The new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices.

OR.NET - secure dynamic networks in the operating room and clinic.

Abstract The open, cross-vendor interoperability of medical devices is an enabling technology for the implementation of context-aware biomedical systems in daily clinical routine. The surgical working environment is both a valuable field of application and a particular challenge. A design of context-aware medical technologies that shows intelligent behaviour and ensures safe operation is demanding; thus implementations are yet limited to prototypes and specific surgical use cases. Many open research questions need to be addressed to empower context-aware medical systems to be a relief and not a burden for the clinical user.

Context-aware medical technologies - relief or burden for clinical users?

Operating Room and Clinic 4.0: The OR.NET Approach

In the complex and safety-critical environment of the operating room the increasing use of technology and the interactions are significant causes for critical incidents and adverse events. Thus, the usability needs to be optimized, e.g. by enhancing the Human-Machine-Interaction, the workflow and therefore the safety for users and patients. Hence, big companies offer integrated operation room systems, with harmonized safety- and HMI-concepts. Unfortunately, these systems come along with closed proprietary communication solutions. This prevents flexible design for the hospital operator and easy integration of medical equipment from small and medium-sized enterprises. To open this market, a safe and dynamic networking approach of medical devices has been established on the basis of an open communication standard (IEEE 11073-SDC). Within the OR.NET follow-up project ZiMT (Certifiable integrated Medical Technology), a mobile control in addition to the central surgical workstation use concept has been developed. The requirement analysis for the tablet concept considers existing integrated OR systems and the development and evaluation of human-machine interfaces, regarding the usability engineering process as well as related standards (e.g. Machinery Directive 2006/42/EC, DIN EN ISO 9241-110, IEC 62366). The graphical user interface provides inter alia a flexible und workflow-oriented assembly of a function group view. To evaluate the developed concept in comparison to the user interface of the workstation, an interaction-centered usability test with nine participants (surgeons and OR nurses) has been conducted. The results show a comparable effectiveness and efficiency. Moreover, the intuitiveness of the tablet control is estimated to be higher and most test subjects prefer to work with the tablet control.

Development and Evaluation of a Tablet-Control for a Surgical Workstation in the Open Integrated Operating Room

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

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

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