>

MEETINGS / EVENTS

RSS

May 05 - 07 2014, 12:00 AM - 12:00 AM

2014 ASA Legislative Conference

>

FDA MEDWATCH ALERTS

April 18, 2014

FDA MedWatch - ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall

Summary:

FDA MedWatch Class I Recall 4 18 14

March 28, 2014

FDA Update on the Shortage of Normal Saline

Summary:

FDA Update on the Shortage of Normal Saline

March 18, 2014

FDA MedWatch - Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

Summary:

Merit Medical Systems Custom Procedural Trays Kits Recall Particulates Found in Hospira Lidocaine

>

ASA FEATURED PRODUCT

Add this product to your shopping cart

Anesthesiology Continuing Education (ACE) Program

SKU: 30702-14CE

... Read more »

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.

« Back to Washington Alerts