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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

Senate HELP Committee Approves Health Reform Bill

Chicago — (July 15, 2009) 

Yesterday the Senate Health, Education, Labor and Pensions (HELP) Committee approved its health reform bill on a 13-10 party-line vote. The bill must now be merged with whatever version emerges from the Senate Finance Committee before floor consideration in the chamber.

Please note that the Senate HELP bill is a different version of health care reform legislation than what was recently introduced in the House, H.R. 3200. The HELP bill includes a public plan option with negotiated rates, whereas H.R. 3200 includes a public plan option based on Medicare payment rates. ASA maintains its strong opposition to a public plan tied to Medicare payment rates.

The following is a statement from ASA President Roger A. Moore, M.D., regarding the Senate HELP bill:

“It is a step in the right direction that the HELP Committee bill includes a public plan option that would allow negotiations with the Secretary of HHS, rather than basing payments on Medicare rates. However, the final provision remains influx since the HELP committee does not have jurisdiction over Medicare matters.

“The legislation approved by the HELP committee is one piece of the increasingly complex debate on health care reform. We are eagerly anticipating the release of a bill from the Senate Finance Committee, the other Senate committee with jurisdiction over health care. We are hopeful that the Senate Finance Committee draft will not include a public plan option based on Medicare’s unsustainably low payment rates, or require mandatory physician participation.

“Anesthesiologists face a Medicare “33 percent problem”: Medicare pays 33 percent of what private insurers pay for anesthesia services. This simply does not reflect the costs of providing anesthesiology medical care. (Meanwhile, Medicare pays an average of 80 percent of what private insurers pay for most other medical specialties.)

“Congress has a tremendous opportunity to strengthen our health care system and help America’s patients by improving health insurance coverage and delivery. However, they must not do so at the expense of physicians, who provide unparalleled leadership and expertise in the care of patients.”

Summary of HELP Committee bill

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