Training activity information
Details
Undertake complex medical device or service-related risk assessments in accordance with ISO 14971.
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?
- How have you reviewed the learning outcomes to ensure you are prepared to apply risk management strategies in accordance with ISO 14971 to ensure the safety of patients and healthcare professionals?
- In what ways do you plan to demonstrate that your assessment appraises and applies the relevant legislative frameworks for healthcare technology management?
- How will you ensure your risk assessment methodology aligns with organisational policy to deliver a safe and high-quality service?
What is your prior experience of this activity?
- What is your existing knowledge of the ISO 14971 standard, and how does it compare to previous risk assessment tasks you have undertaken?
- What specific challenges do you anticipate when identifying complex device or service-related hazards, and how have you planned to handle them?
- How do you recognise the scope of your own practice for this activity, and at what point will you seek advice or help from a senior Clinical Engineer or Risk Manager?
- How would you describe your current feelings regarding the professional responsibility of performing a complex risk assessment that directly impacts patient safety?
What do you anticipate you will learn from the experience?
- What specific insights do you hope to gain regarding the interdependencies between system elements and how they influence risk probability and severity?
- In what ways do you anticipate this activity will improve your proficiency in translating technical risks into actionable safety recommendations for clinical stakeholders?
What additional considerations do you need to make?
- How will you consult actions identified in your previous reflections regarding technical analysis or report writing to ensure you are building upon earlier feedback?
- What important information (e.g., manufacturer technical files, post-market surveillance data, or local incident logs) have you identified that you must consider before embarking on this assessment?
In action
During the activity, is anything unexpected occurring?
- Are you noticing any surprises or deviations from the anticipated risk profile as you investigate the device’s technical specifications or the service workflow?
- How are you addressing ambiguous technical data or conflicting stakeholder feedback that complicates your estimation of risk levels?
- How does this specific assessment compare with your previous experiences of standard risk evaluations?
How are you reacting to the unexpected development?
- How is the unexpected situation leading you to adjust your investigative approach or reprioritise which hazards require the most detailed scrutiny?
- What logic-based decisions are you making right now as you apply ISO 14971 criteria to resolve discrepancies in the evidence?
- How are you feeling in this moment—is the technical complexity or the potential for patient harm affecting your confidence in reaching a robust conclusion?
What is the conclusion or outcome?
- How effectively are you working within your professional scope of practice, and at what point did you determine that senior or specialist intervention was required?
- In what ways are your real-time decisions ensuring that the final risk mitigation strategies are both technically feasible and clinically safe?
On action
What happened?
- How would you summarise the key points of the experience, specifically detailing the identified hazards and the resulting risk control measures?
- Which specific actions or interactions felt most important during the process, such as justifying a risk threshold to a multidisciplinary team?
- Which ‘reflect-in-action’ moments did you notice where you had to adapt your approach, such as re-verifying an assumption because of unexpected clinical feedback?
How has this experience contributed to your developing practice?
- What specific strengths or skills did you demonstrate regarding your ability to critically appraise complex risks within a legislative framework?
- How does the experience of accurately diagnosing systemic risks relate to the requirements for your future post-programme practice as a Clinical Scientist?
- Have your feelings changed now that you are looking back on the experience and the responsibility of ensuring device safety?
What will you take from the experience moving forward?
- What specific areas for continued development in risk management methodologies or specialist technical knowledge have you identified?
- How can you apply the learning from this assessment (e.g., more rigorous hazard identification techniques) to your routine practice in the department?
- What specific ‘next steps’ will you now take, such as reviewing updated safety standards or seeking feedback on report clarity, to support the assimilation of what you have learned?
Beyond action
Have you revisited the experiences?
- How have you re-evaluated your initial risk estimations in light of subsequent learning regarding long-term device performance or departmental safety trends?
- Have you reviewed your actions from previous reflections for this activity to determine if you have successfully completed identified tasks, such as mastering new risk-assessment software?
- In what ways has professional discussions with peers regarding your risk management strategies transformed your perspective on how systemic failures are identified?
How have these experiences impacted upon your current practice?
- How has the accumulated learning from these risk assessments supported your preparation for ‘in-person’ assessments (e.g., Case-Based Discussions) where you must justify safety decisions?
- In what ways has your proficiency in identifying technical risk points improved since you completed this specific activity?
- Can you identify specific instances where your understanding of legislative frameworks has influenced your current approach to routine device maintenance or quality control?
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. |