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 committeeconsists 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.
Committee members released recommendations on SEDASYS® use, particularly for directors of anesthesia services, at last month’s annual meeting. ASA members have an oppor-tunity to provide comments on the recommendations at email@example.com. The guidance will provide recom-mendations on specific clinical and administrative issues that physician anesthesiologists should discuss with gastroenterology services in order to integrate the device into the clinical setting in the safest and most efficient manner. The final guidance document will be available on the ASA website in the beginning of 2014.
In addition, ASA is currently cultivating a relationship with J&J to safely integrate SEDASYS® into practice. On August 19, 2013, members of the Ad Hoc Committee on SEDASYS®, the ASA Executive Committee, ASA CEO Paul Pomerantz and other ASA staff attended the first in-person meeting with J&J at its headquarters in Cincinnati. Participants had the opportunity to interact with the system. We are continuing to hold a series of calls with J&J to ensure all of ASA’s questions are addressed.
ASA also met with key officials from the FDA’s Center for Devices and Radiological Health (CDRH) to explore an enhanced role for ASA with the FDA relative to SEDASYS® and other future CAPS devices. ASA plans to join the FDA’s Network of Experts, which will provide CDRH staff with rapid access to physician anesthesiologists’ expertise.
SEDASYS® is expected to be introduced on a limited basis beginning in 2014.
The Ad Hoc Committee on SEDASYS® welcomes your questions and concerns about the device. Please contact us directly at firstname.lastname@example.org.
Jeffrey L. Apfelbaum, M.D. is Professor and Chair, Department of Anesthesia and Critical Care, University of Chicago, Pritzker School of Medicine.
Rebecca S. Twersky, M.D., M.P.H. is Professor of Clinical Anesthesia and Vice Chair for Research, Department of Anesthesiology, and Medical Director, Ambulatory Surgery Unit, SUNY Downstate Medical Center, Brooklyn, New York.