Researchers have proposed new standards into the decades' old prosthetic donations market, improving the quality of lower limb prosthetic feet by two-thirds – a major quality of life boost for recipients.
An interdisciplinary team of charities, prosthetists and academics led by King's College London designed and implemented the very first set of standardised regulations for exporting prosthetic feet to the Global South, reducing unusable donations from 16% to 5%.
In so doing, the team have laid the foundation for improved prosthetics provision in the UK and an ethical framework for a global circular economy of prosthetics – the first of its kind.
Dr Michael Berthaume, Reader (Associate Professor) in Engineering at King's and lead author of the paper said "The charity sector does great work in helping individuals who are missing lower limbs live their lives to the fullest, but the ecosystem that supports them is not fit for purpose.
"With first steps toward regulation, we can say no more to the 'Not good enough for us, but good enough for them' approach that the current donation system encourages – with potentially serious consequences for the quality of life of patients."
Prosthetic provision in low- and middle-income countries, like those in the Global South, can be reliant on donations from places like Europe and the United States. These are often second-hand prosthetics donated or replaced due to routine maintenance or issues of warranty, as opposed to them being broken.
While often still usable at the time of replacement, because prostheses and their components are often classified as single patient multi-use devices, they are not reused in countries like the UK. Therefore, no standards or regulatory requirements guaranteeing the quality or safety of used prosthetic components have been developed.
Without tests to guarantee the quality of donated components, some in the third sector have claimed that the donation model can lead to ' the propagation of medical equipment graveyards .'
The practice of donating poor quality medical provisions to the Global South that the Global North wouldn't use violates the World Health Organization's principles of good donation and has led to the outcry of ' tell people to stop dumping their junk on us .'
Any donation must meet the regulations and standards of the country of origin, and if standards to not exist – as is the case with used prosthetic components – the team argue that standards must be created.
Tom Williams OBE, CEO of prosthetics charity STAND (formerly Legs4Africa), a key partner of the project, said of the initiative "Since STAND was founded twelve years ago, we have rescued over 67 tonnes of high-quality components from landfills and supported almost 6,000 people with limb differences in walking again. I am incredibly proud of the results of this research, which lays the foundation for increasing the quality of donated prosthetic devices.
"Ultimately, this will ensure people with limb differences in sub-Saharan Africa can access better quality care."
Surveying hundreds of lower-limb prosthetic feet donated from the UK, France and US to STAND for use in Uganda, the team developed a quality checklist for their visual inspection to ensure they can be used by future patients. This included strict guidelines related to the mechanical integrity and cosmetic appearance of parts of the foot.
Taking a sample of 366 prosthetic feet across different sizes, brands and whether they were left or right, the team found that the 170 that had been processed after the quality checks were 94% usable as opposed to the 196 processed before which were only 83% usable.
In addition to improving the quality of lower limb prosthetics in places like Uganda, the team also hope this approach will lay the groundwork for better prosthetic care in the UK.
Although an underexplored area, the often-complex warranty provisions and locally adopted practices in the NHS mean that prosthetic components fitted to one patient, cannot be re-used by another within the UK. So, if a patient tries using a prosthesis, then finds the prosthetic components don't meet their needs, the NHS may not be able to re-use these components with another patient. This means 'like new' devices are likely to be discarded, encouraging a wasteful practice where more devices need to be produced,
Professor Laurence Kenney, Professor of Rehabilitation Technology at the University of Salford and co-author of the paper, said "The NHS has set itself legally binding targets to reduce its carbon footprint by 80% by 2032 and to reach net zero by 2040. Such ambitious goals require all clinical services to consider how they can safely reduce waste."
In the future, the group hopes to develop and embed MOT-like tests to evaluate the quality of second-hand prosthetic components, helping create a circular economy for them. This would enable the NHS to avoid wasteful expenditure and meet their decarbonisation targets by cutting down on unnecessary production.
