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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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Self-Education and Evaluation (SEE) Program

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CMS Releases New Outpatient Measures for the Hospital Compare Website

Friday, July 09, 2010

On July 7, the Centers for Medicare and Medicaid Services (CMS) released a new outpatient surgical measure applicable to anesthesiologists to be added to its Hospital Compare website. The measure is called “Antibiotic Timing” and is described by CMS as “Percentage of outpatients having surgery who were given the right kind of antibiotic at the right time (within one hour before surgery) to help prevent infection of surgical wounds.” This measure is already in place for inpatient data and will be used in conjunction to obtain a more comprehensive view of the quality of care being provided in hospitals.

Please visit the links below to access press releases by HHS and CMS regarding these new measures.

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