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Biocompatibility and performance of medical devicesEdited by J-P Boutrand, Biomatech, France
Woodhead Publishing Series in Biomaterials No. 50
Multiple authors … have come together to present their views on the best options, the best techniques and the optimal methods of interpretation of data. Expertly assembled by Jean-Pierre Boutrand … the contents of this book will allow the reader to attain an insight into the complexities of this testing arena.
Professor David Williams, Wake Forest Baptist Medical Center, USA (from the Foreword)
- examines the key concepts and challenges faced in relation to biocompatibility in medical devices
- discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment
- delivers a comprehensive overview of testing and interpreting medical device performance
- provides information on the international regulation of medical devices in the European Union, Japan and China
- concluding chapters review histopathology principles for biocompatibility and performance studies
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.
ISBN 0 85709 070 4
ISBN-13: 978 0 85709 070 6
October 2012
540 pages 234 x 156mm hardback
£165.00 / US$280.00 / €200.00
Reprinting – not in stock at present
About the editor
Jean-Pierre Boutrand is General Manager and Scientific Director for the European division of NAMSA (the world leading medical device evaluation company). Dr Boutrand has been involved in more than 100 public presentations and publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for ANSM (the French agency for the safety of health products).
Titles which may also be of interest:
Biointegration of medical implant materials
Cellular response to biomaterials
Surfaces and interfaces for biomaterials
Contents
PART 1 INTRODUCTION TO BIOCOMPATIBILITY IN MEDICAL DEVICES
PART 2 EVALUATION AND CHARACTERISATION OF BIOCOMPATIBILITY IN MEDICAL DEVICES
PART 3 TESTING AND INTERPRETING THE PERFORMANCE OF MEDICAL DEVICES
PART 4 INTERNATIONAL REGULATION OF MEDICAL DEVICES
PART 5 HISTOPATHOLOGY PRINCIPLES FOR BIOCOMPATIBILITY AND PERFORMANCE STUDIES
PART 1 INTRODUCTION TO BIOCOMPATIBILITY IN MEDICAL DEVICES
Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes
D Williams, Wake Forest Institute of Regenerative Medicine, USA
- Introduction: traditional biomaterials and biocompatibility test procedures
- The evolution from implantable medical devices to regenerative medicine and bionanotechnology
- New concepts and definitions for biocompatibility
- A proposed conceptual framework for new biocompatibility concepts and testing regimes
- Conclusions and future trends
- References
Challenges in biocompatibility and failure of biomaterials
R Eloy, NAMSA, France
- Introduction
- Concept of biocompatibility
- Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered
- Challenges in biocompatibility evaluation
- Conclusion
- References
Biological safety evaluation planning of biomaterials
D Parente, NAMSA, USA
- Introduction
- The fundamentals of safety evaluation planning
- Safety evaluation planning for biomaterials
- Developing and documenting plans
- Using safety evaluations
- Conclusion
- Sources of further information and advice
Biomechanical and biochemical compatibility in innovative biomaterials
J Huang and Z X Guo, University College London, UK
- Introduction
- Selection of biomaterials
- Three generations of biomedical materials
- State-of-the art development
- Future trends
- Conclusion
- References
PART 2 EVALUATION AND CHARACTERISATION OF BIOCOMPATIBILITY IN MEDICAL DEVICES
Material and chemical characterization for the biological evaluation of medical device biocompatibility
D Albert, NAMSA, USA
- Introduction
- Background
- Requirements of ISO 10993
- Characterization of materials
- Chemical characterization of extracts
- Using chemical and material characterization to demonstrate equivalency
- Acceptance criteria for equivalency
- Risk assessment of extracts
- Conclusion and future trends
- References
Allowable limits for toxic leachables: Practical Use of ISO -Standard
R P Brown, US Food and Drug Administration, USA
- Introduction
- Process for setting tolerable intake (TI) values for compounds released from medical device materials
- Derivation of noncancer tolerable intake (TI) values
- Derivation of cancer-based tolerable intake (TI) values
- Derivation of tolerable intake (TI) values for local effects
- Other issues to consider
- Conclusion
- References
In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices
W H De Jong, National Institute for Public Health and the Environment (RIVM), The Netherlands, J W Carraway, NAMSA, USA, and R E Geertsma, National Institute for Public Health and the Environment (RIVM), The Netherlands
- Introduction
- Pre-testing considerations
- Sample preparation
- In vitro testing
- In vivo testing
- Conclusions
- References
Practical approach to blood compatibility assessments: general considerations and standards
M F Wolf, Medtronic Inc, USA, and J M Anderson, Case Western Reserve University, USA
- Introduction
- Background: blood composition
- Critical distinguishing factors presented by blood-contacting medical devices
- Responses in fluid blood to contact with medical devices
- Responses by materials to contact with blood
