Contrary to what the word implies, "single-use" does not necessarily define the number of uses that are foreseen for the device. In many countries the labelling does not impede third parties to develop validated procedures which guarantee a safe re-use. If a validated procedure for the reprocessing and re-usability of a medical device has been demonstrated to a notified body, the single-use labelling will be considered as disproved. In these countries, medical devices are labelled as "single-use" if the original manufacturer does not demonstrate a validated procedure for a specified number of re-uses. The label limits the liability of the producer to the first use. Hereby a "use" is defined as one medical operation which may include several applications (e.g. surgeries on both eyes).
