Main 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 details

Woodhead Publishing Series in Biomaterials

Foreword

Introduction

Dedication

Part I: Introduction to biocompatibility in medical devices

Chapter 1: Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes

Abstract:

1.1 Introduction: traditional biomaterials and biocompatibility test procedures

1.2 The evolution from implantable medical devices to regenerative medicine and bionanotechnology

1.3 New concepts and definitions for biocompatibility

1.4 A proposed conceptual framework for new biocompatibility concepts and testing regimes

1.5 Conclusions and future trends

Chapter 2: Challenges in biocompatibility and failure of biomaterials

Abstract:

2.1 Introduction

2.2 Concept of biocompatibility

2.3 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered

2.4 Challenges in biocompatibility evaluation

2.5 Conclusion

Chapter 3: Biological safety evaluation planning of biomaterials

Abstract:

3.1 Introduction

3.2 The fundamentals of safety evaluation planning

3.3 Safety evaluation planning for biomaterials

3.4 Developing and documenting plans

3.5 Using safety evaluations

3.6 Conclusion

Chapter 4: Biomechanical and biochemical compatibility in innovative biomaterials

Abstract:

4.1 Introduction

4.2 Selection of biomaterials

4.3 Three generations of biomedical materials

4.4 State-of-the-art development

4.5 Future trends

4.6 Conclusion

Part II: Evaluation and characterisation of biocompatibility in medical devices

Chapter 5: Material and chemical characterization for the biological evaluation of medical device biocompatibility

Abstract:

5.1 Introduction

5.2 Background

5.3 Requirements of ISO 10993

5.4 Characterization of materials

5.5 Chemical characterization of extracts

5.6 Using chemical and material characterization to demonstrate equivalency

5.7 Acceptance criteria for equivalency

5.8 Risk assessment of extracts

5.9 Conclusion and future trends

Chapter 6: Allowable limits for toxic leachables: practical use of ISO 10993-17 standard

Abstract:

6.1 Introduction

6.2 Process for setting tolerable intake (TI) values for compounds released from medical device materials

6.3 Derivation of non-cancer TI values

6.4 Derivation of cancer-based TI values

6.5 Derivation of TI values for local effects

6.6 Other issues to consider

6.7 Conclusion

Chapter 7: In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices

Abstract:

7.1 Introduction

7.2 Pre-testing considerations

7.3 Sample preparation

7.4 In vitro testing

7.5 In vivo testing

7.6 Conclusion

Chapter 8: Practical approach to blood compatibility assessments: general considerations and standards

Abstract:

8.1 Introduction

8.2 Background: blood composition

8.3 Critical distinguishing factors presented by blood-contacting medical devices

8.4 Responses in fluid blood in contact with medical devices

8.5 Responses by materials, or upon their surfaces, in contact with blood

8.6 Assessing hemocompatibility according to international standards

8.8 Sources of further information and advice

Chapter 9: Medical device biocompatibility evaluation: an industry perspective

Abstract:

9.1 Introduction

9.2 Developing a biological evaluation plan

9.3 Implementing a biological evaluation plan

9.4 Biological safety testing

9.5 Creating a biological evaluation report

9.6 Conclusion and future trends

9.7 Sources of further information and advice

9.9 Appendix: example of a material component biological evaluation report template

1.0 Introduction

2.0 Chemical characterization

3.0 Manufacturing processing

4.0 Tissue contact

5.0 Evaluation of ISO 10993-1 compliance

6.0 Discussion

7.0 Conclusions

Chapter 10: Case study: overcoming negative test results during manufacture

Abstract:

10.1 Introduction

10.2 Cardio Medical: a fictitious case study

10.3.The biological safety program

10.4.Extractables and leachables

10.5 Controlling risk at the manufacturing level

10.6 Sterilization residuals

10.7 Conclusion

Chapter 11: Methods for the characterisation and evaluation of drug-device combination products

Abstract:

