Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries

Prosthetic components from high-income countries (HICs) are often replaced not because they are broken, but because of guidelines or expired warranties, meaning they may still be usable. As most HICs classify prostheses as single patient multi-use devices, components are often disposed of or donated to low- and middle- income countries (LMICs) where medical device regulatory frameworks are limited or non-existent. A lack of standards guaranteeing the quality of donated prosthetic components could lead to a violation of the World Health Organization's principles of good donation. Here, we work towards the creation of a set of standards by quantifying the efficacy of a second-hand donated prosthetic foot quality checklist developed by STAND. We compared 170 checked to 196 unchecked feet received by prosthetic and orthotic centres in Fort Portal, Uganda, and found checklist implementation increased the percentage of usable feet from 83.16% to 94.12%. Foot brand significantly affected usability, but further data and samples are needed to disentangle the effects of prosthetic foot brand, prosthetic foot model, and centre from which the feet originated on prosthetic foot usability. We propose a rapid and efficient quality assurance checklist as a first step towards a set of standards towards prosthetic foot reuse and discuss future research directions. Research towards the creation of an international set of standards/regulatory requirements governing the use of prosthetic limbs, like the international standards used for prosthetic limb design, would not only enable the safe, useful provision of prosthetic components in LMICs, but would also set the groundwork for understanding how a repair, reuse, and recycle model for prosthetic components might be implemented in HICs. Globally, this could decrease prosthetic provision time, create a circular economy for prosthetic components, and reduce the carbon footprint of prosthetic component manufacture and provision.