Current Issue : April - June Volume : 2015 Issue Number : 2 Articles : 5 Articles
Aim. Medical device-related adverse events are often ascribed to ââ?¬Å?deviceââ?¬Â or ââ?¬Å?operatorââ?¬Â failure although there are more complex\ncauses. A structured approach, viewing the device in its clinical context, is developed to assist in-depth investigations of the causes.\nMethod. Medical device applications involve devices, clinical teams, patients, and supporting infrastructure. The literature was\nexplored for investigations and approaches to investigations, particularly structured approaches. From this a conceptual framework\nof causes was developed based primarily on device and clinical team caring for the patient within a supporting infrastructure, each\naspect having detailed subdivisions.The approach was applied to incidents fromthe literature and an anonymous incident database.\nResults.The approach identified and classified the underlying causes of incidents described in the literature, exploring the details of\nââ?¬Å?device,ââ?¬Â ââ?¬Å?operator,ââ?¬Â or ââ?¬Å?infrastructureââ?¬Â failures. Applied to incident databases it suggested that causes differ between device types\nand identified the causes of device unavailability. Discussion.The structured approach enables digging deeper to uncover the wider\ncauses rather than ascribing to device or user fault. It can assess global patterns of causes. It can help develop consistent terminology\nfor describing and sharing information on the causes of medical device adverse events....
Background: There is a high probability of accidental perforation of the vertebral\npedicle wall in pedicle screw insertion surgery. A pedicle screw (PS) measurement\ndevice with an optical probe has been reported to send out a warning signal before\nthe PS tip breaking the vertebral pedicle wall.\nMethods: In this study, we explored the detection depth of optical probe in this\nmeasurement device, which was closely related to the effective alarm distance. In the\nboundary, the vertebrae tissues could be treated as 2-layer models including spongy\nbones and compact bones. The Monte Carlo simulation and phantom models were\nperformed to analyse and define the detection depth. Then the porcine vertebrae\nmodels were performed to obtain optical spectrum and reduced scattering coefficient,\nbased on which the detection depths were deduced. Moreover, a comparison was\nmade to explore the most significant pattern factor from the experiment results.\nResults: According to the pattern factor, an alarm threshold was successfully deduced\nto define the alarm distance during pedicle screw monitoring.\nConclusions: Thus, the proposed alarm standard based on detection depth provides a\npotential for guiding pedicle screw in surgery....
Background: Cardiac disease is one of the main causes of catastrophic mortality.\nTherefore, detecting the symptoms of cardiac disease as early as possible is important\nfor increasing the patient�s survival. In this study, a compact and effective architecture\nfor detecting atrial fibrillation (AFib) and myocardial ischemia is proposed. We\ndeveloped a portable device using this architecture, which allows real-time\nelectrocardiogram (ECG) signal acquisition and analysis for cardiac diseases.\nMethods: A noisy ECG signal was preprocessed by an analog front-end consisting of\nanalog filters and amplifiers before it was converted into digital data. The analog\nfront-end was minimized to reduce the size of the device and power consumption by\nimplementing some of its functions with digital filters realized in software. With the\nECG data, we detected QRS complexes based on wavelet analysis and feature\nextraction for morphological shape and regularity using an ARM processor. A classifier\nfor cardiac disease was constructed based on features extracted from a training dataset\nusing support vector machines. The classifier then categorized the ECG data into\nnormal beats, AFib, and myocardial ischemia.\nResults: A portable ECG device was implemented, and successfully acquired and\nprocessed ECG signals. The performance of this device was also verified by comparing\nthe processed ECG data with high-quality ECG data from a public cardiac database.\nBecause of reduced computational complexity, the ARM processor was able to process\nup to a thousand samples per second, and this allowed real-time acquisition and\ndiagnosis of heart disease. Experimental results for detection of heart disease showed\nthat the device classified AFib and ischemia with a sensitivity of 95.1% and a specificity\nof 95.9%.\nConclusions: Current home care and tele medicine systems have a separate device\nand diagnostic service system, which results in additional time and cost. Our proposed\nportable ECG device provides captured ECG data and suspected waveform to identify\nsporadic and chronic events of heart diseases. This device has been built and evaluated\nfor high quality of signals, low computational complexity, and accurate detection....
Background: Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but\naccess to these important tools is often limited in Africa. The regulation of health commodities by National\nRegulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new\nproducts. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve\naccess to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the\nregulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical\ndevices across Partner States of the East African Community (EAC).\nMethods: Data was collected during October 2012 through desk based review of documents and field research, including\nface to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key\nareas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for\nregulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity\nfor regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for\nharmonization in EAC Partner States.\nResults: Control of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes\nsuch as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the\ncapacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure\nquality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market\nsurveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other\nmedical devices.\nConclusions: Regulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States.\nRegulation is weak across the region, and although the majority of States have a legal mandate to regulate medical\ndevices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with\ndiagnostic tests considered a priority area for harmonisation....
Introduction: Enhancement of peripheral\ncirculation using electrical devices has\ndemonstrated benefit in many vascular\ndisorders.\nCase Series: Herein, we present a case series\nof three complex patients illustrating the\nsuccessful use of a new single-use disposable\nneuromuscular electrical stimulation (NMES)\ndevice (gekoTM, Firstkind Ltd, UK). Cases include\nthe management of recalcitrant ulcers, nonreconstructable\ncritical limb ischemia, and an\ninfected arterial bypass graft.\nConclusion: Neuromuscular electrical\nstimulation (NMES) can potentially enhance\nperipheral circulation in vascular patients.\nDifficult or recalcitrant vascular cases may\nbenefit from it as an adjunct to best medical\ncare. NMES has few side effects, and may be\nespecially useful where polypharmacy is an\nissue. The incidence of a skin reaction may\nnecessitate device discontinuation....
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