It is EAMDR’s position that the proposed reforms would provide a win-win solution; where the healthcare system benefits from cost savings, with no additional risk to patient safety.

The cost of reprocessing a medical device to the standards laid down by the RKI in Germany have been established by several pieces of research in Germany over the last five years.

Based on these estimations, and on analyses of the medical device marketplace in Europe, it is estimated that several billions of euros could be saved every year by extending the range of reprocessed medical devices. The projected savings range from €30,000 for smaller hospitals and clinics, to several million for a large medical centre. It is not suggested that all medical devices need to be reprocessed to achieve this – it could be achieved simply by including the 16% of devices currently labelled “single-use” which are suitable.

Of course, this evaluation is only possible when reprocessing is regulated and therefore transparent. The costs of foregoing treatment, or of inappropriate reprocessing, are much harder to analyse because figures are not readily available. It is estimated, however, that these are considerable, at least in terms of the impact on patient welfare.