The remanufacturing of single-use medical devices has the potential to significantly reduce greenhouse gas emissions from health systems, and while there are impressive examples of best practice, there is still a long way to go across much of Europe. Here, Bob Unwin and Josselin Duchateau share an overview of remanufacturing and describe how the practice works at Stepping Hill Hospital, part of Stockport NHS Foundation Trust, UK, and efforts to get programmes started in France.
A growing body of evidence finds that when it comes to harmful greenhouse gas emissions, hospitals are part of the problem.
Health systems generate nearly 5% of all global greenhouse gas emissions and a staggering 71% of these emissions come from the supply chain. In a study looking at emissions from the UK’s NHS, single-use medical devices were found to have an outsized impact on the NHS carbon footprint.
A regulatory framework for commercial remanufacturing of medical devices labelled for ‘single use’, also known as SUDS, began in the United States in 1998, and Germany followed in 2002. Commercial remanufacturers – meaning the work is done by private industry outside of the clinical setting – are regulated under the EU Medical Device Regulation (MDR) 2017/245 in force since May 2021. Today, over 11,900 hospitals and surgical centres use reprocessed devices globally.
Remanufactured SUDs must be compliant with the MDR under Article 17. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) guideline regulated the remanufacturing of SUDs from 2016. CE marked remanufactured devices must obtain the same levels of cleanliness, sterility and functionality as required of a virgin device.
Remanufactured SUDs cost at least 30-50% less than the virgin devices, according to the Association of Medical Device Reprocessors (AMDR). They also reduce waste, greenhouse gas emissions, and reliance on the international supply chain that hospitals found to be vulnerable during the Covid-19 pandemic.
Commercial remanufacturers collect devices, decontaminate, function test, clean, repackage, sterilise and return the SUDs for reuse by hospitals and clinics. Thus, remanufacturing creates a circular economy.
Peer-reviewed life cycle assessments are a well-established resource for comparing environmental impact across numerous categories to examine the cradle-to-grave impact on air, water and land for choices between two or more products.
A research team from Fraunhofer – the prestigious German research society – confirmed through a well-designed life cycle assessment that a remanufactured electrophysiology catheter resulted in a 50% reduction in greenhouse gas emissions compared to its virgin alternative when shipped from the UK to Germany where the devices were remanufactured and returned to the UK. Numerous additional peer reviewed life cycle assessments confirm substantial CO2 reductions at an average of 41% from the use of remanufactured SUDs.
Stepping Hill Hospital’s Green Plan
In 2022, Stockport NHS Foundation Trust staff initiated a Green Plan, which included targets such as reducing greenhouse emissions by 85% by 2032, a 75% cut in business travel emissions by 2030, and achieving a ‘net zero’ carbon footprint by 2040 in line with wider NHS ambitions.
Supply chain leadership had become aware that an inordinate amount of greenhouse gas emissions from hospitals resulted from the supply chain. They sought to implement initiatives proven to reduce greenhouse gas emissions.
The leadership team’s research included review of NHS support for SUD remanufacturing including NHS-funded research and the NHS ‘Device Remanufacture “How to” Guide’ for the use of commercially remanufactured devices that documented substantial savings and emissions benefits at other hospitals.
The remanufacturing programme launched at Stockport NHS Foundation Trust in July 2022 significantly reduced Stepping Hill Hospital’s waste stream and greenhouse gas emissions. The Trust generated savings of approximately £33,000 during the fiscal year 2022/23 and received an additional £350 through a collections agreement with their remanufacturing partner.
While switching products can be difficult, as surgeons always have preferred medical devices, they had no difficulties using the remanufactured products because they were using the same product make and model. In the fiscal year 2023/24, the programme saved £40,763.52. By replacing 183 virgin surgical Harmonic Scissors (devices) with their reprocessed counterparts, Stepping Hill eliminated the use of the equivalent of 209 kg of CO2.
A remanufacturing example for other nations
The Stockport programme underscores the UK’s leadership in circular innovation in healthcare, standing out as a key example.
