Sustaining the Pace

Summary

• Pursuing credible sustainability and environmental protection has become mainstream and is now a shared goal for companies developing medical devices
• At the same time, there is tension between the efforts to recycle or reuse materials and the single-use disposable device culture designed to protect both patient and healthcare worker safety
• Nonetheless, it’s vital to introduce sustainable targets to reduce the substantial waste and energy consumption for which healthcare is responsible—much higher than in most other industries
• In many cases, sustainability programs also make strong business sense by saving money as well as reducing emissions
• Sustainability programs are increasing across the medical sector, focusing on three main areas as outlined in this short paper:
  • Recycling
  • Optimizing manufacturing processes
  • Sustainability by design

Sustainability becomes the standard

Environmental responsibility and good stewardship are quickly being normalized as essential roles for companiesⁱ. On a personal level, many of us are looking for greener options and taking steps to reduce how much we impact the environment. What used to be a niche concern twenty years ago is now a universal requirement.

The medical device sector is also under pressure from regulators, hospital systems, government agencies, and consumers to meet these new standards. However, adapting comes with significant costs, and many feel that if medical device companies don’t act now to boost their environmental responsibility, they risk losing access to global markets.

Challenges for medical products

The main challenge relating to medical products is balancing sustainability with infection control—an especially relevant issue as the world emerges from a pandemic. While dealing with immediate problems such as the disposal of personal protective equipment (PPE), one expert noted that “the disruption caused by COVID-19 can act as a catalyst for long- and short-term changes in plastic waste management across the globeⁱⁱ.” We all want to decrease healthcare waste—but at the same time, we all expect to be as safe as possible while receiving care. According to the European Centre for Disease Prevention and Control, Healthcare Acquired Infection rates range from 5% to 8% of patients in most developed countriesⁱⁱⁱ. This figure is still too high and is threatened further by antimicrobial resistance, as the US Centers for Disease Control notes^iv. They also report that more than 2.8 million antibiotic-resistant infections occur every year in the US, causing more than 35,000 deaths. These issues—including avoidable healthcare worker infections from needlestick injuries—have resulted in a strict single-use, disposable approach for many invasive medical devices and have led to mandatory rules in both the US and Europe. Walking the line between patient safety and environmental responsibility remains challenging.

The scope of the issue

However, there is no question that the environmental impact from healthcare is huge. The US healthcare system produces about 10% of national carbon emissions and 9% of harmful, non-greenhouse air pollutants^v. On top of that, the sector’s greenhouse gas emissions climbed 30% from 2006 to 2016^vi. Combined, the healthcare sectors in the US, Australia, Canada, and England release an estimated 748 million metric tons of greenhouse gases every year—more than the annual carbon output of all but six countries worldwide^vii. In Europe, over the past two decades, laws have been passed to address these problems. European standards like Waste Electrical and Electronic Equipment (WEEE); Restriction on Hazardous Substances (RoHS); Registration, Evaluation, and Authorization of Chemicals (REACH); and Energy Using Products (EuP) rules have greatly impacted manufacturing processes, labeling, compliance with disposal limitations, and developing end-of-life and recycling instructions. Although many medical devices are currently excluded from these regulations, multiple directives—including RoHS and WEEE—are currently under review and may apply in the future. Also, as more devices are now “connected” in an increasingly digital world, they fall under the oversight of agencies regulating electronics. Europe is a key market for many medical device makers, so even in the US, pressure from international customers has already required many US companies to comply with WEEE and RoHS. Many experts now believe strict environmental laws in the US are inevitable.

New business drivers for sustainability

A significant portion of the US healthcare sector—including major hospitals and group purchasing organizations (GPOs)—now realize that sustainable purchasing can actually save money over time. It’s important for responsible actions to be backed by solid business cases, as the combination often brings such policies into the mainstream. In practice, this is shown by many GPOs hiring and empowering senior directors for environmentally preferred sourcing, who are successfully making the case for sustainable purchasing^viii.

Incinerating medical waste has long been used to shrink waste volume and destroy hazardous material. But, it also releases dangerous pollutants such as nitrous oxide and carcinogens like polychlorinated biphenyls, furans, and dioxins^ix. Exposure to these chemicals is linked to health damage in both developing and adult bodies, as well as harming soil and oceans through acidification. Shifting from incineration to recycling therefore cuts both costs and environmental damage. Increasing recycling rates—especially for plastics—is highly desirable, and where not possible, European laws set strict emission limits for clinical waste incinerators^x. Advanced filter systems are also being adopted at incinerators to stop toxic emissions from polluting the air.

