Introduction: Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED®) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of the necessary tools.

Methods: We conducted a single-blinded, randomized controlled non-inferiority trial including 61 patients at two hospitals in Kisumu, Kenya, to validate Chloe SED® for administration of PCB during MVA. PCB administered with Chloe SED® was compared to PCB administered with a standard spinal needle. Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs—three with the Chloe SED® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01 (https://ctr.pharmacyboardkenya.org/applications/index/protocol_no:RUNDVC8xOS8wMy8wMQ__/filter:/investigator:/sites:/pages:5/start_date:/end_date:/disease_condition:/users:/ercs:/stages). An intention-to-treat analysis was completed. The primary outcome was the non-inferiority of the pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included the non-inferiority of the pain score at four other time points and patient satisfaction.

Results: Chloe SED® showed non-inferiority of the primary outcome with a mean pain score during evacuation of 3.8 [90% confidence interval (CI): 3.1–4.6] compared with the spinal needle at 4.1 (90% CI: 3.5–4.7). Non-inferiority of the pain score was shown at all time points. Most patients expressed a desire for the continued use of the device to administer PCB for MVA. No adverse events were noted.

Conclusion: In summary, the Chloe SED® appears non-inferior to the spinal needle and desirable for the administration of PCB during MVA.@en

Introduction: Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED®) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of the necessary tools. Methods: We conducted a single-blinded, randomized controlled non-inferiority trial including 61 patients at two hospitals in Kisumu, Kenya, to validate Chloe SED® for administration of PCB during MVA. PCB administered with Chloe SED® was compared to PCB administered with a standard spinal needle. Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs—three with the Chloe SED® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01 (https://ctr.pharmacyboardkenya.org/applications/index/protocol_no:RUNDVC8xOS8wMy8wMQ__/filter:/investigator:/sites:/pages:5/start_date:/end_date:/disease_condition:/users:/ercs:/stages). An intention-to-treat analysis was completed. The primary outcome was the non-inferiority of the pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included the non-inferiority of the pain score at four other time points and patient satisfaction. Results: Chloe SED® showed non-inferiority of the primary outcome with a mean pain score during evacuation of 3.8 [90% confidence interval (CI): 3.1–4.6] compared with the spinal needle at 4.1 (90% CI: 3.5–4.7). Non-inferiority of the pain score was shown at all time points. Most patients expressed a desire for the continued use of the device to administer PCB for MVA. No adverse events were noted. Conclusion: In summary, the Chloe SED® appears non-inferior to the spinal needle and desirable for the administration of PCB during MVA.

@en

Underfunded healthcare infrastructures in low-resource settings in sub-Saharan Africa have resulted in a lack of medical devices crucial to provide healthcare for all. A representative example of this scenario is medical devices to administer paracervical blocks during gynaecological procedures. Devices needed for this procedure are usually unavailable or expensive. Without these devices, providing paracervical blocks for women in need is impossible resulting in compromising the quality of care for women requiring gynaecological procedures such as loop electrosurgical excision, treatment of miscarriage, or incomplete abortion. In that perspective, interventions that can be integrated into the healthcare system in low-resource settings to provide women needing paracervical blocks remain urgent. Based on a context-specific approach while leveraging circular economy design principles, this research catalogues the development of a new medical device called Chloe SED® that can be used to support the provision of paracervical blocks. Chloe SED®, priced at US$ 1.5 per device when produced in polypropylene, US$ 10 in polyetheretherketone, and US$ 15 in aluminium, is attached to any 10-cc syringe in low-resource settings to provide paracervical blocks. The device is designed for durability, repairability, maintainability, upgradeability, and recyclability to address environmental sustainability issues in the healthcare domain. Achieving the design of Chloe SED® from a context-specific and circular economy approach revealed correlations between the material choice to manufacture the device, the device's initial cost, product durability and reuse cycle, reprocessing method and cost, and environmental impact. These correlations can be seen as interconnected conflicting or divergent trade-offs that need to be continually assessed to deliver a medical device that provides healthcare for all with limited environmental impact. The study findings are intended to be seen as efforts to make available medical devices to support women's access to reproductive health services.@en

