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Medical devices historically have been monolithic units — developed, validated, and approved by regulatory authorities as stand-alone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single(More)
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 real-time and post-hoc assessment, mined to better inform decision-making, and leveraged to automate control of system units.(More)
Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address(More)
The sucking patterns of 42 healthy full-term and 44 preterm infants whose gestational age at birth was 30.9 +/- 2.1 weeks were compared using the Kron Nutritive Sucking Apparatus for a 5-minute period. The measured pressures were used to calculate six characteristics of the sucking response: maximum pressure generated, amount of nutrient consumed per suck,(More)
Both researchers and industry vendors are exploring the concept of systems of interoperable medical devices and health information systems that support safety and enhance clinical functionality. The Integrated Clinical Environment (ICE) has been proposed as an architecture for such systems, and several research and commercial implementations are being(More)
The Integrated Clinical Environment (ICE) has been proposed as an open platform for integrating heterogeneous medical devices and coordinating their activities to automate clinical workflows. A key element of the ICE vision is that pieces of an ICE system are verified and receive regulatory clearance in a component-wise fashion (instead of a pair-wise(More)
The purpose of this study was to determine the diagnostic accuracy of knee extensor muscle torque tracings in patients suspected of having damage to the anterior cruciate ligament of the knee joint. The knee extensor torque tracings of 30 patients suspected of having anterior instability of the knee joint were reviewed independently for abnormalities(More)
Medical devices historically have been monolithic units --- developed, validated, and approved by regulatory authorities as standalone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single(More)
The development of a safety standard is a time-consuming and complex task. Many factors influence the stringency of the requirements, including history with the products and test methods, safety records, and the intended use of the standard and device. Four primary issues are used to illustrate the complexity of developing a safety standard for today's(More)