Biomaterials, Medical Devices, and Combination Products: Biocompatibility Testing and Safety Assessment, 1st Edition (Hardback) book cover

Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment, 1st Edition

By Shayne Cox Gad, Samantha Gad-McDonald

CRC Press

584 pages | 70 B/W Illus.

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Description

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for—or concerned with—developing and ensuring patient safety in the use and manufacture of medical devices.

The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as the devices themselves.

Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products, the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market-ready devices.

Also incorporated are new case examples and citations with the means of access to Internet-based regulatory and scientific sites, reflecting the universal adoption of this technology into our world.

The book takes into consideration the fact that device markets are global, the continual advancement of technology, and the increasing global harmonization of safety regulations. Each aspect of device safety evaluation is reviewed in terms of the International Organization for Standardization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health, Labour, and Welfare (MHLW) perspectives.

Table of Contents

Safety Evaluation of Medical Devices

Introduction

Biocompatibility

Fundamentals of Biocompatibility Tests

Scope of Devices and the Medical Device Market

History

Nonspecific Regulatory Considerations

References

Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Regulatory Basis

Toxicity Testing: Medical Devices

References

Road Map to Test Selections

Key Concepts

References

Materials in Medical Device Design

Introduction

Metals

Ceramics and Glasses

Polymers

Textiles

Biologically Sourced Materials

Surface-Modifying Materials

Tissue Engineering Scaffolds

Nanomaterials

References

What to Test: Sampling and Sample Preparation

Sampling

Randomization

Sample Preparation

Reference Materials

Conclusion

References

Cytotoxicity Testing

Introduction

Background

Crystal Violet Staining

Silicone Microphysiometer

Microtox Test

Neutral Red Uptake (NRU) Assay

MTT

Agar Diffusion Test

Direct Contact Test

Elution Test

Colony-Forming Assay (CFA)

Correlation With In Vivo Results

Conclusion

References

Hemocompatibility (ISO 10993-4)

Noncontact Devices

External Communicating Devices

Implant Devices

Hemolysis Tests

The Osmotic Fragility Test

Erythrocyte Stability

Whole Blood Clotting Time

Thrombogenicity

Complement Activation

Protein Adsorption

Coagulation

Platelets

Conclusion

References

Local Tissue Tolerance

Dermal Irritation

Ocular Irritation Testing

Other Nonparenteral Route Irritation Tests

Parenteral Irritation/Tolerance

Parenteral Routes

Intracutaneous Irritation

Factors Affecting Irritation Responses and Test Outcome

References

Immunotoxicology (ISO 10993-20)

Overview of the Immune System

Immunotoxic Effects

Immunosuppression

Immunostimulation

Evaluation of the Immune System

Immunopathologic Assessments

Humoral Immunity

Cell-Mediated Immunity

Nonspecific Immunity

Host-Resistance Assays

Hypersensitivity

Local Lymph Node Assay (LLNA)

Approaches

Problems and Future Directions

References

Implantation Biology and Studies

Usp Implantation Test

ISO 10993 Implantation Test

Preparation of Specimens for Implantation

Test Method for Implantation in Subcutaneous Tissue

References

Acute Systemic Toxicity Testing and Device Safety Evaluation

Introduction

Acute Systemic Toxicity Characterization

References

Genotoxicity

Introduction

DNA Structure

Cytogenetics

References

Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity

Introduction

Objectives

Regulatory Considerations

Study Design and Conduct

Parameters to Measure

Histopathology

Study Interpretation and Reporting

Reproductive and Developmental Toxicity

Introduction

ICH Study Designs

Methodological Issues

Data Interpretation

References

Carcinogenicity

Animal Model

Dose Selection

Interpretation of Results

References

Degradation Products and Impurities Processes in Medical Devices

Introduction

Metals

Ceramics and Glasses

Degradation Processes

Effects of Sterilization

Interpretation of Sterility Test Results

Heavy Metals

Acknowledgment

References

Special Case Devices

Introduction

Respiratory and Inhalation Devices

Ophthalmic Devices

Cardiovascular Devices and Prostheses

Tampons

Devices for Dentistry

References

Combination Products

Device/Drug Combination Products

Historical Background

References

Clinical Studies for Medical Devices

Design Considerations

Epidemiology

Conclusion

References

Leachables and Extractables from Medical Devices

Introduction

Sample Preparation

General Principles of Leachables and Extractables under ISO 10993

Analytical Methods

Risk Assessment of Extracted Moieties

Introduction to (Q)SAR for Leachable and Extractable Evaluation

Risk Assessment for Leachables and Extractables

References

Toxicokinetics in Biomaterial and Device Safety Evaluation

Introduction

Regulations

Principles

Laboratory Methods

Physiologically Based Pharmacokinetic (PBPK) Modeling

Biologically Derived Materials

References

Special Studies

Anti-Infective Materials

Specific Tests

21-Day Eye Irritation Study in Rabbits

Systemic Injection Test

Production of Toxic Shock Syndrome Toxin-1 (TSST-1)

Inflammatory Responses to Biomaterials

References

Case Histories and Problem Resolution

Phthalates Leaching From Polymer Devices

BPA: Bisphenol A

Talc on Gloves and Condoms

Latex Allergy

Silicones in Devices (Historical)

Intrauterine Devices

Toxic Shock Syndrome (Historical)

Conclusion

References

Appendix A: Selected Regulatory and Toxicological Acronyms

Appendix B: Contract Testing Laboratories

Appendix C: Notable Regulatory Internet Addresses

Appendix D: Non-U.S. Medical Device Regulators

About the Authors

Shayne Cox Gad, PhD, DABT, Gad Consulting Services, Raleigh, North Carolina, USA

Samantha Gad-McDonald, B.S.ENGR, Gad Consulting Services, Raleigh, North Carolina, USA

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
MED096000
MEDICAL / Toxicology
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical