Pharmacy & Therapeutics - October 2008 - (Page 573)

NEW DRUGS management and repor t-generation servers. This wireless link also enables new modules to be introduced in the future. Enhancements have been made to the company’s neurophysiological analysis software, which is included in Advance devices. Sources: www.pharmacyonesource. com; www.neurometroix.com Name: InfraReDx LipiScan NearInfrared (NIR) Catheter Imaging System Manufacturer: InfraReDx Inc., Burlington, Mass. Approval Date: April 29, 2008 Use Classification: The imaging system enables the physician to determine the fat content of the plaque buildup on the wall of the coronary arteries. Description: Infrared imaging is used to detect lipid core-containing plaques of interest and to assess the lipid core burden index in the coronary arteries. A catheter equipped with a fiber-optic laser light is placed into the ar ter y. Nearinfrared light is delivered through the blood to the artery wall, and the light that is reflected back from the artery wall is measured by spectroscopy. The reflected wavelengths vary according to how much fat and other substances are in the plaque in the illuminated portion of the arterial wall. Purpose: With this imaging system, arterial plaques that are prone to rupture can be identified before they cause a heart attack. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots. Benefit: This is the first device that can assess the chemical composition of coronary artery plaques and that can identify plaques with lipid cores. Sources: FDA, www.fda.gov; www. infraredx.com Name Xtrac Velocity Excimer Laser Manufacturer: PhotoMedex, Inc., DRUG NEWS batteries discharged rapidly and produced intense heat and flammable gases. Pressure that built up inside the battery pack resulted in an explosion. Even though no serious injury or damage resulted, patients and staff are at risk any time sparks, arcs, and explosions occur. The cable might have been cut to separate the battery pack for two reasons: staff members are usually told to dispose of batteries in hazardous waste receptacles, and they often take batteries home for personal use. The FDA has received several reports of sparks and smoke occurring after battery pack cables have been cut. To avoid the risk of fires, toxic fumes, and explosions, staff members should read the device manufacturer’s labeling and pay attention to warnings; to place a copy of the labeling on each device; and to avoid removing used batteries or other used items from patient-care settings for their personal use—a practice that is inconsistent with infection-control guidelines. Sources: Nurs Center J 2008;38:13–14; FDA, September 4, 2008, www.fda.gov Expanded Classification: Vertebral Body Replacement The FDA has expanded Titan Spine’s Endoskeleton Vertebral Body Replacement Device 510k to include an indication for an Interbody Fusion Device. Under the new indication, the fusion device is approved for use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2 to S1 who may also have up to grade 1 spondylolisthesis or retro listhesis at the involved level. Patients should have received six months of nonoperative treatment before they are treated with the device. Supplemental fixation may be used. Sources: www.pharmacyonesource. com; Titan spine, July 31, 2008, www.titan spine.com I Montgomeryville, Pa. Approval Date: May 13, 2008 Use Classification: This laser system is more powerful and faster than its predecessor, the Xtrac Ultra, for treating psoriasis, vitiligo, atopic dermatitis, and leukoderma. Description: The new system delivers the highest ultraviolet power of any medical excimer laser available to treat skin conditions. Purpose: The laser can be used to treat moderate-to-severe psoriasis comprising less than 20% body area for which narrow-band ultraviolet B light or psoralen and ultraviolet A light (PUVA) is indicated. Benefit: This system is up to three times faster per treatment than its predecessor. It offers an alternative to costly psoriasis biologic therapies, systemic agents, and PUVA, and potential systemic adverse effects are avoided. The fast laser speed decreases the treatment time for patients and the health care staff. Sources: www.pharmacyonesource. com; www.bioopticsworld.com; www. photomedix.com Safety Problem: Cutting Cable from a Battery-Operated Lavage System A patient with a disposable batteryoperated lavage system under went wound debridement. A staff member separated the battery pack from the device by cutting its cable. The battery pack was placed on a cart, and the rest of the device was discarded. A bit later, the battery pack exploded, spreading ash-like substances throughout the room. Powered by eight to 10 AA (“double A”) alkaline batteries, the lavage system provides pulsed irrigation to remove necrotic or infected tissue and debris from wounds with pressurized irrigating solution. In this case, cutting the battery pack’s cable caused a short circuit. The Vol. 33 No. 10 • October 2008 • P&T® 573 http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://neurometrix.com/ http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.bioopticsworld.com http://www.fda.gov http://www.photomedix.com http://www.photomedix.com http://www.fda.gov http://www.infraredx.com http://www.infraredx.com http://www.pharmacyonesource.com http://www.titanspine.com http://www.pharmacyonesource.com http://www.titanspine.com

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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