- Assessing hemocompatibility according to international standards
- Conclusion and future trends
- Sources of further information and advice
- References
Medical device biocompatibility evaluation: an industry perspective
K Coleman, X Dai, X Deng, F Lakehal and X Tang, Medtronic, Inc, USA
- Introduction
- Developing a biological evaluation plan
- Implementing a biological evaluation plan
- Biological safety testing
- Creating a biological evaluation report
- Conclusion and future trends
- Sources of further information and advice
- References
Case study: overcoming negative tests results during manufacture
D Parente, NAMSA, USA
- Introduction
- Cardio Medical: a fictitious case-study
- The biological safety program
- Extractables and leachables
- Controlling risk at the manufacturing level
- Sterilization residuals
- Conclusion
Methods for the characterisation and evaluation of drug-device combination products
A L Lewis, Biocompatibles UK Ltd, UK
- Introduction to combination products
- Combination product regulation
- Demonstrating safety and efficacy of combination products
- Pre-clinical testing of combination products
- Aspects to consider in the manufacture of combination products
- Clinical studies for combination products
- Conclusion and future trends
- References
PART 3 TESTING AND INTERPRETING THE PERFORMANCE OF MEDICAL DEVICES
Methods and interpretation of performance studies for bone implants
J-P Boutrand, NAMSA, France
- Introduction
- Definitions
- Scope
- Principles for the selection of an in vivo model to evaluate performance of bone implants
- Designing a study to evaluate performance of bone implants
- Selection of reference products and controls
- Osteoinductive and osteogenic performances
- In vitro limitations
- Fracture repair models
- Spinal fusion models
- Cylindrical defect models
- Segmental defect models
- Antimicrobial performances of implants
- Bioabsorbable and biodegradable materials
- Bone debris interaction with implant performance
- Conclusion
- References
Methods and interpretation of performance studies for dental implants
M Dard, New York University College of Dentistry, USA
- Introduction and definitions
- Importance of performance evaluation studies for dental implants
- Experimental design of a performance trial for dental implants
- Choice of model
- Statistical power calculation and analysis
- Analysis
- Translation from animal studies to human clinical trials
- Acknowledgements
- Sources of further information and advice
- References
Non-clinical functional evaluation of medical devices: general recommendations and examples for soft tissue implants
G Clermont, NAMSA, France
- Introduction and definitions
- The purpose of functional studies
- Standards and documentation
- How to design a functional study
- Combining non-clinical functional studies with requirements of safety standards
- Conclusion
- References
Mechanical testing for soft and hard tissues implants
C Kaddick, EndoLab GmbH, Germany
- Introduction
- Principles of setting up a mechanical test
- Implant-specific mechanical performance testing
- Advanced therapy products (ATPs); cartilage
- Conclusion and future trends
- Sources of further information and advice
- References
PART 4 INTERNATIONAL REGULATION OF MEDICAL DEVICES
Biological evaluation and regulation of medical devices in the European Union
A T Keene, SGS, UK
- Introduction
- The regulatory and legislative framework
- Essential requirements
- Presumption of conformity
- Using the EN ISO 10993 series of standards to meet the essential requirements
- The notified body
- Common pitfalls in biological evaluations
- Managing positive results in the biological safety assessment
- Presenting the biological evaluation within the technical file
- Conclusion
- Sources of further information and advice
Biological evaluation and regulation of medical devices in Japan
K Kojima, Hatano Research Institute, Food and Drug Safety Centre, Japan
- Introduction
- Outline of biological safety testing in Japan
- Biological safety tests
- Relationship and comparison between the International Organization for Standardization (ISO) standard and American Society for Testing and Materials (ASTM) standard
- Relationship to classification, examination, and certification in Japan
- Outline of the Medical Device Good Laboratory Practice (GLP)
- Conclusion
- References
Medical device regulations in China
S Likui, SFDA Jinan Quality Supervision and Inspection Center for Medical Devices, China
- Introduction
- Interpretation of ISO 10993 and additional State Food and Drug Administration (SFDA) requirements
- Major professional bodies
- References
PART 5 HISTOPATHOLOGY PRINCIPLES FOR BIOCOMPATIBILITY AND PERFORMANCE STUDIES
Microscopic and ultrastructural pathology in medical devices
A Alves, NAMSA, France, A Metz and J Render, NAMSA, USA
- Introduction
- Morphologic assessment in the safety studies of biomaterials and medical devices
- Assessment of the performance of biomaterials and medical devices
- Processing and sectioning of specimens
- Staining recommendations
- Qualitative and quantitative pathology used in the evaluation of biomaterials and medical devices
- Ultrastructural pathology
- Morphologic assessment of ocular medical devices
- Conclusion
- Acknowledgments
- References