Sterilisation Of Biomaterials And Medical Devices

Book Description :

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes. Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices. With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices

Book Description :

Despite advances in materials and sterilisation, patients who receive biomaterials of medical device implants are still at risk of developing an infection around the implantation site. This book reviews the fundamentals of biomaterials and medical device related infections and methods and materials for the treatment and prevention of infection. The first part of the book provides readers with an introduction to the topic including analyses of biofilms, diagnosis and treatment of infection, pathology and topography. The second part of the book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.

Book Description :

Despite recent advances in medical devices using other materials, metallic implants are still one of the most commercially significant sectors of the industry. Given the widespread use of metals in medical devices, it is vital that the fundamentals and behaviour of this material are understood. Metals in biomedical devices reviews the latest techniques in metal processing methods and the behaviour of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Chapters in part two discuss the mechanical behaviour, degradation and testing of metals with specific chapters on corrosion, wear testing and biocompatibility of biomaterials. Part three covers the processing of metals for biomedical applications with chapters on such topics as forging metals and alloys, surface treatment, coatings and sterilisation. Chapters in the final section discuss clinical applications of metals such as cardiovascular, orthopaedic and new generation biomaterials. With its distinguished editor and team of expert contributors, Metals for biomedical devices is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. Reviews the latest techniques in metal processing methods including surface treatment and sterilisation Examines metal selection for biomedical devices considering biocompatibility of various metals Assesses mechanical behaviour and testing of metals featuring corrosion, fatigue and wear

Book Description :

A wide variety of materials is being used in biomedical engineering for various functions. This includes a range of ceramics, polymers and metallic materials for implants and medical devices. A major question is how these materials will perform inside the body, which is very sensitive to alien materials. The material must not only survive to perform its intended function but also not initiate any damage to the surrounding tissue or induce a wider health problem. The service characteristics of implanted materials are of vital concern to health treatments that alleviate ageing.This book collates information and provides a concise text on the performance of different materials used in devices and implants. The knowledge presented is critical for a biomedical engineer, especially for the purpose of selecting the right materials. In addition, topics such as allergies and infection, tissue scaffolds, and drug delivery are reviewed.

Book Description :

Combining materials science, mechanics, implant design and clinical applications, this self-contained text provides a complete grounding to the field.

Book Description :

Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.

Book Description :

Written by an exceptionally experienced author in the area of medical equipment product design, this text presents a comprehensive overview of such sound principles and state-of-the-art techniques covering a whole host of material types, biocompatability, the design process and future trends within this exciting field. An all-in-one reference text, concise and easy-to-read. Wide audience appeal, from industry professionals to students of design.

Book Description :

Decontamination in Hospitals and Healthcare brings an understanding of decontamination practices and the development of technologies for cleaning and control of infection to a wide audience interested in public health, including healthcare specialists, scientists, students or patients. Part one highlights the importance and history of decontamination in hospitals and healthcare before exploring the role of standards in decontamination, infection control in Europe, and future trends in the area. Part two focuses on decontamination practices in hospitals and healthcare. It considers the role of the nurse in decontamination, the issues of microbial biofilm in waterlines, control of waterborne microorganisms, and the use of gaseous decontamination technologies. Further chapters explore decontamination of prions, the use of protective clothing, no-touch automated room disinfection systems, and controlling the presence of microorganisms in hospitals. Part three discusses practices for decontamination and sterilization of surgical instruments and endoscopes. These chapters examine a range of guidance documents, including the choice framework for local policy and procedures for decontamination of surgical instruments, as well as novel technologies for cleaning and detection of contamination. Decontamination in Hospitals and Healthcare provides a reference source on decontamination for public health professionals and students concerned with healthcare. It is particularly useful for scientists in microbiology and disinfection/decontamination laboratories, healthcare workers who use disinfectants, students in microbiology, clinicians, members of the Institute of Decontamination Sciences/Central Sterilising Club, and those employed in the Central Sterile Services departments of healthcare facilities. Discusses decontamination processes in Europe Provides an in-depth understanding into decontamination in healthcare settings, specifically hospitals and dental practices Examines the decontamination of surgical equipment and endoscopes

Book Description :

Metals for Biomedical Devices, Second Edition, has been fully updated and builds upon the success of its first edition, discussing the latest techniques in metal processing methods and the behavior of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Subsequent chapters cover mechanical behavior, degradation and testing, corrosion, wear testing and biocompatibility, the processing of metals for biomedical applications, including topics such as forging metals and alloys, surface treatment, coatings and sterilization. Chapters in the final section discuss the clinical applications of metals, such as cardiovascular, orthopedic and new generation biomaterials. With its distinguished editor and team of expert contributors, this book is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. Reviews the latest techniques in metal processing methods, including surface treatment and sterilization Examines metal selection for biomedical devices, considering the biocompatibility of various metals Assesses mechanical behavior and the testing of metals, featuring the latest information on corrosion, fatigue and wear Discusses biodegradable alloys, including a new section on Mg alloys Includes a new section that discusses the use of additive manufacturing in the production of medical devices

Book Description :

Implantable sensor systems offer great potential for enhanced medical care and improved quality of life, consequently leading to major investment in this exciting field. Implantable sensor systems for medical applications provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of these devices in a diverse range of medical applications. Part one reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, microassembly, electrode array design and fabrication, and the use of biofuel cells as sustainable power sources. Part two goes on to consider the challenges associated with implantable systems. Biocompatibility, sterilization considerations and the development of active implantable medical devices in a regulated environment are discussed, along with issues regarding data protection and patient privacy in medical sensor networks. Applications of implantable systems are then discussed in part three, beginning with Microelectromechanical systems (MEMS) for in-vivo applications before further exploration of tripolar interfaces for neural recording, sensors for motor neuroprostheses, implantable wireless body area networks and retina implants. With its distinguished editors and international team of expert contributors, Implantable sensor systems for medical applications is a comprehensive guide for all those involved in the design, development and application of these life-changing technologies. Provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of implantable sensor systems in a range of medical applications Reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, and microassembly Considers the challenges associated with implantable systems, including biocompatibility and sterilization

