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Single-Use Yet Sustainable: Three Steps to Tackle Environmental Responsibility.

The increase in use of personal protective equipment (PPE)--which tends to be made of plastic material and is intended for single-use only--to control COVID-19 infection rates has cast a spotlight on one of the medical industry's most burning issues: environmentally sound production and disposal of devices. This is by no means a new issue, however, as medical device manufacturers have been working for quite some time to respond to increasing demand for environmental sustainability from the market, while at the same time protecting the safety of healthcare workers and device users.

The Centers for Disease Control and Prevention in the United States reports about one in 25 U.S. hospital patients is diagnosed with at least one infection related to hospital care each year, (1) and highlights more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, with more than 35,000 resulting deaths. (2) Across the world, parenteral and other invasive devices are, therefore, strictly regulated to help reduce the risk of infection. They typically contain single-use, disposable plastics to achieve this objective.

The U.S. healthcare system contributes 10 percent of the nation's carbon emissions and 9 percent of harmful non-greenhouse air pollutants. (3) Manufacturers of medical devices and orthopedic devices are, therefore, under increasing pressure from regulators, hospital systems, governments, and consumers alike to reduce emissions. Much of the U.S. healthcare system, including large hospitals and group purchasing organizations (GPOs), have also started to recognize that sustainable purchasing practices play a pivotal role in reducing costs over time. As a result, many GPOs have appointed and empowered senior directors of environmentally preferred sourcing who are successfully implementing the sustainable purchasing business case. (4)

In the EU (a key market for many U.S. medical device manufacturers), a number of standards to regulate emissions and disposal of waste have been put into place and, as a result, U.S. companies are already complying with the Waste Electrical and Electronic Equipment (WEEE) and Restriction on Hazardous Substances (RoHS) directives, for example. The passage of strict environmental regulation and/or legislation in the U.S. is also now widely regarded as inevitable by industry commentators. Hence, it is clear we are on the cusp of change and manufacturers who fail to address the issue risk losing access to important markets.

Burn After Reading

Typically, in the EU, medical device disposal is carried out through incineration--an environmentally damaging process that releases nitrous oxide as well as known carcinogens, including polychlorinated biphenyls, furans, and dioxins. (5) Although there are innovative solutions available to contain the impact to the environment, such as sophisticated filtering systems that can help to prevent toxic fumes from polluting the atmosphere or use of bio-based materials, the market is demanding a reduction in incineration in favor of more recycling. With approximately 90 percent of medical device waste consisting of disposable, single-use products or components, (6) the challenge is to resolve the tension between infection control, sustainability, and the need to maintain a healthy market for manufacturers who often rely on disposable products as a critical source of revenue.

Some of the strategies trialed by manufacturers to achieve this include sterilization and reprocessing, but these come with their own severe limitations.

The Sterilization and Reprocessing Route

Sterilization has been repeatedly found to have high energy and environmental costs, often higher than incineration. For example, in the U.S. 50 percent of all sterile medical devices are sterilized with ethylene oxide. However, since this method releases harmful emissions, the U.S. Food and Drug Administration is now encouraging the development of new methods or technologies to reduce dependence on this substance. (7) Similarly, a study in BioProcess International found the energy consumption of a stainless steel pharmaceutical powder handling machine, after factoring in cleaning and sterilization, reached 8,018 megajoules (MJ) of energy. In contrast, the process of manufacturing and disposing of single-use powder handling devices reached 4,156 MJ.

Although reprocessing of single-use devices has an established history in the U.S. (where the practice began in the 1970s (8)), manufacturers exporting to the EU will find the Medical Device Regulation (MDR), which came into force in May 2021, introduces strict reprocessing guidelines and places full product liability on the reprocessor. The safety and performance of reprocessed devices must be equivalent to the original device, in compliance with the MDR. (9)

1. Focus on Recycling

Reprocessing need not address the device in its entirety, but can focus on specific elements. Similarly, these components can be repurposed for different uses provided the original material can be recycled without losing its core properties. Polyvinyl chloride (PVC)-the most widely used plastic for medical devices-is one such plastic, (10) and so are renewable polyethylene and polyethylene terephthalate (PET). Monomer extraction techniques now enable recycled polymers to be broken down to their constituent monomers, promoting an almost limitless recyclability of some polymers.

