Europe's promising (but bumpy) road to embracing single-use device reprocessing

You might be surprised to know that Europe, specifically the European Union (EU), lags far behind the United States in reusing single-use equipment. After all, Europe is often ahead of the United States in initiatives to reduce environmental harm and improve sustainability. However, while the United States began implementing single-use device reprocessing regulations in 2000, the European Union has yet to develop a centralized single-use device reprocessing policy. Instead, the EU has an opt-in system that allows member states to decide whether to allow single-use devices to be reprocessed.

Adoption of reprocessing is fragmented due to the opt-in approach. Some countries – notably Germany, the UK (a non-EU member state) and some other EU countries – eagerly pursue reprocessing. Others resisted.

Germany has allowed reprocessing for many years and is the only country with an established reprocessing industry. Berlin-based Vanguard Group dominates this market and is responsible for the limited success in European reprocessing. Today, the UK has arguably the most advanced reprocessing policy in Europe, with mandatory regulations for healthcare facilities.

Therefore, some places in Europe consider reprocessing of single-use equipment as a sustainable development strategy. However, decentralized adoption of post-processing is problematic for several reasons:

• Since most EU countries have not yet opted in, the environmental impact will be limited.
• The costs of medical equipment absorbed by the EU's state-run healthcare systems are too high.
• The fragmented nature of the European reprocessing market means that it is not an attractive investment area for large U.S. reprocessing companies. As a result, Europe has not been able to benefit from a larger product portfolio in the multiplayer industry or other positive effects of competition.

Part of the explanation for the lack of medical device reuse is that the EU is not a federal system like the United States. Regional and national differences are often allowed to coexist without any attempt to create EU harmonization.

However, late last year (16 December), the European Commission published proposed amendments to existing legislation, effectively removing the opt-in paragraph (this is paragraph 17) and setting out centralized and harmonized rules for the reprocessing of single-use devices (“completely refurbished medical devices”) across all Member States. The amendment now needs to be approved by Parliament and the European Council, a process that will take at least six months.

Revised paragraph 17 of the European Medical Device Regulation (MDR) establishes that reprocessors are considered manufacturers, which means (among other things) that reprocessors should seek CE (European Conformity) certification before selling their reprocessed devices.

However, MDR also provides reprocessors with the option of choosing a different regulatory path, the so-called Common Code. The General Specification for Reprocessing under the EU MDR defines technical and procedural requirements for the safe reprocessing of single-use medical devices, covering quality systems, risk management, validation, documentation (such as reprocessing cycles and device history), clear labeling (with “reprocessing” and cycle count), and external reprocessor contracts to ensure equivalent performance to the original device for reuse within the same facility, where national law allows. For reprocessors, reprocessed devices must be returned exclusively to the healthcare facility that collected the device, thus maintaining a closed-loop system in which the healthcare facility retains ownership of the device.

Common specifications are intended to serve as a “how-to” guide, bridging the gap between broad regulations and actual, safe implementation in healthcare settings. However, in practice, they represent fewer regulatory pathways than CE processes. This alternative route could complicate the industry and create double standards, which will Slowing adoption and creating confusion among end users.

By contrast, in the United States, reprocessors are required to perform the same practices as manufacturers, which helps build confidence in the safety of reprocessing. The Commission should learn from this and abandon the common norm.

Nonetheless, the proposed amendments are good news. If approved, it would mark the start of the EU's embrace of one of the most successful environmental and financial sustainability initiatives in healthcare. This process can be slow and have some problems. However, the involvement of U.S. reprocessors would benefit the process and allow the industry to mature more quickly.

Photo: Flickr user Yukiko Matsuoka

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