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Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.
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
This updated sterilisation manual informs health workers about the simple protocols and procedures that have been developed to prevent hospital-acquired infections both inside and outside the sterilisation plant. The guidelines included in this manual show the steps to follow in cleaning, preparing, sterilizing, storing and transporting hospital equipment so as to obtain sterile material. It is very important to be aware of this information in order to provide patients with safe health care.
The Effect of Sterilization Methods on Plastics and Elastomers, Fourth Edition brings together a wide range of essential data on the sterilization of plastics and elastomers, thus enabling engineers to make optimal material choices and design decisions. The data tables in this book enable engineers and scientists to select the right materials and sterilization method for a given product or application. The book is a unique and essential reference for anybody working with plastic materials that are likely to be exposed to sterilization methods, be it in medical device or packaging development, food packaging or other applications. - Presents essential data and practical guidance for engineers and scientists working with plastics in applications that require sterile packaging and equipment - Updated edition removes obsolete data, updates manufacturers, verifies data accuracy, and adds new plastics materials for comparison - Provides essential information and guidance for FDA submissions required for new medical devices
The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.
Protecting the health and safety of health care workers is vital to the health of each of us. Preparing for and responding to a future influenza pandemic or to a sustained outbreak of an airborne transmissible disease requires a high-level commitment to respiratory protection for health care workers across the wide range of settings in which they work and the jobs that they perform. Keeping health care workers healthy is an ethical commitment both in terms of addressing the occupational risks faced by health care workers and of providing for the continuity of patient care and services needed to maintain the health of individuals and communities. During a public health emergency, challenges will arise concerning the availability of respiratory protective devices (i.e., respirators). Reusable respirators (specifically, reusable half-facepiece elastomeric respirators) are the standard respiratory protection device used in many industries, and they provide an option for use in health care that has to date not been fully explored. The durability and reusability of elastomeric respirators make them desirable for stockpiling for emergencies, where the need for large volumes of respirators can be anticipated. However, they are used infrequently in health care. Reusable Elastomeric Respirators in Health Care explores the potential for the use of elastomeric respirators in the U.S. health care system with a focus on the economic, policy, and implementation challenges and opportunities. This report examines the practicability of elastomeric use in health care on a routine basis and during an influenza pandemic or other large aerosol-transmissible outbreak, when demand for respiratory protective devices by U.S. health care personnel may be larger than domestic supplies. The report also addresses the issues regarding emergency stockpile management of elastomeric respiratory protective devices.
The concept of focal controlled drug delivery has been applied for treating illnesses that are localized to a certain tissue or organ. These delivery systems are applied directly to the diseased site and deliver a desired dose for an extended time period while minimizing systemic distribution of toxic drug. Controlled drug delivery systems have been focused on oral extended release formulations and on systemic delivery of small drugs and peptides. Despite the upsurge of interest in focal targeted drug delivery, there is currently no single reference text on the subject. By comparison, there are numerous authored and edited books on oral, systemic and transdermal drug delivery or books on biodegradable polymers as drug carriers. Thus, the aim of Focal Drug Delivery is to bring together leading experts and researchers in the field to provide an authoritative account of the essential pharmaceutical, technological, physiological and biological sciences underpinning the topic. In addition, the book will review advances in treatment options for diseases localized at a certain tissue or organ.
The WHO Guidelines on Hand Hygiene in Health Care provide health-care workers (HCWs), hospital administrators and health authorities with a thorough review of evidence on hand hygiene in health care and specific recommendations to improve practices and reduce transmission of pathogenic microorganisms to patients and HCWs. The present Guidelines are intended to be implemented in any situation in which health care is delivered either to a patient or to a specific group in a population. Therefore, this concept applies to all settings where health care is permanently or occasionally performed, such as home care by birth attendants. Definitions of health-care settings are proposed in Appendix 1. These Guidelines and the associated WHO Multimodal Hand Hygiene Improvement Strategy and an Implementation Toolkit (http://www.who.int/gpsc/en/) are designed to offer health-care facilities in Member States a conceptual framework and practical tools for the application of recommendations in practice at the bedside. While ensuring consistency with the Guidelines recommendations, individual adaptation according to local regulations, settings, needs, and resources is desirable. This extensive review includes in one document sufficient technical information to support training materials and help plan implementation strategies. The document comprises six parts.
The ways of sterilisation begin as far back as biblical and roman times, from early beginnings to standardization. Sterilisation evolution has gone through a series of trials and wizardry before it achieved the status of science. And even with a scientific approach, some of its modalities frequently has been referred to as an art (an imaginary focus), while most have achieved a certain scientific standardization. This book provides a drawbridge between history, terminology, environmental and fundamentals of sterilisation that beginners to sterilisation should recognize, but continues with advancements, which supervisors and managers should know and apply. So while providing historical and current sterilisation information, the book also provides interfacial areas with design practices, development, environmental control, material compatibility, microbiology, packaging, process selection, statistics, technical information and validation. This book consists of two volumes (Healthcare Sterilisation, Introduction and Standard Practices: Volume 1, and Healthcare Sterilisation, Challenging Practices: Volume 2). Volume 1 provides an introduction, and an overview of sterilisation on early and classical sterilisation principles such as absolutism and overkill, and steadfast and standard methods. It will help answer some healthcare sterilisation queries such as: what are the origins and evolution of sterilisation? How does environmental control and microbiology affect sterilisation? What are some of the classical as well as standard sterilisation methods? What are the most consistent and reliable sterilisation methods? Is sterilisation in your future? An ounce of prevention is worth a pound of cure. Without sterilisation, infectious disease and contamination would run rampant. Consequently, sterilisation has tremendous value and disease control, and this book provides a three dimensional view of it.
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