Biocompatibility and Performance of Medical Devices (Woodhead Publishing Series in Biomaterials)

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market Content: Front Cover -- Biocompatibility and Performance of Medical Devices -- Copyright -- Dedication -- Contents -- Contributors -- Foreword -- Introduction -- Part One: Introduction to biocompatibility in medical devices -- 1 Strategies to accelerate medical market access and manage risks of biocompatibility -- 1.1 Introduction -- 1.2 Medical device development process and significance of material selection -- 1.3 Accelerating time to market -- 1.4 Concept of biocompatibility and impact on market access -- 1.4.1 Appraisal of biocompatibility: Safety and performance 1.4.2 Factors affecting biocompatibility -- 1.4.3 Evaluation and assessment of biocompatibility -- 1.5 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered -- 1.5.1 Metal-on-metal implants combination -- 1.5.2 Residues of solutions used for reprocessing medical devices -- 1.5.3 Toxicological effects of degradation products -- 1.5.4 Opacification of intraocular lenses -- 1.5.5 Corrosion between adjacent devices -- 1.6 Challenges in biocompatibility evaluation and novel materials -- 1.6.1 Extraction conditions 1.6.2 Revisiting the design of sensitization tests -- 1.6.3 Interpretation of biocompatibility test results -- 1.7 Conclusion -- References -- Further reading -- 2 Making use of a biological safety evaluation plan -- 2.1 Introduction -- 2.2 The fundamentals of safety evaluation planning -- 2.3 Safety evaluation planning for biomaterials -- 2.4 Developing and documenting plans -- 2.5 Using safety evaluations -- 2.6 Conclusion -- 2.7 Sources of further information and advice -- 3 Biomechanical and biochemical compatibility in innovative biomaterials -- 3.1 Introduction 3.2 Selection of biomaterials -- 3.3 Three generations of biomedical materials -- 3.4 State-of-the-art development -- 3.4.1 From biologically "inactive" to "active" -- 3.4.2 Mechanical biocompatibility: Matching of stiffness -- 3.4.3 Multifunctional surface modification -- 3.4.4 Control of biodegradability -- 3.5 Future trends -- 3.5.1 Biocompatibility -- 3.5.2 Biodegradability -- 3.5.3 Biointerface -- 3.5.4 Nanomaterials -- 3.5.5 Smart responsive materials -- 3.5.6 In vitro evaluation -- 3.6 Conclusions -- References -- Further reading Part Two: Evaluation and characterization of biocompatibility in medical devices -- 4 A practical approach to analytical chemistry of medical devices -- 4.1 Introduction -- 4.1.1 Risk-based analysis for biocompatibility -- 4.2 The role of analytical chemistry in establishing biocompatibility -- 4.2.1 More chemical characterization-Reduced biological testing -- 4.2.2 The role of ISO 10993 and other international standards -- 4.3 Fulfilling the requirements of ISO 10993 -- 4.3.1 Bioavailability and biocompatibility -- 4.3.2 Solubility and bioavailability of extractables