Healthcare Worker Responsibilities
25 minutes
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Your Role as a Healthcare Worker
Understanding your responsibilities under MDR/IVDR
Device Usage & Safety
- Check device labels for UDI, CE mark, and classification
- Follow instructions for use and manufacturer guidance
- Ensure proper training before using medical devices
- Monitor device performance during use
Incident Recognition & Reporting
- Identify potential incidents including malfunctions
- Report suspected serious incidents immediately
- Cooperate with investigations when incidents occur
- Document observations related to device performance
Remember: Patient Safety First
Your primary responsibility is always patient safety. When in doubt about a device, stop using it and report through your hospital's incident reporting system.
Understanding Incident Types
When and what to report for device incidents
Incident
Any malfunction or deterioration in device characteristics or performance
- • Use-error due to ergonomic features
- • Inadequacy in manufacturer information
- • Undesirable side-effects
Serious Incident
Incident that led to or might lead to serious harm
- • Death or life-threatening illness
- • Permanent impairment of body function
- • Hospitalization or prolonged stay
- • Serious public health threat
Reporting Process
1
Ensure Patient Safety
2
Preserve Device
3
Document Incident
4
Report to Hospital System