Healthcare Technology Management —
Training activity: 3

Details

Investigate an adverse medical device incident:

• 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

Developmental training activity (DTA)

Evidence requirements

Evidence the activity has been undertaken by the trainee​.

Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.

An action plan to implement learning and/or to address skills or knowledge gaps identified.

Considerations

• Regulations and legislation
• National incident reporting policies and systems
• Internal reporting systems
• Manufacturer and MHRA roles in medical device vigilance activities
• Role of the central alerting system
• Role of the medical device safety officer
• Communication with stakeholders
• Communication with manufacturers and suppliers
• No blame culture

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 is the process for investigating adverse incidents?
  • What are the key elements of a comprehensive incident report?
  • How are remedial and corrective actions determined and documented?
  • What are the internal and external incident reporting mechanisms?
• What do you hope to learn about incident investigation and analysis?
  • What insights do you expect to gain about the importance of reporting mechanisms?
  • What existing knowledge do you have about risk management and patient safety?
• How will you approach gathering information related to the incident?
  • What steps will you take to analyse the findings?
  • How will you formulate effective and appropriate recommendations?
  • Where can you find information about the correct incident reporting mechanisms within and outside the organisation?
  • What challenges might you face in investigating or reporting, and how will you prepare for them?
  • How do you feel about dealing with adverse incidents?

In action

• While gathering information and investigating the incident, what lines of inquiry are you pursuing, and what is informing these decisions?
• As you analyse the information, are you identifying any patterns or root causes? How is this influencing your recommendations?
• When considering reporting mechanisms, are you confident you are identifying the correct routes? What makes you say that?

On action

• Summarise the key details of the incident, the investigation process, and the reporting mechanisms involved.
• What did you learn about the process of investigating adverse medical device incidents?
  • Did you gain a better understanding of identifying incident reporting mechanisms?
  • How did you approach drafting the report and recommendations?
  • Were there any unexpected complexities or challenges during the investigation?
  • What did you learn from these?
  • How did your thinking evolve as you gathered information and analysed the incident (reflection-in-action)?
  • How does this experience relate to organisational and national systems for patient safety and incident reporting?
• What aspects of incident investigation and reporting do you need to develop further?
  • How will you apply this learning to future incident investigations?
  • What are your next steps in understanding patient safety and incident reporting?
  • What resources (e.g., root cause analysis tools, organisational policies) would be beneficial?

Beyond action

• Have you been involved in or aware of other adverse medical device incidents since this investigation?
  • How does your understanding of incident investigation processes and reporting mechanisms compare now to your understanding after this DTA?
  • Have you reviewed the report you drafted and considered if any further insights or recommendations could be made with your current knowledge?
• How has this experience influenced your approach to identifying and reporting adverse incidents or near misses?
  • Have you applied the skills learned in drafting incident reports and formulating recommendations in other written communication?
  • Has your understanding of patient safety and the importance of learning from adverse events evolved since this investigation?
• What skills related to incident investigation, root cause analysis, and patient safety did you develop that will be valuable in future leadership roles or quality improvement initiatives?
  • How has this experience shaped your awareness of the organisational and national systems for patient safety and incident reporting?
  • What actions will you take to further develop your skills in incident investigation and the implementation of safety recommendations?

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.