Design of an electrosurgical unit for low- and middle-income countries

Design of an electrosurgical unit for low- and middle-income countries

Westra, M.

Dankelman, J. (mentor)
Guedon, A.C.P. (mentor)

Mechanical, Maritime and Materials Engineering

BioMechanical Engineering

BioMedical Engineering, MIMS

2016-04-25

With the provision of essential surgical care millions of lives can be saved and this realization has reached the international agenda. There are however many obstacles that make it hard to provide safe, qualitative, affordable and accessible surgical care to the more than 4.8 billion people for whom this is currently out of reach. One of the obstacles is the lack of medical equipment that is suitable for use in the harsh environment found at the district hospitals. Problems that could be expected at the district hospital are the shortage of consumables, the lack of spare parts, the lack of a steady electricity network, financing problems and a shortage of qualified surgeons and technicians. The goal of this project is to: design a user-friendly, robust and easy to maintain electrosurgical unit that can safely be used by surgeons and clinical officers at the district hospitals in low- and middle-income countries The electrosurgical unit (ESU) is a device that can be used during many surgical procedures and it would be a welcome addition to the operating rooms (ORs) in these district hospitals. The ESU is however accompanied with its own set of problems. A problem with electrosurgery is that the underlying principles of electrosurgery are not widely known, even though it is a very common surgical technique. In addition to the lack of knowledge, there is the problem that the existing devices are very complex due to the lack of standardization in user-interface, the brand specific names for power and waveform outputs and the wide range of available instruments. To aid personnel in low- and middle- income countries (LMIC) that have limited training possibilities, the focus has been on reducing the complexity of the ESU by only providing the necessary functions on the interface. The minimum set of requirements necessary for an ESU to be safe and effective is unknown. However, data from surgeries performed at Reinier de Graaf Gasthuis (RdGG) and Leiden University Medical Center (LUMC) made it possible to get some insight in how the power settings and modes are used during surgery. It showed that surgeons are free to use the instrument, mode and power setting they prefer. No rules or strict guidelines exist on its use. At LUMC different settings were used for similar surgeries performed at RdGG, so the assumption can be made that the preference for certain power settings is hospital specific. To simplify the interface it was chosen to introduce pre-set power settings. In the new design only four different power settings can be selected that do not show its corresponding value in Watt, but an intensity level. The interface also provides the option to connect a monopolar instrument, a dispersive electrode, a bipolar instrument, a foot pedal and a choice between two coagulation modes. A questionnaire was used to determine if the users would trust the new interface design, if they perceive it as safe and to find out whether the interface has been simplified too much. Two surgeons, one resident and 13 OR assistants have filled out the questionnaire. It could be concluded that staff from RdGG had trouble trusting the new design due to the inability to set precise values. Whether this is because of the limited power settings or because they do not like to see a device they are used to change was not clear. More research is needed to identify the functions that are truly indispensable on the ESU and which ones could be eliminated in order to reduce the complexity of the ESU. To get meaningful feedback from the intended users it would be best to speak to them directly and on scene. During this project it was decided to focus on only one component of the ESU. To make the ESU more suitable for use in LMIC there should be done more research for each component separately. It should also be noted that the differences in resources and such between LMIC are enormous. If the challenges in designing an appropriate ESU have been overcome, there are still problems to expect. To be successful local support and training is needed.

http://resolver.tudelft.nl/uuid:8527bab1-f2a2-4b5c-9e15-37d0af0a5f75

Student theses

master thesis

(c) 2016 Westra, M.