Healthcare Technology Management —
Training activity: 9

Details

Investigate adverse events/incidents involving medical devices:

• Draft a report of findings and make recommendations for remedial and corrective actions
• Identify the correct incident reporting mechanisms and distribution routes for both the incident and the resulting actions, both internal and external to the organisation

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 plan and manage the investigation stage of the healthcare technology management lifecycle?
• How do you plan to demonstrate that your drafted report and recommendations follow organisational policy and national systems for patient safety and incident reporting?
• What essential communication strategies have you identified to effectively gather and provide information to diverse stakeholders, such as clinical staff or manufacturers, during the investigation?

What is your prior experience of this activity?

• What is your existing knowledge regarding incident reporting mechanisms (e.g., Datix, MHRA) and the specific technical principles of the medical device involved in the incident?
• What specific challenges do you anticipate when conducting a root cause analysis (RCA) or interviewing colleagues involved in the event while maintaining a ‘blame-free’ professional culture?
• How do you recognise the scope of your own practice for this investigation, and do you know at what point you will need to seek advice from a senior Clinical Engineer or a Risk Manager?
• How would you describe your current feelings regarding the professional responsibility of investigating an event that may have impacted patient safety?

What do you anticipate you will learn from the experience?

• What specific insights do you hope to gain regarding the impact of medical device failures on the clinical care pathway and the subsequent management of the patient?
• In what ways do you anticipate this activity will improve your proficiency in distinguishing between human factors and systemic equipment failures within the laboratory or clinical environment?

What additional considerations do you need to make?

• How have you consulted the actions identified in your previous reflections to ensure you are applying feedback regarding your reporting style or technical analysis?
• What important information (e.g., device maintenance logs, manufacturer safety alerts, or local SOPs for incident management) have you identified that you must consider before beginning your investigation?

In action

During the activity is anything unexpected occurring?

• What surprises or deviations from the anticipated timeline are you noticing as the investigation unfolds?
• Are you encountering ambiguous technical data from the device’s logs or conflicting information from stakeholders that contradicts your initial plan?
• How does this specific investigation compare with your previous experiences of troubleshooting technical failures in a non-incident context?

How are you reacting to the unexpected development?

• How is the unexpected situation leading you to adjust your investigative approach or communication style to handle sensitive information appropriately?
• What logic-based decisions are you making right now as you apply RCA methodologies (e.g., “5 Whys” or Fishbone diagrams) to resolve discrepancies in the evidence?
• How are you feeling in this moment—is the complexity of the incident or the potential for clinical 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 intervention or manufacturer involvement was required?
• In what ways are your real-time decisions ensuring that the final remedial and corrective actions are both technically feasible and clinically safe?

On action

What happened?

• How would you summarise the key points of the investigation, specifically detailing the identified root cause and the resulting corrective actions?
• Which specific interactions with stakeholders felt most important in helping you gather the necessary information for your report?
• Which ‘reflect-in-action’ moments did you notice where you had to adapt your investigation, such as re-verifying a technical log due to 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 the incident and map out appropriate remedial steps?
• How does the experience of accurately diagnosing a systemic failure 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 recommending changes to service delivery?

What will you take from the experience moving forward?

• What specific areas for continued development in forensic engineering, RCA methodologies, or professional communication have you identified?
• What specific ‘next steps’ will you now take, such as following up on the implementation of your recommendations or seeking feedback on your report clarity?
• What support or resources (e.g., expert mentorship from a Quality Lead or advanced risk assessment training) do you need to further develop your expertise in this field?

Beyond action

Have you revisited the experiences?

• How have you re-evaluated your initial corrective actions in light of subsequent learning about long-term equipment performance or departmental safety trends?
• In what ways has professional discussions with peers regarding this incident transformed your perspective on how systemic failures are managed within your organisation?
• Have you reviewed your actions from previous reflections for this activity to determine if you have successfully completed identified tasks, such as mastering new incident reporting software?

How have these experiences impacted upon your current practice?

• How has the accumulated learning from this investigation supported your preparation for ‘in-person’ assessments for the module, such as Case-Based Discussions on healthcare technology lifecycle management?
• In what ways has your proficiency in identifying technical risk points improved since you completed this specific investigation?
• Can you identify specific instances where your understanding of national safety systems has influenced your current approach to routine device maintenance or quality control?

Relevant learning outcomes

#	Outcome
# 1	Outcome Plan and manage the stages of the healthcare technology management lifecycle.
# 2	Outcome Apply and adapt communication skills to effectively provide and gather information to and from stakeholders.
# 5	Outcome Practice in accordance with organisational policy for healthcare technology management.
# 6	Outcome Practice in accordance with organisational and national systems for patient safety and incident reporting.