Article 24 Tracking of reprocessing cycles
United Kingdom
Reprocessors shall put in place a tracking system allowing the identification of the single-use device throughout the reprocessing cycle and the lifetime of the reprocessed single-use device.
This tracking system shall ensure the following:
record the number of reprocessing cycles that the single-use device has undergone;
ensure that the health institution verifies that the single-use device reprocessed by the external reprocessor and returned to the health institution is the same single-use device that was used in the health institution concerned and sent to the external reprocessor for reprocessing.
The tracking system shall ensure that reprocessed devices can be linked to the correct batch number for the purposes of field safety corrective action in accordance with Article 89 of Regulation (EU) 2017/745.