OR.NET e.V. will present the latest results and developments at the conhIT 2019.

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The EFRE Project ZiMT (Certifiable and Integrated Medical Technology in the OR) will present the latest results at the NRW joint stand at the Medica 2018. In addition, there will be an OR.NET session at the Health-IT-Forum as part of the Medica event.

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Following the trient-annual IEEE 11073 Point-of-Care Devices working group meeting this May in Cologne, representatives of the OR.NET association met with Konstantinos Makrodimitris who serves as the FDA liaison officer to the working group. At the RWTH Aachen University’s Helmholtz-Institute for Biomedical Engineering, Dr. Makrodimitris seized the opportunity to examine prototypical implementations of IEEE 11073 SDC-connected medical devices from multiple vendors in a hands-on session at the extensive demonstrator environment (photo). Based on real-world use cases, technical solutions were discussed with respect to risk management and regulatory issues. Finally, current research projects, MoVE (Modular Validation Environment), funded by the German Federal Ministry for Education and Research (BMBF), und ZiMT (Zertifizierbare integrierte Medizintechnik), funded by the European Regional Development Fund (EFRE) and the federal state of North Rhine-Westphalia, were presented in addition to the novel modular risk management and approval strategy for SDC-based device connectivity. The successful workshop marks another major milestone in the continuing constructive cooperation of OR.NET e.V. and FDA on standardisation, risk management, and regulatory issues and thereby for establishing SDC as the international standard series for interoperability of devices in the OR.

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Together with numerous project partners, the Chair of Medical Technology presented the latest results of the EFRE project ZiMT (Certifiable and Integrated Medical Technology in the OR) at the NRW joint stand at conhIT 2018. In particular, an openly-networked surgical workstation based on the IEEE 11073 communication standard was presented. In addition, the current approaches with regard to test procedures and approval strategies for manufacturer-independent networking of medical devices were presented. The ZiMT booth was very well visited and especially manufacturers of medical devices as well as medical IT systems, hospital operators and users showed great interest in our innovative manufacturer-independent networking approach. The presentation at conhIT was a complete success. Therefore, a presentation at Medica 2018 is already in the planning phase.

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The standardisation process of the IEEE 11073 SDC series of standards for vendor-independent interoperable connectivity of point-of-care medical devices is heading down the home straight. The first two parts IEEE 11073-20702 Medical Devices Communication Profile for Web Services (MDPWS) and IEEE 11073-10207 Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication completed balloting in 2016 and 2017 respectively. The last missing piece, the IEEE Draft Standard P11073-20701 Service-Oriented Medical Device Exchange Architecture & Protocol Binding, is now being balloted. After 137 expert comments in the first round, the second ballot round finished on June 1st 2018 with only 142 comments. We will now incorporate these comments and prepare the document for the upcoming final ballot round. We thank all experts for their valuable input and we are looking forward to completing the ballot phase soon.

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On 01.10.2017, the BMBF research project MoVE started under the direction of OR.NET e.V. The aim of the project is to develop methods that support the approval and certification process as well as the risk management of open networked medical devices in integrated operating rooms and thus enable SMEs to gain access to the market. For this purpose, a simulation environment including suitable protocols, test scenarios and test fields will be developed that is capable of testing the networking of medical devices and software components and validating them with regard to various parameters. A total of 16 partners from industry, services and research are involved in the research project.

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In order to make the results and activities available to the general public, the presence at various trade fairs and conferences at home and abroad is an essential building block of public relations work. The direct contact, the personal exchange in workshops and sessions, as well as the professional discussions with the interested visitors, are just as important as lectures and demonstration of the current work.

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IEEE P11073-20701 – Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding IEEE 11073-20702-2016 – IEEE Approval Draft Standard for Medical Devices Communication Profile for Web Services IEEE P11073-10207 – IEEE Draft Standard for Domain Information & Service Model for Service-Oriented Point-of-Care Medical Device Communication

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Open, standardized interfaces for networking in the operating room Low effort in technical networking and approval for equipment combinations Simple and cost-efficient integration of the devices Innovations, optimizations and modularity Safety for equipment providers, operators and users through modular licensing strategies Free choice of equipment in the operating room Support of intraoperative workflow

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Consulting IEEE 11073 SDC Standard family: data model and protocol Adjustments of the medical device components to the IEEE 11073 SDC standard Connector Software Development Kit Consultancy in the fields of risk management and testing procedures for open networked systems Consultation regarding a user-friendly and safe man-machine interaction in an open-networked surgery User interface development for consistent and standard operating interfaces Information events with topics such as standardization, risk management, implementation and approval Workshops with hands-on for practical implementation Approval of individual system components in the open network for secure dynamic networking in the operating room

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