Ergonomic RFID tag placement on surgical instruments - a preliminary user study.

OBJECTIVES: RFID tags on surgical instruments allow tracking of individual instruments. However, the tags on the instruments can restrict the handling, potentially increasing patient risks. Previous studies analyzed hand contact areas to identify potential locations for tags. However, the studies did not conduct interaction tests using instruments equipped with RFID tags, potentially neglecting the influence of haptic perception. In addition, previous studies required time-consuming evaluations by clinicians. METHODS: Therefore, the present study aims to verify the previous findings in interaction-centered tests with clinicians using real RFID tags on the instruments. Additionally, we had instrument design experts rate RFID tag positions and examined whether they could predict the clinician's preferred tag positions. RESULTS: We found that nearly all RFID tag positions decreased the user satisfaction of clinicians compared to a reference instrument. Compared to previous studies, our study shows that the RFID tag influences the orientations in which an instrument can be comfortably held, which was criticized by clinicians. Instrument design experts could only predict the clinician's preferred tag positions for some instruments. CONCLUSIONS: Therefore, we recommend investigating further changes to instrument design, for what the "ideal" positions proposed by the clinicians in this study can provide initial pointers.

Integration of a surgical robotic arm to the connected operating room via ISO IEEE 11073 SDC.

PURPOSE: Since 2019, intraoperative networking with ISO IEEE 11073 SDC has, for the first time, enabled standardized multi-vendor data exchange between medical devices. For seamless plug-and-play integration of devices without previous configuration, further specifications for device profiles ("device specializations") on top of the existing core standards must be developed. These generic interfaces are then incorporated into the standardization process. METHODS: An existing classification scheme of robotic assistance functions is being adopted and used as a baseline to derive functional requirements for a universal interface for modular robot arms. Additionally, the robot system requires machine-machine interfaces (MMI) to a surgical navigation system and a surgical planning software in order to carry out its function. Further technical requirements are derived from these MMI. The functional and technical requirements motivate the design of an SDC-compatible device profile. The device profile is then assessed for feasibility. RESULTS: We present a new modeling of a device profile for surgical robotic arms intended for neurosurgery and orthopedic surgery. The modeling in SDC succeeds for the most part. However, some details of the proposed model cannot yet be realized within the framework of the existing SDC standards. Some aspects can already be realized, but could be better supported in the future by the nomenclature system. These improvements are being presented as well. CONCLUSION: The proposed device profile presents a first step toward a uniform technical description model for modular surgical robot systems. The current SDC core standards lack some functionality to fully support the proposed device profile. These could be defined in future work and then included in standardization efforts.

Evaluation of an Anesthesia Dashboard Functional Model Based on a Manufacturer-Independent Communication Standard: Comparative Feasibility Study.

BACKGROUND: Current anesthesia workspaces consist of several technical devices, such as patient monitors, anesthesia machines, among others. Commonly, they are produced by different manufacturers; thus, they differ in terms of their modus operandi, user interface, and representation of alarms. Merging the information from these devices using a single joint protocol and displaying it in a single graphical user interface could lead to a general improvement in perioperative management. For this purpose, the recently approved and published Institute of Electrical and Electronics Engineers 11073 service-oriented device connectivity standard was implemented. OBJECTIVE: This paper aims to develop and then evaluate an anesthesia workstation (ANWS) functional model in terms of usability, fulfillment of clinical requirements, and expected improvements in patient safety. METHODS: To compare the self-developed ANWS with the conventional system, a pilot observational study was conducted at the University Hospital Aachen, Germany. A total of 5 anesthesiologists were asked to perform different tasks using the ANWS and then the conventional setup. For evaluation purposes, response times were measured and an interaction-centered usability test with an eye-tracking system was carried out. Finally, the subjects were asked to fill in a questionnaire in order to measure user satisfaction. RESULTS: Response times were significantly higher when using the ANWS, but decreased considerably after one repetition. Furthermore, usability was rated as excellent (≥95) according to the System Usability Scale score, and the majority of clinical requirements were met. CONCLUSIONS: In general, the results were highly encouraging, considering that the ANWS was only a functional model, as well as the lack of training of the participants. However, further studies are necessary to improve the universal user interface and the interplay of the various networked devices.

