Biocompatibility and Performance of Medical Devices

Description

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