Current Issue : October - December Volume : 2015 Issue Number : 4 Articles : 4 Articles
When patients lack sufficient treatment options for serious medical conditions, they rely on\nthe prompt approval and development of new therapeutic alternatives, such as medical devices.\nUnderstanding the development of innovative medical devices, including the characteristics\nof premarket clinical trials and length of Food and Drug Administration (FDA)\nreview, can help identify ways to expedite patient access to novel technologies and inform\nrecent efforts by FDA to more quickly get these products to patients and physicians. We analyzed\npublicly available information on clinical trials and premarket FDA review for innovative\nmedical devices that fill an unmet medical need. In this first-of-its-kind study focusing on\nthese products, we extracted data on the length of the pivotal trials, primary study endpoint\nand FDA review; number of patients enrolled in trials; and in what country the device was\navailable first. We identified 27 approved priority review devices from January 2006 through\nAugust 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3\nmonths to approximately 7 years. Trials had a median primary outcome measure evaluation\ntime of one year and a median enrollment of 297 patients. The median FDA review time\nwas 1 year and 3 months. Most priority review devices were available abroad before\nthey were approved in the United States. Our study indicates that addressing the length of\nclinical studiesââ?¬â?and contributing factors, such as primary outcome measures and enrollmentââ?¬â?\ncould expedite patient access to innovative medical devices. FDA, manufacturers,\nCongress and other stakeholders should identify the contributing factors to the length of\nclinical development, and implement appropriate reforms to address those issues....
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Background: Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use\nof devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the\npatient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has\nbeen primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system\nremains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident\nrecognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition,\nreporting and resolution of medical device-related incidents.\nMethods: We searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled\nTrials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on\nfactors that influence incident recognition, reporting and resolution published and interventions or strategies for their\nimprovement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for\ninclusion.\nResults: Thirty studies were included in our systematic review, but most studies were concentrated on other health\ntechnologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how\nincident reports will be used and time constraints to incident reporting are common barriers to incident recognition\nand reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error\nreporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians\nabout the reported error.\nConclusions: The available evidence on factors influencing medical device-related incident recognition, reporting\nand resolution by healthcare professionals can inform data collection and analysis in future studies. Since evidence\ngaps on medical device-related incidents exist, telephone interviews with frontline clinicians will be conducted to\nsolicit information about their experiences with medical devices and suggested strategies for device surveillance\nimprovement in a hospital context. Further research also should investigate the impact of human, system,\norganizational and education factors on the development and implementation of local medical device surveillance\nsystems....
Most heart diseases are associated with and reflected by the sounds that the heart\nproduces. Heart auscultation, defined as listening to the heart sound, has been a very\nimportant method for the early diagnosis of cardiac dysfunction. Traditional auscultation\nrequires substantial clinical experience and good listening skills. The emergence\nof the electronic stethoscope has paved the way for a new field of computer-aided\nauscultation. This article provides an in-depth study of (1) the electronic stethoscope\ntechnology, and (2) the methodology for diagnosis of cardiac disorders based on\ncomputer-aided auscultation. The paper is based on a comprehensive review of (1) literature\narticles, (2) market (state-of-the-art) products, and (3) smartphone stethoscope\napps. It covers in depth every key component of the computer-aided system with electronic\nstethoscope, from sensor design, front-end circuitry, denoising algorithm, heart\nsound segmentation, to the final machine learning techniques. Our intent is to provide\nan informative and illustrative presentation of the electronic stethoscope, which is\nvaluable and beneficial to academics, researchers and engineers in the technical field,\nas well as to medical professionals to facilitate its use clinically. The paper provides the\ntechnological and medical basis for the development and commercialization of a realtime\nintegrated heart sound detection, acquisition and quantification system...
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