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Clinical Engineering - Coggle Diagram
Clinical Engineering
Healthcare Technology Management (HTM)
Lifecycle Management
Uses Life Cycle Cost Analysis (LCCA) to reduce total cost of ownership
Preventive Maintenance (PM)
Uses reliability engineering (Weibull distribution) to predict failures
Calibration & Metrology
Uses measurement uncertainty to ensure accuracy
Interconnection: HTM reduces malfunctions → supports Risk Management
Medical Device Regulation & Compliance
Regulatory Standards
Follows FDA, CE Marking, ISO 13485
Pre-Market Approval (PMA / 510k)
Requires safety and efficacy testing before use
Post-Market Surveillance (PMS)
Uses Statistical Process Control (SPC) to track failures
Interconnection: Regulation requires standardized data → supports Clinical Informatics
Clinical Informatics & Data Integration
EHR Integration
Uses HL7 standards for data interoperability
Data Security & Privacy
Based on cryptography and HIPAA requirements
Telemedicine & Remote Monitoring
Uses signal processing and real-time data transfer
Interconnection: Informatics data → informs Device Design
Medical Equipment Design & Modification
Clinical Needs Assessment
Identifies gaps and unmet clinical needs
Human Factors & Usability
Uses ergonomic and cognitive load principles
Prototyping & Iteration
Uses Design-Build-Test-Learn (DBTL) cycle
Interconnection: Device designs → become assets → managed by HTM
Risk Management & Patient Safety
Hazard Identification (FMEA)
Quantifies likelihood and severity of failures
Root Cause Analysis (RCA)
Uses the Five Whys technique
Patient Safety Culture
Encourages open reporting and teamwork
Interconnection: Identified risks → determine regulatory safety requirements