Training activity information
Details
Plan/scope the introduction of a non-conforming device into clinical/research use
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee​.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Regulations and legislation
- Selection of applicable standards
- Organisational policies for management of medical devices
- Protocol/clinical guidance
- Risk management
- Alternative conforming devices
- Verification of device safety and function
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Apply risk management strategies to the management of healthcare technology to ensure the safety of patients and healthcare professionals. |
| # 4 |
Outcome
Appraise and apply legislative frameworks for healthcare technology management. |
| # 5 |
Outcome
Practice in accordance with organisational policy for healthcare technology management. |