From SOMDA to application - integration strategies in the OR.NET demonstration sites.

The effective development and dissemination of the open integration for the next generation of operating rooms require a comprehensive testing environment. In this paper, we present the various challenges to be addressed in demonstration applications, and we discuss the implementation approach, the foci of the demonstration sites and the evaluation efforts. Overall, the demonstrator setups have proven the feasibility of the service-oriented medical device architecture (SOMDA) and real-time approaches with a large variety of example applications. The applications demonstrate the potentials of open device interoperability. The demonstrator implementations were technically evaluated as well as discussed with many clinicians from various disciplines. However, the evaluation is still an ongoing research at the demonstration sites. Technical evaluation focused on the properties of a network of medical devices, latencies in data transmission and stability. A careful evaluation of the SOMDA design decisions and implementations are essential to a safe and reliable interoperability of integrated medical devices and information technology (IT) system in the especially critical working environment. The clinical evaluation addressed the demands of future users and stakeholders, especially surgeons, anesthesiologists, scrub nurses and hospital operators. The opinions were carefully collected to gain further insights into the potential benefits of the technology and pitfalls in future work.

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.