Remote Monitoring Systems Eyed as Postmarket Surveillance and Recall Management Tool.  In addition to improved medical management, remote monitoring systems such an implantable defibrillators and pacemakers have a potential role to play in postmarket surveillance and recall management.  FDA has proposed an integrated nationwide safety network, the Sentinel Network, to aggregate data from individual manufacturers' remote monitoring networks to improve agency surveillance and identification of potential device problems earlier.  Additional information is available at www.thegraysheet.com (a subscription service).   

 

CMS Proposes to Extend National Non-Coverage to All Artificial Lumbar Discs.  Unlike the agency's original decision which was limited to Johnson & Johnson/Depuy's Charite lumbar disc, CMS' proposal would cover all current and future artificial lumbar discs for patients older than 60 years of age.  Local Medicare carriers would be left to decide coverage for the younger patients who qualify for Medicare due to disability.  The proposal is available at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=197.  Additional information is available at www.thegraysheet.com (a subscription service).   

 

Device Industry Reacts to Provisions in Patent Reform Act that May Hinder Innovation.  The legislation includes limitations on damages, a new avenue for patents to be challenged, and a change in the way in which infringement penalties are calculated from value based on what the patent added to the overall value of the product, to value based on the isolated patent itself, irrespective of the overall value of the product.  For the medical device industry in particular, this apportionment provision appears to be at odds with the iterative process inherent in medical device development.  Additional information is available at www.thegraysheet.com (a subscription service).  

 

Complete MoisturePlus Multi Purpose Contact Lense Solution Subject of Voluntary Recall.  The manufacturer, Advanced Medical Optics, recalled the product due to reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite, identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).  Additional information can be found at http://www.fda.gov/cdrh/safety/053107-acanthamoeba.html.