Obstacles to sustainability

Right now, about 90% of medical device waste comes from disposable, single-use items or parts. It’s tempting to assume you can just cut the number of throwaway components—but as we’ve covered, safety rules often make that impossible. Plus, the sector’s business model must be considered to ensure change is financially sustainable and to keep products in supply. Most manufacturers make the majority of their revenue by selling disposable items or parts. This business approach is reinforced by the risks of dangerous medical waste, biological contamination, and the high expense of sterilizing and reusing products.

Sterilization—which might seem like an easy path to reuse—is often not environmentally friendly, even with large equipment. For example, a study published in BioProcess International found that running, cleaning, and sterilizing a stainless steel pharmaceutical powder handling machine used 8,018 megajoules (MJ) of energy, while manufacturing and disposing of a single-use powder handling device used 4,156MJ. In this case, the disposable device was actually better for the environment, despite the waste, given how much energy it takes to maintain reusable equipment. Plus, several common sterilization methods, like using glutaraldehyde and ethylene oxide, are not only harmful to the environment but are also tightly regulated for disposal. As a result, many hospitals and medical device companies are switching to less toxic methods like hydrogen plasma^xi.

“Switching to alternative materials is no simple task. Biodegradable materials often require a catalyst to trigger breakdown—like autoclave conditions or water exposure. Lacking those, it’s tough to guarantee the product will work properly, since batch variation and storage changes can cause breakdown at various times. As a result, biodegradable products that degrade in normal conditions typically must be sealed prior to use, which is difficult if you don’t use non-biodegradable plastics.” – Toby Cowe, Technology Development Group Manager R&D, Owen Mumford

Sustainability trends in medical devices

Although the barriers to sustainable design in medical devices are substantial, there’s still a lot that can be accomplished. The industry will likely be challenged by governments and regulators to balance product sustainability, patient safety, and business sense. Many device manufacturers are now documenting their environmental performance and sharing it as a way to highlight their progress. There is growing evidence that sustainability credentials are being included in medical device tenders^xii. As the World Health Organization points out, “harnessing the purchasing power of health systems to maximize positive environmental impacts—and encouraging suppliers to consider environmental impacts in their manufacturing—is a powerful tool for change^xiii.”

So what are the main components of sustainability that leading medical device manufacturers are now implementing to contribute to sustainability while still meeting all of the safety standards for patients and healthcare professionals? We have summarized them here under three key areas.

Recyclability

Two issues make up recyclability: whether a device is safe and effective to reuse and whether its materials can be recycled and reused in medical settings or elsewhere. As discussed, device reuse is fraught with safety concerns and questions about the full environmental impact of sterilizing. Medical Device regulation along with local agency rules like those from the MHRA clearly state that a recycled device must meet the same requirements and approvals as a brand new one. Further developments are on the horizon, too. In August 2019, the European Commission wrapped up public feedback on safety and performance standards for single-use device reprocessing, and further outputs are expected after post-pandemic priorities are addressed.

Regarding recyclable materials, there’s real progress being made. PVC, for example, can be recycled several times without losing its critical properties. Efforts are also underway to use plastics that are easier to recycle, such as renewable polyethylene or PET. Closed-loop recycling programs need to be set up so that waste from hospitals and patients can be collected and put back into the system. These are challenging to implement, but the benefits would be considerable. According to the Healthcare Plastics Recycling Council, over a million tons of clean, non-infectious healthcare plastic waste are generated each year^xiv. And recycling science is moving forward: new monomer extraction techniques allow for polymers to be broken down to their basic units—so if widely adopted, certain plastics could become nearly endlessly recyclable without any loss in quality^xv.

Packaging is also critical in recycling. Some companies are reducing package sizes by using sealed trays instead of pouches. Others are cutting down the number of components in a package—sometimes by laser-etching instructions on the tray itself when allowed by law^xvi. Further research is being done into faster-degrading plastics^xvii. Logistical considerations included early in packaging design can specify efficient transportation, saving energy—especially when cold chain storage is required^xviii.

Question: What changes have you already made to pharmaceutical packaging design and materials to offer a more sustainable alternative? (Please select all that apply)

Base: All respondents; multiple answers allowed (n=166). ¹Other includes: Improved Nonreactive Materials; More Reusable And Biodegradable Components; New Ways To Administer; And Training On Critical Thinking About Sustainability With Several Groups Of Health Professionals
Owen Mumford Pharmaceutical Services, in partnership with Pharma Intelligence, Injectable Combination Products. August 2020.

