European Association for Medical Device Reprocessing


More safety through a clear regulatory framework

Improving patient safety is EAMDR’s first objective, and this is of course the utmost concern of practitioners, reprocessors and the relevant authorities. For effective regulation, all risks must be managed, and the liabilities must be clearly defined and brought in line with the regulatory framework.

When it became legally possible in Germany to reprocess devices labelled as “single-use” under certain parameters that are laid down by law, it was obvious that the manufacturer’s liability could only relate to the first usage of the product. Therefore the label “single-use” is interpreted as a limitation of the manufacturer´s liability to the first use of the device. In order to provide for sufficient patient safety, the reprocessors assume contractual liability for the use of the device after the reprocessing process.

This of course requires that the reprocessing itself meets certain standards and follows a validated procedure. In Germany, these are laid down by the Robert-Koch-Institute and require that a validated procedure be developed and approved for each device before it can legally be reprocessed and reused. 

In the case of Germany, the reprocessor is subject to official supervision by regional authorities. The regions not only undertake spot checks based on samples, but also determine the scope and depth of the supervision. The federal authorities, including the Robert-Koch Institute (RKI), are responsible for determining and evaluating the risks as well as the corresponding levels of testing required before a procedure is validated.

In this new framework, the healthcare provider has wider access to more affordable (reprocessed) medical devices without having to resort to devices reprocessed in-house, or illegally, for which he or she would have to assume liability. He or she can remain secure in the knowledge that the reprocessor holds explicit, insured liability for the device.

Of course, in those countries where the allocation of liability has not been modified to accommodate these reprocessing possibilities, this is not possible. The practitioner often has to choose between implementing illegally reprocessed devices, therefore undertaking enormous personal liability, or else simply not performing the intervention at all. The reforms that EAMDR is promoting would also save healthcare providers from this dilemma.