Clinical Engineering: From Devices to Systems

Clinical Systems Engineering: New Challenges for Future Healthcare covers the critical issues relating to the risk management and design of new technologies in the healthcare sector. It is a comprehensive summary of the advances in clinical engineering over the past 40 years, presenting guidance on compliance and safety for hospitals and engineering teams.

This contributed book contains chapters from international experts, who provide their solutions, experiences, and the successful methodologies they have applied to solve common problems in the area of healthcare technology. Topics include compliance with the European Directive on Medical Devices 93/42/EEC, European Norms EN 60601-1-6, EN 62366, and the American Standards ANSI/AAMI HE75: 2009.

Content coverage includes decision support systems, clinical complex systems, and human factor engineering. Examples are fully supported with case studies, and global perspective is maintained throughout. This book is ideal for clinical engineers, biomedical engineers, hospital administrators and medical technology manufacturers.

Presents clinical systems engineering in a way that will help users answer many questions relating to clinical systems engineering and its relationship to future healthcare needsExplains how to assess new healthcare technologies and what are the most critical issues in their managementProvides information on how to carry out risk analysis for new technological systems or medical softwareContains tactics on how to improve the quality and usability of medical devices

• List of Contributors
• Acknowledgments
• Introduction
• 1. The Evolution of Clinical Engineering: History and the Role of Technology in Health Care
  • Abstract
  • Explaining What Is a Clinical Engineer
  • Requirements to Be a Clinical Engineer
  • Educational System for CEs
  • How Clinical Engineering Shall Evolve
  • Conclusion
  • References
• 2. Clinical Engineering in Growing Markets: The China Case Study
  • Abstract
  • Introduction
  • Overview of Clinical Engineering and Healthcare Technology Management Market
  • The Evolution of Clinical Engineering in China
  • Professional Development of Chinese Clinical Engineers
  • References
• 3. Clinical Engineering in Developing Countries
  • Abstract
  • Introduction
  • Funding
  • Geography
  • Healthcare Policies
  • Traditional Medicine
  • Distinction Between BME and MP
  • Maintenance Difficulties
  • Diversity of Manufacturers
  • Donated Equipment
  • Training
  • Conclusion
  • References
• 4. Clinical Engineering for Consolidated Markets: European Case Study
  • Abstract
  • Introduction
  • Clinical Engineering Work
  • Clinical Engineering Processes
  • Research, Development, and Education
  • Conclusions
  • References
• 5. Hospital Technology Management
  • Abstract
  • Introduction
  • Medical Technology Life Cycle
  • Hospital Technology Management and Clinical Engineering
  • Computerized Maintenance Management Systems
  • Future Perspectives
  • References
• 6. Management of Complex Clinical System
  • Abstract
  • Introduction
  • Foundational Principles and Concepts
  • Managing the Evolution to Today’s Complex Clinical Systems
  • The Rapidly Evolving Complex 21st-Century Clinical System
  • Unintended Consequences: Understanding and Managing Emergent Behaviors in Systems of Systems
  • Management Approaches for 21st-Century Complex Clinical Systems
  • Conclusion
  • References
  • Web References
• 7. Decision Support Systems in Healthcare
  • Abstract
  • Introduction
  • A Clinical Decision Support System for Congestive Heart Failure Management
  • The Heart M&M System
  • The Machine Learning Core
  • A DSS for Hospital Administration and Facilities Management
  • SVG Rendering Engine
  • LICENSE
  • EUREKA
  • References
• 8. Early Stage Healthcare Technology Assessment
  • Abstract
  • Healthcare Technology
  • Health Technology Assessment: Standard De Facto
  • Standard Method Limitations and Weaknesses
  • Early Stage HTA (eHTA)
  • Conclusion
  • References
• 9. Integrated Risk and Quality Management in Hospital Systems
  • Abstract
  • Introduction
  • Methods
  • Case Study
  • References
• 10. Management of New Technologies: Software and Integrated Systems
  • Abstract
  • Introduction
  • Methods
  • Discussion
  • Conclusions
  • References
• 11. Clinical Engineering and Disaster Preparedness
  • Abstract
  • Introduction
  • Overview of Disaster Types Its Management and Terminology
  • What Are the Disaster Stages?
  • How to Prepare?
  • Levels of Responsibility
  • Concluding Advice
  • References
  • Other Resources
• 12. Human Factors Engineering in Healthcare
  • Abstract
  • Human Factor Engineering for Medical Devices
  • A Usability Engineering Process following IEC 62366-1:2015
  • Abbreviations
  • References
• 13. Clinical Engineering Education and Careers: Overview at the University of Connecticut
  • Abstract
  • Introduction
  • Curriculum
  • Clinical Engineering Internship
  • Employment
  • Employment Market
  • Conclusion
  • References
• 14. Certification of Clinical Engineers
  • Abstract
  • Introduction
  • Certification in the United States
  • References
• Index