Published on Jul 08, 2022
The medical devices industry may not be quite ‘bracing itself’ for sustainability regulations, but a recent government consultation suggested that it may be forthcoming. There are imperatives to developing sustainable models within the industry – so let’s have a look at the recent consultation and what it might mean for the industry.
The manufacture, use and disposal of medical devices can have an impact on the environment in many ways – from the sourcing of raw materials to the manufacture and transport of devices, right through to decontamination, repair, sterilisation and disposal.
The government is actively looking at ways to protect the environment and improve public health. The healthcare industry as a whole is a leading emitter of environmental pollutants, and if it were a country, it would be the 5th leading emitter of Greenhouse Gas emissions globally.
So when we look more specifically at medical devices, without a regulatory framework, there has been little imperative to develop sustainable practices, although many businesses have made significant steps towards it. The industry as a whole, though, now needs to look at this not just in the light of the environmental impact, but equally business impact.
The government consultation mentions potential requirements – for instance the completion of conformity assessments, looking at a device’s impact on the environment and public health. This would look at waste and emissions and whether it can be reused.
What can’t be reused would be down to a waste management assessment – could the device be disposed of safely and could parts of it be reused for something different?
Equally, there may be requirements that devices must be designed and manufactured in a manner that reduces risk to public health from substances or particles that might be released from the device after its use, for instance debris or residues.
Two sustainability models are coming into focus for the industry. Firstly, the circular economy model which is based on three core principles:
In this instance, a product is manufactured, used and remanufactured for reuse. There are two examples of this – glass milk bottles are used and reused almost ad infinitum, at least until the glass bottle is broken. It is used, consumed, cleaned, sterilised and returned, and the circle starts again.
Mobile phones are increasingly being refurbished for use elsewhere, either for lower-cost contracts or sent abroad.
Within a medical devices context, however, this model is not always appropriate. As time moves on, competition and technology accelerates and even refurbished models may have been overtaken by the time the user receives them.
The alternative is the spiral economy model, a model which allows products to remain current over time. An example would be found in the IT industry which re-uses components in production of new devices while external parts are manufactured to meet current needs and market expectations.
Businesses within the plastic industry go so far as to re-use plastic for a variety of different conditions dependent on the lifecycle of the plastic. So this means that the recycling of plastic can potentially transcend its original use and industry.
For the medical device industry, the spiral economy model makes more sense. The ability to recycle elements of devices while manufacturing upgrades and new parts that themselves have a pathway to recycling makes it a more sustainable model.
We need equally to think beyond the device itself. There is the packaging – are we using recyclable packaging? Are we using the most environmentally sustainable method of shipping?
What is certain is that a regulatory framework will eventually be put in place, but regardless there are other pressures such as the NHS’s Evergreen framework which puts demands on suppliers to the NHS to fight climate change and tackle economic inequality.
Therefore, the business imperative is increasing, and the more medical device manufacturers do now, the easier it will be to grow over the coming years.
Published on Jul 08, 2022 by Dwane Charalambous