Update on ASA’s three-pronged strategy in response to Premarket Approval for SEDASYS®
On May 3, 2013, Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson (J&J), announced that the Food and Drug Administration (FDA) granted Premarket Approval for the SEDASYS® system, a computer-assisted personalized sedation system. SEDASYS® is expected to be introduced on a limited basis beginning in 2014. ASA issued a bulletin to members on May 6. Public information on the Premarket Approval of SEDASYS® is available on the FDA’s website.
Since the May 3 announcement, ASA members have communicated their questions and concerns about SEDASYS®. As such, we have established a process so members can provide input to ASA regarding the device, which can be sent directly to SEDASYS@asahq.org.
Below is an update to ASA’s three-pronged strategy on SEDASYS®.
- ASA established an Ad Hoc Committee on SEDASYS® chaired by Rebecca Twersky, M.D., Chair, Section on Professional Standards. The Ad Hoc Committee consists of representatives of 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 initial priority of the Ad Hoc Committee was to determine whether the FDA addressed ASA’s concerns and recommendations raised in our previous formal communications to the FDA. However, this priority has evolved as the Ad Hoc Committee recognized that the FDA addressed the majority of ASA’s concerns and that ASA’s priority should be to lead efforts to enhance the safety of the device. The Ad Hoc Committee collaborated with the Anesthesia Quality Institute (AQI) to develop Quality Metrics for Procedural Sedation. Ad Hoc Committee members are currently developing guidance on SEDASYS® for members, and particularly the Directors of Anesthesia Services. This guidance will provide recommendations on specific clinical and administrative issues that Directors of Anesthesia Services and practicing physician anesthesiologists should discuss with Gastroenterology Services in order to integrate the device into practice in the safest and most efficient fashion. Once completed, this guidance will be posted on ASA’s website.
- ASA is developing a relationship with J&J that will allow us to work together to safely and efficiently integrate SEDASYS® into practice. ASA and J&J have had multiple conversations about the safety of the device and how it will be introduced into the clinical setting. On August 19, Ad Hoc Committee members, ASA’s Executive Committee, CEO Paul Pomerantz, and key ASA staff attended the first in-person meeting with J&J at their headquarters in Cincinnati, Ohio. Participants viewed and interacted with the SEDASYS® system and discussed specific issues the Ad Hoc Committee will address in the guidance to ASA members. A series of calls will follow this meeting to ensure all ASA questions are addressed.
- ASA met with key officials from the FDA’s Center for Devices and Radiological Health (CDRH) to discuss ASA’s questions and explore an enhanced role for ASA with the FDA relative to this device and other future devices. ASA will be joining FDA’s Network of Experts, which will provide CDRH staff rapid access to physician anesthesiologists’ expertise when it is needed to supplement existing knowledge within CDRH.
ASA will update members on progress and new developments as they occur.