Clinical Engineering

Clinical Engineering

A Handbook for Clinical and Biomedical Engineers

1st Edition - November 12, 2013

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  • Editors: Azzam Taktak, Paul Ganney, David Long
  • eBook ISBN: 9780123972385

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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 Likelihood

    Third Dimension of Risk

    Risk Appetite

    Risk Acceptability

    Medical Devices Directives

    BS ISO 31000:2009

    AS/NZS 4360:2004

    ISO 14971:2007

    Risk Tools

    References

    Further Reading

    Chapter 7. The Role of Clinical Engineers in Hospitals

    Introduction

    Clinical Engineering as Applied Biomedical Engineering

    Clinical Engineering Activities

    Patient-Focused Engineering

    References

    Part II: Information Technology and Software Engineering

    Introduction

    Overview

    Chapter 8. Information Communications Technology

    The Regulation of Clinical Computing

    Data Security Requirements

    Data Exchange Protocols

    References

    Chapter 9. Software Engineering

    Software Development and Management

    Typical Applications

    References

    Chapter 10. Web Development

    Web Technology

    Programming

    Security

    Further Reading

    Part III: Clinical Instrumentation and Measurement

    Introduction

    Overview

    Chapter 11. Medical Electronics

    Electronic Components

    AC Signals’ Complex Ohm’s Law

    Basic Circuit Design in Instrumentation

    Filter

    Further Reading

    Chapter 12. Clinical Measurement

    Accuracy and Precision

    Measurement Device Errors

    Measurement Errors

    Calibration

    Traceability

    Uncertainty

    Sensitivity and Specificity of Measurement Technique

    Type I and Type II Errors

    Further Reading

    Chapter 13. Cardiology

    Anatomy and Physiology

    Echocardiography

    Electrocardiography

    Further Reading

    Chapter 14. Pressure and Flow

    Introduction

    Blood Pressure

    References

    Chapter 15. Neurological Measurement

    Electromyography

    Evoked Potentials

    Chapter 16. Respiratory

    Introduction

    Lung Volumes and Physiological Parameters

    Volume Conversions

    Lung Conditions

    Reference Values

    Spirometry

    Whole Body Plethysmography

    Gas Transfer

    References

    Part IV: Rehabilitation Engineering and Assistive Technology

    Introduction

    Overview

    Chapter 17. Introduction: Medical Engineering Design, Regulations, and Risk Management

    Introduction

    Medical Engineering Design

    Regulations and Risk Management

    References

    Further Reading

    Chapter 18. Functional Electrical Stimulation

    Introduction

    Defining FES

    Physiological Principles of FES

    Designing a Practical FES System

    The Desired Outcome for the Patient

    Correct Muscles and Nerves to Produce the Desired Response

    Generating the Required Muscle Response

    How to Control the Stimulated Movement for the Specific Application

    Conclusions

    References

    Further Reading

    Chapter 19. Posture Management

    Introduction

    Posture

    Effects of Gravity

    The Role of the Supporting Surface

    24-Hour Postural Management

    Biomechanics as Applied to Postural Management

    Introduction to the Physical Assessment

    Body Configuration

    Critical Measures: Joint Range of Motion and Pelvic/Trunkal Asymmetry

    Modeling a Stable and Functional Seated Posture

    Summary of the Physical Assessment Process

    Recommendations and Rationale for Posture Management

    Secondary Complications

    Summary

    References

    Chapter 20. Pressure Ulceration

    Skin and Soft Tissues

    Pressure Ulcers (PUs)

