Current Issue : January - March Volume : 2013 Issue Number : 1 Articles : 4 Articles
Silver is used widely in wound dressings and medical devices as a broad-spectrum antibiotic. Metallic silver and most inorganic\r\nsilver compounds ionise in moisture, body fluids, and secretions to release biologically active Ag+. The ion is absorbed into the\r\nsystemic circulation from the diet and drinking water, by inhalation and through intraparenteral administration. Percutaneous\r\nabsorption of Ag+ through intact or damaged skin is low. Ag+ binds strongly to metallothionein, albumins, and macroglobulins\r\nand is metabolised to all tissues other than the brain and the central nervous system. Silver sulphide or silver selenide precipitates,\r\nbound lysosomally in soft tissues, are inert and not associated with an irreversible toxic change. Argyria and argyrosis are the\r\nprinciple effects associated with heavy deposition of insoluble silver precipitates in the dermis and cornea/conjunctiva.Whilst these\r\nchanges may be profoundly disfiguring and persistent, they are not associated with pathological damage in any tissue. The present\r\npaper discusses the mechanisms of absorption and metabolism of silver in the human body, presumed mechanisms of argyria and\r\nargyrosis, and the elimination of silver-protein complexes in the bile and urine. Minimum blood silver levels consistent with early\r\nsigns of argyria or argyrosis are not known. Silver allergy does occur but the extent of the problem is not known. Reference values\r\nfor silver exposure are discussed....
Implantable wireless devices may allow localized real-time biomedical treating and monitoring. However, such devices require a\r\npower source, which ideally, should be self-powered and not battery dependent. In this paper, we present a novel self-powered\r\nlight therapeutic device which is designed to implement blood irradiation therapy. This device is self-powered by a miniaturized\r\nturbine-based generator which uses hydraulic flow energy as its power source. The research presented in this paper may become\r\nthe first step towards a new type of biomedical self-operational micromechanical devices deployed for biomedical applications....
Background: Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to\r\ntheir medical device approval and post-market surveillance systems. Data may be available that identify strengths and\r\nweakness of the approaches to medical device regulation in these settings.\r\nMethods and Findings: We performed a systematic review to find empirical studies evaluating medical device regulation in\r\nthe US or EU. We searched Medline using two nested categories that included medical devices and glossary terms\r\nattributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We\r\nsupplemented this search with a review of the US Government Accountability Office online database for reports on US Food\r\nand Drug Administration device regulation, consultations with local experts in the field, manual reference mining of\r\nselected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket\r\nevaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies\r\nprovide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based\r\nlargely on recall data, and relay perceptions of some industry leaders from self-surveys.\r\nConclusions: Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of\r\nUS and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both\r\nsystems, including improving classification of devices in the US and promoting transparency and post-market oversight in\r\nthe EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes.\r\nChanges to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that\r\nthere is better assessment of what works in either setting.\r\nPlease see later in the article for the Editors� Summary....
Background: Deviceââ?¬â??associated infection (DAI) plays an important part in nosocomial infection. Active surveillance\r\nand infection control are needed to disclose the specific situation in each hospital and to cope with this problem\r\neffectively. We examined the rates of DAI by antimicrobial-resistant pathogens, and 30ââ?¬â??day and inââ?¬â??hospital\r\nmortality in the intensive care unit (ICU).\r\nMethods: Prospective surveillance was conducted in a mixed medical and surgical ICU at a major teaching hospital\r\nfrom 2000 through 2008. Trend analysis was performed and logistic regression was used to assess prognostic\r\nfactors of mortality.\r\nResults: The overall rate of DAIs was 3.03 episodes per 1000 deviceââ?¬â??days. The most common DAI type was\r\ncatheterââ?¬â??associated urinary tract infection (3.76 per 1000 urinary catheterââ?¬â??days). There was a decrease in DAI rates\r\nin 2005 and rates of ventilatorââ?¬â??associated pneumonia (VAP, 3.18 per 1000 ventilatorââ?¬â??days) have remained low since\r\nthen (p < 0.001). The crude rates of 30ââ?¬â??day (33.6%) and inââ?¬â??hospital (52.3%) mortality, as well as infection by\r\nantibiotic-resistant VAP pathogens also decreased. The most common antimicrobial-resistant pathogens were\r\nmethicillinââ?¬â??resistant Staphylococcus aureus (94.9%) and imipenemââ?¬â??resistant Acinetobacter baumannii (p < 0.001),\r\nwhich also increased at the most rapid rate. The rate of antimicrobial resistance among Enterobacteriaceae also\r\nincreased significantly (p < 0.05). After controlling for potentially confounding factors, the DAI was an independent\r\nprognostic factor for both 30ââ?¬â??day mortality (OR 2.51, 95% confidence interval [CI] 1.99ââ?¬â??3.17, p = 0.001) and\r\ninââ?¬â??hospital mortality (OR 3.61, 95% CI 2.10ââ?¬â??3.25, p < 0.001).\r\nConclusions: The decrease in the rate of DAI and infection by resistant bacteria on the impact of severe acute\r\nrespiratory syndrome can be attributed to active infection control and improved adherence after 20....
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