Description

Clinical Engineering is intended for professionals and students in the clinical engineering field who need to successfully deploy medical technologies. The book provides a broad reference to the core elements of the subject and draws from the expertise of a range of experienced authors.

In addition to engineering skills, clinical engineers must be able to work with patients and with a range of professional staff, including technicians and clinicians, and with equipment manufacturers. They have to keep up-to-date with fast-moving scientific and medical research in the field and be able to develop laboratory, design, workshop, and management skills. This book is the ideal companion in such studies, covering fundamentals such as IT and software engineering as well as topics in rehabilitation and assistive technology.

Key Features

  • Provides engineers in core medical disciplines and related fields with the skills and knowledge to successfully collaborate to in developing medical devices to approved procedures and standards
  • Covers US and EU standards (FDA and MDD, respectively, plus related ISO requirements), the de facto international standards, and is backed up by real-life clinical examples, case studies, and separate tutorials for training and class use
  • The first comprehensive and practical guide for engineers working in a clinical environment

Readership

Medical and Biomedical Engineers, plus medical and clinical professionals, involved with medical device design, from concept through to commercialization and FDA/regulatory approval.

Table of Contents

Dedication

Acknowledgements

Preface

Foreword

List of Contributors

Part I: General

Introduction

Overview

Chapter 1. Anatomy and Physiology

Introduction

Cell Physiology

Principles of Cell Replication

Bone and Skeletal Physiology

Nerve and Muscle Physiology

Cardiac Physiology

Vascular Physiology

Pulmonary Physiology

Introduction to Blood

Thrombosis, Hemostasis, and Inflammation

Homeostasis and Regulation

Renal Physiology and Homeostasis

Nutrition, the Pancreas, and Glucose Regulation

Chapter 2. Research Methodology

Study Design

Hypothesis Generation and Testing

Application and Interpretation of Statistical Techniques

Literature Searching and Referencing

References

Further Reading

Chapter 3. Good Clinical Practice

Background

Phases of Clinical Research

Standards in Clinical Research

Good Clinical Practice

Clinical Investigations for Medical Devices

Comparing Clinical Trials and Clinical Investigations

ISO 14155 Standard

Clinical Investigation Plan

Approvals to Undertake Research

References

Further Reading

Useful Websites

Chapter 4. Health Technology Management

Introduction

The Strategic Healthcare Technology Management System

Implementing the Healthcare Technology Management Program

Summary of the Healthcare Technology Management Program

References

Chapter 5. Leadership

Introduction

Leadership and Management

Emotional Intelligence

Listening on Three Levels

Seven Habits of Effective Leaders

Examples

Conclusion

References

Chapter 6. Risk Management

Introduction

Definition

Consequences and Likelihoo

Details

No. of pages:
480
Language:
English
Copyright:
© 2014
Published:
Imprint:
Academic Press
eBook ISBN:
9780123972385
Print ISBN:
9780123969613

About the editors

Azzam Taktak

Affiliations and Expertise

Department of Medical Physics & Clinical Engineering, Royal Liverpool University Hospital, UK

Paul Ganney

Affiliations and Expertise

University College London Hospitals NHS Trust, UK

David Long

Affiliations and Expertise

Oxford Centre for Enablement, Oxford University Hospitals NHS Trust, UK

Paul White

Affiliations and Expertise

Medical Physics & Clinical Engineering, Cambridge University Hospitals NHS Foundation Trust; Post Graduate Medical Institute, Anglia Ruskin University, UK