A single incident may not reveal the whole pattern
A hospital receives several reports of a device malfunction across different wards. Trend analysis examines whether the reports share a cause, reflect changing usage or indicate a wider safety concern.
Define comparable events
Incident categories, device models and severity need consistent definitions before counts can be compared.
Consider exposure
More reports may reflect greater device usage or improved reporting. Raw totals alone can mislead.
Look for shared factors
Software versions, maintenance history, location and operating conditions may help identify patterns.
Protect reporting quality
Staff should be able to report concerns without unnecessary blame. Underreporting can conceal risk.
Use multidisciplinary review
Clinical, engineering and quality teams may interpret different parts of the evidence.
Link findings to action
Signals should lead to proportionate investigation, corrective measures and appropriate regulatory processes.
Break-test: incidents rise after a reporting campaign
Can the team distinguish increased reporting from increased device failure?
Connected knowledge
See Device Safety Signal Review, Post Recall Surveillance and HSA.