Prototyping Closed Loop Physiologic Control With the Medical Device Coordination Framework

Medical devices historically have been monolithic units – developed, validated, and approved by regulatory authorities as standalone entities. Despite the fact that modern medical devices increasingly incorporate connectivity mechanisms that enable device data to be streamed to electronic health records and displays that aggregate data from multiple devices, connectivity is not being leveraged to allow an integrated collection of devices to work together as a single system to automate clinical work flows. This is due, in part, to current regulatory policies which prohibit such interactions due to safety concerns. In previous work, we proposed an open source middleware framework and an accompanying model-based development environment that could be used to quickly implement medical device coordination applications – enabling a “systems of systems” paradigm for medical devices. Such a paradigm shows great promise for supporting many applications that increase both the safety and effectiveness of medical care as well as the efficiency of clinical workflows. In this paper, we report on our experience using our Medical Device Coordination Framework (MDCF) to carry out a rapid prototyping of one such application – a multi-device medical system that uses closed loop physiologic control to a affect better patient outcomes for Patient Controlled Anelgesic (PCA) pumps

GSA: A Framework for Rapid Prototyping of Smart Alarm Systems

We describe the Generic Smart Alarm, an architectural framework for the development of decision support modules for a variety of clinical applications. The need to quickly process patient vital signs and detect patient health events arises in many clinical scenarios, from clinical decision support to tele-health systems to home-care applications. The events detected during monitoring can be used as caregiver alarms, as triggers for further downstream processing or logging, or as discrete inputs to decision support systems or physiological closed-loop applications. We believe that all of these scenarios are similar, and share a common framework of design. In attempting to solve a particular instance of the problem, that of device alarm fatigue due to numerous false alarms, we devised a modular system based around this framework. This modular design allows us to easily customize the framework to address the specific needs of the various applications, and at the same time enables us to perform checking of consistency of the system. In the paper we discuss potential specific clinical applications of a generic smart alarm framework, present the proposed architecture of such a framework, and motivate the benefits of a generic framework for the development of new smart alarm or clinical decision support systems

Rationale and Architecture Principles for Medical Application Platforms

The concept of “system of systems” architecture is increasingly prevalent in many critical domains. Such systems allow information to be pulled from a variety of sources, analyzed to discover correlations and trends, stored to enable realtime and post-hoc assessment, mined to better inform decisionmaking, and leveraged to automate control of system units. In contrast, medical devices typically have been developed as monolithic stand-alone units. However, a vision is emerging of a notion of a medical application platform (MAP) that would provide device and health information systems (HIS) interoperability, safety critical network middleware, and an execution environment for clinical applications (“apps”) that offer numerous advantages for safety and effectiveness in health care delivery. In this paper, we present the clinical safety/effectiveness and economic motivations for MAPs, and describe key characteristics of MAPs that are guiding the search for appropriate technology, regulatory, and ecosystem solutions. We give an overview of the Integrated Clinical Environment (ICE) – one particular achitecture for MAPs, and the Medical Device Coordination Framework – a prototype implementation of the ICE architecture

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

Challenges in the Regulatory Approval of Medical Cyber-Physical Systems

We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which o er the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems

Protecting Interoperable Clinical Environment With Authentication

The Integrated Clinical Environment (ICE) is a standard dedicated to promote open coordination of heterogeneous medical devices in a plug-and-play manner. This carries the potential to radically improve medical care through coordinating, cooperating devices, but also to undermine the patient safety by giving rise to security vulnerabilities in the cyber world. In this paper, we propose an authentication framework as the first step to build an ICE security architecture. This framework is designed in a three-layered structure, allowing it to fit in the variety of authentication requirements from different ICE entities and of networking middleware from ICE instantiations. We implement the authentication framework on OpenICE, an open source ICE instantiation. Our experiments shows that the framework can help OpenICE mitigate the vulnerabilities caused by forged identity with negligible performance overload

From Concept to Market: Surgical Robot Development

Surgical robotics and supporting technologies have really become a prime example of modern applied information technology infiltrating our everyday lives. The development of these systems spans across four decades, and only the last few years brought the market value and saw the rising customer base imagined already by the early developers. This chapter guides through the historical development of the most important systems, and provide references and lessons learnt for current engineers facing similar challenges. A special emphasis is put on system validation, assessment and clearance, as the most commonly cited barrier hindering the wider deployment of a system

Seventh Annual Workshop on Space Operations Applications and Research (SOAR 1993), volume 2

This document contains papers presented at the Space Operations, Applications and Research Symposium (SOAR) Symposium hosted by NASA/Johnson Space Center (JSC) and cosponsored by NASA/JSC and U.S. Air Force Materiel Command. SOAR included NASA and USAF programmatic overviews, plenary session, panel discussions, panel sessions, and exhibits. It invited technical papers in support of U.S. Army, U.S. Navy, Department of Energy, NASA, and USAF programs in the following areas: robotics and telepresence, automation and intelligent systems, human factors, life support, and space maintenance and servicing. SOAR was concerned with Government-sponsored research and development relevant to aerospace operations

The AQUAS ECSEL Project Aggregated Quality Assurance for Systems: Co-Engineering Inside and Across the Product Life Cycle

There is an ever-increasing complexity of the systems we engineer in modern society, which includes facing the convergence of the embedded world and the open world. This complexity creates increasing difficulty with providing assurance for factors including safety, security and performance. In such a context, the AQUAS project investigates the challenges arising from e.g., the inter-dependence of safety, security and performance of systems and aims at efficient solutions for the entire product life-cycle. The project builds on knowledge of partners gained in current or former EU projects and will demonstrate the newly developed methods and techniques for co-engineering across use cases spanning Aerospace, Medicine, Transport and Industrial Control.A special thanks to all the AQUAS consortium people that have worked on the AQUAS proposal on which this paper is based, especially to Charles Robinson (TRT), the proposal coordinator. The AQUAS project is funded from the ECSEL Joint Undertaking under grant agreement n 737475, and from National funding

Modularized PCA pump design for an ICE-informed medical device coordination framework

Master of ScienceElectrical and Computer EngineeringSteven WarrenMedical device interoperability and re-configurability continue to be important areas of research toward the realization of verifiable medical systems that can be rapidly assembled to meet the needs of specific patients. This thesis addresses the modularized design of a patient-controlled analgesia (PCA) pump to be used within the context of the Medical Device Coordination Framework (MDCF), an open source framework under development by Kansas State University and the University of Pennsylvania that is informed by the Integrated Clinical Environment (ICE) specification managed by the MD PnP program and its collaborators. The thesis illustrates how to set up the MDCF development environment with Eclipse so that a developer can create software for both a remote MDCF console and a local PCA pump, where ICE channels are used for message transmission. Software development on the MDCF console side includes the development of apps that communicate with a local PCA pump through ICE channels and (b) the development of a GUI that can be launched from an MDCF console to configure, control, and monitor a PCA pump. Software development on the PCA pump side includes the creation of (a) ICE channels that can communicate with an MDCF console and (b) multiple threads for corresponding UART ports that support a modularized design. Several hardware modules were implemented to demonstrate the modularized design approach: an alarm module, a patient button module, a pump module, and a control panel module. These modules employ BeagleBone, Arduino, and MSP430 boards. Status information is displayed on an MDCF console GUI, a PCA pump GUI, and a local LCD screen. An enhanced PCA pump or general medical sub-system with more modules can be developed using a similar method by connecting individual modules to UART ports and then creating the corresponding threads to support device-console communication