Sustainable Manufacturing

Medical device manufacturers have many opportunities to improve the sustainability of their manufacturing processes, each of which has a positive environmental impact that the company can highlight to the procurement chain. Reducing water usage, increasing energy efficiency, optimizing logistics, and decreasing the use of harmful chemicals are all areas that manufacturers are addressing^xix. Manufacturers are working with healthcare providers to outline, report, and measure these improvements through organizations such as the UK’s Sustainable Healthcare Coalition, as well as by collaborating on environmentally sustainable patient pathways within the healthcare system itself.

Energy efficiency plays a key role in making medical device manufacturing more sustainable, not only by directly affecting CO₂ emissions, but by delivering immediate cost savings. Larger sustainability programs often fund themselves by using future savings from reduced energy costs.

Adopting new-generation manufacturing technologies can also lead to productivity gains, while often being more energy efficient, minimizing waste, and speeding up the time to market. For example, using 3D printing to develop and test prototypes can help create the best product molds more quickly, enabling usability testing while refining production parameters to use less raw material and boost productivity. Similarly, ‘digital twin’ production software uses inline sensors to create a real-time virtual representation of the production environment. This makes it possible to develop, test, and implement improvements on the production line without stopping actual physical production. The ultimate aim is to achieve ‘zero defect’ manufacturing and further cut waste.

“Owen Mumford has made many onsite changes to ensure all our energy comes from clean renewable sources. We’re also exploring a wide range of materials and additives that can lower the energy needed for final production. Bio-based materials can offset the carbon released during processing as the monomer source grows. There are now more sources available for bio-based monomers, like wood pulp and sugar cane. Still, when choosing the right material for a part, you have to consider the product’s entire lifecycle. For example, biodegradable polymers can contaminate a recycling stream and release methane when incinerated… and methane’s carbon impact is 25x greater than CO₂.” – Toby Cowe, Technology Development Group Manager R&D, Owen Mumford

Sustainability by Design

Many core principles of sustainable product design begin with developing a product life cycle approach, not just focusing on the product itself, but on every stage: concept, material selection, design and engineering, manufacturing, packaging, transportation, sales, use, and end-of-life disposal. This mindset is already in use to boost manufacturing efficiency, cut time to market, reduce risk, ensure safety and meet regulatory demands, as well as to keep down packaging and transportation costs. It expands existing disciplines to include energy efficiency, environmental impact, material use, and recycling. In some areas, current FDA and EMA quality system rules also reflect these environmental factors—especially around tracking, material safety and efficacy, and disposal. Likewise, LEAN manufacturing techniques target inefficiencies in related areas like overproduction, wait times, transportation, processing, inventory, movement, and waste.

“Design choices can have a big impact on the carbon footprint of therapies. Also, with careful planning in the design phase, it’s possible to reduce the amount of single-use plastic used for each treatment while still keeping products safe and easy to use.” – Toby Cowe, Technology Development Group Manager R&D, Owen Mumford

There are many other specific aspects of sustainability that can be incorporated into product design and engineering. For example, making devices easy to take apart can lower recycling costs and complexity; optimizing device size, simplifying device design, and reducing packaging can decrease waste and shipping impacts; while standardizing materials and manufacturing processes across products can save both cost and waste, as well as give production lines more flexibility. For disposable products, choosing materials that cause less environmental harm when thrown out or burned can cut toxic air emissions and lower waste treatment costs.

“Understanding target market regulations around medical waste helps guide choices for single-use materials (bio-based for markets that incinerate, biodegradable for markets that use landfills). Understanding user behaviors can help select the toughest reusables that offer the best chances for recycling.” – Toby Cowe, Technology Development Group Manager R&D, Owen Mumford

Right now, most devices—especially parenteral or other invasive types—will still need a disposable element to meet safety and regulatory requirements. However, the key is to design the smallest possible disposable part within a reliably reusable shell. As devices become more digitally connected (delivering significant therapy and savings benefits for remote patient management and safe self-administration), business needs will push more development in this direction. The cost of disposable electronics just wouldn’t be practical and, as we’ve pointed out, wouldn’t meet current electronics disposal rules. So the challenge is to create a straightforward, reliable, and repeatable interface between the reusable and disposable components without hurting functionality or effectiveness.

For more information please contact pharmaservices@owenmumford.com