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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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ASA FEATURED PRODUCT

Self-Education and Evaluation (SEE) Program

SKU: 30701-12CE

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Single Copies, Member Price: $300

Congress Fails to Act - SGR Cuts Effective June 1st

Tuesday, June 01, 2010

As a result of Congress’ failure to act, a 21 percent Medicare payment cut is in effect for services provided on or after June 1. CMS is instructing its contractors to hold claims containing services paid under the Medicare Physician Fee Schedule for the first 10 business days of June as a means of temporarily protecting physicians from the payment cuts. Following the Memorial Day Congressional recess May 31-June 8, U.S. House and Senate negotiators are expected to revisit legislative options to avert the implementation of the payment cuts.

Prior to the Memorial Day recess, the House of Representatives passed legislation that would provide a 2.2 percent increase in Medicare payments through 2010, and a 1 percent increase in 2011. The U.S. Senate did not act on the House legislation. It is unclear whether the Senate will consider this or another SGR “fix” following the recess.

ASA supports Congressional action to fully repeal the current SGR formula and implement a new Medicare physician payment update mechanism that accurately reflects the increasing annual costs of providing services to Medicare beneficiaries.

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