Expert review of medical devices
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Expert Rev Med Devices · May 2009
ReviewRadiotherapy-induced pacemaker and implantable cardioverter defibrillator malfunction.
It is well known that ionizing radiation can interfere with circuits in permanent pacemakers and implantable cardioverter defibrillators. Contemporary implantable cardiac devices use complementary metal-oxide silicon in combination with other very sensitive transistors. These sensitive components are especially susceptible to electromagnetic and ionizing radiation, which can potentially cause permanent damage. ⋯ The American Association of Physicists in Medicine last published recommendations regarding irradiation of pacemakers in 1994. This publication is outdated and may not be pertinent for the current technology used both in the field of artificial cardiac pacing and defibrillation and in the field of radiation oncology. Updated guidelines are definitely needed.
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This review examines the diffusion of modern medical devices in India by analyzing trends in India's cross-border trade in medical devices, its domestic medical device production and utilization by households. We explore the implications of this process of diffusion for the efficacy, cost-effectiveness and equitable use of new medical devices in India, and review recent efforts to regulate the Indian medical device sector.
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Expert Rev Med Devices · Mar 2009
Masimo Rad-57 Pulse CO-Oximeter for noninvasive carboxyhemoglobin measurement.
Noninvasive methods of body fluid chemical measurement have been expanding. New technologies are enabling the quantification of different compounds in the blood and interstitial tissues. One example of this is the pulse oximeter, which has facilitated the measurement of oxyhemoglobin rapidly and reliably without the requirement of blood-draws. ⋯ Since the presentation of CO poisoning is nonspecific and overlaps with many other conditions, and since the presence of environmental CO is often unknown, the detection of this condition was only possible in cases where the presence of CO was obvious or where the symptoms were severe. We now know, from studies conducted using the Rad-57, the only US FDA-approved device for noninvasive measurement of SpCO, that there are a significant number of patients who experience CO exposure but are nonsymptomatic. The Rad-57 provides a clinical justification for screening in the healthcare setting to identify patients with significant CO exposure who would otherwise be undetected.
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Expert Rev Med Devices · May 2008
Case ReportsPerioperative monitoring of fluid responsiveness after esophageal surgery using stroke volume variation.
To assess the utility of a new arterial pressure-based cardiac output (FloTrac) and central venous oximetry (PreSep) monitoring system in the perioperative management of patients undergoing radical esophagectomy. ⋯ From May 2006, a new analyzing device (Vigileo monitor; Edwards Lifesciences LLC, Tokyo, Japan), which can be used in combination with the FloTrac and PreSep sensors, has been used in nine patients who have undergone radical operations for thoracic esophageal cancer at our hospital. Stroke volume variation (SVV), calculated for each respiratory cycle and displayed on the Vigileo monitor, precisely predicted intravascular hypovolemia. The maximum SVV of patients who needed fluid resuscitation was significantly higher than that of patients who had a stable circulation. The mean value of the maximum SVV in the patient with or without fluid resuscitation was 25 +/- 6.9 and 13 +/- 1.4%, respectively (p < 0.04). In addition, continuous monitoring of central venous oxygen saturation enabled evaluation of oxygen supply to tissues to aid in determining the need for red blood cell transfusion. The Vigileo monitor (with Flo Trac and PreSep sensors) provided reliable information for the perioperative management of high-risk patients after highly invasive general surgery without the need for an invasive central or pulmonary catheter.
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The number of current advances in robotic surgery for the pediatric population is growing every day: the different procedures range from extirpative to reconstructive, including pyeloplasty, reimplantation, catheterizable channels and augmentation. Despite its early success, robotic surgery still poses many challenges in pediatric patients. ⋯ There are many other procedures that can be performed with the robot, such as ureteral reimplantation, and nephrectomy, both total and partial. The reconstructive aspect has been taken to the next level where more difficult procedures, such as appendicovesicostomy and bladder augmentation, can be performed in children.