It is estimated that in Africa 30,000-130,000 new cases arise annually and a total of 3 million women suffer from untreated vesicovaginal fistulas (VVFs) in Low- and Middle-Income Countries (LMICs) worldwide. A VVF is an abnormal communication between the bladder and vagina that can result in urine leakage through the vagina. This does not only lead to physical but also psychological problems. In LIMCs, the most common cause of a VVF is obstructed labour. Early childbearing (before full pelvic growth is achieved), poor socioeconomic status, low literacy rate, malnourishment, inadequately developed infrastructure for health care for pregnant women and lack of access to emergency obstetric services are factors that impact the high rate of cases in LIMCs. Some of the consequences are stigmatization and social isolation, because obstructed labour is often seen as a punishment from God and patients are abandoned by their families because of the smell of urine. [...]@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.

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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

Background
Strategies are needed to increase the availability of surgical equipment in low‐ and middle‐income countries (LMICs). This study was undertaken to explore the current availability, procurement, training, usage, maintenance and complications encountered during use of electrosurgical units (ESUs) and laparoscopic equipment.

Methods
A survey was conducted among surgeons attending the annual meeting of the College of Surgeons of East, Central and Southern Africa (COSECSA) in December 2017 and the annual meeting of the Surgical Society of Kenya (SSK) in March 2018. Biomedical equipment technicians (BMETs) were surveyed and maintenance records collected in Kenya between February and March 2018.

Results
Among 80 participants, there were 59 surgeons from 12 African countries and 21 BMETs from Kenya. Thirty‐six maintenance records were collected. ESUs were available for all COSECSA and SSK surgeons, but only 49 per cent (29 of 59) had access to working laparoscopic equipment. Reuse of disposable ESU accessories and difficulties obtaining carbon dioxide were identified. More than three‐quarters of surgeons (79 per cent) indicated that maintenance of ESUs was available, but only 59 per cent (16 of 27) confirmed maintenance of laparoscopic equipment at their centre.

Conclusion
Despite the availability of surgical equipment, significant gaps in access to maintenance were apparent in these LMICs, limiting implementation of open and laparoscopic surgery.
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To comply with the large global need for surgery, surgical equipment that fits the challenging environment in low-and middle-income countries (LMICs) should be designed. The aim of this study is to present a context-specific design of an electrosurgical unit (ESU) and a monopolar handheld to improve global access to surgery. This paper presents both a detailed description of electrosurgery in clinical practice in LMICs and the design of an ESU generator and monopolar handheld for this specific setting. Extensive fieldwork (by means of surveys, interviews, observations, and collection of maintenance records) was done by authors RO, KO, and LH. Feedback from users working in Kenya on the first demonstrator designs was obtained, after which the designs were adapted into conceptual prototypes. These were further evaluated by surveying respondents who attended the annual meeting of the College of Surgeons of East, Central, and Southern Africa (COSECSA) in Kigali, Rwanda in December 2018. Conceptual prototypes were developed for (a) an affordable ESU that is compact and battery powered and (b) a robust reusable monopolar handheld that can be cleaned in the autoclave and by chemicals (e.g., glutaraldehyde solution). The conceptual prototypes were positively received by the 51 respondents of the survey. The findings from the field work and the feedback from users during the design phase have led to a clear understanding of the specific needs and potential solutions. The presented conceptual prototypes need to be further developed into functional prototypes, which could be implemented in Kenya and other settings for further evaluation.

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Both cryotherapy and thermal ablation are treatment methods for cervical precancerous lesions in screening programs in resource constrained settings. However, for thermal ablation the World Health Organization stated that there is insufficient data to define a standard treatment protocol. This study used an ex-vivo model to compare the tissue interaction of both cryotherapy and thermal ablation to contribute to a treatment protocol. We used porcine tissue to measure the temperature profile over time at 0, 2, 4 and 6 mm depth. For cryotherapy the standard double freeze method was used, thermal ablation was applied for one cycle of 60 s with 100 °C. Based on literature search we used 4 mm depth as landmark for the depth of precancerous lesions, and -10 °C for cryotherapy and 46 °C for thermal ablation as critical temperature to induce cell necrosis. Cryotherapy achieved the critical temperature for tissue necrosis (-10 °C) in 3 out of 6 experiments at 4 mm depth, median minimum temperature was −9.6 °C (IQR 25–75 -15.8 °C to −4.9 °C). Thermal ablation achieved the critical temperature for tissue necrosis (46 °C) in 3 out of 7 experiments at 4 mm depth, median maximum temperature was 43.1 °C (IQR 25–75 42.3 °C to 49.9 °C). Both treatment modalities achieved tissue necrosis at 4 mm depth in our ex-vivo model. For cryotherapy the double freeze technique should be used. For thermal ablation a single application less than 60 s might not be sufficient and multiple applications should be considered.

