A repaired device is not necessarily a resolved safety problem
A hospital replaces a faulty component and the device passes an immediate test. Weeks later, the same problem recurs. Effectiveness review asks whether the corrective action addressed the underlying cause and remains reliable.
Define the intended correction
State which failure mode, hazard or process weakness the action was meant to resolve.
Verify implementation first
Confirm that affected devices received the approved repair, modification or restriction.
Select meaningful follow-up evidence
Relevant functional tests, incident trends and maintenance findings may help assess sustained effectiveness.
Consider usage and observation time
A lack of reports over a short period may not prove that the risk has disappeared.
Investigate recurrence
Repeated faults may reveal an incomplete root-cause analysis or additional contributing factors.
Use appropriate clinical and technical governance
Safety decisions should involve authorised personnel and applicable manufacturer or regulatory guidance.
Break-test: the same fault occurs on another device
Can the team assess whether the original corrective action should extend to additional assets?
Connected knowledge
See Corrective Action Verification, Device Safety Signal Review and HSA.