| Description |
1 online resource (241 pages) : illustrations |
| 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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
In English |
|
E-Publication PDF |
| Subject |
Medical instruments and apparatus -- Design and construction
|
|
Medical instruments and apparatus -- Design and construction.
|
| Form |
Electronic book
|
| ISBN |
9781260456967 |
|
126045696X |
|
