Reprocessing, in this context, includes the cleaning, disinfection and sterilisation of a used medical device and the related steps in these procedures, as well as reinstating and testing the technical and functional safety of the device.
Reprocessing takes place in a hygienically monitored environment. Reprocessing is subject to validation rules that are backed by scientific evidence and subject to the control and supervision of the public authorities. The validation ensures that the reprocessed device has identical hygiene and functional properties as the original product.
Reprocessing takes place in a closed loop where all steps are hygienically monitored. Medical devices that are reprocessed for third parties are returned to the same people and places where they were picked up. Therefore, reprocessing does not constitute the “placing on the market” of the medical device.
Professional reprocessors shall comply to statutes that require them to:
- Apply validated procedures that are backed by scientific evidence and ensure that the reprocessed device has identical hygiene and functional properties as the original product
- Indicate officially their activities and are subject to the control and supervision of public authorities
- Have implemented total quality management systems to guarantee a consistently high and transparent level of quality
