Module 16 2024

17/10/2024

What types of post-market surveillance are there?

• Complaints management system considerations ‒ Unique complaint ID, customer information (healthcare facility, doctors name, etc.) ‒ Standardised complaint descriptions, consider IMDRF Event Terminology* ‒ Patient and user impact, i.e., death, injury, delayed surgery, misdiagnosis, inconvenience, none, etc. ‒ Root cause investigation/analysis ‒ Risk assessment/evaluation to determine severity/occurrence and risk acceptability ‒ Identification of trends ‒ Vigilance reportability decision tree ‒ Corrective/preventative action(s) including verification of effectiveness ‒ Ability to sort data on device model/type, serial number, customer ID, user ID, complaint type, complaint description, user/patient outcome, date reported, date resolved, CAPA ID, etc. ‒ Handling of missing data ‒ Customer communications/feedback

*https://www.imdrf.org/working-groups/adverse-event-terminology

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The post-market surveillance plan

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