Sandy Weininger

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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 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)
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 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)
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)
In recent years, there has been an increase in the popularity of light-emitting diode (LED)-based, battery-powered transilluminators (BPTs) for facilitating transdermal vascular access in adults and neonates. BPTs are believed to have lower potential for inducing skin burns than prior devices based on high-power broadband lamps; however, the optical and(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)
Objective.To develop and test a method for standardized calibrationof pulse oximeters. Methods.A novel pulse oximeter calibrationtechnique capable of simulating the behavior of real patients is discussed.It is based on an artificial finger with a variable spectral-resolved lightattenuator in conjunction with an extensive clinical database of(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)
Objective.There is no commonly accepted in vivocalibration method for pulse oximeters available up to now. On the basis of a prototype device for the calibration of pulse oximeters which was introduced recently, a second approach based on the same concept was tackled in order to design a reliable method for standardized calibration of pulse oximeters.(More)