OR.NET - Approaches for Risk Analysis and Measures of Dynamically Interconnected Medical Devices

Nowadays, it lacks an open, standardized and dynamic interconnection of medical devices. All existing combinations of medical devices consist of isolated solutions with proprietary interfaces, as no common standards for networking and the exchange of data of medical devices exist. This situation leads to confusing operating rooms and inefficient operations. Thus, new strategies need to be developed for the authorization of dynamically interconnected medical devices. Primarily, those concern of an acquisition and methodical adaption of new requirements and risks resulting from this way of interconnection. The approach is to develop a method for a risk analysis for interconnected medical devices, which is structured modular and consists of a risk assessment of the standalone device and a risk analysis for the interconnection considering the risks involved in the transfer of functions. When interconnecting the medical devices the risk analysis of each of the devices is taken and they are compared by a gap analysis. Through this strategy it will be possible to realize a standard-compliant dynamic interconnection of medical products, which would be advantageous both for clinic operators and producers. This paper presents the current situation of the authorization of combined medical devices and proposes a strategy for the risk management of dynamically interconnected medical devices as a substantial part of the authorization

A gaze-contingent framework for perceptually-enabled applications in healthcare

Patient safety and quality of care remain the focus of the smart operating room of the future. Some of the most influential factors with a detrimental effect are related to suboptimal communication among the staff, poor flow of information, staff workload and fatigue, ergonomics and sterility in the operating room. While technological developments constantly transform the operating room layout and the interaction between surgical staff and machinery, a vast array of opportunities arise for the design of systems and approaches, that can enhance patient safety and improve workflow and efficiency. The aim of this research is to develop a real-time gaze-contingent framework towards a "smart" operating suite, that will enhance operator's ergonomics by allowing perceptually-enabled, touchless and natural interaction with the environment. The main feature of the proposed framework is the ability to acquire and utilise the plethora of information provided by the human visual system to allow touchless interaction with medical devices in the operating room. In this thesis, a gaze-guided robotic scrub nurse, a gaze-controlled robotised flexible endoscope and a gaze-guided assistive robotic system are proposed. Firstly, the gaze-guided robotic scrub nurse is presented; surgical teams performed a simulated surgical task with the assistance of a robot scrub nurse, which complements the human scrub nurse in delivery of surgical instruments, following gaze selection by the surgeon. Then, the gaze-controlled robotised flexible endoscope is introduced; experienced endoscopists and novice users performed a simulated examination of the upper gastrointestinal tract using predominately their natural gaze. Finally, a gaze-guided assistive robotic system is presented, which aims to facilitate activities of daily living. The results of this work provide valuable insights into the feasibility of integrating the developed gaze-contingent framework into clinical practice without significant workflow disruptions.Open Acces

Medical Device Interoperability With Provable Safety Properties

Applications that can communicate with and control multiple medical devices have the potential to radically improve patient safety and the effectiveness of medical treatment. Medical device interoperability requires devices to have an open, standards-based interface that allows communication with any other device that implements the same interface. This will enable applications and functionality that can improve patient safety and outcomes. To build interoperable systems, we need to match up the capabilities of the medical devices with the needs of the application. An application that requires heart rate as an input and provides a control signal to an infusion pump requires a source of heart rate and a pump that will accept the control signal. We present means for devices to describe their capabilities and a methodology for automatically checking an application’s device requirements against the device capabilities. If such applications are going to be used for patient care, there needs to be convincing proof of their safety. The safety of a medical device is closely tied to its intended use and use environment. Medical device manufacturers create a hazard analysis of their device, where they explore the hazards associated with its intended use. We describe hazard analysis for interoperable devices and how to create system safety properties from these hazard analyses. The use environment of the application includes the application, connected devices, patient, and clinical workflow. The patient model is specific to each application and represents the patient’s response to treatment. We introduce Clinical Application Modeling Language (CAML), based on Extended Finite State Machines, and use model checking to test safety properties from the hazard analysis against the parallel composition of the application, patient model, clinical workflow, and the device models of connected devices

