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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

Anesthesia Fast Facts

» Anesthesiology is the practice of medicine dedicated to the relief of pain and total care of the surgical patient before, during and after surgery.

» The American Society of Anesthesiologists (ASA) is an education and professional association of approximately 46,000 physicians. Its purpose is to raise the standards of medical practice by fostering and encouraging education, research and scientific progress in the specialty and to improve the care of the anesthetized patient.

» More than 90 percent of all practicing anesthesiologists in the United States belong to ASA, making it the preeminent voice of the specialty.

» An estimated 40 million anesthetics are administered each year in this country. Anesthesiologists provide or participate in more than 90 percent of these anesthetics.

» In 1985, the Anesthesia Patient Safety Foundation was created to raise the levels of consciousness and knowledge of patient safety issues.

» In early 1986, ASA was the first medical specialty to adopt standards of care for its members. Today more than 30 standards, guidelines and statements developed by the society address standards for the care of patients before, during and after surgery.

» Complications from anesthesia have declined dramatically over the last 50 years. Since the 1970s, the number of anesthesiologists has more than doubled and at the same time patient outcomes have improved. While perioperative deaths attributed to anesthesia were approximately 1 in 1,500 some fifty years ago, today that number has improved nearly ten fold; that’s a dramatic increase in patient safety despite older and sicker patients being treated in operating rooms nationwide. At present, the chances of a healthy patient suffering an intraoperative death attributable to anesthesia is less than 1 in 200,000 when an anesthesiologist is involved in patient care.

» As physicians, anesthesiologists are responsible for administering anesthesia to relieve pain and for managing vital life functions during surgery. After surgery, they maintain the patient in a comfortable state during the recovery, and are involved in the provision of critical care medicine in the intensive care unit. Anesthesiologists' responsibilities to patients include: Preanesthetic evaluation and treatment; Medical management of patients and their anesthetic procedures; Postanesthetic evaluation and treatment; On-site medical direction of any non-physician who assists in the technical aspects of anesthesia care to the patient.

» The role of the anesthesiologist in the operating room is to: provide continual medical assessment of the patient; monitor and control the patient's vital life functions -- heart rate and rhythm, breathing, blood pressure, body temperature and body fluid balance; and control the patient's pain and level of unconsciousness to make conditions ideal for a safe and successful surgery.

» There are three places where anesthesia is administered for surgery: a hospital or medical center, an ambulatory surgical center or a doctor's office.