha Smile Clinic, Saasha Garden, Chennai, Tamil Nadu, India      ⁵ Department of Pharmacology, ACSMCH, DR. MGR Educational & Research Institute, Chennai, Tamil Nadu, India      ⁶ Georgian National University SEU, Tbilisi, Georgia

      Abstract

      Testing cytotoxicity is the first step toward ensuring the biocompatibility of a medical device. Cytotoxicity testing is one of the big three biocompatibility tests, which also include irritation and sensitization testing. These three tests are required for all medical devices that have contact with human tissue. The purpose of cytotoxicity testing is to determine the toxicity of medical devices and their materials by exposing them to tissue cells in vitro and observing the effects. Generally, the tests are performed in vitro on cultured mammalian cells, such as those of mice. The human body has a number of measures in place to protect cells from cytotoxins and pH imbalances. The implication for medical device manufacturers is clear that devices and its materials will need to meet high safety standards to pass a cytotoxicity test. The direct contact assay is the most sensitive for testing the cytotoxicity of the medical devices. The medical devices can be measured even with weak cytotoxicity. The agar overlay assay is suitable for the medical devices that have large toxicity. The bulk filtering and the molecular filtration method is suitable for the biocompatibility evaluation of the toxic components of small-molecular-weight medical

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