A focus on packaging can also significantly reduce the materials that need to be dealt with through either waste or recycling. Packaging manufacturers are therefore decreasing volumes by favoring sealed trays instead of pouches or reducing the number of components required in the overall package.

According to independent research commissioned by Owen Mumford Pharmaceutical Services, 37 percent of device manufacturers now use recyclable materials, (11) and more and more manufacturers are exploring faster degrading plastics. As research continues to evolve, recycling without loss of performance is becoming an increasingly viable option.

2. Sustainable Manufacturing Using faster degrading plastics or material from other sources is a key strategy to reduce harmful pollutants, both at the production and disposal stage, but introducing more environmentally friendly materials should also be supported by an increase in clean, renewable energy sources. Lower energy consumption means fewer carbon emissions and also economic savings, making this a powerful measure to help the industry improve its practices.

Logistics and modes of transport must also be planned at the very beginning of the design process, so energy efficient choices can be made, especially if there is a need for controlled temperature. (12) New technologies and LEAN manufacturing methodologies are already helping to optimize inventory management and reduce overproduction.

3D printing, introduced to develop and test prototypes, can help develop optimum product molds more quickly, refining production parameters to minimize raw materials volumes and maximize output productivity. Similarly, "digital twin" production software uses inline sensors to create a virtual, real-time mirror of the production environment to enable inline refinements and aspire to "zero defect" (and therefore, waste-free) manufacturing.

Owen Mumford Pharmaceutical Services is investigating a wide range of materials and additives that can reduce the energy required to process into final products, including those manufactured for drug delivery. Bio-based materials can offset the carbon emitted during processing as the monomer source grows and a growing range of sources for bio-based monomers-such as wood pulp or sugar cane-is available.

When assessing the most suitable material for a part, however, the entire lifecycle of the product needs to be considered. For example, bio-degradable polymers can contaminate a recycling stream and emit methane when incinerated.

3. Integrating Sustainability in the Design Stage

Medical device sustainability, therefore, rests on an understanding of the full product lifecycle. Concept development, material selection, design and engineering, manufacturing, packaging, transportation, sales, use, and end-of-life disposal all need to be evaluated from a sustainability perspective to ensure an energy saving made at one stage does not have potentially more damaging repercussions at some other point of the lifecycle. The same evaluations made for manufacturing efficiency, time to market, risk reduction, safety and regulatory compliance, and packaging/transportation costs should therefore be extended to energy efficiency, environmental impact, material usage, and recycling.

Considerations made about device design can have an important impact on a therapy's carbon footprint without impacting safety or usability. At the same time, this early stage is the ideal time to thoroughly evaluate medical waste handling regulations for target markets, helping inform the decision to use bio-based materials for incineration markets, or bio-degradables for landfill ones. In addition to this, for recycling plans to work effectively, it is important to have a full understanding of the practices surrounding device use and to establish, where feasible, closed-loop recycling systems that recover the waste materials from hospitals or patients and bring them back into the recycling process.

Conclusion

As we continue to cope with COVID-19 and its wider effects, the importance of preventing the spread of infections is in sharp focus. At the same time, reducing waste and harmful emissions is no longer an issue device manufacturers can just dabble in; the need to address the climate emergency is real and has important commercial implications. Reducing the impact from disposable products and packaging are just one small step toward a more sustainable medical devices industry.

References

(1) bit.ly/mpo210601

(2) bit.ly/mpo210602

(3) bit.ly/mpo210603

(4) bit.ly/mpo210604

(5) bit.ly/mpo210605

(6) bit.ly/mpo210606

(7) bit.ly/mpo210607

(8) bit.ly/mpo210608

(9) bit.ly/mpo210609

(10) pvcmed.org

(11) bit.ly/mpo210611

(12) bit.ly/mpo210612

George I'ons * Head of Product Strategy and Insights, Owen Mumford Pharmaceutical Services
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Title Annotation:PROCESS IMPROVEMENT
Author:I'ons, George
Publication:Medical Product Outsourcing
Date:Jun 1, 2021
Words:1481
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