Historically, manufacturers have been allowed to declare devices as “single-use” or “multiple-use” as they see fit. Medical devices were assigned one of these categories according to whether the manufacturer felt able to guarantee the hygienic and functional quality for one or several uses.
This categorisation was determined by the reprocessing practices available at the time. However, with recent developments in reprocessing techniques, many (up to 16%) devices currently labelled “single-use” are now able to be reprocessed at least a certain number of times, with no discernable loss of quality. Nonetheless, because the categories “single-use” and “multiple-use” have legal status in many countries, health care providers are not legally permitted to take advantage of these improvements.
The fact is, labelling a device “single-use” does not automatically mean that the device cannot be safely reprocessed, it simply means that the manufacturer cannot or will not accept liability for the function of the device beyond its first use. This concern of the manufacturers is understandable, from both a legal and commercial standpoint. However, if reprocessing can be shown to be safe, and the reprocessors themselves are able to assume clear liability for the reprocessed device, then there is no safety or economic reason to prohibit this practice.
Germany is a good example of how the significance of the “single-use” label has been modified along these lines.
In countries where “single-use” labels imply a legal prohibition of recycling, this drives the practice underground (France, Spain).
There is some concern about the CE standard mark, and whether a reprocessed item would still legitimately be able to bear this. EAMDR’s position is that this mark simply allows products to be traded across Europe. As reprocessors do not own the products or place them on the market at any time, the validity of the CE mark is not affected by their actions. It does not constitute a lifetime quality guarantee. As such, reprocessing is not incompatible with CE markings.