Taking this further, in October 2024, the UK’s Department of Health announced ‘a major crackdown on waste’ in an effort to save millions of pounds a year, helping to divert more resources to frontline NHS care. The ‘Design for Life roadmap’ strategy is a full-throttle approach to driving a circular economy. A commitment to use remanufactured SUDs plays a leading role, with plans to radically cut the number of SUDs in the health service and reduce its reliance on foreign imports.
Many European nations, such as Belgium, Germany, and Spain, have also embraced remanufactured devices. However, in the EU, the MDR only allows remanufacturing when permitted by national law within individual Member States, with the requirement to notify the European Commission of their regulations.
This ‘opt-in’ model does not incentivise countries to adopt the practice and adds extra regulatory hurdles before they may do so. As a result, in some European countries, concerned healthcare providers and other industry stakeholders must often raise their voices to advocate change in linear, outdated, or stagnant national policies. An illustrative example of this is France.
Outside of the hospital, France has long been a leader in the promotion of a circular economy – a 2023 policy saw the French Government pay people to repair old clothes rather than throw them away, for example. But French hospitals are given no such treatment, and the use of remanufactured devices has been banned in France.
This ban has been a thorn in the side of environmentally minded French clinicians and healthcare staff. In December 2022, a position paper published in Le Monde signed by representatives of different medical and pharmaceutical scientific societies called for a lift of this ban.
At the April 2023 European Heart Rhythm Association Congress in Barcelona, Spain, numerous French clinicians and researchers spoke forcefully in favour of the use of remanufactured devices. Then, in March 2024, a group of more than 20 doctors from the French Society of Cardiology published a position paper that similarly endorsed remanufacturing and advocated wider regulatory and professional acceptance of remanufactured devices across the continent.
Thankfully, French authorities appear to have seen the writing on the wall: in the Social Security Financing Bill for 2024, the Government included an article finally authorising the use of remanufactured devices as part of a two-year experiment.
Remanufacturing momentum in France
In a recent report detailing how the experiment could work, the General Inspectorate of Social Affairs (IGAS) and the General Inspectorate of the Environment and Sustainable Development (IGEDD) situated the potential adoption of device remanufacturing as part of France’s broader efforts to reduce its healthcare sector’s environmental footprint.
According to the report, the experiment will examine commercial remanufacturing of SUDs for four French healthcare establishments. As France lacks any existing infrastructure for a medical device remanufacturing industry, the report further encourages working with an experienced commercial remanufacturing partner.
In its own report commenting on the experiment, the French National Academies of Medicine, Pharmacy and Surgery highlighted that stakeholders across the board support the idea, provided that safety, technical and regulatory standards are maintained.
It would seem, at last, that the regulatory and medical communities in France are on the same page about this critical issue. The success of this experiment could pave the way for more sustainable practices, aligning with France’s aspirations to be a leader in the sustainable transition of healthcare. All eyes will be on this two-year trial as it explores the safety, cost-effectiveness and sustainability of remanufacturing medical devices in one of Europe’s largest healthcare sectors.
While a firm date for the commencement of the programme has not been set, the Directorate General of Health has stated that the decrees implementing the experiment should be finalised by the end of 2024. The current working draft proposes to evaluate both CE and CS remanufacturing routes, therefore allowing the experiment to cover a wide number of devices.
The experimentation phase should last two years, and the evaluation of the experiment will result in either a prolongation of the ban, or a modification of the law legalising remanufacturing of SUDs in France.
In addition to the UK successes and the French experiment, remanufacturing of SUDs is currently permitted in Belgium, Croatia, Germany, Ireland, the Netherlands, Spain, Portugal, Sweden and Israel. Globally, commercial, regulated remanufacturing of SUDs also takes place in the US, Canada, Japan, Israel and Australia.
The AMDR – the nonprofit trade association representing the remanufacturers – hopes to remove the ‘opt-in’ language in the EU MDR in a move that will make it easier for more countries in Europe to benefit from this sustainable option and reduce greenhouse gas emissions within their health systems.
Authors
Bob Unwin, registered nurse, directorate manager, theatre and critical care at Stepping Hill Hospital, Stockport NHS Foundation Trust, UK
Josselin Duchateau, clinical electrophysiologist, University Hospital of Bordeaux, France
