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Fluids & Electrolytes
The FDA has notified healthcare providers of the increased life-threatening risk of bacterial meningitis in cochlear implant recipients and the importance of fully immunizing these patients. The agency noted that although all children with implants are at increased risk of bacterial meningitis, those with implants containing a positioner are at greatest risk. The only cochlear implant with a positioner was withdrawn from the market in 2002.
Two deaths from meningitis were reported in 2007 in children with cochlear implants with positioners. Neither child was fully immunized. According to the FDA, studies suggest that cochlear implant patients are not receiving vital preventive care that can reduce their risk of this life-threatening illness.
Cytomedix, Inc.'s platelet-rich plasma preparation system, AutoloGel, is now approved for point-of-care treatment of exuding wounds such as pressure ulcers, diabetic ulcers, or mechanically or surgically debrided wounds. According to Cytomedix, the product is the only autologous platelet gel therapy with FDA clearance for a broad indication that includes various types of chronic wounds.
AutoloGel is made from an individual patient's blood and concentrates a high number of platelets in a small volume of plasma.
The system consists of a tabletop centrifuge and a wound-dressing convenience kit that contains blood access and processing devices and reagents. The patient's blood is separated into components through centrifugation to derive liquid platelet-rich plasma, which is mixed with reagents to create a gel consistency.
Verax Biomedical's Platelet Pan Genera Detection has been approved for the detection of bacterial contamination in platelets. According to the company, current culture methods may fail to detect one-half of the contaminated units of platelets transfused each year in the United States.
The new disposable test is a rapid, qualitative immunoassay for detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in leukocyte-reduced apheresis platelets as an adjunct quality-control test. The test offers broad detection, sensitivity, ease of use, small sample size, and built-in procedural controls.
The test consists of a disposable plastic cartridge that can be stored at room temperature, and three dropper bottle sample pretreatment reagents. Within 20 minutes of sample addition, a pink-colored bar appears in one of the two reading windows on the test cartridge if either Gram-negative or Gram-positive bacteria are detected. Nonreactive samples show no color bar in the read windows.
Nanosphere, Inc. (Northbrook, IL) has received FDA approval to market its new Verigene F5/F2/MTHFR Nucleic Acid Test to detect disease-associated gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate. The test is the first approved test for the identification of mutations in three specific genes that together can increase an individual's risk for dangerous blood clots and stroke. Patients that test positive for an increased risk of blood clots can be managed with anticoagulant therapy.
The test is available in single and multitarget formats, allowing users to select the test cartridge that best fits the clinical indications for testing.
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