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Device Use (device + use)
Selected AbstractsPediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical DevicesCONGENITAL HEART DISEASE, Issue 1 2010Jamie S. Sutherell MD ABSTRACT Objective., A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. Study Design., This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. Results., During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. Conclusions., In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications. [source] Functional gait comparison between children with myelomeningocele: shunt versus no shuntDEVELOPMENTAL MEDICINE & CHILD NEUROLOGY, Issue 10 2007Simone Battibugli MD The aim of this study was to compare functional gait differences between patients with myelomeningocele (MM) who have a ventriculoperitoneal shunt (VPS) with those who do not. Our analyses were adjusted for confounding by age, lesion level, orthotic use, and assistive device use. The Functional Mobility Scale (FMS) was used to compare the shunted group (n=98; 60 males, 38 females; mean age 10y 2mo [SD 3y 11mo]; 73 sacral/19 low lumber/six high lumbar lesion level) with the non-shunted group (n=63; 32 males, 31 females; mean age 9y 11mo [SD 3y 11mo]; 45 sacral/12 low lumber/six high lumbar lesion level). Participants with a shunt had lower FMS 500 and FMS 50 scores compared with participants without a shunt; hence the participants without a shunt were more independent in their ambulation at medium and longer distances. For a subset of participants who underwent a three-dimensional gait analysis, we also collected temporal,spatial gait parameters (velocity, cadence, and stride length). Our results show that participants with MM and no shunt who underwent gait analysis(11 males, 10 females; mean age 9y 6mo [SD 4y]; 15 sacral/6 low lumber/0 high lumbar lesion level) tend to walk at a significantly greater velocity and stride length as compared with those with a shunt (33 males, 18 females; mean age 10y [SD 4y]; 38 sacral/13 low lumber/zero high lumbar lesion level). These data allow the treatment team to present more specific information regarding functional ambulatory expectations to patients with MM and their families. [source] Preliminary Results with the Simultaneous Use of Implantable Cardioverter Defibrillators and Permanent Biventricular Pacemakers: Implications for Device Interaction and DevelopmentPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 3 2000S. WALKER We report our preliminary experience with the combined use of implantable cardioverter defibrillutors (ICD) and biventricular pacemakers in six patients with heart failure and malignant ventricular arrhythmia. Two patients underwent ICD implantation for malignant ventricular arrhythmia after previous biventricular pacemaker implantation. One patient underwent biventricular pacemaker insertion for NYHA Class III heart failure after previous ICD implantation. Two patients underwent single device implantation. In the sixth patient, a combined implantation failed due to an inability to obtain a satisfactory left ventricular pacemaker lead position. The potential for device interaction was explored during implantation. In two patients a potentially serious interaction was discovered. Subsequent alterations in device configuration and programming prevented these interactions with long-term use. No complication of combined device use has been demonstrated during a mean follow-up of 2 months (range 1-4 months). Satisfactory ICD and pacemaker function has also been demonstrated. We conclude that combined device implantation may be feasible with currently available pacing technology and that further prospective studies are required in this area. [source] Consanguinity and reproductive wastage in the Palestinian TerritoriesPAEDIATRIC & PERINATAL EPIDEMIOLOGY, Issue 2 2009Shireen Assaf Summary Many studies have found that consanguinity poses a threat to child mortality and health and can also pose a threat to offspring survival before birth. However, there are conflicting findings with some studies having found no increased risk on offspring survival associated with consanguinity. Data from a population-based survey conducted in 2004 in the Palestinian Territories was used to assess the risk of consanguinity on offspring survival. The analysis was conducted on 4418 women aged 15,49 who were asked whether or not they had experienced a stillbirth or a spontaneous abortion. These two outcomes were combined together for the analysis of reproductive wastage. Multivariable negative binomial regression was conducted to calculate the incidence risk ratios (IRR) for each region in the Palestinian Territories separately. The strongest risk factors for reproductive wastage, after controlling for other variables, were found to be consanguinity, age and parity with age presenting the highest IRRs. Standard of living, locality