Singled out

Singled out

Dan Vukelich, the Association of Medical Device Reprocessors, examines issues surrounding ‘single use’ devices, the opportunities available for the reprocessing of these devices in the EU and how it can learn from the US experience

Worldwide, hospitals are reusing many medical devices originally labeled by the manufacturer as ‘single-use’.  Indeed, even in Europe, where countries have policies that explicitly discourage such reuse, it still takes place. This excludes Germany, where reuse is subject to requirements and oversight. In most other European Union Member States, the reuse of ‘single-use’ devices (SUDs) takes place in the shadows, without any validated reuse instructions or oversight, and often in contravention of governmental policy. Hospitals do so out of economic necessity and sometimes, frankly, because many hospital personnel are suspicious that the ‘single-use’ designation used on manufacturer labeling, is more of a marketing ploy to sell devices than it is the result of regulatory requirements.

Regardless as to how we got here, the European Union (EU) now has the opportunity to address the issue at the EU level. As part of a larger EU-wide Medical Device Regulation proposal, both the European Commission and the European Parliament have proposed to regulate the reprocessing of SUDs. 

Supporting SUD reprocessing

The Association of Medical Device Reprocessors (AMDR), the global trade association representing the interests of the third-party medical device reprocessing industry, fundamentally supports the goal of regulating SUD reprocessing. Specifically, AMDR supports the basic framework of the European Commission’s proposal, which would require any entity that reuses an SUD to assume full responsibility as the medical device manufacturer, including demonstrated compliance with the essential requirements to a Notified Body and CE marking. 

Treating SUD reprocessing as manufacturing is not a novel concept. American third-party reprocessors include companies such as Medline ReNewal (part of Medline Industries), Stryker Sustainability Solutions (part of Stryker Corp) and Sterilmed (part of the Johnson & Johnson family of companies). Each of these reprocessing companies, now also part of much larger original equipment manufacturer (OEM) parent companies, must meet the US FDA’s requirements for medical device manufacturers, including premarket clearance and review. The result of US FDA regulation has been dramatic growth in the SUD reprocessing market, which has allowed US hospitals to save hundreds of millions of dollars and prevent millions of tons of medical waste from going to landfills or incinerators. 

What exactly does manufacturer treatment of SUD reprocessing mean? Since the original manufacturer has labeled the original device for ‘single-use’, the reprocessor has to stand in the shoes of that OEM for any subsequent sale of that device. The reprocessor must provide to the notified bodies what the OEM did not – data showing that the device meets manufacturer standards for the pre-set number of reprocessing cycles that have been scientifically validated by the reprocessor. It further means that the reprocessor becomes subject to all the same pre- and post-market requirements of Notified Bodies and competent authorities, as any other manufacturer, including:

Labeling - reprocessors will label the devices, clearly indicating it is reprocessed and with the reprocessor’s name as the responsible manufacturer;

Device identification (including UDI), tracking, and registration requirements;

General manufacturer safety and performance requirements;

Vigilance and market surveillance requirements, including adverse event reporting as the responsible manufacturer (not the OEM);

Quality system requirements including conformity assessment requirements; and

Clinical evaluation requirements.

Put to the test

Beyond meeting these requirements, AMDR’s members go a step further by testing or inspecting 100% of the devices they reprocess. Most manufacturers conduct batch or sample tests. AMDR member reprocessors provide individual scrutiny to each reprocessed SUD. 

Medline ReNewal, Stryker Sustainability and Berlin-based Vanguard, Europe’s largest commercial reprocessor, make up the membership of AMDR. In the US AMDR member-companies meet FDA’s manufacturer requirements meaning they have demonstrated that their reprocessed scalpels, saw blades, pulse oximeter sensors, and cardiac catheters, for instance, are as safe and as effective as a new device. AMDR’s members are fully committed to the manufacturer standard for SUD reprocessing in Europe. 

Not suitable for all devices

Fundamentally, AMDR’s members believe that not all SUDs can and should be reprocessed.  AMDR believes that, based on current technology, only a very small subset of SUDs can be reprocessed. Even reprocessing that small portion of SUDs can have a positive impact on hospitals and healthcare systems without compromising patient safety. The savings potential by reprocessing just 2-3% of SUDs could be billions of Euros – not to mention the sizable amount of medical waste diverted from landfills. 

Regulatory history of reprocessing, using the US FDA regulation as one example, demonstrates that once SUD reprocessing is held to manufacturing standards, inappropriate reuse of SUDs stops because entities that cannot meet the requirements are forced to halt the practice or outsource to entities that meet the standards. 

With some minor but important modifications, the European Commission’s proposed regulatory approach can serve as the basis for the EU’s reprocessing rules. Done correctly, a single framework will ensure patients across the EU can expect the same level of safety from the medical device they receive, new or reprocessed. It is fair to hospitals in that it provides a legal, overt pathway for them to use lower-cost, environmentally friendly reprocessed SUDs. Finally, the approach is fair to both reprocessors and OEMs in that it levels the regulatory playing field.