ABSTRACT
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.
Subject(s)
Equipment Design/standards , Operating Rooms , Computer Systems , HumansABSTRACT
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.
Subject(s)
Operating Rooms/standards , Humans , Risk Management , Systems IntegrationABSTRACT
INTRODUCTION: Alarm conditions of the technical equipment in operating rooms represent a prevalent cause for interruptions of surgeons and scrub nurses, resulting in an increase of workload and potential reduction of patient safety. In this work, an alarm concept for an integrated operating room system based on open communication standards is developed and tested. METHODS: In a laboratory experiment, the reactions of surgeons were analysed, comparing the displaying of alarms on an integrated workstation and on single devices: disruptive effects of alarm handling on primary task (ratings of perceived distraction, resumption lag, deterioration of speed, accuracy, and prospective memory), efficiency and effectiveness of identification of alarms, as well as perceived workload were included. RESULTS: The identification of the alarm cause is significantly more efficient and effective with the integrated alarm concept. Moreover, a slightly lower deterioration of performance of the primary task due to the interruption of alarm handling was observed. CONCLUSION: Displaying alarms on an integrated workstation supports alarm handling and consequently reduces disruptive effects on the primary task. The findings show that even small changes can reduce workload in a complex work environment like the operating room, resulting in improved patient safety.