Training activity information
Details
Retrieve retrospective data from the MDR system to perform a medical device audit and evaluate a specific group of custom medical devices. Present findings at a local meeting
Type
Entrustable training activity (ETA)
Evidence requirements
Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion.
Reflection at multiple timepoints on the trainee learning journey for this activity.
Considerations
- The requirement to audit devices
- Review of a device performance
- The process of assessment
- Audit cycle
- Requirements for Reconstructive Sciences
- In-house production changes and implications on Reconstructive Sciences
- Statutory and regulatory requirements for placing medical devices ‘on the market’
- Post market surveillance process
- Regulations and reporting process of adverse reactions/issues
- Complaints handling process in line with Trust procedures
- Importance of patient feedback in any device lifecycle
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 |
Outcome
Practice in accordance with local and national health and safety policies, regulatory requirements and overall service governance. |
| # 3 |
Outcome
Communicate effectively with patients, relatives, healthcare professionals and other stakeholders. |
| # 10 |
Outcome
Apply the principals of a quality management system to their professional practice. |
| # 11 |
Outcome
Support innovation and development and participate in research, audits and service evaluations. |