Pouchless ostomy management system approved
ConvaTec (Skillman, NJ) Vitala nonintrusive ostomy continence control device has been approved for people with an end colostomy. The Vitala continence control device allows individuals to manage their colostomy without a pouch, belt, or irrigation. Indicated for up to 8 hours, the single-use, disposable disk is worn together with the ConvaTec Natural skin barrier (1 to 3/4" or 2 to 1/4").
The device functions by sealing against the stoma to prevent release of stool while permitting gases to vent through an integrated, deodorizing filter. When in use, stool is stored inside the body, negating the need to wear an ostomy pouch. The product's design eliminates the need for a pouch for an extended period of time each day and minimizes the noise and odors that sometimes accompany pouch use. The Vitala's low profile also helps make the presence of an ostomy less noticeable.
The Vitala is easy to apply and remove, and contains a built-in expandable container to prevent soiling and odor during removal. Vitala is also waterproof.
User-controlled passive needle retraction speed
Unilife Corporation (Lewisberry, Pa.) received FDA approval for the Unitract 1-mL insulin syringe. The syringe is the first and only one of its kind to allow operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe, where it is locked in place. The products can help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needle-stick injuries, aerosol dispersal, and syringe reuse.
New test detects H1NI 2009 and Influenza A
Quest Diagnostics Incorporated announced that the FDA has issued 510(k) clearance to the Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler. The test had already received the CE mark in Europe last fall.
The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is the first to be cleared by the FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA. All other molecular tests for H1N1 flu had been approved under the FDA's emergency use authorization program, which ended in June 2010.
The test uses real-time reverse transcription PCR to qualitatively detect RNA of the virus in a patient's nasal or nasopharyngeal specimens. Results show whether the individual is positive or negative for the presence of 2009 H1N1 or influenza A virus.
Faster protocol reduces PNA FISH turnaround time
AdvanDx (Woburn, Mass.) has received FDA clearance for its fast, 90-minute protocol for Candida albicans PNA FISH and C albicans/C glabrata PNA FISH tests direct from positive blood cultures. The faster protocol reduces the PNA FISH turnaround time from 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes. The faster test has been shown in clinical tests to maintain the very high sensitivity and specificity of the slower, conventional methods.
With the introduction of the faster test, clinicians can further improve antifungal selection, care, and outcomes for patients with candidemia. A study performed at the University of Maryland Medical Center demonstrated that PNA FISH improved time to species identification by 35 to 52 hours. The faster results enabled clinicians to provide optimal antifungal therapy earlier and helped reduce antifungal costs by $1,800 per patient, all without adversely affecting patient outcomes.