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Title:An Analysis Framework for the Safe Use of Medical Device Plug-n-Play (MD PnP) Systems
Author(s):Rahmaniheris, Maryam; Sha, Lui; Ou, Yi-Zong; Weininger, Sandy
Subject(s):Safety Analysis, Medical Device Plug-n-play, Fault Tree
Abstract:Medical Device Plug-and-Play (MD PnP) is a recent NIH (National Institute of Health) sponsored investigation on the interoperability of medical devices and the design of safe integrated medical systems \cite{MDPnP}. An MD PnP system supports a range of safe medical system configurations, where medical devices are "plugged in" as needed, information from different sources are integrated, and medical actions are coordinated to provide an integrated clinical environment. This opens the door to significantly mitigating preventable medical errors. However, MD PnP system consists of commercial computing and communication platforms not designed for safety-critical applications and may fail. Therefore, it is critical to ensure that the MD PnP system is safe for an intended medical application. This means none of the MD PnP components can become a causal factor of the known safety hazards. This paper is an attempt to discuss the issues related to the safety of advanced MD PnP-based medical systems and facilitate the safe use of such systems by proposing a safety analysis framework to ensure no MD PnP component can be a causal factor for known potential safety hazards in specified medical procedures.
Issue Date:2015
Genre:Technical Report
Sponsor:NSF CNS 13-29886
MGH 217183
Date Available in IDEALS:2020-11-10

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