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PublicationModel-Driven Safety Analysis of Closed-Loop Medical Systems(2012-10-01) Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian M.; Lee, InsupIn modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure. PublicationPlug-and-Play for Medical Devices: Experiences From a Case Study(2009-07-01) Arney, David; Fischmeister, Sebastian; Lee, Insup; Goldman, Julian M; Trausmuth, RobertMedical devices are pervasive throughout modern healthcare, but each device works on its own and in isolation. Interoperable medical devices would lead to clear benefits for the care provider and the patient, such as more accurate assessment of the patient’s health and safety interlocks that would enable error-resilient systems. The Center for Integration of Medicine & Innovative Technology (www.CIMIT.org) sponsors the Medical Device Plug-and-Play Interoperability program (www.MDPnP.org), which is leading the development and adoption of standards for medical device interoperability. Such interoperable medical devices will lead to increased patient safety and enable new treatment options, and the aim of this project is to show the benefits of interoperable and interconnected medical devices. PublicationToward Patient Safety in Closed-Loop Medical Device Systems(2010-04-13) Arney, David; Pajic, Miroslav; Goldman, Julian M.; Lee, Insup; Mangharam, Rahul; Sokolsky, OlegA model-driven design and validation of closed-loop medical device systems is presented. Currently, few if any medical systems on the market support closed-loop control of interconnected medical devices, and mechanisms for regulatory approval of such systems are lacking. We present a system implementing a clinical scenario where closed-loop control may reduce the possibility of human error and improve safety of the patient. The safety of the system is studied with a simple controller proposed in the literature. We demonstrate that, under certain failure conditions, safety of the patient is not guaranteed. Finally, a more complex controller is described and ensures safety even when failures are possible. This investigation is an early attempt to introduce automatic control in clinical scenarios and to delineate a methodology to validate such patient-in-the-loop systems for safe and correct operation. PublicationGSA: A Framework for Rapid Prototyping of Smart Alarm Systems(2010-11-11) King, Andrew; Roederer, Alex; Arney, David; Chen, Sanjian; Fortino-Mullen, Margaret; Giannareas, Ana; Hanson III, C. William; Kern, Vanessa; Stevens, Nicholas; Viesca Trevino, Adrian; Park, Soojin; Sokolsky, Oleg; Lee, Insup; Tannen, JonathanWe 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.