It might surprise you that Europe, and specifically the European Union (EU), is lagging far behind the United States when it comes to the re-use of single-use devices. After all, Europe is usually ahead of the United States when it comes to initiatives to reduce environmental harm and improve sustainability. However, while single-use device reprocessing regulation came into place in the United States in 2000, the EU has not had a centralized single-use device reprocessing policy. Instead, the EU has an opt-in system that allows member countries to decide whether or not they want to permit single-use device reprocessing.
As a result of the opt-in approach, adoption of reprocessing is fragmented. Some countries – notably Germany, the United Kingdom (not an EU member), and a few other countries in the EU – have eagerly pursued reprocessing. Others have stubbornly resisted.
Germany has allowed reprocessing for years and is the only country with an existing, mature reprocessing industry. Vanguard in Berlin has dominated this market and is responsible for the limited success of reprocessing in Europe. The United Kingdom today has arguably the most progressive reprocessing policy of all of Europe, with mandates for healthcare facilities.
So, there are places in Europe that have pursued single-use device reprocessing as a sustainability strategy. However, the fragmented adoption of reprocessing is problematic for several reasons:
- The environmental impact is limited, since most EU countries have not opted in.
- Medical device costs, as absorbed by the nationalized healthcare systems of the EU, are far too high.
- The fragmented nature of the reprocessing market in Europe means that it has not been attractive as an investment area for large, U.S.-based reprocessing companies. Thus, Europe has not been able to benefit from the larger product portfolio of a multiplayer industry or the other positive effects of competition.
The explanation, at least partially, for this lack of adoption of medical device re-use, is that the EU is not a federal system like the United States. Regional and national differences are often allowed to co-exist without attempts to create EU harmonization.
However, late last year (December 16), the European 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 six 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 reprocessor should seek CE (Conformité Européene) certification before marketing its reprocessed devices.
However, the MDR also left open an option for reprocessors to choose a different regulatory pathway, the so-called Common Specifications. Common Specifications for reprocessing under the EU MDR define technical and procedural requirements for safely reprocessing single-use medical devices, covering quality systems, risk management, validation, documentation (like reprocessing cycles and device history), clear labeling (with “reprocessed” and 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. This alternate pathway could complicate and create dual standards for the industry, which will slow down adoption and create confusion among end-users.
In the U.S., 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 Commission to learn from this and abandon Common Specifications.
Nevertheless, the proposed amendment is fantastic news. 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 hiccups. Involvement by U.S.-based reprocessors, however, would benefit the process and enable the more rapid maturation of the industry.
Photo: Flickr user Yukiko Matsuoka
Lars Thording, PhD, serves as vice president of marketing and public affairs at Innovative Health LLC. He has a background in academia, consulting, and industry leadership. He has been responsible for the launch of numerous market-disrupting solutions across healthcare, insurance, and technology. Originally from Denmark, Thording has taught at universities in Denmark, Ireland, and the United States. He currently serves as the vice president of marketing and public affairs at Innovative Health, a medical device reprocessing company specializing in electrophysiology and cardiology technology. Lars currently serves on the board of the Association of Medical Device Reprocessors.
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