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FDA MEDWATCH ALERTS

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January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Summary:

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm.  Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

January 12, 2012

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Summary:

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Summary:

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

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U.S. Senate passes H.R. 4213, potentially extending Medicare physician payment freeze

Wednesday, March 10, 2010

Earlier today, the Senate passed H.R. 4213 which, among other provisions, would extend the current freeze to the Medicare Sustainable Growth Rate (SGR) formula through September 30, 2010.  The bill now moves to the House of Representatives.  If the House passes the bill without significant revision or amendment, the Medicare unadjusted anesthesia conversion factor would stay at the current figure of $21.114, and the Resource Based Relative Value System (RBRVS) conversion factor would remain $36.0846 for services provided through September 30, 2010.

A key consideration at this time is whether the bill can be signed into law before the current SGR freeze ends on March 31, 2010.  ASA will post updates as more information becomes available.

 

 

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