A growing awareness of health as a human right, mainly in low- and middle-income countries, is promoting universal health access for increasing numbers of people. Universal access to health to a large extent depends on access to medical equipment and medical staff. In this chapter, we focus on the access to medical equipment, more specifically, equipment for diagnostics and how frugal innovation and distributed manufacturing can contribute to an increase of access to these devices. We present a case study of a frugal design for a centrifuge for sample preparation for schistosomiasis. This neglected tropical disease impacts the lives of over 240 million people, mainly in sub-Saharan Africa@en

Healthcare facilities in low-resource settings in Sub-Saharan Africa are plagued with issues of non-functional and obsolete medical devices, which ultimately end up prematurely disposed of as waste. With increasing healthcare demands, stopping medical device disposal is imperative. One way to achieve this is to leverage circular economy principles in designing medical devices. Circular economy principles aim to retain products and their constituent materials to be reused over time in the economic system. However, to what extent this has been applied in designing medical devices specifically for low-resource settings in Sub-Saharan Africa is missing in literature. Based on a systematic review of 29 out of 1,799 screened scientific papers, we identified the use of circular economy principles of durability, maintenance, repair, and upgrade in designing medical devices for this setting. Whether these principles were intentionally applied from a circular economy approach could not be inferred in this study. The motivational basis for using these principles was to ensure medical device longevity to providing healthcare. No attention was given to the circular economy principles of refurbishment, remanufacturing, and recycling, ensuring that device components and constituent materials are recovered. These study findings serve as a launchpad for exploring how circular principles can be used to support the design of medical devices for low-resource settings in Sub-Saharan Africa. Academicians and designers of medical devices can leverage this research to contribute towards developing medical devices that support access to healthcare for people in low-resource settings and preserve earth's finite resources.

@en

Healthcare facilities in low-resource settings in Sub-Saharan Africa are plagued with issues of non-functional and obsolete medical devices, which ultimately end up prematurely disposed of as waste. With increasing healthcare demands, stopping medical device disposal is imperative. One way to achieve this is to leverage circular economy principles in designing medical devices. Circular economy principles aim to retain products and their constituent materials to be reused over time in the economic system. However, to what extent this has been applied in designing medical devices specifically for low-resource settings in Sub-Saharan Africa is missing in literature. Based on a systematic review of 29 out of 1,799 screened scientific papers, we identified the use of circular economy principles of durability, maintenance, repair, and upgrade in designing medical devices for this setting. Whether these principles were intentionally applied from a circular economy approach could not be inferred in this study. The motivational basis for using these principles was to ensure medical device longevity to providing healthcare. No attention was given to the circular economy principles of refurbishment, remanufacturing, and recycling, ensuring that device components and constituent materials are recovered. These study findings serve as a launchpad for exploring how circular principles can be used to support the design of medical devices for low-resource settings in Sub-Saharan Africa. Academicians and designers of medical devices can leverage this research to contribute towards developing medical devices that support access to healthcare for people in low-resource settings and preserve earth’s finite resources@en

Urinary schistosomiasis is a waterborne parasitic infection caused by Schistosoma haematobium that affects approximately 30 million people annually in Nigeria. Treatment and eradication of this infection require effective diagnostics. However, current diagnostic tests have critical shortcomings and consequently are of limited value to stakeholders throughout the health care system who are involved in targeting the diagnosis and subsequent control of schistosomiasis. New diagnostic devices that fit the local health care infrastructure and support the different stakeholder diagnostic strategies remain a critical need. This study focuses on understanding, by means of Q-methodology, the context of use and application of a new diagnostic device that is needed to effectively diagnose urinary schistosomiasis in Oyo State, Nigeria. Q-methodology is a technique that investigates subjectivity by exploring how stakeholders rank-order opinion statements about a phenomenon. In this study, 40 statements were administered to evaluate stakeholder perspectives on the context of use and application of potential new diagnostic devices and how these perspectives or viewpoints are shared with other stakeholders. Potential new diagnostic devices will need to be deployable to remote or distant communities, be affordable, identify and confirm infection status before treatment in patients whose diagnosis of urinary schistosomiasis is based on self-reporting, and equip health care facilities with diagnostic devices optimized for the local setting while requiring local minimal infrastructural settings. Similarly, the context of use and application of a potential new diagnostic device for urinary schistosomiasis is primarily associated with the tasks stakeholders throughout the health care system perform or procedures employed. These findings will guide the development of new diagnostic devices for schistosomiasis that match the contextual landscape and diagnostic strategies in Oyo.

