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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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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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