Competency information
Details
Commission a medical device; produce protocols for its safe and effective introduction into service
Considerations
- Medical device life cycle
- The importance of training the end user
- Documentation, including technical files and user instructions
- Measurement of outcomes
- Risk assessment methods/techniques and their application
- Relevant local guidelines on equipment procurement, commissioning and maintenance
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 | Outcome Bring new items of equipment, systems, facilities and protocols into service safely and effectively |
| # 2 | Outcome Specify, design, build and bring into service pieces of equipment, using formal design processes, to be used either (a) in a biomechanical or functional assessment, including validation against current clinical methods, or (b) to meet a specific clinical need for a particular clinical problem, including measurement of performance |
| # 3 | Outcome According to established standards, develop and keep up to date the associated documentation, including those relating to technical construction and risk management |