Traceability
Traceability is the documentation collected to link medical devices and their reprocessing records with patient use.5,6
This process is essential for investigations in the event of reprocessing failures, outbreaks or recalls, and can help facilities manage risk. Traceability is required for semi-critical and critical medical devices that undergo HLD or sterilization.
Accrediting agencies look for traceability processes that are compliant with evidence based standards and guidelines. According to American National Standards and the Association of periOperative Registered Nurses, the following data needs to be captured and linked.5,6

Device ID & description
Date & time of HLD
Person performing HLD
HLD lot number
HLD shelf-life date
HLD activation date
HLD reuse-life date
HLD cycle number
Test strip/MEC/MRC testing result
Temperature
Exposure time
Failed reprocessing cycles
Patient ID on whom the device is used
Physician performing procedure
Digitized collection of some or all of the above data will help streamline workflow, ensure data security and integrity, and minimize risk of human error in record keeping.
Learn more about automated traceability with AcuTrace®