Polymers In Disposable Medical Devices

The design and development of tissue-engineered products has benefited from many years of clinical utilization of a wide range of biodegradable polymers. Newly developed biodegradable polymers and modifications of previously developed biodegradable polymers have enhanced the tools available for creating clinically important tissue-engineering applications. Insights gained from studies of cell-matrix interactions, cell-cell signaling, and organization of cellular components, are placing increased demands on medical implants to interact with the patient’s tissue in a more biologically appropriate fashion. Whereas in the twentieth century biocompatibility was largely equated with eliciting no harmful response, the biomaterials of the twenty first century will have to elicit tissue responses that support healing or regeneration of the patient’s own tissue. This chapter surveys the universe of those biodegradable polymers that may be useful in the development of medical implants and tissue-engineered products. Here, we distinguish between biologically derived polymers and synthetic polymers. The materials are described in terms of their chemical composition, breakdown products, mechanism of breakdown, mechanical properties, and clinical limitations. Also discussed are product design considerations in processing of biomaterials into a final form (e.g., gel, membrane, matrix) that will effect the desired tissue response.

Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. Comprehensive coverage of uses of polymers for medical devices. Unique coverage of medical device regulatory aspects, supplier control and process validation. Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices.

The use of polymers in medical devices is growing at a steady rate. These materials are generally relatively cheap and versatile, qualities required in many bulk applications. In more specialised medical devices, polymeric components have been developed to meet challenging property and performance requirements. This review describes the process of developing polymeric products for medical applications from design requirements through to specific examples of medical devices and packaging. An additional indexed section containing several hundred abstracts from the Rapra Polymer Library database gives useful references for further reading.

Poly(vinyl chloride) (PVC) is the most widely used polymer in today's healthcare market. It is still the polymer of choice for single use presterilised medical devices after more than 50 years of service and it continues to dominate in cost-performance terms. This book will prove to be a mine of useful and practical information for healthcare professionals, medical device manufacturers and medical polymer producers.

Silicone materials have been widely used in medicine for over 60 years. Available in a variety of material types, they have unique chemical and physical properties that manifest in excellent biocompatibility and biodurability for many applications. Silicone elastomers have remarkably low glass-transition temperatures and maintain their flexibility over a wide temperature range, enabling them to withstand conditions from cold storage to steam autoclaving. They have high permeability to gases and many drugs, advantageous respectively in wound care or in transdermal drug delivery. They have low surface tension and remarkable chemical stability, enabling biocompatibility and biodurability in many long-term implant applications.

Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance is a comprehensive guide to plastic materials for medical devices, covering fundamentals, materials, applications and regulatory requirements. Sections cover the role of plastics in medical devices, socioeconomic factors, the classification of medical devices. The performance of, medical grades and suppliers of polymer materials, which are categorized by performance level are also explored, along with manufacturing processes for device components, including extrusion, casting, injection molding and assembly processes. The book then covers applications in detail, examining each device and the role that polymers and plastics play in its construction and function. This is an essential resource for engineers, R&D, and other professionals working on plastics for medical devices and those in the plastics industry, medical device manufacturing, pharmaceuticals, packaging and biotechnology. In an academic setting, this book is of interest to researchers and advanced students in medical plastics, plastics engineering, polymer science, mechanical engineering, chemical engineering, biomedical engineering and materials science. Offers systematic coverage of the major classes of polymers used in medical devices, including properties, characteristics, performance, medical grades and suppliers Reviews regulatory requirements of the FDA and other global agencies, as well as considering quality control and socioeconomic factors Includes the latest advances in plastics for medical devices, such as novel applications, use of bio-based polymers, and processing of reusable medical devices

This chapter will present a look at the medical device market with a particular focus on the materials of construction of devices and what we can expect in new products looking ahead. A deeper look at some other trends that have an effect on the direction of the medical device industry will be done. Finally, consideration will be given to a number of global factors that can have dramatic effects on our industry.