The networking of the many computer-controlled medical devices available in a modern operating room (OR) has been gaining in importance for years, because it is the only way to meet the clinical need for more safety, efficiency and ergonomics in the OR. A challenge so far is the networking of devices from different manufacturers. Here, the German research project “OR.NET – Secure Dynamic Networking in the Operating Room and Clinic” (2012-2016) laid important foundations in the form of a service-oriented communication protocol for the dynamic cross-vendor networking of medical devices, which is now part of the ISO/IEEE 11073 “Service-oriented Device Connectivity” series of standards, an internationally recognized standard.
However, a problem in the use of the new standards so far is that manufacturers can model the network representation of similar devices differently, which complicates the integration into a system of networked medical devices as well as testing and approval of networked devices. This is where the project “PoCSpec – Modular Specializations for Point-of-Care Medical Devices”, co-ordinated by OFFIS and funded by the Federal Ministry for Economic Affairs and Energy, started in January 2019. The project will develop additions to the ISO/IEEE 11073 family of standards that specify the networking requirements for specific device categories, i.e. the scope, structure and significance of the data and services offered in the network as well as the behavior of the device at runtime, so that devices from different manufacturers can be uniformly monitored and controlled via the network. This will be implemented as an example for two particularly complex device categories: endoscopy and high-frequency surgery.
Figure 1 shows how the newly designed modular device specializations will fit within the existing IEEE 11073 SDC standard family. All standards prefixed with P (as in proposed standards) are currently work in progress, whereas the core standards were adopted in the given year (see resp. prefix). As shown in figure 1, the new device specializations are built on top of the existing core standards, the key purpose standards and the newly designed ModSpecs. These are reusable building blocks of common device components that re-occur in the various device specialization standards.
In order to be able to build on the widest possible consensus in the development of standards, a large number of manufacturers in the field of endoscopy and high-frequency surgery are involved as partners in the project and will contribute their know-how. Other manufacturers are invited to participate as associated partners in the project and to contribute to the standard development. The ultimate goal of the project is to achieve a higher level of interoperability and to enable the interchangeability of medical devices from different manufacturers on the fly. This will sustainably strengthen Germany’s outstanding international competitive position for medical devices.
Apart from OFFIS, the partners of the project are the companies Aesculap, BOWA, Dräger (associated), embeX, Erbe Elektromedizin, Karl Storz, Olympus Winter & Ibe, Open Connections, Schölly Fiberoptic (associated), steute Technologies (associated) and surgiTAIX (associated) as well as the Institute for Applied Microelectronics and Data Technology (IMD) of the University of Rostock and the Institute for Medical Informatics (IMI) of the University of Lübeck.