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.
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
What does success look like?
- Success involves efficiently retrieving relevant retrospective data from the Medical Device Registry (MDR) system, conducting a thorough audit and evaluation of a specific group of custom medical devices, and presenting clear, insightful findings at a local meeting. The audit should contribute to service improvement or understanding.
- Consider the learning outcomes related to quality management systems, research, audits, and service evaluations.
- Clarify the scope of the audit, the specific devices to evaluate, and the expected format and audience for the presentation.
What is your prior experience of this activity?
- What do you already know about data retrieval from clinical systems, conducting audits, statistical analysis (if applicable), and preparing and delivering presentations?
- What difficulties might arise in accessing data, ensuring data quality, performing the evaluation, or presenting complex information clearly, and how will you plan to mitigate them?
- When would you need to seek advice from IT support for data access, a statistician for analysis, or a senior colleague for audit methodology?
- How do you feel about engaging with data analysis and formal presentation within a clinical governance context?
What do you anticipate you will learn from the experience?
- Focus on enhancing your data analysis skills, your understanding of audit methodologies in a healthcare setting, or your ability to present findings persuasively to a professional audience.
- What insights do you hope to gain about device performance trends, patient outcomes related to specific devices, or the impact of audit findings on service quality?
What additional considerations do you need to make?
- Review any prior experience with data retrieval, audits, or presentations, noting areas for improvement.
- What specific parameters, criteria, or metrics are essential to define for the audit to ensure its relevance and validity before starting the data retrieval?
In action
During the activity is anything unexpected occurring?
- Are you noticing anything surprising or different from what you anticipate during the audit process or presentation? Are you encountering situations such as:
- You found data inconsistencies or missing records within the MDR system?
- Your evaluation revealed unexpected or contradictory findings about the devices?
- There were technical issues during your presentation at the local meeting, or unexpected questions from the audience?
- How does this experience compare with previous experiences of similar activities?
How are you reacting to the unexpected development?
- How is this impacting your actions? For example, are you adapting your data retrieval or evaluation strategy to account for inconsistencies? Are you modifying your presentation on the fly to address audience questions or technical difficulties? Is it affecting your ability to undertake the activity independently?
- Consider the steps you are taking in the moment, such as:
- Are you immediately adjusting your data filtering criteria in the MDR system to account for inconsistencies?
- Are you seeking advice from a more experienced colleague or your training officer on how to address a complex finding or unexpected data pattern?
- Consider how you are feeling in that moment. For instance, are you finding it difficult to adapt? Is it affecting your confidence? Are you feeling positive you could reach a successful conclusion?
What is the conclusion or outcome?
- How are you working within your scope of practice?
- Are you successfully executing the audit by ensuring the data retrieval and evaluation methodology aligns with principles of the quality management system?
- Are you practising within your scope by presenting the findings objectively at the local meeting and outlining the implications for service governance and quality improvement?
- Are you accurately recognising when data inconsistencies found in the MDR system are outside the scope of the local audit and formally escalating the matter to the appropriate governance lead?
- What are you learning as a result of the unexpected development?
- Are you learning advanced data filtering or retrieval methods within the MDR system needing to account for unexpected missing data or inconsistencies in record-keeping?
- Are you gaining proficiency in structuring audit presentations to clearly link technical findings about custom medical devices directly to actionable service quality and governance recommendations?
On action
What happened?
- Summarise the key points of the experience, focusing on retrieving retrospective data from the MDR system, performing a medical device audit, evaluating a specific group of custom medical devices, and presenting the findings.
- Consider specific events, actions, or interactions that felt important. Did you find data inconsistencies, or were there technical issues during your presentation or unexpected questions from the audience?
- Include any ‘reflect-in-action’ moments where you adapted to the situation as it unfolded. For example, how did you modify your data retrieval strategy to account for missing records or adjust the presentation to address audience questions on the fly?
How has this experience contributed to your developing practice?
- Identify what learning you can take from the experience. What strengths did you demonstrate in data retrieval, audit methodology, and effective communication of findings?
- What skills and/or knowledge gaps were evident (e.g., unfamiliarity with the quality management system or compliance with the requirements of Medical Devices Directive (MDD))?
- Compare this experience against previous engagement with similar activities. Has your practice improved in conducting and presenting medical device audits, such as improving data analysis or presentation clarity?
- Identify any challenges you experienced and how you reacted to these. Did these challenges affect your ability to ensure the audit’s credibility or present under pressure?
- Identify anything significant about the activity. Did you need to seek advice or clarification on data interpretation, audit scope, or ensuring the integrity of the audit?
- Acknowledge any changes in your own feelings now that you are looking back on the experience.
What will you take from the experience moving forward?
- Identify the actions / ‘next steps’ you will now take to support the assimilation of what you have learnt.
- What will you do differently next time? For example, reviewing the principles of a quality management system or clarifying specific reporting requirements for legal/educational purposes before the presentation.
- Do you need to practise any aspect of this activity further?
Beyond action
Have you revisited the experiences?
- Have you revisited your previous reflections (reflect-before-action, reflect-in-action, and reflect-on-action) for this specific activity (medical device audit)?
- When revisiting prior audit experiences, how has your ability to retrieve retrospective data from the MDR system and perform a medical device audit improved?
- When reviewing these past reflections, what actions for improvement did you previously identify you would need to take to improve your practice related to data retrieval, evaluation methodology, or the presentation of audit findings?
- Have you completed these previously identified actions? If not, what are the barriers? If so, how did completing them impact your subsequent performance of this activity? Are you ready to demonstrate this new learning confidently and consistently when performing this task?
- Have you engaged in professional storytelling or discussed your experiences of medical device audits with peers, near peers, or colleagues? Has discussing these experiences with others changed your view or understanding of compliance with the requirements of the Medical Devices Directive (MDD) or the role of research, audits, and service evaluations in the prosthetic service?
How have these experiences impacted upon current practice?
- Considering your cumulative experiences and reflections on this activity, how will the learning you have gained support you in preparing for relevant observed ‘in-person’ assessments for the module? For example, how does your proficiency in data retrieval and audit methodology enhance your ability to succeed in a Case-based Discussion (CBD) where you must justify an aspect of the quality management system or service evaluation?
- How has your practice related to applying the principals of a quality management system and supporting innovation and development evolved over time across multiple instances of undertaking this training activity?
- How has ongoing reflection supported your commitment to innovation, development, research, and service evaluations within the prosthetic service?
- Can you identify specific examples of improvement or increased confidence in interpreting complex data discrepancies within the MDR system?
- Based on your experiences, how has your ability to recognise when something related to a medical device audit is beyond your scope of practice improved?
- Do you have a clearer understanding of when and from whom (e.g., supervisor, clinical governance lead) you need to seek advice or clarification regarding managing innovation and prototypes or ensuring legal/educational reporting requirements are met?
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. |