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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…mehr
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
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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.
Inhaltsangabe
Contributors Author bios Introduction 1.Cytotoxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan, Safura Fathima and Krithaksha V. Introduction ISO 10993-5 Cytotoxicity Detection methods Test by indirect contact Quantitative method Abbreviations References 2. Sensitization Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction ISO 10993-10 Test methods Guinea pig tests Guinea pig tests and sensitization potency assessment Guinea pig maximization and Buehler tests Open epicutaneous test Advantages and limitations Local lymph node assay The LLNA and sensitization potency assessment Advantages and limitations Human skin-sensitization testing Advantages and limitations Application of test methods in risk assessment Guinea pig tests Local lymph node assay Human repeat-insult patch test Abbreviation References 3. Irritation test Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Selection of animals Test procedure Alternative methods In vitro tests methods for irritation References 4. Material-mediated pyrogenicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction Broad range of pyrogens Tests using fluid extracts Selection of animal species Animal status Animal care and husbandry Size of groups Number of groups Treatment controls Route of exposure Test sample administration Pyrogen tests LAL test Rabbit test: sham test (in vivo) Interpretation of results Monocyte activation test (in vitro test) Procedure of MAT Advantages Abbreviations References 5. Acute systemic toxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Considerations Acute systemic toxicity Selection of animals Animal status Animal care and husbandry Size and number of groups Routes of exposure Dosing Body weight and food/water consumption Clinical observations Clinical pathology Anatomic pathology Evaluation criteria Final report References 6. Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity) Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran and Harini Sriram Introduction Animal care and husbandry Size and number of groups Routes of exposure Dosing Clinical observations Clinical pathology Anatomic pathology Evaluation criteria Final report References 7. Implantation Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Selection of animals Test procedure References 8. Hemocompatibility Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Krithaksha V., Vinod P. Bhalerao and Sandhiya Thamizharasan Highlights Introduction Types of devices in contact with blood Characterization of blood interactions Categories of tests and blood interactions Preclinical evaluation of cardiovascular devices and prostheses Advantages and limitations of animal and in vitro testing Laboratory testsdprinciples, scientific basis, and interpretation Evaluation of hemolytic properties of medical devices and their components Hemolysis testingdgeneral considerations Abbreviations References 9. Tests for genotoxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran and Harini Sriram Introduction Requirements Genotoxicity Example test method: mouse lymphoma mutagenesis assay Evaluation criteria Results Conclusion References 10. Carcinogenicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Safura Fathima and Sandhiya Thamizharasan Introduction Carcinogenicity test-specific considerations Abbreviations References 11. Reproduction toxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction Principle of the test Description of the method Procedure Data and reporting Abbreviations References 12. Toxicokinetics Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Vinod P. Bhalerao, Sandhiya Thamizharasan, Krithaksha V. and Jayanta Saha Introduction Principles for design of toxicokinetic studies Guidance on test methods Toxicokinetic study sampling Toxicokinetic study report Guidance on specific types of test Absorption Distribution Metabolism and excretion Abbreviations References 13. Data leverage Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Leverage from literature Leverage from Threshold of Toxicological Concern (TTC) Leverage from reviewed devices Leverage from vendors testing References 14. Chemical characterization Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Krithaksha V. Introduction Why characterize materials? Chemical characterization Material characterization Plasticizers Sterilization techniques used for medical devices Corrosion Extractables and leachables Set up a chemical characterization study Conclusion References 15. Biological evaluation report Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Contents Index
Contributors Author bios Introduction 1.Cytotoxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan, Safura Fathima and Krithaksha V. Introduction ISO 10993-5 Cytotoxicity Detection methods Test by indirect contact Quantitative method Abbreviations References 2. Sensitization Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction ISO 10993-10 Test methods Guinea pig tests Guinea pig tests and sensitization potency assessment Guinea pig maximization and Buehler tests Open epicutaneous test Advantages and limitations Local lymph node assay The LLNA and sensitization potency assessment Advantages and limitations Human skin-sensitization testing Advantages and limitations Application of test methods in risk assessment Guinea pig tests Local lymph node assay Human repeat-insult patch test Abbreviation References 3. Irritation test Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Selection of animals Test procedure Alternative methods In vitro tests methods for irritation References 4. Material-mediated pyrogenicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction Broad range of pyrogens Tests using fluid extracts Selection of animal species Animal status Animal care and husbandry Size of groups Number of groups Treatment controls Route of exposure Test sample administration Pyrogen tests LAL test Rabbit test: sham test (in vivo) Interpretation of results Monocyte activation test (in vitro test) Procedure of MAT Advantages Abbreviations References 5. Acute systemic toxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Considerations Acute systemic toxicity Selection of animals Animal status Animal care and husbandry Size and number of groups Routes of exposure Dosing Body weight and food/water consumption Clinical observations Clinical pathology Anatomic pathology Evaluation criteria Final report References 6. Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity) Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran and Harini Sriram Introduction Animal care and husbandry Size and number of groups Routes of exposure Dosing Clinical observations Clinical pathology Anatomic pathology Evaluation criteria Final report References 7. Implantation Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Selection of animals Test procedure References 8. Hemocompatibility Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Krithaksha V., Vinod P. Bhalerao and Sandhiya Thamizharasan Highlights Introduction Types of devices in contact with blood Characterization of blood interactions Categories of tests and blood interactions Preclinical evaluation of cardiovascular devices and prostheses Advantages and limitations of animal and in vitro testing Laboratory testsdprinciples, scientific basis, and interpretation Evaluation of hemolytic properties of medical devices and their components Hemolysis testingdgeneral considerations Abbreviations References 9. Tests for genotoxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran and Harini Sriram Introduction Requirements Genotoxicity Example test method: mouse lymphoma mutagenesis assay Evaluation criteria Results Conclusion References 10. Carcinogenicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Safura Fathima and Sandhiya Thamizharasan Introduction Carcinogenicity test-specific considerations Abbreviations References 11. Reproduction toxicity Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Safura Fathima Introduction Principle of the test Description of the method Procedure Data and reporting Abbreviations References 12. Toxicokinetics Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Vinod P. Bhalerao, Sandhiya Thamizharasan, Krithaksha V. and Jayanta Saha Introduction Principles for design of toxicokinetic studies Guidance on test methods Toxicokinetic study sampling Toxicokinetic study report Guidance on specific types of test Absorption Distribution Metabolism and excretion Abbreviations References 13. Data leverage Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Introduction Leverage from literature Leverage from Threshold of Toxicological Concern (TTC) Leverage from reviewed devices Leverage from vendors testing References 14. Chemical characterization Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran, Sandhiya Thamizharasan and Krithaksha V. Introduction Why characterize materials? Chemical characterization Material characterization Plasticizers Sterilization techniques used for medical devices Corrosion Extractables and leachables Set up a chemical characterization study Conclusion References 15. Biological evaluation report Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath and Indumathy Jagadeeswaran Contents Index
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