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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

... Read more »

Single Copies, Member Price: $300

ASA Submits Comments to CMS Regarding Transition to Version 5010 and ICD-10

Chicago — (October 15, 2008) 

ASA has submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the transition to version 5010 and ICD-10. A rushed implantation of these new systems would create administrative and technical burdens for physicians and practice managers.

Version 5010

The Department of Health and Human Services (HHS) has proposed that version 5010 allow only the reporting of minutes for anesthesia time, rather than anesthesia units. If implemented, this policy would result in significant disruptions for providers who must submit claims to Medicare using anesthesia units, but must use minutes when submitting claims to private payers.

ASA comments regarding version 5010

ICD-10

ASA acknowledges that a transition to ICD-10 will offer many benefits and enhancements to health care reporting and tracking. However, the short timeframe proposed by CMS will place enormous burdens on a system that already faces tremendous challenges.

ASA comments regarding ICD-10 

THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS

Anesthesiologists: Physicians providing the lifeline of modern medicine. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with 46,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.

For more information on the field of anesthesiology, visit the American Society of Anesthesiologists Web site at www.asahq.org. For patient information, visit LifeLineToModernMedicine.com

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Contact:

Jennifer Gremmels
j.gremmels@asahq.org
847-268-9128