Chapter category: BioMaterials
Standards and Guidelines for Biocompatibility of Medical Devices
Biomaterials in the Design and Reliability of Medical Devices
Edited by: Michael N. HelmusISBN: 0-306-47690-8
» Get more information about this book at landesbioscience.com «
Chapter authors:
Sharon J. Northup
Strategic management—the formulation, implementation and achievement of objec tives—is essential to establishing the biocompatibility of a new medical device. The harmonization of global requirements for regulated health care products requires even more attention to regulatory strategy. This Chapter will provide an overview of the product registration requirements, standards and guidelines for biocompatibility testing, chemical characterization, and risk assessment processes that are commonly used to evaluate the safety of medical devices. It will also integrate the information derived with contemporary recommendations for assessing the potential hazards and health risks to the patient from exposure to medical devices. The biocompatibility of medical devices has come under increasing scrutiny with the more widespread recognition that biomaterials may release substances harmful to the patient. Recent issues relating to adverse effects of the silicone gel-filled mammary implant, temporomandibular joint implants, and latex gloves have raised concerns about the sufficiency of preclinical testing. These concerns include not only the materials used to fabricate the medical device but also the durability, biocompatibility and toxicology of the materials that may be implanted for the remainder of the patient’s lifetime. The magnitude of these concerns is illustrated by realizing more than 11 million Americans have an implant of some type and that implants are being placed in younger patients for longer periods of time. The use of nonimplanted medical devices is significantly higher.
Additional chapters from this book:
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
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The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
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The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Tissue Engineering Constructs and Commercialization
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Product Development in a Small Company Environment
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Failure Analysis: Learning for the Future from the Past
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One of the most important tasks a medical device manufacturer can make is to have a detailed methodology in place for explant analysis. The ability to examine the device for both adverse biological ...
Nonclinical Medical Device Testing
Sharon J. Northup
The goal of nonclinical evaluation is to obtain data from in vitro or in vivo studies that will support the safety and efficacy of a medical device. Medical devices are defined as “...any instrument...
Regulation of Medical Devices
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The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States. As depicted in Figure 3.1, there are a variety of possible paths that a medical device manufactur...
Standards and Guidelines for Biocompatibility of Medical Devices
Sharon J. Northup
Strategic management—the formulation, implementation and achievement of objec tives—is essential to establishing the biocompatibility of a new medical device. The harmonization of global requirement...
Overview and Introduction:Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
Michael N. Helmus
Biomaterials include a broad range of materials that must meet stringent and diverse requirements to be acceptable for use in the body and to meet the needs of specific devices. Biomaterials can be ...
