Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.
ObjectiveA 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.MethodsInformation 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.ResultsWe 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.ConclusionMedical 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.
Timely intervention for atonic postpartum hemorrhage (PPH) significantly reduces the incidence of death from PPH. However, technological solutions geared towards this have not received substantial adoption by the health community in sub-Saharan Africa due to limiting factors such as; cumbersome application, being costly, requiring skilled personnel, needing cold chain storage, and the associated side effects. This pilot study aimed to assess the usability, acceptability, and performance of the Maternal PPH Wrap, a first-aid device designed to control atonic PPH after childbirth. Forty subjects were recruited for the study. Twenty of these were women who sought maternity care at Kawempe National Referral Hospital (KNRH). The women wore the device for 120 minutes while their vitals were recorded every 20 minutes. The device’s acceptability and performance were evaluated on the women. The remaining twenty were licensed midwives working at KNRH. The device’s usability was assessed on all the midwives recruited for the pilot study using a usability questionnaire. There was a reduction in blood loss associated with the use of the Maternal PPH Wrap alongside the standard of care as opposed to the standard of care alone. This reduction in blood loss was detected between the 80th and 120th minute of the device application onto the mothers. The acceptability and usability scores from the study participants also scored favorably. The Maternal PPH Wrap demonstrated potential to control PPH and product satisfaction, and these results will support the device’s redesign leading into a Phase I clinical trial.
Timely intervention for atonic postpartum hemorrhage (PPH) significantly reduces the incidence of death from PPH. However, technological solutions geared towards this have not received substantial adoption by the health community in sub-Saharan Africa due to limiting factors such as; cumbersome application, being costly, requiring skilled personnel, needing cold chain storage, and the associated side effects. This pilot study aimed to assess the usability, acceptability, and performance of the Maternal PPH Wrap, a first-aid device designed to control atonic PPH after childbirth. Forty subjects were recruited for the study. Twenty of these were women who sought maternity care at Kawempe National Referral Hospital (KNRH). The women wore the device for 120 minutes while their vitals were recorded every 20 minutes. The device's acceptability and performance were evaluated on the women. The remaining twenty were licensed midwives working at KNRH. The device's usability was assessed on all the midwives recruited for the pilot study using a usability questionnaire. There was a reduction in blood loss associated with the use of the Maternal PPH Wrap alongside the standard of care as opposed to the standard of care alone. This reduction in blood loss was detected between the 80 th and 120 th minute of the device application onto the mothers. The acceptability and usability scores from the study participants also scored favorably. The Maternal PPH Wrap demonstrated potential to control PPH and product satisfaction, and these results will support the device's redesign leading into a Phase I clinical trial.
Timely intervention for atonic postpartum hemorrhage (PPH) significantly reduces the incidence of death from PPH. However, technological solutions geared towards this have not received substantial adoption by the health community in sub-Saharan Africa due to limiting factors such as; cumbersome application, being costly, requiring skilled personnel, needing cold chain storage, and the associated side effects. This pilot study aimed to assess the usability, acceptability, and performance of the Maternal PPH Wrap, a first-aid device designed to control atonic PPH after childbirth. Forty subjects were recruited for the study. Twenty of these were women who sought maternity care at Kawempe National Referral Hospital (KNRH). The women wore the device for 120 minutes while their vitals were recorded every 20 minutes. The device’s acceptability and performance were evaluated on the women. The remaining twenty were licensed midwives working at KNRH. The device’s usability was assessed on all the midwives recruited for the pilot study using a usability questionnaire. There was a reduction in blood loss associated with the use of the Maternal PPH Wrap alongside the standard of care as opposed to the standard of care alone. This reduction in blood loss was detected between the 80th and 120th minute of the device application onto the mothers. The acceptability and usability scores from the study participants also scored favorably. The Maternal PPH Wrap demonstrated potential to control PPH and product satisfaction, and these results will support the device’s redesign leading into a Phase I clinical trial.
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