Table of Contents

Introduction
Need for Reliability Technology, Human Error Studies, and Quality in Health Care
History
Facts and Figures
Terms and Definitions
Useful Information on Reliability Technology, Human Error, and Quality in Health Care
Problems
References

Basic Mathematical Concepts

Introduction
Range, Arithmetic Mean, and Standard Deviation
Boolean Algebra Laws and Probability Properties
Basic Probability-Related Definitions
Probability Distributions
Laplace Transform Definition, Common Laplace Transforms, Final-Value Theorem, and Laplace Transforms’ Application in Solving First-Order Differential Equations
Introduction to Reliability Technology, Human Error, and Quality
Introduction
Bathtub Hazard ate Curve
Commonly Used Formulas in Reliability Analysis
Reliability Configurations
Reliability Analysis Methods
Human Error Facts, Figures, and Causes
Human Error Classifications
Human Error Analysis Methods
Human Error Data Sources
Factors Affecting Product Quality and Services
Quality Assurance System Tasks
Total Quality Management versus Traditional Quality Assurance
TQM lements and Obstacles to TQM Implementation

Medical Device Safety and Quality Assurance

Introduction
Medical Device Safety versus Reliability and Types of Medical Device Safety
Medical Device-Related Safety Requirements and Safety in Device Life Cycle
Safety Analysis Tools for Medical Devices and Considerations for Selecting Safety Analysis Methods
Regulatory Compliance of Medical Device Quality Assurance and Program for Assuring Medical Device Design Quality
Methods for Medical Device Quality Assurance
Medical Device Software Quality Assurance and Risk Assessment
Introduction
Medical Device Software Failure Examples
Classifications of Medical Software
Framework for Defining Software Quality Assurance Programs in Medical Device Manufacturing Organizations
Software Design, oding, nd Testing
Software Metrics
Risk Management Definition and Program Steps
Factors in Medical Device Risk Assessment
Integrating Risk Assessment into Medical Device Design Control
Medical Device Risk Assessment-Related Data
Problems
References
Medical Device Maintenance and Sources for Obtaining Medical Device-Related Failure Data
Introduction
Medical Equipment Classifications
Medical Equipment Maintenance Indexes
Medical Equipment Computerized Maintenance Management Systems
Mathematical Models for Medical Equipment Maintenance
Medical Device-Related Failure Data Sources
Organizations for Obtaining Medical Device-Related Failure Data
Medical Device Failure-Related Data 6.9 Problems

Human Error in Health Care

Introduction
Human Error in Health Care-Related Facts, igures, nd Examples
Human Error in Medication
Human Error in Anesthesia
Human Error in Medical Devices
Human Error in Miscellaneous Health Care Areas
Useful Guidelines to Prevent Occurrence of Human Error in Health Care
Problems
References
Health Care Human Error Reporting Systems and Models for Predicting Human Reliability and Error in Health Care
Introduction
Key Points Associated with Current Event Reporting Systems and Methods Practiced in Such Systems
Health Care Human Error Reporting Systems
Medical and General Human Error-Related Data
Model I: Human Reliability in Normal Work Environment
Model Ii: Human Reliability in Fluctuating Work Environment
Model III: Human Reliability with Critical and Non-Critical Human Errors in Normal Work Environment
Problems

Patient Safety

Introduction
Facts and Figures
Patient Safety Goals
Patient Safety Culture and Its Assessment
Patient Safety Program
Patient Safety Measure Selection and Patient Safety Measures and Analysis Methods
Patient Safety Organizations

Introduction to Quality in Health Care

Introduction
Reasons for Escalating Health Care Costs and Quality Dimensions of Today ’s Health Care Business
Health Care Quality Goals and Their Associated Strategies
Health Care and Industrial Quality Comparisons and Quality Improvement versus Quality Assurance in Health Care Institutions
Common Health Care Administrators’ Appeals for Total Quality and Physicians ’ Reactions
Steps for Improving Quality in Health Care
Implementation of Six Sigma Methodology in Hospitals and Its Advantages and Implementation Barriers
Quality Indicators for Use in Hospital Departments

Quality Methods for Use in Health Care

Introduction
Group Brainstorming
Cause-and-Effect Diagram 11.4 Quality Function Deployment
Process Flow Diagram
Affinity Diagram
Check Sheet
Force Field Analysis
Multivoting
Pareto Chart
Scatter Diagram
Control Chart
Problems
References
Bibliography Index