Environmental protection and credible sustainability are scaling the global social agenda and the corporate world is not standing by. Reducing emissions and waste are now a key part of business strategy across a number of sectors, and pharmaceutical and medical device manufacturers are not excluded. There are in fact, various benefits that can be achieved in addition to compliance with new demands by regulators, hospital systems, governments and consumers to conform to this emerging reality. In addition, companies are well aware that if they do not introduce measures to become more environmentally responsible, they will risk losing access to markets around the world.

A Sizeable Problem

The U.S. healthcare system accounts for 10% of the country’s carbon emissions and 9% of harmful non-greenhouse air pollutants , while the combined healthcare sectors of the United States, Australia, Canada, and England produce about 748 million metric tons of greenhouse gases annually.¹ In Europe, legislation has been introduced to help curb these figures, while in the United States, pressure from a non-domestic customer base has already forced many U.S. companies to comply with the Waste Electrical and Electronic Equipment (WEEE) and Restriction on Hazardous Substances (RoHS) directives. In addition, many commentators are now saying they regard the passage of strict environmental regulation and/or legislation in the United States as inevitable.

Sustainability Stumbling Blocks

While the objective is noble and cost-effective, the medical device sector is faced with a unique mission in its drive towards greater sustainability: Ensuring the safety of healthcare workers and patients using their devices. A topical example is posed by the waste produced by the disposal of personal protective equipment (PPE), which are frequently made of plastic material and tend to be single-use. Similarly, the European Centre for Disease Prevention and Control, Healthcare Acquired Infection (HAI) reports that rates run at between 5% and 8% of patients in most developed countries.² To reduce risk, strict single-use regulations around many invasive medical devices, along with mandatory legislation in the United States and Europe on the use of products for needlestick injury prevention, has been introduced. Safety and sustainability therefore can appear to be at odds unless a strategic, long-view approach is applied by medical device manufacturers.

Waste Worries

Reports show that approximately 90% of medical device waste consists of disposable, one-time-use products or components. Specifically, Practice Greenhealth, a non-profit organization that works to make hospitals more sustainable, estimates that a quarter of all waste generated by hospitals is plastic.³

Traditionally, in Europe incineration has been used to reduce the volume of medical waste and destroy biohazardous materials. This process releases nitrous oxide, as well as known carcinogens.⁴ Historically, sterilization and reprocessing have also been trialed. Sterilization, however, often does not prove environmentally sustainable, as it requires the employment—and later disposal—of harmful chemicals such as glutaraldehyde or ethylene oxide. Recycling strategies need to take into account both safety concerns and the commercial concerns of manufacturers, especially considering that recycled devices would be subject to the same level of scrutiny as a brand new device under the EU Medical Device Regulation.

As a result, the main areas of activity that medical device manufacturers are taking to address the issue can now be classified into three macro-groups: Recyclability, sustainable manufacturing and sustainability by design.

Recyclability

Given that one million tons of clean, non-infectious healthcare plastic waste is generated in healthcare facilities every year, according to the Healthcare Plastics Recycling Council, some medical device manufacturers are choosing to reprocess and reuse materials rather than tackle complex and expensive sterilizing processes.⁵

PVC, for example, can be recycled several times without losing its critical properties and some companies are opting for an increased use of recyclable plastics, such as renewable polyethylene (PR) and polyethylene terephthalate (PET). There is also investigation into a wide range of materials and additives that can reduce the energy required to process into final product. Bio-based materials can offset the carbon emitted during processing as the monomer source grows. A growing range of sources for bio-based monomers is available, including wood pulp and sugar cane. However, when assessing the most appropriate material for a part, the entire lifecycle of the product needs to be considered fully. In addition, for recycling to work, closed loop recycling systems must be put in place to recover waste material from hospitals and patients, and bring it back into the recycling process.

Sustainable Manufacturing

Improving manufacturing processes is another key way of reducing impact on the environment. One example includes making onsite changes to ensure all energy is coming from clean renewable sources. Environmentally sustainable practices increase productivity and therefore appeal to businesses both commercially and ethically. New generation manufacturing technology, for example, is not just more energy efficient, but can also reduce waste and shorten time to market.

Sustainability by Design

Something all effective strategies have in common is a long view that spans the entire lifecycle of the product, from concept development and material selection to transportation methods and end-of-life disposal. Existing design procedure should be updated to include a thorough evaluation of energy efficiency, environmental impact, material usage and recycling. There are already resources available to support this transition. Reducing the number of components at device design stage can, simplify the manufacturing process and reduce waste and transport impact. Products with minimal components that are easy to disassemble will also facilitate recycling, while using more environmentally-friendly materials enables the reduction of toxic air emissions during disposal or incineration, but also reduces waste processing costs.

Parenteral or other invasive products will typically continue to have a disposable component to address safety and hygiene concerns, but introducing a wider use of recyclable materials, and introducing sustainability considerations in manufacturing processes and design could have a significant impact on the environmental sustainability of medical devices.

References

1. Eckelman, M.J. and Sherman, J.D. (April 2018). Estimated Global Disease Burden of US Health Care Sector Greenhouse Gas Emissions. American Journal of Public Health. 108(Suppl 2): S120–S122.
2. European Centre for Disease Prevention and Control, Observed and predicted prevalence of HAIs and antimicrobial use. Retrieved from https://www.ecdc.europa.eu/en/healthcare-associated-infections-acute-care-hospitals/database/prevalence-hais-and-antimicrobial-use/observed
3. Practice Greenhealth. (May 2018). How the healthcare industry is addressing the fast-growing medical waste problem.
4. Ansari, M., et al.(November 2019). Dynamic assessment of economic and environmental performance index and generation, composition, environmental and human health risks of hospital solid waste in developing countries; A state of the art of review. Environment International. Vol 132.
5. HPRC. (January 23, 2019). Why recyclers should consider healthcare plastics as an important feedstock.