Foundations and Strategies for Medical Device Design /

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Hazelwood, Vikki (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, N.Y. : McGraw-Hill Education, [2021]
Edición:First edition.
Temas:
Medical instruments and apparatus > Design and construction.
Electronic books.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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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