11.1 Introduction to combination products

11.2 Combination product regulation

11.3 Demonstrating safety and efficacy of combination products

11.4 Pre-clinical testing of combination products

11.5 Aspects to consider in the manufacture of combination products

11.6 Clinical studies for combination products

11.7 Conclusion and future trends

Part III: Testing and interpreting the performance of medical devices

Chapter 12: Methods and interpretation of performance studies for bone implants

Abstract:

12.1 Introduction

12.2 Definitions

12.3 Scope

12.4 Principles for the selection of an in vivo model to evaluate performance of bone implants

12.5 Designing a study to evaluate performance of bone implants

12.6 Selection of reference products and controls

12.7 Osteoinductive and osteogenic performances

12.8 In vitro limitations

12.9 Fracture repair models

12.10 Spinal fusion models

12.11 Cylindrical defect models

12.12 Segmental defect models

12.13 Antimicrobial performances of implants

12.14 Bioabsorbable and biodegradable materials

12.15 Bone debris interaction with implant performance

12.16 Conclusion

Chapter 13: Methods and interpretation of performance studies for dental implants

Abstract:

13.1 Introduction and definitions

13.2 Importance of performance evaluation studies for dental implants

13.3 Experimental design of a performance trial for dental implants

13.4 Choice of model

13.5 Statistical power calculation and analysis

13.6 Analysis

13.7 Translation from animal studies to human clinical trials

13.8 Acknowledgments

Chapter 14: Non-clinical functional evaluation of medical devices: general recommendations and examples for soft tissue implants

Abstract:

14.1 Introduction and definitions

14.2 The purpose of functional studies

14.3 Standards and documentation

14.4 How to design a functional study

14.5 Combining non-clinical functional studies with requirements of safety standards

14.6 Conclusion

Chapter 15: Mechanical testing for soft and hard tissue implants

Abstract:

15.1 Introduction

15.2 Principles of setting up a mechanical test

15.3 Implant-specific mechanical performance testing

15.4 Advanced therapy products (ATPs) - cartilage

15.5 Conclusion and future trends

15.6 Sources of further information and advice

Part IV: International regulation of medical devices

Chapter 16: Biological evaluation and regulation of medical devices in the European Union

Abstract:

16.1 Introduction

16.2 The regulatory and legislative framework

16.3 Essential requirements

16.4 Presumption of conformity

16.5 Using the EN ISO 10993 series of standards to meet the essential requirements

16.6 The notified body

16.7 Common pitfalls in biological evaluations

16.8 Managing positive results in the biological safety assessment

16.9 Presenting the biological evaluation within the technical file

16.10 Conclusion

16.11 Sources of further information and advice

16.12 Appendix: model content of the biological evaluation submission

Chapter 17: Biological evaluation and regulation of medical devices in Japan

Abstract:

17.1 Introduction

17.2 Outline of biological safety testing in Japan

17.3 Biological safety tests

17.4 Relationship and comparison between the International Organization for Standardization (ISO) standard and American Society for Testing and Materials (ASTM) standard

17.5 Relationship between classification, examination, and certification in Japan

17.6 Outline of the medical device Good Laboratory Practice (GLP)

17.7 Conclusion

Chapter 18: Medical device regulations in China

Abstract:

18.1 Introduction

18.2 Interpretation of ISO 10993 and additional State Food and Drug Administration (SFDA) requirements

18.3 Major professional bodies

Part V: Histopathology principles for biocompatibility and performance studies

Chapter 19: Microscopic and ultrastructural pathology in medical devices

Abstract:

19.1 Introduction

19.2 Morphologic assessment in the safety studies of biomaterials and medical devices

19.3 Assessment of the performance of biomaterials and medical devices

19.4 Processing and sectioning of specimens

19.5 Staining recommendations

19.6 Qualitative and quantitative pathology used in the evaluation of biomaterials and medical devices

19.7 Ultrastructural pathology

19.8 Morphologic assessment of ocular medical devices

19.9 Conclusion

19.10 Acknowledgments

Index