The use of increasingly networked medical devices creates new challenges in risk management and the approval of medical devices. Manufacturers protect themselves by defining the intended purpose of their devices, for example, to determine the type of networking and safety measures to avoid potential hazards to patients. However, a demand-dependent and flexible networking of medical devices allows new, innovative functions to be implemented using software technology and existing deficiencies to be reduced; especially with regard to the currently inadequate data exchange between devices and adjacent clinical information systems. The operators of such an overall system need a controllable method for the reliable networking and interaction of devices and IT systems with assessable risks as well as validation possibilities for conformity assessment and approval of networked medical devices.

For the particularly sensitive area of operating theatres, the Federal Ministry of Education and Research (BMBF) is funding the joint project "OR.NET - Secure and dynamic networking in operating theatres and hospitals" with over 50 partners from all over Germany. Well-known medical device manufacturers, software companies, hospitals as operators and research institutions are dealing with the entire range of relevant topics and are trying to find the broadest possible consensus. For the particularly sensitive area of operating theatres, the Federal Ministry of Education and Research (BMBF) is funding the joint project "OR.NET - Secure and Dynamic Networking in Operating Theatres and Clinics" with over 50 partners from all over Germany. Well-known medical device manufacturers, software houses, hospitals as operators and research institutions are dealing with the whole range of relevant topics and are trying to find the broadest possible consensus.

In an OR.NET sub-project, the Institute for Medical Informatics at the University of Lübeck is developing new methods for the semantic interoperability of networked medical devices in the operating room and for the further processing of device data in adjacent clinical information systems. According to the BMBF call for proposals, devices and information systems that have so far been predominantly isolated with frequently proprietary interfaces (data structures, functions) are to interact reliably and manufacturer-independently in a plug&play architecture. For this purpose, OR.NET conceptually differentiates between two integration layers "Medical Devices (MP)" and (adjacent) "Information Systems (IS)", which are coupled in a controlled manner via a middleware component called Open Surgical Platform (OSP). To ensure semantic interoperability, i.e. the exchanged messages must be as reliable as possible in terms of machine interpretation, an Open Surgical Semantic Interoperability Engine (OSSIE) will be integrated into the OSP, which will be developed in this subproject. The overall system of networked devices and information systems must guarantee, beyond technical forms of communication such as message exchange formats or web services, that used data structures including codes and units are reliably interpreted for all participating systems.

Website: https://ornet.org/