Biocompatibility Protocols for Medical Devices and Materials

1st Edition - April 7, 2023
Authors: Prakash Srinivasan Timiri Shanmugam, Thamizharasan Sampath, Indumathy Jagadeeswaran
Language: English
Paperback ISBN:
9 7 8 - 0 - 3 2 3 - 9 1 9 5 2 - 4
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 8 4 9 2 - 8

Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk asse… Read more

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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 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.

Cover image
Title page
Table of Contents
Copyright
Contributors
Author bios
Introduction
Risk assessment for biocompatibility testing
Considering existing information to mitigate the risks
ISO 10993-1: a risk-based approach
Biocompatibility endpoints evaluation
Conclusion
Chapter 1. Cytotoxicity
Introduction
ISO 10993-5
Cytotoxicity
Detection methods
Test by indirect contact
Quantitative method
Abbreviations
Chapter 2. Sensitization
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
Chapter 3. Irritation test
Introduction
Selection of animals
Test procedure
Alternative methods
In vitro tests methods for irritation
Chapter 4. Material-mediated pyrogenicity
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
Chapter 5. Acute systemic toxicity
Introduction
Considerations
Chapter 6. Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity)
Introduction
Animal care and husbandry
Size and number of groups
Routes of exposure
Dosing
Clinical observations
Clinical pathology
Anatomic pathology
Evaluation criteria
Final report
Chapter 7. Implantation
Introduction
Selection of animals
Test procedure
Chapter 8. Hemocompatibility
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 tests—principles, scientific basis, and interpretation
Evaluation of hemolytic properties of medical devices and their components
Hemolysis testing—general considerations
Abbreviations
Chapter 9. Tests for genotoxicity
Introduction
Requirements
Genotoxicity
Example test method: mouse lymphoma mutagenesis assay
Evaluation criteria
Results
Conclusion
Chapter 10. Carcinogenicity
Introduction
Carcinogenicity test-specific considerations
Abbreviations
Chapter 11. Reproduction toxicity
Introduction
Principle of the test
Description of the method
Procedure
Data and reporting
Abbreviations
Chapter 12. Toxicokinetics
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
Chapter 13. Data leverage
Introduction
Leverage from literature
Leverage from Threshold of Toxicological Concern (TTC)
Leverage from reviewed devices
Leverage from vendors testing
Chapter 14. Chemical characterization
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
Chapter 15. Biological evaluation report
Contents
Index

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.

Affiliations and expertise

Senior Toxicologist, Avanos Medical, Inc., Georgia, U.S.A

Thamizharasan Sampath

Thamizharasan Sampath, PhD, PGDCR, is currently Dean of Research and Professor of Pharmacology & Toxicology at the University of Health Sciences (SBIMS), Raipur, CG, India. He has done his MS and PhD specializing in pharmacology under the faculty of medicine from the Post Graduate Institute of Basic Medical Sciences, University of Madras, and also did his Postgraduate diploma in clinical research at State University. He has 17 years of teaching and research experience. His research areas include cancer pharmacology, clinical research, neurotoxicology, nutraceuticals, reproductive toxicology, endocrine pharmacology, phytopharmacology, molecular pharmacology, drug design, and drug discovery. He has published more than 60 research articles in national and international indexed journals and is the author of the book Bamboo - The Golden seed and has also contributed more than 20 book chapters. He has received many awards from various central organizations for his outstanding research and contribution in the field of medicine. He serves as a Chief Editor, Editorial Board Member, and Reviewer in many medical journals. He is a member of Institutional Research Ethics Committee, Animal Ethics Committee, Indian Pharmacological Society, and UNESCO Bioethics Committee.

Affiliations and expertise

Dean of Research and Professor, Department of Pharmacology & Toxicology, Shri Balaji Institute of Medical Sciences, University of Health Sciences, Raipur, Chhattisgarh, India

Indumathy Jagadeeswaran

Indumathy Jagadeeswaran, PhD, is currently working as a Senior Research Associate in the Department of Pediatrics at UT Southwestern Medical Center, Dallas, Texas, United States. She has an MS in Biotechnology with Biochemistry (interdisciplinary) and PhD in Medical Physiology from the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Pondicherry, India. She has been working in the field of physiology since 2011 and has completed her postdoctoral training from prestigious institutes including the UT Southwestern Medical Center, Dallas, Texas. She has editorial experience including being an Associate Editor (2014–2017) for a peer-reviewed international journal and is presently a Peer-Review Member of the Scientific Committee and Society. She has contributed book chapters on regulatory standards and has also published research articles in various peer-reviewed international journals.

Affiliations and expertise

Senior Research Associate, Department of Pediatrics, UT Southwestern Medical Center, Dallas, Texas, U.S.A