Introduction to Clinical Engineering

Description

Introduction to Clinical Engineering focuses on the application of engineering practice within the healthcare delivery system, often defined as clinical engineering. Readers will explore the fundamental concepts integral to the support of healthcare technology to advance medical care. The primary mission of clinical engineers is the utilization of medical devices, software, and systems to deliver safe and effective patient care throughout technology’s lifecycle. This unique and interdisciplinary workforce is part of the healthcare team and serves as the intersection between engineering and medicine. This book is aimed at practitioners, managers, students, and educators to serve as a resource that offers a broad perspective of the applications of engineering principles, regulatory compliance, lifecycle planning, systems thinking, risk analysis, and resource management in healthcare. This book is an invaluable tool for healthcare technology management (HTM) professionals and can serve as a guide for students to explore the profession in depth. Introduction to Clinical Engineering Copyright Dedication Contents Foreword 1 The profession Introduction What is clinical engineering? Historical perspective The profession Academic pathways Certification and credentialing Responsibilities and roles Potential employers and career pathways Societies and collaboration American College of Clinical Engineering Association for the Advancement of Medical Instrumentation American Society for Health Care Engineering Local societies Professional development Code of ethics American College of Clinical Engineering code of ethics Biomedical Engineering Society code of ethics Future opportunities for clinical engineering Abbreviations References 2 Healthcare technology basics General types of medical technologies utilized in clinical settings FDA definition and categorization EQ89 standard definition Regulatory definition and categorization High-risk (critical) equipment vs. non–high-risk (non-critical) equipment Devices throughout the healthcare system and relationship to patient care Introduction Scenario 1: Outpatient surgery/procedures Scenario 2: Clinic visit (stress test) to emergency department to surgery Outpatient environments Clinics Emergency department Observation units Home health Telehealth Inpatient patient care areas Operating room Procedural areas (cardiac catheterization, endoscopy) Pre-procedure and post-procedure rooms/bays Intensive care unit Intermediate care unit/continuing care unit Acute care—common patient care rooms Labor and delivery Pediatric and neonatal areas Other equipment used across the hospital Other specialty areas Imaging Nuclear medicine Clinical laboratory Pharmacy Sterile processing Technology support life cycle Introduction Medical device inventory Pre-procurement evaluation and selection Request for Information Request for Proposal Selection and acquisition New device installation/integration Operation: repair and maintenance processes Device retirement planning De-installation and disposition Abbreviations References 3 Healthcare technology management Systems engineering theory as applied to the clinical setting The human-device interface and human factors Computerized maintenance management systems Asset tracking Work order management Preventative maintenance work orders Reactive maintenance work orders Other types of work orders Equipment-based work order types Non-equipment-based work order types Labor tracking Parts management Contracts management Reporting Medical device interoperability Project management principles, as applied to clinical engineering Ongoing support planning including service agreements Background Service-level agreements Operational-level agreements Device-specific support plans Scope Defining roles and responsibilities Draft support plan Vendor contracting and vendor management Pre-purchase vendor contracting Post-purchase vendor management Data-driven decisions and data analytic techniques Financial management of medical technology Budget management Capital planning Return-on-investment analysis Clinician connections including communication and collaboration Alarm management and secondary device notification Device/disposable standardization Research Emerging technologies and technology transfer into healthcare settings Abbreviations References 4 Safety and systems safety Introduction Regulations, regulatory bodies, codes, and standards Government regulations Medical device safety Fire safety Radiation safety LASER safety Cybersafety Infection control Research activities and the Institutional Review Board Medical device incidents Investigation Root cause analysis Reporting requirements Recall management Risk management Quality management practices Abbreviations References 5 Information technology The clinical engineering–information technology interface Interoperability and integration of medical device data Integration to medical records Pull workflows Push workflows Picture archiving and communication system integration Laboratory information systems Decision support algorithms Secondary device notification systems Telemedicine Medical devices at home Cybersecurity, threats, vulnerabilities, and mitigation Ransomware Denial-of-service attack Formjacking Cybersecurity of medical devices Cybersecurity incident response plans Abbreviations References 6 Facilities management Introduction Electrical power Plumbing systems and water quality management Dialysis systems Sterile processing systems Laboratory systems Emergency plumbing systems Water quality management Medical gas systems Oxygen Vacuum Waste anesthetic gas disposal Medical air Heating, ventilation, and air-conditioning systems Positive- and negative-pressure rooms Air-conditioning for the operating room Building and renovation project management Emergency preparedness Weather-related events Security events Large-scale events Cyberattacks Summary Infection prevention Hand hygiene Hospital-acquired infections Abbreviations References 7 Human resource management Workforce development, job descriptions, and succession planning Workforce development Job description Succession planning Strategic planning, goal development/cascading, and performance evaluations Introduction Strategic planning Goal development and cascading Performance evaluations Change management Change management models Plan-Do-Check-Act Plan Do Check Act Kotter’s Leading Change eight-step management process Reacting to change Culture of safety Error prevention Skill-based errors Rule-based errors Knowledge-based errors STAR Three-way repeat back SBAR ARCC Stop the line Project management Abbreviations References Appendix: Additional Readings Article 1: An Assessment of industrial activity in biomedical engineering. National Academy of Engineering (1971) Article 2: Human resources for medical devices, the role of biomedical engineers. Geneva: World Health Organization (2017) Article 3: Nader, R., Ralph Nader's Most Shocking Expose. Ladies Home Journal. April 24, 1970. 176–179 Article 4: Building a better delivery system: A new engineering/ health care partnership. National Academy of Engineering a... Article 5: Managing The Lifecycle of Medical Equipment, Tropical Health and Education Trust (THET), London (2015) Index