Table of Contents:
  • 1. Introduction
  • 2. Regulatory framework
  • 2.1 Federal laws, regulations, and codes
  • 2.1.1 Regulations enforced by CMS
  • 2.1.2 Regulations enforced by OCR
  • 2.1.3 Regulations enforced by FDA
  • 2.1.4 Regulations enforced by OSHA
  • 2.2 State laws, regulations, and codes
  • 2.3 Standards and recommended practices
  • 2.3.1 National Fire Protection Association
  • 2.3.2 Association for the Advancement of Medical Instrumentation
  • 3. Core functions of medical equipment maintenance and management
  • 3.1 Equipment incorporation
  • 3.2 Installation and acceptance
  • 3.3 User training
  • 3.4 Equipment maintenance
  • 3.4.1 Maintenance planning
  • 3.4.2 Maintenance implementation
  • 3.4.3 Maintenance monitoring
  • 3.4.4 Maintenance improvement
  • 3.5 Equipment replacement, retirement, and disposal
  • 3.6 Safety and risk management
  • 3.6.1 Recalls, corrections, and upgrades
  • 3.6.2 Incident investigation
  • 4. CE department management
  • 4.1 Management of processes and documents
  • 4.1.1 Policies and procedures
  • 4.1.2 Work instructions
  • 4.2 Computerized maintenance management system (CMMS)
  • 4.3 Staff management and development
  • 4.4 Service provider management
  • 4.5 Financial management
  • 4.6 Relationship with other departments
  • 4.7 Interaction with information technology
  • 4.8 Performance monitoring and continual improvement
  • 5. Performance management
  • 5.1 Maintenance effectiveness
  • 5.2 Maintenance efficiency
  • 5.2.1 Financial efficiency
  • 5.2.2 Staff productivity
  • 5.3 Performance benchmarking
  • 6. Discussion and conclusions
  • 6.1 Challenges related to size, acuity, and geographical location
  • 6.2 Challenges related to cultural tendencies
  • 6.3 Evidence-based maintenance
  • 6.4 Conclusions
  • A. Sample policies for a clinical engineering department
  • B. Information and data sources on internet
  • Bibliography
  • Author's biography.