type, education level, women's employment and past intrauterine device use were not found to be significant risk factors for reproductive wastage. In the West Bank only first cousin level of consanguinity was found to be significant and ,hamola' level (or from same family clan) lost its significance after adjusting for other variables. In the Gaza Strip both the first cousin and ,hamola' levels of consanguinity were significant and presented almost equal IRRs of 1.3. In conclusion, consanguinity was found to be a significant risk factor for reproductive wastage. [source] Use of an Automated Device for External Chest Compressions by First-aid Workers Unfamiliar With the Device: A Step Toward Public Access?ACADEMIC EMERGENCY MEDICINE, Issue 12 2009Frédéric Lapostolle MD Abstract Objective:, The objective was to establish the feasibility of using an automated external chest compression (ECC) device among first-aid workers unfamiliar with the device. Methods:, Eighty first-aid workers unfamiliar with the Autopulse ECC device were randomized into three groups. Group 1 was given two explanatory illustrations on device use. Group 2 was given four explanatory illustrations. Group 3 was shown a 5-minute video on the placement and use of the device and allowed to handle the device for 5 minutes. The time taken to place and start the device on a mannequin was recorded. Results:, There was no significant difference among the three groups with regard to age, sex ratio, experience, and time elapsed since their last training session. No mistakes in device placement were made by any of the groups. All 80 participants started ECC in less than 160 seconds. There was no significant difference between Groups 1 and 2 in time taken to place or start the device (medians and 25,75 percentiles = 72 [54,112] vs. 86 [46,130] seconds and 154 [103,183] vs. 156 [120,197] seconds, respectively). However, Group 3 first-aid workers obtained significantly better results (19 [16,26] seconds to place and 48 [40,65] seconds to start; p<0.0001). Conclusions:, An automated ECC device can be rapidly placed and used by first-aid workers unfamiliar with the device. In the light of these results, use of the device by the general public can be envisaged. [source] Optoelectronic properties of transparent p-type semiconductor CuxS thin filmsPHYSICA STATUS SOLIDI (A) APPLICATIONS AND MATERIALS SCIENCE, Issue 7 2010P. Parreira Abstract Nowadays, among the available transparent semiconductors for device use, the great majority (if not all) have n-type conductivity. The fabrication of a transparent p-type semiconductor with good optoelectronic properties (comparable to those of n-type: InOx, ITO, ZnOx or FTO) would significantly broaden the application field of thin films. However, until now no material has yet presented all the required properties. Cu2S is a p-type narrow-band-gap material with an average optical transmittance of about 60% in the visible range for 50,nm thick films. However, due to its high conductivity at room temperature, 10,nm in thickness seems to be appropriate for device use. Cu2S thin films with 10,nm in thickness have an optical visible transmittance of about 85% rendering them as very good candidates for transparent p-type semiconductors. In this work CuxS thin films were deposited on alkali-free (AF) glass by thermal evaporation. The objective was not only the determination of its optoelectronic properties but also the feasibility of an active layer in a p-type thin film transistor. In our CuxS thin films, p-type high conductivity with a total visible transmittance of about 50% have been achieved. [source] Implantation of the Ossified Cochlea: Management with the Split Electrode ArrayTHE LARYNGOSCOPE, Issue 12 2005D A. Millar BS Abstract Objectives/Hypothesis: To describe indications for, the surgical technique required, and the expected functional results of split electrode array cochlear implants. Study Design: Retrospective chart review. Methods: Data collected included etiology of deafness, radiographic findings, pre- and postoperative aided pure tone thresholds, and speech perception testing. Adult speech perception outcomes were measured using the Consonant Nucleus Consonant (CNC) monosyllable words and Hearing in Noise Test (HINT) in quiet/noise (+10dB). The children were assessed using the Infants and Toddlers Meaningful Auditory Integration Scale. Results: Five patients were implanted with a split electrode array. This included two adults and three children. Both adults had preoperative binaural aided pure tone averages worse than 50d B and scores of 0% on both HINT quiet and CNC words. The children had undetectable preoperative aided thresholds and scored an average 4/40 on the IT-MAIS. Postimplant, the average threshold gain was 38.5 dB in the adults and 81.5 dB in the children. One adult improved to score 51%/22% on HINT quiet/noise at 6 months and 72%/30% at 12 months. The