Full Description
Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices.Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies.With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics.
Contents
Contributor contact detailsWoodhead Publishing Series in BiomaterialsForewordIntroductionDedicationPart I: Introduction to biocompatibility in medical devicesChapter 1: Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimesAbstract:1.1 Introduction: traditional biomaterials and biocompatibility test procedures1.2 The evolution from implantable medical devices to regenerative medicine and bionanotechnology1.3 New concepts and definitions for biocompatibility1.4 A proposed conceptual framework for new biocompatibility concepts and testing regimes1.5 Conclusions and future trendsChapter 2: Challenges in biocompatibility and failure of biomaterialsAbstract:2.1 Introduction2.2 Concept of biocompatibility2.3 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered2.4 Challenges in biocompatibility evaluation2.5 ConclusionChapter 3: Biological safety evaluation planning of biomaterialsAbstract:3.1 Introduction3.2 The fundamentals of safety evaluation planning3.3 Safety evaluation planning for biomaterials3.4 Developing and documenting plans3.5 Using safety evaluations3.6 ConclusionChapter 4: Biomechanical and biochemical compatibility in innovative biomaterialsAbstract:4.1 Introduction4.2 Selection of biomaterials4.3 Three generations of biomedical materials4.4 State-of-the-art development4.5 Future trends4.6 ConclusionPart II: Evaluation and characterisation of biocompatibility in medical devicesChapter 5: Material and chemical characterization for the biological evaluation of medical device biocompatibilityAbstract:5.1 Introduction5.2 Background5.3 Requirements of ISO 109935.4 Characterization of materials5.5 Chemical characterization of extracts5.6 Using chemical and material characterization to demonstrate equivalency5.7 Acceptance criteria for equivalency5.8 Risk assessment of extracts5.9 Conclusion and future trendsChapter 6: Allowable limits for toxic leachables: practical use of ISO 10993-17 standardAbstract:6.1 Introduction6.2 Process for setting tolerable intake (TI) values for compounds released from medical device materials6.3 Derivation of non-cancer TI values6.4 Derivation of cancer-based TI values6.5 Derivation of TI values for local effects6.6 Other issues to consider6.7 ConclusionChapter 7: In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devicesAbstract:7.1 Introduction7.2 Pre-testing considerations7.3 Sample preparation7.4 In vitro testing7.5 In vivo testing7.6 ConclusionChapter 8: Practical approach to blood compatibility assessments: general considerations and standardsAbstract:8.1 Introduction8.2 Background: blood composition8.3 Critical distinguishing factors presented by blood-contacting medical devices8.4 Responses in fluid blood in contact with medical devices8.5 Responses by materials, or upon their surfaces, in contact with blood8.6 Assessing hemocompatibility according to international standards8.8 Sources of further information and adviceChapter 9: Medical device biocompatibility evaluation: an industry perspectiveAbstract:9.1 Introduction9.2 Developing a biological evaluation plan9.3 Implementing a biological evaluation plan9.4 Biological safety testing9.5 Creating a biological evaluation report9.6 Conclusion and future trends9.7 Sources of further information and advice9.9 Appendix: example of a material component biological evaluation report template1.0 Introduction2.0 Chemical characterization3.0 Manufacturing processing4.0 Tissue contact5.0 Evaluation of ISO 10993-1 compliance6.0 Discussion7.0 ConclusionsChapter 10: Case study: overcoming negative test results during manufactureAbstract:10.1 Introduction10.2 Cardio Medical: a fictitious case study10.3.The biological safety program10.4.Extractables and leachables10.5 Controlling risk at the manufacturing level10.6 Sterilization residuals10.7 ConclusionChapter 11: Methods for the characterisation and evaluation of drug-device combination productsAbstract:11.1 Introduction to combination products11.2 Combination product regulation11.3 Demonstrating safety and efficacy of combination products11.4 Pre-clinical testing of combination products11.5 Aspects to consider in the manufacture of combination products11.6 Clinical studies for combination products11.7 Conclusion and future trendsPart III: Testing and interpreting the performance of medical devicesChapter 12: Methods and interpretation of performance studies for bone implantsAbstract:12.1 Introduction12.2 Definitions12.3 Scope12.4 Principles for the selection of an in vivo model to evaluate performance of bone implants12.5 Designing a study to evaluate performance of bone implants12.6 Selection of reference products and controls12.7 Osteoinductive and osteogenic performances12.8 In vitro limitations12.9 Fracture repair models12.10 Spinal fusion models12.11 Cylindrical defect models12.12 Segmental defect models12.13 Antimicrobial performances of implants12.14 Bioabsorbable and biodegradable materials12.15 Bone debris interaction with implant performance12.16 ConclusionChapter 13: Methods and interpretation of performance studies for dental implantsAbstract:13.1 Introduction and definitions13.2 Importance of performance evaluation studies for dental implants13.3 Experimental design of a performance trial for dental implants13.4 Choice of model13.5 Statistical power calculation and analysis13.6 Analysis13.7 Translation from animal studies to human clinical trials13.8 AcknowledgmentsChapter 14: Non-clinical functional evaluation of medical devices: general recommendations and examples for soft tissue implantsAbstract:14.1 Introduction and definitions14.2 The purpose of functional studies14.3 Standards and documentation14.4 How to design a functional study14.5 Combining non-clinical functional studies with requirements of safety standards14.6 ConclusionChapter 15: Mechanical testing for soft and hard tissue implantsAbstract:15.1 Introduction15.2 Principles of setting up a mechanical test15.3 Implant-specific mechanical performance testing15.4 Advanced therapy products (ATPs) - cartilage15.5 Conclusion and future trends15.6 Sources of further information and advicePart IV: International regulation of medical devicesChapter 16: Biological evaluation and regulation of medical devices in the European UnionAbstract:16.1 Introduction16.2 The regulatory and legislative framework16.3 Essential requirements16.4 Presumption of conformity16.5 Using the EN ISO 10993 series of standards to meet the essential requirements16.6 The notified body16.7 Common pitfalls in biological evaluations16.8 Managing positive results in the biological safety assessment16.9 Presenting the biological evaluation within the technical file16.10 Conclusion16.11 Sources of further information and advice16.12 Appendix: model content of the biological evaluation submissionChapter 17: Biological evaluation and regulation of medical devices in JapanAbstract:17.1 Introduction17.2 Outline of biological safety testing in Japan17.3 Biological safety tests17.4 Relationship and comparison between the International Organization for Standardization (ISO) standard and American Society for Testing and Materials (ASTM) standard17.5 Relationship between classification, examination, and certification in Japan17.6 Outline of the medical device Good Laboratory Practice (GLP)17.7 ConclusionChapter 18: Medical device regulations in ChinaAbstract:18.1 Introduction18.2 Interpretation of ISO 10993 and additional State Food and Drug Administration (SFDA) requirements18.3 Major professional bodiesPart V: Histopathology principles for biocompatibility and performance studiesChapter 19: Microscopic and ultrastructural pathology in medical devicesAbstract:19.1 Introduction19.2 Morphologic assessment in the safety studies of biomaterials and medical devices19.3 Assessment of the performance of biomaterials and medical devices19.4 Processing and sectioning of specimens19.5 Staining recommendations19.6 Qualitative and quantitative pathology used in the evaluation of biomaterials and medical devices19.7 Ultrastructural pathology19.8 Morphologic assessment of ocular medical devices19.9 Conclusion19.10 AcknowledgmentsIndex