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.

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.

Development and experimental evaluation of an alarm concept for an integrated surgical workstation.

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.

Human-centered risk management for medical devices - new methods and tools.

Studies regarding adverse events with technical devices in the medical context showed, that in most of the cases non-usable interfaces are the cause for use deficiencies and therefore a potential harm for the patient and third parties. This is partially due to the lack of suitable methods for interlinking usability engineering and human-centered risk management. Especially regarding the early identification of human-induced errors and the systematic control of these failures, medical device manufacturers and in particular the developers have to be supported in order to guarantee reliable design and error-tolerant human-machine interfaces (HMI). In this context, we developed the HiFEM methodology and a corresponding software tool (mAIXuse) for model-based human risk analysis. Based on a two-fold approach, HiFEM provides a task-type-sensitive modeling structure with integrated temporal relations in order to represent and analyze the use process in a detailed way. The approach can be used from early developmental stages up to the validation process. Results of a comparative study with the HiFEM method and a classical process-failure mode and effect analysis (FMEA) depict, that the new modeling and analysis technique clearly outperforms the FMEA. Besides, we implemented a new method for systematic human risk control (mAIXcontrol). Accessing information from the method's knowledge base enables the operator to detect the most suitable countermeasures for a respective risk. Forty-one approved generic countermeasure principles have been indexed as a resulting combination of root causes and failures in a matrix. The methodology has been tested in comparison to a conventional approach as well. Evaluation of the matrix and the reassessment of the risk priority numbers by a blind expert demonstrate a substantial benefit of the new mAIXcontrol method.

Bottlenecks and needs in human-human and human-machine interaction - a view from and into the neurosurgical OR.

The number and complexity of user interfaces in the OR has been considerably increasing during the last years. Moreover, increasing cost and time pressure force surgeons and surgical nurses to perform different tasks in parallel. We analyzed the workflow of 25 neurosurgical procedures with a workflow analysis tool in order to analyze the present situation in the neurosurgical OR and to identify potential use-oriented risks and to develop first proposals for respective countermeasures. Application of the navigation system, the CUSA ultrasonic aspirator, and the PACS-PC was associated with errors and resulting potential risks. A number of different disruptive factors have been identified, the most prominent of those being intraoperative duty phone calls, longer absence of the circulating nurses or slipped off foot switches. Furthermore, the identified problems may lead to risks for patient, and also for staff by use errors, associated with an inappropriate cognitive workload of the surgeon or nurses. Organizational and technical countermeasures are necessary: to enhance communication, team trainings could be helpful, and the setup of a mailbox could reduce the number of intraoperative duty phone calls. Technical deficiencies have to be reduced, e.g. with more user-oriented design of devices, such as foot switches, or standard design for user interfaces. For further risk reduction in the case of use deficiencies, we propose the implementation of device interoperability and the use of a sterile integrated user interface in a networked OR.

Modular user interface design for integrated surgical workplaces.

Severe bottlenecks in usability and human technology interaction (HTI) of existing surgical workplaces and operating room (OR) equipment can occur today: lack of space, cable as trip hazard, communication problems between sterile and non-sterile staff, and operating errors in the handling of the medical devices. In fact, risks that are caused by poor usability can be critical, and studies show that most are preventable. This issue gets even more challenging in the context of open-OR networks regarding consistent and usable integration of user interfaces (UIs) of independently designed systems in one integrated surgical work system. In this work, a concept of generic UI profiles for the modular integration of a UI has been developed and first prototypes have been implemented. The concept is essentially based on the approach of device profiles developed in the context of the Bundesministerium für Bildung und Forschung project OR.NET (www.ornet.org). We developed generic UI profiles to map the different interfaces of the medical devices on an integrated surgical UI. The integrated UI design shall be automatically verified according to agreed usability criteria, guidelines, and human error taxonomies.