Abstract
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repai...
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PMID: 21845785
PDF is available here.
Abstract
The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various serologic...
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PMID: 21826824
PDF is available here.
Abstract
We describe a new aortic retractor that is effective in maintaining aortic root geometry and providing for adequate intraoperative visual valve assessment, and therefore enables the surgeon to perform precise aortic valve repair or replacement procedures.
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PMID: 21718884
PDF is available here.
Abstract
HeartWare continuous flow ventricular assist devices (HVAD) configured as biventricular assist devices maintain diurnal flow variation, lead to end-organ recovery, and provide for a successful bridge-to-heart transplantation in the first successful North American use of continuous flow biventricular...
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PMID: 21718817
PDF is available here.
Abstract
A new computer-assisted colonoscope, controlled using a handheld device, showed excellent cecal intubation rates during screening examinations, with sedation required in only ∼5% of screenees. Further clinical and comparative studies are warranted.Am J Gastroenterol advance online publication, 8 Ma...
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PMID: 21386833
PDF is available here.
Abstract
A one-way nasal resistor has recently been shown to reduce sleep disordered breathing (SDB) in a subset of patients with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS). The purpose of this study was to examine characteristics predictive of therapeutic response to the device and provide pilot data...
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PMID: 21344051
PDF is available here.
Abstract
We registered 776 episodes of ATP occurring because of ventricular tachycardia (VT) in 20 of 22 patients with activated ATP. Overall efficacy of burst ATP was 49.1%; VT was not terminated or was accelerated in 43.2 and 7.6% of cases, respectively. Ramp ATP was effective in 44.3, ineffective--in 33.9...
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PMID: 21626805
PDF is available here.
Abstract
Increasing evidence supports use of convective therapies, such as hemodiafiltration, to improve outcomes for hemodialysis patients. Maximizing convection requires large volumes of substitution solution, which is practical only if online technology is used for its preparation. Substitution solution m...
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PMID: 20938127
PDF is available here.
Abstract
Adequate reliability of algorithms and computations of modern medical systems software is a matter of concern because the system software is in charge of satisfying safety requirements of the system environment, i.e., the patient. This chapter aims to present a framework for specifying the behavior o...
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PMID: 21431605
PDF is available here.
Abstract
Until recently the only mode of mechanical circulatory support available in North America for use as bridge to cardiac transplantation in small children was extra-corporeal membrane oxygenation. However, since 2005 the Berlin Heart pediatric ventricular assist device has been increasingly widely used...
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PMID: 21444059
PDF is available here.
Abstract
We will review the current status of mechanical circulatory support devices and therapy strategies for infants and small children presenting in acute heart failure....
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PMID: 21444048
PDF is available here.
Abstract
The Food and Drug Administration (FDA) is classifying the non-powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance...
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PMID: 21090144
PDF is available here.
Abstract
The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff;...
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PMID: 21066902
PDF is available here.
Abstract
The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type...
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PMID: 21053532
PDF is available here.
Abstract
It is difficult to replicate the regular rate and rhythm described by Ilizarov while lengthening with the Taylor Spatial Frame. The purpose of the study was to examine whether this breach of Ilizarov's principles has any deleterious effect on the ability of children to make healthy regenerate bone....
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PMID: 20739904
PDF is available here.
Abstract
We used data from further hospital stays or information given by phone.
In 42 patients at intervals of 6 and 12 months, stable SR was documented in 7-day Holter monitoring in 18 patients (42.9%, 10/25 and 9/25 for PAF and 8/17 and 9/17 for persAF, respectively). Symptomatic episodes of AF were repo...
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PMID: 20635128
PDF is available here.
Abstract
Insulin pen devices are currently being used by approximately half of insulin users worldwide. ClikSTAR® (sanofi-aventis) is a novel reusable insulin pen for injecting either long-acting insulin glargine or short-acting insulin glulisine. The objective of this study was to demonstra...
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PMID: 20920444
PDF is available here.
Abstract
Exchanging a large canvas bag for several smaller nylon bags has improved the transport of emergency airway equipment, with benefits in carrying the bag, locating equipment, and reducing the transport of pathogens throughout the hospital....
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PMID: 20587096
PDF is available here.
Abstract
Patients using the home treatment device had no evidence of nystagmus in posttreatment Dix-Hallpike maneuvers at 1 week in 88% of cases (n = 40). This rate was comparable to standard treatment. There were no significant complications. CONCLUSION: The use of this device enables patients with an estab...
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PMID: 20644063
PDF is available here.
Abstract
There are approximately 4.2 million tractors on farms and ranches across the United States. The average age of tractors is over 25 years and some of the oldest models are the most popular. Older tractors are less safe than newer tractors, and many older tractors are operated by individuals with incr...
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PMID: 20665310
PDF is available here.
Abstract
Musculoskeletal disorders (MSDs) are increasingly recognized as a significant hazard of agricultural occupation. In agricultural jobs with significant physical labor, MSDs are typically the most frequently reported injury. Although not as lethal as tractor roll-overs, MSDs can result in disability,...
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PMID: 20665313
PDF is available here.
Abstract
MRI examinations were completed safely in 63 patients. Inhibition of pacemaker output was observed in one patient and induction of ventricular fibrillation was observed in another with ICD. A significant increase in PCT was rare and only detected in 1% of all electrodes. CONCLUSION: MRI can be perfo...
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PMID: 20534201
PDF is available here.
Abstract
The investigations for all test devices of applanation tonometers show the compliance within permissible error limits in the observed measuring range for the reverse span with the tonometer AT 870. Some instruments exceed the permissible error limits for test devices for up- and downward force measu...
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PMID: 20349398
PDF is available here.
