Ending the trade-off between patient safety and sustainability

Dr. Ameera Patel, CEO of TidalSense, a pioneering respiratory AI technology company focused on solutions for COPD and asthma patients, wonders whether our healthcare systems have become too dependent on disposable medical devices, arguing that it is possible to encourage more sustainable practices without increasing the risk of patient infection.

In recent months I have had to respond to an increasing number of questions from NHS representatives – both locally and nationally – regarding the sustainability of TidalSense medical devices.

These are not difficult questions to answer; like many mission-driven medtech startups, we have focused on sustainability from the start. But this points to a broader shift in NHS procurement policy and the net zero agenda that could force other medtech manufacturers to change their approach to device sustainability over the next few years.

Great for healthcare, but plastic comes at a high environmental cost

Western healthcare is currently overly dependent on single-use plastic medical devices. This is one of the main reasons why the sector uses an estimated 15 million tons of plastic worldwide each year.

The logic behind moving away from reusable metal and washables to plastic is understandable. These devices are cheap to produce, and using a new device for each patient helps minimise the risk of infection, a priority in healthcare settings since the pandemic. But while there is no doubt about the effectiveness of this approach from a patient safety perspective, the downside is that it drastically increases the amount of equipment required. Across Europe, more than a third of healthcare waste is plastic, and almost half of that waste is incinerated.

It is an oversimplification to blame doctors and practitioners. The reality is that current medical device standards – in the UK, the US and across Europe – prioritise patient safety and risk avoidance, and say nothing about sustainable use. Indirectly, they encourage device manufacturers like us to produce single-use products, which of course can be sold in much larger quantities than reusable products.

It’s time to question basic assumptions about medical device safety

There’s nothing wrong with promoting safety first and foremost among manufacturers. But given that reusable medical devices are simply better for the environment than disposables destined for incinerators, we should at least ask ourselves: what exactly is the difference in cross-contamination risk?

For example, we recently conducted an analysis of the microbial load in one of the single-use plastic components used as the breathing tube that fits into our N-Tidal device. We found that the component in question, which is made of medical-grade plastic, received no or very low levels of microorganisms per use. After 100 uses over a one-month period, the total microbial load was still at a level that would be acceptable for a newly manufactured and packaged item. The study then confirmed that a simple cleaning process reduced this low level by four orders of magnitude, almost completely eliminating the risk of cross-contamination. Implementing this cleaning step allows the component to be used for a longer period than a single use to hundreds of uses.

As our research continues, we may find clear limits to frequency and durability. However, by using scientific analysis to challenge a fundamental assumption about just one of our components, we have immediately made our devices significantly more sustainable, at no additional cost, within the current regulatory framework, and without impacting patient safety, provided the consumable is cleaned to specification.

Changing public procurement requirements increase carbon emission reduction

The NHS has a stated aim to achieve Net Zero by 2040 for direct emissions and by 2050 for emissions it can influence. To achieve this, from April 2024 the NHS will ask all suppliers to declare their current carbon emissions and provide clear carbon reduction plans as a standard part of every procurement route.

We have yet to discover how rigorous and demanding the NHS will be when it comes to assessing or verifying suppliers’ carbon reduction efforts. And there is not yet much guidance for suppliers on what the NHS would like to see in these plans. Nevertheless, it does mark the beginning of some fundamental changes to NHS procurement in the coming years.

For example, in 2027 all suppliers will have to publicly report their Scope 1, 2 and 3 emissions targets. Perhaps most notably, in 2028 reporting will be extended to include emissions at a product level, rather than just at a company level – meaning every product supplied to the NHS will have to have its own carbon footprint mapped alongside a carbon reduction plan.

Device manufacturers must promote sustainable development

Instead of waiting for something to force them to do so, manufacturers should take responsibility for sustainability and become agents of change.

As our latest research shows, it is entirely possible to improve the sustainability of devices without increasing the cost of production. And as sustainability is integrated into more and more healthcare procurement pathways around the world, manufacturers may soon find themselves in a situation where proactive engagement with sustainability is a prerequisite for securing a new contract. The NHS’s new Net Zero strategy may seem like a burden at first, but sustainability is also a business opportunity and an opportunity to reduce the carbon footprint of medical device design decisions.

A broader sector-wide conversation on sustainability

The situation is changing, and the reluctance of device manufacturers to rethink their approach to reuse could put them at a competitive disadvantage in the coming years.

However, we should not forget that the issue of sustainability in healthcare has many aspects and needs to be considered holistically, not just in terms of what can and cannot be reused and recycled.

We need to think together to ensure that well-intended regulatory directives (i.e. prioritizing patient safety in medical device development) do not inadvertently compromise Net Zero goals or vice versa. It is time for the entire sector to recognize that safety and sustainability are not mutually exclusive and to start rebuilding more sustainable working practices in everyday healthcare.