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Background & Objective: The need for surgery is currently not met in Sub-Saharan Africa, requiring both extra workforce and surgical equipment. Currently, there is a gap in the availability of surgical equipment which, among others, limits the provision of safe surgery. To design strategies to increase availability, the use of surgical equipment in this context needs to be understood. This study aims to: 1) identify the different phases surgical equipment goes through during its lifespan (i.e. the surgical equipment journey) in Kenya, and to 2) identify barriers that are perceived by biomedical equipment technicians (BMETs). Material & Methods: Seven semi-structured in-depth interview sessions were conducted with a total of 17 BMETs working in Kenya. Participants worked in six different hospitals (four public, one private and one mission). Interviews were conducted between December 2016 and December 2018. Participants were asked to describe or draw the surgical equipment journey and describe the perceived barriers during this journey. Results: The surgical equipment journey consists of three phases: procurement, usage, and disposal. Stakeholders involved in the surgical equipment journey are users, BMETs, procurement officers, local distributors and in case of donations, donation agencies. Bureaucracy during procurement, difficulties to obtain consumables and spare parts (especially for donated equipment), cleaning with heavy chemicals, and usage in challenging environments were identified as barriers during the surgical equipment journey. Conclusion: Sustainable interventions at multiple organisational levels are required to optimize the surgical equipment journey in hospitals in Kenya. Different strategies that can be applied in parallel to increase availability of surgical equipment in Kenya were identified by the participants in this study: policies on donations, procurement of durable equipment, more well-trained BMETs and university-trained biomedical engineers, and designs and business models that fit the local use in Kenya and presumably other countries in Sub-Saharan Africa.@en

Background: Thermal coagulation is gaining popularity for treating cervical intraepithelial neoplasia (CIN) in screening programs in low- and middle-income countries (LMICs) due to unavailability of cryotherapy. Objectives: Assess the effectiveness of thermal coagulation for treatment of CIN lesions compared with cryotherapy, with a focus on LMICs. Search strategy: Papers were identified from previous reviews and electronic literature search in February 2018 with publication date after 2010. Selection criteria: Publications with original data evaluating cryotherapy or thermal coagulation with proportion of cure as outcome, assessed by colposcopy, biopsy, cytology, and/or visual inspection with acetic acid (VIA), and minimum 6 months follow-up. Data collection and analysis: Pooled proportions of cure are presented stratified per treatment modality, type of lesion, and region. Main results: Pooled cure proportions for cryotherapy and thermal coagulation, respectively, were 93.8% (95% CI, 88.5–97.7) and 91.4% (95% CI, 84.9–96.4) for CIN 1; 82.6% (95% CI, 77.4–87.3) and 91.6% (95% CI, 88.2–94.5) for CIN 2–3; and 92.8% (95% CI, 85.6–97.7) and 90.1% (95% CI, 87.0–92.8) for VIA-positive lesions. For thermal coagulation of CIN 2–3 lesions in LMICs 82.4% (95% CI, 75.4–88.6). Conclusions: Both cryotherapy and thermal coagulation are effective treatment modalities for CIN lesions in LMICs.@en

The need for surgery in low- and middle-income countries (LMICs) is tremendous; more people die from treatable surgical conditions than from tuberculosis, malaria and HIV put together. A crucial barrier to surgical care in LMICs is the limited availability of surgical equipment, which results in delays and cancellations of surgeries on a daily basis. The overall aim of this thesis is to study the use of surgical equipment in LMICs, in order to understand how to increase global availability of surgical equipment in the future. One of the strategies that is researched more thoroughly, is the design of context-specific surgical equipment. As many areas in Africa feel the burden of limited access to surgery, we have used hospitals in Africa as a case study, with a main focus on Kenya. @en

Safe and affordable surgery is not accessible for five billion people when they need it. Multiple surgical capacity studies have shown that hospitals in low-And-middle income countries do not have complete coverage of basic surgical equipment such as, theatre lights, anesthesia machines and electro surgical units. Currently, almost all equipment is designed and manufactured with a main focus on the context in high income countries. The context in low-And-middle income countries in which surgical equipment is used, differs from high income countries, especially in terms of financial resources and access to maintenance, spare parts and consumables. The aim of this study is to present a roadmap for design of surgical equipment for worldwide use. The roadmap consists of four phases: before the start of a design project a clear need for certain surgical equipment should be identified (Phase 0). During Phase 1 the context should be researched thoroughly by determining the barriers encountered by patients to surgical care, the structure of the health care system and if the aspects required for safe surgery are in place. In Phase 2 the implementation strategy and design requirements should be determined and in phase 3 prototyping starts in close interaction with local end-users. We believe that designers should strive for design that is of the same quality and complies with the same safety regulations as equipment designed for HICs. In this way user and patient safety can be assured in any setting worldwide. And we advocate for surgical equipment that fits the context optimally and that will be applicable in comparable settings globally.

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Shortages of medical equipment in low-and-middle income countries (LMICs) have been found by several previous studies that assessed surgical capacity. To increase surgical capacity, there is a need to identify the availability of specific types of surgical equipment on a local, regional and national level. A survey was conducted among surgeons attending the annual meeting of the College Of Surgeons of East, Central and Southern Africa (COSECSA) in December 2016. General information of the facilities, availability of surgical equipment, reasons for limited availability, daily usage of equipment and equipment that could benefit from redesign were assessed. Forty-two respondents participated in this study, representing 33 individual healthcare facilities (14 public referrals, 9 public district and 10 private (for-profit and non-profit)). The respondents worked in 9 countries in East, Central, Western and Southern Africa. A deficiency in availability of basic surgical equipment was found, especially in public district hospitals. Electrosurgical units, endoscopes, defibrillators, infusions pumps and electrocardiogram monitors were of limited availability. Reasons indicated for this limited availability were: no need, too costly, no training, no disposables and no repair. Lack of maintenance and old/overused equipment were identified as major reasons for failure of equipment. Equipment that could benefit from redesign were for example: electrosurgical units, laparoscopic equipment and theatre lights. Availability of surgical equipment should be increased, especially in public district hospitals. Novel context appropriate redesign that is adapted to fit the context in LMICs could decrease the barriers to availability and to failure of surgical equipment.@en