>

WEBINARS

RSS
>

MEETINGS / EVENTS

RSS
>

FDA MEDWATCH ALERTS

RSS

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.

>

ASA FEATURED PRODUCT

Self-Education and Evaluation (SEE) Program

SKU: 30701-12CE

... Read more »

Single Copies, Member Price: $300

New CMS Regulation Allows Unlocked Anesthesia Carts in Secure Areas

Chicago — (November 27, 2006) 

A new rule, effective Jan. 26, 2007, permits anesthesia carts to be unlocked as long as they are in a “secure area” such as an operating suite. Anesthesiologists and their hospitals have long been frustrated by a federal regulation, enforced by JCAHO, requiring anesthesia carts to be locked between cases whenever “authorized personnel” are not present in the room.

ASA has worked hard for several years to persuade CMS to recognize that locked carts create danger for patients when access to critical medications is barred, and that they do not protect against any real danger. In March 2005, ASA wrote a comment letter to CMS strongly supporting a proposed new regulation that would allow anesthesia carts to remain unlocked. Many ASA members submitted their own letters as well.

We are very pleased that CMS’ revised regulation, published in the Nov. 27, 2006 Federal Register, includes the changes we sought and will permit anesthesia drugs and reversal agents to remain in unlocked anesthesia carts in secure areas, including staffed ORs, critical care units and labor and delivery suites.

The CMS rewrite of the regulation removes a serious patient safety risk. Requiring locked anesthesia carts could potentially cost precious seconds—or more—when anesthesiologists must treat their patients in emergency situations.

The final rule does not affect Schedule II, III, IV and V drugs, which must still be kept in locked storage areas, also as urged by ASA.

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

###

Contact:

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