The importance of traceability in the high level disinfection (HLD) of ultrasound probes

Critical Summary

• United States medical device reprocessing standards require facilities to collect reprocessing cycle information, medical device identifiers, procedure information and patient details. The linking of the medical device and reprocessing information to the patient is referred to as tracking, or traceability.

• National standards and guidelines require medical devices classified as semi-critical and critical according to the Spaulding classification be traced to support patient safety.

• Digitization can help reduce manual administrative burden, the risk of operator error and incomplete record keeping.

• In the event of an outbreak or infection prevention breach, a reliable traceability system becomes instrumental for a facility in investigating, identifying and notifying affected patients.