Dhillon Medical Device Reliability and Associated Areas

Erscheinungsjahr 2002
ISBN: 978-1-4200-4223-8
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 264 Seiten

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.

Autoren/Hrsg.

Dhillon, B.S.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen

Inhaltsverzeichnis

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