A safe device can become unsafe through settings
A clinical monitor may be functioning mechanically while its alarm thresholds or routing differ from approved settings. The gold standard of configuration auditing checks whether the device’s actual operating state matches the authorised clinical intent.
Define the audit scope
Device type, clinical setting, software version and relevant configuration controls influence which checks are needed. Follow institutional policies and applicable device guidance.
Establish an approved baseline
Auditors need an authoritative record of the intended configuration, approval status and effective date.
Verify identity and version
Two similar devices may have different approved uses. Confirm the correct asset and software or firmware information before interpreting discrepancies.
Inspect changes and access
Review authorised adjustments, access permissions and relevant change history. Avoid assuming that every difference is an unauthorised change.
Connect technical findings to clinical risk
A configuration discrepancy should be assessed for its potential effect on alerts, treatment or monitoring, with appropriate clinical oversight.
Document correction and retesting
A change should be approved, implemented and verified under suitable procedures. The audit loop is not complete when a ticket is merely closed.
Break-test: an update resets alarm routing
Can the team detect the deviation, protect patients and restore approved operation before relying on the device?
Connected knowledge
See Alert Configuration Change Control, Alert Threshold Validation and HSA.