Development and Evaluation of AI-based Parkinson's Disease Related Motor Symptom Detection Algorithms

Parkinson's Disease (PD) is a chronic, progressive, neurodegenerative disorder that is typically characterized by a loss of (motor) function, increased slowness and rigidity. Due to a lack of feasible biomarkers, progression cannot easily be quantified with objective measures. For the same reason, neurologists have to revert to monitoring of (motor) symptoms (i.e. by means of subjective and often inaccurate patient diaries) in order to evaluate a medication's effectiveness. Replacing or supplementing these diaries with an automatic and objective assessment of symptoms and side effects could drastically reduce manual efforts and potentially help in personalizing and improving medication regime. In turn, appearance of symptoms could be reduced and the patient's quality of life increased. The objective of this thesis is two-fold: (1) development and improvement of algorithms for detecting PD related motor symptoms and (2) to develop a software framework for time series analysis

A decision framework to mitigate vendor lock-in risks in cloud (SaaS category) migration.

Cloud computing offers an innovative business model to enterprise IT services consumption and delivery. However, vendor lock-in is recognised as being a major barrier to the adoption of cloud computing, due to lack of standardisation. So far, current solutions and efforts tackling the vendor lock-in problem have been confined to/or are predominantly technology-oriented. Limited studies exist to analyse and highlight the complexity of vendor lock-in problem existing in the cloud environment. Consequently, customers are unaware of proprietary standards which inhibit interoperability and portability of applications when taking services from vendors. The complexity of the service offerings makes it imperative for businesses to use a clear and well understood decision process to procure, migrate and/or discontinue cloud services. To date, the expertise and technological solutions to simplify such transition and facilitate good decision making to avoid lock-in risks in the cloud are limited. Besides, little research investigations have been carried out to provide a cloud migration decision framework to assist enterprises to avoid lock-in risks when implementing cloud-based Software-as-a-Service (SaaS) solutions within existing environments. Such decision framework is important to reduce complexity and variations in implementation patterns on the cloud provider side, while at the same time minimizing potential switching cost for enterprises by resolving integration issues with existing IT infrastructures. Thus, the purpose of this thesis is to propose a decision framework to mitigate vendor lock-in risks in cloud (SaaS) migration. The framework follows a systematic literature review and analysis to present research findings containing factual and objective information, and business requirements for vendor-neutral interoperable cloud services, and/or when making architectural decisions for secure cloud migration and integration. The underlying research procedure for this thesis investigation consists of a survey based on qualitative and quantitative approaches conducted to identify the main risk factors that give rise to cloud computing lock-in situations. Epistemologically, the research design consists of two distinct phases. In phase 1, qualitative data were collected using open-ended interviews with IT practitioners to explore the business-related issues of vendor lock-in affecting cloud adoption. Whereas the goal of phase 2 was to identify and evaluate the risks and opportunities of lock-in which affect stakeholders’ decision-making about migrating to cloud-based solutions. In synthesis, the survey analysis and the framework proposed by this research (through its step-by-step approach), provides guidance on how enterprises can avoid being locked to individual cloud service providers. This reduces the risk of dependency on a cloud provider for service provision, especially if data portability, as the most fundamental aspect, is not enabled. Moreover, it also ensures appropriate pre-planning and due diligence so that the correct cloud service provider(s) with the most acceptable risks to vendor lock-in is chosen, and that the impact on the business is properly understood (upfront), managed (iteratively), and controlled (periodically). Each decision step within the framework prepares the way for the subsequent step, which supports a company to gather the correct information to make a right decision before proceeding to the next step. The reason for such an approach is to support an organisation with its planning and adaptation of the services to suit the business requirements and objectives. Furthermore, several strategies are proposed on how to avoid and mitigate lock-in risks when migrating to cloud computing. The strategies relate to contract, selection of vendors that support standardised formats and protocols regarding data structures and APIs, negotiating cloud service agreements (SLA) accordingly as well as developing awareness of commonalities and dependencies among cloud-based solutions. The implementation of proposed strategies and supporting framework has a great potential to reduce the risks of vendor lock-in