The application of the principles of reliability engineering to medical devices is relatively recent, and its treatment in the published literature has been quite limited. Nevertheless, it is critical that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques pertinent to the prediction, measurement, and improvement of medical device reliability.

Medical Device Reliability and Associated Areas provides this information in one volume, covering a wide range of topics related directly and indirectly to reliability, including human error in health care systems and software quality assurance. The emphasis is on concepts rather than mathematical rigor; a multitude of examples, exercises, tables, and references are included.

From the Preface: “...Today, a large number of books on general reliability have been published. Only a few discuss medical device reliability but they lack a comprehensive and current coverage of developments in the field. The main objective of this book is to cover current developments in medical device reliability and associated areas, and provide useful tools and techniques to professionals working in the medical device industry. This book fulfills a vital need and puts emphasis on the structure of concepts rather than mathermatical rigor and minute details...”

Target Audience: Specifiers; designers; biomedical, reliability, and quality engineers; research, project, and product managers; and others in the medical device industry.

Table of Contents:

Introduction

Basic Reliability Mathematics and Concepts for Medical Devices

Tools for Medical Reliability Assurance

Human Error in Health Care Systems

Medical Device Software Quality Assurance and Reliability

Medical Device Safety Assurance

Medical Device Risk Assessment and Control

Medical Device Quality Assurance

Medical Device Reliability Testing

Medical Device Costing

Medical Device Maintenance and Maintainability

Reliability-Related Standards, Failure Data Sources, and Failure Data and Analysis for Medical Devices

Bibliography

Index