Sustainability


reprocessing. Requirements for reprocessing differ depending on where you live. In the US, a device must first be cleared for reprocessing by the FDA during its pre-market submission, in which the manufacturer must include additional validation data showing that the device will be as safe and effective as the original once reprocessed. A recent study published in Sustainability, ‘Combining Life Cycle Assessment and Circularity Assessment to Analyze Environmental Impacts of the Medical Remanufacturing of Electrophysiology Catheters’, shows that the carbon footprint created from just one aspect of the production process – producing and processing plastic – for a newly- manufactured electrophysiology catheter was greater than that of the entire remanufacturing process for an equivalent device. Compared with virgin manufacturing, reprocessing was found to reduce the global warming impact by 50.4% and lowered overall use of resources by 28.8%. This study is the first comprehensive life-cycle assessment (LCA) of reprocessed devices versus those disposed of after a single use and applies a circularity metric – a measure of how resource input and value is retained, and waste minimised within a closed loop system – alongside commonly-used LCA modelling approaches to indicate a product’s environmental impact. For original equipment manufacturers (OEMs), this kind of circular thinking can offer a more thorough insight into a product’s environmental impact and potential for reuse, which can then inform materials and design decisions.


Recyclability Whether or not a product is suitable for recycling depends in large part on its material make-up and complexity, says Robert Render, sustainability business development manager at Ravago Recycling. A device is likely to be recycled if there is enough material in it that can be recovered via available recycling processes and the value of the recovered material is greater than the cost of processing. Recycling a device such as a syringe, which is mostly polypropylene, is fairly straightforward – the aim is simply to recover the polypropylene, a valuable material that can be retrieved via a process of density separation. However, when dealing with a device made from a mixture of materials, it may not be possible or worthwhile to target a single material, making it harder to justify the cost and time needed to process it.


Although sometimes the energy requirements for processing outweigh the benefits of recycling a device, executive director of the HPRC Peylina Chu points out that plastic needs to be evaluated differently. “When you look at the refining


Packaging Insight / www.worldpharmaceuticals.net


of crude oil to create plastics, there is no situation where recycled plastics are less environmentally friendly than refining and creating virgin plastics,” she says. As such, if a plastic device isn’t recycled, then it could be because its recyclable materials aren’t considered valuable enough. The HPRC offers design and materials advice to OEMs interested in improving the recyclability of their products. For healthcare plastics, these include designing with mono-materials whenever possible and using materials that are easily separated during automated recycling processes. It’s also important for OEMs to consider the recyclability of the packaging their devices are delivered in. “Packaging is what we consider the low-hanging fruit in terms of plastics recycling, because the hospitals can collect that packaging material before it even has any contact with patients,” says Chu.


Reprocessing


Reprocessed medical devices can be understood as similar to generic drugs – equivalent from a safety and efficacy standpoint, but at a fraction of the cost of creating a virgin product, says Daniel Vukelich, CEO of the Association of Medical Device Reprocessors (AMDR). Materials and design considerations influence whether a device is suitable for reprocessing,


In the US, medical devices require confirmation from the FDA before being cleared for reprocessing.


$1.4bn


Value of the commercial reprocessing industry in 2019.


GMI


20– 25%


HPRC 21


Hospital waste created by plastic packaging and products, 85% of which is free from contamination.


Association of Medical Device Reprocessors


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