Medical Device Reliability and Associated Areas

Medical Device Reliability and Associated Areas

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ISBN 9780849303128
Cat# 0312
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Features

  • Provides the most up-to-date and comprehensive treatment of medical device reliability
  • Covers trends such as human error and medical device software quality assurance and reliability
  • Addresses medical device risk assessment, control, and safety assurance
  • Offers over 50 figures and tables, 120 problems, and 47 solved examples for quick understanding of the material
  • Lists a thorough account of references for further, in-depth study
  • Summary

    Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques.

    Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.

    Table of Contents

    INTRODUCTION
    Historical Developments
    Need of Reliability in Medical Devices
    Medical Device Related Facts and Figures
    Government control and Liability
    Medical Device Recalls
    Medical Equipment Classification
    Medical Device Reliability Associated Areas
    Terms and Definitions
    BASIC RELIABILITY MATHEMATICS AND CONCEPTS FOR MEDICAL DEVICES
    Basic Law of Boolean Algebra and Probability
    Probability Distributions for Time to Failure
    Basic Reliability Related Definitions
    Reliability Configurations
    Aerospace and Medical Equipment Reliability Comparisons
    Guidelines for reliability Professional Working in Health Care
    TOOLS FOR MEDICAL DEVICE RELIABILITY ASSURANCE
    Failure Mode and Effect analysis (FMEA)
    Fault Tree Analysis (FTA)
    Failure Rate Evaluation and Parts Count Methods
    Markov Method
    Common-Cause Failure Analysis Method
    HUMAN ERROR IN HEALTH CARE SYSTEMS
    Facts, Figures, and Example on Human Error in Health Care Systems
    Causes of Patient Injuries and Medical Device Accident Classification
    Medical Devices with High Occurrence of Human Error
    Anesthesia Related most Frequent Incidents, Associated Factors, and Medical Device Related Operator Errors
    General Approach to Human Factors in Medical Device Development Process to Reduce Human Errors
    Human Error Related Analysis Methods useful for the Health Care Systems
    Reducing Medical Device/Equipment User Interface Related Errors
    MEDICAL DEVICE SOFTWARE QUALITY ASSURANCE AND RELIABILITY
    Software Terms and Definitions
    Hardware versus Software and Example of Software Failures in Medical Devices
    Medical Software Classifications and Specification
    Framework to Define Software Quality Assurance Program in a Medical Device Company
    Software Reliability Assurance Program for the Cardioplegia Delivery System and Important Software Issues in the Safety of Cardiac-Rhythm-Management Products
    Software Design, Coding, Testing, and Metrics
    Software Reliability Modeling for Medical Devices
    MEDICAL DEVICE SAFETY ASSURANCE
    Medical Device Safety versus Reliability
    Types of Medical Device Safety and Medical Device Hardware and Software Safety
    Essential Safety Requirements for Medical Devices and Legal Aspects of Device Safety
    Safety in Device Life Cycle
    Safety Analysis Methods
    Accident Probability Estimation of a Medical Device
    Safety Cost Estimation Methods and Models
    MEDICAL DEVICE RISK ASSESSMENT AND CONTROL
    Risk Management, Definitions, and Program Steps
    Risk Assessment
    Medical Device Risk Assessment
    Integrating Risk Assessment with Medical Device Design Control
    Factors Affecting the Values of Consequences and Medical Device Risk Assessment Related Data
    MEDICAL DEVICE QUALITY ASSURANCE
    Terms and Definitions
    Regulatory Compliance of Medical Device Quality Assurance
    Medical Device Design Quality Assurance Program
    Total Quality Management
    Tools for Assuring Medical Device Quality
    Quality Indices
    MEDICAL DEVICE RELIABILITY TESTING
    Test Plan Information and Test Types
    Classifications of Reliability Tests
    Accelerated Testing
    Success Testing
    Mean Time between Failures (MTBF) Calculation Methods in Reliability Testing
    Confidence Limits of Medical Device MBF
    Important Publications on Reliability Testing
    MEDICAL DEVICE COSTING
    Reason for Medical Device Costing and Medical Device Development Economic Analysis Factors
    Methods for Making Medical Device Investment Decisions
    Formulas for Determining the Time Value of Money
    Useful Cost Estimation Models for Medical Devices
    Life Cycle Costing
    MEDICAL DEVICE MAINTENANCE AND MAINTAINABILITY
    Terms and Definitions
    Medical Equipment Classification and Indices for Repair and Maintenance
    Computerized Maintenance Management System for Medical Equipment and Devices and its Selection
    Ventilator Maintenance and Field Performance
    Models for medical Equipment Maintenance
    Maintainability
    Maintainability Measures
    RELIABILITY RELATED STANDARDS, FAILURE DATA SOURCES, AND FAILURE DATA AND ANALYSIS FOR MEDICAL DEVICE
    What is a Standard?
    Organizations Involved with the Development of Medical Device Standards and other Documents
    Names and Addresses Directly or Indirectly Involved with Standard/Other Documents for Medical Devices
    Failure Data and Data Sources
    Failure Data Analysis
    Appendix
    Each chapter also contain problems and references

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