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

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.