Development and Evaluation of a Platform-Independent Surgical Workstation for an Open Networked Operating Theatre Using the IEEE 11073 SDC Communication Standard

Abstract

The modernization of the complex operating theatres comes along with new opportunities and challenges in particular in the areas of data processing, safety, Human-Machine-Interaction and interoperability. With the funding of the BMBF (Federal Ministry of Education and Research), the OR.NET project (2012–2016) developed an approach of an open device connectivity within the operation room (OR) and the clinical environment. Within this approach, the open integration of medical devices from different manufacturers and the development of an international communication Standard family “IEEE 11073 Service-oriented Device Connectivity (SDC)” has been addressed [IEEE Standards Association 2019]. With the SDC standard, medical devices are able to communicate manufacturer-independently. To control medical devices and visualize parameters and function on the basis of the open interconnection approach, there is a need for a surgical and anaesthetic workstation. The aim of this research work has been the development of a cross-device and cross-platform software framework for a workstation at the Chair of Medical Engineering (mediTEC) at the RWTH Aachen University. The requirement analysis considers the functionalities of existing proprietary integrated OR systems (OR1 Neo, Core Nova, Tegris OR) and research projects for open networked OR systems (OR.NET, SCOT and OpenICE). Within the workstation, reusable and configurable components were developed, integrated and tested following the dialogue principles (DIN EN ISO 9241-110) to achieve a high degree of usability (DIN EN IEC 62366, DIN EN ISO 60601-1-6). The graphical user interfaces was integrated for 6 medical devices from different manufacturers for a mobile and a centralized workplace. To test the concept of the surgical workstation, 7 surgeons and 1 orthopedist from the Uniklinikum Aachen solved tasks, which were evaluated and discussed.