Medical device reliability and associated areas. (©2000)

• Record Type: Book
• Further Information: Note: B.S. Dhillon.
• Other Names: Dhillon, B. S (Balbir S.), 1947-
• 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
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2000
• Copyright Date: 2000
• Extent: 1 online resource (240 pages), illustrations
• Subjects: 610/.28; Medical instruments and apparatus -- Standards; Biomedical engineering; Reliability (Engineering); Equipment and Supplies -- standards; Biomedical Engineering; Equipment Failure; Equipment Safety -- standards; Equipment and supplies -- Standards; Equipment Safety -- Standards; Equipment failure; TECHNOLOGY & ENGINEERING -- Biomedical; MEDICAL -- Family & General Practice; MEDICAL -- Allied Health Services -- Medical Technology; MEDICAL -- Biotechnology; MEDICAL -- Lasers in Medicine; Biomedical engineering; Medical instruments and apparatus -- Standards; Reliability (Engineering); Electronic books
• Languages: English
• ISBNs: 0849303125; 9780849303128; 9781420042238; 1420042238
• Notes: Note: "Bibliography: Literature on Medical Device Reliability and Associated Areas": pages 219-236.; Note: Includes bibliographical references and index.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.