Experiences of medical device innovators as they navigate the regulatory system in Uganda.

Objective: A medical device must undergo rigorous regulatory processes to verify its safety and effectiveness while in use. In low-and middle-income countries like Uganda however, medical device innovators and designers face challenges around bringing a device from ideation to being market-ready. This is mainly attributed to a lack of clear regulatory procedures among other factors. In this paper, we illustrate the current landscape of investigational medical devices regulation in Uganda. Methods: Information about the different bodies involved in regulation of medical devices in Uganda was obtained online. Nine medical device teams whose devices have gone through the Ugandan regulatory system were interviewed to gain insights into their experiences with the regulatory system. Interviews focused on the challenges they faced, how they navigated them, and factors that supported their progress towards putting their devices on the market. Results: We identified different bodies that are part of the stepwise regulatory pathway of investigational medical devices in Uganda and roles played by each in the regulatory process. Experiences of the medical device teams collected showed that navigation through the regulatory system was different for each team and progress towards market readiness was fuelled by funding, simplicity of device, and mentorship. Conclusion: Medical devices regulation exists in Uganda but is characterised by a landscape that is still in development which thereby affects the progress of investigational medical devices.

Evaluation of the current status of prosthetic rehabilitation services for major limb loss: a descriptive study in Ugandan Referral hospitals.

PURPOSE: Low-and-middle-income countries (LMICs) have a large burden of major limb loss. No recent study has reported on Uganda's state of public sector prosthetics services. This study aimed to document the landscape of major limb loss, and the structure of available prosthetics services in Uganda. METHODS: This study involved a retrospective review of medical records at Mulago National Referral Hospital, Fort Portal Regional Referral Hospital, and Mbale Regional Referral Hospital, and a cross-sectional survey of personnel involved in the fabrication and fitting of prosthetic devices across orthopaedic workshops in the country. RESULTS: Upper limb amputations accounted for 14.2%, and lower limb accounted for 81.2%. Gangrene (30.3%) was the leading cause of amputation, followed by road traffic accidents and diabetes mellitus. Orthopaedic workshops offered decentralised services, and most materials used were imported. Essential equipment was largely lacking. Orthopaedic technologists had diverse experience and skill sets, but many other factors limited their service provision. CONCLUSION: The Ugandan public healthcare system lacks adequate prosthetic services both in terms of personnel and supporting resources, including equipment, materials, and components. The provision of prosthetics rehabilitation services is limited, especially in rural regions. Decentralising services could improve patients' access to prosthetic services.Implications for RehabilitationAvailability and accessibility of prosthetic services are essential to the rehabilitation and reintegration of amputees into communities in Low-and-Middle-Income countries (LMICs).For stakeholders to formulate effective plans to address issues within prosthetics service provision, quality data on the current state of services is necessary.Service providers should prioritise the decentralisation of prosthetic rehabilitation services, especially for patients in rural areas, to improve access and reach of these services.To achieve optimal limb functionality after amputation for both lower and upper limb amputees, rehabilitation professionals working in LMICs should focus on delivering comprehensive multidisciplinary rehabilitation services.Orthopaedic personnel should ensure complete and accurate documentation of patient information following amputation to enable effective tracking and monitoring of patient care to improve outcomes of rehabilitation.

Evaluating Reachable Workspace and User Control Over Prehensor Aperture for a Body-Powered Prosthesis.

Using a shoulder harness and control cable, a person can control the opening and closing of a body-powered prosthesis prehensor. In many setups the cable does not pass adjacent to the shoulder joint center allowing shoulder flexion on the prosthetic side to be used for prehensor control. However, this makes cable setup a difficult compromise as prosthesis control is dependent on arm posture; too short and the space within which a person can reach may be unduly restricted, too long and the user may not be able to move their shoulder sufficiently to take up the inevitable slack at some postures and hence have no control over prehensor movement. Despite the fundamental importance of reachable workspace to users, to date there have been no studies in prosthetics on this aspect. Here, a methodology is presented to quantify the reduction in the reachable volume due to the harness, and to record the range-of-motion of the prehensor at a series of locations within the reachable workspace. Ten anatomically intact participants were assessed using a body-powered prosthesis simulator. Data was collected using a 3D motion capture system and an electronic goniometer. The harnessed reachable workspace was 38-85% the size of the unharnessed volume with participants struggling to reach across the body and above the head. Across all arm postures assessed, participants were only able to achieve full prehensor range-of-motion in 9%. The methodologies presented could be used to evaluate future designs of both body-powered and myoelectric prostheses.