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MEETINGS / EVENTS

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January 23 - 25 2015, 12:00 AM - 12:00 AM

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit

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FDA MEDWATCH ALERTS

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

Summary:

FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Intravia Containers by Baxter Recall

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

Summary:

FDA Medwatch Alert 10-20-14

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ASA FEATURED PRODUCT

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Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

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Single Copies, Member Price: $360

FDA Grants Premarket Approval for SEDASYS (R)

Tuesday, May 07, 2013

On May 3, 2013, Ethicon Endo-Surgery, Inc. announced that the Food and Drug Administration (FDA) granted Premarket Approval for the SEDASYS® system, a computer-assisted personalized sedation system.  SEDASYS® is indicated "for the intravenous administration of 1 percent (10 milligrams/milliliters) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as identified by the American Society of Anesthesiologists Continuum of Depth of Sedation, in adult patients (American Society of Anesthesiologists physical status I or II) undergoing colonoscopy and esophagoduodenoscopy procedures."  News reports indicate that SEDASYS® is expected to be introduced on a limited basis beginning in 2014.

ASA provided formal written and oral comments in 2009 to the FDA Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee regarding the SEDASYS® system in which concerns were expressed regarding the patient safety implications of the device. Public information related to the Premarket Approval is currently under review by ASA and will be made available as soon as the review is completed.

Learn more about the FDA’s premarket approval process.

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