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.
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
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
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
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
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 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.
"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