Medical Device Reliability and Associated Areas / Edition 1

Hardcover (Print)
Buy New
Buy New from BN.com
$164.95
Used and New from Other Sellers
Used and New from Other Sellers
from $139.42
Usually ships in 1-2 business days
(Save 30%)
Other sellers (Hardcover)
  • All (7) from $139.42   
  • New (4) from $171.41   
  • Used (3) from $139.42   

Overview

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.

Read More Show Less

Editorial Reviews

Booknews
Noting that the great number of books on reliability in general do not afford much coverage to medical devices, Dhillon (mechanical engineering, U. of Ottawa) summarizes current developments and offers tools and techniques to professionals working in the medical device industry and graduate and senior undergraduate students intending to enter it. He emphasizes the structure of concepts rather than mathematical rigor and minute details and includes examples, solutions, and chapter-end problems so readers can test their comprehension. Annotation c. Book News, Inc., Portland, OR (booknews.com)
Read More Show Less

Product Details

  • ISBN-13: 9780849303128
  • Publisher: CRC Press
  • Publication date: 3/29/2000
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 264
  • Product dimensions: 6.40 (w) x 9.50 (h) x 0.86 (d)

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

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation

Reminder:

  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

 
Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)