Will Europe Finally Embrace Single-Use Device Reprocessing?
Germany has allowed reprocessing for years and the country is the only country with an existing, mature reprocessing industry. Vanguard in Berlin (like Innovative Health a member of the Association of Medical Device Reprocessors) has dominated this market and is responsible for the limited success of reprocessing in Europe. The United Kingdom today has the arguably most progressive reprocessing policy of all of Europe, with mandates for healthcare facilities. So there are places in Europe that has pursued single-use device reprocessing as a sustainability strategy. However, the fragmented adoption of reprocessing is problematic for several reasons: Firstly, the environmental impact is limited, since most EU countries have not opted in; secondly, medical device costs, as absorbed by the nationalized healthcare systems of the EU, are far too high; and thirdly, the fragmented nature of the reprocessing market in Europe means that it has not been attractive as an investment area for large, US-based reprocessing companies. This latter point means that Europe has not been able to benefit from the larger product portfolio of a multiplayer industry - nor to the benefits of competition.
...there are places in Europe that has pursued single-use device reprocessing as a sustainability strategy.
The explanation, at least partially, for this lack of adoption of medical device re-use, is that the EU is not really a federal system like the United States, and regional or national difference are often allowed to co-exist without attempts to create EU harmonization.
However, late last year (December 16), the Commission released a proposed amendment to the existing legislation that effectively removes the opt-in paragraph (this is paragraph 17), creating centralized and harmonized rules for single-use device reprocessing ("fully refurbished medical devices”) across all member countries. The amendment now needs to go through the Parliament and the European Council for approval, a process that will take at least 6 months.
The amended paragraph 17 in the European Medical Device Regulation (MDR) determines that reprocessors are considered to be manufacturers, which implies (among other things) that a reprocessed should seek CE (Conformité Européene) certification before marketing its reprocessed devices. However, the MDR also left open for reprocessors to chose a different regulatory pathway, the so-called Common Specifications: Common Specifications for reprocessing under the EU MDR define technical & procedural requirements for safely reprocesssing single-use medical devices, covering quality systems, risk management, validation, documentation (like reprocessing cycles & device history), clear labeling (with "reprocessed" & cycle counts), and contracts for external reprocessors, ensuring performance equivalence to original devices for reuse within the same facility where national law permits. For reprocessors, reprocessed devices must be returned specifically to the healthcare facility from which they were collected, maintaining a closed-loop system where healthcare facilities retain ownership of the devices.
Common Specifications were intended to serve as a “how-to” guide, bridging the gap between broad regulations and practical, safe implementation in healthcare settings. However, in reality, they represent a lesser regulatory path than the CE process, which can complicate and create dual standards for the industry, which WILL slow down adoption and create confusion among end-users. In the US, for comparison, demanding that reprocessors do exactly the same as manufacturers has helped create confidence in the safety of reprocessing. It would be wise for the Commistion to learn from this and abandon Common Specifications.
In the US... demanding that reprocessors do exactly the same as manufacturers has helped create confidence in the safety of reprocessing.
Nevertheless, the proposed amendment is fantastic news, and if approved, this should mark the start of the EU embracing one of the most successful environmental and financial sustainability initiatives in healthcare. The process will be slow and involve hick-ups. Involvement by US-based reprocessors, however, would benefit the process and enable the more rapid maturation of the industry.