Laparoscopic surgery offers significant benefits to patients in low-resource settings compared to open surgery such as faster recovery, less pain, and lower infection rate. However, there exist significant barriers to the safe introduction of laparoscopy such as high costs and limited availability of trained staff. Low- and middle-income country (LMIC) hospitals suffer from higher post-surgical infection which might be due to the limited facilities for the sterile reprocessing of laparoscopic instruments. To design a solution to this issue, a detailed understanding of local settings was needed. Therefore, this research applied a context-driven design approach, based on the Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide. Over several design phases, the need for a reprocessing device was established. An analysis of the sterile reprocessing of laparoscopic instruments led to a list of context-specific design requirements. These were translated to a final conceptual design of a laparoscopic instrument cleaner using a waterfall design method. Finally, a usability study of the loading system of the device was conducted with nurses in four Indian hospitals. A root-cause analysis of the usability study showed that the device was not intuitive enough to use for Indian nurses. A redesign of the loading system was made to improve its ease of use. The design process used in this study can be used as an example for designers wanting to address the critical issue of context-specific medical devices worldwide, or more specifically, the sterile supply of surgical instruments in resource-constrained environments.

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.

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.

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.