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|a 2021936109
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|a 9781260456967 (e-ISBN)
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|z (OCoLC)1233165170
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|2 23
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|a Hazelwood, Vikki,
|e author.
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| 245 |
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0 |
|a Foundations and Strategies for Medical Device Design /
|c Vikki Hazelwood.
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| 250 |
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|a First edition.
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| 264 |
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1 |
|a New York, N.Y. :
|b McGraw-Hill Education,
|c [2021]
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| 264 |
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4 |
|c ?2021
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| 300 |
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|a 1 online resource (241 pages) :
|b illustrations.
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| 336 |
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|a text
|2 rdacontent
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| 337 |
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|a computer
|2 rdamedia
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| 338 |
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|a online resource
|2 rdacarrier
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| 504 |
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|a Includes bibliographical references and index.
|
| 505 |
0 |
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|a 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.
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| 530 |
|
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|a Also available in print edition.
|
| 533 |
|
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|a Electronic reproduction.
|b New York, N.Y. :
|c McGraw Hill,
|d 2021.
|n Mode of access: World Wide Web.
|n System requirements: Web browser.
|n Access may be restricted to users at subscribing institutions.
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| 538 |
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|a Mode of access: Internet via World Wide Web.
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| 546 |
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|a In English.
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| 588 |
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|a Description based on e-Publication PDF.
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| 650 |
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0 |
|a Medical instruments and apparatus
|x Design and construction.
|
| 655 |
|
0 |
|a Electronic books.
|
| 776 |
0 |
8 |
|i Print version:
|t Foundations and Strategies for Medical Device Design.
|b First Edition.
|d New York, N.Y. : McGraw-Hill Education, 2021
|z 9781260456950
|
| 856 |
4 |
0 |
|u https://accessengineeringlibrary.uam.elogim.com/content/book/9781260456950
|z Texto completo
|
