Researchers have proposed a new standard for the decades-old prosthetic donation market, improving the quality of lower limb prostheses by two-thirds and significantly improving the quality of life for recipients.
A multidisciplinary team of charities, prosthetists and academics, led by King’s College London, designed and implemented the first set of standardized regulations for the export of prosthetic limbs to the Global South, reducing unusable donations from 16% to 5%.
In doing so, the team laid the foundations for an ethical framework for improving the provision of prosthetic limbs in the UK and a first-of-its-kind global prosthetic circular economy.
The charity sector does great work in helping people with lower limb loss live their fullest lives, but the ecosystem that supports them is not fit for purpose.
By taking the first steps toward regulation, there is no more need to be said for the ‘not good enough for us, but good enough for them’ approach that current donation systems encourage, which can have serious implications for patients’ quality of life. ”
Dr Michael Barsoum, Reader (Associate Professor), School of Engineering, King’s University, first author of the paper
Provision of prosthetics in low- and middle-income countries, such as those in the Global South, may depend on donations from countries such as Europe and the United States. These are often used prostheses that have been donated or replaced due to routine maintenance or warranty issues, rather than broken ones.
Although often still usable at the time of replacement, the prosthesis and its components are often classified as multi-use devices for a single patient and therefore are not reused in countries such as the UK. Therefore, no standards or regulatory requirements have been developed to guarantee the quality or safety of the prosthetic components used.
Without testing to ensure the quality of donated parts, some in the third sector argue that the donation model could lead to an “expanding medical device graveyard”.
Donating low-quality medical supplies to the Global South that the Global North will not use violates the World Health Organization’s principles of good donation and has prompted a backlash: “Tell the people to stop dumping their junk on us.”
The research team argues that all donations must meet the regulations and standards of the country of origin, and where standards do not exist, such as in the case of used prosthetic parts, standards need to be developed.
Commenting on the initiative, Tom Williams OBE, CEO of the prosthetic limb charity STAND (formerly Legs4Africa), a key partner in the project, said: “STAND was founded 12 years ago. Since then, we have rescued more than 67 tonnes of high-quality parts from landfills and helped almost 6,000 people with limb differences walk. We are very proud of the results of this research, which lays the foundation for improving the quality of donated prosthetic limbs.” device.
“Ultimately, this will ensure that people with limb differences in sub-Saharan Africa receive better quality care.”
The team examined hundreds of lower limb prostheses donated to STAND from the UK, France and the US for use in Uganda, and developed a quality checklist for visual inspection to ensure the prostheses could be used by future patients. This included strict guidelines regarding the mechanical integrity and appearance of the foot area.
They sampled 366 prosthetic legs of different sizes, brands, and left and right sides and found that the 170 that were processed after quality inspection were 94% usable, while the 196 that were processed before quality inspection were only 83% usable.
In addition to improving the quality of lower limb prostheses in places like Uganda, the team hopes this approach will also lay the foundations for better prosthetic care in the UK.
Although this is an untapped area, complex warranty regulations and locally adopted practices in the NHS often prevent prosthetic components fitted to one patient from being reused by another patient within the UK. So if a patient tries using a prosthesis and discovers that the components of the prosthesis do not meet their needs, the NHS may not be able to reuse these components for another patient. This means that “like new” devices are likely to be thrown away, reinforcing the wasteful practice of having to produce more devices.
The NHS has set legally binding targets to reduce carbon emissions by 80% by 2032 and reach net zero by 2040. Such ambitious goals require all clinical services to consider how they can safely reduce waste. ”
Professor Lawrence Kenny, Professor of Rehabilitation Technology at the University of Salford and co-author of the paper
In the future, the group hopes to develop and incorporate MOT-like tests to assess the quality of second-hand prosthetic components, helping to create a circular economy. This will help the NHS meet its decarbonization targets by avoiding wasteful spending and reducing unnecessary production.
