European Association for Medical Device Reprocessing

Uncontrolled reprocessing

Enormous risk due to uncontrolled reprocessing

Perhaps the most significant objection to reprocessing, understandably, is the issue of patient safety. This is the foremost concern, not only of citizens and patients, but also of medical practitioners, and reprocessors, throughout Europe. Therefore, it is paramount that any reprocessing of medical devices be subjected to strict control of the hygienic and functional qualities of the equipment to ensure “as new” performance levels.

In countries where the regulation allows for such high quality reprocessing, these controls are in place and have the full confidence of practitioners, the authorities and insurance companies.

However, it has been observed that prohibition does not eliminate reprocessing. In those countries where hospitals and clinics are not allowed to make use of regulated service providers, there is economical pressure on them to carry out reprocessing themselves, often under unsuitable conditions. In fact, it was to eliminate this practice that the Danish and German governments amended their own framework for medical devices in the first place. 

It can, therefore, be seen that outlawing reprocessing of any devices labelled “single-use” can actually increase the risk to patients by animating hospitals to reprocess their equipment without the appropriate techniques, traceability or accountability measures.

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