In 2000, when FDA led the U.S. to become the first country in the world to regulate the use of reprocessed single-use devices, the agency responded to concerns from manufacturers and physicians that un-regulated re-use of single-use devices could compromise patient safety. Regulation meant that unsafe reprocessing in hospital sterile processing departments ceased—and that third-party reprocessing companies got a regulatory path for reprocessing so that hospitals could gain financial benefit from device re-use without compromising patient safety.
The regulation of reprocessing also—unintentionally—helped U.S. healthcare become more prepared to address climate change concerns. After all, while regulated reprocessing saves hospitals hundreds of thousands of dollars every year, it also dramatically reduces the hospital’s CO2 emissions. However, if the U.S. doesn’t pay attention, that leadership position could soon be in question.
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The environmental benefits of reprocessing
The average EP lab can reduce its CO2 emission by more than 2,200 pounds CO2 equivalent per year through reprocessing. Life-cycle analyses (LCAs) comparing the carbon footprint of new electrophysiology (EP) devices with the carbon footprint of new EP devices have demonstrated that the carbon footprint of a reprocessed device is half the footprint of a new device. This environmental savings impact is significantly greater than that of a device recycling program, which implies that a new catheter will be needed. In other words: Every time a catheter is recycled rather than reprocessed, the EP lab increases CO2 emissions.
Reprocessing has emerged as a prime solution for addressing the need for healthcare to reduce its carbon footprint, and the U.S. FDA became an (unknowing) early champion for reducing healthcare’s carbon emissions footprint. The U.S. has, if you will, been ahead of the rest of the world. This may be changing, however, and there is great risk that the U.S. will be left behind other countries, particularly in Europe, in its efforts to make healthcare more “climate friendly.”
In the UK, for example, the National Health Services (NHS) has aggressively engaged in healthcare sustainability efforts with mandates to implement and prefer more-sustainable solutions—including single-use device reprocessing. In France, the Working Group of Cardiac Pacing and Electrophysiology of the French Society of Cardiology recently published a position paper on sustainability in electrophysiology that presents a solution that represents a more deliberate and far-reaching model than anything we have seen in the U.S.
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An ambitious vision for reprocessing
The French electrophysiology position paper notes why looking at sustainability in EP is particularly important in the broader context of healthcare environmental impact: EP mainly uses high-tech, single-use medical devices, as opposed to other procedure areas, where reusable, low-complexity devices dominate. In EP, rare metals and rare-earth elements are crucial for manufacturing devices, and the materials are sourced from a complex network of suppliers and locations around the world. The fragile nature of this materials supply network can have an impact on EP procedures when, for example, chip shortages lead to cancelled procedures.
Moreover, atrial fibrillation procedures have a carbon footprint of 170 pounds of carbon, with material production and manufacturing contributing 71 percent of this. This means that reprocessing, which re-uses these parts, has a significant impact on the carbon footprint. Additionally, EP procedures grow by 10-15 percent every year in the U.S. and Europe, and due to the use of scarce materials, the supply of these devices might eventually itself become a problem—a problem that could partially be addressed through reprocessing.
The authors of the positioning paper declare that “reprocessing of certain single-use medical devices appears to be a solution for reducing supply tensions, limiting the environmental impact of medical devices (carbon footprint and reduction of raw material extraction) and lowering procedural cost.” This is a compelling statement by a society of cardiologists. Reprocessing is still prohibited in France, but it is noteworthy that the clinical community, which has traditionally been the most hesitant to adopt reprocessing, is now pushing for the practice to be established. That means they are more progressive than the French authorities.
The key risks associated with reprocessing—loss of functionality and contamination—are also addressed in the paper, but the authors reference studies to conclude that “neither the material properties nor the functional characteristics of the devices were altered as a result of reprocessing. Moreover, the reprocessed catheters did not disadvantage patients or medical doctors […] and reuse of electrophysiology catheters was considered safe for patients.”
Interestingly, the authors warn that “some electrophysiological devices are equipped with lumens (sheaths, irrigated catheters, needles), and precautions should be taken because some areas can be difficult to reach. Cleaning and sterilizing the lumens as well as checking that there is no obstruction or leak are essential. Thus, medical devices with lumens should probably only be reprocessed by facilities with dedicated expertise.” Innovative Health holds several patents on micro-lumen cleaning and inspection, as well as several FDA clearances for devices with micro-lumens. Since more and more devices are designed with lumens, the evolution of reprocessing technology that can clean and inspect these is becoming more and more important every day.
In the U.S., substantial numbers of diagnostic catheters, sheaths, cables, and other devices are being reprocessed and re-used. The use of reprocessed mapping catheters is more rare (due to manufacturer interference), and no ablation catheters have been cleared for reprocessing. From both an environmental and fiscal perspective, this means that the potential for reprocessing is far from fully realized. In fact, in an atrial fibrillation procedure, those two catheters typically represent more than 50 percent of the device costs.
In contrast, among French physicians, “The reuse of mapping and ablation catheters emerged as the solution mentioned most frequently by physicians.” If this interest can be activated in Europe in the form of approved reprocessing of mapping and ablation catheters at a high rate, EP reprocessing environmental impact in the country could quickly leap ahead of that in the U.S.
A multifaceted path to sustainability via reprocessing
The position paper is far-reaching in its recommendations for reprocessing EP devices, and it is also realistic about barriers to increasing sustainability in EP. The authors present a framework for how the multiple stakeholders involved (countries, manufacturers, medical societies, hospitals, and physicians) need to take action to create meaningful change:
- National authorities must mandate LCA analyses for devices and establish carbon emission programs such as the NHS program.
- Manufacturers should start reprocessing their own devices (a particularly bold notion).
- Medical societies should integrate carbon emission footprint discussions into scientific meetings.
- Hospitals should integrate carbon emissions into the process of selecting which devices to use.
FDA’s regulation of single-use device reprocessing effectively made the U.S. the leader in EP sustainability efforts early on. However, very little has been done to build on this early leadership. As a result, we will likely have to look abroad to witness improvements in the sustainability of EP procedures—and the charge is led by an unlikely group. Should the collective opinion of French electrophysiologists shape future re-use practices in France, they will be decades ahead of the U.S. in terms of EP sustainability and financial responsibility.
Photo: ChrisGorgio, Getty Images
