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...

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