Medical Device Reliability and Associated Areas

Abstract

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