@en

Urinary schistosomiasis is a waterborne parasitic infection caused by Schistosoma haematobium that affects approximately 30 million people annually in Nigeria. Treatment and eradication of this infection require effective diagnostics. However, current diagnostic tests have critical shortcomings and consequently are of limited value to stakeholders throughout the health care system who are involved in targeting the diagnosis and subsequent control of schistosomiasis. New diagnostic devices that fit the local health care infrastructure and support the different stakeholder diagnostic strategies remain a critical need. This study focuses on understanding, by means of Q-methodology, the context of use and application of a new diagnostic device that is needed to effectively diagnose urinary schistosomiasis in Oyo State, Nigeria. Q-methodology is a technique that investigates subjectivity by exploring how stakeholders rank-order opinion statements about a phenomenon. In this study, 40 statements were administered to evaluate stakeholder perspectives on the context of use and application of potential new diagnostic devices and how these perspectives or viewpoints are shared with other stakeholders. Potential new diagnostic devices will need to be deployable to remote or distant communities, be affordable, identify and confirm infection status before treatment in patients whose diagnosis of urinary schistosomiasis is based on self-reporting, and equip health care facilities with diagnostic devices optimized for the local setting while requiring local minimal infrastructural settings. Similarly, the context of use and application of a potential new diagnostic device for urinary schistosomiasis is primarily associated with the tasks stakeholders throughout the health care system perform or procedures employed. These findings will guide the development of new diagnostic devices for schistosomiasis that match the contextual landscape and diagnostic strategies in Oyo.@en

The Sharepair project aims to decrease the waste of electronic and electric consumer products and increase their useful life, by supporting repair communities and scaling up citizen repairs through digital tools. One of the focus areas of this project is to support the discovery or manufacturing of spare parts. With a 3D CAD model of a part and a 3D printer, repair communities could manufacture spare parts. This paper discusses the possibilities of identifying repairs, within repair communities, that can be met through 3D printed spare parts. To understand and identify these possibilities, the repair entries expressed in the Open Repair Database (ORD) from the Open Repair Alliance were examined. The analysis aimed to identify documented examples of repairs that have broken or missing parts, and estimate how many may be suitable for replacement by 3D printed versions. The ORD includes 41,874 repair data entries from 229 repair communities (Repair Café, Restart Project, Fixit Clinic, and Anstiftung) in eighteen countries. Repair entries include information such as product category, brand, model, repair status and notes regarding the repair process and result, all in different languages. The analysis identified a list of the most commonly repaired product categories, brands, and models, as well as an estimate that between 7.5% and 29% of products in repair cafes that are not repaired today could be repaired with 3D printed spare parts. The analysis also showed that the data and information about the repairs is inconsistent, open to interpretation and often too limited to precisely pinpoint opportunities for 3D printed spare parts. Specifying the product parts that need repair or replacement and their functional requirements would be key to a successful identification. Thus, the study proposes recommendations to improve the process of capturing repair information that specifies the repair needs that can be met by the use of 3D printing.@en

Schistosomiasis is a neglected tropical disease thatis predominantly diagnosed by conventional microscopy in Sub-Saharan Africa. However, effective diagnosis by conventional microscopy is limited by multiple technical and logistic barriers.Alternative diagnostic techniques are needed. The Schistoscope is a digital optical device that has been designed to support microscopists for the detection of schistosomiasis in endemic resource-limited settings. Aim: A user-centered design approachwas used to assess the usability and user-acceptance of the Schistoscope compared to conventional microscopy in the Federal Capital Territory, Abuja, Nigeria. In this study, usability and acceptance are defined as being easy-to-use, efficient, and suitable in the daily workflow by end-users. Methods: Using a qualitative conventional context analysis approach, a mixedmethods questionnaire was used to elucidate themes related to the usability and user-acceptance of the device. Participants included trained microscopists and university students (n=17). Results: Participants answered both ranked and open questions. Overall the device’s use was considered to be easy and acceptable
in the routine workflow of a microscopist. The auto-scan feature was considered to have added value. Critical feedback regarding aesthetics of the device, particularly related to size, was noted by the participants. Conclusion: The usability approach used in this study elucidated valuable insights of end-users. The Schistoscope was very well perceived by both medical students and trained microscopists. Critical feedback will be used to further improve the next iterative design of the device.@en