FDA Update: FDA Rejects ‘Sedasys’ Sedation System

Stanford R. Plavin MD
PCC Board Vice-Chair
President and Managing Partner, Ambulatory Anesthesia of Atlanta

The U.S. Food and Drug Administration (FDA) recently rejected an application that would have approved ‘Sedasys’ a computer-assisted sedation system that was developed by Ethicon-Endo, a division of Johnson&Johnson (J&J). The device is designed to have a nurse or non-anesthesia personnel teams oversee the delivery of propofol.

A number of concerns were expressed during an FDA hearing last year about the efficacy of the Sedasys Sedation System without trained and certified anesthesia personnel present such as a physician anesthesiologist or certified registered nurse anesthesiologist (CRNA). Many organizations including Preventing Colorectal Cancer.Org, American Society of Anesthesiologists (ASA), Safe Sedation, and the American Association of Nurse Anesthetists (AANA) raised similar concerns at the FDA hearing in May 2009. The Sedasys “computer assisted personalized sedation system” (CAPS) raised serious safety concerns because it could have allowed propofol to be dispensed by physician/nurse teams without appropriate training and certification in the delivery of anesthetics and airway management expertise.

After the initial testimonies were heard, the FDA Anesthesiology and Respiratory Therapy Devices Advisory Panel voted in favor of approval by an 8-2 vote. The approval had numerous stipulations attached to it and ultimately would be heard at a higher level of the FDA.

Propofol is a powerful anesthetic with usage instructions/labeling that states it “should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical or diagnostic procedure.” This restriction has withstood repeated attempts on the part of some to lower the bar and allow non-Anesthesiologists and non-CRNAs to dispense this powerful drug without sufficient training in air way management and life support techniques.

The CAPS application submitted by Johnson & Johnson bypassed this requirement that an Anesthesiologist or CRNA be present for sedation. They argued that the computer could precisely measure the vital signs better than a human, and would therefore be an improvement. In PCC.Org arguments against the application, the following statement was included:

The bottom line is that, no matter how precise of a control is exercised over sedation depth, in a large patient series, there will be incidences in which unintended deep sedation or general anesthesia is reached. This occurs not infrequently under the supervision of an anesthesiologist, but with their advanced airway skills, the patient is ‘rescued’. If the personnel who are administering propofol do not possess the necessary airway management skills, the outcome could be catastrophic.¹

It appears that after a year of studying the application, the FDA Advisory Board agreed with the labeling of the drug. An appeal from J&J is likely and updates on the topic will be posted on the PCC website.

1. Irvani M: On computers, nurses, and propofol: further evidence for the jury. Gastrointestinal Endoscopy 2008; 68:510-512