Urine Collection System Approved
Preferred Medical Devices (Boca Raton, Fla.) has received FDA approval for its new UrAssist urine collection/containment system for men and women, which is designed to give patients the ability to urinate without getting out of bed. There are no bedpans or pads, so slip-and-fall accidents are avoided. The automated system is lightweight and portable, operated by a rechargeable battery (good for about 300 hours), and easily attaches to any standard institutional bed.
According to the company, UrAssist may reduce the risk of a urinary tract infection by decreasing reliance on catheterization.
UrAssist's fluid pump technology gently drains the cup into a collection bag, eliminating odor, leakage, and possible spills. Once finished, the pump will automatically shut off.
Urine is collected and stored in the collection bag. Visual and audible alerts indicate when the collection bag is nearly full. Alerts can be silenced with a push of a button and the bag can be easily emptied in less than 30 seconds.
Collagen Wound Dressing Approved
Pegasus Biologics's (Irvine, Calif.) Unite Biomatrix wound dressing has been cleared by the FDA for the local management of moderate to heavy exuding wounds, including partial and full-thickness wounds, draining wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, and surgical wounds.
The dressing is a biocompatible, highly organized type 1 collagen matrix. It is stable, strong, thin and conformable, easy to store, and available in prefenestrated sizes up to 9 cm x 9 cm. It also has a convenient 2-year room-temperature shelf life. The product passes stringent sterility testing.
Studies suggest that the product forms a biologic scaffold that is resistant to enzymes, allowing controlled biodegradation and subsequent remodeling in the patient.
Updated Alert on Fake Blood Glucose Strips
The FDA has provided an update to earlier notifications regarding counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc.'s One Touch blood glucose monitors. The update includes an additional lot number that is being distributed and advice on how to identify the lot.
Counterfeit test strips could potentially give incorrect blood glucose values that might result in a patient taking too much or too little insulin and lead to serious injury or death.
The counterfeit test strips are:
One Touch Basic/Profile lot 272894A, 2619932, 2606340, 2615211, and 227078A (new lot) test strips, and One Touch Ultra lot 2691191 and 2691261 test strips.
For complete information on how to identify the test strips, visit http://www.lifescan.com/company/about/press/counterfeit.
New Memory Pen Records Insulin Dose and Time
Eli Lilly (Indianapolis, Ind.) launched its prescription HumaPen Memoir/Luxura HD insulin pen with digital memory capability for use with the company's insulin lispro injection [rDNA origin] 3.0-mL cartridges (Humalog). The device is intended to simplify daily management of diabetes for people who take several injections of mealtime insulin each day.
The pen features a consumer-friendly "push to know" digital display that lets patients record and review the last 16 insulin doses, including the priming doses.
A smaller version of the pen (HumaPen Luxura HD) is also expected to be available by prescription. The reusable device allows delivery of 1 to 30 units of insulin lispro in half-unit increments and can be useful to children and other patients who do not use large amounts of insulin.