The benefits and harms of robotic-assisted surgery in Malaysia: an ethico-legal analysis / Muhammad Shaiful Jasni

Robotic-assisted surgery is the latest surgical approach adopted in many surgical disciplines. This medical intervention is still considered as a new technology in Malaysia healthcare industry, judging from the use and availability of this technology which are privileged to certain hospitals and still are not very popular. However, since other surgical approaches such as minimally invasive laparoscopic and conventional open method are still available in the market, there is a need for robotic-assisted surgical approach to be evaluated not just from a clinical point of view, but as well as ethical and legal perspectives. This is to ensure that the both known and unknown harms and risks are being identified and encountered beforehand. There are many legal implications are foreseeing to occur as this surgical approach is a new technology. Hence, this study will discuss some of the important legal implications of roboticassisted surgery and compare the regulation and legislation of robotic-assisted surgery available in Malaysia with another country such as the UK. At the end of the study, we concluded that the robotic-assisted surgery offers maximum benefit in certain types of surgery such as prostatectomy and TORS. Although the procedure is safe with many precautionary measures in place, it is recommended for the training and credentialing process to be extended and revised based on local needs. For community to be able to enjoy equal access to the robotic-assisted surgery, more studies need to be done to evaluate cost-effectiveness of the procedure compared with other surgical modalities. Also, it is recommended that separate and more comprehensive consent form is established for the surgical procedure involving new technology. The issue is liability is unclear when it comes to robotic-assisted surgery. By establishing black box system and proper documentation, it will ease every party when litigation takes place. In term of regulation, both Malaysia and the UK have almost similar structure of legislative framework. However, there are lacking provision to restrict inexperienced surgeon from using the technology. Improvisation of the current law is needed to allow this nation to be ready to face the legal challenges that comes together with this technology.