Medical Equipment Management: 1st Edition (Hardback) book cover

Medical Equipment Management

1st Edition

By Keith Willson, Keith Ison, Slavik Tabakov

CRC Press

344 pages | 30 B/W Illus.

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Hardback: 9781420099584
pub: 2013-12-07
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Know What to Expect When Managing Medical Equipment and Healthcare Technology in Your Organization

As medical technology in clinical care becomes more complex, clinical professionals and support staff must know how to keep patients safe and equipment working in the clinical environment. Accessible to all healthcare professionals and managers, Medical Equipment Management presents an integrated approach to managing medical equipment in healthcare organizations. The book explains the underlying principles and requirements and raises awareness of what needs to be done and what questions to ask. It also provides practical advice and refers readers to appropriate legislation and guidelines.

Starting from the medical equipment lifecycle, the book takes a risk-based approach to improving the way in which medical devices are acquired and managed in a clinical context. Drawing on their extensive managerial and teaching experiences, the authors explain how organizational structures and policies are set up, how funding is allocated, how people and equipment are supported, and what to do when things go wrong.


"This book is excellent. It is easy to read and a great tool for clinical engineers, biomedical engineers, and every healthcare provider who is involved in the management of medical equipment. This book was very well needed by managers but also by those who are studying clinical engineering. Vendor organizations and manufacturers of medical devices should also read this book and understand how healthcare organizations operate."

—Jean Ngoie, C.Eng., Regional Manager Biomedical Engineering, Niagara Health System, St. Catharines, Ontario, Canada

"This book contains precisely the information needed by clinical engineers, either studying in academia or working in the healthcare environment. It provides all the knowledge to develop most of the activities today under the responsibility of a clinical engineering group. What most caught my attention is that it teaches not only WHAT must be done to develop such activities but also gives you hints on HOW they should be developed."

—Saide Jorge Calil, MSc, PhD, Chairman of the Clinical Engineering Division, International Federation for Medical and Biological Engineering (IFMBE), and Professor of Biomedical Engineering, University of Campinas (UNICAMP), Brazil

"An excellent timely book that details the underlying principles required for the interesting, exciting, and important art and science of medical equipment management.

Covering the breadth and depth of the discipline, the book proceeds from an introduction to the field and its underlying principles before detailed examinations of the key aspects: the equipment lifecycle, risk regulation and governance, approaches to managing equipment, purchase and replacement, evaluation, staff training, assessing maintenance requirements and contract management, and how to manage and investigate incidents when problems occur with medical devices. How to support innovation and R&D and the necessary associated governance considerations are covered, recognising that innovation involves supporting development of novel equipment, and also the application of equipment in novel ways, including ways not envisaged by the original maker. Equipment disposal is often ignored and a chapter devoted to this important topic discusses the underlying principles and regulations, including environmental considerations. The final chapter deals with performance monitoring, benchmarking, and performance indicators—important tools to guide professionals in assessing their work and that of the team. The penultimate chapter guides professionals to sources of information, including professional societies, that will support them performing and developing their work.

Who will benefit from this book? Clearly those managing medical equipment from day-to-day, both leaders and practitioners, will benefit. It will guide and instruct students. It is also important for those who manage and direct those involved in medical equipment management. … important for senior healthcare managers, medical and nursing directors, chief executives, and board members with responsibility for medical equipment. It will also benefit clinical professionals who interact with medical equipment managers."

— John N. Amoore, PhD, Department of Medical Physics, Crosshouse Hospital, Kilmarnock, Scotland

Table of Contents


Scope of Medical Equipment Management

Who Should Read This Book?

Approach and Content of This Book


Values and Value

Medical Equipment and Its Life Cycle


What Is Medical Equipment?

Equipment Management Processes

Management in Use

What Is Clinical Engineering

Medical Device Risk, Regulation and Governance: An Overview


Medical Device Risks

Risk Management

Governance, Standards and Best Practice

Risk Management and Governance in the Equipment Life Cycle

Liability and Indemnity: When Risk Becomes Reality

Legal Obligations of Healthcare Organisations

Approaches to Equipment Management: Structures and Systems


Organisational Structures to Support Medical Equipment Management

Systems for Equipment Management: Balancing In-House and External Provision

Purchase and Replacement: Allocating Priorities and Managing Resources


Seeking the Ideal: Matching Needs and Resources

Funding Routes for More Expensive Equipment

Identifying Equipment Needs

Relating Funding to Need

Outline of a Possible Bidding Process

Procurement, Specification and Evaluation


Approaching a Replacement Programme and Tender

Preparing a Specification

Tender Receipt, Evaluation and Decision

Collaborative Procurement

Equipment Training for Clinical and Technical Users

Introduction: The Need for Training

Who to Train and What to Learn

How to Train

Organisation and Delivery

Training Records

Assessment of Training and Its Effectiveness

Assessing Maintenance and Support Needs


Balancing Elements of the Maintenance and Support Process

What Options Are Available for Preventive Maintenance and Support?

Assessing Maintenance and Support Requirements for Particular Devices

Assigning Responsibility for Maintenance and Support

Final Review and Decision Making: Deciding Who Performs Maintenance

Maintenance Contract Management


Maintenance Contract Management Life Cycle

Contract Review and Renewal

Adverse Incidents, Investigations, Control and Monitoring


Definitions and Categories

Why Report Adverse Incidents?

Initial Incident Handling

Incident Investigation

Incident Analysis

Devising Control Measures

Outputs from an Incident Investigation


Supporting Research and Development


Legitimising and Managing Research Projects

How an Organisation Manages Risk Associated with Innovative Equipment

Practical Aspects of Getting Novel Medical Equipment into Use

In-House Construction of Novel Devices

Creating a Novel Device

Placing on the Market



Condemning and Disposal Procedures

Legislation Relevant to Disposal

Preparing for Disposal

Disposal Routes

Disposal of Consumables and Batteries

Disposal of Waste from In-House Repair and Manufacturing Activities

Sources of Information for Equipment Management Professionals


Government Agencies and Medical Device Regulatory Bodies

Standards and Standards Bodies

Learned Societies and Professional Bodies

Sources of External Assistance: Commercial, Non-Profit and Peers

Improving Performance: Quality, Indicators, Benchmarking and Audit


Why Monitor Performance?

Internal and External Monitoring

Constructing Performance Indicators

Performance Indicators in Equipment Management

Benchmarking in Clinical Engineering


Appendix A: Practical Issues in Running an In-House Clinical Engineering Service

Appendix B: Electrical Safety for Medical Equipment

A Summary and References appear at the end of each chapter.

About the Series

Series in Medical Physics and Biomedical Engineering

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
BUSINESS & ECONOMICS / Industries / Service Industries
MEDICAL / Administration
MEDICAL / Biotechnology