Articles  |   November 2013
ASA Responds to Premarket Approval for SEDASYS®
Author Affiliations
  • Jeffrey L. Apfelbaum, M.D.
    Ad Hoc Committee on SEDASYS®
  • Rebecca S. Twersky, M.D., M.P.H.
    Section on Professional Standards
Article Information
Ambulatory Anesthesia / Gastrointestinal and Hepatic Systems / Pharmacology / Technology / Equipment / Monitoring / Articles
Articles   |   November 2013
ASA Responds to Premarket Approval for SEDASYS®
ASA Monitor 11 2013, Vol.77, 36.
ASA Monitor 11 2013, Vol.77, 36.
On May 3, 2013, Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson (J&J), announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for the SEDASYS® system, a computer-assisted, personalized sedation (CAPS) machine indicated to deliver propofol during colonoscopies and other procedures for ASA Physical Status I and II patients. In response to the FDA’s premarket approval, ASA developed a three-pronged strategy in response to the FDA’s approval of the device.
First, ASA established an Ad HocCommittee on SEDASYS®. The committee consists of representatives from the committees on Equipment and Facilities; Standards and Practice Parameters; Practice Management; and Quality Management and Departmental Administration, as well as key ASA staff. The committee’s first priority was to determine whether the FDA addressed ASA’s concerns and recommendations in regard to the device. After determining this was the case, our next priority has been focused on leading efforts to enhance the safety of the system.
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