Abstract
Biocompatibility and Performance of Medical Devices is the 50th of the 67 publications in the Woodhead Publishing series in biomaterials that cover a wide range of topics related to medical device development and biomaterials used in medical devices. The editor of the volume, Dr Jean-Pierre Boutrand, is very experienced in the area of development of medical devices and has assembled a stellar group of authors to cover a wide variety of topics related to planning and executing biocompatibility programs. The publication of this work is timely, as the variety of types of medical devices, and the materials that comprise different devices, has expanded tremendously over the past decade. The old definition of biocompatibility included “the property of being biologically compatible by not producing a toxic, injurious, or immunological response in living tissue.” However, the expanded variety of biomaterials and uses for various devices has necessitated reevaluation of the definition of the term biocompatibility to encompass not only the materials in the device but also the intended use of the device. Based upon thinking of medical devices in the context of the biological or physiological system that they are placed into, a new definition has been proposed which reflects “the ability of a biomaterial to perform its desired function with respect to a medical therapy, without eliciting any undesirable local or systemic effects in the recipient or beneficiary of that therapy, but generating the most beneficial cellular or tissue response in that specific situation, and optimizing the clinically relevant performance of that therapy” (D. Williams, chapter 1).
The book has 19 chapters divided into 6 main parts. Part 1, Introduction to Biocompatibility in Medical Devices, has 4 chapters covering basic concepts in biocompatibility testing, challenges and failure of biomaterials, planning of biological safety evaluation of biomaterials, and compatibility of innovative biomaterials. The first chapter is an excellent overview of biocompatibility testing and how testing paradigms have changed to deal with new materials coming into widespread use. The definition of biocompatibility is revised to include not only the toxicity of biomaterials but also the functionality of the medical device and sets the tone for thinking about information in subsequent chapters. The other 3 chapters cover important concepts around device recalls, various challenges in how to conduct appropriate biocompatibility testing with existing and novel biomaterials, and how to develop a scientifically sound plan for biocompatibility testing. The guidance on how to create a testing plan may be especially useful for those just starting out in this field.
Part 2, Evaluation and Characterization of Biocompatibility in Medical Devices, contains 6 chapters with information on ISO 10993 (1) testing requirements as well as practical advice on methodology for in vitro and in vivo testing, including blood compatibility, evaluation of drug–device combinations, and how to deal with negative test results in the context of the entire testing program. The chapter on allowable limits for toxic leechables in particular contains very useful information on setting tolerable intake values in a variety of settings.
Part 3, Testing and Interpreting the Performance of Medical Devices, contains 4 chapters covering evaluation of performance for bone implants, dental implants, soft tissue implants, and soft and hard tissue implants. The topics are covered in sufficient detail to allow the reader to gain a fairly detailed understanding of each area. Part 4, International Regulation of Medical Devices, describes regulations covering biological evaluations in the European Union, Japan, and China. Each of the chapters does a good job of placing the ISO10993 guidance documents in perspective to the respective country requirements. Part 5, Histopathology Principles for Biocompatibility and Performance Studies, contains 1 chapter that provides a wealth of information on preparation of specimens, staining recommendations, and the different types of pathology evaluation used for various biomaterials. Although this chapter is extremely helpful, it is not clear why it is split into Part 5, as it would more logically fit into Part 2 with the other chapters that are focused on the practical aspects of biocompatibility testing.
In summary, Biocompatibility and Performance of Medical Devices is an excellent primer for scientists interested in medical device testing. The chapters are well written and offer a good mix of theoretical concerns and practical advice, with extensive references included both to applicable regulations and appropriate scientific literature. Some of the references to ISO 10993 are repetitive, but this volume should serve as a comprehensive starting point for those entering the arena of medical device testing and is a worthy addition to the reference library of those actively engaged in the field.