OBJECTIVE Heart failure with preserved ejection fraction (HFpEF) is characterized by elevated left atrial pressure during rest and/or exercise. The Reduce LAP-HF (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) trial will evaluate the safety and performance of the Interatrial Shunt Device (IASD) System II, designed to directly reduce elevated left atrial pressure, in patien...

BACKGROUND Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process. OBJECTIVE This paper introduces a cost-effective tool in which the Radio Frequency Identification (RFID) technology is used to identify medical errors in hospital. METHODS The proposed clinical error management system (CEMS) is c...

OBJECTIVE To assess the efficacy and safety of an external urethral barrier for the management of mild to moderate stress urinary incontinence in adult women. METHODS Four hundred eleven women with the symptom of stress urinary incontinence in 12 United States centers participated. Additional inclusion and exclusion criteria were applied before protocol device use, and ultimately 390 subjects...

This paper addresses international standards which can be applied to the requirements for accelerator personnel safety systems. Particular emphasis is given to standards which specify requirements for safety interlock systems which employ programmable electronic subsystems. The work draws on methodologies currently under development for the medical, process control, and nuclear industries.

CONTEXT Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety. OBJECTIVE To determine whether automated safety surveillance of clinical registries using a computerized tool can p...

A novel method is presented for the design of heat exchanger networks. The method is the first to combine sufficient simplicity to be used by hand with near certainty to identify “best” designs, even for large problems. “Best” designs feature the highest degree of energy recovery possible with a given number of capital items. Moreover, they feature network patterns required for good controllabi...