Abstract
Respiration has a slight but statistically significant effect on the rear stability of occupied wheelchairs, with greater stability at full inspiration. This has potential clinical implications for stability testing and the training of wheelchair skills, but further study is needed.
Copyright 2010 A...
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PMID: 20510988
PDF is available here.
Abstract
The design of a medical device should include active consideration of the way in which real users will actually use the device in the real environment of use. This consideration must include making the way in which the user interfaces with the device, for example, the buttons, the displays, the conn...
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PMID: 20541072
PDF is available here.
Abstract
Robotic assistive devices are used increasingly to improve the independence and quality of life of persons with disabilities. Devices as varied as robotic feeders, smart-powered wheelchairs, independent mobile robots, and socially assistive robots are becoming more clinically relevant. There is a gr...
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PMID: 20134305
PDF is available here.
Abstract
We examined two such safety practices as risk factors for injury: (1) the presence of safety devices on machinery and (2) low levels of routine machinery maintenance. Our data source was the Saskatchewan Farm Injury Cohort baseline survey (n=2390 farms). Factor analysis was used to create measures o...
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PMID: 20441836
PDF is available here.
Abstract
Chronic right ventricular apical pacing (RVAP) has been associated with negative hemodynamic and clinical effects. The aim of the present study was to compare RVAP with right ventricular septal pacing (RVSP) in terms of echocardiographic features and clinical outcomes. A total of 93 patients without...
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PMID: 20451689
PDF is available here.
Abstract
An embedded port is frequently used for outpatients with advanced cancer in central venous chemotherapy or hepatic arterial chemoinfusion. The port needle with a safety device in an ambulatory treatment center is indispensable for medical employees and patient plus family to reduce the risk of a nee...
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PMID: 20495336
PDF is available here.
Abstract
In healthy healthcare workers, FFR did not impose any important physiological burden during 1 hour of use, at realistic clinical work rates, but the FFR dead-space carbon dioxide and oxygen levels were significantly above and below, respectively, the ambient workplace standards, and elevated P(CO2)...
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PMID: 20420727
PDF is available here.
Abstract
This study was performed to evaluate the efficacy of a novel chest drainage system. This system employs guide wire-based active chest tube clearance to improve drainage and maintain patency. A 32 Fr chest tube was inserted into pleural cavities of five pigs. On the left, a tube was c...
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PMID: 20179137
PDF is available here.
Abstract
All the instruments used for cervical preparation seemed to be safe and did not damage the dentin structure of the distal wall of mesial root canals of mandibular molars.
Copyright (c) 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved....
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PMID: 20416433
PDF is available here.
Abstract
Electrical safety testing of medical equipment is essential to ensure that the apparatus is safe for operators and patients alike. Rigel Medical's John Backes looks at the latest tests used to assess the integrity of insulation in electrical appliances.
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PMID: 20446485
PDF is available here.
Abstract
Retrievable IVC filters in trauma patients are safe, but complications do occur with thrombosis being the most common. Retrieval has a high technical success rate when attempted. However, a significant number of trauma patients are lost to follow-up and this may impact the utilization of retrievable...
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PMID: 20386285
PDF is available here.
Abstract
There are approximately 10 million pieces of community equipment delivered to 3.5 million clients every year in England and Wales. The service is key for moving people safely around the whole health and social care system, and is used by almost every clinical professional working in the community. I...
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PMID: 20559161
PDF is available here.
Abstract
We report a computational study of the intensity and frequency of thermoelastic pressure waves generated by RF pulses in the human head inside high-field MRI and clinical scanners. The U.S. Food and Drug Administration (U.S. FDA) guides limit the local specific absorption rate (SAR) in the body-incl...
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PMID: 20220368
PDF is available here.
Abstract
We study in vitro evaluation of needle artefacts and image quality for musculoskeletal laser-interventions in an open high-field magnetic resonance imaging (MRI) scanner at 1.0T with vertical field orientation. Five commercially available MRI-compatible puncture needles were assessed based on artefa...
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PMID: 19705200
PDF is available here.
Abstract
This plenary talk at the eighth annual Midwest Rural Agricultural Safety and Health Forum, November 2009, described a conference held earlier in the year focusing on the hazards and risks associated with moving agricultural equipment on public roads. The Farm Equipment-Motor Vehicle Crash Prevention...
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PMID: 20407988
PDF is available here.
Abstract
Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement...
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PMID: 20464854
PDF is available here.
Abstract
Contact lens case contamination is a significant public health concern and may contribute significantly to the development of microbial keratitis in contact lens wearers. Patients should be reminded that they must clean and disinfect their lens cases daily, should avoid the use of tap water for rins...
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PMID: 20090542
PDF is available here.
Abstract
Our data should not be extrapolated to encourage MRI scanning beyond the present labeling. Rather, our data may contribute to further defining safe MRI scanning parameters that might ultimately be adopted in future product labeling as more centers report in detail their experiences....
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PMID: 20374084
PDF is available here.
Abstract
Seven of the 24 patients who reported retained metal fragments were excluded, since there was no validating evidence of their presence. Fragments in the remaining 17 patients (18 MRI examinations) were inflicted by military or terrorist attacks that occurred 2-39 years prior to the MRI. The fragment...
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PMID: 19912071
PDF is available here.
Abstract
The mean gain in range of motion was 26 degrees (range, 2 degrees -60 degrees ). Gains of motion were noted in 35 of 37 elbows. Patients lowered their analgesic use and were highly satisfied with the device (mean satisfaction score of 8.5 of 10 points possible). DISCUSSION: This device compared favo...
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PMID: 19959379
PDF is available here.
Abstract
Although the Ex-PRESS glaucoma shunt is influenced by magnetic field forces, it is likely MR of up to 3 Tesla is safe due to resistance provided by the ocular tissue....
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PMID: 19661826
PDF is available here.