Medical Device Reliability and Associated Areas: 1st Edition (Hardback) book cover

Medical Device Reliability and Associated Areas

1st Edition

By B.S. Dhillon

CRC Press

264 pages

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pub: 2000-03-29
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Description

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

Subject Categories

BISAC Subject Codes/Headings:
BUS070080
BUSINESS & ECONOMICS / Industries / Service Industries
MED002000
MEDICAL / Administration
TEC032000
TECHNOLOGY & ENGINEERING / Quality Control
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical