- Nosokomiale Infektionen Shall Reprocessors Be Treated As Manufacturers?
In the future, Europe-wide requirements shall apply to reprocessing medical devices. This is a positive result of the decisions passed by the European Parliament on the planned European Medical Device Regulation on 22 October 2013. However, there are still many unresolved questions, especially on the reprocessing of single-use devices, as can be seen from the over 900 applications for amendment of the regulation. This was one of the clear results that emerged at the ”Reprocessing of Medical Devices” conference held in October 2013. According to Peter Schröer of Ethicon, treating companies that reprocess single-use medical devices the same as original manufacturers is considered progress. ”We are prepared to meet the same requirements,” emphasized Marcus Bracklo of Vanguard, a reprocessor firm. Whereas Schröer also calls for a conformity assessment procedure for reprocessors, Bracklo claims that it would suffice to set procedures to ensure safety requirements are met. Both experts agree that reprocessing standards should be high, since reprocessing often involves surgically invasive products that demand compliance with the highest risk level stipulations.
PressemeldungBonn/Germany, 24.10.2013, 82/13
Additional requirements on processing
The decision of the European Parliament initially changes nothing in the pending bill of the European Commission, which treats reprocessors of medical devices the same as original manufacturers. There are also additional requirements as reprocessing often covers contaminated and non-homogeneous products. Schröer considers this reasonable, for the reason that complex processing procedures are increasingly similar to original production methods. In contrast, the reprocessor is not subjected to any conformity assessment procedure the way the manufacturer is. Another intention of the bill is that only medical devices marketed in the EU are allowed to be reprocessed and reused. Moreover, member states are permitted to generally prohibit the processing of single-use devices, such as France has done.
Dispute about the ”positive list”
In contrast, the Commission’s proposal to introduce a ”positive list” of reprocessable medical devices is not compatible with the parliament’s decision to consider all products ”with the exception of single-use devices on a negative list” as suitable for reprocessing. Accordingly, the European Commission is maintaining a list of medical devices or groups of medical devices that are not suitable for reprocessing. The manufacturer must provide the proof – and according to Schröer this is practically impossible. Schröer sees some progress in the requirement that reprocessors meet valid EU reprocessing standards in the future.
The upshot according to Schröer: ”The Parliament’s decision is a good basis for the dialog between the Council and the Commission. The defined rules for reprocessing and the fact that reprocessors of single-use devices will be considered manufacturers are positive aspects. Nevertheless, there remains a need for clarification in some areas. For instance, a conformity assessment procedure for reprocessing single-use devices would be desirable.”
