Safety and sustainability in medical device manufacturing

Environmental sustainability is rapidly becoming a key item on the medical device manufacturer’s corporate agenda, reports George I’ons, Head of Product Strategy and Insights, Owen Mumford Pharmaceutical Services

Not only are regulators, hospital systems, governments and consumers demanding that credible measures are put in place, more and more industry tenders now include environmental requirements too.

In addition to this, many group purchasing organisations (GPOs) have appointed and empowered Senior Directors of Environmentally Preferred Sourcing who are successfully implementing a more sustainable purchasing business case, indicating a tangible shift in mentality.1

The reasons for this shift are manifold: on the one hand, greater energy efficiency brings savings and increased productivity; on the other, all sectors are being called on to revise their processes to be more compatible with environmental protection.

The combined healthcare sectors of the US, Australia, Canada and the UK emit an estimated 748 million metric tons of greenhouse gases each year, an output greater than the carbon emissions of all but six nations worldwide.1

Unlike most other sectors, however, medical device manufacturers have to reconcile a reduction in waste and disposables with the need to ensure healthcare worker and patient safety.

George I'ons

Numerous items, such as personal protective equipment (PPE) or injection devices, are in fact made of plastic and specifically designed for single-use to comply with regulations that were developed to protect users from infection. Reports show that approximately 90% of medical device waste consists of disposable, one-time-use products or components.

In the US, these products frequently go to landfill; in Europe, they are generally disposed of by incineration, a process that releases nitrous oxide and well-known carcinogens.2

To reduce incineration volumes, sterilisation and reprocessing have also been trialled. Attempts with sterilisation have been largely unsuccessful as this process often requires the employment — and later disposal — of harmful chemicals such as glutaraldehyde or ethylene oxide, as well as demanding high energy volumes.

As a result, the main areas of activity that medical device manufacturers are now taking to address the issue can be summed up as follows: recyclability, sustainable manufacturing and sustainability by design.

Recyclability

Reprocessing is proving to be a far more successful option as certain materials, such as PVC for example, can be recycled several times without losing their critical properties.

Manufacturers are also opting for recyclable plastics, such as renewable polyethylene (PR) and polyethylene terephthalate (PET). For these strategies to work, however, 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

Another strategy that manufacturers are employing is to evaluate their energy efficiency and ensure that all on-site energy comes from clean, renewable sources. Reduced water use, energy efficiency, logistics optimisation and use of fewer polluting chemicals are rapidly becoming the norm in manufacturers’ process optimisation plans.

Energy efficiency is an appealing objective as it enables businesses to achieve savings while also reducing their carbon footprint. New generation manufacturing technology, for example, is not just more energy efficient, it’s also an enabler of waste reduction and shorter times to market.

Overall sustainability improvement initiatives often harness future savings from energy cost reductions to finance entire programmes.

Sustainability by design

The cornerstone to production that effectively reduces both carbon footprints and pollutants is a clear understanding of the entire lifecycle of the product … right from concept development.

Existing design procedures should be revised to include a thorough evaluation of energy efficiency, environmental impact, material use and recycling, and its impact on every stage, including transportation methods and end-of-life disposal.

Many medical devices, especially invasive ones, will almost certainly continue to have a disposable component to comply with safety regulations; but, taking a new approach to manufacturing processes and design could have a significant impact on the environmental sustainability of medical devices … as well as on company productivity.

References

  1. www.hprc.org/single-post/2018/12/18/Environmentally-Preferred-Sourcing-Powers-Up-Sustainability-in-Healthcare.
  2. https://pubmed.ncbi.nlm.nih.gov/31421384.

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