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.
The 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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The 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.
More Articles on Anesthesia:
Masimo Releases Clinical Studies at International Anesthesia Research Society Meeting
Physician Office Partners Develops Anesthesia Billing Solution
FDA: Drugs From The Compounding Shop May Be Contaminated