A Video News Show for Health Professionals. New broadcasts monthly, with online video and transcripts. http://www.fda.gov/psn/ en-us Mon, 01 Feb 2010 05:00:00 GMT psnews@cdrh.fda.gov http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/rsslogo.gif http://www.fda.gov/psn/ FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or a... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#1 GlaxoSmithKline is notifying healthcare professionals that Lexiva (fosamprenavir calcium), a protease inhibitor, has been associated with an increased risk of myocardial infarction and dyslipidemia in HIV infected adults. The company's letter recomm... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#2 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#2 Update 02/02/10: FDA is extending to 18 months the total recommended time period for transitioning from Steris Corporation?s modified System 1 processor (SS1) to legally-marketed alternative devices. See "Additional Information" link below. FDA ha... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#3 FDA is notifying healthcare professionals about chondrolysis in patients receiving continuous intra-articular infusion of local anesthetics to treat post-surgical pain. FDA has received a number of reports of cartilage necrosis and destruction in th... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#4 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#4 In September, the device company Synthes USA recalled the Synex II Vertebral Body Replacement device, a titanium implant used to replace an unstable or damaged vertebral body in the T1 to L5 portion of the spine. The devices were recalled after ... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#5 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#5 Sanofi-Aventis is notifying healthcare professionals about updated safety information for the antidepressant Norpramin (desipramine hydrochloride). The section on overdosage now notes that overdoses of this drug have resulted in a higher death rate ... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#6 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#6 The FDA, the CDC and the Department of Veterans Affairs have issued a joint safety communication cautioning healthcare facilities about the risks to patients if endoscopes and their accessories are not processed properly between patients. The commun... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#7 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#7 The Institute for Safe Medication Practices (ISMP) has reported medication errors due to name confusion between Kapidex (dexlansoprazole) and Casodex (bicalutamide). Kapidex is used to treat erosive esophagitis and gastroesophageal reflux disease. ... Mon, 01 Feb 2010 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#8 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#8