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Foundations and Strategies for Medical Device Design
Author
Title
Foundations and Strategies for Medical Device Design / Vikki Hazelwood.
ISBN
9781260456967 (e-ISBN)
126045696X (e-ISBN)
9781260456950 (print-ISBN)
1260456951 (print-ISBN)
Edition
First edition.
Publication
New York, N.Y. : McGraw-Hill Education, [2021]
Copyright Notice Date
?2021
Physical Description
1 online resource (241 pages) : illustrations.
Local Notes
Access is available to the Yale community.
Notes
Electronic reproduction. New York, N.Y. : McGraw Hill, 2021. Mode of access: World Wide Web. System requirements: Web browser. Access may be restricted to users at subscribing institutions.
In English.
Description based on e-Publication PDF.
Access and use
Access restricted by licensing agreement.
Variant and related titles
McGraw-Hill's AccessEngineering.
Other formats
Also available in print edition.
Print version: Foundations and Strategies for Medical Device Design. First Edition. New York, N.Y. : McGraw-Hill Education, 2021
Format
Books / Online
Language
English
Added to Catalog
October 15, 2021
Bibliography
Includes bibliographical references and index.
Contents
Cover
Title Page
Copyright Page
Dedication
About the Author
Contents
Acknowledgments
Message to Students
Message to Instructors
CHAPTER 1 Just 100 Years Ago
Learning Objectives
New Terms
If You Were Born Just 100 Years Sooner
How Things Have Changed
Summary
Study Questions
Thought Questions
References
CHAPTER 2 President Eisenhower?s Heart Attack
Learning Objectives
New Terms
September 1955
Electrocardiogram (ECG)
Oxygen Tent
Oxygen Therapy
A Half Century after the President?s Heart Attack
Foundations for Medical Device Advancement
Ike: Resilience Thanks to Biomedical Engineering
Summary
Study Questions
Thought Questions
References
CHAPTER 3 Events That Built Our Key Regulations and Practices
Learning Objectives
New Terms
Food and Drug Administration and the Food, Drug, and Cosmetic Act of 1938
Early Good Manufacturing Practices and the National Institutes of Health
Elixir of Sulfanilamide
Current Good Manufacturing Practices and FDA 21 CFR Part 820
Medical Device Amendments Act of 1976
Safe Medical Devices Act of 1990 and Design Controls
International Standards Organization (ISO) 13485
Summary
Study Questions
Thought Questions
References
CHAPTER 4 Thalidomide
Learning Objectives
New Terms
Thalidomide Tragedy
The Power of One FDA Reviewer
Animal Models and Pregnancy
Kefauver-Harris Drug Amendments Act of 1962
Advancing Animal Models
Summary
Study Questions
Thought Questions
References
CHAPTER 5 The Dalkon Shield
Learning Objectives
New Terms
Preamendment Status
Dalkon Shield
Medical Devices Amendments of 1976
Summary
Study Questions
Thought Questions
References
CHAPTER 6 Understanding Today?s Food and Drug Administration
Learning Objectives
New Terms
FDA Mission
Cost and Time to Market
FDA Structure
Summary
Study Questions
Thought Questions
References
CHAPTER 7 Preparing a Regulatory Strategy
Learning Objectives
New Terms
FDA?s Rationale for Medical Device Classification
Determining Your Regulatory Strategy
Advanced (But Important to Know About) Strategies
Summary
Study Questions
Thought Questions
References
CHAPTER 8 Foundations of Clinical and Preclinical Research
Learning Objectives
New Terms
Living Subjects Research
Animal Research Strategies
Clinical Trials
Summary
Study Questions
Thought Questions
References
CHAPTER 9 Clinical Study Strategies
Learning Objectives
New Terms
Impact of Clinical Study on Design Planning
Reasons for Clinical Testing
Summary
Study Questions
Thought Questions
References
CHAPTER 10 Kyphon and Reimbursement
Learning Objectives
New Terms
The Lawsuit Involving Kyphon, Inc.
What Is Reimbursement?
Summary
Study Questions
Thought Questions
References
CHAPTER 11 Navigating Codes for Reimbursement
Learning Objectives
New Terms
Current Procedural Terminology Codes
International Classification of Diseases Codes
Diagnosis-Related Groups
Healthcare Common Procedure Coding System and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
Summary
Study Questions
Thought Questions
References
CHAPTER 12 Device-Associated Infections
Learning Objectives
New Terms
Nosocomial Infection (aka HAI)
Biofilms and Implant Failure
Surface Treatment to Prevent Infection
Summary
Study Questions
Thought Questions
References
CHAPTER 13 Designing for Postmarket Safety
Learning Objectives
New Terms
Long-Range Data Come Only After a Product Is on the Market
Medical Device Reclassification
Summary
Study Questions
Thought Questions
References
CHAPTER 14 Designing for Biocompatibility and Infection Prevention
Learning Objectives
New Terms
Biocompatibility
Cleaning, Disinfection, and Sterilization
Summary
Study Questions
Thought Questions
References
CHAPTER 15 Designing for the Use Case
Learning Objectives
New Terms
Equipment Management in the Clinic
Patient Adherence
Summary
Study Questions
Thought Questions
References
CHAPTER 16 The Landscape for Medical Devices in the Twenty-First Century
Learning Objectives
New Terms
Goals for Improving Outcomes
Increased Regulation
Internet of Medical Things
Heart Surgery
Data
Pandemic/Summary
Study Questions
Thought Questions
References
Index.
Genre/Form
Electronic books.
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