What should be done if a medical device fails calibration?

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When a medical device fails calibration, its measurements can no longer be trusted, so safety and accuracy must come first. The proper response is to tag the device as out of service, physically isolate it to prevent use, report the issue to a supervisor or QA, and ensure it is not used until it has been recalibrated and validated according to approved procedures. After recalibration, a re-check or acceptance test should confirm the device meets the required specifications before it’s returned to service, with all actions documented for traceability and regulatory compliance. If external service is needed, follow the vendor’s processes and maintain documentation, including any acceptance criteria, so the device’s history remains complete.

Other options bypass critical safety and documentation steps: continuing to use while recalibrating risks relying on potentially inaccurate data; delaying action by ignoring the issue; or sending the device off without proper documentation and verification, which removes traceability and assurance of performance.