    Care Quality and Financial Implications

    Mechanical Loading at the Patient-Support Interface

    Interface Pressure Mapping

    Internal Mechanical State of Loaded Soft Tissues

    Support Surfaces and Pressure Relief Regimens

    Summary

    References

    Chapter 21. Introduction to Mobility and Wheelchair Assessment

    Introduction to Mobility

    Wheelchair Assessment Process

    References

    Chapter 22. Wheelchair Prescription

    Getting into the Details

    Custom-Contoured Seating

    Wheelchair Stability

    References

    Chapter 23. Powered Wheelchairs

    Introduction

    Wheel Layout

    Powered Adjustment to Position

    Aspects of Clinical Assessment Specific to Powered Wheelchairs

    Control Interfaces for Powered Wheelchairs

    Specialized Controls

    Powered Assistance to Manual Wheelchairs

    References

    Chapter 24. Electronic Assistive Technology

    Introduction and Assessment

    Environmental Control Systems

    Augmentative and Alternative Communication

    Access to Electronic Assistive Technology

    Integrated Systems

    Using and Adapting Mainstream Technology for Assistive Technology

    Brain–Computer Interfaces

    Disability and Smart House Technology

    Telecommunications in the Provision of Healthcare

    References

    Further Readings

    Web Resources

    Chapter 25. Clinical Gait Analysis

    Introduction

    Normal Gait

    Patient Functional Self-Assessment Questionnaires

    Clinical or Physical Examination

    Observational Gait Analysis and Video Vector

    Kinematics and Kinetics

    Electromyography

    Energy Expenditure

    Data Interpretation

    Role of the Clinical Movement Analysis Society U.K. and Ireland (CMAS)

    Summary

    Subchapter 25.1 Principles of Kinematics and Kinetics

    References

    References

    Further Reading

    Resources

    Chapter 26. Mechanical and Electromechanical Devices

    Aids for Daily Living

    Prosthetics

    Orthotics

    Orthopedic Biomechanics

    Mobile Arm Supports

    Robotics

    References

    Further Reading

    Resources

    Index

Product details

  • No. of pages: 480
  • Language: English
  • Copyright: © Academic Press 2013
  • Published: November 12, 2013
  • Imprint: Academic Press
  • eBook ISBN: 9780123972385

About the Editors

Azzam Taktak

Azzam Taktak
Azzam Taktak, BEng (Hons), PhD, DipStat, CEng, CSci, FIPEM is Consultant Clinical Scientist at the Royal Liverpool University Hospital and an Honorary Professor at the Universities of Liverpool and Manchester. He is a former Vice President of Engineering, CEng Registrar and a Director of the IPEM. He is a national assessor at the Association of Clinical Scientists and lead assessor at the National School for Healthcare Scientists. His main research interests are mathematical and statistical modelling and the use of artificial intelligence and machine learning in medicine. To date, he has published more than 75 peer-reviewed articles and edited 2 books. He has in the past led a European project on ocular oncology under the Biopattern Network of Excellence which was funded by the European Commission.

Affiliations and Expertise

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

Paul Ganney

Paul Ganney
Paul Ganney, BSc (Hons), MSc, PhD, CSci, MIPEM, FIAP, 34 years, 5 jobs, 3 reorganisations, 2 city moves and a PhD later, Consultant Clinical Scientist Dr. Ganney is turning his attention more towards training the next generations of Computer Scientists, of trying to give them the platform, tools and experience they will need in order for Clinical Scientists and Engineers to always make a positive difference through the software that they write. Paul is currently lecturing part-time at three Universities and has a wealth of experience both within the academic and practical hospital environments that he is keen to apply.

Affiliations and Expertise

Professional Lead for Bioinformatics, National School of Healthcare Science, Health Education West Midlands, Birmingham, UK

David Long

David Long
David Long, BEng (Hons), MSc, CEng, MIPEM, is a Clinical Engineer registered in the UK as a Clinical Scientist with the Health and Care Professions Council. He has over 20 years multi-disciplinary NHS experience in the field of rehabilitation engineering, specialising in the provision of postural management and custom contoured seating. Being a Chartered Engineer as well as a qualified clinician, Dave is particularly able to apply biomechanical principles to the assessment process, and to advise and assist with the more technical aspects of the required equipment. He is employed by AJM Healthcare who deliver a number of wheelchair services on behalf of the NHS. He also retains a contract with Oxford University Hospitals NHS Trust where he teaches on the Oxford Brookes University accredited Postgraduate Certificate in Posture Management for People with Complex Disabilities.

Affiliations and Expertise

David Long, AJM Healthcare, UK, Oxford University Hospitals NHS Foundation Trust, Oxford, UK

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