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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

New Jersey Supreme Court Unanimously Upholds Office-Based Surgery Regulations

Chicago — (July 5, 2005) 

The New Jersey Supreme Court affirmed the Appellate Division's decision and held that the office-based surgery regulations challenged by the New Jersey Association of Nurse Anesthetists were within the Board of Medical Examiners' delegated authority. The Court agreed with the Appellate Division's holding that the administration of anesthesia is the practice of medicine and that the regulations fall squarely within the Board's core jurisdiction, the licensing and qualifications of physicians, and how they perform their professional services. It also agreed that while the regulations have an indirect impact on the CRNAs' profession, the BME is not regulating the nursing profession, but rather the physicians who offer anesthesia in an office setting.

Recognizing the unique nature of the office setting, the Court held that the "wealth of testimony adduced at the public hearings on the regulations supported the need for enhanced education and oversight." This decision upheld the requirement that a qualified physician must supervise a nurse anesthetist who administers and monitors general or regional anesthesia. The regulations specify how many hours of continuing medical education in anesthesia the supervising physician must have completed. Lastly, the Court recognized the value of having an anesthesiologist involved in the delivery of anesthesia care. It is "fundamentally reasonable that additional education and training would enable anesthesiologists administering or overseeing anesthesia to better protect patients and to respond when complications occur."

New Jersey Association of Nurse Anesthetists, Inc. vs. New Jersey State Board of Medical Examiners

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