| Tag |
First Indicator |
Second Indicator |
Subfields |
| LEADER |
00000nam a2200000 i 4500 |
| 001 |
in00005504321 |
| 006 |
m o d |
| 007 |
cr |n||||||||n |
| 008 |
210921s2021||||nyu|||||o|||||||||||eng|| |
| 005 |
20241008175913.5 |
| 010 |
|
|
|a 2021936109
|
| 020 |
|
|
|a 9781260456967 (e-ISBN)
|
| 020 |
|
|
|a 126045696X (e-ISBN)
|
| 020 |
|
|
|a 9781260456950 (print-ISBN)
|
| 020 |
|
|
|a 1260456951 (print-ISBN)
|
| 035 |
|
|
|z (OCoLC)1233165170
|
| 035 |
|
|
|a (IN-ChSCO)ACE21092102
|
| 040 |
|
|
|a IN-ChSCO
|b eng
|e rda
|
| 041 |
0 |
|
|a eng
|
| 050 |
|
4 |
|a R856
|
| 072 |
|
7 |
|a TEC
|x 009070
|2 bisacsh
|
| 082 |
0 |
4 |
|a 610.28/4
|2 23
|
| 100 |
1 |
|
|a Hazelwood, Vikki,
|e author.
|
| 245 |
1 |
0 |
|a Foundations and Strategies for Medical Device Design /
|c Vikki Hazelwood.
|
| 250 |
|
|
|a First edition.
|
| 264 |
|
1 |
|a New York, N.Y. :
|b McGraw-Hill Education,
|c [2021]
|
| 264 |
|
4 |
|c 2021
|
| 300 |
|
|
|a 1 online resource (241 pages) :
|b illustrations.
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a computer
|b c
|2 rdamedia
|
| 338 |
|
|
|a online resource
|b cr
|2 rdacarrier
|
| 504 |
|
|
|a Includes bibliographical references and index.
|
| 505 |
0 |
|
|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, Incorporated -- 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.
|
| 530 |
|
|
|a Also available in print edition.
|
| 533 |
|
|
|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.
|
| 538 |
|
|
|a Mode of access: Internet via World Wide Web.
|
| 546 |
|
|
|a In English.
|
| 588 |
|
|
|a Description based on e-Publication PDF.
|
| 650 |
|
0 |
|a Medical instruments and apparatus
|x Design and construction.
|
| 655 |
|
7 |
|a Electronic books.
|2 local
|
| 710 |
2 |
|
|a McGraw-Hill Companies.
|
| 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 http://proxy.library.tamu.edu/login?url=https://www.accessengineeringlibrary.com/content/book/9781260456950
|z Connect to the full text of this electronic book
|t 0
|
| 949 |
|
|
|a R 856
|w LC
|c 1
|i 210921-1001
|d 09/21/2021
|l MAIN
|m MGH
|q 1
|r Y
|s YWEB
|u 09/21/2021
|x ENG
|
| 999 |
f |
f |
|s 06bc1ada-9d8c-4615-aaf1-8d1ce1e5403d
|i fc86366b-6d7a-4c12-bbd8-8a63ec47f808
|t 0
|
| 952 |
f |
f |
|a Texas A&M University
|b College Station
|c Electronic Resources
|d Available Online
|t 0
|e R856
|h Library of Congress classification
|
| 998 |
f |
f |
|a R856
|t 0
|l Available Online
|