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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As part of the EFRE project ZiMT, the Chair of Medical Technology was visited by the FDA (Food and Drug Administration) on May 17, 2018. In the US, the FDA is responsible, among other things, for the approval of medical devices and pharmaceuticals. The aim was to exchange views on the future of open and manufacturer-independent networking in operating theatres and clinics (according to IEEE 11073 communication standard) and to further synchronize the current approaches and procedures internationally. In a full-day workshop, results regarding approval strategies, modular risk management, standardization as well as test procedures and requirements regarding the human-machine interfaces for the novel approach were discussed. The current ZiMT approaches and procedures were evaluated very positively by the FDA and a follow-up date for a further exchange in the US is already planned.

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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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