Medical devices; ear, nose, and throat devices; classification of olfactory test device. Final rule.
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The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Olfactory Test Device." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that is the special control for the device. (+info)
Range of self-tests available to buy in the United Kingdom: an Internet survey.
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We aimed to describe the availability in the United Kingdom of self-tests that are used to diagnose or screen for conditions without involving a health professional. A systematic Internet search identified 104 unique self-tests related to 24 named conditions including cancers, chronic conditions and infections. These self-tests require various samples including blood obtained using a lancet. The samples are processed at home with results available in minutes or sent to a laboratory for processing with results returned to the individual by e-mail or post. Prices per self-test and condition range from < Pounds 1 to Pounds 76. Self-tests are readily available, and further work is needed to assess their impact. (+info)
The FDA broadens access to lead screening test.
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In September 2006, the Food and Drug Administration expanded the availability of the first simple and portable lead test system to more than 115,000 certified point-of-care locations nationwide, including health care clinics, mobile health units, and schools. This action will make it easier and faster for children and adults to be tested and treated for lead poisoning. (+info)
Contrast enhancement for in vivo visible reflectance imaging of tissue oxygenation.
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Results are presented illustrating a straightforward algorithm to be used for real-time monitoring of oxygenation levels in blood cells and tissue based on the visible spectrum of hemoglobin. Absorbance images obtained from the visible reflection of white light through separate red and blue bandpass filters recorded by monochrome charge-coupled devices (CCDs) are combined to create enhanced images that suggest a quantitative correlation between the degree of oxygenated and deoxygenated hemoglobin in red blood cells. The filter bandpass regions are chosen specifically to mimic the color response of commercial 3-CCD cameras, representative of detectors with which the operating room laparoscopic tower systems are equipped. Adaptation of this filter approach is demonstrated for laparoscopic donor nephrectomies in which images are analyzed in terms of real-time in vivo monitoring of tissue oxygenation. (+info)
A survey of pediatric intensive care services in Turkey.
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The aim of this study was to describe and assess the structure, organization, and staffing of pediatric intensive care services in Turkey. A survey was sent to major university and government hospitals. Out of the 40 hospitals stating to provide pediatric intensive care, 34 responded to the survey (85% response rate). In the majority (81.2%) of hospitals, pediatric intensive care was provided in single room units or within the pediatric ward. Unit size ranged from 1-16 beds with an average of 6.8 +/- 4.2 operational beds per unit. Much of the equipment and a sufficient number of specialists for pediatric intensive care unit (PICU) care were present in the surveyed hospitals. However, only 12 units had a pediatric intensivist on staff and few had special PICU nurses. Many hospitals in Turkey already have various equipment and specialists needed to support pediatric intensive care. Expansion of services and improved care could be achieved if more pediatric intensivists and nurses could be provided and services concentrated in fully equipped tertiary centers. (+info)
Analysis of sleep parameters in patients with obstructive sleep apnea studied in a hospital vs. a hotel-based sleep center.
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BACKGROUND: Polysomnography is associated with changes in sleep architecture called the first-night effect. This effect is believed to result from sleeping in an unusual environment and the technical equipment used to study sleep. Sleep experts hope to decrease this variable by providing a more familiar, comfortable atmosphere for sleep testing through hotel-based sleep centers. In this study, we compared the sleep parameters of patients studied in our hotel-based and hospital-based sleep laboratories. METHODS: We retrospectively reviewed polysomnograms completed in our hotel-based and hospital-based sleep laboratories from August 2003 to July 2005. All patients were undergoing evaluation for obstructive sleep apnea. Hospital-based patients were matched for age and apnea-hypopnea index with hotel-based patients. We compared the sleep architecture changes associated with the first-night effect in the two groups. The associated conditions and symptoms listed on the polysomnography referral forms are also compared. RESULTS: No significant differences were detected between the two groups in sleep onset latency, sleep efficiency, REM sleep latency, total amount of slow wave sleep (NREM stages 3 and 4), arousal index, and total stage 1 sleep. CONCLUSIONS: This pilot study failed to show a difference in sleep parameters associated with the first-night effect in patients undergoing sleep studies in our hotel and hospital-based sleep laboratories. Future studies need to compare the first-night effect in different sleep disorders, preferably in multi-night recordings. (+info)
The bone diagnostic instrument II: indentation distance increase.
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