Safety Evaluation of Medical Devices / Edition 1

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Overview

This practical reference examines the implications of biological and chemical interactions of medical devices with human tissue - offering comprehensive coverage on the evaluation of safety in specialty devices, medical and surgical supplies, imaging systems, in vitro diagnostics, and health information systems. Discussing preapproval and ongoing test requirements necessary for the development of new products, Safety Evaluation of Medical Devices shows how to select individual materials, components, or devices for testing and how to prepare the samples selected...explains cytotoxicity testing for the determination of biocompatibility using mammalian cell cultures...details the evaluation of hemocompatibility and the potential adverse effects of medical devices on the immune system...addresses studies for both short- and long-term implantable devices...delineates possible genotoxic effects of device materials...presents appropriate models for clinical studies of medical devices...describes specialized studies for cardiovascular prostheses, contact lenses and solutions, and tampons as well as the "mouse safety" systemic injection test...and much more.

The book contains black-and-white illustrations.

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Editorial Reviews

Jeremy L. Gilbert
This book explains the process by which one would assess the safety of materials and devices used in medicine. This includes toxicity, carcinogenicity, immunotoxicity, and a variety of other materials' safety concerns. The book is a practical guide for those involved with safety testing of medical materials and devices. It provides insight into several of the toxicology assessment protocols needed to determine whether materials are safe to use in the body. This book is for researchers, particularly those involved in industrial device manufacture. The author is well qualified in the field and presents a good practical guide. The book has limited illustrations of fair quality, and the references are somewhat dated. It does not provide much in the way of photographic assessment of toxicology effects. This book provides a practical guide to testing of safety of materials used in medical devices. It is useful to those beginning to investigate methods and techniques used to assess materials safety. It may also help in establishing appropriate protocols for biocompatibility evaluation.
From The Critics
Reviewer:Jeremy L. Gilbert, PhD (Syracuse University)
Description:This book explains the process by which one would assess the safety of materials and devices used in medicine. This includes toxicity, carcinogenicity, immunotoxicity, and a variety of other materials' safety concerns.
Purpose:The book is a practical guide for those involved with safety testing of medical materials and devices. It provides insight into several of the toxicology assessment protocols needed to determine whether materials are safe to use in the body.
Audience:This book is for researchers, particularly those involved in industrial device manufacture. The author is well qualified in the field and presents a good practical guide.
Features:The book has limited illustrations of fair quality, and the references are somewhat dated. It does not provide much in the way of photographic assessment of toxicology effects.
Assessment:This book provides a practical guide to testing of safety of materials used in medical devices. It is useful to those beginning to investigate methods and techniques used to assess materials safety. It may also help in establishing appropriate protocols for biocompatibility evaluation.
Booknews
Intended as a guide for those who are responsible for ensuring the safety of medical devices for patients and health care providers, as well as the safety of those involved in their manufacture. Discussion includes preapproval and ongoing test requirements necessary for the development of new products; how to select individual materials, components, or devices for testing; and how to prepare samples. Among the areas addressed are testing for cytotoxicity, blood compatibility, genotoxicity, carcinogenicity, and reproductive toxicity. Concluding chapters deal with special studies and case histories for items such as tampons, contact lenses, the Dalkon Shield, and cardiovascular devices and prostheses. Annotation c. by Book News, Inc., Portland, Or.
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Product Details

  • ISBN-13: 9780824798277
  • Publisher: Taylor & Francis
  • Publication date: 1/28/1997
  • Edition number: 1
  • Pages: 387

Table of Contents

Preface
1 Introduction 1
2 Road Map to Test Selections 27
3 What to Test: Sampling and Sample Preparation 65
4 Cytotoxicity Testing 75
5 Blood Compatibility 85
6 Irritation and Pyrogenicity 97
7 Immunotoxicology 131
8 Implantation Studies 189
9 Genotoxicity 209
10 Subchronic and Chronic Toxicity 259
11 Carcinogenicity and Reproductive and Developmental Toxicity 271
12 Sterility, Sterilization, and Heavy Metals 305
13 Clinical Studies for Medical Devices 317
14 Special Studies and Special Cases 339
15 Case Histories and Problem Resolution 363
Appendix: Selected Acronyms 381
Index 383
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