Book Description :

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Book Description :

Drug delivery systems represent a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug delivery devices continues to drive novel product development. Advanced drug delivery devices can offer significant advantages over conventional drugs and devices alone, such as increased efficiency, improved performance and convenience. The purpose of this book is to illustrate how effective drug delivery can be achieved by means other than tablets. The book will provide a thorough analysis of the fundamentals, applications and new technologies of drug-device combination products for use throughout the human body. Part one provides readers with an introduction and background to the field. Chapters in Part two discuss areas of application such as catheter based products, drug eluting stents and beads and anti-biotic loaded cements. Part three covers the development of drug device combination products with chapters on such topics as pre-clinical testing, sterilisation, patent issues and regulation of drug device combination products. With its distinguished editor and team of international contributors, Drug-device combination products: delivery technologies and applications is an invaluable reference for product development specialists, materials scientists and engineers in the biomedical industry and academia as well as those concerned with drug delivery. Illustrates how effective drug delivery can be achieved by means other than tablets providing readers with a comprehensive introduction and background to the field Provides a thorough analysis of the fundamentals, applications and new technologies of drug device combination products Discusses areas of application such as catheter based products and reviews the development of drug device combination products including pre-clinical testing and sterilisation

Book Description :

As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications. Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications. Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives

Book Description :

Bioresorbable materials are extensively used for a wide range of biomedical applications from drug delivery to fracture fixation, and may remain in the body for weeks, months or even years. Accurately predicting and evaluating the degradation rate of these materials is critical to their performance and the controlled release of bioactive agents. Degradation rate of bioresorbable materials provides a comprehensive review of the most important techniques in safely predicting and evaluating the degradation rate of polymer, ceramic and composite based biomaterials. Part one provides an introductory review of bioresorbable materials and the biological environment of the body. Chapters in Part two address degradation mechanisms of commonly used materials such as polymers and ceramics. This is followed by chapters on bioresorption test methods and modelling techniques in Part three. Part four discusses factors influencing bioresorbability such as sterilisation, porosity and host response. The final section reviews current clinical applications of bioresorbable materials. With its distinguished editor and multidisciplinary team of international contributors, Degradation rate of bioresorbable materials: prediction and evaluation provides a unique and valuable reference for biomaterials scientists, engineers and students as well as the medical community. Comprehensively reviews the most pertinent techniques in safely predicting and evaluating the degradation rate of bioresorbable materials Addresses degradation mechanisms of commonly used materials Discusses factors influencing bioresorbability such as sterilisation and host response

Book Description :

This book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it.

Book Description :

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Book Description :

This textbook provides an overview on current cell culture techniques, conditions, and applications specifically focusing on human cell culture. This book is based on lectures, seminars and practical courses in stem cells, tissue engineering, regenerative medicine and 3D cell culture held at the University of Natural Resources and Life Sciences Vienna BOKU and the Gottfried Wilhelm Leibniz University Hannover, complemented by contributions from international experts, and therefore delivers in a compact and clear way important theoretical, as well as practical knowledge to advanced graduate students on cell culture techniques and the current status of research. The book is written for Master students and PhD candidates in biotechnology, tissue engineering and biomedicine working with mammalian, and specifically human cells. It will be of interest to doctoral colleges, Master- and PhD programs teaching courses in this area of research.

Book Description :

The third edition of a bestseller, this comprehensive reference presents the latest polymer developments and most up-to-date applications of polymeric biomaterials in medicine. Expanded into two volumes, the first volume covers the structure and properties of synthetic and natural polymers as well as bioresorbable hybrid membranes, drug delivery systems, cell bioassay systems, and electrospinning for regenerative medicine. This substantially larger resource includes state-of-the-art research and successful breakthroughs in applications that have occurred in the last ten years.

Book Description :

Applications of Polyurethanes in Medical Devices provides detailed coverage of polyurethane (PU) chemistry, processing and preparation for performant medical devices. Polyurethanes have found many uses in medical applications, due to their biocompatibility, biostability, physical properties, surface polarity, and the ability to suit the field of application. This book enables the reader to understand polyurethane and how this valuable material can be used in medical devices. Sections cover the chemistry, structure, and properties of polyurethane, with in-depth sections examining raw materials, reaction chemistry, synthesis techniques, reaction kinetics, material microstructure, and structure-property relationships. Subsequent chapters demonstrate how polyurethane can be utilized in medical device applications, examining biological properties, rheology and processing before methodical coverage explains how polyurethane may be used for each category of medical device. Finally, future directions, and safety and environmental aspects, are covered. Bridges the gap between polyurethane chemistry, processing and preparation for cutting-edge medical device applications Includes in-depth coverage of polyurethane, covering raw materials, chemistry, synthesis techniques, reaction kinetics, properties and microstructural analysis Takes a valuable and practical approach, addressing manufacturing issues and using testing and modeling to solve problems encountered in processing

Book Description :

Plastics in Medical Devices for Cardiovascular Applications enables designers of new cardiovascular medical devices to make decisions about the kind of plastics that can go into the manufacture of their device by explaining the property requirements of various applications in this area, including artificial valves, lead insulation, balloons, vascular grafts, and more. Enables designers to improve device performance and remain compliant with regulations by selecting the best material for each application Presents a range of applications, including artificial valves, stents, and vascular grafts Explains which materials can be used for each application, and why each is appropriate, thus assisting in the design of better tools and processes