European Association for Medical Device Reprocessing


Identification and Documentation of each device

In addition to the improved techniques for the reprocessing itself, the industry has also seen considerable changes in the methods used for identifying and tracking each individual device through the reprocessing cycle.

This is crucial, not only to ensure that a device is only reprocessed a certain number of times (determined by the validated procedure), but also to enable the level of traceability that is required by the rigorous liability regulations. Furthermore, due to the “closed loop” system of most reprocessing, tracking the individual devices plays a key role in making sure that each hospital receives their own equipment back.

Developments such as data matrix marking and Instrument Management System software have made it much more cost-effective to implement this comprehensive tracking and recording practice. This is part of the recent progress in the sector which is making reprocessing a more viable option than has previously been the case, but which requires regulatory reform before the benefits can be passed on to the rest of the healthcare sector.