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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

Medmarx Data Report Analyzes Medication Errors Affecting Surgical Patients

Chicago — (March 7, 2007) 

ASA is sharing with its members information about the latest MEDMARX® report, released March 6, 2007 by U.S. Pharmacopeia. It looks at medication errors reported from 1998-2005 in the perioperative setting. The report makes several recommendations for improving patient safety, including some already being undertaken by ASA. Information about the report may be viewed at www.usp.org. Members may view an Executive Summary under Member News in the ASA Members Only Section. Find out how to order the full report.

Anesthesiologists are specifically mentioned in the report as having made great strides in improving patient safety for many decades. “ASA continues to be involved in many activities--including education, research and promulgation of guidelines and standards— always with the goal of advancing patient safety,” said ASA president Mark J. Lema, M.D., PhD.

Most recently ASA has been working as a leader with other medical and clinical organizations through such groups as the Surgical Care Improvement Project and the AMA Physician Consortium for Performance Improvement. One of the items already being addressed is that of the timing of antibiotic administration, which is mentioned in the MEDMARX® report recommendations.

The report contains data on 221,000 medication errors from 590 facilities and takes a closer look at 11,000 errors with breakdowns according to type of error, setting (i.e., pre-op or O.R.). It breaks down 1,799 cases according to staff responsible. Only about 3 percent of the errors were attributable to anesthesia providers. Many of the errors did not actually affect the patient, and others were caught in time to prevent serious harm. Of the 221,000 errors reported, 17 resulted in death.

ASA is committed to continuing to work in a teamwork environment with other health care providers to ensure optimal care of our patients. According to Dr. Lema, “As the perioperative physicians who care for patients before, during and after surgery, we will take the new data and recommendations into full consideration for future actions related to medication error prevention.”

ASA member Peter Pronovost, M.D, PhD, medical director of the Center for Innovations in Quality Patient Care, The Johns Hopkins University School of Medicine, was one of the experts who helped to prepare the MEDMARX report.

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