Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide

Abstract

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.

A Context-Specific Design of an Electrosurgical Unit and Monopolar Handheld to Enhance Global Access to Surgical Care: A Design Approach Based on Contextual Factors

“…The goal of this paper was to design a context-specific ESU and monopolar handheld to increase global access to electrosurgery. To ensure that the newly designed ESU and monopolar handheld comply with the context of use in LMICs, we used the context-driven design approach that we developed [16]. By the use of quantitative and qualitative research methods (surveys, interviews, and observations) in Kenya and other African countries, we collected contextual factors influencing use.…”

“…This study contains three parts: (1) a field study of the surgical context in LMICs by the use of our context-driven design approach [16], (2) the translation of the collected information into a list of design requirements that were used to design an ESU generator and monopolar handheld, and (3) an evaluation of the designs by surgeons working in Sub-Saharan Africa.…”

“…A context-driven design approach for surgical equipment for safe surgery worldwide [16] that we developed was used to collect contextual factors to determine context-specific design requirements for the ESU and monopolar handheld. The contextual factors included in the context-driven design approach are: (A) type of hospitals and type of surgeries performed, (B) availability of equipment, (C) procurement, (D) infrastructure (water, electricity, etc.…”

“…Aim of this study is to present a multidisciplinary project that the Delft University of Technology started in 2016 to design an electrosurgical unit (ESU) and a monopolar handheld to improve global access to electrosurgery by using a context-driven design approach [16]. We developed this design approach to guide biomedical engineering design teams when designing equipment for global surgery, to ensure that this equipment fits the context of use in LMICs.…”

The Effect of Chemical Cleaning on Mechanical Properties of Three-Dimensional Printed Polylactic Acid

“…However, in LMICs, disposable devices are often cleaned or sterilized and re-used [14]. Tools that are designed for reuse are better suited to the context in low-resource settings, and therefore, cleaning and sterilization of PLA must be taken into account [15,16].…”