other adult continued to score 0% on HINT at 12 months but claimed substantial subjective auditory improvement after the first year of device use. The children averaged 28/40 on the IT MAIS at 6 months after implantation. Forty-two of 48 implanted electrodes were functional. Conclusions: The split electrode array is a useful alternative to traditional cochlear implants in treating deafened patients with cochlear ossification. Patients implanted with the split array show marked improvement in sound and speech perception. [source] Comparison of the C-MAC® videolaryngoscope with the Macintosh, Glidescope®, and Airtraq® laryngoscopes in easy and difficult laryngoscopy scenarios in manikinsANAESTHESIA, Issue 5 2010J. McElwain Summary The C-MAC® comprises a Macintosh blade connected to a video unit. The familiarity of the Macintosh blade, and the ability to use the C-MAC as a direct or indirect laryngoscope, may be advantageous. We wished to compare the C-MAC with Macintosh, Glidescope® and Airtraq® laryngoscopes in easy and simulated difficult laryngoscopy. Thirty-one experienced anaesthetists performed tracheal intubation in an easy and difficult laryngoscopy scenario. The duration of intubation attempts, success rates, number of intubation attempts and of optimisation manoeuvres, the severity of dental compression, and difficulty of device use were recorded. In easy laryngoscopy, the duration of tracheal intubation attempts were similar with the C-MAC, Macintosh and Airtraq laryngoscopes; the Glidescope performed less well. The C-MAC and Airtraq provided the best glottic views, but the C-MAC was rated as the easiest device to use. In difficult laryngo-scopy the C-MAC demonstrated the shortest tracheal intubation times. The Airtraq provided the best glottic view, with the Macintosh providing the worst view. The C-MAC was the easiest device to use. [source] A comparison of McGrath and Macintosh laryngoscopes in novice users: a manikin studyANAESTHESIA, Issue 11 2009D. C. Ray Summary Direct laryngoscopy using the Macintosh laryngoscope is a difficult skill to acquire. Videolaryngoscopy is a widely accepted airway management technique that may be easier for novices to learn. We compared the McGrath® videolaryngoscope and Macintosh laryngoscope by studying the performance of 25 medical students with no previous experience of performing tracheal intubation using an easy intubation scenario in a manikin. The order of device use was randomised for each student. After brief instruction each participant performed eight tracheal intubations with one device and then eight tracheal intubations with the other laryngoscope. Novices achieved a higher overall rate of successful tracheal intubation, avoided oesophageal intubation and produced less dental trauma when using the McGrath. The view at laryngoscopy was significantly better with the McGrath. Intubation times were similar for both laryngoscopes and became shorter with practice. There was no difference in participants' rating of overall ease of use for each laryngoscope. [source] More responsibility needed in advertising related to encouraging mobile Internet device use while engaged in another activityAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 4 2010Joseph Y. Ting No abstract is available for this article. [source] The "criminalization" of off-label device use,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2008Christopher J. White MD No abstract is available for this article. [source] Assistive devices and cerebral palsy: the use of assistive devices at school by children with cerebral palsyCHILD: CARE, HEALTH AND DEVELOPMENT, Issue 5 2009I-C. Huang Abstract Background Although the importance of providing disabled children with assistive devices has always been highlighted, most studies in the field of assistive device research seek the participation of adult users or adult carers. Accordingly, the opinions of young users themselves seem to be overlooked. To start to address the gap, this study aimed to understand the children's perspectives regarding device use in school and to explore the factors related to their device utilization in this setting. Methods Semi-structured interviews were adopted as the main data collection instrument. A total of 44 participants were involved, including 15 Taiwanese children with cerebral palsy, aged between 8 and 15 years, 15 mothers and 14 teachers. Results The interview results show a high frequency of device use in school which can be attributed to children's willingness, teachers' attitudes, mothers' support, physical environmental factors and device-related features. Conclusions The findings not only demonstrate the significance of child,environment interaction but also provide evidence that children's views may be different from those of adults because they are at a different developmental stage and act out different roles in their environment. [source] | ||||||||||