ASA Launches Response to FDA’s Approval of SEDASYS Sedation System

The American Society of Anesthesiologists is launching a three-pronged response to the FDA’s premarket approval of the SEDASYS computer-assisted sedation system by Johnson & Johnson.

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ASA forms ad hoc committee to repsond to FDA's approval of SEDASYSThe SEDASYS is designed to provide intravenous administration of propofol for patients during a colonoscopy or EGD procedure. The system would not require an anesthesiologist to administer the sedative.

ASA has established an ad hoc committee, chaired by Rebecca Twersky, MD, to review the FDA’s restrictions for use. Then the organization’s CEO and chief advocacy officer will meet with J&J representatives regarding supervision, training and post-market studies. Finally, ASA will attempt to work more closely with the FDA’s Center for Device and Radiological Health for future devices.

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